杨柳教授关于白癜风的学术思想及中西医结合临床研究
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摘要
研究背景
杨柳教授从事中医外科学临床、科研、教学工作30余年,治学严谨,笃重临床,对痤疮、脱发等损容性疾病,白癜风、黄褐斑等色素障碍性疾病,疮疡等感染性疾病,荨麻疹、湿疹等瘙痒性疾病都有独到的见解,总结出系统规范的诊疗方法及经验方。尤其是对白癜风的治疗,通过分期论治,擅用中西医结合、内外合治等联合疗法；且通过总结药材颜色与疗效相关的经验,提出”中药色象”理论,在临床中使用“色象中药”,疗效显著。
白癜风是一种临床常见而难治的皮肤色素脱失性疾病,发病率1%～2%,治疗方法虽多,但起效慢、病程长、治愈率低,是皮肤科顽症之一。中医药治疗白癜风的各家学说与疗效报道很多,但是诊疗方案的优化研究很是缺乏,直接影响疗效的评价与疗效的提高。
为了解国内医学领域对白癜风的治疗现状,我们用循证医学来评价中医药治疗白癜风的临床试验,以期客观地评价中医药治疗白癜风的临床疗效,为临床制定治疗方案提供循证医学证据。
此次临床研究基于循证医学原则,按照规范的随机对照试验设计方法探讨中西医结合系统疗法治疗进展期白癜风的临床效果。
目的
1通过跟师学习,记录医案,文献复习,总结杨柳老师治疗色素病的学术思想,临床经验,特别是治疗白癜风的病因病机认识、分期论治、运用“色象中药”,归纳理法方药。
2遵照循证医学的原则,在白癜风流行病学、辨证分型及中西医结合治疗等文献调查研究的基础上,对中西医结合诊疗与治疗的研究成果进行梳理和总结；通过中西医结合治疗白癜风的方案研究,评价中西医结合方案在临床具体实践中对白癜风的确切治疗效果及其安全性。
3通过观察复色1号联合方案与达成共识的西医治疗常规为对照进行临床试验研究,评价中西医结合方案在临床具体实践中对进展期白癜风的确切治疗效果及其安全性,为进一步优化中西医结合分期论治白癜风的诊疗方案提供思考,为制定临床实践指南提供依据。
方法
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,总结老师学术思想、学术特点、治疗特色。
2循证医学：①选用国内权威的《中国期刊全文数据库》(CNKI),进行近十年国内关于中西医结合治疗白癜风的中医药/中西医结合临床研究文献的计量学分析；②通过检索近10年来国内公开发表的中医药治疗白癜风的相关文献,对其中采用随机对照临床试验设计的文献,进行关于中西医结合治疗白癜风临床疗效和安全性的Meta分析。
3临床研究：将2010.8-2012.7在南方医科大学附属中西医结合医院皮肤科门诊、南方医科大学附属南方医院中医外科门诊确诊为进展期白癜风的94例患者,按知情同意原则,对94例患者随机分为二组,中西医结合组47例、西医组47例；观察时间为6个月,随访期半年。通过对疗效指标(主要疗效指标：白斑消退面积百分比；次要评价指标：色素积分)进行分析,评价中西医结合方案的临床效果和对白斑的改善程度。
结果
1经验总结：归纳出老师临床论治白癜风的理法方药,构建基于“中药色象”理论分期论治白癜风的中西医结合治疗体系。
2循证医学
2.1文献计量学分析：①近10年来,国内期刊发表的有关白癜风临床研究的文献数量较多,而且总的趋势是增多的,在2005年达到最高,2006年以后有升有降。②收录文献较多的5种杂志中,以《中国麻风皮肤病杂志》居第1位,共25篇,占8.6%；核心期刊收录文献70篇,占24.1%,不到总量的1/4。另外,近10年来国内有关白癜风临床研究的文献主要集中在皮肤科杂志。③发表文献最多的机构是杭州市第三人民医院,其次是复旦大学华山医院和广州中医药大学,说明这些学术机构在此领域的研究较为活跃。④近10年来,国内有关白癜风研究的热点多集中在防治措施的研究方面,说明白癜风的治疗是难点,且治疗手段丰富多样；其次是关于临床诊断的研究,关于白癜风诊断标准及临床分型的研究；关于白癜风的预后及生存质量的研究,近年来也呈上升趋势。
2.2循证医学评价：最初检索出文献291篇,通过阅读全文,剔除不符合要求的文献238篇,包括西医治疗、实验研究、个案报道、文献综述及重复发表的文献等。剩余53篇文章阅读全文作进一步分析,排除非随机对照试验的研究,最终8篇文献纳入研究。研究显示：经优化的治疗方案疗效优于中药组／西药组；且中医药治疗毒副作用小,疗效稳定,复发率低。
3两组临床疗效比较
3.1两组临床疗效比较：中西医结合组47例患者,痊愈4例,显效17例,好转15例,无效11例,有效率76.6%；西医组47例患者,痊愈0例,显效5例,好转21例,无效21例,有效率55.3%。两组经卡方检验,有效率比较χ2=4.738,p=0.030,差异具有统计学意义。
3.2疗效指标比较分析：中西医结合组与西医组患者治疗前后,两组白斑消退面积百分比比较显示有显著性统计学差异(t=5.039,p=0.000)；中西医结合组及西医组分别进行治疗前后白斑色素积分比比较,中西医结合组(z=-5.553,p=0.000),治疗前后有显著性差异：西医组(z=-5.518,p=0.000),治疗前后有显著性差异；但两组治疗后色素积分比比较,差异无统计学意义(t=-0.426,p=0.670)。由此可见,中西医结合组在白斑面积消退方面的临床疗效优于西医组。
3.3不良反应：中西医结合组47例患者,开始有1例出现轻度的胃肠道反应,停用3日后症状缓解,继续服药未出现明显不良反应。西医组47例患者,有3例出现轻中度胃肠道反应,1例恶心,2例胃痛,均停药7日对症处理后症状缓解,继续服药未出现明显不良反应。吡美莫司乳膏外用局部出现一过性瘙痒5例,其中中西医结合组3例,西医组2例,对症处理后均未影响治疗。
3.4随访：94例患者在疗程结束后,我们成功对78例患者进行了随访,其中有35位患者仍在继续治疗中。通过随访我们发现,部分患者停止治疗后出现局部白斑扩大,其中治疗组5例,1例发生在半年内,4例发生在半年后；对照组6例,4例发生在半年内,2例发生在半年后。
结论
1学术思想
杨柳教授关于白癜风学术思想：白癜风是中医病名,病机特点分期各有倚重；白癜风临床论治勿忘祛风,病初祛风解郁为要,病久滋肾养血,行血以祛风；白癜风调和气血法通过祛风解郁、活血化瘀、补益肝肾综合运用而实现；根据分期论治提出中西医结合治疗方案；提出“中药色象”理论。
2循证医学
2.1临床研究普遍存在的问题：诊断标准和疗效判断标准的不统一：疗效指标的不统一；所选试验均方法学质量不高,大多研究只提及随机,无具体随机方法描述,更无随机方案的隐藏；仅1项试验提及单盲外其他均未使用盲法；这些因素都导致很难避免实施性偏倚。
2.2另一方面是由于中西医体系的差异导致循证医学方法学运用中医疗效评价存在着局限性,建议应根据中医临床诊治特点建立适合评价中医疗效的循证医学方法。
3临床研究
3.1中西医联合疗法治疗进展期白癜风的疗效显著优于单用西药的疗效;
3.2复色1号联合疗法治疗进展期白癜风的有效率显著优于西医组；
3.3复色1号联合疗法治疗进展期白癜风在白斑面积消退方面的临床疗效优于西医组。
Background
With30years of clinical, teaching, research practice in Surgery of TCM, the tutor Professor Yang Liu, has gained rich experience by srudying and exploiting the available achievements in skin diseases, that is Traumatic Diseases such as Acne and Alopecia, Pigment Diseases such as Vitiligo and Chloasma, Infections Diseases such as Furuncles, Itch Dermatoses such as Urticaria and Eczema, having some unique understandings. Professor Yang is good at the treatment of integrated traditional Chinese and western medicine therapy and combined with internal and external treatment by Vitiligo stage, especially the theory of herbal medicine color-effect phenomenon based on clinical practice and further probing into the influence of herbal medicine color on the pigment metabolism, that has significant therapeutic effect in clinical.
