王莒生学术思想与临床经验总结及辨血为主论治寻常型银屑病的临床研究
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摘要
1目的
1.1通过临床跟师学习,记录医案,文献复习,总结王莒生老师学术渊源,临床经验,包括常见皮肤病如白癜风、银屑病、湿疹、荨麻疹、干燥综合征、硬皮病、带状疱疹神经痛、瘙痒症及肺系疾病慢性咳嗽的病因病机认识,治疗特点,归纳理法方药。
1.2通过随机、双盲、对照的研究方法,评价基于辨血为主的思路,使用规范化方剂分证论治银屑病的临床疗效,为进一步优化从血论治银屑病的诊疗方案提供参考；为制订临床实践指南提供依据。
2方法
2.1经验总结：通过门诊跟师临证,记录医案,分析医案,查阅古代及现代相关文献,总结老师学术渊源,学术特点,治疗特色。
2.2临床研究：采用前瞻性、随机、双盲、对照的设计。依照临床流行病学的方法及统计学要求计算样本量,三个证型各120例,按2：1比例分为治疗组及对照组,血热证治疗组给予凉血解毒汤内服,血燥证治疗组给予养血解毒汤内服,血瘀证治疗组给予活血解毒汤内服,对照组均给予安慰剂内服,安慰剂的形、色、味与治疗药物相近；治疗组及对照组均外用白凡士林。疗程8周,每2周复诊一次,观察病情变化,记录相关指标,治疗前后分别进行安全性检查及皮损照相。痊愈患者在结束治疗后3月、6月、9月、12月进行随访。根据银屑病临床体征面积和疾病严重程度评分——PAS I评分的变化评价疗效。
统计采用符合方案数据集进行分析,进行基线特征,疗效分析及安全性分析。使用SAS9.1.3统计软件进行分析。
3结果
3.1学术渊源
继承了中医皮肤科泰斗赵炳南老大夫及现代中西医结合皮肤科的奠基者张志礼教授的学术思想及经验,汲取了内科众多名医的经验,形成自己局部辨证与整体辨证相结合的特点。
3.2王莒生老师治疗皮肤病特点
3.2.1突出整体观念,包括人与自然、人与社会的统一,人体自身是个整体,治疗不仅局限于皮肤,还应重视脏腑的调整,心理状态的调整,饮食起居的调护,环境因素的影响等等。
3.2.2突出从肝论治：重视情致因素对皮肤病的影响,重视疏肝解郁,心理辅导。还配合滋补肝肾、清肝泻火、平肝潜阳等。
3.2.3重视从肺论治：肺主一身皮毛,风湿之邪亦犯肺,风湿之邪是导致皮肤病的重要因素。常用疏风宣肺、清泻肺热之法。
3.2.4善用大方重剂：皮肤病多为慢性病,病机复杂,病情顽固,非重剂难以撼动,非大方难以应对复杂病机。
3.3常见皮肤病治疗经验
3.3.1银屑病治疗经验：从血论治与脏腑论治相结合。重视毒、湿在本病的作用。认为本病的诱因与精神因素相关,治疗本病也应突出从肝论治,认为在各个环节均存在肝气郁滞的病机。辨证分型分为血热内蕴,热毒犯肺；血热内蕴,肝火旺盛；血虚风燥,脾胃虚弱；血虚风燥,肝肾阴虚；气血瘀滞,肝气郁结；气血瘀滞,脾失健运等六型分证论治。
3.3.2白癜风治疗经验：认为肝肾亏虚是基础,肝气郁滞、肝火旺盛、肝阳上亢是不同时期、不同个体的表现。从肝论治是特点,包括滋补肝肾、疏肝解郁、清肝泻火、平肝潜阳等。还需配合活血通络、疏风散风之品,善用虫类药物,善用大方、重剂,重视心理辅导。基本方剂为：白蒺藜、桑白皮、白芷、白僵蚕、补骨脂、首乌藤、生侧柏、沙苑子、黑芝麻、桑椹、全虫、防风。临证还需根据具体情况进行加减,根据发布部位可选用引经药物。
3.3.3带状疱疹神经痛治疗经验：认为本病的病机关键为气滞血瘀,但瘀的性质有所不同,临床治疗要理清虚实寒热。根据患者特点,分别给予理气活血,益气活血,温经通络治疗,活血方剂常用活血散瘀汤、大黄蛰虫丸方、血府逐瘀汤,理气方剂常用柴胡疏肝散方,益气方剂常用四君子汤、温经方剂常用当归四逆汤。
3.3.4湿疹治疗经验：认为本病的发生是内外因共同作用的结果。内因为先天禀赋不耐,肝火、脾湿,外因为风、湿、热邪侵袭,与肝火、脾湿相博,发于肌肤而致本病。日久气血亏耗,化燥生风。亦有先天禀赋不足,气血亏虚,无以濡养肌肤,而致血虚风燥,肌肤甲错者。治疗分为三型,湿热蕴肤证,给予龙胆泻肝汤加减；脾虚湿蕴证,给予除湿胃苓汤加减；血虚风燥证,给予养血润肤饮合全虫方加减。治疗强调祛邪与调节脏腑功能并重。祛邪除祛湿、清热外,还非常重视祛风。调节脏腑功能,除健脾之外,很重视治肝。
3.3.5干燥综合征治疗经验：认为本病的发生多为素体虚弱,各种病因导致脏腑功能失调,气血津液生化不足,出现阴虚干燥证。强调整体调理,补五脏之阴,并辅以温阳,阳中求阴,在养阴的基础上,恢复平衡,称为平衡法。自创滋阴养脏汤治疗。
3.3.6硬皮病治疗经验：认为本病为素体脾肾不足,气血亏虚,卫外不固,阴寒之邪外袭,经络阻隔,气血凝滞,阻于肌肉皮肤之间而发病。治疗本病,除吸收前人经验,应用活血化瘀及温阳通络之剂外,还非常重视健脾。临床常用温补脾肾,活血通络为法,以真武汤合桃红四物汤加减。
3.3.7荨麻疹治疗经验：继承前辈从风论治瘾疹的思路,结合自身临床实践,认为本病与脾肺两脏关系密切,临床治疗,脏腑辨证与六淫辩证相结合。一般分为风邪犯肺、风湿阻肺、血虚风燥、脾肺两虚四型论治。
3.3.8瘙痒的治疗经验：认可瘙痒与风、湿、虫、虚等有关。同时她认为与精神因素关系密切。治疗时,除采用治风、除湿、杀虫、养血等常规方法外,还采用多种调节情志的方法,如清心、清肝、镇肝、疏肝的方法,多方位止痒。
3.3.9慢性咳嗽治疗经验：认为咳嗽是由气道的敏感所致,认为敏感也是风的表现。治疗咳嗽从风论治。慢性咳嗽,病程日久,与脏腑的功能失调有关。临床治疗从治风及调节五脏入手。
3.4临床研究
凉血解毒汤、养血解毒汤治疗血热证、血燥证银屑病,疗效优于安慰剂对于血热证心烦易怒症状、血燥证中鳞屑程度、瘙痒程度、口干舌燥症状有显著改善。
4结论
4.1皮肤病治疗需突出整体观念。不能只着眼于皮肤,还应兼顾脏腑、气血。
4.2辨血为主分证论治白疕,临床有效,还需进一步优化治疗方案,改进研究研究方法。
1.目的
1.1通过随机、对照的研究方法,评价使用规范化方剂分证论治银屑病的临床疗效,为进一步优化从血论治银屑病的诊疗方案提供参考；为制订临床实践指南提供依据。
2.方法
2.1研究方法：采用前瞻性、随机、双盲、对照的设计。依照临床流行病学的方法及统计学要求计算样本量,三个证型各120例,按2：1比例分为治疗组及对照组,血热证治疗组给予凉血解毒汤内服,血燥证治疗组给予养血解毒汤内服,血瘀证治疗组给予活血解毒汤内服,对照组均给予安慰剂内服,安慰剂的形、色、味与治疗药物相近；治疗组及对照组均外用白凡士林。疗程8周,每2周复诊一次,观察病情变化,记录相关指标,治疗前后分别进行安全性检查及皮损照相。痊愈患者在结束治疗后3月、6月、9月、12月进行随访。
2.2疗效评价指标：根据银屑病临床体征面积和疾病严重程度评分——PASI评分的变化评价疗效。
疗效评价标准：
临床痊愈：皮损全部消退,或仅残留几个不明显的小块皮损。PASI评分减少95%以上；显效：皮损消退60%以上,PASI评分减少60～94%；有效：皮损消退30%以上,PASI评分减少30～59%；无效：皮损消退30%以下,或皮损无变化,或皮损加重,PASI评分减少<30%,或无变化,或增多。
同时进行中医主要临床症状的评分及安全性评价及皮损照相。
2.3统计学方法：采用符合方案数据集进行分析,进行受试者人口统计学和其他基线特征,疗效分析及安全性分析。所有的统计检验均采用双侧检验,P值小于或等于0.05将被认为所检验的差别有统计意义。不同试验组各次就诊的计量资料将采用均数上标准差进行统计描述。与筛选期基础值进行比较,采用配对t检验比较组内前后差异。两组治疗前后的变化采用方差分析(ANOVA)和Wilcoxon秩和检验进行比较。
3.结果
3.1基线情况：本研究共入组358例,剔除6例,纳入352例(A组237例、B组115例),其中：安全性分析集(SS)351例(A组236例、B组115例)占入组病例的99.72%。全分析集(FAS)350例(A组235例、B组115例)占入组病例的99.43%。符合方案集(PPS)318例(A组209例、B组109例)占入组病例的90.34%。两组在年龄、性别、婚否、家族史、合并其他疾病、PASI评分、中医临床症状评分等方面均无差异。
