Effect evaluation of Kushen Huangqi decoction combined with Aidi injection in the treatment of primary liver cancer

doi:10.11958/20242336

Abstract

Abstract:

Objective To investigate the therapeutic effect of Kushen Huangqi decoction combined with Aidi injection on primary liver cancer and its impacts on immune function and quality of life. Methods A total of 110 patients with primary liver cancer were randomly divided into the combined group (n=55) and the control group (n=55). The control group was treated with Aidi injection (50 mL) on the basis of routine treatment, and the combined group was treated with Kushen Huangqi decoction on the basis of the control group. The healing effects, traditional Chinese medicine (TCM) symptom scores, quality of life[Karnofsky Performance Status (KPS) score, the MOS 36-item short-form health survey (SF-36)], liver function indicators[total bilirubin (TBIL), aspartate aminotransferase (AST), alanine aminotransferase (ALT)] and immune function indicators before and after treatment were compared between the two groups. Results After treatment, the KPS score, SF-36 score, CD4⁺ and CD4⁺/CD8⁺ were increased in the two groups, and those in the combined group were higher than the control group. The TCM symptom scores, AST, TBIL, ALT and CD8⁺ were decreased in the two groups, and those in the combined group were lower than those in the control group (P<0.05). Conclusion The combination of Kushen Huangqi decoction and Aidi injection is beneficial for enhancing immune function, reducing Chinese medicine syndrome scores and liver function damage, improving efficacy and quality of life in treating primary liver cancer.

Key words: Ai Di Zhu She Ye, drug therapy, combination, drug evaluation, quality of life, Kushen Huangqi Decoction, primary liver cancer, immune function

CLC Number:

