比较非布司他片与别嘌呤醇片治疗高尿酸血症伴痛风的临床研究  

Clinical trial of febuxostat tablets versus allopurinol tablets in the treatment of hyperuricemia and gout

作　　者：黄金沐[1] 池慧琼[1] 林少凯 

机构地区：[1]福建莆田学院附属医院药剂科,福建莆田351100 [2]福建省疾病预防控制中心,福州350001

出　　处：《中国临床药理学杂志》2017年第20期2009-2012,共4页The Chinese Journal of Clinical Pharmacology

基　　金：福建省卫生计生委青年科研课题基金资助项目(2015-2-26)

摘　　要：目的观察不同剂量非布司他与别嘌呤醇治疗高尿酸血症伴痛风的临床疗效及安全性。方法将90例高尿酸血症伴痛风患者随机分为试验A组、试验B组和对照组,每组30例。对照组患者予以口服别嘌呤醇片300 mg tid;试验A组患者予以口服非布司他片35 mg qd,试验B组患者予以口服非布司他片70mg qd,3组患者均治疗24周。比较3组患者的临床疗效和药物不良反应发生率,以及治疗前、治疗12周及24周时患者的血清可溶性细胞黏附因子-1(s ICAM-1)水平和尿酸水平。结果治疗后,试验A组、试验B组和对照组的总有效率分别为56.67%(17例/30例),66.67%(20例/30例)和46.67%(14例/30例),差异均有统计学意义(均P<0.05)。治疗后12周,试验A组、试验B组和对照组的血清s ICAM-1分别为(445.76±135.85),(421.28±122.25)和(493.39±121.27)ng·mL^(-1);治疗后24周,试验A组、试验B组和对照组的血清s ICAM-1分别为(387.71±126.75),(360.85±125.50)和(441.45±122.48)ng·mL^(-1),差异均有统计学意义(均P<0.05);分别与治疗前比较,差异均有统计学意义(均P<0.05)。治疗后12周,试验A组、试验B组和对照组的尿酸分别为(445.57±135.50),(460.60±140.45)和(515.20±142.15)ng·mL^(-1);治疗后24周,试验A组、试验B组和对照组的尿酸分别为(425.10±126.28),(410.10±130.38)和(478.80±164.72)ng·mL^(-1),差异均有统计学意义(均P<0.05);分别与治疗前比较,差异均有统计学意义(均P<0.05)。试验组和对照组在治疗过程中均未发生明显药物不良反应。结论非布司他可降低高尿酸血症伴痛风患者的血清s ICAM-1水平和尿酸水平,临床疗效优于别嘌呤醇。Objective To observe the clinical efficacy and safety profile of febuxostat and allopurinol in patients with hyperuricemia and gout. Methods A total of 90 patients with hyperuricemia and gout were ran- domly divided into three groups： treatment group A, treatment group B and control group. There were 30 patients in each group. The control group was given oral allopurinol tablets 300 mg rid. The treatment group A was given oral administration of febuxostat tablets 35 mg qd, while the treatment group B was given oral administration of febuxostat tablets 70 mg qd. All groups were treated for 24 weeks. The clinical efficacy and the incidence of adverse drug reactions were compared among the three groups, and serum levels of soluble intercellular adhesion molecule - 1（sICAM- 1 ） and uric acid were compared at baseline, 12 weeks and 24 weeks of treatment. Results After treatment, the total effective rates were 56. 67% （ 17 cases/30 cases）, 66.67% （20 cases/30 cases） and 46. 67% （ 14 eases/30 cases） in the treatment group A, the treatment group B and the control group, the difference was statisti- cally significant （P 〈 0. 05 ） ; After 12 weeks of treatment, serum sICAM - 1 in the treatment group A and treatment group B were （445.76 ± 135.85）, （421.28 ± 122.25） and （493.39 ± 121.27） ng · mL-1; After 24 weeks, serum sICAM- 1 of the treatment group A, the treatment group B and the control group were （387.71 ±126.75）, （360. 85 ± 125.50） and （441.45 ± 122. 48） ng mL-J ;After 12 weeks of treatment, uric acid levels in the treatment group A and treatment group B were （445.57 ± 135.50）, （460. 60 ± 140. 45） and （515.20 ± 142. 15） ng·mL-1; After 24 weeks, uric acid levels of the treatment group A, the treatment group B and the control group were （425.10 ± 126.28）, （410. 10 ± 130. 38 ） and （478.80 - 164.72） ng · mL-1, the difference was statistically significant （ all P 〈 0.05 ） ; Statistically significant differences were found among the

关 键 词：非布司他 别嘌呤醇 高尿酸血症 痛风 

分 类 号：R97[医药卫生—药品]