Preventive efficacy of rhGM-CSF combined with Kangfuxin liquid on radiation dermatitis of breast cancer

doi:10.11958/20250747

Abstract

Abstract:

Objective To investigate the preventive efficacy of recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF) combined with Kangfuxin liquid on radiation dermatitis in breast cancer patients underwent radiotherapy. Methods A total of 90 breast cancer patients were randomized into the control group (45 cases, rhGM-CSF alone) and the observation group (45 cases, rhGM-CSF + Kangfuxin liquid). Both groups received radiotherapy. The incidence of radiation dermatitis, the time of first occurrence, the healing time and severity of radiation dermatitis (graded by RTOG criteria) were compared between the two groups. Skin growth factors [epidermal growth factor (EGF), basic fibroblast growth factor (bFGF), transforming growth factor-β (TGF-β)] were measured via enzyme linked immunosorbent assay (ELISA) before radiotherapy and 2 weeks after radiotherapy. The quality of life of patients was assessed using the EORTC QLQ-C30 V3.0 questionnaire. Results The incidence of radiation dermatitis was significantly lower in the observation group (35.56%, 16/45) than that in the control group (68.89%, 31/45, P<0.05), and the first occurrence time of dermatitis was later, the healing time was shorter, and the severity grade of dermatitis was lower (P<0.05). Two weeks after radiotherapy, levels of EGF, bFGF, TGF-β and the scores of QLQ-C30 increased in both groups, and those of the observation group were significantly higher than the control group (P<0.05). Conclusion Combining rhGM-CSF with Kangfuxin liquid can effectively prevent radiation dermatitis in breast cancer patients by reducing incidence and severity, delaying onset time, accelerating healing, and improving quality of life.

Key words: breast neoplasms, radiodermatitis, granulocyte-macrophage colony-stimulating factor, Kangfuxin liquid

CLC Number:

