安徽省HIV感染既往献血人群疾病自然史研究
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摘要
背景
疾病自然史是指在没有药物干预的情况下疾病的自然演变过程。艾滋病病毒(HIV)感染的自然史是指在没有使用抗病毒药物的情况下,从感染HIV到艾滋病(AIDS)发病(艾滋病潜伏期)、从艾滋病发病到死亡(艾滋病生存时间)以及从感染HIV到死亡(HIV感染生存时间)的发展规律。自1981年世界首次报告艾滋病病例以来,各国纷纷开展关于HIV感染自然史及影响因素的研究。UNAIDS/WHO专家组在综合大量研究的基础上指出,在未经过抗病毒治疗的情况下,中低收入国家成人HIV感染者中位生存时间为9年(8~11年)。国外已对HIV感染疾病进展的众多潜在影响因素进行了研究,这些因素主要包括遗传因素、免疫因素、感染HIV时的年龄、性别、传播途径、吸烟、营养、与其它疾病共感染等,但除感染HIV时的年龄和人白细胞抗原(HLA)等少数因素已确认为相关因素外,其它尚缺乏足够的证据。
我国对HIV感染既往献血员(FBD)进行的HIV感染自然史研究较少。在山西曾对78例HIV感染既往献血员的中位生存时间及其影响因素做了初步探讨,调查结果显示其中位生存时间为7.4年,但其样本量偏小,且其调查对象是2002年以前发现的HIV感染者,这些对象由于快速进展出现艾滋病症状到医院就医时接受HIV检测发现的;另外其对影响因素的研究也仅限于性别、感染年份、感染时年龄等。我国自2003年开始实施“四免一关怀”政策,HIV感染者免费接受抗病毒治疗已有3年之久。然而,目前国内尚未见有关HIV感染既往献血员抗病毒治疗效果的报道。本研究以安徽省阜阳市HIV感染既往献血员(FBD)为目标人群,对HIV感染疾病进展、生存时间及抗病毒治疗效果情况进行了调查研究。
目的
1.了解安徽省HIV-1感染既往献血员的疾病进展及影响因素;
2.了解安徽省HIV-1感染既往献血员的生存时间及抗病毒治疗效果情况。
方法
1.于2005年6月至8月,在安徽省阜阳市招募HIV感染既往献血员294人,按照设计好的调查表对研究对象进行艾滋病疾病进展的横断面调查研究。分别采用χ2检验和Logistic回归模型进行单因素和多因素统计分析,分析HIV感染既往献血员疾病进展情况及其相关因素。
2.于2005年9月,在安徽省阜阳市从纳入横断面研究的HIV感染既往献血员中招募研究对象开展前瞻性队列研究,队列组建时筛选了206名HIV感染既往献血员,符合研究纳入标准的186人进入18个月的队列随访。在队列本底和每6个月随访时,完成1次访谈和采集血样进行HIV抗体、HBV表面抗原(HBsAg)、红细胞容积、血红蛋白、白细胞(白细胞分类计数)、CD4+和CD8+ T细胞计数、CD8+ T细胞反应、中和抗体、血浆HIV-1 RNA(病毒载量)、HIV亚型、HIV-1表型等检测。采用Cox比例风险回归模型进行HIV-1感染既往献血员疾病进展影响因素的单因素和多因素分析。
3.于2006年5月至8月,对安徽省阜阳市HIV疫情报告登记系统中1995年和1996年发现的159名HIV感染既往献血员进行死亡情况回顾性调查,调查内容包括社会人口学、高危行为、死亡和抗病毒治疗情况。利用韦伯函数计算中位生存时间,通过比较实际死亡人数和理论死亡人数来评价抗病毒治疗效果。
结果
1.横断面调查的294名HIV感染既往献血员疾病进展率(CD4<200个/μl或WHO临床Ⅲ/Ⅳ期的人数/纳入研究总人数)为27.9 %(82/294)。在多因素Logistic回归模型分析中,若考虑病毒载量,则血细胞压积≥35%(OR, 0.28; 95% CI, 0.14-0.54, P=0.0002)、CD8+ T细胞计数≥800个/μl(OR, 0.18; 95% CI, 0.09-0.37; P<0.0001)、ELISPOT Env≥300 SFC/106(OR, 5.58; 95% CI, 2.13-14.61; P=0.0005)、存在HLA B15等位基因(OR,2.17, 95% CI, 1.06-4.44; P=0.0341)与HIV感染既往献血员疾病进展有统计学意义;若不考虑病毒载量,则血细胞压积≥35%(OR, 0.27; 95% CI, 0.14-0.51, P<0.0001)、淋巴细胞计数≥1200个/μl(OR, 0.04; 95% CI, 0.01-0.29; P<0.0001)、ELISPOT Env≥300 SFC/106(OR, 3.39; 95% CI, 1.43-8.06; P=0.0056)、存在HLA B15等位基因(OR,2.06, 95% CI, 1.08-3.94; P=0.0284)与HIV感染既往献血员疾病进展有统计学意义。
2.在队列18个月的随访中,艾滋病疾病进展(CD4<200个/μl或WHO临床Ⅲ/Ⅳ期或死亡或进行抗病毒治疗)59人,总进展率为26.85/100人年(95%CI: 20.00-33.70)。第6个月、第12个月和第18个月随访中疾病进展分别为23人、29人和7人,进展率分别为28.26/100人年(95%CI: 15.46-31.06)、34.23/100人年(95%CI: 21.77-46.69)和13.04/100人年(95% CI: 3.38-22.70)。多因素Cox回归模型分析中,中性粒细胞计数≥2.0×109/L(HR, 0.43; 95% CI, 0.26-0.73; P=0.0015)、GHOST(IC50)≥100(HR, 2.64; 95% CI, 1.11-6.30; P=0.0282)、ICS IL-2+ IFN-γ- Tat+Rev>0%(HR, 3.04; 95% CI, 1.60-5.77; P=0.0007)与HIV感染既往献血员疾病进展有统计学意义。
