氨酚羟考酮治疗足部手术后早期疼痛的研究  

Efficacy and safety of oxycodone-acetaminophen on early phase pain after pedoperation

作　　者：杨茂伟[1] 李亚伦[1] 初立伟[1] 王旭东[1] 李中华[1] 

机构地区：[1]中国医科大学附属第一医院骨科,沈阳110001

出　　处：《中国新药杂志》2009年第15期1405-1407,共3页Chinese Journal of New Drugs

摘　　要：目的:评价氨酚羟考酮(泰勒宁)用于足部手术后早期疼痛治疗的安全性和有效性。方法:180例足部手术患者采用随机分组、双盲双模拟、对照试验方法,随即分为A,B,C三组。术前1 h给予A组泰勒宁1片,B和C组给予泰勒宁模拟片(成分为赋形剂)1片。A和B组于术后观察0点首次给予泰勒宁片和氨酚待因模拟片剂各2片口服,C组首次给予氨酚待因片和泰勒宁模拟片剂各2片,以后每4 h给药各1片。共计给药时间为12 h,并分别记录0,0.5,1,2,4,6,12 h患者视觉模拟评分(VAS)。结果:A和B组比较,A组疼痛强度差(PID)均高于B组。B组和C组各时点与基线的自身前后比较,差异有统计学意义(P<0.05)。服药后0.5 h起至12 h各时间点A和B组PID均高于C组(P<0.05)。B组完全缓解率明显优于C组(P<0.05)。A和B组不良反应发生率较低(4/53),但与C组(8/53)比较无统计学差异。结论:泰勒宁用于足部手术后早期疼痛治疗镇痛效果明显,安全性良好。Objective： To evaluate the efficacy and safety of oxycodone-acetaminophen on early phase pain after pedoperation. Methods： In a randomized, double-blind, double-imitation, and controlled trial, 180 patients undergoing pedoperation were randomly divided into 3 groups. Patients were treated with 1 tablet of oxycodone-acet-aminophen （A group） or 1 imitation tablet （ B and C groups） 1 h before the operation. Immediately after the operation, patients were treated with 2 tablets of oxycodone-aeetaminophen and the imitation tablets （A and B） , or aeet-aminophen-codeine and the imitation tablets （ C）. Then, patients were treated with 1 tablet of the tablets described above every 4 h according to the situation of patients. The length of treatment time was 12 h. The visual analog scale （VAS） of patients was recorded at 0, 0.5, 1, 2, 4, 6 and 12 h after the operation. Results ： The pain relief was significant at each time point as compared with baseline in B and C groups （P 〈 0.05 ）. The difference in pain intensity （PID） at each time point was higher in A and B groups than in C group from 0.5 to 12 h after treatments （P 〈0.05）. The incidence of side effects trended to be higher in C group （8/53） than in A and B groups （4/53） , but was not significant. Conclusion： Oxycodone-acetaminophen is effective and safe on early phase pain after pedoperation.

关 键 词：氨酚羟考酮 足部手术 镇痛 

分 类 号：R971.1[医药卫生—药品]