人参皂苷Rg3联合沙利度胺对比最佳支持治疗对晚期肝细胞癌患者生活质量及生存期影响的前瞻性研究

Prospective study of ginsenoside Rg3 combined with thalidomide vs best supportive care in advanced hepatocellular carcinoma: impact on quality of life and survival

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DOI 10.12208/j.ijcr.20260137
刊名
International Journal of Clinical Research
年,卷(期) 2026, 10(3)
作者
作者单位

广西科技大学第二附属医院肿瘤科 广西柳州;
柳州市柳铁中心医院肿瘤科 广西柳州;
广西科技大学第二附属医院肿瘤科 广西柳州;
融水县人民医院肿瘤科 广西柳州;

摘要
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。
Abstract
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.
关键词
人参皂苷Rg3;沙利度胺;生活质量;生存期
KeyWord
Ginsenoside Rg3; Thalidomide; Quality of life; Survival time
基金项目
页码 85-89
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陈超庭, 崔碧玉,, 赖祥丽, 刘文健, 沈永奇. 人参皂苷Rg3联合沙利度胺对比最佳支持治疗对晚期肝细胞癌患者生活质量及生存期影响的前瞻性研究 [J]. 国际临床研究杂志. 2026; 10; (3). 85 - 89.

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