厄贝沙坦片联合精蛋白生物合成人胰岛素注射液治疗老年2型糖尿病肾病的临床研究

Clinical trial of irbesartan tablets combined with isophane protamine biosynthetic human insulin injection in the treatment of elderly type 2 diabetic nephropathy

目的观察厄贝沙坦片联合精蛋白生物合成人胰岛素注射液治疗老年2型糖尿病肾病患者的临床疗效及安全性。方法将100例老年2型糖尿病肾病患者随机分为对照组50例和试验组50例。对照组予以精蛋白生物合成人胰岛素0.25 U·kg^(-1)·d^(-1),bid,早餐和晚餐前皮下注射;试验组在对照组治疗的基础上,予以厄贝沙坦150 mg,qd,口服。2组患者均治疗3个月。比较2组患者的临床疗效、血尿素氮(BUN)、血清肌酸酐(SCr)、24 h尿白蛋白排泄率(24 h UAER),以及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94.00%(47/50例)和76.00%(38/50例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的BUN分别为(6.84±0.56)和(7.67±0.70)mmol·L^(-1),SCr分别为(76.49±8.05)和(86.39±8.04)μmol·L^(-1),24 h UAER分别为(68.02±6.75)和(78.70±7.52)mg·24 h^(-1),差异均有统计学意义(均P<0.05)。2组患者的药物不良反应以头痛、眩晕、心悸、咳嗽为主,且试验组和对照组的药物不良反应率分别为16.00%和22.00%,差异无统计学意义(P>0.05)。结论厄贝沙坦片联合精蛋白生物合成人胰岛素注射液治疗老年2型糖尿病肾病的临床疗效确切,其能有效地改善患者的肾功能,且不增加药物不良反应的发生率。

Objective To observe the clinical efficacy and safety of irbesartan tablets combined with isophane protamine biosynthetic human insulin injection in the treatment of elderly type 2 diabetic nephropathy.Methods A total of 100 elderly patients with type 2 diabetic nephropathy were randomly divided into control group and treatment group with 50 cases per group. Control group was treated with progesterone biosynthesis human insulin 0. 25 U·kg^-1·d^-1,bid,subcutaneous injection before breakfast and dinner. Treatment group was orally given irbesartan 150 mg,qd,on the basis of control group. Two groups were treated for 3months. The clinical efficacy,levels of blood urea nitrogen（ BUN）,serum creatinine（ SCr）, 24 h urinary albumin excretion rate（ 24 h UAER）,and adverse drug reactions were compared between two groups. Results After treatment,the total effective rates of treatment and control groups were 94. 00%（ 47/50 cases） and 76. 00%（ 38/50cases） with statistically significant difference（ P〈0. 05）. Aftertreatment, the main indexes in treatment and control groups were compared： BUN were（ 6. 84 ± 0. 56）,（ 7. 67 ± 0. 70） mmol · L^-1; SCr were（ 76. 49 ± 8. 05）,（ 86. 39 ± 8. 04） μmol·L^-1; 24 h UAER were（ 68. 02 ± 6. 75）,（ 78. 70 ± 7. 52） mg·24 h^-1,the differences were statistically significant（ all P〈0. 05）. The adverse drug reactions in two groups headache,dizziness,palpitations and cough. The incidences of adverse drug reactions in treatment and control groups were 16. 00% and 22. 00% without significant difference（ P〉0. 05）.Conclusion Irbesartan tablet combined with isophane protamine biosynthetic human insulin injection has a definitive clinical efficacy in the treatment of elderly type 2 diabetic nephropathy,which can improve the patients ＇ renal function,without increasing the incidence of adverse drug reactions.