3.2有效性评价
3.2.1不同证型银屑病临床疗效
3.2.1.1血热证A组临床痊愈占5.71%；显效占40.00%；有效占25.72%；无效占28.57%；B组临床痊愈占5.71%。显效占20.00%。有效占37.15%。无效占37.14%。总有效率CMH检验的P值为0.1382(>0.05),组间比较差异无统计学意义。愈显率卡方检验的P值为0.0477(<0.05),组间比较差异有统计学意义。
3.2.1.2血燥证
A组临床痊愈占7.04%；显效占35.21%；有效占26.76%；无效占30.99%；B组临床痊愈占0.00%。显效占29.73%。有效占16.22%。无效占54.05%。总有效率CMH检验的P值为0.0279(<0.05),组间比较差异有统计学意义。愈显率卡方检验的P值为0.2031(>0.05),组间比较差异无统计学意义。
3.2.1.3血瘀证A组临床痊愈占4.41%；显效占27.94%；有效占29.41%；无效占38.24%；B组临床痊愈占2.7 0%。显效占43.24%。有效占18.92%。无效占35.14%。总有效率CMH检验的P值为0.4300(>0.05),组间比较差异无统计学意义。愈显率卡方检验的P值为0.1685(>0.05),组间比较差异无统计学意义。
3.2.2不同证型中医证候疗效
3.2.2.1血热证
A组临床痊愈占4.29%；显效占17.14%；有效占4 0.00%；无效占38.57%；B组临床痊愈占0.00%。显效占14.29%。有效占48.57%。无效占37.14%。总有效率CMH检验的P值为0.5450(>0.05),组间比较差异无统计学意义。愈显率卡方检验的P值为0.3796(>0.05)组间比较差异无统计学意义。
3.2.2.2血燥证A组临床痊愈占8.45%；显效占14.08%；有效占46.48%；无效占30.99%；B组临床痊愈占0.00%。显效占10.81%。有效占37.84%。无效占51.35%。总有效率CMH检验的P值为0.0184(<0.05),组间比较差异有统计学意义。愈显率卡方检验的P值为0.1366(>0.05),组间比较差异无统计学意义。
3.2.2.3血瘀证A组临床痊愈占1.47%；显效占2.94%；有效占42.65%；无效占52.94%；B组临床痊愈占0.00%。显效占5.41%。有效占59.45%。无效占35.14%。总有效率CMH检验的P值为0.1681(>0.05),组间比较差异无统计学意义。愈显率卡方检验的P值为1.0000(>0.05),组间比较差异无统计学意义。
3.2.3 PASI评分治疗前后变化疗前、治疗后2周、6周、8周,两组评分变化比较,P>0.05,组间比较差异无统计学意义。治疗后4周,两组评分变化比较P值为0.0429(<0.05),组间比较差异有统计学意义。血热证在2周、4周、6周、8周PASI评分比较无统计学意义,血瘀证在4周PASI评分比较有统计学意义(P<0.05),而血燥证在2周、4周、6周、8周PASI评分比较有统计学意义(P<0.05)。
3.2.4中医临床症状治疗前后变化血热证中瘙痒、心烦易怒症状；血燥证中鳞屑程度、瘙痒程度、口干舌燥症状的评分在治疗后两组比较有显著性差异(P<0.05),其它临床症状变化组间比较无统计学意义。
4.结论
4.1采用凉血解毒汤、养血解毒汤治疗血热证、血燥证银屑病,疗效优于安慰剂。
4.2从血论治银屑病,采用协定处方治疗,对于血热证心烦易怒症状、血燥证中鳞屑程度、瘙痒程度、口干舌燥症状有显著改善。
4.3中医治疗方案还可以进一步优化,临床研究方法可有所调整。
1 Aims
1.1 To summarize Wang Jusheng's academic origin, treatment characteristics, clinical experiences and inductive principle and prescriptions on common skin diseases such as vitiligo, psoriasis, eczema, urticaria, Sjogren syndrome, scleroderma, herpes zoster neuralgia and pruritus and pulmonary diseases, through learning with her, recording medical cases, and literature reviewing.
1.2 To evaluate the clinical curative effect of standardized prescriptions by blood syndrome differentiation treating psoriasis, optimize the treatment of psoriasis treatment program from the blood and provide reference for clinical practice guidelines, a randomized, double blind, controlled research was designed.
2 Methods
2.1 Experience summary
The teacher's academic origin and characteristics and treatment characteristics were summarized through clinical recording, analysis medical records, and reviewing the ancient and modern literature.
2.2 Clinical research
A prospective, randomized, double blind, and placebo controlled research was designed to evaluate the effect of decoctions determined by blood syndrome differentiation. Three syndrome groups included 120 cases each, and according to 2:1 scale, the patients were randomized into the treatment group and the control group. The treatment group was given Liangxue Jiedu Decoction for blood-heat syndrome, Yangxue Jiedu Decoction for blood-dryness syndrome, Huoxue Jiedu Decoction for blood-stasis syndrome, and the control group was given placebo. The treatment group and the control group had topical white vaseline. The course was 8 weeks, and every 2 weeks once again to observe the illness changes and record the related indexes before and after treatment respectively.. Recovery patients were followed up at the 3rd,6th,9th and 12th month after treatment. The clinical symptoms and psoriasis area and severity of index (PASI) scores were taken to evaluate the efficacy.
