低分子肝素预防髋、膝关节手术后下肢深静脉血栓形成的多中心研究

Evaluation of safety and effectiveness of low-molecular-weight heparin in the prevention of deep venous thrombosis in patients undergoing hip or knee operation

目的探讨国人髋、膝关节手术后下肢深静脉血栓(deepvenousthrombosis,DVT)的发生率及应用低分子肝素预防DVT的有效性和安全性。方法根据入选标准选择120例髋、膝关节手术患者,分别在北京、上海、广州三个中心参加该项研究,观察组和对照组分别为68例和52例。观察组中男30例,其中全髋关节置换术19例,全膝关节置换术2例,动力髋螺钉(DHS)9例;女38例,其中全髋关节置换术17例,全膝关节置换术17例,DHS4例。对照组中男21例,其中全髋关节置换术19例,全膝关节置换术1例,DHS1例;女31例,其中全髋关节置换术15例,全膝关节置换术15例,DHS1例。结果除观察组与对照组女性全髋关节置换术患者术中、术后失血量差异有统计学意义(P<0.05)外,其余出血量差异均无统计学意义(P>0.05)。手术前后血红蛋白、血小板、凝血酶原时间及活动度与活化部分凝血活酶时间变化差异均无统计学意义(P>0.05)。两组患者术后下肢DVT发生率差异有统计学意义(P<0.05)。观察组总的不良反应发生率为8.8%(6/68)。结论低分子肝素可以有效预防髋、膝关节置换术后DVT的发生,同时对于已发生的DVT有良好的治疗效果,不良反应发生率低。

Objective To find out the postoperative deep venous thrombosis （DVT） incidence in Chinese popuations undergoing knee or hip surgery, and to evaluate the effectiveness and safety of lowmolecular-weight heparin in the prevention of DVT. Methods From February 1998 to April 1999, according to the selection criteria, 120 patients were selected into this study： 68 in the observation group and 52 in the control group. The observation group comprised 30 males and 38 females. The male patients included 19 cases total hip arthroplasty （THA）, 2 cases total knee arthroplasty （TKA）, and 9 cases dynamic hip screw （DHS）. The female patients included 17 cases THA, 17 cases TKA, and 4 cases DHS. In the control group, 21 cases were male, 31 cases were female. The male patients included 19 cases THA, 1 case TKA, and 1 case DHS. The female patients included 15 cases THA, 15 cases TKA, and 1 case DHS. Results There was no significant change between intra- and postoperative bleeding in all the patients but female patients. There was no significant change of Hb, Pit, PT＋A and APTY on the fourth and tenth day after surgery （P 〉 0.05）. In the observation group, 8 patients had DVT with a rate of 11.8% （8/68）. In the control group, DVT oecarred in 16 cases with an incidence of 30.8% （16/52）. A significant difference in DVT incidence was found between these two groups. The total incidence of side effects in the investigation group was 8.8% （6/68）. Conclusion low-molecular-weight heparin can effectively reduce the incidence of DVT after hip or knee replacements, and has a good resuh in treating DVT with a low incidence of side effects.