5-羟色胺受体拮抗剂与丙氯拉嗪用于控制阿霉素所致延迟性恶心的疗效比较：一项URCC CCOP随机对照试验
5-Hydroxytryptamine-receptor antagonists versus prochlorperazine for control of delayed nausea caused by doxorubicin: a URCC CCOP randomised controlled trial.
作者信息
Hickok Jane T, Roscoe Joseph A, Morrow Gary R, Bole Christopher W, Zhao Hongwei, Hoelzer Karen L, Dakhil Shaker R, Moore Timothy, Fitch Tom R
机构信息
Department of Radiation Oncology and James P Wilmot Cancer Center, University of Rochester School of Medicine and Dentistry, Rochester, NY 14642, USA.
出版信息
Lancet Oncol. 2005 Oct;6(10):765-72. doi: 10.1016/S1470-2045(05)70325-9. Epub 2005 Sep 13.
BACKGROUND
Despite widespread use of short-acting antagonists for the 5-hydroxytryptamine (5-HT) receptor, about 50% of patients given moderately emetogenic chemotherapy have delayed nausea. We aimed to assess whether a 5-HT-receptor antagonist was more effective than was prochlorperazine for control of delayed nausea and delayed vomiting caused by doxorubicin.
METHODS
691 patients who previously had not had chemotherapy and who were scheduled to receive doxorubicin were given a short-acting 5-HT-receptor antagonist and dexamethasone before doxorubicin (day 1), and were randomly assigned to one of three regimens for days 2 and 3: 10 mg prochlorperazine taken orally every 8 h; any first-generation 5-HT-receptor antagonist (except palonosetron) taken as standard dose intravenously or orally; or 10 mg prochlorperazine taken as needed. Nausea and vomiting were assessed by use of a home record. The primary endpoint was mean severity of delayed nausea. The secondary endpoint was quality of life. Analyses were done by intention to treat.
FINDINGS
519 (77%) of the 671 evaluable patients had delayed nausea, with a mean severity of 3.33 (95% CI 3.22-3.44). 161 (71%) of 226 patients assigned prochlorperazine every 8 h reported delayed nausea (mean severity 3.37 [3.16-3.58]), as did 179 (79%) of 226 patients assigned 5-HT-receptor antagonists (3.29 [3.09-3.48]) and 179 (82%) of 219 patients assigned prochlorperazine as needed (3.33 [3.15-3.50]); groups did not differ in mean severity (p=0.853, one-way ANOVA). Patients allocated prochlorperazine every 8 h had less delayed nausea than did those allocated 5-HT-receptor antagonists (p=0.05, t test) and those allocated prochlorperazine as needed (p=0.009, t test).
INTERPRETATION
Short-acting 5-HT-receptor antagonists are no better than is prochlorperazine in control of delayed nausea caused by doxorubicin. Although fewer patients taking prochlorperazine report delayed nausea, the proportion was unacceptably high.
背景
尽管5-羟色胺（5-HT）受体短效拮抗剂已被广泛使用，但约50%接受中度致吐性化疗的患者仍会出现延迟性恶心。我们旨在评估5-HT受体拮抗剂在控制多柔比星引起的延迟性恶心和延迟性呕吐方面是否比氯丙嗪更有效。
方法
691例既往未接受过化疗且计划接受多柔比星治疗的患者在多柔比星治疗前（第1天）给予短效5-HT受体拮抗剂和地塞米松，并在第2天和第3天随机分配至三种治疗方案之一：每8小时口服10mg氯丙嗪；任何第一代5-HT受体拮抗剂（除帕洛诺司琼外）按标准剂量静脉或口服给药；或按需服用10mg氯丙嗪。通过家庭记录评估恶心和呕吐情况。主要终点为延迟性恶心的平均严重程度。次要终点为生活质量。分析采用意向性治疗。
结果
671例可评估患者中有519例（77%）出现延迟性恶心，平均严重程度为3.33（95%CI 3.22 - 3.44）。每8小时服用氯丙嗪的226例患者中有161例（71%）报告有延迟性恶心（平均严重程度3.37 [3.16 - 3.58]），服用5-HT受体拮抗剂的226例患者中有179例（79%）（3.29 [3.09 - 3.48]），按需服用氯丙嗪的219例患者中有179例（82%）（3.33 [3.15 - 3.50]）；各组平均严重程度无差异（p = 0.853，单因素方差分析）。每8小时服用氯丙嗪的患者延迟性恶心比服用5-HT受体拮抗剂的患者少（p = 0.05，t检验），也比按需服用氯丙嗪的患者少（p = 0.009，t检验）。
解读
短效5-HT受体拮抗剂在控制多柔比星引起的延迟性恶心方面并不比氯丙嗪更好。虽然服用氯丙嗪报告有延迟性恶心问题的患者较少，但这一比例仍高得令人难以接受。
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