摘要
目的观察非甾体抗炎药依托芬那酯凝胶联合中枢性肌松药替扎尼定对治疗有潜在胃肠道风险的急性痉挛性颈肩腰痛的疗效和安全性。方法 2012年3月-5月共诊断急性痉挛性颈肩痛及腰痛患者375例,依据排除标准排除33例,根据分组标准将有潜在胃肠道疾病风险者设为试验组(A组,n=63),明确无胃肠道疾病史者按照年龄、性别和疼痛部位与试验组进行配伍设为阳性对照组(B组,n=63)和安慰剂对照组(C组,n=63),未分组144例不纳入统计。试验组服用替扎尼定2 mg,2次/d,同时外用依托芬那酯凝胶5～10 cm均匀涂抹患处,3次/d;对照组服用替扎尼定2 mg,2次/d,同时口服塞来昔布0.2 g,2次/d;安慰剂对照组服用替扎尼定2 mg,2次/d,同时安慰剂1粒,2次/d。观察药物疗效和不良反应。结果 A组随访57例,平均起效时间为(2.17±0.99)d,总有效44例(77.2%),胃肠道不良反应2例(3.5%);B组随访54例,平均起效时间为(1.78±0.96)d,总有效45例(83.3%),胃肠道不良反应发生3例(5.5%);C组随访55例,平均起效时间(4.10±1.63)d,总有效35例(63.6%),胃肠道不良反应发生2例(3.6%)。结论依托芬那酯凝胶和口服非甾体抗炎药疗效和起效时间相当,胃肠道耐受性较好,联合用药效果优于单独使用肌松药。对于有潜在胃肠道风险的痉挛性颈肩腰背痛患者可选择外用非甾体抗炎药联合中枢性肌松药的治疗方案,以获得更好的疗效以及较高耐受性。
Objective To assess the effectiveness and safety of 10% etofenamate gel combined with tizanidine on the treatment of acute local painful muscle spasms（neck,shoulder,waist）.Methods Between March and May,2012,375 outpatients with acute painful muscle spasms were included,in whom 63 were selected with potential gastrointestinal risk as group A and treated with etofenamate gel for external use（thrice per day） combined with tizanidine 2 mg（twice per day）.Others were divided into group B（63 patients） and C（63 patients） randomly which had the same constituent ratio with group A on patients＇ age,gender,and pain location.Group B and C were treated with celecoxib 0.2 g（twice per day） combined with tizanidine 2 mg（twice per day） or placebo（1 pill,twice per day） with tizanidine 2 mg（twice per day） for 8 days respectively.The efficacy and side effects were observed.Results There were 57,54 and 55 patients finished the follow-up in group A,B and C,respectively.The overall effective rates on the day 2 after administration in 3 groups were 50.8%,68.5% and 20.0%（P0.001）;and on the day 8 were 77.2%,83.3% and 63.6%（P0.05）,respectively.On the other side,the gastrointestinal side-effects rate in 3 groups were 3.5%,5.5% and 3.6% without significant difference（P0.05）.Conclusion The etofenamate gel has the same effect compared with celecoxib,and when combines with tizanidine,it is more effective and has better toleration than tizanidine itself dose in acute painful muscle spasms patients with potential gastrointestinal risk.
出处
《华西医学》
CAS
2012年第12期1784-1787,共4页
West China Medical Journal
关键词
依托芬那酯凝胶
胃肠道风险
急性肌痉挛痛
疗效
安全性
Etofenamate
Gastrointestinal risk
Acute painful muscle spasms
Therapeutic effect
Safety
