Yamada Takeshi, Kanazawa Yoshikazu, Aoki Yuto, Uchida Eiji
Department of Gastrointestinal and Hepato-Billiary-Pancreatic Surgery, Nippon Medical School.
J Nippon Med Sch. 2015;82(2):100-5. doi: 10.1272/jnms.82.100.
Nausea and vomiting are the most frequent side effects of opioids and may cause the opioids to be discontinued. New methods for preventing opioid-induced nausea can improve cancer pain management. Oxycodone is one of the most frequently used opioid used in Japan because patients receiving oxycodone report less nausea and vomiting than do patients receiving morphine. The reported incidence of oxycodone-induced nausea varies widely, although the true incidence remains unclear. As a first step toward preventing oxycodone-induced nausea, we aimed to determine the incidence of and risk factors for oxycodone-induced nausea and vomiting.
In this observational study, we analyzed a series of consecutive inpatients with cancer who received oxycodone with prochlorperazine as a preventive antiemetic agent. Oxycodone (5 mg) was administered either at 08:00 and 20:00 or at 09:00 and 21:00, and prochlorperazine (5 mg) was also given at the same times for 5 days.
Of the 145 enrolled patients, 138 were suitable for analysis. The incidence of nausea was 18.1%, and that of vomiting was 5.8%. The incidence of nausea was higher, but not to a significant degree, in women than in men (P=0.07). Furthermore, the incidence of vomiting in women was equal to that in men (P=0.28), whereas the incidences of both nausea (P=0.99) and vomiting (P=0.89) in elderly patients were equal to those in younger patients. In addition, the incidence of nausea (P=0.52) and vomiting (P=0.91) in patients with digestive system cancer was equal to that of patients with non-digestive system cancer.
The incidence of nausea induced by oxycodone with prochlorperazine was 18.1% in opioid-naïve Japanese inpatients. Female sex may be a risk factor for oxycodone-induced nausea. These results suggest that a clinical study would require 314 participants (157 in each group) to decrease the incidence from 18% to 8% (10% decrease) with a new preventive treatment (alpha error=0.05, beta error=0.2).
恶心和呕吐是阿片类药物最常见的副作用，可能导致停用阿片类药物。预防阿片类药物引起的恶心的新方法可以改善癌症疼痛管理。羟考酮是日本最常用的阿片类药物之一，因为接受羟考酮治疗的患者报告的恶心和呕吐比接受吗啡治疗的患者少。尽管羟考酮引起恶心的真实发生率尚不清楚，但报告的发生率差异很大。作为预防羟考酮引起恶心的第一步，我们旨在确定羟考酮引起恶心和呕吐的发生率及危险因素。
在这项观察性研究中，我们分析了一系列连续接受羟考酮联合氯丙嗪作为预防性止吐药的癌症住院患者。羟考酮（5毫克）于08:00和20:00或09:00和21:00给药，氯丙嗪（5毫克）也在相同时间给药，持续5天。
在145名登记患者中，138名适合分析。恶心发生率为18.1%，呕吐发生率为5.8%。女性恶心发生率高于男性，但差异无统计学意义（P=0.07）。此外，女性呕吐发生率与男性相等（P=0.28），而老年患者恶心（P=0.99）和呕吐（P=0.89）发生率与年轻患者相等。此外，消化系统癌症患者恶心（P=0.52）和呕吐（P=0.91）发生率与非消化系统癌症患者相等。
在未使用过阿片类药物的日本住院患者中，羟考酮联合氯丙嗪引起恶心的发生率为18.1%。女性可能是羟考酮引起恶心的危险因素。这些结果表明，一项临床研究需要314名参与者（每组157名）才能通过新的预防性治疗将发生率从18%降至8%（降低10%）（α错误=0.05，β错误=0.2）。