Per-Protocol Set was for analysis. The baseline characteristics, efficacy and safety were analyzed. SAS9.1.3 statistic software was used to undertake analysis.
3 Results
3.1 Academic origin
Professor Wang Jusheng inherited traditional Chinese medicine dermatology Master Zhao Bingnan's and integrated dermatology founder professor Zhang Zhili's academic thoughts and experiences, and learned from the experiences of many famous doctors of internal medicine, and formed her own local syndrome differentiation and integral syndrome differentiation combined features.
3.2 The characteristics of treating skin disease teacher
3.2.1 The prominent of overall concepts, including human and nature, human and society is unified, the body as a whole, the treatment is not only confined to the skin, attentions should also be paid to the adjustment of psychological state of viscera, adjustment, and the adjustment of daily life, environmental factors and so on.
3.2.2 Highlights the treatment of liver
Focusing on the importance of emotion factors on skin disease affects seriously, soothing the liver to remove stagnancy of liver-Qi, psychological counseling, along with nourishing the liver and kidney, clearing liver and purging fire, hyperactive liver yang.
3.2.3 Attached to the treatment from lung
The Lung governs body fur, and wind-dampness also easily infringes on lung. The wind-dampness pathogen was a leading cause of skin disease. Dispelling wind and dispersing lung, clearing away lung heat were the main methods.
3.2.4 Generous weight decoctions
Skin diseases always were chronic, complex, and resistant. Non heavy decoctions it was difficult to cure, and not easy to deal with the complicated pathogenesis.
3.3 Experiences in the treatment of common skin diseases
3.3.1 Experiences in the treatment of psoriasis
The treatment of blood and viscera were combined in treating psoriasis and the importance of poison and wet in this disease were focused on. That the causes related to mental factors, the treatment of this disease was stressed on liver. Hepatic stagnation existed in the whole pathogenesis. The syndromes of blood-heat connotation, heat-toxin invading lung, blood-deficiency and wind-attack, weakness of the spleen and stomach, liver-yin and kidney-yin deficiency, stagnation of Qi and blood stasis, and stagnation of liver Qi and blood stasis were differentiated for treatment.
3.3.2 Experiences in the treatment of vitiligo
The deficiency of liver and kidney was the basis pathogenesis. Hepatic stagnation, irascibility exuberant and hyperactivity of liver Yang were the different periods of performance. Treating liver was the keystone, which including nourishing the liver and kidney, soothing liver Qi stagnation, clearing liver and purging fire and soothing hyperactive liver yang. Promoting blood circulation to remove obstruction from meridians and expelling the wind were needed to cooperate. The insect drugs, generous and heavy decoctions were skillfully used. Psychological counseling was also much accounted of. The basic drugs were Tribulus terrestris, Morus alba, Radix Angelicae dahuricae, Bombyx Batryticatus, psoralen, Caulis Polygoni Multiflori, Platycladus orientalis, sandy, black sesame, mulberry, scorpion and Saposhnikovia divaricata Schischk. The herbs were used according to the lesions position and meridians.
3.3.3 Herpes zoster neuralgia treatment experiences
The key pathogenesis was Qi stagnation and blood stasis, but the nature of stasis was different, including deficiency, excessive, cold, and heat. The prescriptions of Huoxue Sanyu decoction, Dahuang Zhechong pill, Xuefu Zhuyu decoction, were commonly used to promote blood circulation, and Chaihu Shugan decoction for regulating Qi, Sijunzi decoction for invigorating Qi, Danggui Sini decoction for warming meridian.
3.3.4 Experiences in the treatment of eczema
The occurrence of eczema was the result of joint action of internal and external pathogens. Internal causes included congenital intolerance, liver fire, spleen dampness, and external pathogens were the wind, wet and heat evil. The invasion of external pathogens and deficiency of internal viscera were the main pathogenesis. Three syndromes were differentiated, which were damp heat syndrome treated by Longdan Xiegan decoction, spleen deficiency and dampness syndrome treated by Chushi Weiling decoction, and blood deficiency and wind attack syndrome treated by Yangxue Runfuying combined with Quanchongfang decoction. The treatment emphasized both eliminating pathogenic factors and adjusting the internal organs'functions. In addition, the importance of dispelling the wind evil besides heat evil and dampness evil, adjusting liver besides spleen was emphsized.
3.3.5 Experiences in the treatment of Sjogren syndrome
The occurrence of this disease was on body weak attacked by various etiological factors, which leading to organ dysfunction and blood fluid deficiency, which was Yin-deficiency syndrome. The whole body conditioning, nourishing the five internal organs of Yin, and supplemented with warming yang was emphasized. And the nourishing yin and visera decoction was created for the treatment.
3.3.6 Experiences in the treatment of scleroderma
Spleen and kidney deficiency, blood deficiency, Wei Qi deficiency, cold evil passage barrier, meridians stagnation, Qi and blood stagnation resistance between the muscles and skin were the main pathogenesis. Strengthening spleen besides the application of promoting blood circulation to remove blood stasis and Yang collaterals agent was the characteristic. The Zhenwu decoction combined with Taohongsiwu decoction, which warming and invigorating spleen and kidney, activating blood circulation, were mainly used.
3.3.7 Experiences in the treatment of urticaria
Besides wind evil, spleen and lung were also very important in the treatment and the combined treatment of six-evil and visceral organ was used. The main four syndromes were wind evil attacking lung, wind dampness obstructing lung, blood-deficiency and wind-attack, spleen and lung deficiency.
3.3.8 The pruritus treatment experiences
The pruritus was related to wind, wet, worms, and deficiency, and spiritual factors was also very closely. Treatment, In addition to the treatment of eliminating wind, dampness, insecticidal, nourishing blood, a variety of emotional adjustment methods were also used, which including clearing heart fire, liver fire and soothing the liver Qi.
3.3.9 Experiences in the treatment of chronic cough
The cough was caused by airway sensitization, which was the performance of the wind. The Treatment of cough was dealing with the wind. Chronic cough, because of the long course duration, was related to the viscera function disorders. Treating wind and adjusting the internal organ functions were the principle.
3.4 Clinical research
The efficacy of cooling blood and detoxification decoction treating blood heat syndrome, nourishing blood and detoxification decoction treating blood dryness syndrome were better than placebo. The response of symptoms of irritability, scales, itching and dry mouth were significant improved of psoriasis patients treated by standardized TCM prescriptions based on blood syndrome differentiation, compared with the placebo.
4 Conclusions
4.1 The treatment of skin disease needs to highlight the overall concept, not only focus on the skin, but also the viscera, Qi and blood.
4.2 Treating psoriasis through blood differentiation was effective, but optimized scheme and improved research method were needed.
1. Objective
To evaluate the standardized traditional Chinese medical prescriptions effect in psoriasis.
2. Methods
2.1 Methods:This randomized, blind, placebo-controlled,8-week study assessed the efficacy of 3 standardized prescriptions, which were cooling blood and detoxification decoction treating blood heat syndrome group, nourishing blood and detoxification decoction treating blood dryness syndrome group and promoting blood circulation and detoxification treating blood stasis syndrome group. According to the methods of clinical epidemiology and statistical calculation of sample size requirements, this experiments needs 360 patients, and which divided according to a 2:1 ratio into treatment group and control group. Treatment group and control group were both topical white petroleum jelly. Clinical and laboratory assessments were done at screening, baseline, and every 2 weeks thereafter until 8 weeks after the start of therapy. The security checks and lesions photography were taken before and after the treatments. And the cured patients were followed at the 3rd,6th,9th an 12th month to find the recurrence.
