机构地区:[1]中国中医科学院中医药防治艾滋病研究中心,北京100700 [2]中国中医科学院中医基础理论研究所,北京100700 [3]河南中医药大学第一附属医院,郑州450008 [4]首都医科大学附属北京地坛医院感染中心,北京100015 [5]广州市第八人民医院,广州510060 [6]云南省中医中药研究院,昆明650223 [7]新疆维吾尔自治区中医院,乌鲁木齐830000 [8]重庆市公共卫生医疗救治中心,重庆400030 [9]贵阳市公共卫生救治中心,贵阳550001 [10]成都中医药大学,成都610075
出 处:《中华中医药杂志》2022年第7期4170-4175,共6页China Journal of Traditional Chinese Medicine and Pharmacy
基 金:国家“十三五”科技重大专项(No.2017ZX10205501)。
摘 要:目的:探索青蒿琥酯用于艾滋病免疫功能重建不全的适宜人群、有效剂量和最佳疗程。方法:多中心、前瞻性队列研究设计,纳入符合研究标准的艾滋病抗反转录病毒疗法(ART)后免疫功能重建不全患者,在ART常规抗病毒治疗基础上加用青蒿琥酯片,疗程48周。其中,青蒿A组:50 mg/次,1次/d;青蒿B组:50 mg/次,2次/d;ART组:单纯ART;于基线及治疗24、48周评价3组T淋巴细胞亚群计数或比例情况。结果:3组比较:24周青蒿B组CD4^(+)计数显著高于其他两组(P<0.05);24、48周青蒿B组CD45RA^(+)计数显著高于其他组(P<0.05)。分层比较:CD4^(+)T>200 cells/μL亚组:24、48周青蒿B组CD4^(+)计数显著高于其他两组(P<0.05);48周青蒿B组CD45RA^(+)、CD45RO^(+)计数显著高于其他两组(P<0.05);48周青蒿A组CD4^(+)Ki67^(+)/CD4^(+)比值显著高于ART组(P<0.05);年龄≥40岁亚组:24周青蒿B组CD4^(+)、CD45RA^(+)计数显著高于其他两组(P<0.05);24周青蒿A组CD4^(+)Ki67^(+)/CD4^(+)比值显著高于其他两组(P<0.05),48周ART组CD4^(+)Ki67^(+)/CD4^(+)比值显著低于其他两组(P<0.05);48周青蒿A组CD8^(+)Ki67^(+)/CD8^(+)比值显著高于ART组(P<0.05)。结论:对基线CD4^(+)T>200 cells/μL和年龄≥40岁患者,高剂量、中短程(24周)应用青蒿琥酯可促进免疫重建。为避免T淋巴细胞激活,不建议低剂量下任何疗程以及长疗程下任何剂量使用。Objective: To explore the appropriate population, effective dose and optimal treatment course of artesunate for HIV/AIDS patients with incomplete immune reconstitution. Methods: A multicenter, prospective clinical trial was conducted to include HIV/AIDS patients with incomplete immune reconstitution after antiretroviral (ART) who met the research standard. All subjects received conventional antiviral treatment, furthermore, low-dose artesunate group (group A) received oral administration of artesunate tablets (50mg/time, qd, for 48 weeks), while high-dose artesunate group (group B) was given 50 mg/time twice a day for 48 weeks. Group ART received ART only. T lymphocyte subsets counts and distribution were evaluated at baseline, week 24 and 48 respectively. Results:Through comparison among these three groups, the following results were found. CD4^(+)T lymphocytes count of group B was significantly higher than that in group A and group ART at week 24 (P<0.05);CD45RA^(+)T subsets count of group B were significantly higher than those of the other groups at week 24 and 48 (P<0.05). Stratified comparison of baseline CD4^(+)T count: In the subgroup of CD4^(+)T>200 cells/μL, CD4^(+)T counts in group B were significantly higher than those of the other two groups at week 24 and 48 (P<0.05). The subsets counts of CD45RA^(+)T and CD45RO^(+)T of group B after 48 weeks were significantly higher than those of the other groups (P<0.05).The ratio of CD4^(+)Ki67^(+)/CD4^(+) in group A was significantly higher than that of group ART at week 48 (P<0.05). In the subgroup of age≥40 years old: The count of CD4^(+)T and CD45RA^(+) in group B was significantly higher than that of the other groups at week24 (P<0.05). The ratio of CD4^(+)Ki67^(+)/CD4^(+) in group A was significantly higher than those of the other groups at week 24 (P<0.05), and it was significantly lower in group ART than the other groups at week 48 (P<0.05). The ratio of CD8^(+)Ki67^(+)/CD8^(+) in group A was significantly higher than that of group ART at week 48 (P<0.
关 键 词:艾滋病 人类免疫缺陷病毒 抗反转录病毒疗法 免疫功能重建不全 青蒿琥酯 疗效特点
分 类 号:R259[医药卫生—中西医结合]
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