应用含时依协变量Cox回归模型探讨美沙酮维持治疗者HCV阳转危险因素

Applying Time-dependent Cox Regression Model to Explore the Risk Factors of HCV Seroconversion among Clients in Methadone Maintenance Treatment

目的了解广东省社区美沙酮维持治疗(MMT)受治者中丙型肝炎病毒(HCV)的阳转率,探讨MMT受治者HCV阳转危险因素。方法选取广东省15家社区MMT门诊的所有受治者从2006年7月开诊至2014年3月进行追踪调查。调查基线时一般人口学特征,高危行为,HIV、HCV、梅毒及结核感染情况。入组后每天记录受治者服药剂量,每月对受治者进行尿吗啡检测,并每半年进行一次高危行为调查和HCV检测。定义观察终点为受治者发生HCV阳转。通过阳转人数除以随访人年数计算阳转率。采用含时依协变量的Cox回归模型分析HCV阳转的影响因素。比例风险假定采用Martingale残差法和Schoenfeld残差法进行检验。结果本研究共纳入1077名受治者,发生阳转440名,总随访2142.2人年,HCV阳转率为20.54/100人年。研究发现服用MMT剂量高于60ml(HR:1.53,1.09-2.14)、过去1个月注射吸毒(HR:2.49,1.60-3.87)的受治者发生HCV阳转的风险较大。结论较高的服药剂量和过去一个月注射吸毒是HCV阳转的危险因素。

Objective To explore the incidence of HCV sere, conversion among clients in methadone maintenance treatment in Guangdong Province, and the risk factors of HCV sere, conversion. Methods We selected all the clients in 15 MMT clinics in Guangdong Province. The clients were included from July 2006 to March 2014, and were followed from their enrolments to drop-outs. Clients were investigated on the demographic information, risk behaviors, and the results of HIV, HCV, and syphilis tests at baseline. Thereafter,daily dosage were also recorded. All clients were required to submit urine samples to test for opioids monthly. HCV testing were conducted twice a year. Clients were also investigated biyearly on their risk behaviors. The primary outcome of our study was HCV seroconversion. We calculated the seroconversion rate using HCV seroconversion cases dividing the duration of follow-up. Time-dependent Cox regression model was applied to explore the risk factors of HCV seroconversion. Proportional hazard assumption was examined using Martingale and Schoenfeld residual methods. Results Totally 1077 seronegative clients were included in our analysis. Of whom,440 cases of HCV seroconversion. We followed for 2142.2 person-years in total. The seroconversion rate was 20. 54 person-years. Clients who intake an average MMT dosage over 60 ml （HR：1. 53,1.09 -2. 14） ,and inject drugs in the past 1 month（HR：2.49,1.60 -3.87） ,have higher odds of HCV seroconversion. Conclusion High dosage of methadone and injection in the past 1 month predict HCV seroconversion.