羟苯磺酸钙胶囊联合贝那普利片治疗早期糖尿病肾病患者的临床研究

Clinical trial of calcium dobesilate capsules combined with benazepril tablets in the treatment of patients with early diabetic nephropathy

目的观察羟苯磺酸钙胶囊联合贝那普利片治疗早期糖尿病肾病(diabetic nephropathy,DN)患者的临床疗效及安全性。方法将108例早期DN患者随机分为对照组54例和试验组54例。对照组给予贝那普片每次10 mg,qd,口服;试验组在对照组治疗的基础上,给予羟苯磺酸钙胶囊每次0.5 g,tid,口服。2组患者均治疗2个月。比较2组患者的临床疗效、血糖指标、肝肾功能和药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为82.69%(43例/52例)和60.00%(30例/50例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的糖化血红蛋白分别为(6.06±0.62)%和(6.37±0.65)%,谷丙转氨酶分别为(21.50±6.05)和(26.23±5.79)U·L^(-1),谷草转氨酶分别为(19.71±3.63)和(21.91±3.27)U·L^(-1),血清肌酸酐分别为(92.06±9.36)和(102.71±9.28)μmol·L^(-1),尿素氮分别为(4.63±0.61)和(5.67±0.65)mmol·L^(-1),差异均有统计学意义(均P<0.05)。试验组发生的药物不良反应主要有恶心和水肿,对照组发生的药物不良反应有水肿。试验组和对照组的总药物不良反应发生率分别为9.62%和6.00%,差异无统计学意义(P>0.05)。结论羟苯磺酸钙胶囊联合贝那普利片治疗早期DN患者的疗效比单用贝那普利片更佳,且不增加药物不良反应的发生率。

Objective To observe the clinical efficacy and safety of calcium dobesilate capsules combined with benazepril tablets in the treatment of patients with early diabetic nephropathy(DN).Methods A total of 108 patients with early DN were randomly divided into control and treatment groups with 54 cases per group.Control group was given benazepril tablet 10 mg per time,qd,orally.Treatment group received calcium dobesilate capsules 0.5 g per time,tid,orally,on the basis of control group.Two groups were treated for 2 months.The clinical efficacy,blood glucose indexes,liver and kidney functions and adverse drug reactions were compared between two groups.Results After treatment,the total effective rates of treatment and control groups were 82.69%(43 cases/52 cases)and 60.00%(30 cases/50 cases)with significant difference(P<0.05).After treatment,the glycated hemoglobin of treatment and control groups were(6.06±0.62)%and(6.37±0.65)%,the glutamic-pyruvic transaminase were(21.50±6.05)and(26.23±5.79)U·L^(-1),the glutamic-oxaloacetic transaminase were(19.71±3.63)and(21.91±3.27)U·L^(-1),the serum creatinine were(92.06±9.36)and(102.71±9.28)μmol·L^(-1),the blood urea nitrogen were(4.63±0.61)and(5.67±0.65)mmol·L^(-1),the differences were statistically significant(all P<0.05).The adverse drug reactions of treatment group were nausea and edema,while those in the control groups were edema.The total incidences of adverse drug reactions in the treatment and control groups were 9.62%and 6.00%without significant difference(P>0.05).Conclusion The efficacy of calcium dobesilate capsules combined with benazepril tablets in the treatment of patients with early DN is better than that of benazepril tablets alone,without increasing the incidences of adverse drug reactions.