24个月抗艾滋病病毒治疗效果的初步评价

目的观察人类免疫缺陷病毒1型（HIV-1）感染者经24个月高效抗逆转录病毒治疗（HAART）的抗病毒效果、免疫重建效果和毒副反应。方法27例HIV-1感染者以去羟肌苷、司他夫定和奈韦拉平治疗24个月,分别在治疗前,治疗后3、6、12、18和24个月时采血检测血浆HIVRNA病毒载量,检测外周血CD3^＋CD4^＋、CD3^＋CD8^＋淋巴细胞数,CD4^＋CD45RA^＋CD62L^＋纯真细胞数,CD4^＋CD45RO^＋记忆细胞数,CD8^＋CD38^＋激活淋巴细胞数和CD8^＋CD38^＋／CD3^＋CD8^＋百分比;并观察药物的毒副反应、血常规和主要生化指标的变化,以及发生的不良事件。结果27例HIV-1感染者在24个月的治疗中,病毒学和各项免疫学指标均有明显改善,其变化以3或6个月时较显著,24个月时上述各项检测指标均未达到正常对照组数值。其中19例感染者先后出现过消化道反应、周围神经炎、皮疹、腹痛、头痛、发热和脱发等毒副反应,有21例感染者发生过血相异常、肝功能或肾功能变化、血脂异常以及γ-谷氨酰转肽酶和淀粉酶升高等。有3例感染者先后因Ⅲ级外周神经炎和疑为乳酸中毒而改药。结论HIV-1感染者经去羟肌苷、司他夫定和奈韦拉平治疗24个月,显示了较好的抗病毒效果和免疫重建效果。但药物的副反应较多。

Evaluation for two-year highly active antiretroviral therapy in Chinese HIV-1 infection patients

OBJECTIVE: To observe that antiretroviral efficacy, immune reconstitution of two-year HAART, and evaluate its side effect in Chinese HIV-1-infected patients. METHODS: Three drug regimen composed of didanosine (ddI), stavudine (d4T), and nevirapine (NVP) was used on 27 HIV-1 infected patients, Within 2 weeks before treatment, and 3, 6, 12, 18, and 24 months after the beginning of treatment peripheral blood samples were collected to measure the HIV-RNA viral load (VL) by fluorescent quantitative polymerase chain reactions (FQ-PCR), and the counts of CD3+CD4+ cells, CD3+CD8+ cells, CD4+CD45RA+CD62L+ cells, CD4+CD45RO+ cells, CD8+CD38+ cells, and CD8+CD38+/CD3+CD8+ percentage. The side effects, blood routine, main biochemical parameters, and other disadvantageous accidents were monitored during the 24-mouth treatment period. 17 males and 10 females, aged 33 +/- 11. Thirty-one sex- and age-matched healthy persons were used as controls. RESULTS: FQ-PCR showed that the plasma HIV-1 RNA levels 2 weeks before treatment, and 3, 6, 12, 18, and 24 months after the beginning of treatment were 5.15 logs (copies/ml), 3.37 logs, 2.24 logs, 2.02 logs, 1.97 logs, and 2.15 logs respectively. 24 months after the treatment. In 56.6% (13/24) of the patients the HIV-1 VL was < 50 copies/ml 24 months after treatment, and the counts of CD3+CD4+ cells, CD4+CD45RA+62L+ cells (nave cells), and CD4+CD45RO+ cells (memory cells) 24 months after treatment were (317 +/- 175) cells/microl, (133 +/- 65) cells/microl, and (207 +/- 85) cells/microl respectively, all significantly hoi/higher than the baseline levels [(185 +/- 73) cells/microl, (51 +/- 21) cells/microl, and (115 +/- 57) cells/microl respectively]. And the CD3+CD8+ cell count, CD8+CD38+ cell count, and CD8+CD38+/CD3+CD8+ percentage decreased from (907 +/- 435) cells/microl, (614 +/- 299) cells/microl, and 67.7% to (775 +/- 303) cells/microl, (385 +/- 131) cells/microl, and 49.7% respectively, with the lowest values in the months 3 and 6. But by the month 24, all of the parameters failed to reach the normal level. 19 of the 27 patients had side effects, such as peripheral polyneuropathy, various rashes, central nervous system disorders, abdominal pain, fullness or bloating, fever, and baldness, 21 showed abnormalities in blood routine, liver function, renal function, or lipid tests and increased gamma glutamyl transferase (GGT) and amylase. The regimen had to be changed for 3 of these patients because of paresthesia and suspected lactic acidosis. CONCLUSION: The regimen with ddI, d4T and NVP foe 24 months showed a good antiretroviral effect and immune reconstitution on the HIV-1 infected persons. However, there are side effects, especially in the respect of gastrointestinal disorder and peripheral neuritis, decrease of WBC and increase of GGT and amylase.