2.2 Clinical assessments included physical examinations, vital signs, concomitant medications, monitoring for adverse events, and measures of Psoriasis Area Severity Index (PASI).A response was defined as attaining a poor (0-29% clearing with little or no change), good (30-59% clearing with moderate improvement), excellent (60-94% clearing with striking improvement), or clear (95-100% clearing) rating on the PASI. 2.3 Statistical analysis The primary analysis was done according to Per-protocol. The subjects demographic and other baseline characteristics, efficacy analysis and safety were analyzed. A two-sidedα=0.05 was regarded as significant. Student's t-test was used to analyze differences between groups. Then, group-by-time repeated measures analysis of variance (ANOVA) and Wilcoxon rank sum test were used to examine changes.
3. Results
3.1358 patients were included in the study, and 318 cases were analyzed according to Per-protocol, in which 209 were assigned TCM treatment, and 109 placebo. The three treatment groups were similar with regard to age range, sex, marital status, family history, combination with other diseases baseline disease severity and TCM clinical symptoms score.
3.2 Efficacy
3.2.1 PASI efficacy Twelve of 209 (5.74%) patients in the TCM group achieved the primary endpoint of a clear, 72 (34.45%) achieved an excellent,57 (27.27%) achieved a good, and 68 (32.54%) attained a poor rating on the PASI at week 8, compared with 3 of 109 (2.75%) patients clear,34 (31.19%) excellent,26(23.86%) good,46(42.20%) poor, in the placebo group (P=0.0884>0.05). The response was no difference that who achieved the primary endpoint of a good, excellent, or clear rating on the PASI at week 8, compared the placebo group(P=0.2762>0.05).
3.2.1 TCM symptoms efficacy Ten of 209 (4.78%) patients in the TCM group achieved the primary endpoint of a clear,24 (11.48%) achieved an excellent,90 (43.07%) achieved a good, and 85 (40.67%) attained a poor rating on the TCM symptoms at week 8, compared with 0 of 109 (0.00%) patients clear, 11 (10.09%) excellent,53(48.63%) good,45(41.28%) poor, in the placebo group (P= 0.2025>0.05). The response was no difference that who achieved the primary endpoint of a good, excellent, or clear rating on the TCM symptoms at week 8, compared the placebo group(P=0.1337>0.05).
3.2.3 PASI efficacy in different syndromes 3.2.3.1 Blood heat syndrome Four of 70 (5.71%) patients in the blood heat syndrome group achieved the primary endpoint of a clear,28(40.00%) achieved an excellent,18 (25.72%) achieved a good, and 20 (28.57%) attained a poor rating on the PASI at week 8, compared with 2 of 35 (5.71%) patients clear,7 (20.00%) excellent,13(37.15%) good,13(37.15%) poor, in the placebo group (P= 0.1382>0.05). The response was significantly greater in patients who achieved the primary endpoint of a excellent, or clear rating on the PASI at week 8, compared the placebo group(P =0.0477<0.05).
3.2.3.2 Blood dryness syndrome Five of 71 (7.04%) patients in the blood dryness group achieved the primary endpoint of a clear,25 (35.21%) achieved an excellent,19 (26.76%) achieved a good, and 22 (30.99%) attained a poor rating on the PASI at week 8, compared with 0 of 37 (0.00%) patients clear,11 (29.73%) excellent,6(16.22%) good,20(54.05%) poor, in the placebo group (P= 0.0279<0.05). The response was no difference in patients who achieved the primary endpoint of a excellent, or clear rating on the PASI at week 8, compared the placebo group(P=0. 2031>0.05).
3.2.3.3 Blood stasis syndrome Three of 68 (4.41%) patients in the blood stasis group achieved the primary endpoint of a clear,19(27.94%) achieved an excellent,20 (29.41%) achieved a good, and 26 (38.24%) attained a poor rating on the PASI at week 8, compared with 1 of 37 (2.70%) patients clear, 16(43.24%) excellent,7(18.92%) good,13(35.14%) poor, in the placebo group (P= 0.4300>0.05). The response was significantly greater in patients who achieved the primary endpoint of a excellent, or clear rating on the PASI at week 8, compared the placebo group(P =0.1685>0.05).
3.2.4 TCM symptoms efficacy in different syndromes
3.2.4.1 Blood heat syndrome
Three of 70 (4.29%) patients in the blood heat syndrome group achieved the primary endpoint of a clear,12(17.14%) achieved an excellent,28 (40.00%) achieved a good, and 27 (38.57%) attained a poor rating on the TCM symptoms at week 8, compared with 0 of 35 (0.00%) patients clear,5(14.29%) excellent,17(48.57%) good,13(37.14%) poor, in the placebo group (P=0.5450>0.05). The response was no difference in patients who achieved the primary endpoint of a excellent, or clear rating on the TCM symptoms at week 8, compared the placebo group(P=0.3796>0.05).
3.2.4.2 Blood dryness syndrome Six of 71 (8.45%) patients in the blood dryness syndrome group achieved the primary endpoint of a clear,10(14.08%) achieved an excellent,33 (46.68%) achieved a good, and 22 (30.99%) attained a poor rating on the TCM symptoms at week 8, compared with 0 of 37(0.00%) patients clear,4(10.81%) excellent,14(37.84%) good,19(51.35%) poor, in the placebo group (P=0.0184<0.05). The response was no difference in patients who achieved the primary endpoint of a excellent, or clear rating on the TCM symptoms at week 8, compared the placebo group(P=0.1366>0.05).
3.2.4.3 Blood stasis syndrome
One of 68 (1.47%) patients in the blood stasis syndrome group achieved the primary endpoint of a clear,2(2.94%) achieved an excellent,29 (42.65%) achieved a good, and 36 (52.94%) attained a poor rating on the TCM symptoms at week 8, compared with 0 of 37 (0.00%) patients clear,2(5.41%) excellent,22(59.45%) good,13(35.14%) poor, in the placebo group (P=0.1681>0.05). The response was no difference in patients who achieved the primary endpoint of a excellent, or clear rating on the TCM symptoms at week 8, compared the placebo group(P=1.0000>0.05).
3.2.5 PASI efficacy in different points At 4 weeks, the TCM groups showed significant improvement in PASI compared with the placebo group (P=0.0429<0.05), and no difference in the other weeks. The response was significantly greater on PASI at all measured time points in patients who received TCM decoctions in blood dryness group relative to those receiving placebo (P<0.05), but for the blood heat and blood stasis groups (P>0.05).
3.2.6 TCM symptoms efficacy The response of symptoms of irritability in the blood heat group and scales, itching and dry mouth in the blood dryness group were significant improved compared with the placebo group, but for the other symptoms in different groups.
4. Conclusions
4.1 The overall efficacy was fairly between standardized TCM prescriptions, based on blood syndrome differentiation which including blood heat, blood dryness and blood stasis syndromes, treating psoriasis and placebo.
4.2 The efficacy of cooling blood and detoxification decoction treating blood heat syndrome group, nourishing blood and detoxification decoction treating blood dryness syndrome group were better than placebo.
4.3 The response of symptoms of irritability, scales, itching and dry mouth were significant improved of psoriasis patients treated by standardized TCM prescriptions based on blood syndrome differentiation, compared with the placebo.
