【目的】 系统性评价补肾活血法联合环孢素及雄激素方案治疗再生障碍性贫血（aplastic anemia，AA）的临床有效性和安 全性。【方法】 检索国内外主要数据库中采用补肾活血法联合环孢素及雄激素（试验组）对比环孢素及雄激素（对照组）治疗AA 的随机对照试验（randomized controlled trials，RCTs），筛选符合纳入标准的高质量 RCTs，采用 RevMan 5.3 软件进行 Meta 分 析。【结果】 共纳入 6 项研究，涉及 365 例患者。Meta 分析结果显示，试验组治疗 AA 总有效率显著优于对照组[OR = 4.43， 95% CI （2.50，7.84）；P＜0.000 01]，试验组在改善外周血象指标如血红蛋白（HGB）水平[MD = 14.85，95% CI （10.66，19.05）； P＜0.000 01]、白细胞（WBC）水平[MD = 0.61，95% CI（0.21，1.01）；P = 0.003] 、血小板（PLT）水平[MD = 16.51，95% CI （9.28，23.75）；P＜0.000 01]等方面优于对照组，且未增加多毛症发生率 [OR = 0.24，95% CI （0.10，0.61）；P = 0.003]、痤疮 发生率 [OR = 0.30，95% CI（0.13，0.66）；P = 0.003]、肝功能异常发生率 [OR = 0.28，95% CI（0.09，0.83）；P = 0.02]等不 良反应。【结论】 补肾活血法联合环孢素及雄激素治疗AA在提高临床疗效、改善外周血象方面均优于单纯使用环孢素及雄激 素治疗，同时在减轻不良反应方面有一定优势。

Objective To systematically evaluate the clinical efficacy and safety of therapy of tonifying kidney and promoting blood circulation（shortened as Bushen Huoxue method）combined with cyclosporine plus androgen for the treatment of aplastic anemia（AA）. Methods Randomized controlled trials（RCTs）of Bushen Huoxue method combined with cyclosporine plus androgen（trial group）versus cyclosporine plus androgen alone（control group）for the treatment of AA were retrieved from the major domestic and oversea databases，and then high-quality RCTs that met the inclusion criteria were screened. RevMan 5.3 software was used for meta-analysis. Results A total of 6 RCTs involving 365 patients were included. The results of meta-analysis showed that the total effective rate of AA in the trial group was significantly superior to that of the control group [OR = 4.43，95% CI（2.50，7.84）；P＜ 0.000 01]. The trial group was superior to the control group on improving the peripheral blood indicators such as hemoglobin（HGB）level [MD = 14.85，95% CI（10.66，19.05）；P＜0.000 01]，white blood cell（WBC）level [MD = 0.61，95% CI（0.21，1.01）；P = 0.003]，platelet（PLT）level [MD = 16.51，95% CI（9.28，23.75）； P＜0.000 01]，and did not increase the incidence of adverse reactions such as hirsutism [OR = 0.24，95% CI （0.10，0.61）；P = 0.003]，acne [OR = 0.30，95% CI（0.13，0.66）；P = 0.003]，and abnormal liver function [OR = 0.28，95% CI（0.09，0.83）；P = 0.02] . Conclusion Bushen Huoxue method combined with cyclosporine plus androgen for the treatment of AA is superior to the use of cyclosporine plus androgen alone on enhancing clinical efficacy and improving the peripheral blood indicators， and has certain advantages in reducing the incidence of adverse reactions.

R259.565

国家自然科学基金面上项目（编号：81973583）；广东省自然科学基金面上项目（编号：2021A1515011575）