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刘云鹏治疗盆腔炎性疾病的经验
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摘要
研究目的
     盆腔炎性疾病是临床常见病、多发病,临床以腹痛、带下、盆腔组织增厚、粘连、包块形成为主要特征。是造成慢性盆腔疼痛、异位妊娠和不孕的重要原因,其病程缠绵难愈,容易复发,严重影响患者的身心健康,发病有逐年增高的趋势。因此,在妇科领域,盆腔炎性疾病的防治是一项值得重视的课题,提高盆腔炎性疾病的痊愈率已成为目前治疗盆腔炎性疾病所要解决的首要问题。本课题通过查阅理论文献和临床研究,总结整理全国名老中医刘云鹏主任医师治疗盆腔炎性疾病的经验,为进一步推广应用名老中医经验提供依据。
     研究方法
     一、跟师临床
     通过临床跟师,学习刘云鹏主任医师的临证思维方法,总结刘云鹏主任医师对盆腔炎性疾病的治疗经验、用药特点。
     二、临床研究
     通过观察刘云鹏经验方妇炎清颗粒治疗盆腔炎性疾病后遗症(湿热瘀结证)患者临床疗效和妇炎清颗粒对盆腔炎性疾病后遗症(湿热瘀结证)患者血清白细胞介素-2(IL-2)、T细胞亚群(CD4+、CD8+)的影响,探讨妇炎清颗粒治疗盆腔炎性疾病后遗症(湿热瘀结证)的安全性、有效性及可能作用机制。
     (一)病例来源
     选取2010年8月至2011年2月期间在荆州市中医医院门诊和住院治疗的,符合病例筛选标准的70例盆腔炎性疾病后遗症(湿热瘀结证)患者。
     (二)诊断标准
     1.西医诊断标准
     参照《中药新药临床研究指导原则》(2002年版)中关于慢性盆腔炎的诊断标准制定。
     2.中医辨证标准
     湿热瘀结证辨证标准参照《中药新药临床研究指导原则》(2002年版)中药新药治疗盆腔炎的临床研究指导原则中湿热瘀结证的辨证标准制定。
     3.症状分级量化评分标准
     参考《中药新药临床研究指导原则》(2002年版)中药新药治疗盆腔炎的临床研究指导原则中慢性盆腔炎症状分级量化标准拟定。
     (三)治疗方法
     将70例患者随机分为治疗组与对照组,治疗组35例,服用妇炎清颗粒,1日3次,每次1包,温开水冲服,疗程4周。对照组35例,服用金刚藤胶囊,1日3次,每次4粒,温开水送服,疗程4周。所有患者在治疗期间不使用其他抗生素或治疗本病的其他药物。
     (四)疗效评价标准
     1.临床疗效判定
     参考《中药新药临床研究指导原则》(2002年版)拟定。
     2.证候疗效判定标准
     参考《中药新药临床研究指导原则》(2002年版)拟定。
     (五)观察指标
     1.临床症状和体征:治疗前、用药第8天、用药4周后、停药4周,各观测和记录1次。
     2.血IL-2、CD4+、CD8+,治疗前、用药4周后,各检查1次。
     3.一般体检项目:治疗前、治疗后,各检查1次。
     4.查心电图、肝功能(ALT)、肾功能(BUN),治疗前后各1次
     5.不良事件随时记录。
     (六)统计方法
     所有数据用统计软件包SPSS18.0进行统计分析,计量资料采用x±s,min,max,M表示,组间比较采用t检验,非正态分布采用秩和检验;计数资料采用构成比及率,组间比较采用x2检验,等级资料组间比较采用秩和检验。
     研究结果
     (一)总结整理刘云鹏主任医师治疗盆腔炎性疾病的经验方、用药特点、辨证要点。发表有关刘云鹏治疗盆腔炎性疾病经验的文章3篇后遗症,出版《刘云鹏医案医话》。
     (二)妇炎清颗粒临床疗效
     临床研究表明,妇炎清颗粒治疗盆腔炎性疾病(湿热瘀结证)有较好疗效,总有效率和金刚藤胶囊相当,痊愈率明显高于金刚藤胶囊。治疗组和对照组有效率均为100%;治疗组和对照组痊愈率分别为31.4%和11.4%,两组比较差异有显著性意义(P<0.05);两组对小腹痛、腰痛、带下异常等症状均有显著疗效,治疗前后积分比较,差异有显著性意义(P<0.01)。
     (三)药物对免疫功能的影响
     1.对外周血T细胞亚群的影响
     在本研究中,治疗前两组患者CD4+、CD8+、CD4+/CD8+组间比较,差异无显著性意义(P>0.05),具有可比性;治疗后治疗组CD4+上升,CD8+下降,CD4+/CD8+上升,与治疗前比较,差异有极显著性意义(P<0.01);治疗后对照组CD4+上升,CD8+下降,CD4+/CD8+上升,与治疗前比较,差异有显著性意义(P<0.05)。
     2.对白细胞介素-2(IL-2)的影响
     研究表明,治疗前两组血清IL-2浓度比较,差异无显著性意义(P>O.05),具有可比性。治疗后治疗组和对照组IL-2值均较治疗前升高,治疗组与治疗前比较,差异有极显著性意义(P<0.01),对照组与治疗前比较,差异有显著性意义(P<0.05)
     研究结论
     刘云鹏主任医师行医济世八十余年,对妇科疾病的诊断治疗形成了系统的理论,本文从刘老的学术思想、对盆腔炎性疾病的认识、治疗、处方用药特点等方面进行了总结。刘老诊断疾病强调舌脉,强调辨证论治,治疗妇科疾病重视肝脾肾,刘老认为盆腔炎性疾病的主要病因病机为湿瘀互结,治疗盆腔炎性疾病强调祛邪的同时注重调肝脾,理气血以扶正,柴枳败酱汤(妇炎清颗粒)和除湿化瘀方是刘老根据多年临床经验形成的疗效可靠的验方。临床研究显示刘老治疗盆腔炎性疾病的处方妇炎清颗粒可有效消除或改善盆腔炎性疾病后遗症(湿热瘀结证)患者临床症状,调节机体免疫功能,增强机体抵抗力,促进盆腔局部炎症吸收,不失为临床治疗盆腔炎性疾病的有效途径。妇炎清颗粒治疗盆腔炎性疾病(湿热瘀结证)后遗症有较好的疗效,但由于条件限制,本研究仅采用了随机对照的方法,未使用更为客观的盲法,故在结果中不能绝对排除不客观的因素。由于时间和经费等客观条件的限制,本课题的研究还不够深入,对其机理的探讨,有待于今后做更深入的研究。
[objective]
