剖宫产术后曲马多与舒芬太尼静脉自控镇痛治疗方案的疗效、安全性及经济性评价

Efficacy, safety and economic evaluation of Tramadol and Sufentanil PCIA treatment after cesarean section

目的开展前瞻性临床观察研究,评价剖宫产术后静脉自控镇痛(PCIA)曲马多与舒芬太尼用药方案的疗效、安全性及经济性。方法在新疆维吾尔自治区某三甲医院实施临床试验(注册号为:Chi CTR-IPR-16008261)。纳入剖宫产术后使用PCIA进行术后镇痛并满足入排标准的产妇240例,运用随机数字表法分为曲马多(T)、舒芬太尼(S)两组,各120例。收集有效性、不良反应及成本数据,对两组用药方案进行疗效、安全性及经济性评价。结果两组分别纳入116、113例,T组疗效指标均优于S组,不良反应主要为恶心呕吐、头晕嗜睡,T组不良反应表现类型较S组少且发生率低,成本-效果分析显示T组治疗方案更优,且敏感性分析结果稳定。结论剖宫产术后PCIA治疗方案曲马多较舒芬太尼疗效更好,不良反应更少,经济性更优。

Objective To evaluate the efficacy,safety and economic of tramadol and sufentanil in PCIA after cesarean section.Methods A study was conducted in a top three hospital in Xinjiang Uygur Autonomous Region（registration number： Chi CTR-IPR-16008261）.The patients were divided into tramadol（T） and sufentanil（S） in 120 cases by postoperative cesarean section who had postoperative analgesia with PCIA for maternal postoperative analgesia and met the criteria.The validity,adverse effects and cost data were collected and the two groups were evaluated economically.Results Two groups were included 116,113 cases.T group was superior to the S group,the adverse reactions were mainly nausea and vomiting,dizziness,sleepiness,T group,less adverse events than the S group and the incidence of low cost analysis showed that T group of treatment regimen more,sensitive analysis results are stable.Conclusion Tramadol is more effective than sufentanil after PCIA for cesarean section,less adverse and more economical.