国产前列地尔注射液治疗糖尿病肾病的疗效及安全性

Efficacy and safety of domestic alprostadil injection in the treatment of diabetic nephropathy

目的评估国产前列地尔注射液治疗糖尿病肾病的疗效和安全性。方法选取2011年1月~2013年10月在我院治疗的糖尿病肾病的患者140例,随机分为两组:治疗组(国产前列地尔组)68例,对照组(非国产前列地尔组)72例。在糖尿病的基础治疗的前提下,两组患者分别给予国产和非国产前列地尔各10μg,静脉注射,1次/d,连续给药4周。用药前和用药后4周后检查患者血尿素氮(BUN)、血肌酐(SCr)、24 h尿蛋白量(Upr)、尿蛋白排泄率(UAER);血脂相关指标包括高密度脂蛋白胆固醇(HDL-C)、血清总胆固醇(TC)、低密度脂蛋白胆固醇(LDL-C)和甘油三脂(TG);凝血相关指标包括激活的部分凝血活酶时间(APTT),凝血酶原时间(PT),血清纤维蛋白原(FIB),D-二聚体(D-D)。观察治疗期间的药物不良反应。结果两组患者治疗后BUN、SCr、Upr、UAER、TG、TC、LDL-C和FIB、D-D均下降(P<0.05),HDL-C上升(P<0.05),治疗后两组指标间比较差异无统计学意义(P>0.05)。两组均未见严重不良反应。结论国产前列地尔注射液是治疗糖尿病肾病的安全有效药物。

Objective To evaluate the efficacy and safety of domestic alprostadil injection in the treatment of diabetic nepbropathy. Methods A total of 140 patients with diabetic nephropathy treated in our hospital from January 2011 to October 2013 were randomly divided into two groups including treatment group（domestic alprostadil group） with 68 cases and control group （non-domestic alprostadil group） with 72 cases. Under the premise of the basic treatment of diabetes, both groups were given the domestic and non-domestic alprostadil 10 μg, intravenous injection, once a day, continuously for 4 weeks, respectively. Blood urea nitrogen（BUN）, serum creatinine （SCr）, 24 h urinary protein（Upr） and urinary protein excretion rate （UAER） were measured before and 4 weeks after treatment. Serum lipid-related indexes including high density lipoprotein cholesterol （HDL-（TC）, low density lipoprotein cholesterol （LDL-C） and triglyeeride （TG）, thecoagu lation-related indexes including activated partial thromboplastin time（APTl＇）, prothrombin time（PT）, Serum fibrinogen （FIB）, D-dimer （DD） were also measured before and 4 weeks after treatment.Adverse drug reactions during treatment were observed. Results The levels of BUN, SCr, Upr, UAER, TG, TC, LDL-C and FIB all decreased and the level of HDL-C increased in both groupsafter treatment（P〈0.05）. There was no significant difference in the indexes between the two groups after treatment （P〉0.05）. No serious adverse events were observed in both groups. Conclusion Domestic al- prostadil injection is a safe and effective drug for the treatment of diabetic nephropathy.