痛风气雾剂治疗急性痛风性关节炎220例临床研究

Clinical study on the treatment of 220 cases of acute gouty arthritis with Gout Aerosol

目的:探讨痛风气雾剂对急性痛风性关节炎(湿热蕴结证)的治疗效果和安全性。方法:采用随机、双盲、平行对照临床实验研究,选择2014年8月至2017年8月220例符合纳入标准的急性痛风性关节炎患者随机分为试验组和对照组。试验组予痛风气雾剂外喷患处,日3次,对照组予肿痛气雾剂外喷患处,日3次,均治疗5d。观察治疗前后血尿酸(UA)、C反应蛋白(CRP)、血沉(ESR)、VAS、中医证候全面评价评分及临床疗效,进行统计学分析。结果:两组治疗后UA、ESR、CRP均较治疗前显著下降(P<0.05,P<0.01),试验组CRP较对照组低(P<0.01)。两组患者VAS评分及全面评价总积分均较治疗前显著下降(P<0.01),试验组优于对照组(P<0.05),治疗组总有效率93.5%(101/108),优于对照组的85.5%(94/110)(P<0.05)。结论:痛风气雾剂对急性痛风性关节炎(湿热蕴结证)有缓解关节肿痛作用,且未见不良反应,安全、无刺激性,是一种安全有效、方便易行的治疗急性痛风性关节炎的外用药物。

Objective:To explore the therapeutic effect and safety of gout aerosol on acute gouty arthritis(dampheat accumulation syndrome).Methods:A randomized,double-blind,parallel controlled clinical trial was conducted.From August 2014 to August 2017,220 patients with acute gouty arthritis who met the inclusion criteria were randomly divided into experimental group and control group.The experimental group was treated with gout aerosol 3 times a day,while the control group was treated with zhongtong aerosol 3 times a day for 5 days.Serum uric acid(UA),C-reactive protein(CRP),ESR,VAS,comprehensive evaluation score of TCM syndromes and clinical efficacy were observed before and after treatment,and statistical analysis was made.Results:After treatment,UA,ESR and CRP in both groups were significantly lower than those before treatment(P<0.05,P<0.01),and CRP in the experimental group was lower than that in the control group(P<0.01).The VAS scores and overall evaluation scores of patients in both groups were significantly lower than those before treatment(P<0.01),and the experimental group was superior to the control group(P<0.05).The total effective rate of the treatment group was 93.5%(101/108),which was superior to that of the control group(85.5%,94/110)(P<0.05).Conclusion:Gout aerosol can relieve joint swelling and pain in acute gouty arthritis(damp-heat accumulation syndrome),and has no adverse reaction.It is safe,effective and convenient for external use.