3.安徽省阜阳市未接受抗病毒治疗的既往献血人群HIV感染平均时间为1994年底,中位生存时间为9.7年。当地2003年开始抗病毒治疗后,比预期死亡人数减少65.3%。
结论
1.观察到血细胞压积、中性粒细胞计数、淋巴细胞计数、CD8+ T细胞计数、ELISPOT Env、HLA B15等位基因、GHOST(IC50)、ICS IL-2+ IFN-γ- Tat+Rev与疾病进展有联系。
2.利用韦伯函数估算的未接受抗病毒治疗的HIV-1感染既往献血员的中位生存时间为9.7年。当地抗病毒治疗初现成效。
Background
Natural history refers to the course of a disease from onset to death without any intervention. The natural history of HIV infection refers to disease progression from the onset of HIV infection to AIDS (AIDS incubation), from infection to death (Survival time of HIV infection), and from diagnosis of AIDS to death (AIDS survival time). Since the first AIDS case was reported in 1981, enormous amounts of studies have focused on survival time from HIV infection to death. UNAIDS/WHO recommended that, an overall median survival time of 9 years should be used as an estimate for adults who are not receiving antiretroviral therapy, with arrange of 8 to 11 years, the age at HIV seroconversion and HLA gene have effects on disease progression. Many potential factors, such as immune factors, genetic factors, the age at HIV seroconversion, gender, mode of transmission, smoking, nutrition and co-infection with other diseases were studied, while only a few factors (such as the age at HIV seroconversion and HLA gene) were confirmed to be associated with the progress of the disease, others should be investigated further.
Studies from China on the natural history of HIV-positive former blood doners are limited. A survey in Shanxi Province showed that the median survival time of HIV-positive former blood donors was 7.4 years, but the 78 participants in Shanxi Province were HIV-positive former blood donors who were identified before 2002, they were received HIV testing and discovered to be HIV-infected due to the AIDS symptom. Although the Chinese government eradicated the illegal plasma/blood collection practices in 1996, antiretroviral therapy (ART) was not available to those HIV-infected rural residents until the end of 2003. Since then, HIV-infected FBDs have received free ART for three years, only limited data are available on the effect of antiretroviral therapy (ART). This is the first investigation on the natural history and the effect of antiretroviral therapy (ART) among the HIV-1 infected former blood donors which largely occurred in the mid of 1990s in China.
Objectives
1. To estimate the progress of the disease and its impact factors among HIV-1- positive former blood donors in Fuyang of Anhui province, China.
