痛风胶囊对非急性期痛风患者临床观察

Clinical observation of Tongfeng Granules on patients with non-acute gout

关键词:  痛风  痛风胶囊  清热利湿解毒  活血通络

Key words:  gout  Tongfeng Granule  clearing heat and promoting dampness and detoxification  promoting blood circulation and activating collaterals

摘要:

[目的] 评价痛风胶囊干预非急性期痛风（湿热瘀毒型）患者的临床疗效与安全性。[方法] 采用随机、对照的设计方法。计划纳入60例，按照1∶1的比例随机分为中西药组和西药组，两组均接受相同的常规干预，中西药组口服痛风胶囊和别嘌醇片治疗、西药组口服别嘌醇片治疗。连续干预8周，评价中医证候疗效，观察血尿酸（BUA）、总胆固醇（TC）、三酰甘油（TG）、血糖（GLU）变化，急性痛风发作次数及不良反应发生情况。[结果] 中西药组治疗后症状积分为（3.73±2.13）分，低于西药组为（5.00±2.10）分，差异具有统计学意义（P<0.05）。在降尿酸方面，中西药组血尿酸降幅为（166.38±100.68） μmol/L，高于西药组（101.33±103.78） μmol/L差异具有统计学意义（P<0.05）。在急性痛风性关节炎发作次数方面，中西药组明显优于西药组，差异具有统计学意义（P<0.05）；两组病例治疗前后TC、TG、GLU及组间比较均无统计学意义（P>0.05）；临床试验过程中，无严重不良反应或不良事件发生。[结论] 痛风胶囊联合别嘌醇片可进一步降低血尿酸水平，改善中医证候，减少急性痛风性关节炎发作次数，预防痛风反复发作，临床应用安全性较好，为中医药对痛风病的防治提供临床依据。

Abstract:

[Objective] To evaluate the clinical efficacy and safety of Tongfeng Granules in the treatment of patients with non-acute gout (damp-heat stasis toxin type).[Methods] A randomized,controlled clinical study was designed. The trial intended to include 60 patients,who were randomly divided into a western medicine group and a traditional Chinese and western medicine group according to 1:1 ratio. The traditional Chinese and Western medicine group was treated with Tongfeng Granules combined with allopurinol oral treatment,and the Western medicine group was treated with allopurinoloral treatment for 8 weeks. The symptom scores,clinical efficacy,the number of acute attacks of gouty arthritis,and the decrease of BUA,TC,TG and GLU concentration before and after treatment were compared,and the safety of the treatment was also evaluated.[Results] The symptom score after treatment in the traditional Chinese and western medicine group was (3.73±2.13) points,which was lower than the western medicine group (5.00±2.10) points,(P<0.05). The blood uric acid of the traditional Chinese and western medicine group decreased by(166.38±100.68) μmol/L,which was higher than that of the western medicine group (101.33±103.78) μmol/L(P<0.05). The differences between the number of acute gouty arthritis attacks of the traditional Chinese and Western medicine group and the western medicine group were statistically significant (P<0.05). The decrease TC,TG and GLU concentration between the two groups were not statistically significant (P>0.05). During the clinical trial,no severe adverse reactions or adverse events were observed in either group.[Conclusion] Tongfeng Granules combined with allopurinol can further reduce the level of serum uric acid,improve the clinical symptoms of patients,reduce the number of acute gouty arthritis attacks and prevent recurrent gout attacks,and has good safety in clinical application,which provides a clinical basis for the prevention and treatment of gout with traditional Chinese medicine.