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目的:对小剂量秋水仙碱长期维持预防痛风性关节炎反复发作的疗效与安全性评估。方法:选取2013年2月-2015年2月温州市中西医结合医院收治的90例痛风性关节炎患者,将其按照随机数字表法随机分为治疗组和对照组2组,每组45例,2组均给予一般治疗,治疗组急性期给予美洛昔康7.5mg,2次/d;秋水仙碱1mg 2次/d,疼痛改善后以每1~2d0.5mg预防维持。对照组急性期给予美洛昔康7.5mg,2次/d,秋水仙碱0.5mg,每1h1次,疼痛缓解后停用秋水仙碱,比较2组的临床疗效及不良反应。并随访1年,观察2组患者的复发情况。结果:2组患者临床症状缓解时间比较差异无统计学意义(t=0.45,P>0.05);2组患者在治疗1个月时、关节炎发作次数方面比较无统计学意义(t=0.59,P>0.05);3个月、6个月时治疗组的关节炎发作次数显著性低于对照组(t=12.36、16.07,均P<0.05);2组随访1年,治疗组的复发率显著性低于对照组(χ2=21.045,P<0.05)。治疗后2组患者与治疗前相比,血尿酸、WBC及血沉显著下降(t≥3.85,均P<0.05),但治疗后2组相比差异无统计学意义(t≤0.50,均P>0.05);与治疗前相比,2组治疗后血肌酐、尿素氮、血沉、RBC、ALT与治疗前相比无明显变化,治疗后2组相比差异也无统计学意义(t≤1.01,均P>0.05)。治疗组不良反应发生率11.1%显著性低于对照组的48.9%(χ2=15.291,P<0.05)。结论:采用小剂量秋水仙碱长期维持预防痛风性关节炎反复发作,不仅符合新指南的要求,而且安全性高、耐受性好、效果良好,值得临床推广应用。
OBJECTIVE: To evaluate the efficacy and safety of long-term maintenance of small dose colchicine in prevention of recurrent gouty arthritis. Methods: Totally 90 patients with gouty arthritis admitted to Wenzhou Hospital of Integrated Traditional Chinese and Western Medicine from February 2013 to February 2015 were randomly divided into treatment group and control group according to a random number table method, with 45 cases in each group , 2 groups were given general treatment, the treatment group given meloxicam 7.5mg, 2 times / d in the acute phase; colchicine 1mg 2 times / d, the pain was improved every 1 ~ 2d0.5mg prevention and maintenance. The patients in the control group were given meloxican 7.5mg twice a day, colchicine 0.5mg every 1h, and the colchicine was stopped after the pain was relieved. The clinical curative effect and adverse reactions of the two groups were compared. Followed up for 1 year, observed the recurrence of 2 groups of patients. Results: There was no significant difference between the two groups in the time of clinical symptom relief (t = 0.45, P> 0.05). There was no significant difference in the number of arthritic episodes between the two groups at 1 month (t = 0.59, P> 0.05). The incidences of arthritis in the treatment group were significantly lower than those in the control group at 3 and 6 months (t = 12.36 and 16.07, all P <0.05) Significantly lower than the control group (χ2 = 21.045, P <0.05). After treatment, the serum uric acid, WBC and erythrocyte sedimentation rate decreased significantly in both groups (t≥3.85, both P <0.05), but there was no significant difference between the two groups after treatment (t≤0.50, all P> 0.05). Compared with those before treatment, serum creatinine, blood urea nitrogen, erythrocyte sedimentation rate, RBC and ALT had no significant difference between the two groups after treatment, and there was no significant difference between the two groups after treatment (t≤1.01, All P> 0.05). The incidence of adverse reactions in the treatment group was significantly lower than that in the control group (11.1% vs 48.9%, χ2 = 15.291, P <0.05). Conclusion: The long-term maintenance of small doses of colchicine to prevent recurrence of gouty arthritis, not only meet the requirements of the new guidelines, but also high safety, good tolerance, good effect, worthy of clinical application.