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Determination of depression prevalence in pregnant women living with HIV aged 18 years and older: A meta-analysis study.
IF 1.4 4区 医学 Q4 IMMUNOLOGY Pub Date : 2025-01-28 DOI: 10.1177/09564624251316048
Sibel Gürbüz, Elif Nur Yildirim Öztürk, Simge Sari, Saliha Kazci, Meltem Çöl

Background: Pregnant women living with HIV are known to be at higher risk of depression than pregnant women without HIV. Accompanied by a systematic literature review, the aim of this study was to determine the global prevalence of depression in pregnant women living with HIV.

Methods: PubMed, Scopus, Google Scholar and Web of Science databases were searched. The references of the included publications and a similar meta-analysis study were also reviewed. The 19 included studies were assessed for quality using standard forms. Pooled prevalence was calculated using a random effects model. Heterogeneity and publication bias were assessed using various methods. Subgroup analyses and meta-regression were also performed.

Results: Of the 19 studies included in the review, six of the studies were published between 2008 and 2014, and 13 were published between 2017 and 2023. 15 studies were conducted in African countries. According to study type, eight studies were cross-sectional and seven were cohort studies. The pooled prevalence of depression was calculated to be 45%. The prevalence in African countries was 37.7%. The studies were found to be statistically significantly heterogeneous. Tests and funnel plots showed no publication bias in this meta-analysis. The variables place, study type and scale made the model significant in the meta-regression.

Conclusion: In this meta-analysis, 6379 women aged 18 years and older were examined and their depression levels were found to be high. Taking steps to struggle with HIV and depression in people living with HIV seems important.

背景:众所周知,与未感染艾滋病毒的孕妇相比,感染艾滋病毒的孕妇患抑郁症的风险更高。本研究通过系统性文献回顾,旨在确定全球感染 HIV 的孕妇中抑郁症的发病率:方法:检索了 PubMed、Scopus、Google Scholar 和 Web of Science 数据库。方法:对 PubMopus、Scopus、Google Scholar 和 Web Science 数据库进行了检索,并查阅了所纳入出版物的参考文献和一项类似的荟萃分析研究。采用标准表格对纳入的 19 项研究进行了质量评估。使用随机效应模型计算了汇总流行率。采用多种方法对异质性和发表偏倚进行了评估。此外,还进行了分组分析和元回归分析:在纳入综述的 19 项研究中,6 项研究发表于 2008 年至 2014 年,13 项研究发表于 2017 年至 2023 年。15项研究在非洲国家进行。根据研究类型,8 项研究为横断面研究,7 项为队列研究。经计算,抑郁症的合计患病率为 45%。非洲国家的患病率为 37.7%。这些研究在统计学上存在明显的异质性。测试和漏斗图显示,该荟萃分析没有发表偏倚。地点、研究类型和规模等变量使元回归模型具有显著性:在这项荟萃分析中,共研究了 6379 名 18 岁及以上的女性,发现她们的抑郁水平较高。采取措施与艾滋病病毒感染者和抑郁症作斗争似乎很重要。
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引用次数: 0
2024 British Association for Sexual Health and HIV (BASHH) UK national guideline on the management of vulval conditions. 2024年英国性健康和艾滋病毒协会(BASHH)英国外阴疾病管理国家指南。
IF 1.4 4区 医学 Q4 IMMUNOLOGY Pub Date : 2025-01-21 DOI: 10.1177/09564624241311629
Sarah K Edwards, Fiona Lewis, Imali Fernando, Lisa Haddon, Deepa Grover

Background: The management of vulval disorders in Genitourinary Medicine (GUM) clinics requires targeted approaches due to the wide range of conditions affecting the vulva. Vulval diseases encompass various aetiologies, including dermatoses, pain syndromes, and pre-malignant conditions, necessitating specialized care often involving multidisciplinary collaboration.

Purpose: This guideline aims to provide evidence-based recommendations for the diagnosis and management of specific vulval conditions that may present in GUM clinics. The focus is on conditions commonly managed by Genitourinary Physicians, either independently or in partnership with other specialists, depending on available local expertise. Additionally, guidance on onward referral is included to ensure optimal patient care.

Study sample: The guideline primarily addresses the management of individuals aged 16 years and older presenting to GUM clinics with non-infective vulval conditions.

Data collection: Recommendations within this guideline are derived from a review of existing literature, clinical expertise, and consensus among specialists. Emphasis is placed on diagnostic tests and treatment regimens tailored to the following conditions: Lichen sclerosus, Lichen planus, Eczema, Lichen simplex, Psoriasis, Vulval high-grade squamous intraepithelial lesions (previously vulval intraepithelial neoplasia), Vulval pain syndromes, and Non-sexually acquired acute genital ulceration (Ulcer of Lipschütz).

Conclusions: This guideline offers practical recommendations for the effective management of specific vulval disorders in GUM settings. It is not intended to be a comprehensive review of all vulval diseases but rather a focused resource to assist clinicians in providing high-quality, patient-centred care. Onward referral pathways are also outlined to support collaborative and multidisciplinary management of complex cases.

