Acquired immune deficiency syndrome

获得性免疫缺陷综合征
  • 文章类型: Journal Article
    背景:这项研究考察了获得性免疫缺陷综合征(AIDS)发病率的全球趋势,死亡率,和1990年至2019年的残疾调整寿命年(DALYs),重点关注艾滋病发病率的地区差异,死亡率,不同水平的社会人口指数(SDI)和DALY。它还调查了艾滋病发病率的变化,死亡率,和不同年龄段的DALY,并预测未来25年的具体趋势。
    方法:从GBD研究中获得了204个国家和地区1990年至2019年艾滋病的综合数据。这包括艾滋病发病率的信息,死亡率,DALYs,和年龄标准化率(ASR)。使用贝叶斯年龄周期队列模型生成了未来25年艾滋病发病率和死亡率的预测。
    结果:从1990年到2019年,全球HIV病例发病率从1,989,282增加到2,057,710,而年龄标准化发病率(ASIR)从37.59下降到25.24,估计年变化百分比(EAPC)为-2.38。ASIR在高SDI和中高SDI地区表现出上升趋势,SDI中部地区的稳定趋势,中低SDI和低SDI地区呈下降趋势。在SDI较高的地区,男性的ASIR高于女性,而在较低的SDI地区则相反。整个1990年至2019年,年龄标准化死亡率(ASDR)和年龄标准化DALY率保持稳定,EAPC分别为0.24和0.08。影响妇女和五岁以下儿童的艾滋病毒负担最高的国家主要位于SDI较低地区,特别是在撒哈拉以南非洲。预测显示,今后25年艾滋病按年龄标出的发病率和死亡率持续显著下降,总体和性别。
    结论:全球ASIR从1990年到2019年下降。在较低的SDI地区观察到较高的发病率和死亡率,表明女性和<15岁的人更容易感染艾滋病。这突出表明,迫切需要增加该地区防治艾滋病的资源,重点关注保护妇女和<15岁的优先群体。在撒哈拉以南非洲,艾滋病的流行仍然很严重。未来25年的预测表明,年龄标准化的发病率和死亡率都将大幅下降。
    BACKGROUND: This study examines global trends in acquired immune deficiency syndrome (AIDS) incidence, mortality, and disability-adjusted life years (DALYs) from 1990 to 2019, focusing on regional disparities in AIDS incidence, mortality, and DALYs across various levels of socio-demographic index (SDI). It also investigates variations in AIDS incidence, mortality, and DALYs across different age groups, and projects specific trends for the next 25 years.
    METHODS: Comprehensive data on AIDS from 1990 to 2019 in 204 countries and territories was obtained from a GBD study. This included information on AIDS incidence, mortality, DALYs, and age-standardized rates (ASRs). Projections for AIDS incidence and mortality over the next 25 years were generated using the Bayesian age-period-cohort model.
    RESULTS: From 1990 to 2019, the global incidence of HIV cases increased from 1,989,282 to 2,057,710, while the age-standardized incidence rate (ASIR) decreased from 37.59 to 25.24 with an estimated annual percentage change (EAPC) of -2.38. The ASIR exhibited an upward trend in high SDI and high-middle SDI regions, a stable trend in middle SDI regions, and a downward trend in low-middle SDI and low SDI regions. In regions with higher SDI, the ASIR was higher in males than in females, while the opposite was observed in lower SDI regions. Throughout 1990 to 2019, the age-standardized death rate (ASDR) and age-standardized DALY rate remained stable, with EAPCs of 0.24 and 0.08 respectively. Countries with the highest HIV burden affecting women and children under five years of age are primarily situated in lower SDI regions, particularly in sub-Saharan Africa. Projections indicate a significant continued decline in the age-standardized incidence and mortality rates of AIDS over the next 25 years, for both overall and by gender.
