【摘要】 目的在中国中医药研究院的新药开发研究工作基础上,对未经抗病毒治疗的人免疫缺陷病毒(HIV)感染者进行24周口服中药复方黄芪颗粒治疗,初步评价其有效性和安全性。方法22例HIV感染者服用复方黄芪颗粒治疗24周,于0、24周检测HIV RNA病毒载量,0、8、24周检测CD4+、CD8+细胞及细胞因子,0、8、16、24周记录临床症状积分以及血常规、肝肾功能等实验室指标,同时记录治疗期间发生的不良事件。结果治疗24周,CD4+细胞数较基线值(0周)平均上升22/μL(t=2.08,P=0.03);细胞因子白细胞介素(IL)-2和干扰素(IFN)-γ较基线值分别平均上升7.29pg/mL和3.82pg/mL(分别t=3.46,P=0.00;t=5.94,P=0.00),IL-4下降3.71pg/mL(t=8.18,P=0.00);HIV RNA较基线值平均下降0.40lg拷贝/mL(t=2.65,P=0.02);体重上升>2kg者6例,增减未超过2kg者10例,患者体重评分有效率72.73%;血常规、肝肾功能等结果均在正常范围内;未观察到不良事件。结论中药复方黄芪颗粒可提高HIV感染者CD4+细胞数,对HIV复制有一定抑制作用,具有一定免疫调节作用;可以显著改善HIV感染者的临床症状,使患者体重增加,无明显毒副作用。更多还原

【Abstract】 Objective To evaluate the preliminary efficacy and safety of compound astragalus mongholicus granule in the 24-week treatment of patients infected with HIV.Methods Twenty-two patients infected with HIV received an oral administration of compound astragalus mongholicus granule for 24 weeks.HIV RNA were detected at week 0 and week 24;CD4+,CD8+ cell counts and levels of cytokines(IL-2,IL-4,IFN-γ) were examined at week 0,week 8 and week 24.Clinic symptoms,blood routine examination,liver and renal function and adverse events were recorded at week 0,8,16 and 24,respectively.Results The CD4+ cell counts increased 22 cell/μL(t=2.08,P=0.03) when compared with the baseline.IL-2 and IFN-γ increased 7.29pg/mL and 3.82pg/mL respectively(t=3.46,P=0.00;t=5.94,P=0.00),while IL-4 reduced 3.71pg/mL(t=8.18,P=0.00);HIV RNA deceased 0.40 lg copy/mL(t=2.65,P=0.02);6 patients gained weight of more than 2 kg,10 patients gained weight of no more than 2 kg.The results of blood routine examination,liver and renal function were normal.No obvious adverse events were observed.Conclusion Compound astragalus mongholicus granule can increase the number of CD4+ cells in patients infected with HIV,inhibit HIV replication and with immune regulation function to a certain extent.It can also improve HIV infection symptoms and gain the patients’ weight.No obvious side effects were observed in this clinical trial.更多还原