中国组织工程研究 ›› 2022, Vol. 26 ›› Issue (9): 1467-1476.doi: 10.12307/2022.447

• 骨与关节循证医学 evidence-based medicine of the bone and joint • 上一篇    

活血类中药注射剂预防骨科术后深静脉血栓形成的网状Meta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:2021-07-12 修回日期:2021-07-13 接受日期:2021-08-07 出版日期:2022-03-28 发布日期:2021-12-10
  • 通讯作者: 张玥,主任医师,博士生导师,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,主要从事中西医结合周围血管疾病研究。
  • 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:刘效敏

Traditional Chinese medicine injection for promoting blood circulation in prevention of deep vein thrombosis after orthopedic surgery: network meta-analysis

Jing Jinpeng1, Zhang Yue2, Liu Xiaomin3, Liu Yi1   

  1. 1First Clinical Medical College, Shandong University of Traditional Chinese Medicine, Jinan 250014, Shandong Province, China; 2Department of Peripheral Vascular Disease, 3Department of Orthopedics of Athletic Injuries, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan 250014, Shandong Province, China
  • Received:2021-07-12 Revised:2021-07-13 Accepted:2021-08-07 Online:2022-03-28 Published:2021-12-10
  • Contact: Zhang Yue, Chief physician, Doctoral supervisor, 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, First Clinical Medical College, Shandong University of Traditional Chinese Medicine, Jinan 250014, Shandong Province, China
  • Supported by:
    the National Natural Science Foundation of China, No. 81774311 (to ZY); Development Foundation of Traditional Chinese Medicine Technology of Shandong Province, No. 2019-0149 (to LXM)

摘要:

文题释义:
中药注射剂:是中国独创的新剂型药物,以中医药理论为指导,采用现代科学技术将中药或天然药物中提取的有效物质制成可供注入体内使用的灭菌制剂及浓缩液。
深静脉血栓形成:是由于深静脉内血液异常凝结导致静脉完全或不完全阻塞,从而引起的静脉血液回流障碍性疾病,是骨科术后患者的常见并发症之一。

目的:临床研究发现中药注射剂能有效预防骨科术后患者发生深静脉血栓,但目前临床应用的中药注射剂种类较多,尚缺乏不同种类注射剂之间的对比研究。文章运用网状Meta分析的方法评价活血类中药注射剂预防骨科术后患者发生深静脉血栓形成的疗效和安全性的差异。
方法:计算机检索中国知网、万方、维普、中国生物医学文献服务系统、PubMed、Embase和Cochrane Library数据库自建库至2021年3月所发表的中药注射剂预防骨科术后患者发生深静脉血栓的临床随机对照试验;结局指标为深静脉血栓发生率、血浆凝血酶原时间、活化部分凝血活酶时间、纤维蛋白原、D-二聚体和安全性评价(不良反应发生情况)结果。使用Cochrane系统评价员手册5.1.0版随机对照试验偏倚风险评估工具及改良Jadad评分对文献进行质量评价。提取文献数据后,应用RevMan 5.3、Stata 16.0、ADDIS 1.16.8软件进行数据分析。
结果:①共检索出1 685篇文献,最终纳入67项随机对照试验,共6 052例患者,涉及11种中药注射液,干预措施包括常规西药治疗、活血类中药与常规西药联合治疗。②纳入文献质量普遍偏低,改良Jadad评分均≤3分。③网状Meta分析结果显示:在降低深静脉血栓发生率方面,共涉及11种中药注射液,最优的前3位概率排序为:常规西药联合疏血通注射液(0.440)>联合丹红注射液(0.104)>联合红花黄色素注射液(0.103);在延长血浆凝血酶原方面,共涉及10种中药注射液,最优的前3位概率排序为:常规西药联合红花注射液(0.354)>联合丹红注射液(0.275)>联合血塞通注射液(0.109);在延长部分凝血活酶时间方面,共涉及9种中药注射液,最优的前3位概率排序为:常规西药联合红花注射液(0.405)>联合苦碟子注射液(0.256)>联合丹红注射液(0.098);在降低纤维蛋白原水平方面,共涉及8种中药注射液,最优的前3位概率排序为常规西药联合苦碟子注射液(0.248)>联合血塞通注射液(0.231)>联合红花注射液(0.216);在降低D-二聚体水平方面,共涉及10种中药注射液,最优的前3位概率排序为:常规西药联合丹参川芎嗪注射液(0.235)>联合疏血通注射液(0.232)>联合苦碟子注射液(0.190);在安全性方面,共涉及9种中药注射液,最优的前3位概率排序为:常规西药联合银杏达莫注射液(0.482)、联合红花黄色素注射液(0.169)、联合丹参多酚酸盐注射液(0.140)。
结论:基于现有的随机对照试验证据表明,①在常规西药应用的基础上,联合使用中药注射剂可有效预防骨科术后患者发生深静脉血栓;②疏血通注射液在降低深静脉血栓发生率方面最优,红花注射液在延长凝血酶原时间和活化部分凝血活酶时间最优,苦碟子注射液在降低纤维蛋白原水平方面最优,丹参川芎嗪注射液在降低D-二聚体水平方面最优,银杏达莫注射液在安全性评价方面最优。

https://orcid.org/0000-0002-2701-1477 (靖金鹏);https://orcid.org/0000-0001-5149-9612 (张玥) 