R735.7，R286.91

Figures/Tables 6

References 26

[1]	LI X, RAMADORI P, PFISTER D, et al. The immunological and metabolic landscape in primary and metastatic liver cancer[J]. Nat Rev Cancer, 2021, 21(9):541-557. doi:10.1038/s41568-021-00383-9.
[2]	刘欣, 李丽. 原发性肝癌患者体液变化的研究[J]. 天津医药, 2021, 49(7):756-759.
	LIU X, LI L. The study on changes of body fluid in patients with primary liver cancer[J]. Tianjin Med J, 2021, 49(7):756-759. doi:10.11958/20203264.
[3]	李佳颖, 曾普华. 曾普华基于”癌毒致病”和”方证辨证”治疗肝癌临床经验[J]. 亚太传统医药, 2022, 18(5):107-110.
	LI J Y, ZENG P H. Zeng Puhua’s clinical experience in treating liver cancer based on “Cancer Toxic Disease” and “Differential and Syndrome Dialectics”[J]. Asia-Pacific Tra M, 2022, 18(5):107-110. doi:10.11954/ytctyy.202205025.
[4]	何亚莉, 杨志一, 强依凡, 等. 中药汤剂消癌化癖饮对原发性肝癌TACE术后患者血管生成因子及临床疗效的影响[J]. 中国医药导刊, 2022, 24(10):998-1003.
	HE Y L, YANG Z Y, QIANG Y F, et al. Effects of Xiaoaihuapi decoction on angiogenesis factors and clinical efficacy in patients with primary liver cancer after TACE[J]. Chinese Journal of Medicinal Guide, 2022, 24(10):998-1003. doi:10.3969/j.issn.1009-0959.2022.10.009.
[5]	中华中医药学会肝胆病分会, 李秀惠. 原发性肝癌中医诊疗指南[J]. 临床肝胆病杂志, 2024, 40(5):919-927.
	Hepatobiliary Disease Branch of the Chinese Association of Traditional Chinese Medicine,LI X H. Guideline for traditional Chinese medicine diagnosis and treatment of primary liver cancer[J]. Journal of Clinical Hepatology, 2024, 40(5):919-927. doi:10.12449/JCH240509.
[6]	YANG M, SHEN C, ZHU S J, et al. Chinese patent medicine Aidi injection for cancer care:an overview of systematic reviews and meta-analyses[J]. J Ethnopharmacol, 2022,282:114656. doi:10.1016/j.jep.2021.114656.
[7]	苏玉茜, 胡鑫, 韩涛. 基于肿瘤微环境学说探讨苦参黄芪汤对原发性肝癌患者血清生长因子及免疫功能的影响[J]. 辽宁中医杂志, 2023, 50(4):55-59.
	SU Y Q, HU X, HAN T. Effect of kushen huangqi decoction on serum growth factors and lmmune function of patients with primary liver cancer (based on tumor microenvironment theory)[J]. Liaoning Journal of Traditional Chinese Med, 2023, 50(4):55-59. doi:10.13192/j.issn.1000-1719.2023.04.016.
[8]	中华人民共和国国家卫生健康委员会医政医管局. 原发性肝癌诊疗规范(2019年版)[J]. 中华肝脏病杂志, 2020, 28(2):112-128.
	Medical Administration and Medical Management Bureau, National Health Commission,PRC. Guidelines for diagnosis and treatment of primary liver cancer in China(2019 edition)[J]. Chinese Journal of Hepatology, 2020, 28(2):112-128. doi:10.3760/cma.j.issn.1007-3418.2020.02.004.
[9]	中国中西医结合学会活血化瘀专业委员会. 实用血瘀证诊断标准[J]. 中国中西医结合杂志, 2016, 36(10):1163.
	Professional Committee for Promoting Blood Circulation and Removing Stasis of the Chinese Society of Integrated Traditional Chinese and Western Medicine. Practical diagnostic criteria of blood stasis syndrome[J]. Chin J Integr Tradit West Med, 2016, 36(10):1163. doi:10.7661/CJIM.2016.10.1163.
[10]	EISENHAUER E A, THERASSE P, BOGAERTS J, et al. New response evaluation criteriain solid tumours:revised RECIST guideline (version 1.1)[J]. Eur J Cancer, 2009, 45(2):228-227.
[11]	FRIENDLANDER A H, ETTINGER R L. Karnofsky performance status scale[J]. Spec Care Dentist, 2009, 29(4):147-148. doi:10.1111/j.1754-4505.2009.00088.x.
[12]	王坤. 健康状况调查简表(SF-36)[J]. 中华神经外科杂志, 2012, 28(6):571.
	WANG K. The MOS item short from health survey(SF-36)[J]. Chin J Neurosurg, 2012, 28(6):571.
[13]	郑筱萸. 中药新药临床研究指导原则(试行)[M]. 北京: 中国医药科技出版社, 2002.
	ZHENG X Y. Guiding principles for clinical research of new Chinese medicine(Trial)[M]. Beijing: China Pharmaceutical Science and Technology Press, 2002.
[14]	BRAY F, LAVERSANNE M, SUNG H, et al. Global cancer statistics 2022:GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries[J]. CA Cancer J Clin, 2024, 74(3):229-263. doi:10.3322/caac.21834.
[15]	Global Burden of Disease Cancer Collaboration,FITZMAURICE C. Global,regional,and national cancer incidence,mortality,years of life lost,years lived with disability,and disability-adjusted life-years for 29 cancer groups,1990 to 2017:a systematic analysis for the global burden of disease study[J]. JAMA Oncol, 2019, 5(12):1749-1768. doi:10.1001/jamaoncol.2019.2996.
[16]	王远珍, 魏红艳, 常丽仙, 等. 原发性肝癌干预前并发肺部感染风险预测模型的建立与验证[J]. 天津医药, 2024, 52(9):940-945.
	WANG Y Z, WEI H Y, CHANG L X, et al. Establishment and validation of a risk prediction model for primary liver cancer complicated with pulmonary infection before intervention[J]. Tianjin Med J, 2024, 52(9):940-945. doi:10.11958/20240147.
[17]	姜爱萍, 濮忠建. 温阳化癥汤联合化疗治疗中晚期肝癌效果及对化疗不良反应的影响[J]. 中医药学报, 2024, 52(12):99-103.
	JIANG A P, PU Z J. Effect of wenyang huazheng decoction combined with chemotherapy in the treatment of advanced liver cancer and its impact on chemotherapy-related adverse reactions[J]. Acta Chinese Medicine and Pharmacology, 2024, 52(12):99-103. doi:10.19664/j.cnki.1002-2392.240257.
[18]	WANG J, LI G, YU L, et al. Aidi injection plus platinum-based chemotherapy for stage IIIB/IV non-small cell lung cancer:a meta-analysis of 42 RCTs following the PRISMA guidelines[J]. J Ethnopharmacol, 2018, 221:137-150. doi:10.1016/j.jep.2018.04.013.
[19]	李开双, 罗茜怡, 农志欢, 等. 鸡血藤活性成分及抗肿瘤作用研究[J]. 医学信息, 2023, 36(7):176-179,188.
	LI K S, LUO Q Y, NONG Z H, et al. Research progress on active components and anti-tumor effects of suberect spatholobus stem[J]. Medical Information, 2023, 36(7):176-179,188. doi:10.3969/j.issn.1006-1959.2023.07.036.
[20]	邢明远, 黄清云, 苏乙花. 正肝化症汤联合艾迪注射液对原发性肝癌患者肝功能的影响[J]. 世界中医药, 2019, 14(11):2983-2987.
	XING M Y, HUANG Q Y, SU Y H. Effects of Zhenggan Huazheng Decoction combined with Addie Injection on liver function of patients with primary liver cancer[J]. World Chinese Medicine, 2019, 14(11):2983-2987. doi:10.3969/j.issn.1673-7202.2019.11.034.
[21]	WANG C Q, ZHENG X T, CHEN X F, et al. The optimal adjuvant strategy of aidi injection with gemcitabine and cisplatin in advanced non-small cell lung cancer:a meta-analysis of 70 randomized controlled trials[J]. Front Pharmacol, 2021,12:582447. doi:10.3389/fphar.2021.582447.
[22]	胡帅航, 王烁, 徐思雨, 等. 艾迪注射液联合FOLFOX4化疗方案治疗中晚期结直肠癌的系统评价[J]. 药物评价研究, 2022, 45(7):1387-1398.
	HU S H, WANG S, XU S Y, et al. Systematic review of Aidi Injection in combination with FOLFOX4 chemotherapy regimen for treatment of intermediate to advanced colorectal cancer[J]. Drug Evaluation Research, 2022, 45(7):1387-1398. doi:10.7501/j.issn.1674-6376.2022.07.022.
[23]	LU P, ZHANG W, CHEN L, et al. ICG fluorescence imaging technology in laparoscopic liver resection for primary liver cancer:a meta-analysis[J]. Math Biosci Eng, 2023, 20(9):15918-15941. doi:10.3934/mbe.2023709.
[24]	王浩艺, 何胜利, 殷保兵, 等. 二术解毒汤治疗中晚期脾虚湿热型原发性肝癌的疗效观察[J]. 中医药学报, 2024, 52(9):54-59.
	WANG H Y, HE S L, YING B B, et al. Efficacy of erzhu jiedu decoction on mid-to-late stage primary liver cancer with spleen-deficiency and damp-heat type[J]. Acta Chinese Medicine and Pharmacology, 2024, 52(9):54-59. doi:10.19664/j.cnki.1002-2392.240181.
[25]	燕彩霞, 王达, 魏传霞, 等. 酸味方对原发性肝癌经导管肝动脉化疗栓塞术后血清AFP、CEA、CA-125及CD4⁺/CD8⁺水平的影响[J]. 中华中医药学刊, 2024, 42(8):98-102.
	YAN C X, WANG D, WEI C X, et al. Effects of Suanwei Formula(酸味方) on Levels of AFP,CEA,CA-125 and CD4⁺/CD8⁺in serum after TACE operation for primary liver cancer[J]. Chinese Archives of Traditional Chinese Medicine, 2024, 42(8):98-102. doi:10.13193/j.issn.1673-7717.2024.08.021.
[26]	ZHOU W, DENG J, CHEN Q, et al. Expression of CD4⁺CD25⁺CD127^Low regulatory T cells and cytokines in peripheral blood of patients with primary liver carcinoma[J]. Int J Med Sci, 2020, 17(6):712-719. doi:10.7150/ijms.44088.

