脉管复康片治疗下肢动脉硬化性闭塞症临床疗效的Meta分析

Clinical effect of Maiguan Fukang Tablets in treatment of lower extremity arteriosclerosis obliterans：a Meta analysis

关键词:  脉管复康片  下肢动脉硬化性闭塞症  随机对照试验  Meta分析

Key words:  Maiguan Fukang Tablet  lower extremity arteriosclerosis obliterans  randomized controlled trial  Metaanalysis

摘要:

[目的] 系统评价脉管复康片治疗下肢动脉硬化性闭塞症的临床疗效。[方法] 计算机检索PubMed、EMbase、The Cochrane Library、Web of Science、Scopus、中国知网（CNKI）、万方（Wanfang data）、维普（VIP）、中国生物医学文献数据库（CBM）数据库，搜集脉管复康片治疗下肢动脉硬化性闭塞症的随机对照试验（RCT），检索时限均从建库至2023年1月31日。由2名评价员独立筛选文献、提取资料并评价纳入研究的偏倚风险后，采用RevMan 5.4软件进行Meta分析。[结果] 共纳入11个RCT，包括809例患者。Meta分析结果显示：脉管复康片治疗组的总有效率[RR=1.16，95%CI（1.02，1.32），P=0.030 0]高于对照组，间歇性跛行发生率[RR=0.36，95%CI（0.23，0.58），P＜0.000 1]、静息痛发生率[RR=0.28，95%CI（0.12，0.66），P=0.004 0]、截肢率[RR=0.32，95%CI（0.13，0.78），P=0.010 0]低于对照组。与对照组相比，脉管复康片能够提高血管踝肱指数[SMD=0.13，95%CI（0.11，0.15），P＜0.000 1]，降低高切黏度[SMD=-0.89， 95%CI（-1.46，-0.31），P=0.003 0]水平，但未发现低切黏度的差异具有统计学意义[SMD=-1.34，95%CI（-3.43，0.74），P=0.210 0]。[结论] 当前证据表明，脉管复康片能够改善下肢动脉硬化性闭塞症患者的间歇性跛行、静息痛与截肢发生情况，提高血管踝肱指数，降低高切黏度水平。受纳入研究质量的限制，上述结论尚需开展更多高质量研究予以验证。

Abstract:

[Objective] To systematically review the clinical efficacy of Maiguan Fukang Tablet on patients with lower extremity arteriosclerosis obliterans. [Methods] PubMed，EMbase，The Cochrane Library，Web of Science，Scopus，CNKI，Wanfang data，VIP，CBM databases were electronically searched to collect randomized controlled trials （RCTs） on the clinical efficacy of Maiguan Fukang Tablets for lower extremity arteriosclerosis obliterans from inception to January 31st，2023. Two reviewers independently screened literature，extracted data and assessed the risk of bias in included studies，and then meta-analysis was performed by using RevMan 5.4 software. [Results] A total of 11 RCTs involving 809 patients were included. The results of meta-analysis showed that the Maiguan Fukang Tablets group exhibited an increased efficacy rate [RR=1.16，95%CI 1.02 to 1.32，P=0.03] and a decreased rate of intermittent claudication [RR=0.36，95%CI 0.23 to 0.58，P＜0.000 1]，rest pain [RR=0.28，95%CI 0.12 to 0.66，P=0.004] and amputation [RR=0.32， 95%CI 0.13 to 0.78，P=0.01]. Compared with the control group，the Maiguan Fukang Tablets significantly improved the ankle brachial index [SMD=0.13，95%CI （0.11，0.15），P＜0.000 1] and reduced the high shear viscosity level [SMD=-0.89，95%CI （-1.46，-0.31），P=0.0030]，whereas no statistically significant difference was found for the low shear viscosity level [SMD=-1.34，95%CI （-3.43，0.74），P=0.2100]. [Conclusion] Current evidence suggests that Maiguan Fukang Tablets can significantly improve intermittent claudication，rest pain and amputation，increase the ankle brachial index，and decrease the high shear viscosity level. Due to the limited quantity and quality of included studies，more high-quality studies are required to verify above conclusions.