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姜胶囊治疗化疗引起的恶心和呕吐的II期试验。

Phase II trial of encapsulated ginger as a treatment for chemotherapy-induced nausea and vomiting.

作者信息

Zick Suzanna M, Ruffin Mack T, Lee Julia, Normolle Daniel P, Siden Rivka, Alrawi Sara, Brenner Dean E

机构信息

Departments of Family Medicine, University of Michigan, Ann Arbor, MI, USA.

出版信息

Support Care Cancer. 2009 May;17(5):563-72. doi: 10.1007/s00520-008-0528-8. Epub 2008 Nov 13.

DOI:10.1007/s00520-008-0528-8
PMID:19005687
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4131259/
Abstract

GOALS OF WORK

Ginger has been used to treat numerous types of nausea and vomiting. Ginger has also been studied for its efficacy for acute chemotherapy-induced nausea and vomiting (CINV). However, its efficacy for delayed CINV in a diverse oncology population is unknown.

MATERIALS AND METHODS

We performed a randomized, double-blind, placebo-controlled trial in 162 patients with cancer who were receiving chemotherapy and had experienced CINV during at least one previous round of chemotherapy. All participants were receiving a 5-HT3 receptor antagonists and/or aprepitant. Participants were randomized to receive either 1.0 g ginger, 2.0 g ginger daily, or matching placebo for 3 days. The primary outcome was change in the prevalence of delayed CINV. Secondary outcomes included acute prevalence of CINV, acute and delayed severity of CINV, and assessment of blinding.

MAIN RESULTS

There were no differences between groups in the prevalence of delayed nausea or vomiting, prevalence of acute CINV, or severity of delayed vomiting or acute nausea and vomiting. Participants who took both ginger and aprepitant had more severe acute nausea than participants who took only aprepitant. Participants were able to accurately guess which treatment they had received. Ginger appeared well tolerated, with no difference in all adverse events (AEs) and significantly less fatigue and miscellaneous AEs in the ginger group.

CONCLUSIONS

Ginger provides no additional benefit for reduction of the prevalence or severity of acute or delayed CINV when given with 5-HT3 receptor antagonists and/or aprepitant.

摘要

工作目标

生姜已被用于治疗多种类型的恶心和呕吐。生姜对急性化疗引起的恶心和呕吐(CINV)的疗效也已得到研究。然而,其对不同肿瘤患者群体中延迟性CINV的疗效尚不清楚。

材料与方法

我们对162例正在接受化疗且在至少一轮先前化疗中经历过CINV的癌症患者进行了一项随机、双盲、安慰剂对照试验。所有参与者均接受5-羟色胺3(5-HT3)受体拮抗剂和/或阿瑞匹坦。参与者被随机分为三组,分别接受每日1.0克生姜、每日2.0克生姜或匹配的安慰剂,持续3天。主要结局是延迟性CINV患病率的变化。次要结局包括CINV的急性患病率、CINV的急性和延迟严重程度以及盲法评估。

主要结果

在延迟性恶心或呕吐的患病率、急性CINV的患病率或延迟性呕吐或急性恶心和呕吐的严重程度方面,各组之间没有差异。同时服用生姜和阿瑞匹坦的参与者比仅服用阿瑞匹坦的参与者有更严重的急性恶心。参与者能够准确猜出他们接受的是哪种治疗。生姜的耐受性似乎良好,在所有不良事件(AE)方面没有差异,且生姜组的疲劳和其他不良事件明显较少。

结论

当与5-HT3受体拮抗剂和/或阿瑞匹坦合用时,生姜在降低急性或延迟性CINV的患病率或严重程度方面没有额外益处。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/46be/4131259/ecf8f121a45a/nihms-619439-f0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/46be/4131259/ecf8f121a45a/nihms-619439-f0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/46be/4131259/ecf8f121a45a/nihms-619439-f0001.jpg

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