母牛分枝杆菌菌苗辅助治疗复治肺结核的Meta分析

Adjuvant Effect of Mycobacterium Vaccae on Treatment of Recurrent Treated Pulmonary Tuberculosis:A Meta-analysis

目的 系统评价母牛分枝杆菌菌苗（微卡）联合抗结核药物治疗复治肺结核的疗效与安全性。方法 检索PubMed（1990～2006）、中文期刊全文数据库（1997～2006）、万方数据库（1997～2006）、Cochrane临床对照试验数据库（2006年第4期）、National Research Register（1996～2006）等，纳入比较微卡辅助治疗组与对照组的随机对照临床试验，由两名评价者独立提取资料并进行方法学质量评价。试验数据的统计分析采用Cochrane协作网提供的Rev Man4．2．2软件。结果 最终纳入11个RCT。Meta分析结果显示，微卡辅助治疗组与对照组相比，痰菌阴转情况[RR=1．36，95％CI（1．21，1．54）]，病灶吸收情况[RR=1．39，95％CI（1．13，1．72）]，病灶未吸收情况[RR=0．46，95％CI（0．36，0．60）]的差异均有统计学意义。未报道与微卡临床应用相关的严重系统性不良反应。结论 现有临床证据表明，微卡联合抗痨治疗能有效改善复治肺结核患者的细胞免疫功能，增强化疗效果，有助于痰菌转阴，病灶好转吸收。受本评价纳入研究质量所限，尚需开展更多高质量的研究进一步分析。

Objectives To evaluate the effect and safety of mycobacterium vaccae in the treatment of recurrent treated pulmonary tuberculosis. Methods We searched PubMed （1997 to 2006）, VIP （1997 to 2006）, Wanfang database （1997 to 2006）, The Cochrane Central Register of Controlled Trials （Issue 4, 2006） and the National Research Register （1996 to 2006）. Randomized controlled trials comparing the mycobacterium vaccae immunotherapy group and the control group were included. Two reviewers independently performed data extraction and quality assessment. Data were analyzed using RevMan 4.2.2 software by The Cochrane Collaboration. Results Eleven high quality trials were included. Metaanalyses showed that mycobacterium vaccae immunotherapy plus chemotherapy resulted in higher sputum negative conversion rate （RR=1.36, 95%CI 1.21 to 1.54）, higher lesion absorption rate （RR=1.39, 95%CI 1.13 to 1.72）, and lower lesion non-absorption rate （RR=0.46, 95%CI 0.36 to 0.60）, compared with the control group. These differences were all statistically significant. No serious adverse events were reported. Conclusion As an adjunct to chemotherapy, mycobacterium vaccae is helpful for patients with recurrent treated pulmonary tuberculosis in terms of improving cell-medicated immunity, sputum negative conversion and X-ray manifestation. More high quality studies are needed for further analysis.