Guo Li, Hong Shi-Cui, Wang Xuan, Wang Sheng-Qi, Wang Neng, Wei Xiao-Qing, Situ Hong-Lin, Wang Zhi-Yu
Breast Disease Specialist Hospital of Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, Guangdong, 510120, People's Republic of China.
The Second Clinical College of Guangzhou University of Chinese Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, Guangdong, 510120, People's Republic of China.
Breast Cancer (Dove Med Press). 2024 May 31;16:289-303. doi: 10.2147/BCTT.S462296. eCollection 2024.
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.
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).
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.
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.
Registration website: www.chictr.org.cn, Registration date: 2018-1-19, Registration number: ChiCTR1800014535.
三阴性乳腺癌（TNBC）是最具侵袭性的恶性肿瘤。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。在使用异种移植小鼠模型的临床前研究中，消痞方（一种国家批准用于乳腺癌高危患者的药物）可抑制CXCL1表达并提高生存率。中药在改善患者情绪障碍和生活质量方面具有独特优势。然而，消痞方对TNBC患者血清CXCL1水平、心理困扰和生活质量的影响目前尚不清楚。
在本研究中，我们设计了一项随机、双盲、安慰剂对照试验。TNBC患者被随机分配接受消痞方或安慰剂治疗三个月。主要结局包括血清CXCL1表达、自评焦虑量表（SAS）和自评抑郁量表（SDS）。次要结局包括匹兹堡睡眠质量指数（PSQI）和癌症治疗功能评估-乳腺癌（FACT-B）。
共有60例TNBC患者参与了本研究。结果显示，与对照组相比，消痞方可显著降低CXCL1表达。此外，与安慰剂相比，消痞方提高了FACT-B评分，同时降低了SDS、SAS和PSQI评分。
对于TNBC患者，消痞方可能有效降低CXCL1水平，改善心理健康和生活质量。虽然我们的研究提供了一种可能改善TNBC预后的天然替代疗法，但未来对其治疗效果的验证需要大规模、长期的临床试验。
注册网站：www.chictr.org.cn，注册日期：2018年1月19日，注册号：ChiCTR1800014535。
