中华中医药学刊

半夏泻心汤治疗晚期结直肠癌伊立替康化疗相关迟发性腹泻的疗效及机制

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王司敏 , 邓立春 , 曾洁 , 孙闻佳 , 吴春 , 沈伟生 , 奚蕾

中华中医药学刊 | 国家项目点击 2026,44(8): 105-110

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中华中医药学刊 |国家项目点击 2026 , 44 (8) : 105 -110

半夏泻心汤治疗晚期结直肠癌伊立替康化疗相关迟发性腹泻的疗效及机制

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王司敏（1988-），女，江苏丹阳人，主治中医师，硕士，研究方向：中西医结合肿瘤内科。

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王司敏（1988-），女，江苏丹阳人，主治中医师，硕士，研究方向：中西医结合肿瘤内科。

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王司敏, 邓立春, 曾洁, 孙闻佳, 吴春, 沈伟生, 奚蕾

作者信息

江阴市人民医院，江苏　江阴　214400

通讯作者:

奚蕾（1976-），女，江苏江阴人，主任中医师，硕士，研究方向：中西医结合肿瘤内科诊疗。E-mail：jyxilei@sina.cn。

作者简介:

王司敏（1988-），女，江苏丹阳人，主治中医师，硕士，研究方向：中西医结合肿瘤内科。

Efficacy and Mechanisms of Banxia Xiexin Decoction (半夏泻心汤) in Treating Delayed-Onset Diarrhea Induced by CPT-11 Chemotherapy in Advanced Colorectal Cancer

Simin WANG, Lichun DENG, Jie ZENG, Wenjia SUN, Chun WU, Weisheng SHEN, Lei XI

Affiliations

Jiangyin People's Hospital, Jiangyin 214499, Jiangsu, China

出版时间: 2026-08-10 doi: 10.13193/j.issn.1673-7717.2026.08.023

文章导航

摘要

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目的

探讨半夏泻心汤在晚期结直肠癌患者伊立替康（CPT-11）化疗相关迟发性腹泻中的临床疗效及机制，重点从肠道菌群调节角度评估其止泻作用的可能机制，以期为中西医结合治疗化疗相关腹泻提供科学依据。

方法

选择2022年7月—2024年6月在江阴市人民医院中西医结合肿瘤科确诊为晚期结直肠癌并接受CPT-11化疗后出现寒热错杂型迟发性腹泻的患者103例，随机分为试验组（51例，接受半夏泻心汤联合蒙脱石散治疗）和对照组（52例，仅接受蒙脱石散治疗）。两组均接受2周治疗，禁止使用抗生素、益生菌等影响肠道菌群的药物。主要观察指标包括腹泻严重程度（依据NCI CTCAE 5.0分级标准）、中医证候积分、肠道菌群结构（16S rDNA高通量测序分析）、生活质量评分（Karnofsky评分，KPS评分）及炎症因子水平[肿瘤坏死因子-α（Tumor necrosis factor-α，TNF-α）、白细胞介素-6（Interleukin，IL-6）]。次要指标为两组临床疗效（显效率、总有效率）及治疗安全性。不良反应发生情况亦记录并评估。

结果

治疗后，试验组患者腹泻严重程度（NCI CTCAE分级）和中医证候积分显著低于对照组（P<0.05）。试验组显效率和总有效率分别为54.9%（28/51）和94.1%（48/51），显著高于对照组的26.9%（14/52）和73.1%（38/52）（P<0.05）。16S rDNA测序结果显示，试验组患者肠道菌群多样性显著提高（P<0.05），厚壁菌门比例增加，拟杆菌门和变形菌门等条件致病菌比例显著降低（P<0.05），优于对照组。试验组血清炎症因子TNF-α和IL-6水平显著降低（P<0.05），其下降幅度优于对照组。KPS评分显示试验组患者生活质量显著改善（P<0.05）。安全性方面，试验组和对照组均未出现严重不良反应，少数患者出现轻微恶心或口干等症状，均无需特殊处理。

结论

半夏泻心汤在改善晚期结直肠癌CPT-11化疗相关迟发性腹泻方面疗效显著，其机制可能与调节肠道菌群结构，减少条件致病菌比例，恢复肠道微生态平衡相关。同时，半夏泻心汤能够改善患者生活质量，安全性良好。研究为中医药在化疗相关腹泻的临床应用及机制研究提供了新的依据。

关键词

半夏泻心汤 / CPT-11 / 化疗相关迟发性腹泻 / 肠道菌群 / 中医药治疗

Abstract

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Objective

This study aimed to explore the clinical efficacy and underlying mechanisms of Banxia Xiexin Decoction (半夏泻心汤) in treating delayed-onset diarrhea induced by CPT-11 chemotherapy in the patients with advanced colorectal cancer. The primary focus was to evaluate its potential antidiarrheal mechanisms through gut microbiota modulation, providing scientific evidence for integrating traditional Chinese medicine (TCM) with Western medicine in the treatment of chemotherapy-related diarrhea.

