黄芪注射液联合赖诺普利胶囊和醋酸泼尼松片治疗急性肾病综合征的临床研究

Clinical trial of astragalus injection combined with lisinopril capsule and prednisone tablets in the treatment of acute nephrotic syndrome

目的观察黄芪注射液联合赖诺普利和醋酸泼尼松治疗急性肾病综合征的临床疗效和安全性,及其对血清肿瘤标志物及肾功能的影响。方法将96例肾病综合征患者随机分为对照组48例与试验组48例。对照组予以口服赖诺普利10 mg·d^(-1),qd+口服醋酸泼尼松5~10 mg·kg^(-1)·d^(-1),bid。试验组在对照组治疗的基础上,予以静脉滴注黄芪注射液2 m L,bid。2组患者一个周期均为28 d,共治疗2个周期。比较2组患者的临床疗效、血清肿瘤标志物及肾功能,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95.83%(46/48例)和83.33%(40/48例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的血清尿蛋白分别为(0.89±0.09),(1.31±0.16)g·d^(-1);β2微球蛋白分别为(2.01±0.27),(2.69±0.27)mg·L^(-1);血尿素氮分别为(8.63±1.68),(10.56±1.77)mmo·L^(-1);血清肌酸酐分别为(229.93±24.23),(276.58±29.53)μmol·L^(-1);糖抗原125分别为(43.91±5.92),(74.02±8.03)μg·L^(-1);糖抗原153分别为(8.43±1.12),(10.83±1.24)μg·L^(-1);糖抗原199水平分别为(12.92±1.42),(15.93±1.73)μg·L^(-1);肌酸酐清除率分别为(48.42±9.01),(39.11±4.06)m L·min^(-1),差异均有统计学意义(P<0.05)。试验组发生的药物不良反应有头痛、恶心、皮疹;对照组发生的药物不良反应有头痛、血清肌酸酐轻度上升、恶心、皮疹。试验组和对照组的药物不良反应发生率分别为6.25%和14.58%,差异无统计学意义(P>0.05)。结论黄芪注射液联合赖诺普利和醋酸泼尼松治疗急性肾病综合征的临床疗效显著,可显著改善患者的血清肿瘤标志物及肾功能水平,且不增加药物不良反应发生率。

Objective To evaluate the clinical efficacy and safety of astragalus injection combined with lisinopril and prednisone acetate in the treatment of acute nephrotic syndrome.Methods A total of 96 patients with acute nephrotic syndrome were divided into control group（n = 48）and treatment group（n = 48）.Control group was received lisinopril 10mg·d^（-1）oral,qd ＋ prednisone 5-10 mg·kg^（-1）·d^（-1）oral,bid.Treatment group was received astragalus injection 2 m L,intravenous infusion,bid,on the basis of control group.Two groups were treated for 2 cycles with 28 d per cycle.The clinical efficacy,serum tumor markers,renal function and incidence of adverse drug reactions were compared between two groups.Results After treatment,the total effective rates in treatmentand control groups were 95.83%（46/48） and 83.33%（40/48）,with significant difference（P 0.05）.After treatment,the main observation indexes in treatment and control group：urinary protein were（0.89 ± 0.09）,（1.31 ± 0.16） g·d^（-1）;β2-microglobulin were（2.01 ± 0.27）,（2.69 ± 0.27） mg ·L^（-1）;blood urea nitrogen were（8.63 ± 1.68）,（10.56 ± 1.77） mmo · L-1;serum creatinine were（229.93 ± 24.23）,（276.58 ± 29.53）μmol·L^（-1）;carbohydrate antigen 125 were（43.91 ± 5.92）,（74.02 ± 8.03） μg·L^（-1）;carbohydrate antigen 153were（8.43 ± 1.12）,（10.83 ± 1.24） μg · L-1;carbohydrate antigen 199 were（12.92 ± 1.42）,（15.93 ± 1.73）μg·L^（-1）;the creatinine clearance were（48.42 ± 9.01）,（39.11 ± 4.06） m L·min^（-1）,with statistically significant difference（P 0.05）.The adverse drug reactions were based on headache,nausea and rash in treatment group,also which was added with mild increase in blood creatinine in control group.The incidence of adverse drug reactions has no significant difference between treatment and control groups（6.25% vs 14.58%,P 0.05）.Conclusion Astragalus injection combined with lisinopril and prednisone in the treatment of acute nephrotic syndrome was effective and safety.