    CONCLUSIONS: The global ASIR decreased from 1990 to 2019. Higher incidence and death rates were observed in the lower SDI region, indicating a greater susceptibility to AIDS among women and < 15 years old. This underscores the urgent need for increased resources to combat AIDS in this region, with focused attention on protecting women and < 15 years old as priority groups. The AIDS epidemic remained severe in sub-Saharan Africa. Projections for the next 25 years indicate a substantial and ongoing decline in both age-standardized incidence and mortality rates.
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  • 文章类型: Journal Article
    隐球菌病是一种侵袭性感染,通常影响免疫抑制个体,尤其是HIV感染者。HIV感染患者中的隐球菌感染应被视为主要的健康问题,因为它与高发病率和死亡率有关。在这项研究中,我们旨在评估人类免疫缺陷病毒(HIV)感染患者隐球菌感染的临床特征和预后因素,以促进有效的临床管理并改善患者预后.
    我们回顾并分析了首都医科大学附属北京佑安医院2013年至2023年间隐球菌培养阳性和保留菌株的HIV感染患者的临床数据和相关实验室检测结果。比较患者的临床特征和实验室检查结果,并分析各参数与患者在不同观察时间点(3、6、9和12个月)的预后之间的相关性。
    共有76名患者(男性70名,女性6名;中位年龄,37年)纳入本研究。结果表明,在诊断为HIV感染后(>6个月)开始抗逆转录病毒治疗(ART)越晚,死亡的可能性越高。对ART启动时间与隐球菌感染治疗时机的相关性分析表明,ART启动时间与不同时间点的生存率密切相关。在0-4周内开始ART时间,开始治疗隐球菌感染的4-6周和6周以上与12个月时较低的死亡率相关,三个月,分别为6个月和9个月的随访时间点。
    尽管艾滋病毒感染者的隐球菌感染仍然是一个具有挑战性和错综复杂的问题,ART是影响其预后的关键因素。后来的ART开始了,感染的预后越差。应根据不同的临床疗程进一步完善和平衡ART起始时间和隐球菌感染的治疗时机。因此,临床医师应密切关注HIV感染患者的隐球菌感染,并根据患者的临床情况启动ART。
    UNASSIGNED: Cryptococcosis is an invasive infection that commonly affects immunosuppressed individuals, especially patients with HIV infection. Cryptococcal infection in HIV-infected patients should be considered a major health concern because it is associated with high morbidity and mortality rates. In this study, we aimed to evaluate the clinical characteristics and prognostic factors of cryptococcal infections in human immunodeficiency virus (HIV)-infected patients to facilitate effective clinical management and improve patient outcomes.
    UNASSIGNED: We reviewed and analyzed the clinical data and relevant laboratory test results of HIV-infected patients with positive cryptococcal cultures and reserved strains between 2013 and 2023 from Beijing Youan Hospital affiliated to Capital Medical University. The clinical characteristics and laboratory test results of the patients were compared, and the correlation between parameters and the prognoses of the patients at different observation timepoints (3, 6, 9, and 12 months) was analyzed.
    UNASSIGNED: A total of 76 patients (70 males and six females; median age, 37 years) were included in this study. The results indicated that the later the initiation of antiretroviral therapy (ART) after the diagnosis of HIV infection (> 6 months), the higher the probability of death. Analysis of the correlation between the time of ART initiation and the timing of treatment for cryptococcal infections showed that the time of ART initiation was strongly related to survival at different timepoints. Initiation of ART time within 0-4 weeks, 4-6 weeks and more than 6weeks of starting treatment for Cryptococcus infection was associated with a lower mortality rate at 12-month, the 3-month, 6- and 9-month follow-up timepoint separately.
    UNASSIGNED: Although cryptococcal infection in HIV-infected patients continues to be a challenging and intricate issue, ART is a key factor that affects its prognosis. The later ART is started, the worse the prognosis of the infection. The time of ART initiation and the timing of treatment for cryptococcal infections should be further refined and balanced based on different clinical courses. Thus, clinicians should pay closer attention to cryptococcal infections in patients with HIV infection and initiate ART based on the patient\'s clinical condition.
