低分子肝素与普通肝素治疗急性肺血栓栓塞症疗效和安全性比较的Meta分析

目的根据现有随机对照临床研究,综合评价低分子肝素(LMWH)和普通肝素(UFH)作为初始治疗方案对非大面积肺血栓栓塞症(PTE)的有效性和安全性.方法从1966年1月～2003年8月MEDLINE光盘数据库和1978年1月～2003年8月中国生物医学文献光盘数据库(CBM-Disk)中,检索以非大面积PTE为研究对象,比较LMWH和UFH作为初始抗凝药物治疗效果和安全性的随机对照试验(RCT)文献,并对RCT结果进行Meta分析.结果共5项RCT 999例患者入选.与UFH抗凝治疗比较,LMWH治疗PTE的合并比数比(OR)结果如下:(1)病死率比较:合并OR为0.81,95%可信区间为0.36～1.81,OR合并假设检验,χ2合并=0.52,P＞0.05;(2)静脉血栓栓塞症(VTE)复发率比较:1项研究显示LMWH组TE复发率差异低于UFH组,合并OR为0.37,95%可信区间为0.14～1.00,OR合并假设检验,χ2合并=1.95,P=0.05;(3)严重出血率比较:合并OR为0.47,95%可信区间为0.16～1.39,OR合并假设检验,χ2合并=1.37,P＞0.05;(4)肝素诱导的血小板减少症(HIT)发生率比较:1项研究显示LMWH组HIT发生率显著低于UFH组,合并OR为0.66,95%可信区间为0.06～6.92,OR合并假设检验,χ2合并=0.35,P＞0.05.结论与UFH抗凝治疗比较,LMWH治疗非大面积PTE病死率无差异;部分研究提示UFH组(VTE)复发率显著高于LMWH组,但合并效应量显示无差异;LMWH的严重出血率与UFH亦无显著差异;部分研究提示HIT的发生率UFH组显著高于LMWH组,但合并效应量显示无差异.就总体而言,LMWH治疗非大面积PTE的疗效与安全性至少与UFH相当.

Comparison of unfractionated heparin and low molecular weight heparin in pulmonary thromboembolism: meta-analysis

OBJECTIVE: To pool the data of studies about anticoagulation in non-massive pulmonary thromboembolism (PTE) and evaluate the efficacy and safety of low molecular weight heparin (LMWH) and unfractionated heparin (UFH) as the initial treatment. METHODS: MEDLINE CD-ROM from January 1966 to August 2003 and CBM CD-ROM from January 1978 to August 2003 were chosen for searching the randomized clinical trials (RCTs) that compared the efficacy or safety of LMWH and UFH in non-massive PTE. A meta-analysis was employed to evaluate the results of these two therapies. RESULTS: Five RCTs including 999 cases were analyzed. Compared with UFH, the combined odds ratio (OR) of LMWH in treating PTE was as follows: (1) The total OR of mortality of PTE patients treated with LMWH was 0.81 (95%CI 0.36-1.81, P > 0.05); (2) The total OR of recurrence of venous thromboembolism (VTE) in PTE patients treated with LMWH was 0.37 (95%CI 0.14-1.00, P=0.05); (3) The total OR of bleeding in LMWH was 0.47 (95%CI 0.16-1.39, P > 0.05);(4) The total OR of heparin-induced thrombocytopenia (HIT) in LMWH was 0.66 (95%CI 0.06-6.92, P > 0.05). CONCLUSIONS: LMWH and UFH can reduce the mortality and recurrence of VTE in patients with PTE in the same degree. The risk of major bleeding was similar in the two treatment groups. Initial subcutaneous therapy with the LMWH appeared to be as effective and safe as intravenous UFH in the initial treatment of PTE.