R730.5，R758.13

Figures/Tables 4

References 22

[1]	LEE S F, SHARIATI S, CAINI S, et al. StrataXRT for the prevention of acute radiation dermatitis in breast cancer:a systematic review and meta-analysis of randomized controlled trials[J]. Support Care Cancer, 2023, 31(9):515. doi:10.1007/s00520-023-07983-1.
[2]	KAO Y S, WU Y C, WU M Y, et al. Topical prevention of radiation dermatitis in breast cancer patients:a network meta-analysis of randomized controlled trials[J]. In Vivo, 2023, 37(3):1346-1357. doi:10.21873/invivo.13216.
[3]	LUO B, SUN H T, WANG Y T, et al. Clinical efficacy of rhGM-CSF gel and medical collagen sponge on deep second-degree burns of infants:A randomized clinical trial[J]. Medicine(Baltimore), 2024, 103(1):e36304. doi:10.1097/MD.0000000000036304.
[4]	WANG J, ZHONG L, BO Y, et al. Pharmaceutical preparations of Periplaneta americana (KangFuXin liquid) in the treatment of pressure ulcer:A meta-analysis[J]. Int Wound J, 2023, 20(7):2855-2868. doi:10.1111/iwj.14123.
[5]	ACOVELLI N A, TORRENTE Y, CIUFFREDA A, et al. Topical treatment of radiation-induced dermatitis:current issues and potential solutions[J]. Drugs Context, 2020, 9(12):4-7. doi:10.7573/dic.2020-4-7.
[6]	LIU C, WEI J, WANG X, et al. Radiation-induced skin reactions:oxidative damage mechanism and antioxidant protections[J]. Front Cell Dev Biol, 2024, 12(9):1480571. doi:10.3389/fcell.2024.1480571.
[7]	毕钊, 王永胜, 邱鹏飞, 等. 2024版NCCN乳腺癌临床实践指南更新解读[J]. 中国肿瘤外科杂志, 2024, 16(5):417-422.
	BI Z, WANG Y S, QIU P F, et al. Interpretation of the 2024 NCCN guidelines for breast cancer updates[J]. Chinese Journal of Surgical Oncology, 2024, 16(5):417-422. doi:10.3969/j.issn.1674-4136.20205.001.
[8]	FAKHRY C, TEWARI S R, ZHANG L, et al. RTOG-0129 risk groups are reproducible in a prospective multicenter heterogeneously treated cohort[J]. Cancer, 2021, 127(19):3523-3530. doi:10.1002/cncr.33682.
[9]	WAGHMARE C M, PAWAR H J, BHALWAR R, et al. Psychometric analysis of Marathi version of an updated European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Module (EORTC QLQ-H&N43)[J]. Indian J Cancer, 2024, 61(1):180-192. doi:10.4103/ijc.ijc_617_21.
[10]	朱康琳, 王莉莉, 姬秋晨. 有氧运动联合抗阻训练对接受芳香化酶抑制剂治疗的绝经后乳腺癌患者生活质量的影响[J]. 新疆医科大学学报, 2020, 43(8):1078-1083,1088.
	ZHU K L, WANG L L, JI Q C. Effect of combined aerobic exercise and resistance training on quality of life in postmenopausal breast cancer patients treated with aromatase inhibitors[J]. Journal of Xinjiang Medical University, 2020, 43(8):1078-1083,1088. doi:10.3969/j.issn.1009-5551.2020.08.018.
[11]	吴海东, 朱占永, 章强, 等. 重组粒细胞巨噬细胞集落刺激因子对烧伤患者创面愈合、溶痂情况及纤维连接蛋白、表皮生长因子变化影响[J]. 临床军医杂志, 2022, 50(8):858-861.
	WU H D, ZHU Z Y, ZHANG Q, et al. Effects of recombinant granulocyte-macrophage colony-stimulating factor on wound healing,eschar dissolution,fibronectin and epidermal growth factor in burn patients[J]. Clinical Journal of Military Physicians, 2022, 50(8):858-861. doi:10.16680/j.1671-3826.2022.08.25.
[12]	TANG M, NI L L, XU J L, et al. Kangfuxin Liquid Ameliorates Dextran Sulfate Sodium (DSS)-induced acute ulcerative colitis in mice by modulating immune response and suppressing inflammation[J]. Med Sci Monit Basic Res, 2021, 27(11):e930887. doi:1059/MSMBR.930887.
[13]	JUHL P, BONDESEN S, HAWKINS C L, et al. Dermal fibroblasts have different extracellular matrix profiles induced by TGF-β,PDGF and IL-6 in a model for skin fibrosis[J]. Sci Rep, 2020, 10(1):17300. doi:10.1038/s41598-020-74179-6.
[14]	林海鹏, 党旭红, 左雅慧. 神经肽P物质对放射损伤皮肤成纤维细胞分泌功能及VEGF、bFGF、PDGF表达的影响[J]. 天津医药, 2022, 50(10):1009-1013.
	LIN H P, DANG X H, ZUO Y H. Effects of substance P on secretory function and VEGF,bFGF,PDGF expression in radiation-injured dermal fibroblasts[J]. Tianjin Med J, 2022, 50(10):1009-1013. doi:10.11958/20220599.
[15]	吴红云, 薛瑞, 董华进, 等. 热促药物渗透技术在经皮给药系统中的应用研究进展[J]. 国际药学研究杂志, 2020, 47(6):403-408,423.
	WU H Y, XUE R, DONG H J, et al. Advances in thermophoresis-enhanced transdermal drug delivery systems[J]. International Journal of Pharmaceutical Research, 2020, 47(6):403-408,423. doi:10.13220/j.cnki.jipr.2020.06.001.
[16]	夏卫东, 陈光夷, 戴文统, 等. 重组人粒细胞-巨噬细胞集落刺激因子凝胶应用于糖尿病患者中厚皮移植术后供皮区的临床效果[J]. 上海交通大学学报(医学版), 2021, 41(11):1498-1501.
	XIA W D, CHEN G Y, DAI W T, et al. Clinical efficacy of recombinant human granulocyte-macrophage colony-stimulating factor gel in donor site management after split-thickness skin grafting in diabetic patients[J]. Journal of Shanghai Jiaotong University (Medical Science), 2021, 41(11):1498-1501. doi:10.3969/j.issn.1674-8115.2021.11.
[17]	王钦, 刘克娜, 孔彩华, 等. 美洲大蠊提取物的活性成分及其抗氧化应激的研究现状[J]. 中华中医药学刊, 2021, 39(7):124-127.
	WANG Q, LIU K N, KONG C H, et al. Research progress on active components and antioxidant stress effects of Periplaneta americana extracts[J]. Chinese Archives of Traditional Chinese Medicine, 2021, 39(7):124-127. doi:10.13193/j.issn.1673-7717.2021.07.032.
[18]	朱文颖, 袁瑞兴. 益生菌辅助清肠愈疡汤联合康复新液保留灌肠对溃疡性结肠炎疗效、免疫炎症和氧化应激的影响[J]. 现代消化及介入诊疗, 2024, 29(6):726-730.
	ZHU W Y, YUAN R X. Effects of probiotic-assisted Qingchang Yuyang decoction combined with Kangfuxin liquid retention enema on ulcerative colitis:efficacy,immune inflammation and oxidative stress[J]. Modern Digestion & Intervention, 2024, 29(6):726-730. doi:10.3969/j.issn.1672-2159.2024.06.01.
[19]	KUSZAI O, DAY M, TSE S S W, et al. A critical review of randomized controlled trials on topical corticosteroids for the prevention of radiation dermatitis in breast cancer[J]. Support Care Cancer, 2025, 33(2):147. doi:10.1007/s00520-025-09178-2.
[20]	罗文莉, 邱丽霞, 徐冠军, 等. 重组牛碱性成纤维细胞生长因子联合康复新液保留灌肠在老年放射性直肠炎中的应用[J]. 中国老年学杂志, 2023, 43(19):4684-4687.
	LUO W L, QIU L X, XU G J, et al. Application of recombinant bovine basic fibroblast growth factor combined with Kangfuxin liquid retention enema in elderly radiation proctitis[J]. Chinese Journal of Gerontology, 2023, 43(19):4684-4687. doi:10.3969/j.issn.1005-9202.2023.19.022.
[21]	林祥弘, 苏顺琴, 黄玲, 等. 康复新液辅助治疗放射性皮炎的研究进展[J]. 中国现代医生, 2023, 61(33):108-111.
	LIN X H, SU S Q, HUANG L, et al. Research progress on adjuvant therapy of Kangfuxin liquid for radiation dermatitis[J]. China Modern Doctor, 2023, 61(33):108-111. doi:10.3969/j.issn.1673-9701.2023.33.028.
[22]	杨丽娴, 郑磊. 康复新液对乳腺癌患者应用盐酸多柔比星脂质体致手足综合征的临床研究[J]. 国际临床研究杂志, 2023, 6(5):51-53.
	YANG L X, ZHENG L. Clinical study of Kangfuxin liquid on doxorubicin liposome-induced hand-foot syndrome in breast cancer patients[J]. International Journal of Clinical Research, 2023, 6(5):51-53. doi:10.12208/j.ijcr.20220207.