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  • 文章类型: Case Reports
    地堡分枝杆菌是一种不可培养的,非结核分枝杆菌,偶尔引起免疫缺陷个体的严重感染。由于其不可培养的性质,其抗菌药物敏感性尚未评估,最佳治疗方案尚不清楚。在这里,我们报告了一例播散性T.tilburgii感染艾滋病患者,使用宏基因组学下一代测序(mNGS)和聚合酶链反应(PCR)进行鉴定。
    一名33岁男子有3个月的腹痛史,淋巴结病,间歇性夜间潮热,盗汗,和减肥。在最初的常规调查中未检测到病原体。随后使用mNGS在左颈淋巴结样品中鉴定了tilburgii。此外,基于16SrRNA的PCR和hsp65基因测序,在骨髓样品中检测到M.tilburgii感染。该人接受了莫西沙星的联合治疗,克拉霉素,乙胺丁醇,rifabutin,还有阿米卡星.实验室结果有所改善,病人的症状也得到了缓解.
    M.在诊断测试中可能会错过tilburgii,因为它不能使用常规培养技术进行培养。早期诊断和及时有效的治疗是临床治疗的关键,因此,分子技术被推荐用于怀疑有M.tilburgii感染的患者。
    UNASSIGNED: Mycobacterium tilburgii is a nonculturable, nontuberculous mycobacterium that occasionally causes serious infections in individuals with immune deficiencies. Owing to its nonculturable nature, its antimicrobial susceptibility has not been assessed, and the optimal treatment regimen is unclear. Herein, we report a case of disseminated M. tilburgii infection in a person with AIDS, identified using metagenomics next-generation sequencing (mNGS) and polymerase chain reaction (PCR).
    UNASSIGNED: A 33-year-old man presented with a 3-month history of abdominal pain, lymphadenopathy, intermittent night hot flashes, night sweats, and weight loss. No pathogen was detected during initial routine investigations. M. tilburgii was subsequently identified in a left cervical lymph node sample using mNGS. Furthermore, M. tilburgii infection was detected in a bone marrow sample based on PCR of 16S rRNA and hsp65 gene sequencing. The person was treated with a combination of moxifloxacin, clarithromycin, ethambutol, rifabutin, and amikacin. The laboratory results improved, and the patient\'s symptoms resolved.
    UNASSIGNED: M. tilburgii may be missed in diagnostic tests because it cannot be grown using routine culture techniques. Early diagnosis and timely and effective treatment are critical in patients with M. tilburgii infection; therefore, molecular techniques are recommended for patients with suspected M. tilburgii infection.
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  • 文章类型: Journal Article
    我们旨在在蛋白质组学水平上区分获得性免疫缺陷综合征(AIDS)患者的不同中医(CM)综合征。
    我们收集了渭氏县诊断为不同CM综合征的艾滋病患者,开封市,河南省,中国,包括气虚证(QD组)和湿热证(DH组)。从渭氏县收集健康人群作为对照,开封市,河南省,中国。三组的血浆用ITRAQ标记,LC/MC用于蛋白质定量分析。最后,进行序列搜索和聚类分析。
    总的来说,发现了27种不同的蛋白质。QD组有3种蛋白上调,2种蛋白下调,DH组中11种蛋白质上调,13种蛋白质下调。与DH组相比,QD组有7种不同的蛋白质,其中5种蛋白下调,2种蛋白上调。当DH组的靶蛋白上调时,HC组蛋白表达下调。
    蛋白质结果的显著性分析和聚类表明,在蛋白质水平上,DH组与QD组和HC组差异有统计学意义(P<0.05)。然而,QD组与HC组无法有效区分.AAT,PF4、C反应蛋白和c4bp可作为DH组潜在的生物标志物。基于特征选择的质谱可用于对不同的CM综合征进行分类。
    UNASSIGNED: We aimed to distinguish the different Chinese medicine (CM) syndromes of acquired immune deficiency syndrome (AIDS) patients at the proteomics level.
