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Clinical value of modified Shenling Baizhu powder (加味参苓白术散) in treating targeted therapy-induced diarrhea in non-small cell lung cancer
Received date: 2023-05-11
Accepted date: 2023-10-17
Online published: 2024-09-11
Supported by
Clinical Study of Shenling Baizhu Powder Flavoring Intervention on Diarrhea Associated with Targeted Treatment of Non-small Cell Lung Cancer, Zhejiang Science and Technology Program of Traditional Chinese Medicine(2022ZA151)
OBJECTIVE: To assess clinical value of modified Shenling Baizhu powder (加味参苓白术散, SBP) in intervening targeted therapy-induced diarrhea.
METHODS: This study was a prospective randomized controlled study. Eighty-five non-small cell lung cancer (NSCLC) patients with diarrhea who took targeted drugs were randomly divided into two groups. The experimental group received modified SBP, while the control group received imodium. During 2 courses of treatment (1 week/course) and 2 weeks of follow-up, we observed remission and recurrence of diarrhea, as well as the improvement of Karnofsky score (KPS) in the two groups and drug safety.
RESULTS: Eighty cases were completed, with 40 cases in the experimental group and 40 cases in the control group. The control group’s diarrhea remission rate was significantly lower than the experimental group’s (P<0.05). After 2 courses of treatment, the symptom scores of both groups were lower than before, with that of the experimental group remarkably lower (P<0.05). Furthermore, the experimental group experienced less abdominal fullness and appetite loss than the control group (P<0.05). There was no prominent difference in overall diarrhea recurrence, time, or KPS after treatment between the two groups (P>0.05). No unique adverse events occurred in experimental group or control group.
CONCLUSION: The modified SBP could improve targeted therapy-induced diarrhea in NSCLC, and is superior to imodium in relieving diarrhea, improving related symptom scores and symptoms, with no obvious drug-related adverse events.
Ming WANG , Yun ZHENG . Clinical value of modified Shenling Baizhu powder (加味参苓白术散) in treating targeted therapy-induced diarrhea in non-small cell lung cancer[J]. Journal of Traditional Chinese Medicine, 2024 , 44(5) : 1000 -1005 . DOI: 10.19852/j.cnki.jtcm.20240806.008
| 1. | Greenhalgh J, Boland A, Bates V, et al. First-line treatment of advanced epidermal growth factor receptor (EGFR) mutation positive non-squamous non-small cell lung cancer. Cochrane Database Syst Rev 2021; 3: CD010383. |
| 2. | Hsu WH, Yang JC, Mok TS, Loong HH. Overview of current systemic management of EGFR-mutant NSCLC. Ann Oncol 2018; 29: i3-9. |
| 3. | Aw DC, Tan EH, Chin TM, et al. Management of epidermal growth factor receptor tyrosine kinase inhibitor-related cutaneous and gastrointestinal toxicities. Asia Pac J Clin Oncol 2018; 14: 23-31. |
| 4. | Yang JC, Reguart N, Barinoff J, et al. Diarrhea associated with afatinib: an oral ErbB family blocker. Expert Rev Anticancer Ther 2013; 13: 729-36. |
| 5. | Hirsh V, Blais N, Burkes R, Verma S, Croitoru K. Management of diarrhea induced by epidermal growth factor receptor tyrosine kinase inhibitors. Curr Oncol 2014; 21: 329-36. |
| 6. | Hu S, Dan W, Liu J, et al. The use of Traditional Chinese Medicine in relieving EGFR-TKI-associated diarrhea based on network pharmacology and data mining. Evid Based Complement Alternat Med 2021; 2021: 5530898. |
| 7. | Chinese Society of Lung Cancer CA-CA. EGFR-TKI ADR management Chinese expert consensus. Zhong Guo Fei Ai Za Zhi 2019; 22: 57-81. |
| 8. | Xu W, Han Q, Liang S, et al. Modified Shenlingbaizhu decoction reduces intestinal adenoma formation in adenomatous polyposis coli multiple intestinal neoplasia mice by suppression of hypoxia-inducible factor 1alpha-induced CD4+CD25+forkhead box P3 regulatory T cells. J Tradit Chin Med 2018; 38: 22-32. |
| 9. | Ji HJ, Kang N, Chen T, et al. Shen-ling-bai-zhu-san, a spleen-tonifying Chinese herbal formula, alleviates lactose-induced chronic diarrhea in rats. J Ethnopharmacol 2019; 231: 355-62. |
