普瑞巴林、塞来昔布以及两者联合治疗纤维肌痛综合征的临床研究

THE CLINICAL STUDY OF FIBROMYALGIA TREATED WITH PREGABALIN , CELECOXIB AND THEIR COMBINATION

目的:探讨普瑞巴林、塞来昔布以及两者联合治疗纤维肌痛综合征的有效性及安全性。方法:本研究采用交叉设计,纳入符合标准的50例患者,45例完成试验;每位患者均按照入组序号循环接受3种不同的治疗方案。方案I:治疗顺序为塞来昔布+安慰剂(C方法)、普瑞巴林+安慰剂(P方法)、塞来昔布+普瑞巴林(C+P方法);方案II:治疗顺序为P方法、C方法、C+P方法;方案III:治疗顺序为C+P方法、C方法、P方法,以此类推;各方案中的各方法,均持续3周(处理期)后休息1周(洗脱期)。治疗前后盲法评价患者的视觉模拟评分(visual analogue scale,VAS)、痛点数目和伴随症状缓解情况。结果:各方案的各方法药物治疗后,患者VAS评分和痛点数目与治疗前相比均有不同程度下降;普瑞巴林+塞来昔布治疗后与治疗前的两个指标比较,差异有统计学意义(P<0.05);普瑞巴林+塞来昔布治疗后与普瑞巴林+安慰剂和塞来昔布+安慰剂治疗后的两个指标比较,差异有统计学意义(P<0.05)。联合治疗能有效缓解患者的伴随症状(P<0.05),未见其他不良反应。结论:普瑞巴林联合塞来昔布治疗纤维肌痛综合征具有较好的临床效果及安全性。

Objective： To study the efficacy and safety of the celecoxib, pregabalin, and their combination for treatment of fibromyalgia syndrome, Methods： In this cross-over design, 50 patients meeting the inclusive criteria were included, and 45 patients completed the trial. According to the group number, all patients periodically received 3 differernt treatment scheme. Treatment order of Scheme I： celecoxib plus placebo （C method）, pregabalin plus placebo （P method）, pregabalin plus celecoxib （P＋C method）; scheme II： P method, C method, C＋P method; scheme III： C＋P method, C method, P method, and so on. Each method lasted for 3 weeks （therapy period）, after which patients underwent a 7-day washout period prior to next treatment period. All patients were assessed before and after treatment using visual analogue scale （VAS, 0-100 mm）. Pain spot and concomitant symptom were evaluated by investigator blinded to the treatment. Results： VAS scores and pain spot number of each patient decreased to different extents than pre-treatment in all methods. Difference between before and after treatment in combination treatment method has a significant meaning （P 〈 0.05）, and difference between combination treatment method and other two methods after treatment has a significant meaning （P 〈 0.05）. Combination therapy can also significantly relieve concomitant symptom （P 〈 0.05）. Other adverse reactions were not observed. Conclusions： The association of celecoxib and pregabalin for fibromyalgia syndrome has better clinical efficacy and safety.