Li Wenhui, Xu Feng, Huang Renyan, Fan Weijing, Fu Changgeng, Xu Lei, Wang Xvhong, Lu Huimin, Li Yuanxiang
Shanghai University of Medicine & Health Sciences, Shanghai, China.
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Evid Based Complement Alternat Med. 2021 Apr 7;2021:6622925. doi: 10.1155/2021/6622925. eCollection 2021.
In recent years, the incidence of deep venous thrombosis (DVT) presents an increasing trend year by year. The current evidence regarding the efficacy and safety of Xueshuantong injection for DVT is controversial. This systematic review (SR) aimed to assess the efficacy and safety of Xueshuantong injection in the treatment of DVT systematically and provide an evidence-based reference for clinical treatment.
Nine electronic databases were used to identify the literature consisting of randomized controlled trials (RCTs) with a date of search of 1 November 2020. Clinical effective rate and incidence rate of adverse events were investigated as primary outcomes. Patency rate of femoral vein, patency rate of popliteal vein, patency rate of posterior tibial vein, circumference difference, activated partial thromboplastin time (APTT), and D-dimer (D-D) were investigated as secondary outcomes. Revman 5.4.1 was used to analyze the results. Analysis of the power of evidence was performed with Trial Sequential Analysis (TSA).
A total of 12 articles including 1018 patients were included. The results of the meta-analysis showed that the clinical effective rate in the experimental group was higher than that in the control group, the incidence rate of adverse events in the experimental group was higher than that in the control group; after the operation, the patency rate of femoral vein, patency rate of popliteal vein, patency rate of posterior tibial vein, circumference difference, APTT, and D-D in the experimental group were significantly improved compared with those in the control group, and the difference between the groups was statistically significant. TSA suggested that the meta-analysis concerning the clinical effectiveness of Xueshuantong injection in the treatment of DVT was of adequate power to reach firm conclusions.
Based on the current analysis, Xueshuantong injection as an add-on treatment provided better treatment effect for DVT with adequate power but this benefit should be considered with caution because of the small number of studies included in the meta-analysis and the high or unclear risk of bias of the included trials, suggesting that further studies are needed.
近年来，深静脉血栓形成（DVT）的发病率呈逐年上升趋势。目前关于血栓通注射液治疗DVT有效性和安全性的证据存在争议。本系统评价（SR）旨在系统评估血栓通注射液治疗DVT的有效性和安全性，并为临床治疗提供循证参考。
使用九个电子数据库检索截至2020年11月1日的随机对照试验（RCT）文献。将临床有效率和不良事件发生率作为主要结局指标进行研究。将股静脉通畅率、腘静脉通畅率、胫后静脉通畅率、周径差、活化部分凝血活酶时间（APTT）和D-二聚体（D-D）作为次要结局指标进行研究。采用Revman 5.4.1软件进行结果分析。使用试验序贯分析（TSA）进行证据力度分析。
共纳入12篇文章，涉及1018例患者。Meta分析结果显示，试验组的临床有效率高于对照组，试验组不良事件发生率高于对照组；术后试验组股静脉通畅率、腘静脉通畅率、胫后静脉通畅率、周径差、APTT及D-D较对照组均有明显改善，组间差异有统计学意义。TSA提示，关于血栓通注射液治疗DVT临床有效性的Meta分析有足够的力度得出确切结论。
基于目前的分析，血栓通注射液作为辅助治疗对DVT有较好的治疗效果且证据力度充足，但由于Meta分析纳入的研究数量较少且纳入试验的偏倚风险较高或不明确，该益处应谨慎考虑，提示需要进一步研究。
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