别嘌醇缓释胶囊联合药用炭胶囊治疗痛风肾病的临床研究

Clinical trial of allopurinol sustained-release capsules combined with medicinal charcoal capsules in the treatment of gouty nephropathy

目的观察别嘌醇缓释胶囊联合药用炭胶囊治疗痛风肾病的临床疗效及安全性。方法将85例痛风肾病患者随机分为对照组40例和试验组45例。对照组予以别嘌醇每次0. 25 g,qd,口服;试验组在对照组治疗的基础上,予以药用炭胶囊每次1. 5 g,tid,口服。2组患者均治疗3个月。比较2组患者的临床疗效、尿酸和肾功能,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86. 67%(39例/45例)和67. 50%(27例/40例),差异有统计学意义(P <0. 05)。治疗后,试验组和对照组的尿酸分别为(373. 35±32. 78)和(429. 94±26. 59)μmol·L^-1,血清肌酸酐分别为(101. 45±14. 91)和(118. 64±19. 12)μmol·L^-1,血尿素氮分别为(7. 43±1. 00)和(9. 61±1. 79) mmol·L^-1,24 h尿蛋白分别为(1. 00±0. 12)和(1. 37±0. 17) g,差异均有统计学意义(均P <0. 05)。试验组的药物不良反应主要有恶心呕吐,对照组的药物不良反应主要有恶心呕吐和腹泻。试验组和对照组的总药物不良反应发生率分别为8. 89%和10. 00%,差异无统计学意义(P> 0. 05)。结论别嘌醇缓释胶囊联合药用炭胶囊治疗痛风肾病的临床疗效显著,且不增加药物不良反应的发生率。

Objective To observe the clinical efficacy and safety of allopurinol sustained - release capsules combined with medicinal charcoal capsules in the treatment of gouty nephropathy. Methods Eighty - five patients with gouty nephropathy were randomly divided into control group ( n = 40 cases) and treatment group ( n = 45 cases). Control group was treated with allopurinol sustained - release capsules 0. 25 g per time,qd, orally. Treatment group received medicinal charcoal capsules 1. 5 g per time,tid,orally,on the basis of control group. Two groups were treated for 3 months. The clinical efficacy,uric acid,renal function and adverse drug reactions were compared between two groups. Results After treatment, the total effective rates of treatment and control groups were 86. 67%( 39 cases / 45 cases) and 67. 50%( 27 cases / 40 cases) with significant difference ( P < 0. 05). After treatment,the main indexes of treatment and control groups were compared: uric acid were ( 373. 35 ± 32. 78 ) and ( 429. 94 ± 26. 59 )μmol · L^-1,creatinine ( 101. 45 ± 14. 91 ) and ( 118. 64 ± 19. 12 )μmol·L^-1,blood urea nitrogen were ( 7. 43 ± 1. 00 ) and ( 9. 61 ± 1. 79 ) mmol ·L^-1,24 h urine protein were ( 1. 00 ± 0. 12 ) and ( 1. 37 ± 0. 17) g,the differences were statistically significant( all P < 0. 05). The adverse drug reactions of treatment group were nausea and vomiting,which in control group were nausea and vomiting and diarrhea. The total incidences of adverse drug reactions in the treatment and control groups were 8. 89% and 10. 00% without significant difference ( P > 0. 05). Conclusion Allopurinol sustained - release capsules combined with medicinal charcoal capsules have a definitive clinical efficacy in the treatment of gouty nephropathy,without increasing the incidence of adverse drug reactions.