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0．401g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。
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 ＋ ceils 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.
出处
《中国感染控制杂志》
CAS
2009年第1期21-24,共4页
Chinese Journal of Infection Control
关键词
艾滋病
复方黄芪颗粒
HIV感染
中药
安全性
治疗效果
human immunodeficiency virus
compound astragalus mongholicus granule
HIV infection
Chinese medicinal herb
safety
curative efficacy
