目的:探讨清热解毒、利湿化浊法治疗痛风的疗效与安全性。方法:纳入天津中医药大学第一附属医院风湿科门诊及病房2015年1月至2016年1月间湿热蕴结证的痛风患者71例,按数字表法随机分为治疗组36例和对照组35例。治疗组给予清热解毒、利湿化浊法复方中药汤剂口服,对照组口服双氯芬酸钠缓释片,两组疗程均为2周,入组期间两组患者均采用低嘌呤饮食。疗程结束后进行中医证候疗效评估,记录治疗前后受试者关节肿胀、压痛评分及其血尿酸水平,并在研究期间监测不良事件。结果:与对照组比较,治疗组中医证侯疗效评分差异无统计学意义;与治疗前比较,两组治疗后关节肿胀、压痛,血尿酸水平差异有统计学意义(P〈0.05),治疗后治疗组血尿酸水平低于对照组,差异有统计学意义(P〈0.05)。研究期间,治疗组未见不良反应发生,对照组不良反应45例,停药或经对症处理后即恢复正常。结论:清热解毒、利湿化浊法治疗痛风可以有效减轻关节肿胀、压痛等症状,并能更好得降低患者血尿酸水平,具有良好的疗效与安全性。
Objective: To discuss the efficacy and safety of the method of clearing heat and detoxicating, removing dampness and dissolving turbidity on gout. Methods: Seventy-one gout patients in the syndrome of stagnation of dampness and heat from the outpatient and ward of the Rheumatism Department of First Teaching Hospital of Tianjin University of TCM from January 2015 to January 2016 were included and divided into a treatment group(36 cases) and a control group(35 cases) according to the random number table. The treatment group was treated with the decoction by the method of clearing heat and detoxicating, removing dampness and dissolving turbidity, while the control group was treated with diclofenac sodium sustained release tablets, 2 weeks were required for the two groups with low purine diet. TCM syndrome efficacy evaluation was observed after the treatment. The joint swelling rate, tenderness rate and the level of blood uric acid were recorded before and after the treatment, as well as, the adverse reaction was observed during the treating course. Results: Compared with the control group, the TCM syndrome efficacy score had no significant difference in the treatment group. When compared with before the treatment, joint swelling rate, tenderness rate and the level of blood uric acid in two groups had significant difference(P0.05), and the level of blood uric acid in the treatment was lower than the control group with significant difference(P0.05). In the treatment, there was no adverse reaction in the treatment group, while there were 45 cases in the control group, and patients returned to be normal after stopping the medicine or expectant treatment. Conclusion: The method of clearing heat and detoxicating, removing dampness and dissolving turbidity could relieve the swelling and tenderness effectively on gout, and decrease the level of blood uric acid, with good effect and safety.