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