International Journal of Clinical Research
International Journal of Clinical Research. 2026; 10: (3) ; 10.12208/j.ijcr.20260137 .
总浏览量: 26
1广西科技大学第二附属医院肿瘤科 广西柳州
2柳州市柳铁中心医院肿瘤科 广西柳州
3融水县人民医院肿瘤科 广西柳州
*通讯作者： 沈永奇,单位：柳州市柳铁中心医院肿瘤科 广西柳州; ；
目的 探讨人参皂苷 Rg3 联合沙利度胺对拒绝规范治疗的晚期肝细胞癌（HCC）患者的临床疗效及安全性。方法 采用前瞻性随机对照设计，纳入30例晚期HCC患者（BCLC C/D 期，ECOG 0-3分），随机分为治疗组（n=14，人参皂苷Rg3 20mg bid+沙利度胺100-200mg qn+最佳支持治疗）与对照组（n=16，仅最佳支持治疗）。主要终点为生活质量（EORTC QLQ-C15 量表）及总生存期（OS），次要终点为不良反应（NCI CTCAE 4.0）。结果 治疗组生存时间中位数为5.5个月（95% CI: 4.3-7.8个月）；对照组生存时间中位数为5.1个月（95% CI: 3.7-7.8个月）。采用Log-rank（Mantel-Cox）检验比较两组生存分布，结果表明治疗组与对照组的生存分布无统计学显著差异（Log-rank χ²=0.563，p=0.453）。生活质量方面，治疗组QOL“一般及以上”比例达85.7%，高于对照组的43.8%（P=0.026）。两组不良反应发生率无统计学差异（P＞0.05），均以1-2级为主。结论 对于拒绝规范治疗的晚期肝细胞癌患者，人参皂苷 Rg3 联合沙利度胺虽未显著延长总生存期，但可显著改善生活质量且用药安全性可控。
Objective To evaluate the efficacy and safety of ginsenoside Rg3 combined with thalidomide in patients with advanced hepatocellular carcinoma (HCC) who refused radical treatment. Methods A prospective randomized controlled trial was conducted. Thirty advanced HCC patients (BCLC C/D stage, ECOG 0-3) were randomly assigned to receive either ginsenoside Rg3 (20 mg bid) + thalidomide (100-200 mg qn) + best supportive care (BSC) (treatment group, n=14) or BSC alone (control group, n=16). Primary endpoints included quality of life (QOL, EORTC QLQ-C15 scale) and overall survival (OS). Secondary endpoints were adverse events (NCI CTCAE 4.0). Results Median OS was 5.5 months (95%CI:4.3–7.8) in the treatment group vs 5.1 months (95%CI:3.7–7.8) in the control group (Log-rank χ²=0.563, p=0.453). QOL improvement (≥"fair") was significantly higher in the treatment group (85.7% vs 43.8%, p=0.026). Adverse events were comparable between groups (all grade 1-2, p>0.05). Conclusion Ginsenoside Rg3 combined with thalidomide does not significantly prolong OS but improves QOL with manageable toxicity in advanced HCC patients refusing radical treatment.
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