1.1通过临床跟师学习,记录医案,文献复习,总结王莒生老师学术渊源,临床经验,包括常见皮肤病如白癜风、银屑病、湿疹、荨麻疹、干燥综合征、硬皮病、带状疱疹神经痛、瘙痒症及肺系疾病慢性咳嗽的病因病机认识,治疗特点,归纳理法方药。
1.2通过随机、双盲、对照的研究方法,评价基于辨血为主的思路,使用规范化方剂分证论治银屑病的临床疗效,为进一步优化从血论治银屑病的诊疗方案提供参考；为制订临床实践指南提供依据。
2方法
2.1经验总结：通过门诊跟师临证,记录医案,分析医案,查阅古代及现代相关文献,总结老师学术渊源,学术特点,治疗特色。
2.2临床研究：采用前瞻性、随机、双盲、对照的设计。依照临床流行病学的方法及统计学要求计算样本量,三个证型各120例,按2：1比例分为治疗组及对照组,血热证治疗组给予凉血解毒汤内服,血燥证治疗组给予养血解毒汤内服,血瘀证治疗组给予活血解毒汤内服,对照组均给予安慰剂内服,安慰剂的形、色、味与治疗药物相近；治疗组及对照组均外用白凡士林。疗程8周,每2周复诊一次,观察病情变化,记录相关指标,治疗前后分别进行安全性检查及皮损照相。痊愈患者在结束治疗后3月、6月、9月、12月进行随访。根据银屑病临床体征面积和疾病严重程度评分——PAS I评分的变化评价疗效。
统计采用符合方案数据集进行分析,进行基线特征,疗效分析及安全性分析。使用SAS9.1.3统计软件进行分析。
3结果
3.1学术渊源
继承了中医皮肤科泰斗赵炳南老大夫及现代中西医结合皮肤科的奠基者张志礼教授的学术思想及经验,汲取了内科众多名医的经验,形成自己局部辨证与整体辨证相结合的特点。
3.2王莒生老师治疗皮肤病特点
3.2.1突出整体观念,包括人与自然、人与社会的统一,人体自身是个整体,治疗不仅局限于皮肤,还应重视脏腑的调整,心理状态的调整,饮食起居的调护,环境因素的影响等等。
3.2.2突出从肝论治：重视情致因素对皮肤病的影响,重视疏肝解郁,心理辅导。还配合滋补肝肾、清肝泻火、平肝潜阳等。
3.2.3重视从肺论治：肺主一身皮毛,风湿之邪亦犯肺,风湿之邪是导致皮肤病的重要因素。常用疏风宣肺、清泻肺热之法。
3.2.4善用大方重剂：皮肤病多为慢性病,病机复杂,病情顽固,非重剂难以撼动,非大方难以应对复杂病机。
3.3常见皮肤病治疗经验
3.3.1银屑病治疗经验：从血论治与脏腑论治相结合。重视毒、湿在本病的作用。认为本病的诱因与精神因素相关,治疗本病也应突出从肝论治,认为在各个环节均存在肝气郁滞的病机。辨证分型分为血热内蕴,热毒犯肺；血热内蕴,肝火旺盛；血虚风燥,脾胃虚弱；血虚风燥,肝肾阴虚；气血瘀滞,肝气郁结；气血瘀滞,脾失健运等六型分证论治。
3.3.2白癜风治疗经验：认为肝肾亏虚是基础,肝气郁滞、肝火旺盛、肝阳上亢是不同时期、不同个体的表现。从肝论治是特点,包括滋补肝肾、疏肝解郁、清肝泻火、平肝潜阳等。还需配合活血通络、疏风散风之品,善用虫类药物,善用大方、重剂,重视心理辅导。基本方剂为：白蒺藜、桑白皮、白芷、白僵蚕、补骨脂、首乌藤、生侧柏、沙苑子、黑芝麻、桑椹、全虫、防风。临证还需根据具体情况进行加减,根据发布部位可选用引经药物。
3.3.3带状疱疹神经痛治疗经验：认为本病的病机关键为气滞血瘀,但瘀的性质有所不同,临床治疗要理清虚实寒热。根据患者特点,分别给予理气活血,益气活血,温经通络治疗,活血方剂常用活血散瘀汤、大黄蛰虫丸方、血府逐瘀汤,理气方剂常用柴胡疏肝散方,益气方剂常用四君子汤、温经方剂常用当归四逆汤。
3.3.4湿疹治疗经验：认为本病的发生是内外因共同作用的结果。内因为先天禀赋不耐,肝火、脾湿,外因为风、湿、热邪侵袭,与肝火、脾湿相博,发于肌肤而致本病。日久气血亏耗,化燥生风。亦有先天禀赋不足,气血亏虚,无以濡养肌肤,而致血虚风燥,肌肤甲错者。治疗分为三型,湿热蕴肤证,给予龙胆泻肝汤加减；脾虚湿蕴证,给予除湿胃苓汤加减；血虚风燥证,给予养血润肤饮合全虫方加减。治疗强调祛邪与调节脏腑功能并重。祛邪除祛湿、清热外,还非常重视祛风。调节脏腑功能,除健脾之外,很重视治肝。
3.3.5干燥综合征治疗经验：认为本病的发生多为素体虚弱,各种病因导致脏腑功能失调,气血津液生化不足,出现阴虚干燥证。强调整体调理,补五脏之阴,并辅以温阳,阳中求阴,在养阴的基础上,恢复平衡,称为平衡法。自创滋阴养脏汤治疗。
3.3.6硬皮病治疗经验：认为本病为素体脾肾不足,气血亏虚,卫外不固,阴寒之邪外袭,经络阻隔,气血凝滞,阻于肌肉皮肤之间而发病。治疗本病,除吸收前人经验,应用活血化瘀及温阳通络之剂外,还非常重视健脾。临床常用温补脾肾,活血通络为法,以真武汤合桃红四物汤加减。
3.3.7荨麻疹治疗经验：继承前辈从风论治瘾疹的思路,结合自身临床实践,认为本病与脾肺两脏关系密切,临床治疗,脏腑辨证与六淫辩证相结合。一般分为风邪犯肺、风湿阻肺、血虚风燥、脾肺两虚四型论治。
3.3.8瘙痒的治疗经验：认可瘙痒与风、湿、虫、虚等有关。同时她认为与精神因素关系密切。治疗时,除采用治风、除湿、杀虫、养血等常规方法外,还采用多种调节情志的方法,如清心、清肝、镇肝、疏肝的方法,多方位止痒。
3.3.9慢性咳嗽治疗经验：认为咳嗽是由气道的敏感所致,认为敏感也是风的表现。治疗咳嗽从风论治。慢性咳嗽,病程日久,与脏腑的功能失调有关。临床治疗从治风及调节五脏入手。
3.4临床研究
凉血解毒汤、养血解毒汤治疗血热证、血燥证银屑病,疗效优于安慰剂对于血热证心烦易怒症状、血燥证中鳞屑程度、瘙痒程度、口干舌燥症状有显著改善。
4结论
4.1皮肤病治疗需突出整体观念。不能只着眼于皮肤,还应兼顾脏腑、气血。
4.2辨血为主分证论治白疕,临床有效,还需进一步优化治疗方案,改进研究研究方法。
1.目的
1.1通过随机、对照的研究方法,评价使用规范化方剂分证论治银屑病的临床疗效,为进一步优化从血论治银屑病的诊疗方案提供参考；为制订临床实践指南提供依据。
2.方法
2.1研究方法：采用前瞻性、随机、双盲、对照的设计。依照临床流行病学的方法及统计学要求计算样本量,三个证型各120例,按2：1比例分为治疗组及对照组,血热证治疗组给予凉血解毒汤内服,血燥证治疗组给予养血解毒汤内服,血瘀证治疗组给予活血解毒汤内服,对照组均给予安慰剂内服,安慰剂的形、色、味与治疗药物相近；治疗组及对照组均外用白凡士林。疗程8周,每2周复诊一次,观察病情变化,记录相关指标,治疗前后分别进行安全性检查及皮损照相。痊愈患者在结束治疗后3月、6月、9月、12月进行随访。
2.2疗效评价指标：根据银屑病临床体征面积和疾病严重程度评分——PASI评分的变化评价疗效。
疗效评价标准：
临床痊愈：皮损全部消退,或仅残留几个不明显的小块皮损。PASI评分减少95%以上；显效：皮损消退60%以上,PASI评分减少60～94%；有效：皮损消退30%以上,PASI评分减少30～59%；无效：皮损消退30%以下,或皮损无变化,或皮损加重,PASI评分减少<30%,或无变化,或增多。
同时进行中医主要临床症状的评分及安全性评价及皮损照相。
2.3统计学方法：采用符合方案数据集进行分析,进行受试者人口统计学和其他基线特征,疗效分析及安全性分析。所有的统计检验均采用双侧检验,P值小于或等于0.05将被认为所检验的差别有统计意义。不同试验组各次就诊的计量资料将采用均数上标准差进行统计描述。与筛选期基础值进行比较,采用配对t检验比较组内前后差异。两组治疗前后的变化采用方差分析(ANOVA)和Wilcoxon秩和检验进行比较。
3.结果
3.1基线情况：本研究共入组358例,剔除6例,纳入352例(A组237例、B组115例),其中：安全性分析集(SS)351例(A组236例、B组115例)占入组病例的99.72%。全分析集(FAS)350例(A组235例、B组115例)占入组病例的99.43%。符合方案集(PPS)318例(A组209例、B组109例)占入组病例的90.34%。两组在年龄、性别、婚否、家族史、合并其他疾病、PASI评分、中医临床症状评分等方面均无差异。
3.2有效性评价
3.2.1不同证型银屑病临床疗效
