去羟肌苷、司他夫定和奈韦拉平抗人免疫缺陷病毒治疗的初步观察

A Twenty Four Week Clinical Trial Using Didonosine, Stavudine and Nevirapine for Highly Active Antiretrioviral Therapy

目的 观察去羟肌苷、司他夫定和奈韦拉平联合治疗人免疫缺陷病毒 (HIV) -1感染者的抗病毒效果、免疫重建效果和毒副作用。方法 用该三种药物对 8例无明显艾滋病症状的HIV -1感染者进行规范的高效抗逆转录病毒治疗 (HAART) ,分别在用药前、用药开始后 4周、12周和 2 4周检测其血浆HIV -1RNA载量和外周血CD4+ 、CD8+ 淋巴细胞数 ,并观察和记录用药后的毒副反应和血常规、主要生化指标的变化。结果 HAART开始后 12周和 2 4周 ,8例HIV -1感染者的病毒载量由平均 ( 2 83 ,12 5± 187,2 17)拷贝 /ml下降到 ( 1,5 0 1± 93 0 )拷贝 /ml和 ( 669± 477)拷贝 /ml ,比治疗开始前下降约 2 2 8logs和 2 63logs ,其中 7例并已降到可检测水平以下 ;CD4+ 淋巴细胞由平均 ( 3 3 7± 2 2 1)个 /μl上升到 ( 3 93± 3 0 1)个 /μl和 ( 4 14± 2 84)个 /μl ,CD8+ 淋巴细胞数由平均 ( 918± 3 71)个 /μl下降到 ( 82 3± 3 15 )个 /μl和 ( 812± 3 0 5 )个 /μl ;治疗开始后部分病例出现皮疹、头痛、乏力、恶心呕吐、腹痛腹泻 ,多属于第一级和第二级毒副反应 ,部分病例有轻度血相和生化改变 ,暂无病例因此停药或改药。结论 观察去羟肌苷、司他夫定和奈韦拉平三药联合的HAART治疗 ,在最初 12周和 2

Objective To obserre antiviral effect, immune rebuilding efficacy and side effects of didonosine, stavudine and nevirapine combination therapy for human immunodeficiency virus (HIV) type 1 infection. Methods Three medicines were administered for 8 HIV-1 infected cases. Plasma HIV RNA load, and the levels of CD 4 + T cell and CD 8 + T cell were detected before starting treatment and 4,12 and 24 weeks after starting treatment. Side effects and changes in laboratory's examinations were observed during the trial. Results After 12 and 24 week treatment, the plasma HIV-1 level reduced 2 28 logs and 2 63 logs, from a mean baseline of (283,125±187,217) copies/ml to (1,501±930) copies/ml and (669±477) copies/ml, the CD 4 + T cell counts increased from a mean baseline of (337±221) cells/ml to (393±301) cells/ml and (414±284) cells/ml, and CD 8 + T cell counts decreased from a mean baseline of (918±371) cells/ml to (823±315) cells/ml (812±305) cells/ml, respectively. Part of cases occurred mild or medium rash, nausea, headache, fatique, abdomina1 pain and diarrhea, and had blood transaminase increased, and leucocyte and hemoglobin decreased. Conclusions Didonosine, stavudine and nevirapine showed high anti-HIV and immune rebuilding effects in highly active antiretroviral therapy (HAART). The medicine regimen was well tolerated in a six-month clinical trial.