Efficacy of ginseng-based Renshenguben oral solution for cancer-related fatigue among patients with advanced-stage hepatocellular carcinoma:A prospective multicenter cohort study

Background:Cancer-related fatigue(CRF)is a common and debilitating symptom experienced by patients with advanced-stage cancer,especially those undergoing antitumor therapy.This study aimed to evaluate the efficacy and safety of Renshenguben(RSGB)oral solution,a ginseng-based traditional Chinese medicine,in alleviating CRF in patients with advanced hepatocellular carcinoma(HCC)receiving antitumor treatment.Methods:In this prospective,open-label,controlled,multicenter study,patients with advanced HCC at BCLC stage C and a brief fatigue inventory(BFI)score of≥4 were enrolled.Participants were assigned to the RSGB group(RSGB,10 mL twice daily)or the control group(with supportive care).Primary and secondary endpoints were the change in multidimensional fatigue inventory(MFI)score,and BFI and functional assessment of cancer therapy-hepatobiliary(FACT-Hep)scores at weeks 4 and 8 after enrollment.Adverse events(AEs)and toxicities were assessed.Results:A total of 409 participants were enrolled,with 206 assigned to the RSGB group.At week 4,there was a trend towards improvement,but the differences were not statistically significant.At week 8,the RSGB group exhibited a significantly lower MFI score(P<0.05)compared to the control group,indicating improved fatigue levels.Additionally,the RSGB group showed significantly greater decrease in BFI and FACT-Hep scores at week 8(P<0.05).Subgroup analyses among patients receiving various antitumor treatments showed similar results.Multivariate linear regression analyses revealed that the RSGB group experienced a significantly substantial decrease in MFI,BFI,and FACT-Hep scores at week 8.No serious drug-related AEs or toxicities were observed.Conclusions:RSGB oral solution effectively reduced CRF in patients with advanced HCC undergoing antitumor therapy over an eight-week period,with no discernible toxicities.These findings support the potential of RSGB oral solution as an adjunctive treatment for managing CRF in this patient population.

人参固本(丸)口服液抗氧化作用研究

采用光化学扩增法测定小鼠血液和脑组织中超氧化物歧化酶(SOD)含量,用硫代巴比妥酸分光光度法测定小鼠血浆及脑组织中脂质过氧化物—丙二醛(MDA)含量,进而分析人参固本(丸)口服液的抗氧化作用。结果表明:人参固本丸及其口服液均可提高因甲状腺素片、利血平片所致的肾阴虚模型小鼠血液和脑组织中 SOD 活力,降低血浆及脑组织中 MDA 的含量,具有较强的抗氧化能力和抑制体内脂质过氧化反应的作用。

高效液相色谱-蒸发光散射检测法测定人参固本口服液中人参皂苷的含量

目的建立人参固本口服液中人参皂苷Rg1和Re含量测定的方法。方法色谱柱为C18柱;流动相为乙腈-水(22:78,调甲酸pH至2.4);流速1.0 ml.min-1;ELSD参数:漂移管温度110℃,空气流速3.0 L.min-1。结果人参皂苷Rg1在0.4～2.4μg范围内呈良好的线性关系(r=0.997 0),平均回收率为98.9%,RSD=0.32%;Re在0.2～1.2μg的浓度范围内呈良好的线性关系(r=0.998 6),平均回收率为97.7%,RSD=0.25%。结论用此法分析结果准确可靠,适用于此制剂的质量控制。

人参固本汤中人参叶替代人参治疗阴虚气弱咳嗽的临床疗效分析

目的:观察人参叶在人参固本汤中替代人参治疗肺肾阴虚气弱咳嗽的疗效。方法:治疗组在人参固本汤中用人参叶替代人参,对照组为原人参固本汤,空白组为人参固本汤去人参并不加人参叶,三组均为30例。结果:治疗组与对照组在治愈率和总有效率方面均无显著性差异(P>0.05),治疗组和对照组与空白组对照比较均有显著性差异(P<0.01)。结论:人参叶同人参在治疗肺肾阴虚气弱咳嗽上功效相同,人参叶在治疗阴虚气弱咳嗽方面可替代人参。

基于网络药理学和分子对接分析人参固本口服液的物质基础和机制研究

目的利用网络药理学探讨人参固本口服液物质基础,预测其作用靶点和机制。方法通过文献、中药系统药理学分析平台得到人参固本口服液的化学成分和作用靶点。构建其中药-成分-靶点的网络,通过String数据库构建蛋白互作网络。通过Metascape数据库进行功能富集分析和通路分析,预测其作用机制。采用AutoDock Vina软件,探索关键靶点与活性成分的结合方式和亲和力。结果共得到人参固本口服液的61个活性成分、223个靶点,核心靶点48个;对核心靶点进行分析,得到功能分析条目1411个和126条信号通路,涉及25条癌症相关通路、12条免疫系统相关通路、14条心血管系统相关通路等。人参固本口服液的活性成分与靶点具有强烈的结合能力,结合形式有氢键、疏水作用、π-cation作用和π-π堆积。结论人参固本口服液功效具有多成分-多靶点-多通路的特点,可通过提高免疫力、保护心血管系统等起到补益的作用,为临床阴虚气弱证的应用提供参考。

TLC法测定人参固本口服液中人参皂苷Rg_1的含量

目的 建立人参固本口服液中人参皂苷Rg1的含量测定方法。方法 应用双波长薄层扫描法测定人参固本口服液中人参皂苷Rg1的含量。结果 该方法在人参皂苷Rg1点样量1．08～5．40μg时，峰面积与点样量呈良好的线性关系（r=1.000）,回收率为96．6％（r=6），RSD=1．66％。结论 该方法展开系统稳定，专属性强，重复性高，可以用于该制剂的质量控制。