A factorial trial of six interventions for the prevention of postoperative nausea and vomiting
A factorial trial of six interventions for the prevention of postoperative nausea and vomiting
复制标题
DOI：
10.1056/nejmoa032196
复制
发表时间：
2004-06-10
影响因子：
158.5
通讯作者：
Roewer, N
中科院分区：
文献类型：
--
作者：
Apfel, CC;Korttila, K;Roewer, N
背景：如果不进行治疗，三分之一的手术患者会出现术后恶心和呕吐。虽然已经进行了许多试验，但单独或联合给予预防性止吐干预的相对益处仍不清楚。方法：我们招募了5199名术后恶心和呕吐的高危患者，进行了一项随机、对照析因设计试验，旨在评估多达三种止吐干预措施之间的相互作用。在这些患者中，4123人被随机分配到的六种可能的预防干预组合中的一种：4毫克恩丹西酮或不使用恩丹西酮；4毫克地塞米松或不使用地塞米松；1.25毫克或不使用氟哌利多；异丙酚或挥发性麻醉剂；氮气或一氧化二氮；以及瑞芬太尼或芬太尼。其余的患者根据前四种干预措施被随机分配。结果恩丹西酮、地塞米松和氟哌利多分别将术后恶心和呕吐的风险降低了约26%。异丙酚降低了19%的风险，氮气降低了12%；因此，这两种药物(即全静脉麻醉)的风险降低与每种止吐药物所观察到的相似。所有干预措施相互独立，与患者的基线风险无关。因此，综合干预措施的相对风险可以通过乘以每项干预措施的相对风险来估算。然而，绝对风险降低是患者基线风险的关键功能。结论由于止吐干预措施同样有效且独立起作用，应首先使用最安全或最便宜的干预措施。低风险患者很少需要预防，中等风险患者可能从单一干预中受益，而高危患者应保留多种干预措施。
BACKGROUNDUntreated, one third of patients who undergo surgery will have postoperative nausea and vomiting. Although many trials have been conducted, the relative benefits of prophylactic antiemetic interventions given alone or in combination remain unknown.METHODSWe enrolled 5199 patients at high risk for postoperative nausea and vomiting in a randomized, controlled trial of factorial design that was powered to evaluate interactions among as many as three antiemetic interventions. Of these patients, 4123 were randomly assigned to 1 of 64 possible combinations of six prophylactic interventions: 4 mg of ondansetron or no ondansetron; 4 mg of dexamethasone or no dexamethasone; 1.25 mg of droperidol or no droperidol; propofol or a volatile anesthetic; nitrogen or nitrous oxide; and remifentanil or fentanyl. The remaining patients were randomly assigned with respect to the first four interventions. The primary outcome was nausea and vomiting within 24 hours after surgery, which was evaluated blindly.ResultsOndansetron, dexamethasone, and droperidol each reduced the risk of postoperative nausea and vomiting by about 26 percent. Propofol reduced the risk by 19 percent, and nitrogen by 12 percent; the risk reduction with both of these agents ( i.e., total intravenous anesthesia) was thus similar to that observed with each of the antiemetics. All the interventions acted independently of one another and independently of the patients' baseline risk. Consequently, the relative risks associated with the combined interventions could be estimated by multiplying the relative risks associated with each intervention. Absolute risk reduction, though, was a critical function of patients' baseline risk.CONCLUSIONSBecause antiemetic interventions are similarly effective and act independently, the safest or least expensive should be used first. Prophylaxis is rarely warranted in low-risk patients, moderate-risk patients may benefit from a single intervention, and multiple interventions should be reserved for high-risk patients.