口服氨酚羟考酮和盐酸曲马多治疗妇科腹腔镜手术后早期疼痛的研究  

Safety and efficacy of early oral oxycodone/acetaminophen and tramadol in Chinese gynecology patients undergoing laparoscopy operation

作　　者：张志永[1] 贾乃光[2] 黄文起[3] 黄宇光[1] 刘薇[1] 冷金花[1] 高雪松[1] 杨扬[1] 张亚军[2] 刘春霞[2] 曹雷[2] 林世清[3] 

机构地区：[1]中国医学科学院中国协和医科大学北京协和医院麻醉科,北京100730 [2]卫生部中日友好医院麻醉科,北京100029 [3]中山大学附属第一医院麻醉科,广州510080

出　　处：《中国临床药理学与治疗学》2005年第2期168-171,共4页Chinese Journal of Clinical Pharmacology and Therapeutics

摘　　要：目的 :观察妇科腹腔镜手术病人术后早期单次口服氨酚羟考酮 (泰勒宁 )和盐酸曲马多 (奇曼丁 )进行镇痛的有效性和安全性。方法 :12 0例VAS评分 >3分的妇科腹腔镜手术病人 ,随机分 3组 ,分别口服泰勒宁、奇曼丁或安慰剂 1片 ,3组病人均给予吗啡静脉自控止痛泵作为补救镇痛用药。观察并记录服药即刻、服药后 0 .2 5、0 .5、0 .75、1、2、4、6、8、12、2 4h的VAS评分、PCA用量以及不良反应 ,根据VAS评分计算疼痛缓解度 ,2 4h进行总体镇痛满意度评估。结果 :泰勒宁组和奇曼丁组VAS评分低于安慰剂组 (P <0 .0 5 ) ,泰勒宁组和奇曼丁组之间VAS评分相近 (P >0 .0 5 )。泰勒宁组和奇曼丁组补救PCA吗啡用量明显低于安慰剂组 (P <0 .0 5 ) ,泰勒宁组和奇曼丁组补救PCA吗啡用量相当 (P >0 .0 5 )。泰勒宁组和奇曼丁组总体镇痛满意度评估优于安慰剂组 (P <0 .0 5 )。 2 4h恶心呕吐率方面 ,奇曼丁组明显高于其他两组 (P <0 .0 5 )。结论 :口服泰勒宁和奇曼丁能有效地缓解妇科腹腔镜病人手术后的中至重度疼痛 ,早期口服给药镇痛的方式安全、有效。与奇曼丁组相比 ,泰勒宁组的不良反应发生率更低。AIM: To evaluate the safety and efficacy of oral oxycodone /acetaminophen or tramadol in early postoperative patients undergoing laparoscopic gynecological operations. METHODS: 120 gynecologic patients receiving laparoscopy operation were enrolled in a randomized,double blind, placebo controlled, multi center clinical trial with early oral analgesics if the vasual analgesia scores (VAS) was scored higher than 3.0. All patients were randomly received a single dose of oral analgesic: oxycodone/acetaminophen, tramadol or placebo, respectively. For rescue medication, PCA pump was provided in all three groups with a dose of 1 mg morphine and lockout of 5 minutes. The VAS scores, pain relief, PCA morphine consumption and side effects were evaluated at the following occasions of 0.25 , 0.5 , 0.75 , 1, 2, 4, 6, 8, 12 and 24 h throughout the study. RESULTS: The VAS scores and pain relief were significantly different in three groups at 0.75 , 1, 2, 4, 6, 8 and 12 h. The VAS scores and PCA morphine consumption was significantly lower in oxycodone/acetaminophen and tramadol groups than those in placebo group. Pain relief in oxycodone/acetaminophen and tramadol groups was better than those in placebo group. The incidence of side effects such as nausea and vomiting significantly increased in tramadol group at 24 h compared with those in the other two groups. CONCLUSION: Early oral administration of oxycodone /acetaminophen or tramadol can provide surgical patients with good and safe postoperative analgesia after laparoscopy gynecologic operation. The incidence of side effects in oxycodone /acetaminophen group is lower than that in tramadol group in this clinical trial.

关 键 词：口服镇痛药 泰勒宁 奇曼丁 氨酚羟考酮 曲马多 术后镇痛 

分 类 号：R969.4[医药卫生—药理学]