洛芬待因缓释片对癌痛和术后痛的双盲模拟对照研究  

The analgesic effect of ibuprofen-c odeine sustained release tablets on postoperative and cancer pain

作　　者：陈勇川[1] 朱卫民[1] 梁后杰[1] 吴国庆[1] 

机构地区：[1]解放军第三军医大学西南医院国家药品临床研究基地,重庆市400038

出　　处：《中国临床康复》2003年第8期1290-1291,共2页Chinese Journal of Clinical Rehabilitation

摘　　要：目的阿片类与非甾体抗炎药的复方制剂已被广泛用于缓解各类疼痛。可待因作为中枢镇痛药既可单独使用也可与其他非甾体抗炎药联合应用。观察洛芬待因(布洛芬/可待因)缓释片治疗癌痛和手术后疼痛的安全性和有效性。方法采用双盲、双模拟、自身交叉对照法,18例癌痛患者均接受洛芬待因缓释片400/26mg、可待因片30mg、安慰剂3次服药。60例术后疼痛患者随机分为两组,分别接受洛芬待因缓释片400/26mg和可待因片30mg的治疗。结果纳入疗效分析的合格病例共78例,洛芬待因缓释片的临床镇痛效率与可待因片相当,两药无显著性差异(P>0.05),但对于术后疼痛患者洛芬待因缓释片平均镇痛持续时间长于可待因,两药有显著性差异(P<0.05)。试验中未见不良反应发生。结论洛芬待因缓释片治疗癌痛和手术后疼痛的疗效确切,不良反应少。Aim Opioid /nonsteroidal anti-inflamm atory drugs combina-tion analgesics are widely prescrib ed for the relief of pain.Codeine is a synthetic analgesic that has been sh own to be effective both alone and in combination with nonsteroidal anti-inflammatory drugs.The purpose of this study was to observe the efficacy and safety of ibuprofen-codeine sustained release tablets in treating cancer p ain and postoperative pain.Methods The trial was designed in randomized,double-blind,double dummy,cross-over and parallel-group comp arison method.18cancer pain patien ts received ibuprofen-codeine sustai ned release tablets 400/26mg,codeine 30mg and placebo by turns.60postopera tive pain patients were randomly di-vided into two groups,one group received ibuprofen-codeine sustained release tablets 400/26mg ,the other group received codeine 30mg.Results18cancer pain patients and 60postoperative pain patients were evaluated.There was no statistically significant di fference in pain relief efficacy between ibuprofen-codeine sustained release tablets and codeine phosphate(P>0.05).The ibuprofen-codeine sustained r elease tablets was effective in re-lieving pain with a longer analgesic duration than codeine for postopera tive pain patients(P<0.05).There was no adverse reaction was found.Conclusion Ibuprofen-codeine sustained relea se tablets is a safe and potent analgesic agent in treatment of cancer pain and postoperative pain.

关 键 词：疼痛 术后 洛芬待因缓释片 非甾体抗炎药 镇痛药 癌痛 安全性 有效性 

分 类 号：R971.1[医药卫生—药品]