Vitiligo is a kind of common, intractable depigmentation diseases. The incidence is around1%-2%of the general population. Despite of numerous therapies in use, most of them are slow in effectiveness, long in treatment course, low in recovery rate. Vitiligo is deemed to be one of the most difficult dermatological disease to cure. Many theories and the study of TCM in the treatment of Vitiligo are reported, but it's difficult to evaluate or improve the effect because of lack of the optimization treatment scheme.
For understanding the treatment of domestic medical field of Vitiligo, we evaluated the clinical study of TCM treatment of by evidence-based medicine, and we should know the clinical curative effect of objective evaluation and provide evidence for clinical treatment scheme.
In this research, the evidence-based medicine based randomized controlled methodology has been applied in the evaluation of clinic effect of integrated traditional Chinese and western medicine in the treatment of Active Vitiligo Vulgaris.
Object
1To summarize Yang Liu's academic origin, treatment characteristics, clinical experiences and inductive principle and prescriptions on Pigment Diseases, especially on Vitiligo, through learning with him, recording medical cases, and literature reviewing.
2To analyze types of TCM treatment to Vtiligo clinic literature and the features of randomized controlled literature, find problems in the current situation for the evaluation of TCM effectiveness based on evidence-based medicine.
3Various1theatments compared with the commonly recognized controlled treatment in the clinic trials to detect the actual effectiveness of integrated traditional Chinese and western medicine in the treatment of Active Vitiligo Vulgaris.
Method
1Experience summary
The teacher's academic origin and characteristics and treatment characteristics were summarized through clinical recording, analysis medical records, and treatment characteristics were summarized through clinical recording, analysis medical records, and reviewing the ancient and modern literature.
2Evidence-based Medicine
According to the analysis to all the literatures on TCM treatment for Vitiligo retrieved from2001to2010from CNKI, the literatures can be classified as randomized controlled trial, controlled trial, case series study and experts' experiences conferences. Of all the randomized controlled trial literatures, the ones chich fit the Evidence-based Medicine standards are further reviewed on meta-analysis for efficacy and safety for integrated traditional Chinese and western medicine in the treatment of Vitiligo.
3Clinical research
From August,2010to July,2009,94participants had been selected in the Traditional-Integrated Hospital and Nafang Hospital of outpatient departments. The participants were divided into two groups,47for integrated traditional Chinese and western medicine,47for western medicine. Before and after the treatment, the participants have been evaluated by main outcome measures of white spot subsided area percentage, and secondary endpoints of pigment integral. After treatment for6months, the participants were reviewed according for efficacy and safety for integrated traditional Chinese and western medicine.
Results
1Experience summary
Treatment characteristics, clinical experiences and inductive principle and prescriptioms on Vitiligo, the treatment system should be established by vitiligo stage based on herbal medicine color-effect phenomennon theory.