组别	性别（男/女）	年龄/ 岁	病程/ 年	TNM分期			Child-Pugh分级
组别	性别（男/女）	年龄/ 岁	病程/ 年	Ⅱ	Ⅲ	Ⅳ	A级	B级
对照组	45/10	54.20±5.11	1.28±0.28	12	26	17	24	31
联合组	42/13	53.84±5.20	1.25±0.24	14	23	18	26	29
χ²或t	0.495	0.369	0.629	0.366			0.147
组别		BMI/（kg/m²）	饮酒		吸烟			乙型肝炎
对照组		22.45±1.69	29（52.73）		23（41.82）			27（49.09）
联合组		22.38±1.31	27（49.09）		24（43.64）			25（45.45）
χ²或t		0.242	0.146		0.037			0.146

组别	性别（男/女）	年龄/ 岁	病程/ 年	TNM分期			Child-Pugh分级
组别	性别（男/女）	年龄/ 岁	病程/ 年	Ⅱ	Ⅲ	Ⅳ	A级	B级
对照组	45/10	54.20±5.11	1.28±0.28	12	26	17	24	31
联合组	42/13	53.84±5.20	1.25±0.24	14	23	18	26	29
χ²或t	0.495	0.369	0.629	0.366			0.147
组别		BMI/（kg/m²）	饮酒		吸烟			乙型肝炎
对照组		22.45±1.69	29（52.73）		23（41.82）			27（49.09）
联合组		22.38±1.31	27（49.09）		24（43.64）			25（45.45）
χ²或t		0.242	0.146		0.037			0.146

组别	n	完全缓解	部分缓解	稳定	恶化	总有效
对照组	55	0	18	21	16	18（32.73）
联合组	55	0	29	19	7	29（52.73）
χ²						4.495^＊

组别	n	完全缓解	部分缓解	稳定	恶化	总有效
对照组	55	0	18	21	16	18（32.73）
联合组	55	0	29	19	7	29（52.73）
χ²						4.495^＊

组别	n		KPS评分
组别	n		治疗前		治疗后		t
对照组	55		63.29±6.30		71.62±7.19		6.411^＊＊
联合组	55		63.47±6.72		78.35±7.42		11.410^＊＊
t			0.146		4.828^＊＊
组别		SF-36评分
组别		治疗前		治疗后		t
对照组		58.60±7.76		67.24±6.61		6.402^＊＊
联合组		58.24±6.62		78.33±8.20		13.593^＊＊
t		0.264		7.811^＊＊