红细胞包蔽曲马多用于手术后镇痛的临床研究

目的:探讨红细胞包蔽曲马多(RBC-T)溶液用于术后镇痛的可行性。方法:(1)采用放免法测定RBC-T溶液红细胞(RBC)内外曲马多(T)的浓度;(2)采用双盲法和视觉模拟评分(VAS)法比较研究了择期上腹部手术病人应用RBC-T和T后(各20例)术后镇痛的时效,并同时观察了术后病人恶心呕吐及瘙痒等症状的发生率;(3)从上述病例中各随机选择8例,均分别于静脉给药后2、5、10、30min,以及1、2、4、8、10、24h测定动脉血曲马多浓度。结果:(1)RBC-M溶液RBC内外曲马多的浓度无显著性差异;(2)RBC-T组术后24h疼痛VAS评分显著高于T组,两组病人术后恶心呕吐和瘙痒等副作用的发生率有显著性差异;(3)药时曲线以两室模型的拟合相关性最好,RBC-T组的t1/2(α)和t1/2(β)与曲马多组相比均显著延长。结论:RBC-T溶液术后镇痛时效可满足术后镇痛需要,且具有较好的安全性。

Clinical study on Tramadol encapsulated in erythrocytes for postoperative analgesia

Objective: To study the feasibility to use tramadol encapsulated in erythrocytes for postoperative analgesia. Methods: The concentrations of Tramadol inside and outside RBC in RBC-T solutions, the effect of RBC-T solutions on postoperative analgesia and the pharmacokinetics of RBC-T solutions were investigated. Results: (1) The concentrations of Tramadol inside and outside RBC were 31±1.38mg/ml and 22.3±1.12mg/ml respectively (P>0.05); (2) The VAS scores in postoperative 24h was significantly lower in group RBC-T than those in group T, and the occurrence of nausea, emetic and itch episode in group RBC-T was not significantly different from that group T; (3)The values of t1/2(α) and t1/2(β) were significantly longer in group RBC-T than those in group T. Conclusion: RBC-T solutions is more potent for postoperative analgesia than the T solution.