2Evidence-based Medicine
2.1Bibliometric analysis
In the pst10years, it's a large number on Vitiligo clinical studies that many literatures was published, and the number was increasing, almost the largest in2005, but enstable after2006. The number of literature was the most in China Journal of Leprosy and Skin Disease,25which weighs8.6%;70are controlled trials24.1%in core journals, less than quarter of the total. The literatures of clinical research on vitiligo were concentrated in the Department of Dermatology in the past10years. The institution was the3rd People's Hospital of Hangzhou which had the most research, secondly was Huashan Hospital of Fudan University and Guangzhou University of TCM, which explained the research in the field of these academic institutions were more active. The focus of domestic relevant Vitiligo were on prevention and treatment, that were difficult, and the treatment of various ways were much, secondly were study on diagnosis standard and clinical type, thirdly were the study on the prognosis and quality of life of Vitiligo, which were on the rise recently.
2.2The evaluation on Evidence-based medicine
Within the total291litertures,238are disagreement to the requirements, because of the treatment of western medicine, experimental research, case reports, reviews and repetitive literatures. Finally, there were8literatures are included in the study from53articles, study of non randomized controlled trials being excluded. It's showed that the treatment effect of optimization was better than TCM group or western medicine group, and Chinese medicine treatment had small side effects, stable curative effect, low recurrence rate.
3Two groups of clinical curative effect comparison
3.1The analysis showed that4cases were cured,17cases were effective,15cases were improved,11cases were ineffective, and effectiveness for group combined traditional Chinese and Western medicine are76.6%, of47patients, then nobody was cured,5cases were effective,21cases were improved,21cases were ineffective, and effectiveness for that are55.3%, both of which are significant different (X2=4.738, p=0.030)
3.2The analysis of therapeutic effect index showed significant statistical difference(t=5.039,p=0.000) between two groups of white spot subsided percentage comparison, and no differences (t=-0.426,p=0.670) of leukoplakia pigment ratios compatison, before and after treatment, then the clinical efficacy of combined group was better than western medicine group on white spot subsided percentage comparison.
3.3There were1case who had mild gastronintestinal reaction, recovered after3days of pause, then continue the treat, no obvious adverse reactions again, in group combined traditional Chinese and Western medicine. There were3cases who had moderate gastronintestinal reaction, including1nausea, and2stomach pain, recovered after7days of pause and symptomatic treatment, then continue the treat. There5cases who had a transient itching, then continue to treat after symptomatic treatment,3cases of combined group,2cases of western group.
3.4Follow-up
78of94patients were followed up, and35of which were treating. It showed that one part of the patients had a relapse.5cases were in combined group,1been occurred in the first half of the year, the other after the first half of the year.6cases were in western group,4cases been in the first half of the year,2cases after then.
Conclusion
1Academic Thoughts on Vitiligo
Baidianfeng is a Chinese name of disease, pathogenesis features have relied on stage treatment of Vitiligo. Dispelling Wind is the one of best treatment. Dispelling Wind and Reliving Depression in the earlys days, Nourishing Kidney and Nourishing Blood for the long days; The method of Regulating Qi and Blood is realized by Dispelling Wind and Reliving Depression, Activating Blood and Resoving Stasis, and Nourishing Liver and Kidney; Construction the treatment system by Vitilugo stage based on herbal medicine color-effect phenomennon theory; The theory of herbal medicine color-effect phenomenon based on clinical practice and further probing into the influence of herbal medicine color on the pigment metabolism.
2Evidence-based Medicine
Currently the qualities of literature for the clinical study of TCM are quite low which no unified standard of diagnosis and no uniform curative effect judgment standard, low selected test methodology, most of that only mention randomly, without a specific description of random method, hide on more random scheme; only one case mentioned single blind, others no using blind method, that have led to the bias.
Then, it is suggertested important to establish the evidence-based medicine evaluation for the TCM according to its feature, because of the limited function of evidence-based medicine due to the differences between TCM and Western medicine.
3Clinical research
3.1Effectiveness of treatment combined traditional Chinese and Western medicine are better than that of Westetn medicine.
3.2The efficiency of No.1combined therapy for active vitiligo is significantly better than that of western medicine.
3.3The effect of No.1combined therapy was better than western medicine, which in the main indicators the effect of the white spot area subsided.
