依托芬那酯凝胶结合足矫形器治疗拇外翻的临床观察

Etofenamate Gel and Foot Orthosis for Painful Hallux Valgus:A Randomized Controlled Clinical Trail

目的了解依托芬那酯凝胶对有疼痛症状的轻中度拇外翻畸形的治疗效果。方法对2010年3月-2011年7月门诊收治的轻中度拇外翻患者共65足,随机分成两组,治疗组采取托芬那酯凝胶局部应用和佩戴夜间支具,对照组佩戴夜间支具,局部应用安慰剂,治疗周期1个月。记录症状明显缓解时间,治疗前后对患者进行视觉模拟疼痛评分和美国骨科足踝分会跖趾及趾间关节评分,并测量拇外翻角和第一跖骨间角改变。结果全部患者完成治疗,疼痛缓解时间治疗组为(3.28±1.04)d,对照组(7.03±2.15)d,差异有统计学意义(P<0.05),佩戴足矫形器治疗1个月,拇外翻角和第一跖骨间角改变无统计学差异(P>0.05)。结论局部应用依托芬那酯凝胶结合足矫形器治疗轻中度拇外翻能快速缓解疼痛症状,改善活动能力,延缓畸形加重,依托芬那酯凝胶局部给药患者能良好耐受,可避免口服非甾体抗炎药(NSAIDs)带来的副作用。

Objective To evaluate the therapeutic effect of etofenamate gel for painful hallux valgus.Methods From March 2010 to July 2010,65 patients with mild or moderate painful hallux valgus were randomly divided into observation group treated by etofenamate gel and foot orthosis,and control group treated by foot orthosis and placebo for one month.Outcome measures included the pain relief time,visual analogue scale,AOFAS Hallux Metatarsophalangealinterphalangeal(HMI) scale,hallux valgus angle and intermetatarsal angle at the beginning and the end of the treatment.Results All patients completed the treatment.There was no significant difference between the observation group [(3.28 ± 1.04) days] and the control group [(7.03 ± 2.15) days] in terms of the pain relief time(P < 0.05).There was no statistically significant difference in hallux valgus angle and intermetatarsal angle between the beginning and the end of the trail by foot orthosis treatment(P > 0.05).Conclusions Local application of etofenamate gel combined with foot orthosis treatment for mild to moderate hallux valgus can quickly relieve pain,improve mobility,and delay deformity.Localized drug delivery of etofenamate gel can be well tolerated by patients,and can avoid the side effects of oral NSAIDs.