中国组织工程研究杂志出版内容重点:人工关节;骨植入物;脊柱;骨折;内固定;数字化骨科;组织工程

关键词: 中药注射剂, 骨科术后, 深静脉血栓形成, 临床疗效, 安全性, 网状Meta分析, 预防, 随机对照试验

Abstract: OBJECTIVE: Clinical studies have found that traditional Chinese medicine injections can effectively prevent deep vein thrombosis in patients after orthopedic surgery. However, there are many types of traditional Chinese medicine injections in clinical application, and there is still a lack of comparative studies among different types of injections. In this study, network meta-analysis was used to evaluate the efficacy and safety of traditional Chinese medicine injections for the prevention of deep vein thrombosis in patients after orthopedic surgery.  
METHODS:  Randomized controlled trials of traditional Chinese medicine injections for the prevention of deep vein thrombosis in patients after orthopedic surgery were searched from CNKI, Wanfang, VIP, Chinese Biomedical Literature Service System, PubMed, Embase and Cochrane Library until March 2021. Outcome indicators were the incidence of deep vein thrombosis, prothrombin time, activated partial thromboplastin time, fibrinogen, D-dimer, and safety evaluation (the occurrence of adverse reactions). The quality of the included articles was evaluated using the Cochrane Systematic Reviewer's Manual Version 5.1.0 randomized controlled trials risk of bias assessment tool and modified Jadad score. After data extraction, RevMan 5.3, Stata 16.0 and ADDIS 1.16.8 softwares were used for data analysis.  
RESULTS: (1) A total of 1 685 articles were retrieved, and 67 randomized controlled trials involving a total of 6 052 patients were finally included, involving 11 kinds of Chinese medicine injections, and the intervention measures were all controlled studies of activating blood circulation combined with conventional western medicine and conventional western medicine. (2) The quality of the included articles was generally low, and the modified Jadad scores were all ≤ 3, indicating low quality studies. (3) The results of mesh meta-analysis showed that in terms of reducing the incidence of deep vein thrombosis, a total of 11 traditional Chinese medicine injections were involved, and the top three were conventional western medicine combined with Shuxuetong injection (0.440)>   combined with Danhong injection (0.104) > combined with Safflower Yellow injection (0.103). In terms of prolongation of prothrombin time, a total of 10 traditional Chinese medicine injections were involved, and the top three best were conventional western medicine combined with Honghua injection (0.354) > combined with Danhong injection (0.275) > combined with Xuesaitong injection (0.109). In terms of prolongation of activated partial thromboplastin time, a total of nine traditional Chinese medicine injections were involved, and the top three were conventional western medicine combined with Honghua injection (0.405) > combined with Kudeizi injection (0.256) > combined with Danhong injection (0.098). In terms of reducing fibrinogen, a total of eight traditional Chinese medicine injections were involved, and the top three best were conventional western medicine combined with Kudezi injection (0.248) > combined with Xuesaitong injection (0.231) > combined with Honghua injection (0.216). In terms of reducing D-dimer, a total of 10 traditional Chinese medicine injections were involved, and the top three best were conventional western medicine combined with Miltiorrhiza and Ligustrazine injection (0.235) > combined with Shuxuetong injection (0.232) > combined with Kudezi injection (0.190). In terms of safety, a total of nine Chinese medicine injections were involved, and the top three were conventional western medicine combined with Ginkgo Leaf Extract and Dipyridamole injection (0.482), combined with Safflower Yellow injection (0.169) and combined with salvianolate injection (0.140). 
CONCLUSION: Based on existing randomized controlled trial evidence: (1) On the basis of conventional application of western medicine, combined use of traditional Chinese medicine injection can effectively prevent deep vein thrombosis in patients after orthopedic surgery. (2) Shuxuetong injection was the best in reducing the incidence of deep vein thrombosis. Honghua injection was the best in prothrombin time and activated partial thromboplastin time. Kudeizi injection was the best in reducing fibrinogen. Miltiorrhiza and Ligustrazine injection was the best in reducing D-dimer. Ginkgo Leaf Extract and Dipyridamole injection was the best in safety evaluation. 

Key words: traditional Chinese medicine injection, postoperative orthopedic surgery, deep vein thrombosis, clinical effect, security, network meta-analysis, prevention, randomized controlled trial

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