以安慰剂为对照评价国产盐酸帕洛诺司琼注射液预防术后恶心呕吐的有效性和安全性

A placebo-controlled clinical trial to evaluate the efficacy and safety of domestic palonosetron hydrochlo-ride injection on the prevention of postoperative nausea and vomiting

目的：本研究旨在评价国产盐酸帕洛诺司琼注射液预防术后恶心呕吐（PONV）的有效性和安全性。方法本研究为多中心、随机、双盲、平行、安慰剂对照的临床研究,入组患者共281例,研究组141例,对照组140例。研究组于麻醉诱导前静脉注射盐酸帕洛诺司琼注射液0.075 mg,对照组静脉注射生理盐水1.5 ml。两组均静脉注射丙泊酚、芬太尼和罗库溴铵行麻醉诱导,采用七氟醚吸入和静脉注射芬太尼维持麻醉。评价术后0-6 h、6-72 h、0-72 h 呕吐的完全缓解率和治疗失败时间。结果在0-6 h、6-72 h 和0-72 h 时的 CR%研究组分别为107（75.89%）、104（73.76%）和92例（65.25%）,对照组分别为81例（57.86%）、70例（50.00%）和62例（42.86%）,研究组的 CR%明显高于对照组（P 〈0.01）。治疗失败时间研究组和对照组分别为386.5 min 和300.0 min,两组差异无统计学意义。结论国产盐酸帕洛诺司琼注射液能有效预防 PONV。

Objective To evaluate the efficacy and safety of domestic palonosetron hydrochlo-ride injection on its prevention of postoperative nausea and vomiting.Methods A multi-centered,ran-domized,double-blinded and placebo-controlled clinical trial was carried out.A total of 281 patients were enrolled,with 141 of patients in study group and 140 of patients in control group respectively. 0.075 mg of intravenous palonosetron hydrochloride injection was delivered in the study group before anesthesia induction.The drug was substituted by 1.5 ml of NS in the control group.All anesthesia inductions were conducted by the intravenous injection of propofol,fentanyl and rocuronium,and were maintained with sevoflurane and fentanyl.Complete remission rate and treatment failure cut-off time of vomiting were evaluated at 0-6 h,6-72 h,0-72 h postoperatively.Results In the study group CR% 0-6 h,6-72 h and 0-72 h were 107 （75.89%）,104 （73.76%）and 92 （65.25%）,the control group was 81 （57.86%）,70 （50%）and 62 （42.86%）,CR% of the study group was significantly higher than that of the control group （P 〈0.01）.Insignificant statistical difference but significant clin-ical difference exists in their treatment failure cut-off time,386.5 min and 300.0 min,respectively be-tween the groups.Conclusion Domestic palonosetron hydrochloride injection is safe and effective in the prevention of postoperative nausea and vomiting.