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一项比较阿瑞匹坦和福沙匹坦对妇科癌症治疗患者化疗引起的恶心和呕吐影响的随机对照试验性研究。

A Randomized Controlled Pilot Study Comparing the Impact of Aprepitant and Fosaprepitant on Chemotherapy Induced Nausea and Vomiting in Patients Treated for Gynecologic Cancer.

作者信息

Micha John P, Rettenmaier Mark A, Brown John V, Mendivil Alberto, Abaid Lisa N, Lopez Katrina L, Goldstein Bram H

机构信息

*Gynecologic Oncology Associates; and †Nancy Yeary Women's Cancer Research Foundation, Newport Beach, CA.

出版信息

Int J Gynecol Cancer. 2016 Feb;26(2):389-93. doi: 10.1097/IGC.0000000000000593.

DOI:10.1097/IGC.0000000000000593
PMID:26588232
Abstract

OBJECTIVE

The purpose of this pilot study was to compare the response rates and daily living activities of patients with newly diagnosed gynecologic cancer treated with fosaprepitant or aprepitant in the management of chemotherapy-induced nausea and vomiting.

METHODS AND MATERIALS

Eligible participants were randomized to either intravenous fosaprepitant (150 mg, day 1) or oral aprepitant (125 mg on day 1 and 80 mg on days 2-3) before undergoing weekly paclitaxel (80 mg/2)(2) and monthly carboplatin (AUC 6)-based chemotherapy. In addition, standard premedications (eg, ranitidine, dexamethasone, and diphenhydramine) were administered intravenously on day 1. Response evaluation and impact on daily life were measured throughout the acute phase (0-24 hours), delayed period (days 2-4), and overall phase (0-120 hours) of the patients' initial chemotherapy cycle via the Functional Living Index-Emesis.

RESULTS

In the current investigation, 20 gynecologic cancer subjects were treated with either fosaprepitant (n = 10) or aprepitant (n = 10) before their first chemotherapy cycle. We observed 7 overall complete responses (70%, no emetic episodes or rescue medications) in the aprepitant group and 6 (60%) in the fosaprepitant cohort (P = 0.660). In addition, both treatment groups reported similarly, favorable rates of daily living activities throughout the acute (P = 0.626) and delayed (P = 0.648) phases of cycle 1 chemotherapy.

CONCLUSIONS

The findings from the current analysis suggest that intravenous fosaprepitant and oral aprepitant confer beneficial antiemetic prevention. Moreover, the 2 medications theoretically afford a favorable impact on daily living, thereby potentially facilitating the completion of a patient's clinically prescribed chemotherapy regimen.

摘要

目的

本初步研究的目的是比较接受磷丙泊酚或阿瑞匹坦治疗的新诊断妇科癌症患者在化疗引起的恶心和呕吐管理中的缓解率及日常生活活动情况。

方法和材料

符合条件的参与者在接受基于每周紫杉醇(80mg/2)(2)和每月卡铂(AUC 6)的化疗前,被随机分为静脉注射磷丙泊酚组(第1天150mg)或口服阿瑞匹坦组(第1天125mg,第2 - 3天80mg)。此外,在第1天静脉给予标准预处理药物(如雷尼替丁、地塞米松和苯海拉明)。通过功能性生活指数 - 呕吐量表在患者初始化疗周期的急性期(0 - 24小时)、延迟期(第2 - 4天)和全期(0 - 120小时)测量缓解评估及对日常生活的影响。

结果

在本次研究中,20名妇科癌症受试者在首次化疗周期前接受了磷丙泊酚(n = 10)或阿瑞匹坦(n = 10)治疗。我们观察到阿瑞匹坦组有7例总体完全缓解(70%,无呕吐发作或使用救援药物),磷丙泊酚组有6例(60%)(P = 0.660)。此外,两个治疗组在第1周期化疗的急性期(P = 0.626)和延迟期(P = 0.648)报告的日常生活活动良好率相似。

结论

当前分析的结果表明,静脉注射磷丙泊酚和口服阿瑞匹坦具有有益的止吐预防作用。此外,这两种药物理论上对日常生活有良好影响,从而有可能促进患者完成临床规定的化疗方案。

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