2. To estimate the median survival and the effect of antiretroviral therapy (ART) among HIV-1-positive former blood donors in Fuyang of Anhui province, China.
Methods
1. From June through August 2005, 294 HIV-positive former blood donors were recruited from Fuyang, Anhui, and interviewed. Factors hypothesized to be associated with with the progress of the disease were analyzed with chi-square test in univariate analysis and Logistic regression model in multivariate analysis.
2. In September 2005, a baseline survey was conducted to recruit 206 HIV-sero- negative FBDs for a prospective cohort study in Fuyang County of Anhui Province, China. Follow-up visits were conducted every 6 months to investigate clinical symptoms and signs, and blood specimens were also collected to test for HIV antibody, HBsAg, hematology, CD4, CD8, CD8+ T cell, HIV-1 RNA, HIV subtype, HIV-1 phenotype. Factors hypothesized to be associated with the progress of the disease were analyzed with univariate and ultivariate Cox regression analysis.
3. From May to August, 2006, a retrospective survey was conducted to collect data about demographics, high risk HIV behaviors, death and ART among HIV-positive former blood donors who were identified from the HIV/AIDS reporting system between 1995 or 1996. Weibull function was used to calculate median survival of HIV-positive former blood donors. The effect of ART was estimated through comparing the actual number of deaths and the expected number of deaths.
Results
1. Of the 294 HIV-positive former blood donors, 82 (27.9%) had progression (CD4+ counts<200 cells/mm3 or Clinical StageⅢ/Ⅳas per WHO Staging System) of HIV-1 disease. Considering viral load, multiple logistic regression analyses demonstrated that Hematocrit≥35% (OR, 0.28; 95% CI, 0.14-0.54, P=0.0002), CD8+ T cell counts≥1200 cells/mm3 (OR, 0.18; 95% CI, 0.09-0.37; P<0.0001)、ELISPOT Env≥300 SFC/106 (OR, 5.58; 95% CI, 2.13-14.61; P=0.0005) and HLA B15 (OR,2.17, 95% CI, 1.06-4.44; P=0.0341) were associated with the progress of the disease; if viral load not included, then Hematocrit≥35% (OR, 0.27; 95% CI, 0.14-0.51, P<0.0001), total lymphocyte counts≥1200 cells/mm3 (OR, 0.04; 95% CI, 0.01-0.29; P<0.0001)、ELISPOT Env≥300 (OR, 3.39; 95% CI, 1.43-8.06; P=0.0056) and HLA B15 (OR, 2.06; 95% CI, 1.08-3.94; P=0.0284) were associated with the progress of the disease.
2. A total of 59 progressors (CD4+ counts<200 cells/mm3 or Clinical StageⅢ/Ⅳas per WHO Staging System or initiation of ART for any reason or death) were found during the 1.5-year follow-up study. The progress rate of the cohort was 26.85 per 100 person-years (95% CI: 20.00-33.70), decreasing from 28.26/100 person-years at the first followup (95%CI: 15.46-31.06), to 34.23/100 person-years at the second followup (95%CI: 21.77-46.69), to 13.04/100 person-years at the last followup (95% CI: 3.38-22.70). Neutrophil≥2.0×109/l, (Hazard Ratio [HR], 0.43; 95% CI: 0.26, 0.73; P=0.0015), GHOST(IC50)≥100, (HR, 2.64; 95% CI: 1.11, 6.30; P=0.0282) and ICS IL-2+ IFN-γ- Tat+Rev>0%, (HR, 3.04; 95% CI: 1.60, 5.77; P=0.0007) were found to be associated with the progress of the disease in the final Cox regression model.
3. The median period of HIV infection was at the end of 1994, the median survival of HIV-positive former blood donors in Fuyang was 9.7 years. 65.3% of death among HIV-positive former blood donors was reduced by ART initiated by the end of 2003.
Conclusion
1. Hematocrit, Neutrophil, CD8+ T cell counts, total lymphocyte counts, ELISPOT Env, HLA B15, GHOST(IC50) and ICS IL-2+ IFN-γ- Tat+Rev were associated with the progress of the disease.
2. The median survival was 9.7 years and ART has a great effect of reducing death among HIV-positive former blood donors.