组别	年龄/岁			BMI/（kg/m²）		月经状态
组别	年龄/岁			BMI/（kg/m²）		绝经		未绝经
对照组	53.53±15.84			21.13±2.37		27（60.00）		18（40.00）
观察组	53.71±16.08			20.95±2.12		29（64.44）		16（35.56）
t或χ²	0.053			0.375		0.189
组别		病变部位			TNM分期
组别		左胸	右胸		Ⅱ期		Ⅲ期
对照组		30（66.67）	15（33.33）		25（55.56）		20（44.44）
观察组		28（62.22）	17（37.78）		26（57.78）		19（42.22）
χ²		0.194			0.045

组别	年龄/岁			BMI/（kg/m²）		月经状态
组别	年龄/岁			BMI/（kg/m²）		绝经		未绝经
对照组	53.53±15.84			21.13±2.37		27（60.00）		18（40.00）
观察组	53.71±16.08			20.95±2.12		29（64.44）		16（35.56）
t或χ²	0.053			0.375		0.189
组别		病变部位			TNM分期
组别		左胸	右胸		Ⅱ期		Ⅲ期
对照组		30（66.67）	15（33.33）		25（55.56）		20（44.44）
观察组		28（62.22）	17（37.78）		26（57.78）		19（42.22）
χ²		0.194			0.045

组别	发生例数	首次发生时间/d	痊愈时间/d	严重程度（RIOG分级）
组别	发生例数	首次发生时间/d	痊愈时间/d	1—2级	3—4级
对照组	31（68.89）	10.61±3.07	20.17±1.56	18（58.06）	13（41.94）
观察组	16（35.56）	14.03±3.45	16.29±1.33	14（87.50）	2（12.50）
χ²或t	10.020^＊	4.967^＊	12.696^＊	4.208^＊

组别	发生例数	首次发生时间/d	痊愈时间/d	严重程度（RIOG分级）
组别	发生例数	首次发生时间/d	痊愈时间/d	1—2级	3—4级
对照组	31（68.89）	10.61±3.07	20.17±1.56	18（58.06）	13（41.94）
观察组	16（35.56）	14.03±3.45	16.29±1.33	14（87.50）	2（12.50）
χ²或t	10.020^＊	4.967^＊	12.696^＊	4.208^＊

组别	EGF/（ng/L）			bFGF/（ng/L）			TGF-β/（μg/L）
组别	放疗前	放疗后	t	放疗前	放疗后	t	放疗前	放疗后	t
对照组	6.43±1.44	8.74±1.46	7.556^＊	0.76±0.15	1.46±0.29	14.382^＊	6.51±0.46	8.59±0.27	26.159^＊
观察组	6.47±1.41	10.88±2.30	10.966^＊	0.75±0.12	2.43±0.55	20.020^＊	6.52±0.45	10.71±0.42	45.662^＊
t	0.138	5.498^＊		0.349	10.920^＊		0.108	29.721^＊