Sussman G, Shurman J, Creed M R, Larsen L S, Ferrer-Brechner T, Noll D, Allegra J, Montgomery R, Schreck D, Grafstein E, Ramalanjaona G, Patel V, Ducharme J, Ortenwall P, Foster E, Ames M
Illinois Center for Clinical Trials, Chicago, USA.
Clin Ther. 1999 Jul;21(7):1216-27. doi: 10.1016/s0149-2918(00)80024-7.
This randomized, double-masked, placebo-controlled, multicenter trial was conducted in 9 countries to assess the safety and efficacy of 2 doses of intravenous ondansetron (8 and 16 mg) for the control of opioid-induced nausea and vomiting. A total of 2574 nonsurgical patients who presented with pain requiring treatment with an opioid analgesic agent participated in this trial. The most common presenting painful condition was back or neck pain, reported by approximately one third of patients. A total of 520 patients (317 females, 203 males) developed nausea or vomiting after opioid administration and were randomly assigned to receive a single dose of 1 of 3 study treatments: placebo (n = 94), ondansetron 8 mg (n = 215), or ondansetron 16 mg (n = 211). Ondansetron 8 and 16 mg led to complete control of emesis in 134 of 215 patients (62.3%) and 145 of 211 patients (68.7%), respectively. Results with both doses were significantly better than those seen with placebo (43 of 94 patients [45.7%]). Complete control of nausea was achieved in 6.8% of placebo patients, 14.8% of ondansetron 8-mg-treated patients, and 19.4% of ondansetron 16-mg treated patients; only ondansetron 16 mg was significantly better than placebo (P = 0.007). Significantly more patients who received ondansetron 8 mg than patients who received placebo were satisfied/very satisfied with their antiemetic treatment, as assessed by 4 patient-satisfaction questions. Significantly more patients who received ondansetron 16 mg compared with placebo were satisfied/very satisfied on 2 of 4 satisfaction questions. In conclusion, based on the observed incidence of opioid-induced nausea and vomiting in this study, it may be more appropriate to treat symptoms on occurrence rather than administering antiemetic agents prophylactically. The results of this study demonstrate that intravenous ondansetron in doses of 8 or 16 mg is an effective antiemetic agent for the control of opioid-induced nausea and vomiting in nonsurgical patients requiring opioid analgesia for pain.
这项随机、双盲、安慰剂对照的多中心试验在9个国家进行，旨在评估2种剂量的静脉注射昂丹司琼（8毫克和16毫克）控制阿片类药物引起的恶心和呕吐的安全性和有效性。共有2574名因疼痛需要使用阿片类镇痛药治疗的非手术患者参与了该试验。最常见的疼痛症状是背部或颈部疼痛，约三分之一的患者报告有此症状。共有520名患者（317名女性，203名男性）在使用阿片类药物后出现恶心或呕吐，并被随机分配接受3种研究治疗中的1种单剂量治疗：安慰剂（n = 94）、8毫克昂丹司琼（n = 215）或16毫克昂丹司琼（n = 211）。8毫克和16毫克昂丹司琼分别使215名患者中的134名（62.3%）和211名患者中的145名（68.7%）的呕吐得到完全控制。两种剂量的结果均显著优于安慰剂组（94名患者中的43名[45.7%]）。安慰剂组患者中有6.8%的恶心得到完全控制，8毫克昂丹司琼治疗组患者中有14.8%，16毫克昂丹司琼治疗组患者中有19.4%；只有16毫克昂丹司琼显著优于安慰剂（P = 0.007）。根据4个患者满意度问题评估，接受8毫克昂丹司琼治疗的患者中对其止吐治疗感到满意/非常满意的人数显著多于接受安慰剂治疗的患者。在4个满意度问题中的2个问题上，接受16毫克昂丹司琼治疗的患者与接受安慰剂治疗的患者相比，感到满意/非常满意的人数显著更多。总之，根据本研究中观察到的阿片类药物引起的恶心和呕吐发生率，在症状出现时进行治疗可能比预防性使用止吐药更为合适。本研究结果表明，8毫克或16毫克剂量的静脉注射昂丹司琼是一种有效的止吐药，可控制需要使用阿片类镇痛药治疗疼痛的非手术患者中阿片类药物引起的恶心和呕吐。