Methods

A total of 103 patients with advanced colorectal cancer who developed cold-heat mixed type delayedonset diarrhea following CPT-11 chemotherapy were recruited from the Department of Integrated Traditional Chinese and Western Medicine Oncology, Affiliated Hospital of Southeast University School of Medicine (Jiangyin People's Hospital) between July 2022 and June 2024. The patients were randomly assigned to either the experimental group (51 patients, treated with Banxia Xiexin Decoction combined with Montmorillonite Powder) or the control group (52 patients, treated with Montmorillonite Powder alone). Both groups received treatment for 2 weeks, and the use of antibiotics, probiotics or other medications that could affect gut microbiota was prohibited. The primary outcome measures included the severity of diarrhea (assessed using the NCI CTCAE 5.0 grading system), TCM symptom scores, gut microbiota composition (analyzed using 16S rDNA high-throughput sequencing), quality of life [Karnofsky performance status scale (KPS) score and inflammatory cytokine levels [tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6)]. Secondary outcomes included clinical efficacy (response rate and total effective rate) and safety of the treatment. Adverse events were recorded and evaluated.

Results

After treatment, the severity of diarrhea (NCI CTCAE grading) and TCM symptom scores in the experimental group were significantly lower than those in the control group (P<0.05). The response rate and total effective rate in the experimental group were 54.9% (28/51) and 94.1% (48/51), respectively, significantly higher than those [26.9% (14/52) and 73.1% (38/52)] in the control group (P<0.05). 16S rDNA sequencing results showed that the gut microbiota diversity in the experimental group was significantly increased (P<0.05), with a higher proportion of Firmicutes and a significant decrease in the proportion of pathogenic bacteria such as Bacteroidetes and Proteobacteria (P<0.05) compared to those in the control group. The serum levels of TNF-α and IL-6 were significantly lower in the experimental group (P<0.05), with a greater reduction compared to those in the control group. KPS scores indicated a significant improvement in the quality of life of the patients in the experimental group (P<0.05). In terms of safety, no serious adverse reactions occurred in either group. A few patients experienced mild nausea or dry mouth, which did not require special treatment.

Conclusion

Banxia Xiexin Decoction significantly improves delayed-onset diarrhea induced by CPT-11 chemotherapy in the patients with advanced colorectal cancer. The potential mechanism may involve the modulation of gut microbiota, reduction in pathogenic bacteria and restoration of gut microbial balance. Furthermore, Banxia Xiexin Decoction enhances patients' quality of life and demonstrates good safety. This study provided new evidence for the clinical application and mechanistic research of traditional Chinese medicine in chemotherapy-related diarrhea.

Key words

Banxia Xiexin Decoction (半夏泻心汤) / CPT-11 / chemotherapy-related delayed-onset diarrhea / gut microbiota / traditional Chinese medicine treatment

引用本文

王司敏, 邓立春, 曾洁, 孙闻佳, 吴春, 沈伟生, 奚蕾. 半夏泻心汤治疗晚期结直肠癌伊立替康化疗相关迟发性腹泻的疗效及机制. 中华中医药学刊, 2026 , 44 (8) : 105 -110 . DOI: 10.13193/j.issn.1673-7717.2026.08.023

Simin WANG, Lichun DENG, Jie ZENG, Wenjia SUN, Chun WU, Weisheng SHEN, Lei XI. Efficacy and Mechanisms of Banxia Xiexin Decoction (半夏泻心汤) in Treating Delayed-Onset Diarrhea Induced by CPT-11 Chemotherapy in Advanced Colorectal Cancer[J]. Chinese Archives of Traditional Chinese Medicine, 2026 , 44 (8) : 105 -110 . DOI: 10.13193/j.issn.1673-7717.2026.08.023

基金

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国家中医临床研究基地项目(JD2022SZ06)
徐州医科大学江阴临床学院项目(ZYYB34)

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2026年第44卷第8期

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doi: 10.13193/j.issn.1673-7717.2026.08.023

首发时间：2026-10-20
出版时间：2026-08-10

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国家中医临床研究基地项目(JD2022SZ06)

徐州医科大学江阴临床学院项目(ZYYB34)

作者信息

江阴市人民医院，江苏　江阴　214400

通讯作者:

奚蕾（1976-），女，江苏江阴人，主任中医师，硕士，研究方向：中西医结合肿瘤内科诊疗。E-mail：jyxilei@sina.cn。

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2种不同金属材料的力学参数

科 Family	属数 Number of genus	种数 Number of species	占总种数比例 Percentage of total species (%)	属 Genus	种数 Number of species	占总种数比例 Percentage of total species (%)
鹅膏菌科Amanitaceae	2	11	5.26	鹅膏菌属 Amanita	10	4.78
小菇科 Mycenaceae	2	12	5.74	丝盖伞属 Inocybe	5	2.39
多孔菌科 Polyporaceae	8	14	6.70	蜡蘑属 Laccaria	5	2.39
红菇科 Russulaceae	3	23	11.00	小皮伞属 Marasmius	6	2.87
				小菇属 Mycena	11	5.26
				光柄菇属 Pluteus	5	2.39
				红菇属 Russula	17	8.13
				栓菌属 Trametes	5	2.39

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