青蒿琥酯片对HIV/AIDS患者ART后免疫功能重建不全影响的研究

The Clinical Effects and Safety of Artesunate in Immunologic Non-responders of ART-Treated HIV/AIDS Patients:A Pilot Study

目的观察比较青蒿琥酯片对HIV/AIDS患者ART后免疫功能重建不全人群的临床疗效和安全性。方法用多中心、前瞻性队列研究方法,将符合标准的患者分为单纯ART组(简称对照组),ART+青蒿琥酯片A组(青蒿琥酯片50 mg qd,简称A组)和ART+青蒿琥酯片B组(青蒿琥酯片50 mg bid,简称B组)。于治疗基线、治疗24周及48周评定比较分析免疫重建有效率、CD4细胞计数、CD45RA+分子表达水平、CD45RO+分子表达水平和安全性指标。结果治疗24周,与对照组、A组比较,B组CD4细胞计数水平明显升高(Padj<0.05);治疗48周,三组间CD4细胞计数水平差异无统计学意义(P>0.05)。治疗24周、48周,对照组、A组及B组三组间比较免疫功能重建有效率方面差异无统计学意义(P>0.05)。治疗24、48周,与对照组和A组比较,B组CD45RA+分子表达水平差异具有统计学意义(Padj<0.05)。治疗24周、48周,与对照组相比,A组、B组CD45RO+分子表达水平差异无统计学意义(Padj>0.05)。治疗24周、48周,与对照组相比,A组、B组在安全性指标方面差异无统计学意义(Padj>0.05)。结论青蒿琥酯片能够在一定程度上改善HIV/AIDS患者ART后免疫功能重建不全人群的CD4细胞计数水平,通过改善初始T细胞计数水平以促进患者重建免疫功能,HIV/AIDS患者ART后免疫功能重建不全人群在获得病毒学有效抑制后应尽早启动免疫抑制剂联合治疗方案,且其具备良好的用药安全性。

Objective To observe and compare the clinical efficacy and safety of artesunate tablets in HIV/AIDS patients with incomplete immune reconstitution after ART.Methods We conducted a multicenter,prospective cohort study.Patients who met the criteria were divided into the ART treatment only group(control group),the ART+ artesunate tablets group A(artesunate tablets 50 mg QD,group A),and the ART + artesunate tablets group B(artesunate tablets 50 mg bid,group B).The effective rate of immune reconstitution,CD4 cell count,CD45RA+ molecular expression level,CD45RO+ molecular expression level,and safety indexes were evaluated and analyzed at baseline,24 weeks,and 48 weeks of treatment.Results After 24 weeks of treatment,the CD4 cell count in group B was significantly higher than that in the control group and group A(Padj< 0.05);After 48 weeks of treatment,there was no significant difference in CD4 cell count among the three groups(P > 0.05).After 24 and 48 weeks of treatment,there was no significant difference in the effective rate of immune function reconstruction among the control group,group A and group B(P > 0.05).After 24 and 48 weeks of treatment,compared with the control group and group A,the expression level of CD45RA+ in group B was statistically significant(Padj< 0.05).After 24 and 48 weeks of treatment,compared with the control group,there was no significant difference in the expression level of CD45 RO+between group A and group B(Padj> 0.05).After 24 and 48 weeks of treatment,compared with the control group,there was no significant difference in safety indexes between group A and group B(Padj> 0.05).Conclusion Artesunate tablets can improve the CD4 cell count level of the population with incomplete immune function reconstruction after ART in HIV/AIDS patients to a certain extent,and promote the reconstruction of immune function by improving the initial T cell count level.HIV/AIDS patients with incomplete immune function reconstruction after ART should start the combined immunosuppressant treatment scheme as soon as possible after obtaining effective virological inhibition with good drug safety.