杨柳教授从事中医外科学临床、科研、教学工作30余年,治学严谨,笃重临床,对痤疮、脱发等损容性疾病,白癜风、黄褐斑等色素障碍性疾病,疮疡等感染性疾病,荨麻疹、湿疹等瘙痒性疾病都有独到的见解,总结出系统规范的诊疗方法及经验方。尤其是对白癜风的治疗,通过分期论治,擅用中西医结合、内外合治等联合疗法；且通过总结药材颜色与疗效相关的经验,提出”中药色象”理论,在临床中使用“色象中药”,疗效显著。
白癜风是一种临床常见而难治的皮肤色素脱失性疾病,发病率1%～2%,治疗方法虽多,但起效慢、病程长、治愈率低,是皮肤科顽症之一。中医药治疗白癜风的各家学说与疗效报道很多,但是诊疗方案的优化研究很是缺乏,直接影响疗效的评价与疗效的提高。
为了解国内医学领域对白癜风的治疗现状,我们用循证医学来评价中医药治疗白癜风的临床试验,以期客观地评价中医药治疗白癜风的临床疗效,为临床制定治疗方案提供循证医学证据。
此次临床研究基于循证医学原则,按照规范的随机对照试验设计方法探讨中西医结合系统疗法治疗进展期白癜风的临床效果。
目的
1通过跟师学习,记录医案,文献复习,总结杨柳老师治疗色素病的学术思想,临床经验,特别是治疗白癜风的病因病机认识、分期论治、运用“色象中药”,归纳理法方药。
2遵照循证医学的原则,在白癜风流行病学、辨证分型及中西医结合治疗等文献调查研究的基础上,对中西医结合诊疗与治疗的研究成果进行梳理和总结；通过中西医结合治疗白癜风的方案研究,评价中西医结合方案在临床具体实践中对白癜风的确切治疗效果及其安全性。
3通过观察复色1号联合方案与达成共识的西医治疗常规为对照进行临床试验研究,评价中西医结合方案在临床具体实践中对进展期白癜风的确切治疗效果及其安全性,为进一步优化中西医结合分期论治白癜风的诊疗方案提供思考,为制定临床实践指南提供依据。
方法
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,总结老师学术思想、学术特点、治疗特色。
2循证医学：①选用国内权威的《中国期刊全文数据库》(CNKI),进行近十年国内关于中西医结合治疗白癜风的中医药/中西医结合临床研究文献的计量学分析；②通过检索近10年来国内公开发表的中医药治疗白癜风的相关文献,对其中采用随机对照临床试验设计的文献,进行关于中西医结合治疗白癜风临床疗效和安全性的Meta分析。
3临床研究：将2010.8-2012.7在南方医科大学附属中西医结合医院皮肤科门诊、南方医科大学附属南方医院中医外科门诊确诊为进展期白癜风的94例患者,按知情同意原则,对94例患者随机分为二组,中西医结合组47例、西医组47例；观察时间为6个月,随访期半年。通过对疗效指标(主要疗效指标：白斑消退面积百分比；次要评价指标：色素积分)进行分析,评价中西医结合方案的临床效果和对白斑的改善程度。
结果
1经验总结：归纳出老师临床论治白癜风的理法方药,构建基于“中药色象”理论分期论治白癜风的中西医结合治疗体系。
2循证医学
2.1文献计量学分析：①近10年来,国内期刊发表的有关白癜风临床研究的文献数量较多,而且总的趋势是增多的,在2005年达到最高,2006年以后有升有降。②收录文献较多的5种杂志中,以《中国麻风皮肤病杂志》居第1位,共25篇,占8.6%；核心期刊收录文献70篇,占24.1%,不到总量的1/4。另外,近10年来国内有关白癜风临床研究的文献主要集中在皮肤科杂志。③发表文献最多的机构是杭州市第三人民医院,其次是复旦大学华山医院和广州中医药大学,说明这些学术机构在此领域的研究较为活跃。④近10年来,国内有关白癜风研究的热点多集中在防治措施的研究方面,说明白癜风的治疗是难点,且治疗手段丰富多样；其次是关于临床诊断的研究,关于白癜风诊断标准及临床分型的研究；关于白癜风的预后及生存质量的研究,近年来也呈上升趋势。
2.2循证医学评价：最初检索出文献291篇,通过阅读全文,剔除不符合要求的文献238篇,包括西医治疗、实验研究、个案报道、文献综述及重复发表的文献等。剩余53篇文章阅读全文作进一步分析,排除非随机对照试验的研究,最终8篇文献纳入研究。研究显示：经优化的治疗方案疗效优于中药组／西药组；且中医药治疗毒副作用小,疗效稳定,复发率低。
3两组临床疗效比较
3.1两组临床疗效比较：中西医结合组47例患者,痊愈4例,显效17例,好转15例,无效11例,有效率76.6%；西医组47例患者,痊愈0例,显效5例,好转21例,无效21例,有效率55.3%。两组经卡方检验,有效率比较χ2=4.738,p=0.030,差异具有统计学意义。
3.2疗效指标比较分析：中西医结合组与西医组患者治疗前后,两组白斑消退面积百分比比较显示有显著性统计学差异(t=5.039,p=0.000)；中西医结合组及西医组分别进行治疗前后白斑色素积分比比较,中西医结合组(z=-5.553,p=0.000),治疗前后有显著性差异：西医组(z=-5.518,p=0.000),治疗前后有显著性差异；但两组治疗后色素积分比比较,差异无统计学意义(t=-0.426,p=0.670)。由此可见,中西医结合组在白斑面积消退方面的临床疗效优于西医组。
3.3不良反应：中西医结合组47例患者,开始有1例出现轻度的胃肠道反应,停用3日后症状缓解,继续服药未出现明显不良反应。西医组47例患者,有3例出现轻中度胃肠道反应,1例恶心,2例胃痛,均停药7日对症处理后症状缓解,继续服药未出现明显不良反应。吡美莫司乳膏外用局部出现一过性瘙痒5例,其中中西医结合组3例,西医组2例,对症处理后均未影响治疗。
3.4随访：94例患者在疗程结束后,我们成功对78例患者进行了随访,其中有35位患者仍在继续治疗中。通过随访我们发现,部分患者停止治疗后出现局部白斑扩大,其中治疗组5例,1例发生在半年内,4例发生在半年后；对照组6例,4例发生在半年内,2例发生在半年后。
结论
1学术思想
杨柳教授关于白癜风学术思想：白癜风是中医病名,病机特点分期各有倚重；白癜风临床论治勿忘祛风,病初祛风解郁为要,病久滋肾养血,行血以祛风；白癜风调和气血法通过祛风解郁、活血化瘀、补益肝肾综合运用而实现；根据分期论治提出中西医结合治疗方案；提出“中药色象”理论。
2循证医学
2.1临床研究普遍存在的问题：诊断标准和疗效判断标准的不统一：疗效指标的不统一；所选试验均方法学质量不高,大多研究只提及随机,无具体随机方法描述,更无随机方案的隐藏；仅1项试验提及单盲外其他均未使用盲法；这些因素都导致很难避免实施性偏倚。
2.2另一方面是由于中西医体系的差异导致循证医学方法学运用中医疗效评价存在着局限性,建议应根据中医临床诊治特点建立适合评价中医疗效的循证医学方法。
3临床研究
3.1中西医联合疗法治疗进展期白癜风的疗效显著优于单用西药的疗效;
3.2复色1号联合疗法治疗进展期白癜风的有效率显著优于西医组；
3.3复色1号联合疗法治疗进展期白癜风在白斑面积消退方面的临床疗效优于西医组。
Background
With30years of clinical, teaching, research practice in Surgery of TCM, the tutor Professor Yang Liu, has gained rich experience by srudying and exploiting the available achievements in skin diseases, that is Traumatic Diseases such as Acne and Alopecia, Pigment Diseases such as Vitiligo and Chloasma, Infections Diseases such as Furuncles, Itch Dermatoses such as Urticaria and Eczema, having some unique understandings. Professor Yang is good at the treatment of integrated traditional Chinese and western medicine therapy and combined with internal and external treatment by Vitiligo stage, especially the theory of herbal medicine color-effect phenomenon based on clinical practice and further probing into the influence of herbal medicine color on the pigment metabolism, that has significant therapeutic effect in clinical.