    UNASSIGNED: We collected AIDS patients diagnosed with different CM syndromes from Weishi County, Kaifeng City, Henan Province, China, including Qi-deficiency syndrome (named QD group) and dampness-heat syndrome (named DH group). Healthy people were collected as controls from Weishi County, Kaifeng city, Henan Province, China. The plasma from three groups were labeled with ITRAQ, LC/MC was used for protein quantitative analysis. Finally, sequence search and cluster analysis were performed.
    UNASSIGNED: Overall, 27 different proteins were found. Three proteins were up-regulated and 2 proteins down-regulated in the QD group, 11 proteins up-regulated and 13 proteins down-regulated in the DH group. Compared with DH group, there were 7 different proteins in QD group, among which 5 proteins were down-regulated and 2 proteins were up-regulated. When the target protein of DH group was up-regulated, the protein of HC group was down-regulated correspondingly.
    UNASSIGNED: The significance analysis and clustering of protein results showed that DH group was significantly different from QD group and HC group at the protein level (P<0.05). However, the QD group could not be effectively distinguished from the HC group. AAT, PF4, C-reactive protein and c4bp may be used as potential biomarkers in DH group. Mass spectrometry based on feature selection can be used to classify different CM syndromes.
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  • 文章类型: Journal Article
    Hepatitis B is a major infectious disease that seriously endangers the health of the people of China. Patients with hepatitis B have a large base in our country, and the core indicators such as detection and antiviral treatment ratio are far from the real goal of eliminating the public health threat of uiral hepatitis.Notably, the chronic hepatitis B prevention and control system lacks a wide targeted strategies. This paper systematically analyzes our country\'s main successful experience with AIDS prevention and control and, on that basis, proposes the ideas and strategic paths for the construction of a chronic hepatitis B prevention and control system, analyzes and discusses the current difficulties and problems in prevention and control, and looks forward to future prevention and control efforts.
    乙型肝炎是严重危害我国人民群众健康的重大传染性疾病,我国乙型肝炎患者基数大,检测发现和抗病毒治疗比例等核心指标距离实现消除病毒性肝炎作为公共卫生危害目标差距较大,缺乏针对性的慢性乙型肝炎防控体系和防控策略、措施。该文系统分析了我国艾滋病防控的主要成功经验,在此基础上提出了我国慢性乙型肝炎防控体系建设和防控策略的思路和路径,对目前存在的防控难点及问题进行了分析和探讨,并对未来防控工作进行了展望。.
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  • 文章类型: Review
    塔拉真菌病是由马尔尼菲塔拉真菌病引起的一种严重的机会性传染病,主要发生在免疫功能低下的患者。该病主要流行于东南亚和南亚的热带国家和地区,但非流行地区也有塔拉真菌病患者。本病无特征性临床表现,诊断困难。延迟诊断通常会导致死亡。
    两名患者均有细胞免疫缺陷。病例1有获得性免疫缺陷综合征病史,病例2有肾移植史和葡萄糖-6-磷酸脱氢酶缺乏症。他们都发烧了,贫血,疲劳,和皮肤损伤。病例1有消化道出血,淋巴结肿大,和肝脾肿大.病例2有咳嗽和呼吸困难。两名患者均有血小板减少症和低白蛋白血症;中性粒细胞比率增加,降钙素原,和C反应蛋白;肝功能异常和凝血功能障碍。病例1痰培养,血培养,支气管肺泡灌洗液为马尔尼菲氏杆菌阳性。在病例2的血液培养中检测到马尔尼菲T.Marneffei,并感染了近叶念珠菌和肺孢子虫。胸部CT扫描主要表现为肺渗出性病变。尽管这两名患者得到了积极的治疗,他们死于疗效不佳。
    塔拉真菌病发病隐匿,漫长的课程,不典型的临床症状,成像性能和实验室结果,诊断困难,和高死亡率。因此,重要的是要及时考虑和治疗感染后免疫功能低下患者的塔拉真菌病,以降低死亡率。
    UNASSIGNED: Talaromycosis is a serious opportunistic infectious disease caused by Talaromyces marneffei, which mostly occurs in immunocompromised patients. The disease is mainly prevalent in tropical countries and regions of Southeast Asia and South Asia, but non-endemic areas also have patients with Talaromycosis. The disease has no characteristic clinical manifestations and is difficult to diagnose. Delayed diagnosis often leads to death.