疾病自然史是指在没有药物干预的情况下疾病的自然演变过程。艾滋病病毒(HIV)感染的自然史是指在没有使用抗病毒药物的情况下,从感染HIV到艾滋病(AIDS)发病(艾滋病潜伏期)、从艾滋病发病到死亡(艾滋病生存时间)以及从感染HIV到死亡(HIV感染生存时间)的发展规律。自1981年世界首次报告艾滋病病例以来,各国纷纷开展关于HIV感染自然史及影响因素的研究。UNAIDS/WHO专家组在综合大量研究的基础上指出,在未经过抗病毒治疗的情况下,中低收入国家成人HIV感染者中位生存时间为9年(8~11年)。国外已对HIV感染疾病进展的众多潜在影响因素进行了研究,这些因素主要包括遗传因素、免疫因素、感染HIV时的年龄、性别、传播途径、吸烟、营养、与其它疾病共感染等,但除感染HIV时的年龄和人白细胞抗原(HLA)等少数因素已确认为相关因素外,其它尚缺乏足够的证据。
我国对HIV感染既往献血员(FBD)进行的HIV感染自然史研究较少。在山西曾对78例HIV感染既往献血员的中位生存时间及其影响因素做了初步探讨,调查结果显示其中位生存时间为7.4年,但其样本量偏小,且其调查对象是2002年以前发现的HIV感染者,这些对象由于快速进展出现艾滋病症状到医院就医时接受HIV检测发现的;另外其对影响因素的研究也仅限于性别、感染年份、感染时年龄等。我国自2003年开始实施“四免一关怀”政策,HIV感染者免费接受抗病毒治疗已有3年之久。然而,目前国内尚未见有关HIV感染既往献血员抗病毒治疗效果的报道。本研究以安徽省阜阳市HIV感染既往献血员(FBD)为目标人群,对HIV感染疾病进展、生存时间及抗病毒治疗效果情况进行了调查研究。
目的
1.了解安徽省HIV-1感染既往献血员的疾病进展及影响因素;
2.了解安徽省HIV-1感染既往献血员的生存时间及抗病毒治疗效果情况。
方法
1.于2005年6月至8月,在安徽省阜阳市招募HIV感染既往献血员294人,按照设计好的调查表对研究对象进行艾滋病疾病进展的横断面调查研究。分别采用χ2检验和Logistic回归模型进行单因素和多因素统计分析,分析HIV感染既往献血员疾病进展情况及其相关因素。
2.于2005年9月,在安徽省阜阳市从纳入横断面研究的HIV感染既往献血员中招募研究对象开展前瞻性队列研究,队列组建时筛选了206名HIV感染既往献血员,符合研究纳入标准的186人进入18个月的队列随访。在队列本底和每6个月随访时,完成1次访谈和采集血样进行HIV抗体、HBV表面抗原(HBsAg)、红细胞容积、血红蛋白、白细胞(白细胞分类计数)、CD4+和CD8+ T细胞计数、CD8+ T细胞反应、中和抗体、血浆HIV-1 RNA(病毒载量)、HIV亚型、HIV-1表型等检测。采用Cox比例风险回归模型进行HIV-1感染既往献血员疾病进展影响因素的单因素和多因素分析。
3.于2006年5月至8月,对安徽省阜阳市HIV疫情报告登记系统中1995年和1996年发现的159名HIV感染既往献血员进行死亡情况回顾性调查,调查内容包括社会人口学、高危行为、死亡和抗病毒治疗情况。利用韦伯函数计算中位生存时间,通过比较实际死亡人数和理论死亡人数来评价抗病毒治疗效果。
结果
1.横断面调查的294名HIV感染既往献血员疾病进展率(CD4<200个/μl或WHO临床Ⅲ/Ⅳ期的人数/纳入研究总人数)为27.9 %(82/294)。在多因素Logistic回归模型分析中,若考虑病毒载量,则血细胞压积≥35%(OR, 0.28; 95% CI, 0.14-0.54, P=0.0002)、CD8+ T细胞计数≥800个/μl(OR, 0.18; 95% CI, 0.09-0.37; P<0.0001)、ELISPOT Env≥300 SFC/106(OR, 5.58; 95% CI, 2.13-14.61; P=0.0005)、存在HLA B15等位基因(OR,2.17, 95% CI, 1.06-4.44; P=0.0341)与HIV感染既往献血员疾病进展有统计学意义;若不考虑病毒载量,则血细胞压积≥35%(OR, 0.27; 95% CI, 0.14-0.51, P<0.0001)、淋巴细胞计数≥1200个/μl(OR, 0.04; 95% CI, 0.01-0.29; P<0.0001)、ELISPOT Env≥300 SFC/106(OR, 3.39; 95% CI, 1.43-8.06; P=0.0056)、存在HLA B15等位基因(OR,2.06, 95% CI, 1.08-3.94; P=0.0284)与HIV感染既往献血员疾病进展有统计学意义。
2.在队列18个月的随访中,艾滋病疾病进展(CD4<200个/μl或WHO临床Ⅲ/Ⅳ期或死亡或进行抗病毒治疗)59人,总进展率为26.85/100人年(95%CI: 20.00-33.70)。第6个月、第12个月和第18个月随访中疾病进展分别为23人、29人和7人,进展率分别为28.26/100人年(95%CI: 15.46-31.06)、34.23/100人年(95%CI: 21.77-46.69)和13.04/100人年(95% CI: 3.38-22.70)。多因素Cox回归模型分析中,中性粒细胞计数≥2.0×109/L(HR, 0.43; 95% CI, 0.26-0.73; P=0.0015)、GHOST(IC50)≥100(HR, 2.64; 95% CI, 1.11-6.30; P=0.0282)、ICS IL-2+ IFN-γ- Tat+Rev>0%(HR, 3.04; 95% CI, 1.60-5.77; P=0.0007)与HIV感染既往献血员疾病进展有统计学意义。
3.安徽省阜阳市未接受抗病毒治疗的既往献血人群HIV感染平均时间为1994年底,中位生存时间为9.7年。当地2003年开始抗病毒治疗后,比预期死亡人数减少65.3%。