Vitiligo is a kind of common, intractable depigmentation diseases. The incidence is around1%-2%of the general population. Despite of numerous therapies in use, most of them are slow in effectiveness, long in treatment course, low in recovery rate. Vitiligo is deemed to be one of the most difficult dermatological disease to cure. Many theories and the study of TCM in the treatment of Vitiligo are reported, but it's difficult to evaluate or improve the effect because of lack of the optimization treatment scheme.
For understanding the treatment of domestic medical field of Vitiligo, we evaluated the clinical study of TCM treatment of by evidence-based medicine, and we should know the clinical curative effect of objective evaluation and provide evidence for clinical treatment scheme.
In this research, the evidence-based medicine based randomized controlled methodology has been applied in the evaluation of clinic effect of integrated traditional Chinese and western medicine in the treatment of Active Vitiligo Vulgaris.
Object
1To summarize Yang Liu's academic origin, treatment characteristics, clinical experiences and inductive principle and prescriptions on Pigment Diseases, especially on Vitiligo, through learning with him, recording medical cases, and literature reviewing.
2To analyze types of TCM treatment to Vtiligo clinic literature and the features of randomized controlled literature, find problems in the current situation for the evaluation of TCM effectiveness based on evidence-based medicine.
3Various1theatments compared with the commonly recognized controlled treatment in the clinic trials to detect the actual effectiveness of integrated traditional Chinese and western medicine in the treatment of Active Vitiligo Vulgaris.
Method
1Experience summary
The teacher's academic origin and characteristics and treatment characteristics were summarized through clinical recording, analysis medical records, and treatment characteristics were summarized through clinical recording, analysis medical records, and reviewing the ancient and modern literature.
2Evidence-based Medicine
According to the analysis to all the literatures on TCM treatment for Vitiligo retrieved from2001to2010from CNKI, the literatures can be classified as randomized controlled trial, controlled trial, case series study and experts' experiences conferences. Of all the randomized controlled trial literatures, the ones chich fit the Evidence-based Medicine standards are further reviewed on meta-analysis for efficacy and safety for integrated traditional Chinese and western medicine in the treatment of Vitiligo.
3Clinical research
From August,2010to July,2009,94participants had been selected in the Traditional-Integrated Hospital and Nafang Hospital of outpatient departments. The participants were divided into two groups,47for integrated traditional Chinese and western medicine,47for western medicine. Before and after the treatment, the participants have been evaluated by main outcome measures of white spot subsided area percentage, and secondary endpoints of pigment integral. After treatment for6months, the participants were reviewed according for efficacy and safety for integrated traditional Chinese and western medicine.
Results
1Experience summary
Treatment characteristics, clinical experiences and inductive principle and prescriptioms on Vitiligo, the treatment system should be established by vitiligo stage based on herbal medicine color-effect phenomennon theory.
2Evidence-based Medicine
2.1Bibliometric analysis
In the pst10years, it's a large number on Vitiligo clinical studies that many literatures was published, and the number was increasing, almost the largest in2005, but enstable after2006. The number of literature was the most in China Journal of Leprosy and Skin Disease,25which weighs8.6%;70are controlled trials24.1%in core journals, less than quarter of the total. The literatures of clinical research on vitiligo were concentrated in the Department of Dermatology in the past10years. The institution was the3rd People's Hospital of Hangzhou which had the most research, secondly was Huashan Hospital of Fudan University and Guangzhou University of TCM, which explained the research in the field of these academic institutions were more active. The focus of domestic relevant Vitiligo were on prevention and treatment, that were difficult, and the treatment of various ways were much, secondly were study on diagnosis standard and clinical type, thirdly were the study on the prognosis and quality of life of Vitiligo, which were on the rise recently.
2.2The evaluation on Evidence-based medicine
Within the total291litertures,238are disagreement to the requirements, because of the treatment of western medicine, experimental research, case reports, reviews and repetitive literatures. Finally, there were8literatures are included in the study from53articles, study of non randomized controlled trials being excluded. It's showed that the treatment effect of optimization was better than TCM group or western medicine group, and Chinese medicine treatment had small side effects, stable curative effect, low recurrence rate.