     Chronic Pelvic Inflammation sequela is clinical frequently-seen and encountered disease. Its clinical symptons are abdominal pain, morbid leucrrhea, tissue incrassation in pelvic cavity, accretion and the formation of enclosed mass, which may cause chronic pain in pelvis cavity, ectopic pregnancy and infertility. The disease lasts long time, hard to cure and easy to relapse, which may affect the physical and psychological health of the patients. With the disease increasing year by year, the prevention of it has become a worthwhile issue. The priority is to improve cure rate in treating Chronic Pelvic Inflammation sequela. Through reviewing the literature and studying clinically, the paper is to sum up the remedial experience of national famous herbist doctor Liuyunpeng for the treatment of Pelvic Inflammation sequela and provide theoretical basis for the application and dissemination of the remedial experience of national famous herbist doctors
     [Method]
     1practice with Liyunpeng clinically Practicing along with Liuyunpeng clinically can help to learn about his clinical thought and to sum up his clinical experience and his herb administration in treating pelvis Inflammation.
     2clinical study
     The study is to observe the clinical effect of Fuyanqing granule on Chronic Pelvic Inflammation of Damp-Heat blood stasis type and the clinical effect of Fuyanqing granule on serum IL-2and T-cell subsets (CD4+,CD8+)of the patients, further discuss the safety and efficacy and mechanism of Fuyanqing granule.
     (1) source of patients
     70patients with Chronic Pelvic Inflammation of Damp-Heat blood stasis type are selected based on screening standards from the clinical and hospitalized patients who came to Jingzhou hospital of Tranditional Chinese Medicine during the August of2010and the Feburary of2011
     (2)Dignostic standards
     1) Dignostic standard of western medicine
     The dignostic standard of Chronic Pelvic Inflammation refers to the guidance principle of clinical study on new drug of traditional Chinese medicine (2002)
     2) Dignostic standard of chinese medicine
     The dignostic standard of Damp-Heat blood stasis type refer to the guidance principle of clinical study on new drug of traditional Chinese medicine (2002)
     3) Grading and quantitation standard of sympton
     It refers to Grading and quantitation standard of sympton of chronic pelvic inflammation in the guidance principle of clinical study on new drug of traditional Chinese medicine (2002)
     (3)Therapautic method
     70patients are divided randomly into into treating group (orally taking one package of Fuyanqing granule with lukewarm water three times a day) and contrast group (orally taking4capsules of Jinggangteng with lukewarm water three times a day) for4weeks. All the subject patients do not take any other antibiotics or other medicine for treating Chronic Pelvic Inflammation.
