中文摘要
HIV母婴传播给儿童造成了极大的危害,在HIV感染孕产妇服用抗病毒药物人群中发现了HIV耐药株,国内有研究发现耐药率为10%-12%,但是目前我国在HIV孕妇抗病毒药物防治中尚没有开展HIV耐药常规检测。本研究拟建立HIV感染孕妇研究队列,通过流行病学调查、临床研究、实验室技术等收集资料。利用测序技术将HIV Pol区进行扩增,所得序列提交斯坦福大学耐药数据库(www.hivdb.stanford.edu/)进行耐药评价。选用耐药产生为结局事件,HIV感染时间、用药时长、用药方案、停药时长、病毒载量、CD4+T数、行为特征、营养状态和临床特征等影响因素为自变量,将样本随机分为训练样本和检验样本,利用Cox回归模型进行建模、评估和检验,并从专业角度评估实际意义和价值。研究结果对提高母婴阻断抗病毒药物临床用药的精准性和我国HIV母婴传播的防治水平有重要意义。
英文摘要
Mother-to-child transmission of HIV poses great harm to children’s health. HIV resistant strains are detected among HIV-infected pregnant women on anti-retroviral drugs. Studies in China reported that the prevalence rates of resistance to therapy were between 10% and 12% and the rates were even higher reported by studies conducted abroad. However, testing on resistance to therapy is not routinely provided for HIV-infected pregnant women on anti-retroviral drugs in China. Our study aims to follow-up a cohort of HIV-infected pregnant women and collection data from epidemiologic survey, clinical research, laboratory techniques, etc. Genome sequences techniques will be used to expand HIV pol locus and the results of sequences will be submitted to Stanford University HIV Drug Resistance Database(www.hivdb.stanford.edu/) for resistance assessment. The samples will be separated into training samples and testing samples randomly and Cox regression model will be conducted for assessment and statistical tests using resistance to therapy as outcomes. Independent factors include duration of HIV infection, duration of therapy, ARV regimens, withdrawal time, viral load, CD4+T counting , behavior characteristics,nutrition,clinical features etc. Practice value will be evaluated from professional perspective. The research results will be critical for promoting clinical therapy precision and improving control and prevention strategies on mother-to-child transmission of HIV in our country.
