含水蛭中药复方预防髋关节置换术后深静脉血栓有效性及安全性的Meta分析

Meta analysis of efficacy and safety of traditional Chinese medicine containing leech in preventing deep vein thrombosis after hip arthroplasty

目的系统评价含水蛭中药复方预防髋关节置换术后深静脉血栓(DVT)的疗效和安全性。方法计算机检索中国知网、中国生物医学文献数据库、维普中文科技期刊数据库、万方数据知识服务平台及PubMed数据库中关于含水蛭中药复方预防髋关节置换术后DVT的随机对照试验(RCT),检索时间为建库至2021年10月,筛选符合标准的文献并收集文献信息,采用Review Manager 5.3软件及Stata 16软件进行系统评价及统计学分析,连续型变量采用均方差(MD)表示,分类变量采用风险比(RR)表示。结果共纳入15篇RCT研究,包括1481例髋关节置换术后DVT患者,观察组740例,对照组741例。Meta分析结果显示,观察组患者的DVT发生率明显低于对照组患者,差异有统计学意义(RR=0.34,95%CI:0.23~0.49,P﹤0.01);D-二聚体水平明显低于对照组患者,差异有统计学意义(MD=-0.58,95%CI:-0.72~-0.44,P﹤0.01);纤维蛋白原(FIB)水平明显低于对照组患者,差异有统计学意义(MD=-0.71,95%CI:-1.01~-0.42,P﹤0.01);活化部分凝血活酶时间(APTT)明显长于对照组患者,差异有统计学意义(MD=4.40,95%CI:2.64~6.16,P﹤0.01)。随机效应模型分析结果显示,观察组患者的全血高切黏度明显低于对照组患者,差异有统计学意义(MD=-0.69,95%CI:-0.92~-0.46,P﹤0.01)。3篇RCT研究亚组分析结果显示,观察组患者的全血高切黏度明显低于对照组患者,差异有统计学意义(MD=-0.76,95%CI:-0.89~-0.62,P﹤0.01);2篇RCT研究亚组分析结果显示,两组患者的全血高切黏度比较,差异无统计学意义(P=0.08)。观察组患者的血浆黏度明显低于对照组患者,差异有统计学意义(MD=-0.19,95%CI:-0.28~-0.09,P﹤0.01)。两组患者的血小板计数(PLT)、不良反应发生率比较,差异均无统计学意义(P﹥0.05)。经Egger's检验,RCT研究存在发表偏倚的可能性较小。结论含水蛭中药复方在预防髋关节置换术后DVT方面较单纯西药更有优势,且不会增加不良反应。

Objective To systematically evaluate the efficacy and safety of traditional Chinese medicine containing leech in the prevention of deep vein thrombosis(DVT)after hip arthroplasty.Method The randomized controlled trial(RCT)of traditional Chinese medicine containing leech in the prevention of DVT after hip arthroplasty from China National Knowledge Infrastructure,China biology medicine database,VIP,Wanfan database and PubMed database were searched through computer.The search period was from the establishment of the database to October 2021.The literatures that met the standards were selected and the literature information was collected.The Review Manager 5.3 and Stata 16 were used for system evaluation and statistical analysis,continuous variables were represented by mean difference(MD),and categorical variables were represented by risk ratio(RR).Result A total of 15 RCT were included,including 1481 patients with DVT after hip arthroplasty,including 740 in the observation group and 741 in the control group.The Meta-analysis results showed that the incidence of DVT in the observation group was significantly lower than that in the control group,and the difference was statistically significant(RR=0.34,95%CI:0.23-0.49,P<0.01);D-dimer level was significantly lower than that in the control group,and the difference was statistically significant(MD=-0.58,95%CI:-0.72--0.44,P<0.01);fibrinogen(FIB)level was significantly lower than that in the control group,with statistical significance(MD=-0.71,95%CI:-1.01--0.42,P<0.01);activated partial thromboplastin time(APTT)was significantly longer than that in the control group,and the difference was statistically significant(MD=4.40,95%CI:2.64-6.16,P<0.01).The random effects model analysis result showed that the whole blood high shear viscosity of the observation group was significantly lower than that of the control group,and the difference was statistically significant(MD=-0.69,95%CI:-0.92--0.46,P<0.01).The subgroup analysis results of three RCT studies showed that the whole blood high shear viscosity of the observation group were significantly lower than those of the control group,and the difference were statistically significant(MD=-0.76,95%CI:-0.89--0.62,P<0.01);the subgroup analysis results of two RCT studies showed that there were no statistically significant differences in whole blood high shear viscosity between the two groups of patients(P=0.08).The plasma viscosity of the observation group was significantly lower than that of the control group,and the difference was statistically significant(MD=-0.19,95%CI:-0.28--0.09,P<0.01).There was no statistically significant difference in platelet count(PLT)and incidence of adverse reactions between the two groups of patients(P>0.05).According to Egger's test,the possibility of publication bias in RCT was relatively small.Conclusion Traditional Chinese medicine containing leech has more advantages than simple western medicine in preventing DVT after hip arthroplasty,and will not increase the incidence of adverse reactions.