    UNASSIGNED: Both patients had cellular immunodeficiency. Case 1 had a history of acquired immune deficiency syndrome, and case 2 had a history of renal transplantation and glucose-6-phosphate dehydrogenase deficiency. They all had fever, anemia, fatigue, and skin lesions. Case 1 had gastrointestinal bleeding, enlarged lymph nodes, and hepatosplenomegaly. Case 2 had cough and dyspnea. Both patients had thrombocytopenia and hypoalbuminemia; an increased neutrophil ratio, procalcitonin, and C-reactive protein; and abnormal liver function and coagulation dysfunction. Case 1 sputum culture, blood culture, and bronchoalveolar lavage fluid were positive for T. marneffei. T. marneffei was detected in the blood culture of case 2, with infection of Candida parapsilosis and Pneumocystis jirovecii. Chest computed tomography scan mainly showed pulmonary exudative lesions. Although these two patients were actively treated, they died of poor efficacy.
    UNASSIGNED: Talaromycosis has an insidious onset, long course, atypical clinical symptoms, imaging performance and laboratory results, difficult diagnosis, and high mortality. Therefore, it is important to promptly consider and treat Talaromycosis in immunocompromised patients upon infection in order to reduce mortality.
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  • 文章类型: Journal Article
    背景:2009年在河南省引入了二线抗逆转录病毒治疗(ART)。开始这种治疗的患有人类免疫缺陷病毒(HIV)的人数正在增加。
    目的:本研究旨在调查该组患者的生存率和影响死亡率的因素。
    方法:我们对2010年5月1日至2016年5月1日期间转为二线ART的HIV感染者(PLHIV)进行了回顾性队列研究。,使用Kaplan-Meier方法和Cox比例风险模型。
    结果:我们追踪了3,331PLHIV,持续了26,988人年,其中508人(15.3%)死亡。死亡率为1.88/100人年。在调整混杂因素后,我们发现是一个女人(危险比[HR],0.66;95%置信区间[CI]0.55-0.79),>50岁(HR,2.69;95CI,2.03-3.56),单/窗口(HR,1.26;95CI,1.04-1.52),拥有>6年的教育(HR,0.78;95CI,0.65-0.94),中医(HR,0.75;95CI,0.52-0.96),肝损伤(HR,1.58;95CI,1.19-2.10),和CD4+T细胞计数<200细胞/μl(HR,1.94;95CI,1.47-2.55),或200-350细胞/μl(HR,1.37;95CI,1.03-1.82)与死亡风险相关。
    结论:我们发现转到二线ART的PLHIV患者的死亡率低于大多数以前的研究。回顾性队列的局限性可能,因此,有偏见的数据,需要前瞻性研究来确认结果。此外,中药联合二线ART显示出治疗HIV的潜力。
    BACKGROUND: Second-line antiretroviral therapy (ART) was introduced in Henan Province in 2009. The number of people living with human immunodeficiency virus (HIV) starting this therapy is increasing.
    OBJECTIVE: This study aimed to investigate the survival and factors affecting mortality among this group.
    METHODS: We conducted a retrospective cohort study of people living with HIV (PLHIV) who switched to second-line ART between May 1, 2010, and May 1, 2016, using the Kaplan-Meier method and Cox proportional hazards models.
    RESULTS: We followed 3,331 PLHIV for 26,988 person-years, of whom 508 (15.3%) died. The mortality rate was 1.88/100 person-years. After adjusting for confounding factors, we found being a woman (hazard ratio (HR), 0.66; 95% confidence interval (CI) 0.55-0.79), > 50 years old (HR, 2.69; 95% CI, 2.03-3.56), single/widowed (HR, 1.26; 95% CI, 1.04-1.52), having > 6 years of education (HR, 0.78; 95% CI, 0.65-0.94), Chinese medicine (HR, 0.75; 95% CI, 0.52-0.96), liver injury (HR, 1.58; 95% CI, 1.19-2.10), and CD4+ T cell count <200 cells/μl (HR, 1.94; 95% CI, 1.47-2.55), or 200-350 cells/μl (HR, 1.37; 95% CI, 1.03-1.82) were associated with mortality risk.
