Lindley Celeste, Goodin Susan, McCune Jeannine, Kane Michael, Amamoo M Ahinee, Shord Stacy, Pham Trin, Yowell Sally, Laliberte Kevin, Schell Michael, Bernard Stephen, Socinski Mark A
University of North Carolina at Chapel Hill, Chapel Hill, North Carolina 27599-7360, USA.
Am J Clin Oncol. 2005 Jun;28(3):270-6. doi: 10.1097/01.coc.0000145983.35929.2a.
The purpose of this article is to assess the comparative antiemetic efficacy of prochlorperazine, ondansetron, and dexamethasone in the prevention of delayed chemotherapy-induced nausea and vomiting (CINV) after moderately high to highly emetogenic chemotherapy. Cancer patients (n = 232) receiving moderately high to highly emetogenic chemotherapy were randomized to 1 of 3 treatments: 15 mg prochlorperazine spansules twice daily; 8 mg ondansetron tablets twice daily; or 8 mg dexamethasone tablets twice daily on days 2 through 5. All patients received 24 mg ondansetron and 20 mg dexamethasone orally before chemotherapy. Daily assessment (days 1 through 5) included the number of episodes of retching and vomiting, severity of nausea, restlessness, difficulty concentrating and fatigue, treatment satisfaction, and overall quality of life (measured using a 10-cm VAS). The Functional Living Index-Emesis (FLIE) was completed on day 5. Other side effects attributed to antiemetic therapy were recorded daily. For acute CINV, total control, defined as no vomiting, retching, nausea <1 cm on a 10-cm visual analog scale, and no administration of rescue medications, was achieved in 78% in the overall group and was not significantly different in the patients randomized to the 3 treatment arms for delayed CINV. Delayed CINV was reported by 43% to 57% of patients, with the highest incidence reported on day 3. For delayed CINV, patients receiving prochlorperazine reported the lowest average nausea score on days 2 to 5, whereas patients receiving ondansetron reported the highest nausea score (P = 0.05). No statistically significant differences in CINV or side effects of antiemetic therapy were noted between treatment groups on days 2 to 5. For patients similar to those included in this study, there does not appear to be a clinically important difference in efficacy, adverse effects, or treatment satisfaction among dexamethasone, prochlorperazine, and ondansetron in the doses used in these delayed CINV regimens on days 2 to 5 in this study.
本文旨在评估氯丙嗪、昂丹司琼和地塞米松在预防中高度至高度致吐性化疗后延迟性化疗引起的恶心和呕吐（CINV）方面的相对止吐疗效。接受中高度至高度致吐性化疗的癌症患者（n = 232）被随机分为3种治疗方法中的1种：每日2次，每次15 mg丙氯拉嗪长效胶囊；每日2次，每次8 mg昂丹司琼片；或在第2至5天每日2次，每次8 mg地塞米松片。所有患者在化疗前口服24 mg昂丹司琼和20 mg地塞米松。每日评估（第1至5天）包括干呕和呕吐发作次数、恶心严重程度、烦躁不安、注意力不集中和疲劳、治疗满意度以及总体生活质量（使用10 cm视觉模拟量表测量）。在第5天完成功能生活指数-呕吐（FLIE）评估。每日记录归因于止吐治疗的其他副作用。对于急性CINV，总体控制定义为无呕吐、干呕、在10 cm视觉模拟量表上恶心<1 cm且未使用救援药物，总体组中78%的患者达到此标准，在随机分配至3种治疗组的患者中，延迟性CINV的控制情况无显著差异。43%至57%的患者报告有延迟性CINV，第3天报告的发生率最高。对于延迟性CINV，接受丙氯拉嗪的患者在第2至5天报告的平均恶心评分最低，而接受昂丹司琼的患者报告的恶心评分最高（P = 0.05）。在第2至5天，各治疗组之间在CINV或止吐治疗副作用方面未观察到统计学上的显著差异。对于与本研究纳入患者相似的患者，在本研究中第2至5天这些延迟性CINV治疗方案中使用的剂量下，地塞米松、丙氯拉嗪和昂丹司琼在疗效、不良反应或治疗满意度方面似乎没有临床上的重要差异。