| 10. | Shen J, Zheng X, Zhang X, Yuan Y. Clinical study of Shen-Ling-Bai-Zhu powder applied to umbilical cord in treating chronic diarrhea of spleen-deficiency type in children. Asian J Surg 2022; 45: 1500-1. |
| 11. | Ma Q, Ouyang Y, Meng F, et al. A review of pharmacological and clinical studies on the application of Shenling Baizhu San in treatment of ulcerative colitis. J Ethnopharmacol 2019; 244: 112105. |
| 12. | Lai J, Jiang F, Zhuo X, et al. Effects of Shenling Baizhu powder on pyrotinib-induced diarrhea: analysis of gut microbiota, metabonomics, and network pharmacology. Chin Med 2022; 17: 140. |
| 13. | Association CM. Clinical practice guidelines for tumor. Beijing: People's Medical Publishing House, 2009: 83-6. |
| 14. | Kumar A, Kumar S, Gilja S, et al. Reconsidering the American Joint Committee on Cancer Eighth Edition TNM staging manual classifications for T2b and T 3 NSCLC. J Thorac Oncol 2021; 16: 1672-83. |
| 15. | Services USDoHaH. Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Bethesda: National Cancer Institute, 2017: 13-5. |
| 16. | Zheng X. Guidelines for the clinical use of new prescriptions of TCM. Beijing: China Medical Science and Technology Press, 2002: 51-3. |
| 17. | Zhou J. Practice of medical oncology treatment. Beijing: Beijing Science and Technology Press, 2010: 239-41. |
| 18. | Wang X, Yang Q, Zhou X, et al. Shenling Baizhu powder inhibits RV-SA11-induced inflammation and rotavirus enteritis via TLR4/MyD88/NF-kappa B signaling pathway. Front Pharmacol 2021; 12: 642685. |
| 19. | Friendlander AH, Ettinger RL. Karnofsky performance status scale. Spec Care Dentist 2009; 29: 147-8. |
| 20. | National Cancer Research and Control Office P, Association CA-C. Primary Bronchopulmonary Cancer. Beijing: Peking Union Medical College Press, 1990: 49-51. |
| 21. | China MoHotPsRo. Decree of the Ministry of Health of the People's Republic of China No. 81. 2011-05-04, cited 2011-05-24; Available from URL: https://www.gov.cn/flfg/2011-05/24/content_1870110.htm. |
| 22. | Aggarwal C. Targeted therapy for lung cancer: present and future. Ann Palliat Med 2014; 3: 229-35. |
| 23. | Liao BC, Lin CC, Lee JH, Yang JC. Optimal management of EGFR-mutant non-small cell lung cancer with disease progression on first-line tyrosine kinase inhibitor therapy. Lung Cancer 2017; 110: 7-13. |
| 24. | Yang JC, Ahn MJ, Kim DW, et al. Osimertinib in pretreated T790M-positive advanced non-small-cell lung cancer: AURA study phaseⅡextension component. J Clin Oncol 2017; 35: 1288-96. |
| 25. | Ding PN, Lord SJ, Gebski V, et al. Risk of treatment-related toxicities from EGFR tyrosine kinase inhibitors: a Meta-analysis of clinical trials of gefitinib, erlotinib, and afatinib in advanced EGFR-mutated non-small cell lung cancer. J Thorac Oncol 2017; 12: 633-43. |
| 26. | Chen P, Wang L, Liu B, et al. EGFR-targeted therapies combined with chemotherapy for treating advanced non-small-cell lung cancer: a Meta-analysis. Eur J Clin Pharmacol 2011; 67: 235-43. |
| 27. | Jiao L, Xu J, Sun J, et al. Chinese herbal medicine combined with EGFR-TKI in EGFR mutation-positive advanced pulmonary adenocarcinoma (CATLA): a multicenter, randomized, double-blind, placebo-controlled trial. Front Pharmacol 2019; 10: 732. |
| 28. | Tang M, Wang S, Zhao B, et al. Traditional Chinese Medicine prolongs progression-free survival and enhances therapeutic effects in epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) treated non-small-cell lung cancer (NSCLC) patients harboring EGFR mutations. Med Sci Monit 2019; 25: 8430-7. |
| 29. | Liu ZL, Zhu WR, Zhou WC, et al. Traditional Chinese medicinal herbs combined with epidermal growth factor receptor tyrosine kinase inhibitor for advanced non-small cell lung cancer: a systematic review and Meta-analysis. J Integr Med 2014; 12: 346-58. |
| 30. | Lyu C, Shi C, Li L, Wen X, Xian CJ. Chinese herbal medicines in the prevention and treatment of chemotherapy-induced nausea and vomiting. Curr Opin Support Palliat Care 2018; 12: 174-80. |
| 31. | Lyu W, Liu C, Ye C, et al. Structural modulation of gut microbiota during alleviation of antibiotic-associated diarrhea with herbal formula. Int J Biol Macromol 2017; 105: 1622-9. |
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