Meta-Analysis of the Clinical Efficacy and Safety of Softening Hardness and Dispelling Masses TCM Compound Formulations in Treating Breast Cancer

Author：GAO Xinhai1, LIU Ruijuan2, DENG Hualiang3, WANG Lu4, YAO Yan2, LIU Cun5, ZHANG Minpu6, GUO Zichen1, SUN Changgang2,5

Unit：1.The First Clinical Medical College, Shandong University of Traditional Chinese Medicine, Jinan Shandong 250355, China; 2.Weifang Hospital of Traditional Chinese Medicine, Weifang Shandong 261000, China; 3.Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan Shandong 250355, China; 4.Shandong University of Traditional Chinese Medicine, Jinan Shandong 250355, China; 5.School of Traditional Chinese Medicine, Shandong Second Medical University, Weifang Shandong 261000, China; 6.School of Chinese Medicine, Macau University of Science and Technology, Macau 999078, China

Quote：引用：高鑫海，刘瑞娟，邓华亮，王璐，姚燕，刘存，张民仆，郭梓辰，孙长岗.软坚散结中药复方治疗乳腺癌临床疗效及安全性的Meta分析[J].中医药导报,2025,31(10):131-137,177.

DOI：10.13862/j.cn43-1446/r.2025.10.023

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Abstract：

Objective: To systematically evaluate the efficacy, safety, and quality of evidence of TCM compound formulations with the effect of softening hardness and dispelling masses combined with conventional Western medicine therapy for breast cancer. Methods: Databases including CNKI, Wanfang data, CSTJ, PubMed, and Web of Science were searched to identify randomized controlled trials (RCTs) on TCM compounds for softening hardness and dispelling masses combined with conventional Western medicine for breast cancer. The methodological quality of included studies was assessed using the Cochrane risk-of-bias tool. Meta-analysis was performed using RevMan 5.3 software. Results: Fourteen studies involving 1 118 breast cancer patients were included. Meta-analysis showed that, compared to the control group, the combination therapy significantly improved clinical effective rate [RR=1.33, 95%CI(1.18, 1.50), Z=4.55, P＜0.000 1], reduced carcinoembryonic antigen [MD=-3.16, 95%CI(-4.33, -1.99), Z=5.31, P＜0.01], cancer antigen 125 [MD=-13.66, 95%CI(-18.61, -8.72), Z=5.42, P＜0.01], and CA15-3 levels [MD=-10.98, 95%CI(-14.78, -7.18), Z=5.66, P＜0.01], increased serum CD4 cell levels [MD=6.40, 95%CI(2.93, 9.86), Z=3.62, P＜0.01], decreased CD8 cell levels [MD=-2.91, 95%CI(-3.57, -2.26), Z=8.71, P＜0.01], reduced the incidence of leukopenia [RR=0.76, 95%CI(0.65, 0.89), Z=3.48, P＜0.01] and nausea/vomiting [RR=0.66, 95%CI(0.55, 0.80), Z=4.19, P＜0.01], and improved Karnofsky Performance Status scores [MD=4.84, 95%CI(2.63, 7.05), Z=4.30, P＜0.01]. Conclusion: TCM compound formulations for softening hardness and dispelling masses can enhance the clinical remission rate in breast cancer patients, and demonstrate significant advantages in reducing tumor markers, improving immune function, decreasing treatment-related side effects, and enhancing functional status.

Key words：breast cancer; traditional Chinese medicine compound prescription; softening hardness and dispelling masses; clinical efficacy; Meta-analysis

摘要：

目的：系统评价软坚散结中药复方联合西医常规疗法治疗乳腺癌的有效性、安全性及证据质量。方法：检索中国知网（CNKI）、万方数据知识服务平台（Wanfang Data）、维普中文期刊服务平台（CSTJ）、PubMed、Web of Science数据库，从中筛选出软坚散结中药复方联合西医常规疗法治疗乳腺癌的随机对照试验，并通过Cochrane偏倚风险评估工具评价纳入研究的方法学质量，使用RevMan 5.3软件对结局指标进行Meta分析。结果：共纳入14篇研究文献，涵盖1 118例乳腺癌患者。Meta分析显示，与对照组比较，软坚散结中药复方联合西医常规疗法在提高临床有效率[RR=1.33，95%CI（1.18，1.50），Z=4.55，P<0.001]，降低癌胚抗原（CEA）[MD=-3.16，95%CI（-4.33， -1.99），Z=5.31，P<0.01]、糖类抗原125（CA125）[MD=-13.66，95%CI（-18.61，-8.72），Z=5.42，P<0.01]、CA15-3[MD=   -10.98，95%CI（-14.78， -7.18），Z=5.66，P<0.01]，提升患者血清CD4细胞水平[MD=6.40，95%CI（2.93，9.86），Z=3.62，P<0.01]，降低CD8细胞水平[MD=-2.91，95%CI（-3.57，-2.26），Z=8.71，P<0.01）]，降低白细胞减少[RR=0.76， 95%CI（0.65，0.89），Z=3.48，P<0.01]、恶心呕吐[RR=0.66，95%CI（0.55，0.80），Z=4.19，P<0.01]情况发生率，提升患者KPS评分[MD=4.84，95%CI（2.63，7.05），Z=4.30，P<0.001）]方面有显著效果。结论：软坚散结中药复方可以提高乳腺癌患者临床缓解率，同时在降低肿瘤标志物，改善免疫水平，减少治疗毒副反应及改善患者功能状态方面有显著优势。

关键词：乳腺癌；中药复方；软坚散结；临床疗效；Meta分析

Release time：2026-01-08

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