3.2.1.1血热证A组临床痊愈占5.71%；显效占40.00%；有效占25.72%；无效占28.57%；B组临床痊愈占5.71%。显效占20.00%。有效占37.15%。无效占37.14%。总有效率CMH检验的P值为0.1382(>0.05),组间比较差异无统计学意义。愈显率卡方检验的P值为0.0477(<0.05),组间比较差异有统计学意义。
3.2.1.2血燥证
A组临床痊愈占7.04%；显效占35.21%；有效占26.76%；无效占30.99%；B组临床痊愈占0.00%。显效占29.73%。有效占16.22%。无效占54.05%。总有效率CMH检验的P值为0.0279(<0.05),组间比较差异有统计学意义。愈显率卡方检验的P值为0.2031(>0.05),组间比较差异无统计学意义。
3.2.1.3血瘀证A组临床痊愈占4.41%；显效占27.94%；有效占29.41%；无效占38.24%；B组临床痊愈占2.7 0%。显效占43.24%。有效占18.92%。无效占35.14%。总有效率CMH检验的P值为0.4300(>0.05),组间比较差异无统计学意义。愈显率卡方检验的P值为0.1685(>0.05),组间比较差异无统计学意义。
3.2.2不同证型中医证候疗效
3.2.2.1血热证
A组临床痊愈占4.29%；显效占17.14%；有效占4 0.00%；无效占38.57%；B组临床痊愈占0.00%。显效占14.29%。有效占48.57%。无效占37.14%。总有效率CMH检验的P值为0.5450(>0.05),组间比较差异无统计学意义。愈显率卡方检验的P值为0.3796(>0.05)组间比较差异无统计学意义。
3.2.2.2血燥证A组临床痊愈占8.45%；显效占14.08%；有效占46.48%；无效占30.99%；B组临床痊愈占0.00%。显效占10.81%。有效占37.84%。无效占51.35%。总有效率CMH检验的P值为0.0184(<0.05),组间比较差异有统计学意义。愈显率卡方检验的P值为0.1366(>0.05),组间比较差异无统计学意义。
3.2.2.3血瘀证A组临床痊愈占1.47%；显效占2.94%；有效占42.65%；无效占52.94%；B组临床痊愈占0.00%。显效占5.41%。有效占59.45%。无效占35.14%。总有效率CMH检验的P值为0.1681(>0.05),组间比较差异无统计学意义。愈显率卡方检验的P值为1.0000(>0.05),组间比较差异无统计学意义。
3.2.3 PASI评分治疗前后变化疗前、治疗后2周、6周、8周,两组评分变化比较,P>0.05,组间比较差异无统计学意义。治疗后4周,两组评分变化比较P值为0.0429(<0.05),组间比较差异有统计学意义。血热证在2周、4周、6周、8周PASI评分比较无统计学意义,血瘀证在4周PASI评分比较有统计学意义(P<0.05),而血燥证在2周、4周、6周、8周PASI评分比较有统计学意义(P<0.05)。
3.2.4中医临床症状治疗前后变化血热证中瘙痒、心烦易怒症状；血燥证中鳞屑程度、瘙痒程度、口干舌燥症状的评分在治疗后两组比较有显著性差异(P<0.05),其它临床症状变化组间比较无统计学意义。
4.结论
4.1采用凉血解毒汤、养血解毒汤治疗血热证、血燥证银屑病,疗效优于安慰剂。
4.2从血论治银屑病,采用协定处方治疗,对于血热证心烦易怒症状、血燥证中鳞屑程度、瘙痒程度、口干舌燥症状有显著改善。
4.3中医治疗方案还可以进一步优化,临床研究方法可有所调整。
1 Aims
1.1 To summarize Wang Jusheng's academic origin, treatment characteristics, clinical experiences and inductive principle and prescriptions on common skin diseases such as vitiligo, psoriasis, eczema, urticaria, Sjogren syndrome, scleroderma, herpes zoster neuralgia and pruritus and pulmonary diseases, through learning with her, recording medical cases, and literature reviewing.
1.2 To evaluate the clinical curative effect of standardized prescriptions by blood syndrome differentiation treating psoriasis, optimize the treatment of psoriasis treatment program from the blood and provide reference for clinical practice guidelines, a randomized, double blind, controlled research was designed.
2 Methods
2.1 Experience summary
The teacher's academic origin and characteristics and treatment characteristics were summarized through clinical recording, analysis medical records, and reviewing the ancient and modern literature.
2.2 Clinical research
A prospective, randomized, double blind, and placebo controlled research was designed to evaluate the effect of decoctions determined by blood syndrome differentiation. Three syndrome groups included 120 cases each, and according to 2:1 scale, the patients were randomized into the treatment group and the control group. The treatment group was given Liangxue Jiedu Decoction for blood-heat syndrome, Yangxue Jiedu Decoction for blood-dryness syndrome, Huoxue Jiedu Decoction for blood-stasis syndrome, and the control group was given placebo. The treatment group and the control group had topical white vaseline. The course was 8 weeks, and every 2 weeks once again to observe the illness changes and record the related indexes before and after treatment respectively.. Recovery patients were followed up at the 3rd,6th,9th and 12th month after treatment. The clinical symptoms and psoriasis area and severity of index (PASI) scores were taken to evaluate the efficacy.
