国内单独应用麒麟丸或联合其他药物治疗少弱精子症疗效的Meta分析

A meta-analysis of Chinese medicine Qilin pill alone or Qilin pill combined with other drugs for treatment of oligospermia and asthenospermia

目的采用Meta分析方法分析麒麟丸单独用药或联合其他药物治疗少弱精子症的疗效。方法检索Cochrane图书馆、Pubmed、中国生物医学(CBMdisc)、中国知网(CNKI)、中文科技期刊全文(VIP)以及万方(Wangfang Data)等数据库,进行关键词检索,检索时间自建库至2021年12月,纳入麒麟丸治疗少弱精子症的随机对照临床研究(RCTs),应用Jadad量表进行方法学质量评价,采用RevMan 5.3软件评估其偏倚风险并进行敏感性分析。结果最终共纳入22篇RCTs文献,累计病例2873例。Meta分析结果显示,麒麟丸联合用药在改善和提高PR级精子[WMD=8.67,95%CI(5.67,11.67),P<0.01]、PR+NP级精子[WMD=7.72,95%CI(6.29,9.14),P<0.01]、精子浓度[WMD=8.65,95%CI(6.84,10.45),P<0.01]、临床治愈(妊娠)率[RR=1.77,95%CI(1.29,2.43),P<0.01]、显效率[RR=1.48,95%CI(1.07,2.03),P<0.01]以及总有效率[RR=1.27,95%CI(1.14,1.40),P<0.01]方面较麒麟丸单独用药疗效显著(P<0.01)。结论麒麟丸联合用药可有效改善和提高PR级精子、PR+NP级精子、精子浓度、临床痊愈(妊娠)率、显效率、总有效率,是协同治疗少弱精子症的有效药物;但本结论仍需更多大样本、高质量、多中心的随机对照的双盲临床试验进一步远期验证。

Objective:To explore the effect of the Chinese medicine Qilin pill alone or Qilin pill combined with other drugs for treatment of oligospermia and asthenospermia by meta-analysis.Methods:The randomized controlled trials(RCTs)involved treatment of oligospermia and asthenospermia with Qilin pill were searched from the databases,such as the Cochrane Library,Pubmed,CBM disc,CNKI,VIP and Wangfang from the establishment of database to December 2021.The methodology quality,of the selected studies was evaluated by Jadad scale,and bias risk assessment and sensitivity analysis was conducted by the software RevMan 5.3.Results:Twenty-two eligible studies including 2873 patients were included.Meta-analysis results showed that Qilin pills combined with the other drugs effectively improved and increased PR grade sperm[WMD=8.67,95%CI(5.67,11.67),P<0.01],Progressive(PR)+non-progressive(NP)grade sperm[WMD=7.72,95%CI(6.29,9.14),P<0.01],sperm concentration[WMD=8.65,95%CI(6.84,10.45),P<0.01],clinical cure(pregnancy)rate[RR=1.77,95%CI(1.29,2.43),P<0.01],effective rate[RR=1.48,95%CI(1.07,2.03),P<0.01]and total effective rate[RR=1.27,95%CI(1.14,1.40),P<0.01],which was more effective than Qilin pill alone.Conclusions:Qilin pills combined with the other drugs can effectively improve the increase PR grade sperm,PR+NP grade sperm,sperm concentration,clinical cure(pregnancy)rate,effective rate and total effective rate,which is a synergistic therapeutic drug for oligoasthenozoospermia.However,more large-sample,high-quality,multi-center randomized controlled,double-blind clinical trials are needed for further long-term verification.