3Two groups of clinical curative effect comparison
3.1The analysis showed that4cases were cured,17cases were effective,15cases were improved,11cases were ineffective, and effectiveness for group combined traditional Chinese and Western medicine are76.6%, of47patients, then nobody was cured,5cases were effective,21cases were improved,21cases were ineffective, and effectiveness for that are55.3%, both of which are significant different (X2=4.738, p=0.030)
3.2The analysis of therapeutic effect index showed significant statistical difference(t=5.039,p=0.000) between two groups of white spot subsided percentage comparison, and no differences (t=-0.426,p=0.670) of leukoplakia pigment ratios compatison, before and after treatment, then the clinical efficacy of combined group was better than western medicine group on white spot subsided percentage comparison.
3.3There were1case who had mild gastronintestinal reaction, recovered after3days of pause, then continue the treat, no obvious adverse reactions again, in group combined traditional Chinese and Western medicine. There were3cases who had moderate gastronintestinal reaction, including1nausea, and2stomach pain, recovered after7days of pause and symptomatic treatment, then continue the treat. There5cases who had a transient itching, then continue to treat after symptomatic treatment,3cases of combined group,2cases of western group.
3.4Follow-up
78of94patients were followed up, and35of which were treating. It showed that one part of the patients had a relapse.5cases were in combined group,1been occurred in the first half of the year, the other after the first half of the year.6cases were in western group,4cases been in the first half of the year,2cases after then.
Conclusion
1Academic Thoughts on Vitiligo
Baidianfeng is a Chinese name of disease, pathogenesis features have relied on stage treatment of Vitiligo. Dispelling Wind is the one of best treatment. Dispelling Wind and Reliving Depression in the earlys days, Nourishing Kidney and Nourishing Blood for the long days; The method of Regulating Qi and Blood is realized by Dispelling Wind and Reliving Depression, Activating Blood and Resoving Stasis, and Nourishing Liver and Kidney; Construction the treatment system by Vitilugo stage based on herbal medicine color-effect phenomennon theory; The theory of herbal medicine color-effect phenomenon based on clinical practice and further probing into the influence of herbal medicine color on the pigment metabolism.
2Evidence-based Medicine
Currently the qualities of literature for the clinical study of TCM are quite low which no unified standard of diagnosis and no uniform curative effect judgment standard, low selected test methodology, most of that only mention randomly, without a specific description of random method, hide on more random scheme; only one case mentioned single blind, others no using blind method, that have led to the bias.
Then, it is suggertested important to establish the evidence-based medicine evaluation for the TCM according to its feature, because of the limited function of evidence-based medicine due to the differences between TCM and Western medicine.
3Clinical research
3.1Effectiveness of treatment combined traditional Chinese and Western medicine are better than that of Westetn medicine.
3.2The efficiency of No.1combined therapy for active vitiligo is significantly better than that of western medicine.
3.3The effect of No.1combined therapy was better than western medicine, which in the main indicators the effect of the white spot area subsided.
引文
[1]邓燕,杨柳,安胜利.不同浓度的中药刺蒺藜对黑素细胞及酪氨酸酶的作用[J].第一军医大学学报,2002,22(11)：1017-9
[2]邓燕,杨柳.当归对体外黑素细胞及酪氨酸酶的激活作用[J].第一军医大学学报,2003,23(3)：239-41
[3]杨柳,邓燕.紫河车体外对黑素细胞增殖及酪氨酸酶活性的影响[J].第一军医大学学报,2004,24(9)：1040-4
[4]洪逊强,杨柳,刘利利,潘恩山.色象中药对人A375黑素瘤细胞增殖及黑素合成的影响[J].陕西中医,2011,32(6)：755-757
[5]谢家宝,洪逊强,刘利利,潘恩山,马玲玲,杨柳.色象中药对人A375黑素瘤细胞酪氨酸酶活性的影响[J].陕西中医,2011,32(3)：361-363
[6]杨柳,刘利利,洪逊强,潘恩山.常用中药脱色对人A375黑素瘤细胞酪氨酸酶活性的影响研究[J].陕西中医,2011,32(5)：634-635
[7]邓燕,马玲玲,杨柳.中医药治疗白癜风的循证医学评价[J].新中医,2011,43(10)：106-108
[8]邓燕,陈秋源,许活利,胡亚南,谢旭敏,郑楚,隋京利,杨柳.近10年白癜风临床研究现状的文献计量学分析[J].新中医,2011,43(1)：120-121
[1]赵辨.临床皮肤病学[M].3版.苏州：江苏科学技术出版社,2001：1046-1049.
[1]赵辨主编.临床皮肤病学[M].第3版.苏州：江苏科学技术出版社,2001：1046-1049.
[2]张予.白癜风片、搽剂治疗白癜风88例临床观察.四川中医,21(12)：74-75.
[3]刘志军,向亚平.消白合剂治疗白癜风的临床观察.中国中西医结合杂志,23(8)：596-598.
[4]李振洁,朱慧兰,刘玉梅,梁燕梅.他卡西醇治疗白癜风的临床观察,中国美容医学,2006,15(3)：315-316.
[5]于建斌,王宏瑾,李红文,苗青,何秋波,张江安.补骨脂注射液联合卤米松乳膏治疗成人白癜风疗效观察.中国皮肤性病学杂志,20(9)：7-8.
[6]谢勇.祛白酊治疗白癜风的临床研究.中国麻风皮肤病杂志,2006,22(12)：997-999.
[7]邓德选,李金辉,孙本海,朱爱霞,卢庆芳.白癜风汤联合窄谱UVB治疗白癜风的临床研究.中国麻风皮肤病杂志,2008,24(1)：39-40.
[8]王一枫,高家鉴.祛癜复色软膏治疗寻常型白癜风40例疗效观察.浙江中医杂志,2009,44(4)：284.
