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测试止吐指南的有效性:日本CINV研究组前瞻性登记研究结果

Testing the effectiveness of antiemetic guidelines: results of a prospective registry by the CINV Study Group of Japan.

作者信息

Tamura Kazuo, Aiba Keisuke, Saeki Toshiaki, Nakanishi Yoichi, Kamura Toshiharu, Baba Hideo, Yoshida Kazuhiro, Yamamoto Nobuyuki, Kitagawa Yuko, Maehara Yoshihiko, Shimokawa Mototsugu, Hirata Koichi, Kitajima Masaki

机构信息

Division of Medical Oncology, Hematology and Infectious Diseases, Department of Medicine, School of Medicine, Fukuoka University, 7-45-1, Nanakuma, Jonan-ku, Fukuoka, Fukuoko, 814-0180, Japan.

Division of Clinical Oncology/Hematology, Department of Internal Medicine, The Jikei University School of Medicine, 3-25-8, Nishi-shimbashi, Minato-ku, Tokyo, 105-8461, Japan.

出版信息

Int J Clin Oncol. 2015 Oct;20(5):855-65. doi: 10.1007/s10147-015-0786-7. Epub 2015 Feb 15.

DOI:10.1007/s10147-015-0786-7
PMID:25681876
Abstract

BACKGROUND

Many cancer patients suffer from the common side effect of chemotherapy-induced nausea and vomiting (CINV). Guidelines recommend a combination of two prophylactic antiemetics for moderately emetogenic chemotherapy (MEC) and three for highly emetogenic chemotherapy (HEC) and certain MEC regimens.

METHODS

This multicenter, prospective, observational study analyzed data for 1,910 patients in Japan scheduled for MEC or HEC. Use of antiemetic prophylaxis in relation to type of chemotherapy, incidences of and risk factors for nausea, vomiting, and acute versus delayed CINV, and estimated incidence of CINV by staff were analyzed using Fisher's exact test and multivariate logistic regression. The patients recorded the incidence of CINV and severity of nausea by visual analogue scales daily for 7 days after receiving chemotherapy.

RESULTS

A total of 240 (20.1 %) HEC and 476 MEC patients (66.6 %) received 2 antiemetics, compared with 883 (73.9 %) and 200 (28.0 %), respectively, who received 3 antiemetics. Approximately 74 % of HEC and 95 % of MEC patients received antiemetic therapy in compliance with guidelines. Acute nausea and vomiting were well controlled, but high incidences of delayed nausea occurred in both HEC and MEC patients. Delayed vomiting (p < 0.0001) was significantly less frequent in patients receiving three compared with 2 antiemetics. Female sex was a major risk factor for CINV. Medical staff tended to overestimate the incidence of CINV. Among HEC regimens, the incidence of CINV and the degree of nausea on day 1 of anthracycline-cyclophosphamide combination therapy were higher than with a cisplatin-based regimen.

CONCLUSIONS

Adherence to antiemetic guidelines effectively controls vomiting but is less effective against delayed nausea in HEC and MEC patients. Identification of individual risk factors, such as female sex, will assist in the development of personalized treatments for CINV. More intensive antiemetic therapy or a different modality of prophylaxis should be considered for the control of acute CINV in an anthracycline-cyclophosphamide regimen.

摘要

背景

许多癌症患者会遭受化疗引起的恶心和呕吐(CINV)这种常见的副作用。指南推荐对于中度致吐性化疗(MEC)采用两种预防性止吐药联合使用,对于高度致吐性化疗(HEC)以及某些MEC方案采用三种预防性止吐药联合使用。

方法

这项多中心、前瞻性、观察性研究分析了日本1910例计划接受MEC或HEC治疗的患者的数据。使用Fisher精确检验和多因素逻辑回归分析了与化疗类型相关的预防性止吐药的使用情况、恶心、呕吐以及急性与延迟性CINV的发生率和危险因素,以及工作人员估计的CINV发生率。患者在接受化疗后的7天内每天使用视觉模拟量表记录CINV的发生率和恶心的严重程度。

结果

共有240例(20.1%)HEC患者和476例MEC患者(66.6%)接受了两种止吐药治疗,相比之下,分别有883例(73.9%)和200例(28.0%)接受了三种止吐药治疗。大约74%的HEC患者和95%的MEC患者按照指南接受了止吐治疗。急性恶心和呕吐得到了很好的控制,但HEC和MEC患者中延迟性恶心的发生率都很高。接受三种止吐药治疗的患者延迟性呕吐(p<0.0001)的发生率明显低于接受两种止吐药治疗的患者。女性是CINV的主要危险因素。医务人员往往高估了CINV的发生率。在HEC方案中,蒽环类药物-环磷酰胺联合治疗第1天的CINV发生率和恶心程度高于基于顺铂的方案。

结论

遵循止吐指南可有效控制呕吐,但对HEC和MEC患者的延迟性恶心效果较差。识别个体危险因素,如女性,将有助于开发针对CINV的个性化治疗方案。对于蒽环类药物-环磷酰胺方案中急性CINV的控制,应考虑采用更强化的止吐治疗或不同的预防方式。

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