Jansen Klaus, Brockmeyer N H, Hahn M, Kaul I, Fenske S, Rausch M, Kuhlmann B, Ulmer A, Lauenroth-Mai E, Harrer T, Hower M, Skaletz-Rorowski A, Michalik C
Competence Network for HIV/AIDS, Clinic for Dermatology and Allergology, Ruhr-Universität Bochum, Bochum, Germany.
Eur J Med Res. 2009 Sep 28;14(10):415-25. doi: 10.1186/2047-783x-14-10-415.
As its central basis for research, the Competence Network for HIV/AIDS (KompNet) established a nationwide cohort study on HIV-positive patients being in medical care in Germany. In this paper, we describe the epidemiological composition, and clinical as well as treatment characteristics of the KompNet cohort over time.
The KompNet cohort is an open, retrospective and prospective, multi-center, disease-specific and nationwide cohort study that started gathering data in June 2004. Semiannually, follow up visits of the patients are documented, covering a wide range of clinical and sociodemographic data. At enrollment and three years afterwards, an EDTA-sample is taken; a serum-sample is taken at every follow up.
As of 20.10.2008, a total of 15,541 patients were enrolled by 44 documenting sites. In September 2007, the cohort size was reduced to ten outpatient clinics and fifteen private practitioners, covering a total of 9,410 patients. The documentation of these patients comprised 24,117 years of follow up-time since enrollment (mean: 2.6 years), 62,862 person years inclusive data documented retrospectively on course of HIV-infection and antiretroviral therapy (ART, mean: 6.7 years). Due to the short period of recruitment till now, rates of death (0.3%-0.8%) and losses to follow up (1.1%-5.5%) were low. 84.9% of patients were men. Main risk of transmission was sex between men (MSM: 62.9%). Mean age was 45 years. About two third of patients were classified as CDC-stage B or C. Therapy regimens of currently treated patients complied with recent guidelines. Trends of mean CD4 cell count/microl regarding the initial therapy and concerning the population under treatment reflected the developments and the changing standards of antiretroviral therapy over time.
The KompNet cohort covers about a quarter of all patients estimated as being under treatment in Germany. Its composition can be accounted approximately representative for the situation of clinical care and treatment in the scope of HIV/AIDS in Germany. Therefore, it is an important instrument for measuring the course of HIV/AIDS, the reality of use of antiretroviral therapy and its clinical and psychosocial outcomes in Germany.
作为其核心研究基础,德国艾滋病能力网络(KompNet)开展了一项针对在德国接受医疗护理的HIV阳性患者的全国性队列研究。在本文中,我们描述了KompNet队列随时间推移的流行病学构成、临床特征及治疗特点。
KompNet队列是一项开放、回顾性和前瞻性、多中心、疾病特异性的全国性队列研究,于2004年6月开始收集数据。每半年记录患者的随访情况,涵盖广泛的临床和社会人口统计学数据。在入组时及三年后采集乙二胺四乙酸(EDTA)样本;每次随访时采集血清样本。
截至2008年10月20日,44个记录点共纳入15541例患者。2007年9月,队列规模缩减至10个门诊诊所和15名私人执业医生,共涵盖9410例患者。这些患者的记录包括自入组以来24117年的随访时间(平均:2.6年),62862人年的回顾性记录数据,包括HIV感染病程和抗逆转录病毒治疗(ART,平均:6.7年)。由于目前招募期较短,死亡率(0.3%-0.8%)和失访率(1.1%-5.5%)较低。84.9%的患者为男性。主要传播风险是男性之间的性行为(男男性行为者:62.9%)。平均年龄为45岁。约三分之二的患者被归类为美国疾病控制与预防中心(CDC)B期或C期。目前接受治疗患者的治疗方案符合最新指南。初始治疗及接受治疗人群的平均每微升CD4细胞计数趋势反映了抗逆转录病毒治疗随时间的发展及标准变化。
KompNet队列涵盖了德国估计接受治疗的所有患者的约四分之一。其构成大致可代表德国HIV/AIDS临床护理和治疗的情况。因此,它是衡量德国HIV/AIDS病程、抗逆转录病毒治疗实际使用情况及其临床和心理社会结局的重要工具。