东莨菪碱透皮贴剂：可替代昂丹司琼和氟哌利多用于预防手术后呕吐症状的新制剂  

作　　者：Patti F. White, PhD, MD Jun Tang, MD Dajun Song, MD, PhD Jayne E. Coleman, MD Ronald H. Wender, MD Babatunde Ogunnaike, MD Alexander Sloninsky, MD Rajani Kapu, MD Mary Shah, MD Tom Webb, MD 潘明(译) 王多友(校) 

机构地区：[1]Department of Anesthesiology and Pain Management,University of Texas Southwestern Medical Center at Dallas, Dallas, Texas [2]Department of Anesthesiology, Cedars Sinai Medical Center in Los Angeles, Los Angeles, California [3]不详

出　　处：《麻醉与镇痛》2008年第1期64-69,共6页Anesthesia & Analgesia

摘　　要：背景鉴于对使用氟哌利多的争议和5-HT3受体拮抗剂的高昂价格，人们期望出现一种效价合理、可常规用于预防呕吐的药物来替代它们。我们设计了两个平行、随机、双盲、空白和安慰剂对照研究来比较东莨菪碱透皮贴剂（TDS）1．5mg和静脉注射昂丹司琼4mg及氟哌利多1．25mg作为多模式给药方案的一部分，对手术后呕吐“高危”人群早期和晚期的止吐效果及其副作用。方法150例患者参与本研究，其中包括腹腔镜手术（n=80）和整形外科手术（n=70）。患者入手术室前60分钟接受一枚有效的TDS贴剂（含东莨菪碱1．5mg）或一个外表相同的空白贴片。所有患者均接受标准全身麻醉。第2次给药是在手术接近结束时给予患者静脉注射2ml生理盐水（TDS贴剂的两组）、氟哌利多1．25mg或昂丹司琼4mg（空白贴片组）。记录患者手术后恶心、呕吐／干呕的发生率、是否需要止吐药物治疗、用药后的完全有效率（即用药后既无迁延性恶心亦无反复发生呕吐，无需使用止吐药物进行治疗）。此外，对手术后72小时之内的视觉紊乱、口干、昏睡和烦躁不安等不良反应进行记录。结果手术后72小时内，TDS贴剂组、氟哌利多组和昂丹司琼组患者呕吐和需要止吐药物治疗的患者差异无显著性。各治疗组中完全有效率为41％-51％，各组间差异无显著性。TDS组口干的发生率显著高于氟哌利多组和昂丹司琼组（21％vs3％）。结论TDS贴剂作为手术前给药用于预防手术后早期和晚期恶心、呕吐与氟哌利多1．25mg或昂丹司琼4mg效果相同，但是TDS贴剂更易引起口干。BACKGROUND： Given the controversy regarding the use of droperidol and the high cost of the 5-HT3 antagonists, a cost-effective alternative for routine use as a prophylactic antiemetic would be desirable. We designed two parallel, randomized, double-blind sham and placebo-controlled studies to compare the early and late anfiemetic efficacy and adverse event profile of transderrnal scopolamine （TDS） 1.5 mg, to ondansetron 4 mg IV, and droperidol 1.25 mg IV for anfiemetic prophylaxis as part of a mulfimodal regimen in ＂at risk＂ surgical populations. METHODS： A total of 150 patients undergoing major laparoscopic （n = 80） or plastic （n = 70） surgery procedures received either an active TDS patch （containing scopolamine 1.5 nag） or a similar appearing sham patch 60 min before entering the operating room. All patients received a standardized general anesthetic technique. A second study medication was administered in a 2-ml numbered syringe contai- ning either saline （for the two active TDS groups）, droperidol, 1.25 mg, or ondansetron, 4 mg （for the sham patch groups）, and was administered IV near the end of the procedure. The occurrence of postoperative nausea and vomiting/retching, need for rescue antiemetics, and the complete response rates （i. e., absence of protracted nausea or repeated episodes of emesis requiring antiemetic rescue medication） was reported. In addition, complaints of visual disturbances, dry mouth, drowsiness, and restlessness were noted up to 72 h after surgery. RESULTS： There were no significant differences in any of the emetic outcomes or need for rescue anfiemefics among the TDS, droperidol, and ondansetron groups in the first 72 h after surgery. The complete response rates varied from 41% to 51%, and did not significantly differ among the treatment groups. The overall incidence of dry mouth was significantly more frequent in the TDS groups than in the droperidol and ondansetron groups （21% vs 3% ）. CONCLUSIONS： Premedication with TDS was as effective

关 键 词：手术后呕吐 透皮贴剂 氟哌利多 呕吐症状 昂丹司琼 东莨菪碱 预防 5-HT3受体拮抗剂 

分 类 号：R616[医药卫生—外科学] R730.53[医药卫生—临床医学]