Per-Protocol Set was for analysis. The baseline characteristics, efficacy and safety were analyzed. SAS9.1.3 statistic software was used to undertake analysis.
3 Results
3.1 Academic origin
Professor Wang Jusheng inherited traditional Chinese medicine dermatology Master Zhao Bingnan's and integrated dermatology founder professor Zhang Zhili's academic thoughts and experiences, and learned from the experiences of many famous doctors of internal medicine, and formed her own local syndrome differentiation and integral syndrome differentiation combined features.
3.2 The characteristics of treating skin disease teacher
3.2.1 The prominent of overall concepts, including human and nature, human and society is unified, the body as a whole, the treatment is not only confined to the skin, attentions should also be paid to the adjustment of psychological state of viscera, adjustment, and the adjustment of daily life, environmental factors and so on.
3.2.2 Highlights the treatment of liver
Focusing on the importance of emotion factors on skin disease affects seriously, soothing the liver to remove stagnancy of liver-Qi, psychological counseling, along with nourishing the liver and kidney, clearing liver and purging fire, hyperactive liver yang.
3.2.3 Attached to the treatment from lung
The Lung governs body fur, and wind-dampness also easily infringes on lung. The wind-dampness pathogen was a leading cause of skin disease. Dispelling wind and dispersing lung, clearing away lung heat were the main methods.
3.2.4 Generous weight decoctions
Skin diseases always were chronic, complex, and resistant. Non heavy decoctions it was difficult to cure, and not easy to deal with the complicated pathogenesis.
3.3 Experiences in the treatment of common skin diseases
3.3.1 Experiences in the treatment of psoriasis
The treatment of blood and viscera were combined in treating psoriasis and the importance of poison and wet in this disease were focused on. That the causes related to mental factors, the treatment of this disease was stressed on liver. Hepatic stagnation existed in the whole pathogenesis. The syndromes of blood-heat connotation, heat-toxin invading lung, blood-deficiency and wind-attack, weakness of the spleen and stomach, liver-yin and kidney-yin deficiency, stagnation of Qi and blood stasis, and stagnation of liver Qi and blood stasis were differentiated for treatment.
3.3.2 Experiences in the treatment of vitiligo
The deficiency of liver and kidney was the basis pathogenesis. Hepatic stagnation, irascibility exuberant and hyperactivity of liver Yang were the different periods of performance. Treating liver was the keystone, which including nourishing the liver and kidney, soothing liver Qi stagnation, clearing liver and purging fire and soothing hyperactive liver yang. Promoting blood circulation to remove obstruction from meridians and expelling the wind were needed to cooperate. The insect drugs, generous and heavy decoctions were skillfully used. Psychological counseling was also much accounted of. The basic drugs were Tribulus terrestris, Morus alba, Radix Angelicae dahuricae, Bombyx Batryticatus, psoralen, Caulis Polygoni Multiflori, Platycladus orientalis, sandy, black sesame, mulberry, scorpion and Saposhnikovia divaricata Schischk. The herbs were used according to the lesions position and meridians.
3.3.3 Herpes zoster neuralgia treatment experiences
The key pathogenesis was Qi stagnation and blood stasis, but the nature of stasis was different, including deficiency, excessive, cold, and heat. The prescriptions of Huoxue Sanyu decoction, Dahuang Zhechong pill, Xuefu Zhuyu decoction, were commonly used to promote blood circulation, and Chaihu Shugan decoction for regulating Qi, Sijunzi decoction for invigorating Qi, Danggui Sini decoction for warming meridian.
3.3.4 Experiences in the treatment of eczema
The occurrence of eczema was the result of joint action of internal and external pathogens. Internal causes included congenital intolerance, liver fire, spleen dampness, and external pathogens were the wind, wet and heat evil. The invasion of external pathogens and deficiency of internal viscera were the main pathogenesis. Three syndromes were differentiated, which were damp heat syndrome treated by Longdan Xiegan decoction, spleen deficiency and dampness syndrome treated by Chushi Weiling decoction, and blood deficiency and wind attack syndrome treated by Yangxue Runfuying combined with Quanchongfang decoction. The treatment emphasized both eliminating pathogenic factors and adjusting the internal organs'functions. In addition, the importance of dispelling the wind evil besides heat evil and dampness evil, adjusting liver besides spleen was emphsized.
3.3.5 Experiences in the treatment of Sjogren syndrome
The occurrence of this disease was on body weak attacked by various etiological factors, which leading to organ dysfunction and blood fluid deficiency, which was Yin-deficiency syndrome. The whole body conditioning, nourishing the five internal organs of Yin, and supplemented with warming yang was emphasized. And the nourishing yin and visera decoction was created for the treatment.
3.3.6 Experiences in the treatment of scleroderma
Spleen and kidney deficiency, blood deficiency, Wei Qi deficiency, cold evil passage barrier, meridians stagnation, Qi and blood stagnation resistance between the muscles and skin were the main pathogenesis. Strengthening spleen besides the application of promoting blood circulation to remove blood stasis and Yang collaterals agent was the characteristic. The Zhenwu decoction combined with Taohongsiwu decoction, which warming and invigorating spleen and kidney, activating blood circulation, were mainly used.
3.3.7 Experiences in the treatment of urticaria
Besides wind evil, spleen and lung were also very important in the treatment and the combined treatment of six-evil and visceral organ was used. The main four syndromes were wind evil attacking lung, wind dampness obstructing lung, blood-deficiency and wind-attack, spleen and lung deficiency.
3.3.8 The pruritus treatment experiences
The pruritus was related to wind, wet, worms, and deficiency, and spiritual factors was also very closely. Treatment, In addition to the treatment of eliminating wind, dampness, insecticidal, nourishing blood, a variety of emotional adjustment methods were also used, which including clearing heart fire, liver fire and soothing the liver Qi.
3.3.9 Experiences in the treatment of chronic cough
The cough was caused by airway sensitization, which was the performance of the wind. The Treatment of cough was dealing with the wind. Chronic cough, because of the long course duration, was related to the viscera function disorders. Treating wind and adjusting the internal organ functions were the principle.
3.4 Clinical research
The efficacy of cooling blood and detoxification decoction treating blood heat syndrome, nourishing blood and detoxification decoction treating blood dryness syndrome were better than placebo. The response of symptoms of irritability, scales, itching and dry mouth were significant improved of psoriasis patients treated by standardized TCM prescriptions based on blood syndrome differentiation, compared with the placebo.
4 Conclusions
4.1 The treatment of skin disease needs to highlight the overall concept, not only focus on the skin, but also the viscera, Qi and blood.
4.2 Treating psoriasis through blood differentiation was effective, but optimized scheme and improved research method were needed.
1. Objective
To evaluate the standardized traditional Chinese medical prescriptions effect in psoriasis.
2. Methods
2.1 Methods:This randomized, blind, placebo-controlled,8-week study assessed the efficacy of 3 standardized prescriptions, which were cooling blood and detoxification decoction treating blood heat syndrome group, nourishing blood and detoxification decoction treating blood dryness syndrome group and promoting blood circulation and detoxification treating blood stasis syndrome group. According to the methods of clinical epidemiology and statistical calculation of sample size requirements, this experiments needs 360 patients, and which divided according to a 2:1 ratio into treatment group and control group. Treatment group and control group were both topical white petroleum jelly. Clinical and laboratory assessments were done at screening, baseline, and every 2 weeks thereafter until 8 weeks after the start of therapy. The security checks and lesions photography were taken before and after the treatments. And the cured patients were followed at the 3rd,6th,9th an 12th month to find the recurrence.
