背景:本系统综述和荟萃分析旨在评估桃红四物汤(THSWD)联合低分子量肝素(LMWH)的疗效,除了THSWD之外,深静脉血栓形成(DVT)的发生率,D-二聚体水平,凝血酶原时间(PT),活化部分凝血活酶时间(APTT),视觉模拟量表(VAS)疼痛评分,髋部骨折或置换手术患者的小腿肿胀,与LMWH相比。
方法:根据预定义的纳入标准,我们对随机对照试验(RCTs)进行了全面检索,这些试验研究了TSWD联合LMWH或TSWD与LMWH相比,在髋部骨折或接受置换手术的患者中的疗效.在包括中国国家知识互联网在内的多个数据库中进行了搜索,万方,Sinomed,独秀,PubMed,Embase,谷歌学者,科克伦,和WebofScience从成立到2023年12月。此外,检索相关文献参考文献,并对相关期刊进行手工检索。纳入试验的方法学质量评估按照Cochrane手册中概述的指南进行。评审经理5.4用于分析和综合。
结果:共纳入18个RCTs,1353例患者。Meta分析结果显示,与对照组相比,联合组对DVT发生率有较好的影响[RR=0.32,95%CI(0.17,0.58;P=.0002],D-二聚体[SMD=-5.88,95%CI(-7.66,-4.11);P<.00001],VAS[MD=-1.16,95%CI(-1.81,-0.50);P=.0005],小腿周长差[MD=-0.56,95%CI(-1.05,-0.08);P=.02]。联合组与对照组PT、APTT比较差异无统计学意义。Meta分析结果显示,D-二聚体,DVT的发生率,PT,和APTT在THSWD和LMWH组之间没有显着差异。
结论:这项荟萃分析表明,与低分子肝素相比,THSWD联合LMWH治疗髋关节术后DVT具有较好的疗效,没有显著增加不良事件的发生率。此外,联合治疗还可以降低D-二聚体,VAS,和肿胀。然而,由于纳入研究的局限性(如小样本量和低质量证据),这些结果需要在更严格的多中心临床试验中进一步验证,且样本量较大.
BACKGROUND: This systematic
review and meta-analysis aimed to evaluate the effects of Taohong Siwu Decoction (THSWD) combined with low molecular weight heparin (LMWH), as well as THSWD alone, on the incidence of Deep vein thrombosis (DVT), D-dimer levels, prothrombin time (PT), activated partial thromboplastin time (APTT), visual analogue scale (VAS) pain score, and calf swelling in patients undergoing hip fracture or replacement surgery, compared to LMWH.
METHODS: According to the predefined inclusion criteria, we conducted a comprehensive search for randomized controlled trials (RCTs) examining the efficacy of THSWD combined with LMWH or THSWD compared to LMWH in patients with hip fractures or undergoing replacement surgery. The search was performed across multiple databases including China National Knowledge Internet, WanFang, Sinomed, Duxiu, PubMed, Embase, Google Scholar, Cochrane, and Web of Science from their inception until December 2023. Additionally, relevant literature references were retrieved and hand searching of pertinent journals was conducted. The methodological quality assessment of the included trials was carried out following the guidelines outlined in the Cochrane Handbook.
Review Manager 5.4 was applied in analyzing and synthesizing.
RESULTS: A total of 18 RCTs with 1353 patients were included. The results of meta-analysis showed that compared with the control group, the combined group had a better effect on the incidence of DVT [RR = 0.32, 95% CI(0.17, 0.58; P = .0002], D-dimer [SMD = -5.88, 95% CI(-7.66, -4.11); P < .00001], VAS [MD = -1.16, 95% CI(-1.81, -0.50); P = .0005], Calf circumference difference [MD = -0.56, 95% CI(-1.05, -0.08); P = .02]. There was no significant difference in PT and APTT between the combined group and the control group. Meta-analysis results show that the D-dimer, incidence of DVT, PT, and APTT did not significantly differ between the THSWD and the LMWH groups.
CONCLUSIONS: This meta-analysis shows that compared with LMWH, THSWD combined with LMWH has a better efficacy in the treatment of DVT after hip surgery, without a significant increase in the incidence of adverse events. Additionally, the combined therapy can also reduce D-dimer, VAS, and swelling. However, due to the limitations of the included studies (such as small sample size and low-quality evidence), the results need to be further verified in more rigorous multicenter clinical trials with a large sample size.