仙方活命饮治疗痤疮的meta分析及临床疗效观察

发布时间：2018-04-02 23:23

本文选题：仙方活命饮　切入点：痤疮　出处：《广州中医药大学》2017年硕士论文

【摘要】：目的仙方活命饮是治疗疮疡肿毒阳证的常用方,临床常用之治疗痤疮,疗效颇佳,但至今未有循证医学的证据证明其有效性及安全性。本研究通过对仙方活命饮治疗痤疮的RCT文献行meta分析,并通过观察仙方活命饮治疗痰瘀互结型痤疮的临床疗效,为仙方活命饮治疗痤疮的临床应用提供并补充循证医学的依据。方法一、Meta分析:通过计算机检索中外电子数据库,检索时间定为2016年12月31日以前,治疗组以口服中药方仙方活命饮为主要治疗手段,对照组以西药或中成药为主要治疗手段。严格按照纳入标准及排除标准的要求对相关文献进行筛选,对最终的纳入文献进行数据的提取及文献质量评价,应用Revman5.3软件对其有效率、不良反应发生率及治疗后皮损评分进行统计评价。二、临床疗效观察:将符合研究条件的80例痰瘀互结型痤疮的患者随机分为治疗组及对照组,治疗组(40例)予仙方活命饮汤剂,对照组(40例)予盐酸米诺环素胶囊口服,两组均联合火针外治,以4周为一个疗程,共治疗两个疗程。治疗后对皮损评分、中医症候评分、综合疗效、不良反应发生率进行评定。结果一、Meta分析:本研究共纳入13篇文献,实验组共纳入研究对象711例,对照组共纳入研究对象682例。Meta分析结果表明:1.有效率:仙方活命饮组治疗痤疮有效率高于抗生素组(OR=3.03,95%CI[1.90,4.83],P0.00001)及中成药组(OR=2.22,95%CI[1.10,4.45],P=030.05),且中西医结合治疗痤疮疗效高于单纯使用抗生素或维A酸类药组治疗(OR=3.34,95%CI[2.23,4.99],P0.00001),而与维A酸类药物相比则疗效相当(OR=1.11,95%CI[0.51,2.43],P=0.790.05)。2.不良反应发生率:仙方活命饮组不良反应发生率低于西药组(OR=0.33,95%CI[0.20,0.56],P0.0001),而仙方活命饮组与中成药组对比不良反应发生率相当(OR=3.09,95%CI[0.31,30.40],P=0.33)。3.治疗后皮损评分:只有2篇纳入文献对治疗结束后皮损评分进行了评定,且对照组干预措施均为中成药,结果显示仙方活命饮对患者皮损的改善优于中成药(MD=-4.44,95%CI[-6.33,-2.55],Z=4.60(P0.00001)。二、临床疗效观察:80名痰瘀互结型痤疮受试者中,实验组脱落3例,对照组脱落2例,最终共有可评价患者75例,其中实验组37例,对照组38例。1.基线比较:经检验,两组患者性别、年龄、病程、治疗前皮损评分、中医症候评分差异无统计学意义,基线可比。2.皮损评分:两组治疗4周后组内皮损评分比较,P值均小于0.05,差异具有显著性;两组治疗4周后组间皮损评分比较,P=0.480(P0.05),差异不具有显著性,两组治疗4周后的皮损评分差值比较,P=0.060(P0.05),差异不具有显著性;两组治疗8周后组间皮损评分比较,P=0.002(P0.05),差异具有显著性。治疗8周后的皮损评分差值比较,P=0.010(P0.05),差异具有显著性。说明两种治疗方案都是有效的,治疗4周后两组间皮损评分无显著差异,而随着疗程延长,8周后仙方活命饮组对皮损的改善优于盐酸米诺环素组。3.中医症候评分:两组治疗4周后组内中医症候评分比较,P值均小于0.05,差异具有显著性;两组治疗4周后组间中医症候评分比较,P=0.002(P0.05),差异具有显著性;组间治疗4周后中医症候评分差值比较,P=0.002(P0.05),差异具有显著性。两组治疗8周后组间中医症候评分比较,P=0.000,差异具有显著性。两组治疗8周后的中医症候评分差值比较,P=0.000(P0.05),差异具有显著性。说明两种治疗方法均能有效改善中医症候,而仙方活命饮组对中医症候的改善优于盐酸米诺环素组。4.综合疗效:治疗8周后,实验组总有效率为97.30%,对照组总有效率为84.2%,P=0.006(P0.05),差异具有显著性,说明仙方活命饮组综合疗效优于盐酸米诺环素组。5.不良反应发生率:两组不良反应发生情况经Fisher的精确检验,P=0.24,P0.05,差异无显著性。结论一、Meta分析:本研究表明:仙方活命饮治疗痤疮有效率高于抗生素、中成药,而与维A酸类药物相比无显著差异,且本方联合西药治疗有效率高于单纯西药治疗。仙方活命饮不良反应发生率较西药低,与中成药相比无显著差异。仙方活命饮对患者皮损的改善优于中成药。但鉴于本研究所纳入的文献数相对较少、纳入文献质量普遍不高,可能影响结果的准确性和可靠性。二、临床疗效观察:通过对两组皮损评分、中医症候评分、综合疗效、不良反应发生率的比较,证实了两组治疗方案的有效性,且实验组对皮损评分、中医症候评分、综合疗效的改善优于对照组,两组不良反应发生率无显著差异。仙方活命饮是治疗痰瘀互结型痤疮的良方,值得临床推广应用。
[Abstract]:Objective to Xianfang Huoming decoction is commonly used in treatment of sores Yang Syndrome, the clinical efficacy is quite commonly used in treatment of acne, but so far no evidence-based evidence of its effectiveness and safety. Through the analysis of the Xianfang Huoming Decoction in the treatment of acne RCT literature meta, and through the observation of Xian Fang a clinical curative effect of decoction for the treatment of phlegm and blood stasis type of acne, and provide evidence-based basis for the clinical application of Xianfanghuoming Decoction for the treatment of acne. Methods: a Meta analysis, Chinese and foreign electronic database through computer retrieval, retrieval time for before December 31, 2016, the treatment group were treated with oral medicine decoction for the treatment of Xianfang. Methods control group with western medicine or Chinese medicine as the main treatment. The related literatures were screened according to the inclusion criteria and exclusion criteria, the final literatures and