结论
1.观察到血细胞压积、中性粒细胞计数、淋巴细胞计数、CD8+ T细胞计数、ELISPOT Env、HLA B15等位基因、GHOST(IC50)、ICS IL-2+ IFN-γ- Tat+Rev与疾病进展有联系。
2.利用韦伯函数估算的未接受抗病毒治疗的HIV-1感染既往献血员的中位生存时间为9.7年。当地抗病毒治疗初现成效。
Background
Natural history refers to the course of a disease from onset to death without any intervention. The natural history of HIV infection refers to disease progression from the onset of HIV infection to AIDS (AIDS incubation), from infection to death (Survival time of HIV infection), and from diagnosis of AIDS to death (AIDS survival time). Since the first AIDS case was reported in 1981, enormous amounts of studies have focused on survival time from HIV infection to death. UNAIDS/WHO recommended that, an overall median survival time of 9 years should be used as an estimate for adults who are not receiving antiretroviral therapy, with arrange of 8 to 11 years, the age at HIV seroconversion and HLA gene have effects on disease progression. Many potential factors, such as immune factors, genetic factors, the age at HIV seroconversion, gender, mode of transmission, smoking, nutrition and co-infection with other diseases were studied, while only a few factors (such as the age at HIV seroconversion and HLA gene) were confirmed to be associated with the progress of the disease, others should be investigated further.
Studies from China on the natural history of HIV-positive former blood doners are limited. A survey in Shanxi Province showed that the median survival time of HIV-positive former blood donors was 7.4 years, but the 78 participants in Shanxi Province were HIV-positive former blood donors who were identified before 2002, they were received HIV testing and discovered to be HIV-infected due to the AIDS symptom. Although the Chinese government eradicated the illegal plasma/blood collection practices in 1996, antiretroviral therapy (ART) was not available to those HIV-infected rural residents until the end of 2003. Since then, HIV-infected FBDs have received free ART for three years, only limited data are available on the effect of antiretroviral therapy (ART). This is the first investigation on the natural history and the effect of antiretroviral therapy (ART) among the HIV-1 infected former blood donors which largely occurred in the mid of 1990s in China.
Objectives
1. To estimate the progress of the disease and its impact factors among HIV-1- positive former blood donors in Fuyang of Anhui province, China.
