中国组织工程研究

中国组织工程研究 ›› 2021, Vol. 25 ›› Issue (20): 3267-3274.doi: 10.3969/j.issn.2095-4344.3201

• 组织构建循证医学 evidence-based medicine in tissue construction • 上一篇    下一篇

补阳还五汤预防骨科术后深静脉血栓形成的系统评价及试验序贯分析

靖金鹏1，张  玥2，刘效敏3，刘  壹1   

  1. 1山东中医药大学第一临床医学院，山东省济南市  250014；山东中医药大学附属医院，2周围血管病科，3运动损伤骨科，山东省济南市  250014
  • 收稿日期:2020-05-20 修回日期:2020-05-21 接受日期:2020-06-12 出版日期:2021-07-18 发布日期:2021-01-18
  • 通讯作者: 张玥，主任医师，山东中医药大学附属医院周围血管病科，山东省济南市 250014
  • 作者简介:靖金鹏，男，1994年生，山东省淄博市人，汉族，山东中医药大学在读硕士，医师，主要从事中西医结合治疗周围血管疾病研究。
  • 基金资助:
    国家自然科学基金(面上项目)(81774311)，项目负责人：张玥；山东省中医药科技发展计划项目(2019-0149)，项目负责人：张玥

Buyang Huanwu Decoction in prevention of deep venous thrombosis after orthopedic surgery: meta-analysis and trial sequential analysis

Jing Jinpeng1, Zhang Yue2, Liu Xiaomin3, Liu Yi1   

  1. 1First Clinical Medicine School, Shandong University of Traditional Chinese Medicine, Jinan 250014, Shandong Province, China; 2Department of Peripheral Vascular Disease, 3Department of Orthopedics for Athletic Injuries, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan 250014, Shandong Province, China
  • Received:2020-05-20 Revised:2020-05-21 Accepted:2020-06-12 Online:2021-07-18 Published:2021-01-18
  • Contact: Zhang Yue, Chief physician, Department of Peripheral Vascular Disease, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan 250014, Shandong Province, China
  • About author:Jing Jinpeng, Master candidate, Physician, First Clinical Medicine School, Shandong University of Traditional Chinese Medicine, Jinan 250014, Shandong Province, China
  • Supported by:
    the National Natural Science Foundation of China (General Project), No. 81774311 (to ZY); Development Foundation of Traditional Chinese Medicine Technology of Shandong Province, No. 2019-0149 (to ZY)

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摘要：

文题释义：
试验序贯分析：试验序贯分析用于系统综述或Meta分析样本量估算，克服了经典的系统综述或Meta分析的不足，能增加结果的可信度和合理性。亦为Meta分析的更新提供了参考，相比于传统的Meta分析能及时建议终止无效的试验，防止医疗资源的浪费，更加符合伦理的要求。
Meta分析：是系统综述中应用的一种统计学方法，它将多个临床试验的数据结果进行系统的、定量的综合分析，通过增大样本量来增加研究结论的可信度，被广泛应用于治疗、诊断、病因、预后甚至疾病的流行病学研究中。

目的：目前部分临床随机对照研究证明补阳还五汤能有效预防骨科术后患者发生深静脉血栓，但尚缺乏循证医学证据的支持。文章系统评价补阳还五汤加减预防骨科患者术后发生深静脉血栓的临床疗效及安全性。
方法：截止至2020年3月，检索PubMed、Embase、Cochrane Library、中国知网、维普、万方、中国生物医学数据库收录的关于补阳还五汤加减预防骨科术后深静脉血栓的临床随机对照试验文献。试验对象为骨科术后患者，试验组为补阳还五汤预防患者术后发生深静脉血栓，对照组为常规西药预防。根据Cochrane Handbook 5.1.0评价标准及改良Jadad评分量表对纳入文献进行质量评估，采用RevMan 5.3和Stata 16软件进行Meta分析，TSA 0.9.5.10 Beta 软件进试验序贯分析，比较试验组与对照组患者术后深静脉血栓的发生率、凝血酶原时间、活化部分凝血活酶时间、纤维蛋白原、D-二聚体、术后引流量和不良反应发生率方面的差异。
结果：①所纳入文献Jadad评分均在4分及以下，文献总体质量不高；②共纳入文献16篇，涉及1 075例患者，其中试验组540例，对照组535例；③Meta分析结果显示：试验组深静脉血栓发生率(RR=0.54，95%CI：0.41-0.71，P < 0.000 1)、D-二聚体(WMD=-0.13，95%CI：-0.22至-0.04，P=0.003)和术后引流量(WMD=-80.39，95%CI：-102.14至-58.64，P  < 0.000 01)均显著低于对照组，延长凝血酶原时间不及对照组(WMD=-0.59，95%CI：-1.07至-0.01，P=0.02)，活化部分凝血活酶时间(WMD=0.23，95%CI：-1.72-2.17，P=0.82)及纤维蛋白原(WMD= -0.27，95%CI：-0.63-0.09，P=0.15)指标的改善水平两组无显著性差异，不良反应发生率显著低于对照组(RR=0.31，95%CI：0.14-0.68，P=0.004)；④试验序贯分析(TSA)显示，深静脉血栓发生率累积纳入的研究穿过了传统界值和序贯分析界值，进一步肯定了其临床疗效。
结论：补阳还五汤加减能有效降低骨科术后患者深静脉血栓的发生率，且具有一定的安全性，但仍需纳入更多高质量的随机对照试验进一步验证。

