复方血栓通胶囊治疗青光眼有效性与安全性的系统评价与Meta分析

The Effectiveness and Safety of Fufang Xueshuantong Capsules (复方血栓通胶囊) in the Treatment of Glaucoma: A Systematic Review with Meta-analysis

目的系统评价复方血栓通胶囊治疗青光眼的临床疗效及安全性。方法全面检索中国知网、万方数据库、维普中文科技期刊全文数据库、中国生物医学文献服务系统数据库,以及PubMed、the Cochrane Library、Web of Science外文数据库,检索时间段均为从各数据库建立至2021年5月8日。纳入使用复方血栓通胶囊治疗青光眼的随机对照试验。使用Cochrane手册评估研究的内容是否存在偏倚风险,使用RevMan 5.3软件对包括总有效率、总灰度值、眼血流动力学指标(收缩期峰值流速、舒张末期血流速度、搏动指数、阻力指数)、光敏度、缺损度等结局指标进行Meta分析,并同时评价安全性。结果共纳入16项研究,涉及研究对象1482例。纳入的研究总体方法学质量偏低。Meta分析结果显示,与对照组相比,治疗组可显著提高青光眼患者的临床治愈率[RR=1.23,95%CI(1.18,1.29),P<0.01],降低灰度值范围[MD=-63.99,95%CI(-66.49,-61.48),P<0.01],提高眼部血管收缩期峰值流速[MD=2.29,95%CI(2.10,2.47),P<0.01]、舒张末期血流速度[MD=1.79,95%CI(1.43,2.16),P<0.01],降低眼部血管的搏动指数[MD=-0.27,95%CI(-0.34,-0.21),P<0.01]和阻力指数[MD=-0.18,95%CI(-0.20,-0.15),P<0.01],增加光敏度[MD=5.36,95%CI(4.47,6.24),P<0.01]和减少缺损度[MD=3.04,95%CI(2.78,3.30),P<0.01]。仅有4项研究报道了不良事件发生情况。结论复方血栓通胶囊联合常规干预或复方血栓通单独治疗青光眼可一定程度上提高临床总有效率,改善血流动力学指标,提高患者视野水平,且未见严重不良反应事件。

Objective To systematically assess the clinical effectiveness and safety of Fufang Xueshuantong Capsules(复方血栓通胶囊,FXC)in the treatment of glaucoma.Methods Chinese and English databases including CNKI,Wanfang,VIP,Sinomed,PubMed,the Cochrane Library,and Web of Science were systematically searched from the inception dates to May 8 th,2021 for randomized controlled trials(RCTs)on FXC in the treatment of glaucoma.Risk of bias tool in the Cochrane Handbook was used to assess the quality of the RCTs.Rev Man 5.3 software was used to perform meta-analyses on total effective rate,total gray value,ocular hemodynamic parameters including peak systolic velocity(PSV),end diastolic velocity(EDV),pulsatility index(PI),and resistivity index(RI),photosensitivity and defect,as well as on the safety.Results Sixteen RCTs were included involving 1482 participants.The overall methodological quality of the included RCTs was relatively low.Results from meta-analyses showed that compared to the control group,the treatment group could significantly improve the total effective rate(RR=1.23,95%GI1.18,1.29,P<0.01),reduce the gray value(MD=-63.99,95%CI-66.49,-61.48,P<0.01),improve PSV(MD=2.29,95%CI 2.10,2.47,P<0.01)and EDV(MD=1.79,95%CI1.43,2.16,P<0.01),reduce PI(MD=-0.27,95%CI-0.34,-0.21,P<0.01)and RI(MD=-0.18,95%CI-0.20,-0.15,P<0.01),increase photosensitivity(MD=5.36,95%CI 4.47,6.24,P<0.01)and decrease defect(MD=3.04,95%CI2.78,3.30,P<0.01)in glaucoma patients.Adverse events were reported in only four RCTs.Conclusion FXC combined with routine treatment or FXC alone can increase the total effective rate to a certain extent,improve the hemodynamic parameters,and improve the visual field in glaucoma patients,and no serious adverse events were observed.