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一项关于生姜(姜科植物姜)治疗癌症化疗所致恶心的II/III期随机、安慰剂对照、双盲临床试验:一项正在进行入组的URCC CCOP癌症控制研究。

A Phase II/III Randomized, Placebo-Controlled, Double-Blind Clinical Trial of Ginger (Zingiber officinale) for Nausea Caused by Chemotherapy for Cancer: A Currently Accruing URCC CCOP Cancer Control Study.

作者信息

Hickok Jane T, Roscoe Joseph A, Morrow Gary R, Ryan Julie L

机构信息

James P. Wilmot Cancer Center at the University of Rochester, NY.

出版信息

Support Cancer Ther. 2007 Sep 1;4(4):247-50. doi: 10.3816/SCT.2007.n.022.

Abstract

Despite the widespread use of 5-HT3 receptor antagonist antiemetics such as ondansetron and granistron, up to 70% of patients with cancer receiving highly emetogenic chemotherapy agents experience postchemotherapy nausea and vomiting. Delayed postchemotherapy nausea (nausea that occurs >/= 24 hours after chemotherapy administration) and anticipatory nausea (nausea that develops before chemotherapy administration, in anticipation of it) are poorly controlled by currently available antiemetic agents. Scientific studies suggest that ginger (Zingiber officinale) might have beneficial effects on nausea and vomiting associated with motion sickness, surgery, and pregnancy. In 2 small studies of patients with cancer receiving chemotherapy, addition of ginger to standard antiemetic medication further reduced the severity of postchemotherapy nausea. This article describes a phase II/III randomized, dose-finding, placebo-controlled, double-blind clinical trial to assess the efficacy of ginger for nausea associated with chemotherapy for cancer. The study is currently being conducted by private practice oncology groups that are funded by the National Cancer Institute's Community Clinical Oncology Program and affiliated with the University of Rochester Cancer Center Community Clinical Oncology Program Research Base.

摘要

尽管5-羟色胺3(5-HT3)受体拮抗剂类止吐药如昂丹司琼和格拉司琼已被广泛使用,但接受高致吐性化疗药物的癌症患者中,仍有高达70%的人在化疗后出现恶心和呕吐。化疗后延迟性恶心(化疗给药后≥24小时出现的恶心)和预期性恶心(在化疗给药前因预期化疗而出现的恶心)目前可用的止吐药难以有效控制。科学研究表明,生姜(姜科植物姜)可能对晕动病、手术及妊娠相关的恶心和呕吐有有益作用。在两项针对接受化疗的癌症患者的小型研究中,在标准止吐药物中添加生姜可进一步减轻化疗后恶心的严重程度。本文描述了一项II/III期随机、剂量探索、安慰剂对照、双盲临床试验,以评估生姜对癌症化疗相关恶心的疗效。该研究目前由私人执业肿瘤学小组开展,这些小组由美国国立癌症研究所的社区临床肿瘤学项目资助,并与罗切斯特大学癌症中心社区临床肿瘤学项目研究基地相关联。

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