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一项评估中药(黄芪桂枝五物汤)治疗白蛋白结合型紫杉醇所致周围神经病变疗效的前瞻性、随机、安慰剂对照研究。

A Prospective, Randomized, Placebo-Controlled Study Assessing the Efficacy of Chinese Herbal Medicine (Huangqi Guizhi Wuwu Decoction) in the Treatment of Albumin-Bound Paclitaxel-Induced Peripheral Neuropathy.

作者信息

Chai Yue, Zhao Fang, Ye Peizhi, Ma Fei, Wang Jiayu, Zhang Pin, Li Qing, Wang Jiani, Wang Wenna, Li Qiao, Xu Binghe

机构信息

Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.

Nursing Department of the Cancer Hospital, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.

出版信息

J Clin Med. 2023 Jan 7;12(2):505. doi: 10.3390/jcm12020505.

Abstract

Objective: This study aimed to evaluate the efficacy and safety of Huangqi Guizhi Wuwu decoction (HGWD), which is composed of five crude drugs (Astragali Radix, Cinnamomi Ramulus, Paeoniae Radix Alba, Zingiberis Rhizoma Recens, and Jujubae Fructus), in the treatment of albumin-bound paclitaxel (nab-PTX)-induced peripheral neuropathy (PN) in Chinese patients with breast cancer (BC). Methods: This trial was conducted at the National Cancer Center in China from January 2020 to June 2022. The eligible participants were assigned randomly in a 1:1 ratio to an HGWD group or a control group. The outcome measure was EORTC QLQ-CIPN20 questionnaire. Results: 92 patients diagnosed with BC were enrolled and randomized to either HGWD group (n = 46) or control group (n = 46). There were no significant differences in baseline characteristics between the two groups (p > 0.05). A statistical analysis of the sensory and motor functions of the EORTC QLQ-CIPN20 scores showed that patients in the HGWD group reported a larger decrease in CIPN sensory scores than those in the control group (p < 0.001). The EORTC QLQ-CIPN20 autonomic scores showed no statistical significance between the two groups (p > 0.05). Conclusions: HGWD packs could significantly improve patients’ nab-PTX-induced PN, increase the tolerance for nab-PTX-containing chemotherapy, and further improve the quality of life of patients with BC.

摘要

目的

本研究旨在评估由黄芪、桂枝、白芍、生姜和大枣五味中药材组成的黄芪桂枝五物汤(HGWD)治疗中国乳腺癌(BC)患者白蛋白结合型紫杉醇(nab-PTX)所致周围神经病变(PN)的疗效和安全性。方法:本试验于2020年1月至2022年6月在中国国家癌症中心进行。符合条件的参与者按1:1比例随机分配至HGWD组或对照组。观察指标为欧洲癌症研究与治疗组织生活质量问卷CIPN20(EORTC QLQ-CIPN20)。结果:92例确诊为BC的患者被纳入并随机分为HGWD组(n = 46)或对照组(n = 46)。两组基线特征无显著差异(p > 0.05)。对EORTC QLQ-CIPN20评分的感觉和运动功能进行统计分析显示,HGWD组患者的CIPN感觉评分下降幅度大于对照组(p < 0.001)。两组的EORTC QLQ-CIPN20自主神经评分无统计学意义(p > 0.05)。结论:HGWD可显著改善患者的nab-PTX所致PN,提高含nab-PTX化疗的耐受性,并进一步改善BC患者的生活质量。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/49eb/9863646/51c268f774fc/jcm-12-00505-g001.jpg

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