2. To estimate the median survival and the effect of antiretroviral therapy (ART) among HIV-1-positive former blood donors in Fuyang of Anhui province, China.
Methods
1. From June through August 2005, 294 HIV-positive former blood donors were recruited from Fuyang, Anhui, and interviewed. Factors hypothesized to be associated with with the progress of the disease were analyzed with chi-square test in univariate analysis and Logistic regression model in multivariate analysis.
2. In September 2005, a baseline survey was conducted to recruit 206 HIV-sero- negative FBDs for a prospective cohort study in Fuyang County of Anhui Province, China. Follow-up visits were conducted every 6 months to investigate clinical symptoms and signs, and blood specimens were also collected to test for HIV antibody, HBsAg, hematology, CD4, CD8, CD8+ T cell, HIV-1 RNA, HIV subtype, HIV-1 phenotype. Factors hypothesized to be associated with the progress of the disease were analyzed with univariate and ultivariate Cox regression analysis.
3. From May to August, 2006, a retrospective survey was conducted to collect data about demographics, high risk HIV behaviors, death and ART among HIV-positive former blood donors who were identified from the HIV/AIDS reporting system between 1995 or 1996. Weibull function was used to calculate median survival of HIV-positive former blood donors. The effect of ART was estimated through comparing the actual number of deaths and the expected number of deaths.
Results
1. Of the 294 HIV-positive former blood donors, 82 (27.9%) had progression (CD4+ counts<200 cells/mm3 or Clinical StageⅢ/Ⅳas per WHO Staging System) of HIV-1 disease. Considering viral load, multiple logistic regression analyses demonstrated that Hematocrit≥35% (OR, 0.28; 95% CI, 0.14-0.54, P=0.0002), CD8+ T cell counts≥1200 cells/mm3 (OR, 0.18; 95% CI, 0.09-0.37; P<0.0001)、ELISPOT Env≥300 SFC/106 (OR, 5.58; 95% CI, 2.13-14.61; P=0.0005) and HLA B15 (OR,2.17, 95% CI, 1.06-4.44; P=0.0341) were associated with the progress of the disease; if viral load not included, then Hematocrit≥35% (OR, 0.27; 95% CI, 0.14-0.51, P<0.0001), total lymphocyte counts≥1200 cells/mm3 (OR, 0.04; 95% CI, 0.01-0.29; P<0.0001)、ELISPOT Env≥300 (OR, 3.39; 95% CI, 1.43-8.06; P=0.0056) and HLA B15 (OR, 2.06; 95% CI, 1.08-3.94; P=0.0284) were associated with the progress of the disease.
2. A total of 59 progressors (CD4+ counts<200 cells/mm3 or Clinical StageⅢ/Ⅳas per WHO Staging System or initiation of ART for any reason or death) were found during the 1.5-year follow-up study. The progress rate of the cohort was 26.85 per 100 person-years (95% CI: 20.00-33.70), decreasing from 28.26/100 person-years at the first followup (95%CI: 15.46-31.06), to 34.23/100 person-years at the second followup (95%CI: 21.77-46.69), to 13.04/100 person-years at the last followup (95% CI: 3.38-22.70). Neutrophil≥2.0×109/l, (Hazard Ratio [HR], 0.43; 95% CI: 0.26, 0.73; P=0.0015), GHOST(IC50)≥100, (HR, 2.64; 95% CI: 1.11, 6.30; P=0.0282) and ICS IL-2+ IFN-γ- Tat+Rev>0%, (HR, 3.04; 95% CI: 1.60, 5.77; P=0.0007) were found to be associated with the progress of the disease in the final Cox regression model.
3. The median period of HIV infection was at the end of 1994, the median survival of HIV-positive former blood donors in Fuyang was 9.7 years. 65.3% of death among HIV-positive former blood donors was reduced by ART initiated by the end of 2003.
Conclusion
1. Hematocrit, Neutrophil, CD8+ T cell counts, total lymphocyte counts, ELISPOT Env, HLA B15, GHOST(IC50) and ICS IL-2+ IFN-γ- Tat+Rev were associated with the progress of the disease.
2. The median survival was 9.7 years and ART has a great effect of reducing death among HIV-positive former blood donors.
引文
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