机构地区:[1]河南中医药大学第二附属医院风湿病科,河南郑州450009
出 处:《中国新药与临床杂志》2018年第8期472-477,共6页Chinese Journal of New Drugs and Clinical Remedies
基 金:河南省科技厅科技攻关项目(162102310447);河南省中医院院级科研项目(2017YJKT6)
摘 要:目的研究痛风舒联合双氯芬酸治疗痛风性关节炎(GA)湿热瘀阻证的疗效及安全性。方法将117例GA湿热瘀阻证患者随机分为痛风舒组、双氯芬酸组和联合组,各39例。痛风舒组口服痛风舒,每次0.96 g,每日3次;双氯芬酸组口服双氯芬酸,每次0.1 g,每日1次;联合组同时口服痛风舒和双氯芬酸,给药方法同前。疗程均为4周。观察治疗前后各组临床症状、血清及关节液中肿瘤坏死因子-α(TNF-α)、前列腺素E_2(PGE_2)、白细胞介素-6(IL-6)、白细胞介素-1β(IL-1β)和血清尿酸(SUA)的变化,比较各组总有效率、不良反应发生率及2个月随访复发率。结果研究期间共脱落患者10例,痛风舒组完成36例,双氯芬酸组完成37例,联合组完成34例。联合组总有效率97%,高于痛风舒组(83%)和双氯芬酸组(81%),差异有显著意义(P<0.05)。联合组临床症状及实验室指标改善优于痛风舒组和双氯芬酸组(P<0.05)。联合组不良反应发生率为35%,高于痛风舒组(6%,P<0.05),低于双氯芬酸组(76%,P<0.05)。随访2个月,联合组复发率为7%,低于痛风舒组(22%)和双氯芬酸组(41%),差异有显著意义(P<0.05)。结论痛风舒治疗GA湿热瘀阻证的疗效与双氯芬酸相当,且较安全,其联合双氯芬酸治疗GA湿热瘀阻证,疗效优于单用痛风舒片或双氯芬酸。AIM To explore the therapeutic effect and security of Tongfengshu combined with diclofenac in treating gouty arthritis(GA) dampness-heat stagnant syndrome. METHODS A total of 117 GA patients with dampness-heat stagnant syndrome were randomly divided into the Tongfengshu group, the diclofenac group and the combination group, 39 patients in each group. The Tongfengshu group was treated with Tongfengshu, 0.96 g each time, 3 times per day. The diclofenac was applied in the diclofenac group, 0.1 g each time, 1 time per day. The Tongfengshu combined with diclofenac was adopted in the combination group. The usage of Tongfengshu was the same as Tongfengshu group, and the usage of diclofenac was the same as diclofenac group. The course of treatment was 4 weeks. The clinical symptoms, the levels of tumor necrosis factor-α(TNF-α), prostaglandin E2(PGE2), interleukin-6(IL-6), interleukin-1β(IL-1β) in the serum and joint fluid, and the serum uric acid(SUA) were observed. The total effective rate, adverse reaction rate and recurrence rate after two months of follow-up were compared among three groups. RESULTS Ten patients were lost during the study. There were36, 37, and 34 patients completed the study in the Tongfengshu group, diclofenac group and combination group. The total effective rate of the combination group was 97% and higher than Tongfengshu group and diclofenac group(83% and 81%, P〈0.05). The clinical symptoms and laboratory indexes of the combination group improved better than Tongfengshu group and diclofenac group(P〈0.05). The adverse reaction rate of the combination group(35%) was higher than Tongfengshu group(6%, P〈0.05), and less than diclofenac group( 76%, P〈0.05). After two months of follow-up, the recurrence rate of the combination group was 7% and lower than Tongfengshu group and diclofenac group(22% and 41%, P〈0.05). CONCLUSION The effect of Tongfengshu in the treatment of GA dampness-heat stagnant syndrome was similar to that of diclofenac, and
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