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A randomized, double-blind, placebo-controlled, multicenter study of a ginger extract in the management of chemotherapy-induced nausea and vomiting (CINV) in patients receiving high-dose cisplatin.
一项随机、双盲、安慰剂对照的多中心研究,研究生姜提取物在接受大剂量顺铂治疗的患者化疗引起的恶心呕吐 (CINV) 中的作用。
cancer dietary supplementation ginger herbal therapies scientific evidence
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摘要

Background:The activity of ginger in the management of chemotherapy-induced nausea and vomiting (CINV) has been suggested, but design inadequacies, heterogeneity of the population, small numbers and poor quality of tested products limit the possibility to offer generalizable results.
Patients and methods:We conducted a randomized, double-blind, placebo-controlled, multicenter study in patients planned to receive ≥2 chemotherapy cycles with high dose (>50 mg/m2) cisplatin. Patients received ginger 160 mg/day (with standardized dose of bioactive compounds) or placebo in addition to the standard antiemetic prophylaxis for CINV, starting from the day after cisplatin administration. CINV was assessed through daily visual-analogue scale and Functional Living Index Emesis questionnaires. The main objective was protection from delayed nausea; secondary end points included intercycle nausea and nausea anticipatory symptoms.
Results:In total, 121 patients received ginger and 123 placebo. Lung (49%) and head and neck cancer (HNC; 35%) were the most represented tumors. No differences were reported in terms of safety profile or compliance. The incidence of delayed, intercycle and anticipatory nausea did not differ between the two arms in the first cycle and second cycle. A benefit of ginger over placebo in Functional Living Index Emesis nausea score differences (day 6-day 1) was identified for females (P = 0.048) and HNC patients (P = 0.038).
Conclusions:In patients treated with high-dose cisplatin, the daily addition of ginger, even if safe, did not result in a protective effect on CINV. The favorable effect observed on nausea in subgroups at particular risk of nausea (females; HNC) deserves specific investigation.

译文

背景: 生姜在化疗引起的恶心和呕吐 (CINV) 中的活性已经被提出,但是设计不足,人群异质性, 测试产品数量少且质量差,限制了提供可推广结果的可能性。
患者和方法: 我们进行了一项随机、双盲、安慰剂对照的多中心研究,研究对象是计划接受 ≥ 2 个大剂量 (> 50 mg/m2) 顺铂化疗周期的患者。患者接受生姜 160 毫克/天 (标准剂量的生物活性化合物) 或安慰剂,除了 CINV 的标准止吐预防,从给药后的第二天开始。通过每日视觉模拟量表和功能性生活指数呕吐问卷评估 CINV。主要目的是防止延迟恶心; 次要终点包括周期间恶心和恶心预期症状。
结果: 总共有 121 名患者接受生姜治疗,123 名患者接受安慰剂治疗。肺癌 (49%) 和头颈癌 (HNC; 35%) 是最具代表性的肿瘤。在安全性或合规性方面没有报告差异。在第一个周期和第二个周期中,两组的延迟、周期间和预期恶心的发生率没有差异。在功能性生活指数呕吐恶心评分差异 (第 6 天-第 1 天) 中,生姜比安慰剂的益处被确定为女性 (p = 0.048) 和 HNC 患者 (p = 0.038)。
结论: 在接受大剂量顺铂治疗的患者中,每日添加生姜,即使安全,也不会对 CINV 产生保护作用。在特别有恶心风险的亚组 (女性; HNC) 中观察到的对恶心的有利影响值得具体研究。

chemotherapy induced nausea and vomiting

消化 化疗副反应 临床研究术语
概述  :  

化疗所致恶心呕吐(CINV)是肿瘤治疗过程中常见的并发症之一,处理不当将对患者后续治疗及疾病转归造成严重影响。化疗所致的恶心呕吐是因化疗药物导致的恶心呕吐反应。按照发生时间的不同,CINV可分为5类:急性、延迟性、预期性、爆发性及难治性急性呕吐。急性呕吐发生在初次化疗后24小时以内,迟发型呕吐则在初次化疗后几天发生。 止吐药的分类简介1. 多巴胺受体抑制剂,代表药物有甲氧氯普胺、多潘立酮,因其能够促进泌乳素分泌而不适用于乳腺癌患者。2. NK-1受体抑制剂,已经

chemotherapy 英 /ˌkiːməʊˈθerəpi/  美 /ˌkiːmoʊˈθerəpi/

释义   n. [临床] 化学疗法

例句   "There was no chemotherapy back then, only the knife, " she said. 她说:“那时还没有什么化学疗法,只能动手术。”

 

induced 英 /ɪn'djuːst/  美 /ɪn'djʊst/

释义   v. 引诱;说服(induce的过去分词) adj. 感应的;诱发

例句   The vascular wall stress is of great importance in the vascular remodeling process induced either by the change of blood flow or by hypertension. 无论是由血液流量改变或是由高血压引起的血管重建,血管壁上的应力都起着至关重要的作用。

 

nausea 英 /ˈnɔ:ziə/  美 /ˈnɔːziə,ˈnɔːsiə/

释义   n. 恶心,晕船;极端的憎恶

例句   I have headache, nausea and diarrhea. 我头痛,恶心,还有腹泻。

 

vomiting  英 /'vɔmitiŋ/   美 /'vɑmɪt/

释义   v. 呕吐(vomit的ing形式)

例句   Never prepare food for others if you have diarrhea or vomiting. 如果你腹泻或呕吐,千万不要为他人准备食物。


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