extract data in the literature Quality evaluation, application of Revman5.3 software on the efficiency, rate and adverse reactions after treatment of skin lesions were statistically evaluated. Two. Clinical observation: 80 cases of phlegm and blood stasis will meet the conditions on the stasis type of acne patients were randomly divided into treatment group and control group, treatment group (40 cases) treated with Xianfanghuoming Yin decoction, the control group (40 cases) treated by oral administration of Minocycline Hydrochloride Capsules, the two groups were combined with acupuncture treatment, 4 weeks for a course of treatment, a total of two courses of treatment. Scores of lesions after treatment, TCM symptoms, comprehensive curative effect, the incidence of adverse reactions were evaluated. Results: This study, Meta analysis a total of 13 literatures were included in the study object, the experimental group 711 cases, control group were included in the study of 682 cases of.Meta analysis showed that: 1. efficiency: Xianfang Huoming Decoction group for the treatment of acne is more efficient than the antibiotics group (OR=3.03,95%CI, [1.90,4.83], P0.00001) and the traditional Chinese Medicine Group (OR=2.22,95%CI[1.10,4.45], P=030.05), and the combination is higher than that of simple antibiotics or vitamin A acid treatment group therapy is effective in treating acne (OR=3.34,95%CI[2.23,4.99], P0.00001), and compared with the similar efficacy with vitamin A acid drugs (OR=1.11,95%CI[0.51,2.43], P= 0.790.05.2.) the incidence of adverse reactions: Xianfang Huoming Decoction group adverse reaction rate is lower than western medicine group (OR=0.33,95%CI[0.20,0.56], P0.0001), and the occurrence of Xianfanghuoming Decoction group and traditional Chinese medicine group compared the rate of adverse reactions (OR=3.09,95%CI[0.31,30.40], P=0.33) is.3. after the treatment of skin lesions: only 2 literatures on after the treatment of skin lesions was evaluated, and the control group interventions are medicine, showed by xianfanghuomingyin on the skin lesions of patients with better medicine (MD=-4.44,95%CI[-6.33, -2.55], Z=4.60 (P0.00001). Two, 80: To observe the clinical curative effect of phlegm and blood stasis type Acne subjects, the experimental group 3 cases were lost and 2 in the control group. The cases, there were 75 evaluable cases, including 37 cases in the experimental group, 38 cases of the control group.1.: baseline examination, two groups of patients with gender, age, course of disease, before the treatment of skin lesions, no significant symptom score the difference, baseline score than.2. lesions: two groups after 4 weeks of treatment group lesions score comparison, P values were less than 0.05, the difference was significant; the two groups after 4 weeks of treatment between groups of skin lesions, P=0.480 (P0.05), the difference was not significant, compared with lesions score difference after 4 weeks two the treatment group, P=0.060 (P0.05), the difference was not significant between the two groups; after 8 weeks of treatment between groups of skin lesions, P=0.002 (P0.05), the difference was significant. Comparing