[9]张虹亚,冯璐,查日煌,刘小平,刘涛峰,孙洪波.复方补乌糖浆治疗白癜风临床观察及对血清肾上腺素和去甲肾上腺素的影响.新中医,2009,41(10)：35-36.
[1]杨柳,紫铜消白方对白癜风患者黑素细胞影响的研究[J].湖南中医药导报1995(1)：22
[2]杨柳.紫铜消白方对白癜风患者郎格罕细胞影响的研究[J].湖南中医药导报1996(2)：31
[3]杨柳.白癜风患者黑素细胞与郎格罕细胞形态计量学研究[J].第一军医大学学报1997,17(3)：218
[4]杨柳.白癜风中西医研究进展[J].中国中医药信息杂志1998,5(9)：22,
[5]杨柳.当归对体外黑素细胞和酪氨酸酶的激活作用[J].第一军医大学学报2003,23(3)：239
[6]杨柳.女贞子首乌血清对酪氨酸酶活性的影响[J].四川中医杂志2004,22(5)：20
[7]杨柳.不同剂量配伍白蒺藜血清灭活与否对TYE活性的影响[J].中华实用中西医杂志2004,4(17)：10：1472-1474
[8]杨柳.调和气血复方对体外培养黑素细胞和酪氨酸酶活性影响的实验研究[J].中华实用中西医杂志2004,4(17)16：2528-2530
[9]杨柳.紫河车对体外黑素细胞增殖及酪氨酸酶活性的影响[J].第一军医大学学报2004,24(9)：1040～41,
[10]杨柳.白蒺藜血清对酪氨酸酶活性的双向调节作用[J].陕西中医杂志2005,26(4)：370～373
[11]杨柳.刺蒺藜对小鼠毛囊黑素细胞刺激素表达的影响[J].南方医科大学学报,2006,(12)：1777-1779
[12]杨柳.α-黑素细胞刺激素在不同实验动物表皮中的表达及意义[J].浙江中医药大学学报2008,32(1)：27-29
[1]邓燕,刘祯,肖艳,刘咏基.六味地黄方对体外培养的人正常黑素细胞增殖及黑素合成的影响[J].南方医科大学学报,2009；29(4)：701-703,706
[2]邓燕,朱晓雯,郑晓霞,李鹏.六味地黄方含药血清对酪氨酸酶活性的影响[J].新中医,2010,42(3)：99-100
[3]Spritz RA. The genetics of generalized vitiligo[M]. CurrDir Autoimmun,2008: 244-257
[4]Le poole IC, Luiten RM. Autoimmune etiology of generalized vitiligo[M], CurrDir Autoimmun,2008:227-243
[5]Ma HJ, Yue XZ, Wang DQ Li CR, Zhu WY. A modified method for purifying amelanotic melanocytes from human follicles [J]. J Dermatol,2006,33(4):239-248
[6]肖艳,刘祯,邓燕(通讯作者).复方中药对黄褐斑的实验研究进展[J].现代中西医结合杂志,2009,18(9)：1056-1058
[7]邓燕,杨柳.中药对黑素细胞及酪氨酸酶调节作用的研究进展[J].新中医,2003(5)：72
[8]刘祯,肖艳,邓燕(通讯作者).中药对黑素细胞及酪氨酸酶双向调节作用的研究进展[J].新中医,2008,40(4)：117-118
[9]邓燕,杨柳.当归对体外黑素细胞和酪氨酸酶的激活作用[J].第一军医大学学 报,2003,23(3)：239-241
[10]杨柳,邓燕.紫河车体外对黑素细胞增殖及酪氨酸酶活性的影响[J].第一军医大学学报,2004,24(9)：1040-1044
[11]邓燕,杨柳.不同浓度的中药刺蒺藜对黑素细胞和酪氨酸酶的作用[J].第一军医大学学报,2002,22(11)：1017-1019
[12]邓燕,陈秋源,许活利,胡亚南,谢旭敏,郑楚,隋京利,杨柳.近10年白癜风临床研究现状的文献计量学分析.新中医,2011,43(1)：120-121
[13]邓燕,马玲玲,杨柳.中医药治疗白癜风的循证医学评价.新中医,2011,43(10)：106-108
[14]邓燕,杨柳.基于”中药色象”理论构建白癜风分期论治体系初探.中国医药导报.2012,9(34)：99-100
[2]邓燕,杨柳.当归对体外黑素细胞及酪氨酸酶的激活作用[J].第一军医大学学报,2003,23(3)：239-41
[3]杨柳,邓燕.紫河车体外对黑素细胞增殖及酪氨酸酶活性的影响[J].第一军医大学学报,2004,24(9)：1040-4
[4]洪逊强,杨柳,刘利利,潘恩山.色象中药对人A375黑素瘤细胞增殖及黑素合成的影响[J].陕西中医,2011,32(6)：755-757
[5]谢家宝,洪逊强,刘利利,潘恩山,马玲玲,杨柳.色象中药对人A375黑素瘤细胞酪氨酸酶活性的影响[J].陕西中医,2011,32(3)：361-363
[6]杨柳,刘利利,洪逊强,潘恩山.常用中药脱色对人A375黑素瘤细胞酪氨酸酶活性的影响研究[J].陕西中医,2011,32(5)：634-635
[7]邓燕,马玲玲,杨柳.中医药治疗白癜风的循证医学评价[J].新中医,2011,43(10)：106-108
[8]邓燕,陈秋源,许活利,胡亚南,谢旭敏,郑楚,隋京利,杨柳.近10年白癜风临床研究现状的文献计量学分析[J].新中医,2011,43(1)：120-121
[1]赵辨.临床皮肤病学[M].3版.苏州：江苏科学技术出版社,2001：1046-1049.
