高效抗反转录病毒治疗艾滋病患儿近期不良反应71例

Study on Short-Term Adverse Effects of Highly Activity Antiretroviral Therapy in Children with Acquired Immunodeficiency Syndrome

目的观察人类免疫缺陷病毒(HIV)感染者或艾滋病(AIDS)患儿接受联合高效抗反转录病毒治疗(HAART)不良反应的发生情况。方法71例经酶联免疫法初筛、Westernblot法确诊HIV感染、以前未接受过HAART的儿童入选本前瞻性队列研究。男49例(69.0%),女22例(31.0%);平均年龄9.2(2～16)岁。其中46例接受齐多夫定(AZT)加拉米夫定(3TC)加奈韦拉平(NVP)治疗,25例接受司他夫定(d4T)加3TC加NVP治疗,记录治疗开始6个月内的不良反应(包括恶心、呕吐、腹泻、腹痛等消化道症状,中性粒细胞、Hb下降,转氨酶升高,皮疹,血淀粉酶升高等)发生率,并比较2种治疗方案的不良反应。结果主要不良反应发生情况如下:消化道症状(包括恶心、呕吐、腹泻、腹痛)52例(73.2%)、Hb下降30例(42.3%)、中性粒细胞下降12例(16.9%)、ALT升高15例(21.1%)、皮疹10例(10.4%)和血清淀粉酶升高6例(8.5%),多为轻到中度。Hb下降的发生率AZT加3TC加NVP组(56.5%)显著高于d4T加3TC加NVP组(16.0%)(P=0.001)。6例因不良反应而更改治疗方案,其中3例因AZT引起贫血改用d4T,1例因皮疹、2例因ALT升高将NVP改为依非韦仑(EFV)。无患者因不良反应而停止HAART。结论儿童AIDS的HAART近期不良反应较少,程度较轻,耐受性良好。AZT较d4T的骨髓抑制作用明显。

Objective To study on short - term adverse effects of highly activity antiretroviral therapy （HAART） in children infected with human immunodcfieiency virus （HIV） - 1 or acquired immune deficiency syndrome （AIDS）. Methods Seventy - one chihtren with H IV/AIDS,including 49 male and 22 female,aged 9.2 years old （ranged 2 to 16 years） were included in this prospective observational study. Forty -five cases received zidovudinc（AZT） plus lamivudine（3TC） plus nevirapine（NVP） and 26 cases received stavudine（d4T） plus 3TC plus NVP. The adverse effects including gastrointestinal diaturbances, neutropenia, hemoglobin declining, transaminase elevation, rash, serum amyalse elevation） observed within 6 months after the initiation of therapy were compared between 2 regimens. Results The major adverse effects including gastrointestinal disturbance including nausea, vomit, diarrhea, stomachache, hemoglobin decline, neutrophil decline, elevated alanine transaminase elevation（AI,T） ,rash,serum amylase elevation were seen in 52 cases （73.2%） ,30 cases （42.3%）, 1.2 cases （ 16.9% ）, 15 cases （21.1%） , 10 cases （10.4%） and 6 cases （8.5%） ,respectively. No differences in adverse effects incidence were observed between AZT- containing and d4T- containing regimens,except in hemoglobin decline which was much common in zidovudine（AZT） -containing regimen compared with d4T - containnig regimen （ 56.5% vs 16.0% P = 0. 001 ）. Six cases changed regimens,3 cases changed to stavudine （d4T） due to AZT - related anemia, 1 case changed to efaviren（EFV） due to NVP - related rash and 2 cases changed to EFV due to ALT elevation. No one discontinuated HAART because of the adverse effects. Conclusions The adverse effects are mild or moderate and well tollerated in children with HIV/AIDS receiving either AZT plus 3TC plus NVP or d4T plus 3TC plus NVP, Bone marrow suppression is more common in AZT - containing regimen compared with d4T - containing regimen.