the lesions after 8 weeks of treatment the score difference, P=0.010 (P0.05), the difference was significant. Two treatments are effective after 4 weeks of treatment, two No significant difference between the groups of skin lesions, and extend along with the course of 8 weeks, Houxian Huoming Decoction group score was better than that of the lesions of minocycline hydrochloride group.3. TCM syndrome: two groups after 4 weeks of treatment in the scores of TCM symptoms, P values were less than 0.05, the difference was significant; the two groups after 4 weeks of treatment group Chinese medicine symptom score, P=0.002 (P0.05), the difference was significant; comparison of TCM syndrome score difference between groups after 4 weeks of treatment, P=0.002 (P0.05), the difference was significant. The two group after 8 weeks of treatment group of Chinese medicine symptom score, P=0.000, the difference was significant between the two groups in 8. After weeks of TCM syndrome score, P=0.000 (P0.05), the difference was significant. Two kinds of methods of treatment can effectively improve the symptoms of traditional Chinese medicine, and by xianfanghuomingyin group of TCM symptoms was better than that of minocycline hydrochloride group.4. comprehensive curative effect: after 8 weeks of treatment, the experimental group The total effective rate was 97.30%, control group total effective rate was 84.2%, P=0.006 (P0.05), the difference was significant, indicating the Xianfang Huoming Decoction group comprehensive curative effect is better than that of minocycline hydrochloride group.5. the incidence rate of adverse reaction in two groups: the incidence of adverse reactions after the exact test, Fisher P=0.24, P0.05, no significant difference. Conclusion a Meta analysis, this study shows that: the Xianfang Huoming Decoction for the treatment of acne is more efficient than the traditional Chinese medicine, antibiotics, and vitamin A acid drugs showed no significant difference, and the recipe combined with western medicine treatment is more efficient than the pure Western Medicine treatment. Xian Fang live life to drink the adverse reaction rate is low compared with western medicine and traditional Chinese medicine, no significant the difference. The Xianfang Huoming Decoction on patients with lesions was better than that of traditional Chinese medicine. But given the relatively small number of documents this research into the literature, quality is not high, the accuracy could affect the results and reliability. Two, the clinical curative effect Study: the score for the two groups of lesions, TCM symptoms, comprehensive curative effect, adverse reaction rate comparison, confirmed the effectiveness of treatment group two, and experimental group of lesion score, TCM symptoms, comprehensive curative effect was better than the control group, two groups of adverse reactions was no significant difference between Xian. Huoming decoction is the cure of phlegm and blood stasis type of acne, it is worthy of clinical application.

【学位授予单位】：广州中医药大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R275.9

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