Dai Yi, Qiu Zhi-feng, Li Tai-sheng, Han Yang, Zuo Ling-yan, Xie Jing, Ma Xiao-jun, Liu Zheng-yin, Wang Ai-xia
Department of Infectious Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing 100730, China.
Chin Med J (Engl). 2006 Oct 20;119(20):1677-82.
Highly active antiretroviral therapy (HAART) produces profound suppression of HIV replication, substantial increase in CD4(+) T cells, and partial reconstitution of the immune system. However, the numbers of subjects were small in previous Chinese studies. This study evaluated the efficacy and side effects of HAART in Chinese advanced AIDS patients.
One hundred and three antiretroviral drug naive AIDS patients were enrolled in this study and were divided into two groups by their baseline CD4(+) count: < 100 cells/microl or > or = 100 cells/microl. Clinical, virological and immunological outcomes were monitored at baseline and at 1, 3, 6, 9 and 12 months during the course of treatment with HAART.
One patient died and another was lost from the follow-up. For the remaining 101 HIV/AIDS patients at the 12th month during the HAART, the plasma viral load (VL) was reduced to (3.2 +/- 0.7) lg copies/ml, the CD4(+) count increased to (168 +/- 51) cells/microl [among which the naive phenotype (CD45RA(+)CD62L(+)) increased to (49 +/- 27) cells/microl and the memory phenotype (CD45RA(-)) increased to (119 +/- 55) cells/microl], and the percentage of CD4(+)CD28(+) cells increased. At the same time, there was a significant reduction of CD8(+) T cell activation. In the 69 patients with the baseline CD4(+) count < 100 cells/microl, 37 had a VL < 50 copies/ml; while in the 34 patients with the baseline CD4(+) count > or = 100 cells/microl, 25 had a VL < 50 copies/ml, the difference between the two groups was statistically significant. The CD4(+) T cell count showed a two-phase increase during HAART and a significant positive correlation was shown between the change of CD4(+) count and plasma VL. Over 12 months of HAART, 10 patients had gastrointestinal side effects, 13 peripheral neuritis, 7 hepatic lesions, 8 hematological side effects, 8 skin rashes, 10 lipodystrophy and 1 renal calculus.
Immune reconstitution as well as the significantly improved clinical outcomes is observed in Chinese advanced AIDS patients after HAART. Side effects are common during HAART and require clinical attention.
高效抗逆转录病毒治疗（HAART）可显著抑制HIV复制，大幅增加CD4(+) T细胞数量，并部分重建免疫系统。然而，以往中国的研究纳入的受试者数量较少。本研究评估了HAART在中国晚期艾滋病患者中的疗效和副作用。
103例初治抗逆转录病毒药物的艾滋病患者纳入本研究，根据基线CD4(+)细胞计数分为两组：<100个细胞/微升或≥100个细胞/微升。在HAART治疗过程中，于基线及治疗后1、3、6、9和12个月监测临床、病毒学和免疫学指标。
1例患者死亡，另1例失访。对于HAART治疗12个月时其余101例HIV/AIDS患者，血浆病毒载量（VL）降至（3.2±0.7）lg拷贝/毫升，CD4(+)细胞计数增至（168±51）个细胞/微升[其中初始表型（CD45RA(+)CD62L(+)）增至（49±27）个细胞/微升，记忆表型（CD45RA(-)）增至（119±55）个细胞/微升]，且CD4(+)CD28(+)细胞百分比增加。同时，CD8(+) T细胞活化显著降低。在基线CD4(+)细胞计数<100个细胞/微升的69例患者中，37例VL<50拷贝/毫升；而在基线CD4(+)细胞计数≥100个细胞/微升的34例患者中，25例VL<50拷贝/毫升，两组间差异有统计学意义。HAART治疗期间CD4(+) T细胞计数呈两阶段增加，且CD4(+)细胞计数变化与血浆VL呈显著正相关。HAART治疗12个月期间，10例患者出现胃肠道副作用，13例出现周围神经炎，7例出现肝脏损害，8例出现血液学副作用，8例出现皮疹，10例出现脂肪代谢障碍，1例出现肾结石。
中国晚期艾滋病患者经HAART治疗后出现免疫重建，临床结局显著改善。HAART治疗期间副作用常见，需临床关注。
