Imperiale T F, Speroff T
Department of Medicine, Case Western Reserve University at MetroHealth Medical Center, Cleveland, Ohio 44109-1998.
JAMA. 1994 Jun 8;271(22):1780-5.
While several methods of prophylaxis have been shown to reduce the risk of venous thromboembolism following total hip replacement, the safest and most effective agent is unclear. To clarify this issue, we performed a meta-analysis of the randomized trials of methods used to prevent venous thromboembolism following total hip replacement.
English-language human studies articles from 1966 through 1993 were obtained from a MEDLINE database search with indexing terms including thromboembolism, hip replacement or hip prosthesis, and randomized controlled trials. Additional references were obtained from study bibliographies.
The following criteria were used to select studies for inclusion: study design--randomized clinical trial; study population--patients undergoing elective total hip replacement; interventions--aspirin, warfarin, dextran, heparin, low-molecular-weight heparin, compression stockings; and outcomes--venous thromboembolism, major hemorrhage.
Methodological and descriptive data from each study were abstracted by one author who was blinded to quantitative outcomes data.
Ninety-one treatment groups and 25 control groups were identified from 56 trials. Four treatment groups were excluded because of rarely used combinations. Trial populations were clinically homogeneous. When compared with the control arm, all treatments except aspirin reduced the risk of all deep venous thromboses (risk differences range, 0.18 to 0.31; all P values < .05). All treatments except aspirin reduced the risk of proximal venous thrombosis (risk differences range, 0.09 to 0.18; all P values < .05). Only low-molecular-weight heparin and stockings reduced the risk of pulmonary embolism, both with risk differences equal to 0.02. The crude risks of clinically important bleeding as defined by the individual trials were 0% for stockings, 0.3% for controls, and 1.8% for low-molecular-weight heparin.
The results suggest that low-molecular-weight heparin and compression stockings have the greatest relative efficacy in preventing venous thromboembolism following total hip replacement. Low-molecular-weight heparin may be more effective, though at a small risk of clinically important bleeding.
虽然已证明几种预防方法可降低全髋关节置换术后静脉血栓栓塞的风险,但最安全有效的药物尚不清楚。为阐明这一问题,我们对用于预防全髋关节置换术后静脉血栓栓塞的方法的随机试验进行了荟萃分析。
1966年至1993年的英文人体研究文章通过MEDLINE数据库检索获得,检索词包括血栓栓塞、髋关节置换或髋关节假体以及随机对照试验。其他参考文献从研究参考文献中获取。
采用以下标准选择纳入研究:研究设计——随机临床试验;研究人群——接受择期全髋关节置换的患者;干预措施——阿司匹林、华法林、右旋糖酐、肝素、低分子肝素、压力袜;结局指标——静脉血栓栓塞、大出血。
每项研究的方法学和描述性数据由一位对定量结局数据不知情的作者提取。
从56项试验中确定了91个治疗组和25个对照组。由于使用组合很少,排除了4个治疗组。试验人群在临床上具有同质性。与对照组相比,除阿司匹林外的所有治疗均降低了所有深静脉血栓形成的风险(风险差异范围为0.18至0.31;所有P值<0.05)。除阿司匹林外的所有治疗均降低了近端静脉血栓形成的风险(风险差异范围为0.09至0.18;所有P值<0.05)。只有低分子肝素和压力袜降低了肺栓塞的风险,两者的风险差异均为0.02。各试验定义的具有临床意义的出血的粗略风险,压力袜为0%,对照组为0.3%,低分子肝素为1.8%。
结果表明,低分子肝素和压力袜在预防全髋关节置换术后静脉血栓栓塞方面具有最大的相对疗效。低分子肝素可能更有效,尽管有小的临床重要出血风险。