[1]赵辨主编.临床皮肤病学[M].第3版.苏州：江苏科学技术出版社,2001：1046-1049.
[2]张予.白癜风片、搽剂治疗白癜风88例临床观察.四川中医,21(12)：74-75.
[3]刘志军,向亚平.消白合剂治疗白癜风的临床观察.中国中西医结合杂志,23(8)：596-598.
[4]李振洁,朱慧兰,刘玉梅,梁燕梅.他卡西醇治疗白癜风的临床观察,中国美容医学,2006,15(3)：315-316.
[5]于建斌,王宏瑾,李红文,苗青,何秋波,张江安.补骨脂注射液联合卤米松乳膏治疗成人白癜风疗效观察.中国皮肤性病学杂志,20(9)：7-8.
[6]谢勇.祛白酊治疗白癜风的临床研究.中国麻风皮肤病杂志,2006,22(12)：997-999.
[7]邓德选,李金辉,孙本海,朱爱霞,卢庆芳.白癜风汤联合窄谱UVB治疗白癜风的临床研究.中国麻风皮肤病杂志,2008,24(1)：39-40.
[8]王一枫,高家鉴.祛癜复色软膏治疗寻常型白癜风40例疗效观察.浙江中医杂志,2009,44(4)：284.
[9]张虹亚,冯璐,查日煌,刘小平,刘涛峰,孙洪波.复方补乌糖浆治疗白癜风临床观察及对血清肾上腺素和去甲肾上腺素的影响.新中医,2009,41(10)：35-36.
[1]杨柳,紫铜消白方对白癜风患者黑素细胞影响的研究[J].湖南中医药导报1995(1)：22
[2]杨柳.紫铜消白方对白癜风患者郎格罕细胞影响的研究[J].湖南中医药导报1996(2)：31
[3]杨柳.白癜风患者黑素细胞与郎格罕细胞形态计量学研究[J].第一军医大学学报1997,17(3)：218
[4]杨柳.白癜风中西医研究进展[J].中国中医药信息杂志1998,5(9)：22,
[5]杨柳.当归对体外黑素细胞和酪氨酸酶的激活作用[J].第一军医大学学报2003,23(3)：239
[6]杨柳.女贞子首乌血清对酪氨酸酶活性的影响[J].四川中医杂志2004,22(5)：20
[7]杨柳.不同剂量配伍白蒺藜血清灭活与否对TYE活性的影响[J].中华实用中西医杂志2004,4(17)：10：1472-1474
[8]杨柳.调和气血复方对体外培养黑素细胞和酪氨酸酶活性影响的实验研究[J].中华实用中西医杂志2004,4(17)16：2528-2530
[9]杨柳.紫河车对体外黑素细胞增殖及酪氨酸酶活性的影响[J].第一军医大学学报2004,24(9)：1040～41,
[10]杨柳.白蒺藜血清对酪氨酸酶活性的双向调节作用[J].陕西中医杂志2005,26(4)：370～373
[11]杨柳.刺蒺藜对小鼠毛囊黑素细胞刺激素表达的影响[J].南方医科大学学报,2006,(12)：1777-1779
[12]杨柳.α-黑素细胞刺激素在不同实验动物表皮中的表达及意义[J].浙江中医药大学学报2008,32(1)：27-29
[1]邓燕,刘祯,肖艳,刘咏基.六味地黄方对体外培养的人正常黑素细胞增殖及黑素合成的影响[J].南方医科大学学报,2009；29(4)：701-703,706
[2]邓燕,朱晓雯,郑晓霞,李鹏.六味地黄方含药血清对酪氨酸酶活性的影响[J].新中医,2010,42(3)：99-100
[3]Spritz RA. The genetics of generalized vitiligo[M]. CurrDir Autoimmun,2008: 244-257
[4]Le poole IC, Luiten RM. Autoimmune etiology of generalized vitiligo[M], CurrDir Autoimmun,2008:227-243
[5]Ma HJ, Yue XZ, Wang DQ Li CR, Zhu WY. A modified method for purifying amelanotic melanocytes from human follicles [J]. J Dermatol,2006,33(4):239-248
[6]肖艳,刘祯,邓燕(通讯作者).复方中药对黄褐斑的实验研究进展[J].现代中西医结合杂志,2009,18(9)：1056-1058
[7]邓燕,杨柳.中药对黑素细胞及酪氨酸酶调节作用的研究进展[J].新中医,2003(5)：72
[8]刘祯,肖艳,邓燕(通讯作者).中药对黑素细胞及酪氨酸酶双向调节作用的研究进展[J].新中医,2008,40(4)：117-118
[9]邓燕,杨柳.当归对体外黑素细胞和酪氨酸酶的激活作用[J].第一军医大学学 报,2003,23(3)：239-241
[10]杨柳,邓燕.紫河车体外对黑素细胞增殖及酪氨酸酶活性的影响[J].第一军医大学学报,2004,24(9)：1040-1044
[11]邓燕,杨柳.不同浓度的中药刺蒺藜对黑素细胞和酪氨酸酶的作用[J].第一军医大学学报,2002,22(11)：1017-1019
[12]邓燕,陈秋源,许活利,胡亚南,谢旭敏,郑楚,隋京利,杨柳.近10年白癜风临床研究现状的文献计量学分析.新中医,2011,43(1)：120-121
[13]邓燕,马玲玲,杨柳.中医药治疗白癜风的循证医学评价.新中医,2011,43(10)：106-108
[14]邓燕,杨柳.基于”中药色象”理论构建白癜风分期论治体系初探.中国医药导报.2012,9(34)：99-100