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长效粒细胞集落刺激因子对新诊断上皮性卵巢癌患者发热性中性粒细胞减少症的预防作用:一项随机对照研究。

The prophylactic effects of long-acting granulocyte colony-stimulating factor for febrile neutropenia in newly diagnosed patients with epithelial ovarian cancer: a randomised controlled study.

机构信息

Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Beijing, China.

Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Beijing, China

出版信息

BMJ Support Palliat Care. 2019 Dec;9(4):373-380. doi: 10.1136/bmjspcare-2019-001862. Epub 2019 Aug 29.

Abstract

OBJECTIVE

This study explored the prophylactic effects of long-acting granulocyte colony-stimulating factor (G-CSF) for febrile neutropenia (FN) in newly diagnosed patients with epithelial ovarian cancer (EOC).

METHODS

Patients were randomised into a study group (long-acting G-CSF for all chemotherapy cycles) and a control group (short-acting G-CSF for first cycle and treatment per physician discretion for subsequent cycles) at a ratio of 1:2. The incidences of FN and myelosuppression and the number of clinical visits, medication doses, complete blood count (CBC) tests and adverse events were compared between the two groups. A regression model was used to determine the risk factors for FN.

RESULTS

From 30 November 2018 to 1 April 2019, 84 cases were included in the final analysis; there were 24 (28.6%) and 60 (71.4%) patients in the study and control groups, respectively, and 605 chemotherapy cycles. The study group or chemotherapy cycles utilising long-acting G-CSF had significantly fewer utilisations and doses of short-acting G-CSF; clinical visits; CBC tests; and incidences of FN and myelosuppression; and less G-CSF-associated pain. The utilisation of G-CSF was the only independent factor for FN in a binary regression model.

CONCLUSION

Long-acting G-CSF could effectively reduce the incidences of FN and myelosuppression and had mild adverse effects in newly diagnosed patients with EOC receiving chemotherapy.

TRIAL REGISTRATION NUMBER

NCT03740464.

摘要

目的

本研究旨在探讨长效粒细胞集落刺激因子(G-CSF)预防初诊上皮性卵巢癌(EOC)患者化疗后发热性中性粒细胞减少症(FN)的效果。

方法

患者按 1:2 的比例随机分为研究组(所有化疗周期均使用长效 G-CSF)和对照组(第 1 周期使用短效 G-CSF,随后周期根据医生判断使用)。比较两组 FN 和骨髓抑制的发生率、就诊次数、药物剂量、全血细胞计数(CBC)检查次数和不良反应发生情况。采用回归模型确定 FN 的危险因素。

结果

2018 年 11 月 30 日至 2019 年 4 月 1 日,最终纳入 84 例患者进行分析,研究组和对照组各 24 例(28.6%)和 60 例(71.4%),共 605 个化疗周期。研究组或化疗周期使用长效 G-CSF 时,短效 G-CSF 的使用次数和剂量、就诊次数、CBC 检查次数、FN 和骨髓抑制发生率以及 G-CSF 相关疼痛均显著减少。在二项回归模型中,G-CSF 的使用是 FN 的唯一独立因素。

结论

长效 G-CSF 可有效降低初诊 EOC 患者化疗后 FN 和骨髓抑制的发生率,且不良反应轻微。

临床试验注册号

NCT03740464。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0213/6923945/c9459b421605/bmjspcare-2019-001862f01.jpg

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