【作者】 刘树辉；

【导师】 姚美玉；

【作者基本信息】 黑龙江中医药大学 ， 中医妇科学， 2010， 硕士

【摘要】 目的:系统分析中药复方治疗抗精子抗体阳性免疫性不孕症的有效性、安全性,以期做出客观、可信的评价,指导临床用药,并提出临床研究中存在的问题和拟采取的对策,为选择中药复方治疗的医患提供当前可得知的最好证据,为今后的临床研究提供了依据和基础,并通过循证医学的研究方法,促进中药复方治疗抗精子抗体阳性免疫性不孕症的推广应用。方法:采用循证医学的方法,全面检索国内外已发表的关于中药复方治疗抗精子抗体阳性免疫性不孕症的临床研究随机对照实验,并按照改良的Jadad质量评分方法对研究文献进行质量评价。采用RevMan4.2(ReviewManager)免费软件,根据异质性检验选用固定或者随机效应模型(fixedorrandomeffectsmodels)计算比值比(OR)及其95%可信区间(CI),临床总有效率、临床总治愈率和临床总复发率的比较,采用卡方检验进行统计分析。结果:共有12篇文献符合纳入标准,中药复方治疗组共计660例患者,治疗有效人数为589例,治愈人数为331例;西医对照组共计426例患者,其中单纯西药组为237例,单纯工具(避孕套)组为154例,单纯西药+工具(避孕套)组为35例,有效人数为237例,治愈人数为71例。研究表明,抗精子抗体阳性免疫性不孕症的临床总有效率以及患者疗程结束后的临床总治愈率,中药复方治疗组均高于西医对照组,而对于临床总复发率而言,中药复方治疗组却低于西医对照组,其比值比分别为:OR=8.34(I2=14%,固定效应模型,95%CI:5.86-11.87P<0.01)、OR=5.33(I2=0%,固定效应模型,95%CI:3.87-7.35P<0.01)、OR=0.09(I2=0%,固定效应模型,95%CI:0.04-0.21P<0.01)。结论:中药复方治疗抗精子抗体阳性免疫性不孕症的临床总有效率是西医对照组的8.34倍,临床总治愈率是西医对照组的5.33倍,而临床复发率则是西医对照组为中药复方治疗组的0.09倍。由于所纳入的随机对照实验的质量较低,存在潜在的发表偏倚,其临床疗效及安全性有待今后通过大样本随机对照实验进一步证实。更多还原

【Abstract】 Objective: Analyse systematically the effectiveness and security of the compound traditional Chinese medicine on immune infertilitas feminis with positive anti-sperm antibodies, in order to make objective and credible eva- luation,instruct clinical treatment.And we can propose the problems in clini- cal studies and measures to be taken.The result provided the best evidence currently available for the patients who choose to use compound Chinese herbal to treat disease and the basis and foundation for the future clinical studies.Through such methods, the expand and applications of the treatment of the compound traditional Chinese medicine on immune infertilitas feminis with positive anti-sperm antibodies can be promoted.Methods: By using the evidence-based medicine approach, compre- hensively search the randomized controlled trials of the clinical experiments published in domestic and foreign of treatment of compound Chinese herbal on the anti-sperm antibodies of immune infertility , and evaluate the quality of the research literature in accordance with the modified Jadad quality score method . By RevMan4.2 (Review Manager) free software and choosing a fixed or random effects models according to the heterogeneity test , calculate odds ratio (OR) and 95% confidence interval (CI).For the comparison of theclinical total effective ,cure rate and relapse rate, we can use Chi-square test for the statistical analysis.Results: A total of 12 studies met the inclusion criteria.a group ofChinese herbal formula treatment totally includes 660 patients,589 cases of which have effective treatment and 331 cases cured; Western control group patients have a total of 426 cases, of which only western group of 237 cases,simple tools (condoms) group of 154,and only western + tool (condoms) group of 35, and the effective number is 237, the cured 71. Studies have shown that in the aspect of the clinical total efficiency and overall cure rate after the end of the treatment on the compound traditional Chinese medicine on immune infer- tilitas feminis with positive anti-sperm antibodies, Chinese herbal formula treatment group is higher than Western medicine control group, while for the clinical total recurrence rate, traditional Chinese medicine compound is lower than Western medicine control group.The odds ratio are: OR = 8.34 (I2 = 14%, fixed effects model, 95% CI :5.86-11 .87 P <0.01), OR = 5.33 (I2 = 0%, fixed effect model, 95% CI :3.87-7 .35 P <0.01), OR = 0.09 (I2 = 0%, fixed effects model, 95% CI :0.04-0 .21 P <0.01).Conclusion: The clinical total effective rate of Chinese herbal formula treatment of immune infertility with positive antisperm antibody is 8.34 times of the Western control group, and clinical total cure rate 5.33 times , while the clinical relapse rate of Western medicine control group is 0.09 times of Chinese herbal formula treatment group. Because of the low quality of the inclusion of randomized controlled trials , there are potential publication bias, and the clinical efficacy and safety need to be further confirmed in the future by a large randomized controlled trials .更多还原