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预测化疗相关恶心和呕吐的风险因素评估:一项欧洲前瞻性观察性研究的结果

Evaluation of risk factors predicting chemotherapy-related nausea and vomiting: results from a European prospective observational study.

作者信息

Molassiotis Alexander, Aapro Matti, Dicato Mario, Gascon Pere, Novoa Sylvia A, Isambert Nicolas, Burke Thomas A, Gu Anna, Roila Fausto

机构信息

School of Nursing, The Hong Kong Polytechnic University, Hong Kong.

Medical Oncology and Radiation, IMO Clinique de Genolier, Genolier, Switzerland.

出版信息

J Pain Symptom Manage. 2014 May;47(5):839-848.e4. doi: 10.1016/j.jpainsymman.2013.06.012. Epub 2013 Sep 24.

DOI:10.1016/j.jpainsymman.2013.06.012
PMID:24075401
Abstract

CONTEXT

Demographic, personal, clinical, and behavioral factors predicting chemotherapy-induced nausea and vomiting (CINV) have been assessed in the past, but inconsistencies exist in the literature, studies have methodological shortcomings, and many risk factors have been examined in cross-sectional studies and univariate analyses.

OBJECTIVES

To evaluate the predictive power of personal and treatment-related characteristics in the development of CINV, using a large and prospectively evaluated sample of a heterogeneous group of cancer patients receiving routine chemotherapy.

METHODS

This was a multicountry, multisite prospective study over three cycles of chemotherapy. Adult patients from eight European countries about to receive highly and moderately emetogenic chemotherapy were recruited. Clinicians completed a case report form at or before the initial chemotherapy treatment, recording patient demographic and baseline clinical characteristics. Participants completed a daily patient diary for six days per chemotherapy cycle describing their CINV experience. Baseline patient data also included a history of nausea/vomiting (yes/no), patient expectation of nausea (0-100 mm visual analogue scale [VAS]), prechemotherapy anxiety (0-100 mm VAS), and prechemotherapy nausea (0-100 mm VAS) measured during the 24-hour period before chemotherapy initiation.

RESULTS

There were 991 evaluable patients with complete Cycle 1 data, 888 for Cycle 2 data, and 769 for Cycle 3 data. A complex picture of predictor variables was shown, with different contribution of variables to the acute, delayed, and overall phases of CINV. Key predictor variables included the use of antiemetics inconsistent with international guidelines, younger age, prechemotherapy nausea, and no CINV complete response in an earlier cycle (all at P < 0.05). Anxiety, history of nausea/vomiting, and expectations of nausea were important predictors for some phases and cycles but not consistently across the CINV pathway.

CONCLUSION

The results of this study provide clarity for the relative contribution of a set of characteristics in the development of CINV. Following evidence-based clinical antiemetic guidelines is of paramount importance, alongside treating patients with increased risk for CINV more aggressively, which both could lead to more optimal CINV management. These data can assist clinicians in making decisions about the antiemetic management of their patients.

摘要

背景

过去已对预测化疗引起的恶心和呕吐(CINV)的人口统计学、个人、临床和行为因素进行了评估,但文献中存在不一致之处,研究存在方法学缺陷,且许多危险因素已在横断面研究和单变量分析中进行了检验。

目的

使用接受常规化疗的异质性癌症患者的大型前瞻性评估样本,评估个人和治疗相关特征对CINV发生的预测能力。

方法

这是一项针对三个化疗周期的多国、多中心前瞻性研究。招募了来自八个欧洲国家即将接受高度和中度致吐性化疗的成年患者。临床医生在初始化疗治疗时或之前填写病例报告表,记录患者的人口统计学和基线临床特征。参与者在每个化疗周期的六天内完成每日患者日记,描述他们的CINV经历。基线患者数据还包括恶心/呕吐史(是/否)、患者对恶心的预期(0 - 100毫米视觉模拟量表[VAS])、化疗前焦虑(0 - 100毫米VAS)以及化疗开始前24小时内测量的化疗前恶心(0 - 100毫米VAS)。

结果

有991例患者可评估第1周期的完整数据,888例可评估第2周期的数据,769例可评估第3周期的数据。显示出预测变量的复杂情况,不同变量对CINV的急性、延迟和总体阶段有不同贡献。关键预测变量包括使用不符合国际指南的止吐药、年龄较小、化疗前恶心以及早期周期中无CINV完全缓解(所有P < 0.05)。焦虑、恶心/呕吐史和对恶心的预期在某些阶段和周期是重要的预测因素,但在CINV过程中并非始终如此。

结论

本研究结果明确了一组特征在CINV发生中的相对贡献。遵循循证临床止吐指南至关重要,同时更积极地治疗CINV风险增加的患者,这两者都可能导致更优化的CINV管理。这些数据可协助临床医生对患者的止吐管理做出决策。

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