    CONCLUSIONS: We found lower mortality among PLHIV who switched to second-line ART than most previous studies. The limitations of a retrospective cohort may, therefore, have biased the data, and prospective studies are needed to confirm the results. Moreover, Chinese medicine combined with second-line ART shows potential as a treatment for HIV.
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  • 文章类型: Case Reports
    背景:与嗜酸性粒细胞性胃肠炎相关的获得性免疫缺陷综合征(AIDS)很少见。我们报告了一例AIDS患者十二指肠“结石”诱发急性胰腺炎伴嗜酸性胃十二指肠炎的病例。
    方法:一名73岁女性艾滋病患者因反复腹痛20天来医院就诊。计算机断层扫描(CT)显示胰腺炎有渗出,胃窦下有高密度阴影。胃镜检查显示十二指肠的下降部分被“结石”阻塞。十二指肠粘膜粗糙,在胃体上发现了一个红色息肉。病理结果为十二指肠粘膜和胃体息肉中嗜酸性粒细胞慢性炎症。
    结论:当艾滋病患者患有急性胰腺炎时,需要考虑嗜酸性粒细胞性胃肠炎的可能性,以使患者能够接受及时的治疗。
    BACKGROUND: Acquired immune deficiency syndrome (AIDS) associated with eosinophilic gastroenteritis is rare. We report a case of duodenal \"stone\" inducing acute pancreatitis with eosinophilic gastroduodenitis in an AIDS patient.
    METHODS: A 73-year-old female AIDS patient came to the hospital with recurrent abdominal pain for 20 days. Computed tomography (CT) showed pancreatitis with exudation and a high-density shadow under the gastric antrum. Gastroscopy showed that the descending part of the duodenum was blocked by a \"stone\". The mucosa of the duodenum was rough, and a red polyp was found on the gastric body. The pathology result was chronic inflammation with eosinophilic granulocytes in the duodenal mucosa and gastric body polyp.
    CONCLUSIONS: When AIDS patients suffer acute pancreatitis, the possibility of eosinophilic gastroenteritis needs to be considered to enable the patient to accept timely treatment.
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  • 文章类型: Case Reports
    背景:中国的HIV感染学生比例呈现上升趋势。本研究旨在确定山东省HIV感染学生的流行病学特征和HIV护理连续体。中国。
    方法:从国家艾滋病综合应对信息管理系统获取HIV感染学生的病例报告和随访数据。采用Logistic回归分析HIV感染学生在30天接受CD4+T细胞(CD4)检测和抗病毒治疗(ART)的相关因素,并使用ArcGIS软件进行空间分析。
    结果:2017年至2019年,山东省共报告403名HIV感染学生。其中大多数是男性(99.5%),并通过同性性行为传播(92.1%)。他们大多数住在济南市和青岛市。68.5%(276例)在30天内接受CD4检测,48.6%(196例)在30天内开始ART。异性传播病例(AOR=0.458,95CI:0.210-0.998),在西部地区接受HIV护理的患者(AOR=0.266,95CI:0.147-0.481)在30天内不太可能检测CD4;年龄在23-25岁的患者(AOR=2.316,95CI:1.009-5.316)和在30天内检测过CD4的患者(AOR=4.377;95CI:2.572-7.447)更喜欢在30天内接受ART治疗;在中部地区接受HIV护理
    结论:山东省HIV感染学生的HIV护理连续性仍需加强。对于通过异性性行为传播的病例,应加强健康教育和病例管理,在中西部地区接受艾滋病毒护理,并通过自愿献血诊断。
    BACKGROUND: The proportion of HIV-infected students in China showed an increasing trend. This study aimed to identify the epidemiological characteristics and the HIV care continuum for HIV-infected students in Shandong Province, China.
