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一项关于放射治疗中呕吐的前瞻性观察性试验:在 45 个意大利放射肿瘤学中心招募的 1020 名患者的分析。

A prospective observational trial on emesis in radiotherapy: analysis of 1020 patients recruited in 45 Italian radiation oncology centres.

机构信息

Radiotherapy Centre, S. Maria Hospital, Via T. di Joannuccio, 1, O5100 Terni, Italy.

出版信息

Radiother Oncol. 2010 Jan;94(1):36-41. doi: 10.1016/j.radonc.2009.11.001. Epub 2009 Dec 4.

Abstract

PURPOSE

A prospective observational multicentre trial was carried out to assess the incidence, pattern, and prognostic factors of radiation-induced emesis (RIE), and to evaluate the use of antiemetic drugs in patients treated with radiotherapy or concomitant radio-chemotherapy. The application in clinical practice of the Multinational Association of Supportive Care in Cancer guidelines was also studied.

MATERIALS AND METHODS

Forty-five Italian radiation oncology centres took part in this trial. The accrual lasted for 3 consecutive weeks and only patients starting radiotherapy or concomitant radio-chemotherapy in this period were enrolled. Evaluation was based on diary card filled in daily by patients during treatment and one week after stopping it. Diary card recorded the intensity of nausea/vomiting and prophylactic/symptomatic antiemetic drug prescriptions.

RESULTS

A total of 1020 patients entered into the trial, and 1004 were evaluable. Vomiting and nausea occurred in 11.0% and 27.1% of patients, respectively, and 27.9% patients had both vomiting and nausea. In multifactorial analysis, the only statistically significant patient-related risk factors were concomitant chemotherapy and previous experience of vomiting induced by chemotherapy. Moreover, two radiotherapy-related factors were significant risk factors for RIE, the irradiated site (upper abdomen) and field size (>400 cm(2)). An antiemetic drug was given only to a minority (17%) of patients receiving RT, and the prescriptions were prophylactic in 12.4% and symptomatic in 4.6%. Different compounds and a wide range of doses and schedules were used.

CONCLUSIONS

These data were similar to those registered in our previous observational trial, and the radiation oncologists' attitude in underestimating RIE and under prescribing antiemetics was confirmed.

摘要

目的

进行了一项前瞻性观察性多中心试验,以评估放射性呕吐(RIE)的发生率、模式和预后因素,并评估在接受放射治疗或放化疗的患者中使用止吐药物的情况。还研究了癌症支持治疗多国协会指南在临床实践中的应用。

材料和方法

45 家意大利放射肿瘤学中心参与了这项试验。入组时间持续 3 周,仅在该期间开始放射治疗或放化疗的患者被纳入研究。评估基于患者在治疗期间和停止治疗后一周每天填写的日记卡。日记卡记录了恶心/呕吐的强度和预防/对症止吐药物的处方。

结果

共有 1020 名患者入组该试验,其中 1004 名患者可评估。11.0%的患者发生呕吐,27.1%的患者发生恶心,27.9%的患者同时发生呕吐和恶心。多因素分析中,唯一具有统计学意义的患者相关危险因素是同时进行化疗和以前因化疗引起的呕吐经历。此外,两个与放疗相关的因素是 RIE 的显著危险因素,即照射部位(上腹部)和照射野大小(>400cm2)。只有少数(17%)接受 RT 的患者使用了止吐药物,其中 12.4%为预防用药,4.6%为对症用药。使用了不同的化合物,剂量和方案范围广泛。

结论

这些数据与我们之前的观察性试验中登记的数据相似,证实了放射肿瘤学家低估 RIE 和止吐药物处方不足的态度。

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