| 姚明龙,傅开龙,陈兰玉,何勤思,郑智.参苓白术散对脾虚湿盛型PD-1抑制剂相关性腹泻及生活质量影响的临床研究[J].实用中西医结合临床,2026,26(3): |
| 参苓白术散对脾虚湿盛型PD-1抑制剂相关性腹泻及生活质量影响的临床研究 |
| Clinical Study on the Effect of Shenling Baizhu Powder on PD-1 Inhibitor-Associated Diarrhea and Quality of Life in Patients with Spleen Deficiency and Dampness Pattern |
| 投稿时间：2025-05-09 修订日期：2025-07-13 |
| DOI： |
| 中文关键词: 参苓白术散 PD-1抑制剂 免疫相关性腹泻 恶性肿瘤 临床研究 |
| 英文关键词: Shenling Baizhu Powder PD-1 inhibitor immune-related diarrhea malignant tumor clinical study |
| 基金项目:赣鄱俊才支持计划-领军人才项目（20232BCJ22057）；福建省“十四五” 非中医医疗机构中医药科室建设项目（闽卫中医函〔2023〕344号），江西省中医药管理局课题（2019A057） |
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| 中文摘要: |
| 目的：本研究旨在研究参苓白术散在缓解恶性肿瘤患者使用PD-1抑制剂后出现的免疫相关腹泻疗效,并深入探讨其对患者生活质量的潜在影响。方法：本研究共纳入54例在江西省肿瘤医院、江西省人民医院接受单用PD-1抑制剂治疗后发生腹泻的恶性肿瘤患者,经中医辨证属于脾虚湿盛证,随机分配为两组,每组各27人。对照组患者采用双歧杆菌三联活菌胶囊治疗。试验组患者在接受对照组相同的西药治疗的基础上,还采用参苓白术散(口服,每日两次)进行治疗。研究的主要评估指标包括腹泻程度(依据CTCAE 4.0分级评价标准)和MDASIC-TCM量表积分。采用SPSS 21.0软件进行统计分析。结果：干预前,两组患者的腹泻分级无显著统计学差异(Z=-0.268, P=0.789>0.05)。干预后,试验组腹泻发生率低于对照组,卡方检验χ2=6.471,P=0.011<0.05,显示出统计学上的显著差异。秩和检验(Z=-2.751, P=0.006<0.05)发现试验组腹泻分级显著优于对照组。通过MDASIC-TCM量表评估,试验组在治疗后乏力、恶心、胃口最差程度、呕吐等胃肠道症状的严重程度以及在一般活动、工作(包括劳务活动)、走路等体力活动方面的评分均显著优于对照组(P<0.05)。结论：参苓白术散可显著缓解脾虚湿盛型PD-1抑制剂相关性腹泻,并改善患者的生活质量及胃肠道相关症状。 |
| 英文摘要: |
| Objective: This study aimed to investigate the efficacy of Shenling Baizhu Powder in alleviating PD-1 inhibitor-induced immune-related diarrhea in patients with malignant tumors and to evaluate its impact on patients" quality of life.Methods: A total of 54 patients with malignant tumors who
had diarrhea after receiving single PD-1 inhibitor treatment at Jiangxi Cancer Hospital and Jiangxi Provincial People"s Hospital were enrolled. All the patients were diagnosed with spleen deficiency and dampness pattern based on the principles of traditional Chinese medicine (TCM). The participants were randomly assigned into two groups, each comprising 27 patients. The control group received Bifidobacterium triple viable capsules, while the experimental group received Shenling Baizhu Powder (oral, twice daily) in addition to the same treatment as the control group. The primary evaluation indicators included the severity of diarrhea (based on CTCAE 4.0 grading criteria) and MDASIC-TCM scale scores. Data analysis was performed using SPSS 21.0 software.Results: Prior to the intervention, no significant difference in diarrhea grading was observed between the two groups (Z=-0.268, P=0.789). Following the intervention, the experimental group exhibited a significantly lower incidence of diarrhea compared to the control group (χ2 = 6.471, P = 0.011), and the diarrhea grading in the experimental group was significantly better than that in the control group (Z = -2.751, P = 0.006). According to the MDASIC-TCM scale, the experimental group showed significant improvements in gastrointestinal symptoms such as fatigue, nausea, poor appetite, and vomiting, as well as in physical activities (e.g., general activities, work, and walking) compared to the control group (P<0.05).Conclusion: Shenling Baizhu Powder can significantly alleviate PD-1 inhibitor-induced diarrhea in patients with spleen deficiency and dampness syndrome, improve gastrointestinal symptoms, and enhance quality of life, providing a new therapeutic option for clinical treatment. |
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