2.2 Clinical assessments included physical examinations, vital signs, concomitant medications, monitoring for adverse events, and measures of Psoriasis Area Severity Index (PASI).A response was defined as attaining a poor (0-29% clearing with little or no change), good (30-59% clearing with moderate improvement), excellent (60-94% clearing with striking improvement), or clear (95-100% clearing) rating on the PASI. 2.3 Statistical analysis The primary analysis was done according to Per-protocol. The subjects demographic and other baseline characteristics, efficacy analysis and safety were analyzed. A two-sidedα=0.05 was regarded as significant. Student's t-test was used to analyze differences between groups. Then, group-by-time repeated measures analysis of variance (ANOVA) and Wilcoxon rank sum test were used to examine changes.
3. Results
3.1358 patients were included in the study, and 318 cases were analyzed according to Per-protocol, in which 209 were assigned TCM treatment, and 109 placebo. The three treatment groups were similar with regard to age range, sex, marital status, family history, combination with other diseases baseline disease severity and TCM clinical symptoms score.
3.2 Efficacy
3.2.1 PASI efficacy Twelve of 209 (5.74%) patients in the TCM group achieved the primary endpoint of a clear, 72 (34.45%) achieved an excellent,57 (27.27%) achieved a good, and 68 (32.54%) attained a poor rating on the PASI at week 8, compared with 3 of 109 (2.75%) patients clear,34 (31.19%) excellent,26(23.86%) good,46(42.20%) poor, in the placebo group (P=0.0884>0.05). The response was no difference that who achieved the primary endpoint of a good, excellent, or clear rating on the PASI at week 8, compared the placebo group(P=0.2762>0.05).
3.2.1 TCM symptoms efficacy Ten of 209 (4.78%) patients in the TCM group achieved the primary endpoint of a clear,24 (11.48%) achieved an excellent,90 (43.07%) achieved a good, and 85 (40.67%) attained a poor rating on the TCM symptoms at week 8, compared with 0 of 109 (0.00%) patients clear, 11 (10.09%) excellent,53(48.63%) good,45(41.28%) poor, in the placebo group (P= 0.2025>0.05). The response was no difference that who achieved the primary endpoint of a good, excellent, or clear rating on the TCM symptoms at week 8, compared the placebo group(P=0.1337>0.05).
3.2.3 PASI efficacy in different syndromes 3.2.3.1 Blood heat syndrome Four of 70 (5.71%) patients in the blood heat syndrome group achieved the primary endpoint of a clear,28(40.00%) achieved an excellent,18 (25.72%) achieved a good, and 20 (28.57%) attained a poor rating on the PASI at week 8, compared with 2 of 35 (5.71%) patients clear,7 (20.00%) excellent,13(37.15%) good,13(37.15%) poor, in the placebo group (P= 0.1382>0.05). The response was significantly greater in patients who achieved the primary endpoint of a excellent, or clear rating on the PASI at week 8, compared the placebo group(P =0.0477<0.05).
3.2.3.2 Blood dryness syndrome Five of 71 (7.04%) patients in the blood dryness group achieved the primary endpoint of a clear,25 (35.21%) achieved an excellent,19 (26.76%) achieved a good, and 22 (30.99%) attained a poor rating on the PASI at week 8, compared with 0 of 37 (0.00%) patients clear,11 (29.73%) excellent,6(16.22%) good,20(54.05%) poor, in the placebo group (P= 0.0279<0.05). The response was no difference in patients who achieved the primary endpoint of a excellent, or clear rating on the PASI at week 8, compared the placebo group(P=0. 2031>0.05).
3.2.3.3 Blood stasis syndrome Three of 68 (4.41%) patients in the blood stasis group achieved the primary endpoint of a clear,19(27.94%) achieved an excellent,20 (29.41%) achieved a good, and 26 (38.24%) attained a poor rating on the PASI at week 8, compared with 1 of 37 (2.70%) patients clear, 16(43.24%) excellent,7(18.92%) good,13(35.14%) poor, in the placebo group (P= 0.4300>0.05). The response was significantly greater in patients who achieved the primary endpoint of a excellent, or clear rating on the PASI at week 8, compared the placebo group(P =0.1685>0.05).
3.2.4 TCM symptoms efficacy in different syndromes
3.2.4.1 Blood heat syndrome
Three of 70 (4.29%) patients in the blood heat syndrome group achieved the primary endpoint of a clear,12(17.14%) achieved an excellent,28 (40.00%) achieved a good, and 27 (38.57%) attained a poor rating on the TCM symptoms at week 8, compared with 0 of 35 (0.00%) patients clear,5(14.29%) excellent,17(48.57%) good,13(37.14%) poor, in the placebo group (P=0.5450>0.05). The response was no difference in patients who achieved the primary endpoint of a excellent, or clear rating on the TCM symptoms at week 8, compared the placebo group(P=0.3796>0.05).
3.2.4.2 Blood dryness syndrome Six of 71 (8.45%) patients in the blood dryness syndrome group achieved the primary endpoint of a clear,10(14.08%) achieved an excellent,33 (46.68%) achieved a good, and 22 (30.99%) attained a poor rating on the TCM symptoms at week 8, compared with 0 of 37(0.00%) patients clear,4(10.81%) excellent,14(37.84%) good,19(51.35%) poor, in the placebo group (P=0.0184<0.05). The response was no difference in patients who achieved the primary endpoint of a excellent, or clear rating on the TCM symptoms at week 8, compared the placebo group(P=0.1366>0.05).
3.2.4.3 Blood stasis syndrome
One of 68 (1.47%) patients in the blood stasis syndrome group achieved the primary endpoint of a clear,2(2.94%) achieved an excellent,29 (42.65%) achieved a good, and 36 (52.94%) attained a poor rating on the TCM symptoms at week 8, compared with 0 of 37 (0.00%) patients clear,2(5.41%) excellent,22(59.45%) good,13(35.14%) poor, in the placebo group (P=0.1681>0.05). The response was no difference in patients who achieved the primary endpoint of a excellent, or clear rating on the TCM symptoms at week 8, compared the placebo group(P=1.0000>0.05).
3.2.5 PASI efficacy in different points At 4 weeks, the TCM groups showed significant improvement in PASI compared with the placebo group (P=0.0429<0.05), and no difference in the other weeks. The response was significantly greater on PASI at all measured time points in patients who received TCM decoctions in blood dryness group relative to those receiving placebo (P<0.05), but for the blood heat and blood stasis groups (P>0.05).
3.2.6 TCM symptoms efficacy The response of symptoms of irritability in the blood heat group and scales, itching and dry mouth in the blood dryness group were significant improved compared with the placebo group, but for the other symptoms in different groups.
4. Conclusions
4.1 The overall efficacy was fairly between standardized TCM prescriptions, based on blood syndrome differentiation which including blood heat, blood dryness and blood stasis syndromes, treating psoriasis and placebo.
4.2 The efficacy of cooling blood and detoxification decoction treating blood heat syndrome group, nourishing blood and detoxification decoction treating blood dryness syndrome group were better than placebo.
4.3 The response of symptoms of irritability, scales, itching and dry mouth were significant improved of psoriasis patients treated by standardized TCM prescriptions based on blood syndrome differentiation, compared with the placebo.
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