Zhou Tianhui, Zhang Yingying, Lu Yuqing, Sun Zhaodong, Wang Dehui, Zhang Xiaolong, Wang Yu, Wei Yinuo, Zhang Tiange, Zhang Xin, Wei Ruohan, Hu Po, Yang Guangming, Wang Xinzhu, Pan Yang
School of Pharmacy, Nanjing University of Chinese Medicine, 138 Xianlin Avenue, Qixia District, Nanjing 210023, China.
Department of Surgery, The Royal Melbourne Hospital, The University of Melbourne, Parkville, VIC 3050, Australia.
Pharmaceuticals (Basel). 2025 Jun 13;18(6):884. doi: 10.3390/ph18060884.
Existing clinical data suggest that Huaier granules effectively improve the condition of PLC patients. However, their specific efficacy and safety in PLC patients remain unclear. This study aimed to investigate the effects of Huaier granules as an adjunctive therapy for PLC patients. This cohort study includes 4577 PLC patients, with data retrieved up to 2024. The patients were divided into the Huaier group ( = 2404) and a control group ( = 2173), and the treatment effects and safety between the two groups were compared. Review Manager 5.3 was used to analyze the clinical data. The fixed-effects and random-effects models were adopted. Stata 17.0 was used for sensitivity and bias analyses to evaluate publication bias. Heterogeneity testing and analysis using a random-effects model showed that the combination of Huaier granules and conventional treatment significantly reduced the recurrence rate (OR = 0.65, 95% CI 0.50-0.85, = 0.002) and improved the one-year survival rate (OR = 0.79, 95% CI 0.65-0.96, = 0.02). Huaier granules also improved quality of life, reduced AFP levels ( < 0.00001), and significantly impacted immune function by altering the levels of the T lymphocyte subtypes CD, CD, CD and the CD/CD ratio. When Huaier granules were used in combination with other medications, no significant changes in side effects were observed. Huaier combination therapy shows good therapeutic efficacy and safety in PLC patients. However, this conclusion needs to be further validated through prospective clinical studies.
现有临床数据表明，槐耳颗粒可有效改善PLC患者的病情。然而，其在PLC患者中的具体疗效和安全性仍不明确。本研究旨在探讨槐耳颗粒作为PLC患者辅助治疗的效果。这项队列研究纳入了4577例PLC患者，数据收集截至2024年。将患者分为槐耳组（n = 2404）和对照组（n = 2173），比较两组的治疗效果和安全性。使用Review Manager 5.3分析临床数据。采用固定效应模型和随机效应模型。使用Stata 17.0进行敏感性和偏倚分析以评估发表偏倚。采用随机效应模型进行异质性检验和分析，结果显示槐耳颗粒与传统治疗联合使用可显著降低复发率（OR = 0.65，95%CI 0.50 - 0.85，P = 0.002），并提高一年生存率（OR = 0.79，95%CI 0.65 - 0.96，P = 0.02）。槐耳颗粒还可改善生活质量，降低甲胎蛋白水平（P < 0.00001），并通过改变T淋巴细胞亚群CD4、CD8、CD4/CD8比值显著影响免疫功能。当槐耳颗粒与其他药物联合使用时，未观察到副作用有显著变化。槐耳联合治疗在PLC患者中显示出良好的治疗效果和安全性。然而，这一结论需要通过前瞻性临床研究进一步验证。
