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190例髋关节置换术中血栓栓塞的预防。低分子量肝素与安慰剂的比较。

Prevention of thromboembolism in 190 hip arthroplasties. Comparison of LMW heparin and placebo.

作者信息

Lassen M R, Borris L C, Christiansen H M, Boll K L, Eiskjaer S P, Nielsen B W, Schøtt P, Olsen A D, Rodenberg J C, Lucht U

机构信息

Department of Orthopedics, Aalborg Hospital, Denmark.

出版信息

Acta Orthop Scand. 1991 Feb;62(1):33-8. doi: 10.3109/17453679108993088.

Abstract

Prophylactic efficacy and safety of a low molecular weight (LMW) heparin against postoperative thromboembolic complications were investigated in a double-blind, randomized study. Totally, 210 consecutive patients undergoing total hip replacement were allocated to two groups. Patients in the heparin group received 50 IU anti-Xa per kilo body weight of Logiparin once daily, and patients in the placebo group received one daily injection of saline. Additional prophylaxis in all the patients was thigh-length compression stockings beginning on the day of the operation. Deep vein thrombosis was diagnosed by bilateral ascending phlebography between Days 8 and 10 after the operation. Twenty patients were excluded from the evaluation. Thirty of 93 patients in the heparin group compared with 45 of 97 patients in the placebo group suffered a thromboembolic complication during the study (P = 0.02). The postoperative blood loss and total number of blood transfusions in the heparin group were higher than in the placebo group. However, the observed differences were of no clinical importance. Adverse effects, including bleeding complications and wound hematomas, were observed in 13 heparin patients and 7 placebo patients (NS). One patient in each group died. Thrombo-prophylaxis with LMW heparin once daily was safe and more effective than the placebo in patients undergoing total hip replacement.

摘要

在一项双盲随机研究中,对低分子量(LMW)肝素预防术后血栓栓塞并发症的疗效和安全性进行了调查。共有210例连续接受全髋关节置换术的患者被分为两组。肝素组患者每天接受一次每公斤体重50 IU抗Xa的洛吉肝素注射,安慰剂组患者每天注射一次生理盐水。所有患者均从手术当天开始使用大腿长度的加压弹力袜进行额外预防。术后第8天至第10天通过双侧上行静脉造影诊断深静脉血栓形成。20例患者被排除在评估之外。肝素组93例患者中有30例,而安慰剂组97例患者中有45例在研究期间发生了血栓栓塞并发症(P = 0.02)。肝素组术后失血量和输血总量高于安慰剂组。然而,观察到的差异无临床意义。在13例使用肝素的患者和7例使用安慰剂的患者中观察到了不良反应,包括出血并发症和伤口血肿(无统计学意义)。每组各有1例患者死亡。对于接受全髋关节置换术的患者,每天一次使用LMW肝素进行血栓预防比安慰剂更安全、更有效。

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