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中药改善卵巢癌化疗患者生活质量的研究:免疫监测下的双盲安慰剂对照随机试验

The use of Chinese herbal medicine to improve quality of life in women undergoing chemotherapy for ovarian cancer: a double-blind placebo-controlled randomized trial with immunological monitoring.

机构信息

Department of Obstetrics and Gynaecology, Queen Mary Hospital, Hong Kong.

出版信息

Ann Oncol. 2011 Oct;22(10):2241-9. doi: 10.1093/annonc/mdq749. Epub 2011 Feb 25.

Abstract

BACKGROUND

This study aimed to evaluate traditional Chinese medicine (TCM) in improving quality of life (QOL), reducing chemotoxicity and modulating immune function in patients undergoing chemotherapy.

PATIENTS AND METHODS

Patients with ovarian cancer were randomized to receive either TCM or placebo in addition to standard chemotherapy. The primary outcome was global health status (GHS) score, assessed by European Organization for Research and Treatment of Cancer questionnaire, while the secondary outcomes were other QOL items, chemotoxicity according to World Health Organization criteria and alterations in immune function as measured by immune cells count and the numbers of cytokines-secreting cells.

RESULTS

There was no significant difference in the GHS between the two groups. With adjustment for stage, chemotherapy type, disease status, age and baseline value, emotional function, cognitive function and nausea and vomiting were found to be worse or less improved in the TCM group compared with placebo group after six cycles of chemotherapy. The TCM group had less neutropenia after three cycles (0% grade 4 neutropenia versus 28.6%). There were no other significant differences in terms of chemotoxicity. Lymphocyte counts and cytokine activities decreased less in the TCM group.

CONCLUSIONS

TCM did not improve QOL but did have some effects in terms of maintaining immune function.

摘要

背景

本研究旨在评估中医药在改善生活质量(QOL)、减轻化疗毒性和调节免疫功能方面对接受化疗的患者的作用。

患者与方法

卵巢癌患者随机接受中医药或安慰剂联合标准化疗。主要结局指标是欧洲癌症研究与治疗组织问卷评估的总体健康状况(GHS)评分,次要结局指标是其他 QOL 项目、根据世界卫生组织标准评估的化疗毒性以及免疫细胞计数和细胞因子分泌细胞数量测量的免疫功能改变。

结果

两组患者的 GHS 评分无显著差异。调整分期、化疗类型、疾病状态、年龄和基线值后,与安慰剂组相比,中医药组在接受六个周期化疗后,情绪功能、认知功能和恶心呕吐的评分更差或改善更少。中医药组在三个周期后中性粒细胞减少症发生率较低(无 4 级中性粒细胞减少症,而安慰剂组为 28.6%)。在化疗毒性方面,无其他显著差异。中医药组的淋巴细胞计数和细胞因子活性下降较少。

结论

中医药并未改善 QOL,但在维持免疫功能方面有一定作用。

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