中医药治疗神经性皮炎的系统评价

发布时间：2019-05-10 21:38

【摘要】：研究背景：神经性皮炎(Neurodermatitis, ND),是一种情绪波动密切相关与神经系统功能障碍,大脑皮质兴奋和抑制平衡失调有关,以阵发性皮肤瘙痒和皮肤苔藓化为主症。近年来发病率有增高趋势,中医治疗对神经性皮炎具有很好的临床效果,且副作用较低。临床上对中医药治疗神经性皮炎报道越来越多。目的：按照循证医学的方法来评价中医药治疗神经性皮炎的疗效性,通过Meta分析系统性评价中医药治疗与西医常规治疗神经性皮炎患者的疗效,从而为中医药治疗的临床运用提供循证医学证据。资料和方法：检索清华同方系列数据库(CNKI),万方数据库,维普资讯,中国生物医学文献数据库(CBM), PubMed医学文献检索服务系统,时间截止至2015年10月31日。严格按照制定的纳入标准和排除标准。按照Cochrane Reviewer Handbook5.1对每个纳入试验进行方法学质量评价标准偏倚风险和质量评估,工具包括6个方面：随机分配方案；分配方案隐藏；盲法(研究对象、治疗方案实施者、研究结果测量者,针对每一研究结果评估)：结果数据的完整性(针对每一研究结果评估)；选择性报告研究结果；其他偏倚来源。进行Cochrane协作网提供的RevMan5.3软件分析证据质量。计数资料采用Peto方法选用比值比OR (odds ratio),均以计算95%可信区间(confidence intervals,CI)。为判断联合各试验进行分析的合理性,采用卡方检验进行各试验间的异质性检验,如果同质性好(P0.1)使用固定效应模型(fixed effects model)进行Meta分析。同质性不好(P0.1)则采用随机效应模型(random effects model)进行Meta分析。结果：共收集文献175篇,排除不合格文献,通过阅读全文,诊断明确为神经性皮炎,疗效观察指标标准一致为《中药新药临床研究指导原则》(由中华人民共和国卫生部制定,1997版)或卫生部1993年颁布的《中药新药临床研究指导原则》,最终纳入中医药治疗神经性皮炎的随机对照研究(RCT)文献12篇试验研究文献进行系统评价,共计1182例病人,纳入研究方法学质量学评估等级大部分为B级,部分为C级。提取数据后,进行Meta分析系统性评价,结果显示中药内服临床疗效与西药的对比OR为2.66；95% CI为[1.58,4.50],Z值为3.66,P=0.0002,提示差异有统计学意义；中药内服并用中药外洗的临床疗效与西药的对比OR为4.33；95% CI为[2.25,8.35],Z值为4.38,P0.0001提示差异有统计学意义；中药内服并用外用外涂软膏临床疗效与西药的对比OR为2.72；95%CI为[1.36,5.42],Z值为2.83,P=0.0050.05提示差异有统计学意义；中药内服+中医理疗临床疗效与西药的对比OR为3.33；95% CI为[1.68,6.60],Z值为3.45,P=0.0006提示差异有统计学意义,即整体疗效用中药较西药治疗神经性皮炎要好。结论：目前证据显明,中医药治疗神经性皮炎与西医治疗临床疗效较好,且复发率低。本研究的文献对中医药治疗神经性皮炎的文献中报告质量不够高。存在多种方法学缺陷,难免产生各种结果选择性偏倚,影响了试验结果的可靠性及真实性。期待有更高质量的完全临床试验来对本研究结果做进一步的证实,提供更多更好的临床证据依据。
[Abstract]:Background: Neurodermatitis (ND) is a kind of emotional fluctuation, which is related to the dysfunction of the nervous system, the activation of the cerebral cortex and the inhibition of the balance of the balance. In recent years, the incidence of neurodermatitis has a tendency to increase, and the treatment of Chinese medicine has a good clinical effect on neurodermatitis, and the side effect is low. The clinical application of traditional Chinese medicine to the treatment of neurodermatitis is more and more. Objective: To evaluate the curative effect of traditional Chinese medicine in the treatment of neurodermatitis in accordance with the method of evidence-based medicine. Materials and Methods: To search the database of the peer-to-peer series (CNKI), the Wanfang database, the VIP information, the Chinese Biomedical Literature Database (CBM), the PubMed medical literature search service system, and the time as of October 31,2015. The standards and exclusion criteria are strictly followed. The standard bias risk and quality assessment for each of the included tests was evaluated according to the Cochrane Reviewer Handbook 5.1. The tool included 6 aspects: the random allocation scheme; the allocation scheme hiding; the blind method (study object, the treatment plan implementer, the study result measurement, Evaluation for each of the study results): the integrity of the results data (for each study result assessment); the selective reporting of the study results; and other sources of bias. The quality of the evidence was analyzed by the RevMan5.3 software provided by the Cochrane collaborative network. The ratio OR (odds ratio) is used for counting data to calculate the confidence interval (CI) of 95%. In order to judge the rationality of the analysis of the joint trials, the heterogeneity test between the tests was carried out by the chi-square test, and if the homogeneity was good (P0.1), the fixed effect model was used for Meta-analysis. The homogeneity is not good (P0.01), and a random effect model is used for Meta-analysis. Results:175 articles of the literature were collected, and the non-conforming documents were excluded, and the diagnosis was identified as neurodermatitis by reading the full text. The standard of the curative effect observation index is consistent with the guiding principle of the clinical research of the new drug of the traditional Chinese medicine (formulated by the Ministry of Health of the People's Republic of China, the 1997 edition) or the Guidelines for Clinical Research of the New Drugs of the Chinese Medicine promulgated by the Ministry of Health in 1993. A total of 1182 patients were enrolled in the randomized controlled study (RCT) of the Chinese medicine for the treatment of neurodermatitis. A total of 1182 patients were included in the study methodology. The evaluation grade of the methodological quality was mostly Class B and part C. After the data was extracted, the systematic evaluation of the meta-analysis was carried out. The results showed that the comparative OR of the traditional Chinese medicine and the western medicine was 2.66;95% CI was[1.58, 4.50], the Z value was 3.66, P = 0.0002, and the difference was of statistical significance; The 95% CI was[2.25, 8.35], the Z value was 4.38, and the difference between the two groups was 2.72;95% CI was[1.36, 5.42], the Z value was 2.83, P = 0.0050.05, and the difference was statistically significant. The comparative OR of the traditional Chinese medicine and the western medicine is 3.33, the 95% CI is[1.68, 6.60], the Z value is 3.45, P = 0.0006, the difference is of statistical significance, that is, the overall curative effect is better than that of the western medicine for treating the neurodermatitis. Conclusion: The present evidence shows that the treatment of neurodermatitis with Chinese medicine is better than that of western medicine, and the recurrence rate is low. The literature of this study has a high quality in the literature on the treatment of neurodermatitis by traditional Chinese medicine. There are many methodological defects, which can result in the selective bias of the results, and the reliability and the authenticity of the test results are affected. It is expected that higher quality full clinical trials will provide further confirmation of the results of this study and provide more and better evidence of clinical evidence.
【学位授予单位】：成都中医药大学
【学位级别】：硕士
【学位授予年份】：2016
【分类号】：R275.9

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