关键词: 骨, 中医药, 补阳还五汤, 骨科, 深静脉血栓形成, 预防, 随机对照试验, Meta分析

Abstract: OBJECTIVE: At present, some randomized controlled clinical studies have proved that Buyang Huanwu Decoction can effectively prevent the occurrence of deep vein thrombosis in patients after orthopedic surgery, but it still lacks evidence-based medicine support. Here, we systematically evaluate the clinical efficacy and safety of Buyang Huanwu Decoction in the prevention of deep venous thrombosis after orthopedic surgery.
METHODS: By March 2020, literatures regarding clinical randomized controlled trials on the prevention of deep vein thrombosis after orthopedic surgery by Buyang Huanwu Decoction were retrieved from PubMed, Embase, Cochrane Library, CNKI, VIP, WanFang and China Biological Literature Database. The experimental subjects were patients after orthopedic surgery. In trial group, Buyang Huanwu Decoction was given for prevention of postoperative deep vein thrombosis in patients, and in control group, routine western medicine given for prevention. The quality of the retrieved original literature was evaluated according to the evaluation criteria of Cochrane Handbook 5.1.0 and Modified Jadad scale. Meta-analysis was performed using RevMan 5.3 and Stata 16, and TSA 0.9.5.10 Beta software was used for trial sequential analysis. Postoperative incidence of deep vein thrombosis, prothrombin time, activated partial thromboplastin time, fibrinogen, D-dimer, postoperative drainage volume and incidence of adverse reactions were compared between the two groups.
RESULTS: The Jadad scores of all the included articles were 4 points or below, and the overall quality of the literatures was not high. Sixteen articles involving 1 075 patients were enrolled, including 540 in the trial group and 535 in the control group. The results of meta-analysis showed that: The incidence of deep vein thrombosis in the trial group [relative risk (RR)=0.54, 95% confidence interval (CI): 0.41-0.71, P < 0.000 1], D-dimer [weighted mean difference (WMD)=-0.13, 95%CI: -0.22 to-0.04, P=0.003] and postoperative drainage (WMD=-80.39, 95%CI: -102.14 to -58.64, P < 0.000 01) were all significantly lower than those in the control group, and the level of prolonged prothrombin time was lower than that in the control group (WMD=-0.59, 95%CI:  -1.07 to -0.01, P=0.02). There was no significant difference in the activated partial thromboplastin time (WMD=0.23, 95%CI: -1.72 to 2.17, P=0.82) and fibrinogen (WMD=-0.27, 95%CI: -0.63 to 0.09, P=0.15) between the two groups. The incidence of adverse reactions in the trial group was significantly lower than that in the control group (RR=0.31, 95%CI: 0.14-0.68, P=0.004). Sequential analysis of the trial showed that the cumulative incidence of deep vein thrombosis crossed the traditional boundary value and the boundary value of trial sequential analysis, which further confirmed the clinical efficacy of Buyang Huanwu Decoction. 
CONCLUSION: Buyang Huanwu Decoction can effectively reduce the incidence of deep vein thrombosis in patients after orthopedic surgery, and has a certain degree of safety. However, more high-quality randomized controlled trials need to be included for further verification.

Key words: bone, traditional Chinese medicine, Buyang Huanwu Decoction, orthopedics, deep venous thrombosis, prevention, randomized controlled clinical studies, meta-analysis

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