PREVENTION OF DEEP-VEIN THROMBOSIS AFTER ELECTIVE HIP-SURGERY - A RANDOMIZED TRIAL COMPARING LOW-MOLECULAR-WEIGHT HEPARIN WITH STANDARD UNFRACTIONATED HEPARIN

被引:295
作者
LEVINE, MN
HIRSH, J
GENT, M
TURPIE, AG
LECLERC, J
POWERS, PJ
JAY, RM
NEEMEH, J
机构
[1] MCMASTER UNIV, HAMILTON L8S 4L8, ONTARIO, CANADA
[2] HAMILTON CIV HOSP, RES CTR, HAMILTON, ONTARIO, CANADA
[3] MCGILL UNIV, MONTREAL H3A 2T5, QUEBEC, CANADA
[4] UNIV MONTREAL, MONTREAL H3C 3J7, QUEBEC, CANADA
关键词
D O I
10.7326/0003-4819-114-7-545
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Objective: To determine the relative efficacy and safety of low molecular weight (LMW) heparin (Enoxaparin) compared with standard calcium heparin for the prevention of postoperative deep vein thrombosis in patients undergoing elective hip surgery. Design: A double-blind, randomized, controlled trial. Patients: Six hundred sixty-five consecutive patients undergoing hip replacement at five participating hospitals. Interventions: Patients received either fixed-dose LMW heparin, 30 mg subcutaneously twice daily, or fixed-dose standard calcium heparin, 7500 units subcutaneously twice daily; both regimens were started 12 to 24 hours after surgery and continued for 14 days or until discharge if sooner. Measurements: All patients had postoperative I-125-fibrinogen leg scanning and impedance plethysmography. If results of one or both tests were positive, then venography was done. Otherwise, venography was done between day 10 and day 14, or sooner if the patient was ready for discharge. Results: Evaluable venograms were obtained in 258 of the 333 patients randomly assigned to receive LMW heparin and in 263 of the 332 patients assigned to receive calcium heparin. For patients with evaluable venograms, thrombosis was detected in 50 patients (19.4%) who received LMW heparin compared with 61 patients (23.2%) who received standard heparin (difference, - 3.8%; 95% CI, - 11.1% to 3.6%) (P > 0.2). Proximal deep vein thrombosis was detected in 5.4% of the patients receiving LMW heparin and in 6.5% of the patients receiving standard heparin (difference, - 1.1%; CI, - 5.2% to 3.3%) (P > 0.2). For the entire group of 665 patients, venous thrombosis occurred in 17.1% given LMW heparin and in 19.0% given standard heparin. Hemorrhagic complications occurred in 31 patients (9.3%) given standard heparin and in 17 patients (5.1%) given LMW heparin (difference, 4.2%; CI, 0.3% to 8.2%) (P = 0.035). The relative risk reduction was 45%. The rate of major bleeding in the standard heparin group was 5.7% compared with 3.3% in the LMW heparin group (difference, 2.4%; CI, - 1.0% to 5.4%) (P = 0.13). The relative risk reduction was 42%. Conclusion: Low molecular weight heparin is significantly less hemorrhagic than standard unfractionated heparin; the difference in the rate of deep vein thrombosis, although not statistically significant (P > 0.2), favors the use of LMW heparin.
引用
收藏
页码:545 / 551
页数:7
相关论文
共 43 条
[1]   A NEW LOW-MOLECULAR WEIGHT HEPARIN DERIVATIVE - INVITRO AND INVIVO STUDIES [J].
AIACH, M ;
MICHAUD, A ;
BALIAN, JL ;
LEFEBVRE, M ;
WOLER, M ;
FOURTILLAN, J .
THROMBOSIS RESEARCH, 1983, 31 (04) :611-621
[2]   SUBCUTANEOUS ADMINISTRATION OF HEPARIN - A RANDOMIZED COMPARISON WITH INTRAVENOUS ADMINISTRATION OF HEPARIN TO PATIENTS WITH DEEP-VEIN THROMBOSIS [J].
ANDERSSON, G ;
FAGRELL, B ;
HOLMGREN, K ;
JOHNSSON, H ;
LJUNGBERG, B ;
NILSSON, E ;
WILHELMSSON, S ;
ZETTERQUIST, S .
THROMBOSIS RESEARCH, 1982, 27 (06) :631-639
[3]   ANTICOAGULANT PROPERTIES OF HEPARIN FRACTIONATED BY AFFINITY CHROMATOGRAPHY ON MATRIX-BOUND ANTITHROMBIN-3 AND BY GEL-FILTRATION [J].
ANDERSSON, LO ;
BARROWCLIFFE, TW ;
HOLMER, E ;
JOHNSON, EA ;
SIMS, GEC .
THROMBOSIS RESEARCH, 1976, 9 (06) :575-583
[4]   AN OBJECTIVE STUDY OF ALTERNATIVE METHODS OF HEPARIN ADMINISTRATION [J].
BENTLEY, PG ;
KAKKAR, VV ;
SCULLY, MF ;
MACGREGOR, IR ;
WEBB, P ;
CHAN, P ;
JONES, N .
THROMBOSIS RESEARCH, 1980, 18 (1-2) :177-187
[5]   ANTICOAGULANT EFFECTS OF 2 TYPES OF LOW-MOLECULAR WEIGHT HEPARIN ADMINISTERED SUBCUTANEOUSLY [J].
BERGQVIST, D ;
HEDNER, U ;
SJORIN, E ;
HOLMER, E .
THROMBOSIS RESEARCH, 1983, 32 (04) :381-391
[6]  
BLAJCHMAN MA, 1989, ANN NY ACAD SCI, V556, P245
[7]   PHARMACOKINETIC STUDIES OF STANDARD UNFRACTIONATED HEPARIN, AND LOW-MOLECULAR WEIGHT HEPARINS IN THE RABBIT [J].
BONEU, B ;
CARANOBE, C ;
CADROY, Y ;
DOL, F ;
GABAIG, AM ;
DUPOUY, D ;
SIE, P .
SEMINARS IN THROMBOSIS AND HEMOSTASIS, 1988, 14 (01) :18-27
[8]   PROPHYLAXIS OF VENOUS THROMBOSIS AFTER MAJOR THORACIC-SURGERY [J].
CADE, JF ;
CLEGG, EA ;
WESTLAKE, GW .
AUSTRALIAN AND NEW ZEALAND JOURNAL OF SURGERY, 1983, 53 (04) :301-304
[9]  
CARTER CJ, 1982, BLOOD, V59, P1239
[10]  
COLDITZ GA, 1986, LANCET, V2, P143