Objective: To explore the causes of secondary drug resistance among HIV infected persons who were receiving antiretroviral therapy in Shandong province, and provide evidence for the improvement of antiretroviral therapy strategy. Methods: A case-control study was designed with 1∶2 matching on case and control groups. Household and face-to-face interview were conducted in October, 2015. All the study subjects were screened from both the drug resistant database of antiretroviral therapy of Shandong provincial laboratory and national comprehensive HIV/AIDS database in Shandong. The sample size was estimated as 330 cases including 110 drug resistant and 220 non-drug resistant cases. Subjects were people living with HIV/AIDS (PLWHA) aged 15 or older and received antiretroviral therapy for more than 6 months with records of virus load (VL). Subjects who presented VL above 1 000 copies/ml would receive drug resistance testing. Subjects who were confirmed resistant to with secondary drug, were selected as case group, the rest subjects with non-secondary drug resistance would form the control group. EpiData 3.1 software and SPSS 22.0 software were used to establish a database. Related influencing factors were analyzed with non- conditional stepwise logistic regression model. Results: A total of 288 cases were enrolled, including 103 in the case and 185 cases in the control groups, with average age as (37.62±1.06) years and (37.90±0.74) years old, respectively. Most of them were male, married/cohabitant, with education level of junior/senior high school or below and under Han nationality. Results from the multivariate logistic regression model showed that ORs (95%CI) of receiving antiretroviral therapy for 1-3 years, or more than 3 years were equal to 8.80 (3.69-21.00), 3.00 (1.20-7.53), compared with receiving antiretroviral therapy less than one year, respectively. OR (95%CI) of Among the PLWHA that with missing rate above 25.0% on medication, the OR appeared as 15.41(4.59-51.71), compared with not missing medication. OR (95%CI) among those who took the medicine themselves was 0.22 (0.07-0.74). Conclusions: Factors as duration of treatment, missing rate on medication and taking medicine by oneself were of influence on secondary drug resistance. Other factors as duration on antiretroviral therapy longer than 1 year, missing rate above 25.0% on medication, were related to the risk on secondary drug resistance. However, if the medicine was taken by oneself, it served as a protective factor for secondary drug resistance. It is necessary to strengthen the intervention and health education programs related to antiretroviral therapy.
目的： 了解HIV感染者抗病毒治疗发生继发性耐药的影响因素，为提高山东省抗病毒治疗效果提供依据。 方法： 按照病例对照研究设计，1∶2匹配病例组和对照组，2015年10月进行入户面对面调查。根据山东省级实验室自建的HIV感染者抗病毒治疗耐药数据库和艾滋病综合防治数据信息系统，筛选研究对象。样本量估计为330例（病例110例、对照组220例），研究对象为在山东省存活的HIV感染者、年龄≥15岁、参加抗病毒治疗≥6个月并检测病毒载量（VL）。针对VL>1 000拷贝/ml者进行实验室耐药检测，筛选出继发性耐药者作为病例组，非继发性耐药者为对照组。采用EpiData 3.1软件和SPSS 22.0软件建立数据库，运用非条件逐步logistic回归分析继发性耐药的影响因素。 结果： 研究对象共288例（病例组103例、对照组185例）。病例组年龄为（37.62±1.06）岁，对照组年龄为（37.90±0.74）岁，以男性、已婚/同居者、高中及以下文化程度、汉族为主。多因素logistic回归分析结果显示，与治疗时间<1年相比，治疗时间1~3年和>3年的OR值分别为8.80（95%CI：3.69~21.00）、3.00（95%CI：1.20~7.53）；与未漏服相比，漏服比例>25.0%的OR值为15.41（95%CI：4.59~51.71）；本人领药OR值为0.22（95%CI：0.07~0.74）。 结论： HIV感染者的治疗时间、漏服比例、本人领药为其抗病毒治疗继发性耐药的影响因素。治疗时间≥1年、漏服药物比例>25%为继发性耐药的危险因素，本人领药为继发性耐药的保护因素。应加强治疗优化的干预力度，提高HIV感染者本人对服药的认知水平。.
Keywords: AIDS; Antiretroviral therapy; Case-control study; Secondary drug resistance.