    METHODS: Case report and follow-up data of HIV-infected students were obtained from the National HIV/AIDS comprehensive response information management system. Logistic regression analyses were used to analyze the associating factors of HIV-infected students accepting CD4 + T cells (CD4) test and antiviral therapy (ART) in 30 days, and ArcGIS software was used for the spatial anlysis.
    RESULTS: From 2017 to 2019, 403 HIV-infected students were reported in Shandong Province. The majority of them were male (99.5%) and transmitted through homosexual sexual activity(92.1%). Most of them lived in Jinan city and Qingdao city. 68.5% (276 cases) accepted CD4 test in 30 days, and 48.6% (196 cases) started ART in 30 days. The heterosexual transmitted cases (AOR = 0.458, 95%CI: 0.210-0.998), patients accepting HIV care in western area (AOR = 0.266,95%CI: 0.147-0.481) were less likely to test CD4 within 30 days; patients aged 23-25 (AOR = 2.316, 95%CI: 1.009-5.316) and patients who had tested CD4 within 30 days (AOR = 4.377; 95%CI: 2.572-7.447) prefered to receive ART within 30 days; patients accepted HIV care in central area (AOR = 0.407; 95%CI: 0.251-0.657) and western area (AOR = 0.508; 95%CI: 0.261-0.989) and patients diagnosed by voluntary blood donation (AOR = 0.352; 95%CI: 0.144-0.864) were less willing to receive ART in 30 days.
    CONCLUSIONS: The HIV care continuum of HIV-infected students in Shandong Province still needed strenghthing. More health education and case management should be done for cases transmitted through heterosexual behavior, accepted HIV care in central and western area, and diagnosed by voluntary blood donation.
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  • 文章类型: Randomized Controlled Trial
    这是单剂量,随机化,开放标签,2期交叉研究,以评估ACC008(测试制剂[T])与联合给药ainuovirine(ANV)150mg的生物等效性,拉米夫定(3TC)300毫克,和富马酸替诺福韦酯300mg(参考配方[R])在中国健康成年人的禁食状态。符合条件的受试者随机分为2组,以2个序列中的1个接受治疗(T→R,R→T)。在每个时期中从给药前1小时到给药后144小时收集PK样品。ANV的浓度,3TC,采用液相色谱-串联质谱法测定血浆中替诺福韦的含量。采用PhoenixWinNonlin软件进行药代动力学参数计算和生物等效性评价。所有最大浓度的90%置信区间,从时间零点到最后检测时间的浓度-时间曲线下的面积,从时间零到无穷大的浓度-时间曲线下的面积落在生物等效性范围内。两种治疗的安全性相当,无III/VI级或严重不良事件。ACC008与其单个成分的给药具有生物等效性,包括ANV150毫克,3TC300毫克,和富马酸替诺福韦酯300毫克,具有良好的安全性。
    This was a single-dose, randomized, open-label, 2-period crossover study to evaluate the bioequivalence of the ACC008 (test formulation [T]) versus coadministered ainuovirine (ANV) 150 mg, lamivudine (3TC) 300 mg, and tenofovir disoproxil fumarate 300 mg (reference formulation [R]) in the fasted state among the Chinese healthy adults. Eligible subjects were randomized into 2 cohorts to received treatment in 1 of 2 sequences (T → R, R → T). PK samples were collected from 1 hour before dosing to 144 hours after dosing in each period. The concentrations of ANV, 3TC, and tenofovir in plasma were determined by liquid chromatography-tandem mass spectrometry. Phoenix WinNonlin software was used for pharmacokinetic parameter calculation and bioequivalence evaluation. All the 90% confidence intervals of maximum concentration, area under the concentration-time curve from time zero to the last detectable time, and area under the concentration-time curve from time zero to infinity fell within the bioequivalence range. The safety was comparable between the 2 treatments, with no Grade III/VI or serious adverse events. ACC008 was bioequivalent to administration of its individual components, including ANV 150 mg, 3TC 300 mg, and tenofovir disoproxil fumarate 300 mg with favorable safety profile.
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