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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 observe the clinical efficacy and safety of astragalus injection combined with lisinopril and prednisone in the treatment of acute nephritic syndrome and its effects on serum tumor markers and renal function. Methods Ninety-six patients with nephrotic syndrome were randomly divided into control group (n = 48) and experimental group (n = 48). The control group was given oral lisinopril 10 mg · d -1 and qd + oral prednisone 5 ~ 10 mg · kg -1 · d -1, bid. The experimental group in the control group based on the treatment, to be intravenous infusion of Astragalus 2 m L, bid. One cycle of two groups of patients were 28 days, a total of 2 cycles. The clinical efficacy, serum tumor markers and renal function, as well as the incidence of adverse drug reactions, were compared between the two groups. Results After treatment, the total effective rate was 95.83% (46/48 cases) and 83.33% (40/48 cases) in experimental group and control group, respectively. The difference was statistically significant (P <0.05). After treatment, the urinary protein levels of test group and control group were (0.89 ± 0.09) and (1.31 ± 0.16) g · d -1, respectively, and those of β2 microglobulin were (2.01 ± 0.27) and (2.69 ± 0.27 (mg · L -1), blood urea nitrogen were (8.63 ± 1.68) and (10.56 ± 1.77) mmo · L -1, respectively. Serum creatinine were (229.93 ± 24.23) and (276.58 ± 29.53 ) (μmol·L -1). The levels of carbohydrate antigen 125 were (43.91 ± 5.92) and (74.02 ± 8.03) μg · L -1, respectively. The levels of carbohydrate antigen 153 were (8.43 ± 1.12) and (10.83 ± 1.24 ) μg · L -1; the levels of carbohydrate antigen 199 were (12.92 ± 1.42) and (15.93 ± 1.73) μg · L -1, creatinine clearance rates were (48.42 ± 9.01) and ± 4.06) m L · min ~ (-1), the differences were statistically significant (P <0.05). Adverse drug reactions occurred in the test group headache, nausea, rash; adverse drug reactions occurred in the control group had headache, serum creatinine mildly increased, nausea, rash. The incidence of adverse drug reactions in the experimental group and the control group were 6.25% and 14.58%, respectively, with no significant difference (P> 0.05). Conclusion Astragalus injection combined with lisinopril and prednisone acetate in the treatment of acute nephritic syndrome, the clinical efficacy was significantly improved in patients with serum tumor markers and renal function levels, and does not increase the incidence of adverse drug reactions.