A Meta-Analysis on the Efficacy and Safety of Xihuang Pill/Capsule（ 西黄丸/胶囊） as an Adjuvant to Radio⁃therapy and Chemotherapy in the Treatment of Malignant Digestive Tract Tumors
10.13288/j.11-2166/r.2025.09.008
- VernacularTitle:西黄丸/胶囊辅助放疗和（或）化疗治疗消化道恶性肿瘤有效性和安全性的Meta分析
- Author:
Mengyi LI
1
;
Lei ZHANG
1
;
Lijun WANG
1
;
Xing GAO
1
Author Information
1. School of Medicine，Tianjin University/Tianjin Hospital，Tianjin，300211
- Publication Type:Journal Article
- Keywords:
malignant gastrointestinal tumors;
Xihuang Pill （西黄丸）;
Xihuang Capsule （西黄胶囊）;
radiothe-rapy;
chemotherapy;
Meta-analysis
- From:
Journal of Traditional Chinese Medicine
2025;66(9):912-919
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTo evaluate the efficacy and safety of Xihuang Pill/Capsule （西黄丸/胶囊， XP/XC） as an adjuvant to radiotherapy and/or chemotherapy in the treatment of malignant digestive tract tumors. MethodsA systematic search was conducted in the China Biomedical Literature Database， China National Knowledge Infrastructure （CNKI）， Wanfang Data Knowledge Service Platform， VIP Database， PubMed， Web of Science， Embase， and Cochrane Library for randomized controlled trials （RCTs） published before March 6， 2024， regarding the use of XP/XC in clinical adjuvant treatment of malignant digestive tract tumors. The methodological quality of the included studies was assessed using the risk of bias assessment tool. RevMan 5.4 was used to perform a Meta-analysis on 1-year survival rate， 2-year survival rate， clinical efficacy， including objective response rate and disease control rate， Karnofsky Performance Status （KPS） score， immune markers （CD3+， CD4+， CD8+， and CD4+/CD8+ ratio）， and adverse event rates （incidence of gastrointestinal reactions and bone marrow suppression）. ResultsThirteen RCTs involving 962 patients were included， with 527 patients in the experimental group and 435 patients in the control group. Meta-analysis results showed that the experimental group had better outcomes than the control group in terms of 2-year survival rate ［RR = 0.49， 95% CI （0.31， 0.78）］， objective response rate ［RR = 0.68， 95% CI （0.60， 0.77）］， disease control rate ［RR = 0.85， 95% CI （0.80， 0.91）］， and immune markers CD3+ ［MD = -7.99， 95% CI （-9.12， -6.86）］， CD4+ ［MD = -5.42， 95% CI （-7.11， -3.74）］， and CD4+/CD8+ ratio ［MD = -0.26， 95% CI （-0.32， -0.20）］ （P＜0.05）. However， no statistically significant differences were found between the experimental and control groups in terms of 1-year survival rate ［RR = 0.91， 95% CI （0.73， 1.14）］， KPS ［MD = -3.73， 95% CI （-8.67， 1.21）］， CD8+ ［MD = -0.53， 95% CI （-1.45， 0.39）］， incidence of gastrointestinal reactions ［RR = 0.82， 95% CI （0.46， 1.46）］， and incidence of bone marrow suppression ［RR = 0.93， 95% CI （0.72， 1.20）］ （P＞0.05）. ConclusionCompared with radiotherapy/chemotherapy alone， the combination of XP/XC with radiotherapy/chemotherapy can effectively improve clinical efficacy and 2-year survival rate， enhance immune function， and achieve similar adverse event rates as radiotherapy/chemotherapy alone in patients with malignant digestive tract tumors.
