补肾清热类中药复方治疗免疫性男性不育的系统评价

Chinese medicine of Tonifing Kidney and Dispelling Heat Type (Bushenqingre) for male immunologic infertility: a systematic review

目的评价补肾清热类中药复方治疗男性免疫性不育的疗效和安全性。方法制定高敏感检索策略，全面检索截止2006年7月23日补肾清热类中药复方治疗男性免疫性不育的临床研究文献，运用改良后Jadad量表评价纳入文献的方法学质量并提取有效数据进行Meta-分析，用RevMan4．2软件完成统计和系统评价。结果共10篇文献包含1625名患者符合纳入标准。均为低质量。Meta分析结果表明，在提高患者配偶妊娠率，中药复方优于强的松（RR2．47，95％CI1．45—4．21），中药复方联合强的松优于单用强的松（RR2．30，95％CI1．58—3．33）：在降低患者抗精子抗体滴度，中药优于强的松（滴度降低1／2，RR1．82，95％CI1．21-2．75）、（滴度降低1/3，RR1．29，95％CI1．05-1．59）。10篇试验中3篇报告了不良事件的结局，严重副作用有结核病和胃溃疡。结论在提高男性免疫性不育患者配偶妊娠率方面，补肾清热类中药复方可能优于强的松，中药合用强的松优于单用强的松；在降低患者抗精子抗体滴度，中药优于强的松。然而，由于现有试验的方法学质量普遍较低，且该类补肾清热类中药复方使用的变异性大，目前尚无足够证据支持其治疗应用，尚需更多高质量的临床随机对照试验。

Objective To evaluate the efficacy and safety of compound Chinese medicine of Tonifing Kidney and Dispelling Heat Type （Bushenqingre） in the treatment of male immunologic infertility. Methods Randomized clinical trials （RCTs） or controlled clinical trials（CCTs） comparing Bushenqingre versus plant america, other herbal medicine or western medicine therapy in the treatment of male immunologic infertility were identified by electronic and manual search. Trials of Bushenqingre plus western medicine therapy versus western medicine therapy alone were also included. The methodolological quality of the included trials was assessed and Meta-analysis was performed with Revman 4.2 software. Results Ten RCTs and CCTs （n=1625） were identified. The methodological quality ranked low all. Meta-analysis indicated Bushenqingre were more effective than prednisone on enhancing the patient spouse pregnancy rate （RR 2.47, 95%CI 1.45-4.21）, and Bushenqingre plus. prednisone were more effective than prednisone alone （RR 2.30, 95%CI 1.58-3.33）; Bushenqingre were more effective than prednisone on reducing the patient anti-spermatozoon antibody titers （antibody titers degraded 1/2, RR 1.82, 95%CI 1.21-2.75）, （antibody titers degraded 1/3, RR 1.29, 95%CI 1.05-1.59）. Bushenqingre had no obvious superiority than western medicine therapy on causing the patient antisperm antibody to negative. Three articles reported side effects and serious adverse events （Tuberculosis and Gastrelcosis） were reported. Conclusion Based on the review, Bushenqingre may be effective on enhancing the patient spouse pregnancy rate and reducing the patient anti-spermatozoon antibody titers than prednisone in the treatment of Immunomale sterility. However, the evidence is not strong due to the generally low methodological quality and the variations of the herbs. More RCTs are required.