文章摘要
疏肝活血颗粒预防选择性脊柱术后静脉血栓栓塞症的疗效及安全性
Efficacy and safety of Shugan Huoxue granule in preventing venous thromboembolism after selective spinal surgery
投稿时间:2022-06-25  修订日期:2022-06-25
DOI:
中文关键词: 静脉血栓栓塞症  深静脉血栓  肺栓塞  脊柱手术  中医中药
英文关键词: venous thromboembolism  deep venous thrombosis  pulmonary embolism  spine surgery  traditional Chinese medicine
基金项目:桐乡市重点科技计划项目20200149
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中文摘要:
      目的:探讨疏肝活血颗粒(三七9g 当归6g 川芎9g 柴胡9g 酒白芍9g 丹参9g 黄芪9g 地龙6g)预防选择性脊柱术后静脉血栓栓塞症(VTE)的疗效及安全性。方法:①选择性脊柱术后且下肢深静脉血栓(DVT)高危风险患者165例,分为非进椎管手术组A与进椎管手术组B,再按1:1随机分为对照组i与试验组ii。②对照组:术后12h开始皮下注射低分子肝素钠,前3天2500IU 每日1次,后5000IU 每日1次至出院,出院后口服阿司匹林肠溶片0.1g 每日1次至术后5周。试验组:术后12小时开始口服疏肝活血颗粒1包,每日2次,至术后5周。③比较对照组与试验组间DVT及肺栓塞(PE)发生率,硬膜外血肿(EDH)发生率,D-二聚体(D-Dimer)值、凝血酶原时间(PT)值差异。结果:①入组165例患者,完成134例,退出6例,脱落25例。对照组与试验组患者性别、年龄、体重及Caprini评分经统计检验基线一致。②对照组与试验组DVT及PE事件发生率无差异。③对照组与试验组EDH事件发生率无差异。④在不同时间点,对照组PT值均高于试验组。⑤对照组与试验组D-Dimer值无差异。结论:试验组与对照组疗效相当,EDH概率相当,但PT值低于对照组。口服疏肝活血颗粒可预防选择性脊柱术后VTE事件发生,同时可以降低出血风险。
英文摘要:
      Objective: To investigate the efficacy and safety of Shugan Huoxue granule (Panax notoginseng 9g, Angelica sinensis 6g, Ligusticum chuanxiong 9g, Bupleurum chinense 9g, white peony 9g, Salvia miltiorrhiza 9g, Astragalus 9g, earthworm 6g) in preventing venous thromboembolism (VTE) after selective spinal surgery. Methods: ①165 patients with high risk of lower extremity deep venous thrombosis (DVT) after selective spinal surgery were divided into non spinal canal operation group A and spinal canal operation group B, and then randomly divided into control group i and observed group ii according to 1:1. ②Control group: low molecular weight heparin sodium was injected subcutaneously 12 hours after operation, 2500IU once a day for the first 3 days, 5000IU once a day until discharge, and aspirin enteric coated tablets 0.1g once a day until 5 weeks after discharge. Observed group: take one package of Shugan Huoxue granule orally at 12 hours after operation, twice a day until 5 weeks after operation. ③The incidence of DVT, pulmonary embolism (PE), epidural hematoma (EDH), D-Dimer value and prothrombin time (PT) were compared between the control group and the observed group. Results: ①Of 165 patients enrolled, 134 were completed, 6 were withdrawn and 25 were dropped out. The gender, age, weight and Caprini score of patients in the control group and the observed group were consistent with each other through statistical observed. ②There was no difference in the incidence of DVT and PE between the control group and the experimental group. ③There was no difference in the incidence of EDH events between the control group and the observed group. ④ At different time points, PT values of the control group were higher than those of the observed group. ⑤ There was no difference in D-Dimer value between the control group and the observed group. Conclusion: the curative effect and EDH probability of the experimental group and the control group are the same, but the PT value is lower than that of the control group. Oral administration of Shugan Huoxue granule can prevent VTE events after selective spinal surgery and reduce the risk of bleeding.
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