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目的 采用多中心、随机、开放的平行对照研究 ,评价低分子肝素对肾病综合征患者的蛋白尿和肾功能改善的疗效及安全性。方法 上海市 7所 3级医院确诊的肾病综合征患者 118例 ,随机分为两组 :①肾病综合征标准治疗组 (常规组 ,2 3例 ) :给予标准剂量的泼尼松 ;②标准治疗 +低分子肝素钙治疗组 (低分子肝素钙组 ,95例 ) :给予低分子肝素钙 (商品名为速碧林 ,Sanofi公司 ) 0 .3～ 0 .6ml/d ,每日 1次 ,腹壁皮下注射 ,每 2～ 4周进行生化等指标评估。两组患者均随访 8周。结果 治疗后 14d低分子肝素钙组患者的 2 4h尿蛋白及血清白蛋白水平均有明显改善 ,但常规组无明显变化。其他可能的影响因素如血压、年龄、性别、肾功能、血小板及白陶土部分凝血活酶时间 (KPTT)均无明显变化。治疗后 5 6d ,低分子肝素钙组患者的血尿素氮和血肌酐均明显下降 ,而常规组无改变。两组患者均未发生大出血、肾静脉血栓形成等严重不良事件。结论 低分子肝素作为肾病综合征高凝状态时的对症治疗 ,对于改善肾功能和蛋白尿具有一定的疗效 ,且安全、可靠
Objective To evaluate the curative effect and safety of low molecular weight heparin on the improvement of proteinuria and renal function in patients with nephrotic syndrome by multicenter, randomized and open parallel controlled study. Methods A total of 118 patients with nephrotic syndrome diagnosed in 7 tertiary hospitals in Shanghai were randomly divided into two groups: ① nephrotic syndrome standard treatment group (23 cases); standard dose of prednisone; ② standard treatment + Low molecular weight heparin treatment group (low molecular weight heparin group, 95 cases): given low molecular weight heparin (trade name Supibilin, Sanofi company) 0.3 ~ 0.6ml / d, once daily, abdominal wall Subcutaneous injection, biochemical evaluation every 2 to 4 weeks. Two groups of patients were followed up for 8 weeks. Results In the low molecular weight heparin group, the levels of 24 h urinary protein and serum albumin were significantly improved after 14 days of treatment, but there was no significant change in the routine group. Other possible influencing factors such as blood pressure, age, gender, renal function, platelet and kaolin partial thromboplastin time (KPTT) showed no significant change. At 56 days after treatment, blood urea nitrogen and serum creatinine were significantly decreased in low molecular weight heparin group, but no change in routine group. Two groups of patients did not occur major bleeding, renal vein thrombosis and other serious adverse events. Conclusion Low molecular weight heparin as symptomatic treatment of nephrotic syndrome hypercoagulable state, to improve renal function and proteinuria have a certain effect, and safe, reliable