     (4)Evaluation standards of curative effect
     1) Evaluation standard of clinical effect
     It refers to the guidance principle of clinical study on new drug of traditional Chinese medicine (2002)
     2) Syndrom evaluation standard
     It refers to the guidance principle of clinical study on new drug of traditional Chinese medicine (2002)
     (5) Index observation
     1) clinical sympton and physical signs will be observed and recorded before beginning treatment, on the8th day after medicine treatment, after4-week medicine treatment,and after4-week medicine withdrawal.
     2) test IL-2、CD4+、CD8+before treatment and after4-week medicine treatment.
     3) normal physical examination will be done before and after treatment.
     4) examine electrocardiogram, ALT, BUN before and after treatment.
     5) record all adverse events during treatment
     (6)Statistic methods All data will be analyzed by SPAA18.0. For measurement data, x±s, min,max,M will be used and comparison between groups is made by t test, Wilcoxon rank sum test is used to get abnormal distribution. For enumeration data, constituent ratio and rate will be used, and comparison between group will be made by t2test, comparison between ranked data is made by Wilcoxon rank sum test.
     [Result]
     1The study sums up Liuyunpeng's prescriptions of treating Chronic Pelvic Inflammation, his drug administration and his dignostic key points. Three articles are published about Liuyunpeng's experience of treating Chronic Pelvic Inflammation and one book is published about his cases and his thoughts.
     2curative effect of Fuyanqing granule
     The result shows that Fuyanqing has better efficacy. The effective rate of Fuyanqing is equal to that of Jinggangteng capsule and cure rate of Fuyanqing is markedly higher than that of Jinggangteng. The effective rate is100%in treating group and contrast group. The cure rate is31.4%for treating group and11.4%for contrast group and the two groups are significantly different (P <0.05); It has remarkable effect on eliminating the sympton of hypogastric pain, lumbago,abnormal morbit leukorrhea, in both groups than before treatment (P<0.01)
     3Effect of medicine on immune system
     (1) effect on PB T cell subsets
     Before beginning treatment, the comparison of CD4+、CD8+、CD4+/CD8+between groups shows they are unremarkeablly different(p>0.05) and they have comparablity. After treatment, CD4+rises and CD8+falls and CD4+/CD8+rises in treating group and they are significantly different (P<0.01) compared with before treatment. In contrast group, CD4rises and CD8falls and CD4+/CD8+rises and they are significantly different (P<0.05) compared with before treatment.
     (2) Effect on IL-2
     Before beginning treatment, comparison of IL-2in both groups shows that they are unremarkably different (P>0.05) and they have comparablity. After beginning treatment, IL-2rises in both groups compared with before treatment and the difference is highly significant for treating group (P<0.01) and the difference is significant for contrast group (P<0.05)
     [Conclusion] Liuyunpeng practices medicine for over80years and forms a systematic dignostic and prescriptive thought for gychaecological disease. The paper is to sum up his academic thought, including his understanding about Chronic Pelvic Inflammation sequela, his dignostic and prescriptive feature. Liuyunpeng stresses tongue and pulse parameters and treatment based on syndrom differentiation. He stresses liver, speen and kidney in the treament of gychaecological disease stresses. He thinks that the pathogenic factor for pelvic inflammation is dampness together with stagnation. So, he stresses harmonizing liver and speen and regulating vital energy and blood to strengthen body resistence while eliminating pathogenes. Fuyanqing granule and another experienced prescription of eliminating dampness and eliminating blood stasis are his prescriptions obtained in his clinical life. Clinical study shows that Fuyanqing can eliminate clinical Pelvic Inflammation syndrom, regulate body immunity, strengthen body resistance and promote the absorption of inflammation. Clinical study shows that Fuyanqing has good effect on pelvic inflammation of Damp-Heat blood stasis type. With limited conditions, the study adopts random comparison rather than more objective blinding, so the non-objective factors can not be excluded absolutely in the study. Due to the limitation of cost and time, the pathology of pelvic inflammation need to be further studied in the future.
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