Modulatory Effects of XIAOPI Formula on CXCL1 and Selected Outcomes in Triple-Negative Breast Cancer: A Randomized Controlled Clinical Trial.

IF 3.3 4区 医学 Q2 ONCOLOGY
Breast Cancer : Targets and Therapy Pub Date : 2024-05-31 eCollection Date: 2024-01-01 DOI:10.2147/BCTT.S462296
Li Guo, Shi-Cui Hong, Xuan Wang, Sheng-Qi Wang, Neng Wang, Xiao-Qing Wei, Hong-Lin Situ, Zhi-Yu Wang
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引用次数: 0

Abstract

Background: Triple-negative breast cancer (TNBC) is the most aggressive malignancy. Psychological distress and elevated CXCL1 level have been reported to be closely associated with the poor prognosis and quality of life of patients with TNBC. In preclinical studies using xenograft mouse models, XIAOPI formula, a nationally approved drug prescribed to patients at high risk for breast cancer, inhibited CXCL1 expression and improved survival. Traditional Chinese medicine has unique advantages in improving patients' emotional disorders and quality of life. However, the impact of XIAOPI formula on the serum level of CXCL1, psychological distress, and quality of life among patients with TNBC is currently unknown.

Methods: In this study, we designed a randomized, double-blind, placebo-controlled trial. Patients with TNBC were randomly assigned to receive either the XIAOPI formula or a placebo for three months. The primary outcomes include serum CXCL1 expression, Self-Rating Anxiety Scale (SAS), and the Self-Rating Depression Scale (SDS). Secondary outcomes included the Pittsburgh Sleep Quality Index (PSQI) and the Functional Assessment of Cancer Therapy-Breast (FACT-B).

Results: A total of 60 patients with TNBC were enrolled in the investigation. The results showed that the XIAOPI formula significantly decreased CXCL1 expression compared with the control group. Moreover, in comparison to the placebo, the XIAOPI formula increased FACT-B scores while decreasing SDS, SAS, and PSQI scores.

Conclusion: In patients with TNBC, XIAOPI formula may be effective in reducing CXCL1 levels, enhancing psychological well-being, and quality of life. While our research offers a natural alternative therapy that may enhance the prognosis of TNBC, future validation of its therapeutic effects will require large-scale, long-term clinical trials.

Clinical registration number: Registration website: www.chictr.org.cn, Registration date: 2018-1-19, Registration number: ChiCTR1800014535.

XIAOPI配方对三阴性乳腺癌CXCL1和部分结果的调节作用:随机对照临床试验》。
背景:三阴性乳腺癌(TNBC三阴性乳腺癌(TNBC)是侵袭性最强的恶性肿瘤。据报道,心理困扰和 CXCL1 水平升高与 TNBC 患者的不良预后和生活质量密切相关。在利用异种移植小鼠模型进行的临床前研究中,国家批准的乳腺癌高危患者处方药--"霞客方 "抑制了CXCL1的表达,并提高了患者的生存率。中药在改善患者的情绪障碍和生活质量方面具有独特的优势。然而,霞客方对TNBC患者血清中CXCL1水平、心理困扰和生活质量的影响目前尚不清楚:本研究设计了一项随机、双盲、安慰剂对照试验。TNBC患者被随机分配接受XIAOPI配方或安慰剂治疗三个月。主要结果包括血清 CXCL1 表达、焦虑自评量表(SAS)和抑郁自评量表(SDS)。次要结果包括匹兹堡睡眠质量指数(PSQI)和乳腺癌治疗功能评估(FACT-B):共有60名TNBC患者参与了调查。结果显示,与对照组相比,XIAOPI配方能显著降低CXCL1的表达。此外,与安慰剂相比,XIAOPI配方提高了FACT-B评分,同时降低了SDS、SAS和PSQI评分:结论:对于 TNBC 患者,XIAOPI 配方可有效降低 CXCL1 水平,提高心理健康水平和生活质量。虽然我们的研究提供了一种可改善 TNBC 预后的天然替代疗法,但其治疗效果的未来验证还需要大规模、长期的临床试验:注册网址:www.chictr.org.cn,注册日期:2018-1-19,注册号::ChiCTR1800014535.
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
4.10
自引率
0.00%
发文量
40
审稿时长
16 weeks
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