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桃红四物汤预防髋关节手术患者深静脉血栓形成的有效性:系统评价和随机对照试验的荟萃分析。

Effectiveness of Taohong Siwu decoction in the prevention of deep vein thrombosis in hip surgery patients: A systematic review and meta-analysis of randomized controlled trials.

机构信息

Fuzhou Medical College of Nanchang University, Jiangxi, China.

Ankang University, Shanxi, China.

出版信息

Medicine (Baltimore). 2024 Mar 1;103(9):e37241. doi: 10.1097/MD.0000000000037241.

Abstract

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.

CONCLUSION

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.

摘要

背景

本系统评价和荟萃分析旨在评估桃红四物汤(THSWD)联合低分子肝素(LMWH)与单独使用 THSWD 对髋部骨折或置换术后深静脉血栓形成(DVT)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)疼痛评分和小腿肿胀的影响,与 LMWH 相比。

方法

根据预先确定的纳入标准,我们对评估 THSWD 联合 LMWH 或 THSWD 与 LMWH 治疗髋部骨折或置换术患者疗效的随机对照试验(RCT)进行了全面检索。检索范围包括中国知网、万方、中国生物医学文献服务系统、维普、PubMed、Embase、谷歌学术、Cochrane 以及 Web of Science 等多个数据库,检索时间从建库至 2023 年 12 月。此外,还检索了相关文献参考文献,并对相关期刊进行了手工检索。对纳入试验的方法学质量评估按照 Cochrane 手册中的指南进行。使用 Review Manager 5.4 进行分析和综合。

结果

共纳入 18 项 RCT,涉及 1353 名患者。荟萃分析结果表明,与对照组相比,联合组 DVT 发生率[RR=0.32,95%CI(0.17,0.58;P=0.0002)]、D-二聚体[SMD=-5.88,95%CI(-7.66,-4.11);P<0.00001]、VAS[MD=-1.16,95%CI(-1.81,-0.50);P=0.0005]和小腿周长差异[MD=-0.56,95%CI(-1.05,-0.08);P=0.02]改善更优。联合组与对照组在 PT 和 APTT 方面无显著差异。荟萃分析结果显示,THSWD 组与 LMWH 组的 D-二聚体、DVT 发生率、PT 和 APTT 无显著差异。

结论

本荟萃分析表明,与 LMWH 相比,THSWD 联合 LMWH 治疗髋部手术后 DVT 的疗效更好,不良事件发生率无显著增加。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(如样本量小和证据质量低),结果需要在更多具有大样本量的严格多中心临床试验中进一步验证。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e20e/10906615/9e150d264ea2/medi-103-e37241-g001.jpg

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