背景:生殖泌尿医学(GUM)诊所的外阴疾病管理需要有针对性的方法,因为影响外阴的条件范围很广。外阴疾病包括各种病因,包括皮肤病、疼痛综合征和恶性前病变,需要经常涉及多学科合作的专门护理。目的:本指南旨在为龈临床可能出现的特定外阴疾病的诊断和管理提供循证建议。重点是通常由泌尿生殖系统医生独立或与其他专家合作管理的疾病,具体取决于当地的专业知识。此外,指导转诊包括,以确保最佳的病人护理。研究样本:该指南主要针对在牙龈诊所就诊的16岁及以上非感染性外阴疾病患者的管理。数据收集:本指南中的建议来自对现有文献、临床专业知识和专家共识的回顾。重点是针对以下情况量身定制的诊断测试和治疗方案:硬化地衣、扁平地衣、湿疹、单纯性地衣、银屑病、外阴高度鳞状上皮内病变(以前的外阴上皮内瘤变)、外阴疼痛综合征和非性获得性急性生殖器溃疡(lipsch溃疡)。结论:本指南为GUM患者特殊外阴疾病的有效治疗提供了实用建议。它的目的不是全面审查所有外阴疾病,而是一个重点资源,以协助临床医生提供高质量的,以病人为中心的护理。后续转诊途径也概述,以支持复杂病例的协作和多学科管理。
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引用次数: 0
A correspondence on elevated IL-10 serum levels are associated with slower serological response following syphilis treatment during pregnancy. 妊娠期梅毒治疗后血清IL-10水平升高与血清学反应较慢相关。
IF 1.4 4区 医学 Q4 IMMUNOLOGY Pub Date : 2025-01-21 DOI: 10.1177/09564624251315785
Chenwei Diao, Huan Wang
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引用次数: 0
Use of patient portals to disclose STI test histories to sex partners among U.S. men who have sex with men: A call for research and guidance. 使用患者门户网站向美国男男性行为者的性伴侣披露STI检测历史:呼吁进行研究和指导。
IF 1.4 4区 医学 Q4 IMMUNOLOGY Pub Date : 2025-01-21 DOI: 10.1177/09564624251315783
Kevon-Mark P Jackman, Kaitlyn Atkins, Sarah M Murray, Tom Carpino, Iaah Lucas, Travis Sanchez, Stefan Baral

Background: This study investigates the use of patient portals for disclosing sexually transmitted infection (STI) test result histories to sexual partners among men who have sex with men (MSM) in the United States.

Methods: Using data from the 2022-2023 American Men's Internet Survey, this cross-sectional analysis examined demographic, behavioral, and healthcare-related factors associated with MSM's utilization of patient portals for sharing STI test results. Participants (N = 2601) were surveyed on portal use, STI testing frequency, and partner disclosure practices.

Results: 18% of survey participants used portals to disclose a STI test result to parrtners, with higher prevalences among individuals aged 16-37 years old versus 56 years and older, black non-Hispanic (26.4%) versus white non-Hispanic (16.8%), and those reporting nine or more times being tested for STIs (30.1%) versus 1 to 3 times (7.5%). Participants reporting sex work (33.3% vs 17.7%) and HIV pre-exposure prophylaxis (PrEP) use (24.2% vs 13.0%) also had a higher prevalence of portal use for disclosure. Multivariable Poisson regression analysis with robust error variance showed that sexual behavioral stigma from family and friends [adjusted prevalence ratio (aPR) = 1.11; p = .04] also, being tested for STIs four to 8 (aPR = 2.21; p < .001) and nine or more times aPR = 3.42; p < .001) were significantly associated with prevalence of portal-based disclosure.

Conclusion: Findings suggest patient portals may be viable tools for STI prevention in MSM communities, especially among individuals with increased vulnerability to STI acquisition. Addressing disparities in portal access and explaining patient portal capabilities may enhance the role of digital health in reducing STI transmission among MSM communities.

背景:本研究调查了美国男男性行为者(MSM)使用患者门户网站向性伴侣披露性传播感染(STI)检测结果历史的情况。方法:利用2022-2023年美国男性互联网调查的数据,本横断面分析检查了与男男性行为者利用患者门户网站分享性病检测结果相关的人口统计学、行为和医疗相关因素。对参与者(N = 2601)进行了门户使用、STI检测频率和合作伙伴披露实践的调查。结果:18%的调查参与者使用门户网站向伴侣披露性传播感染检测结果,16-37岁人群的患病率高于56岁及以上人群,非西班牙裔黑人(26.4%)高于非西班牙裔白人(16.8%),报告接受过9次或以上性传播感染检测的人群(30.1%)高于1至3次(7.5%)。报告性工作的参与者(33.3%对17.7%)和使用艾滋病毒暴露前预防(PrEP)的参与者(24.2%对13.0%)使用门户网站进行信息披露的比例也较高。多变量泊松回归分析显示,来自家人和朋友的性行为污名化[校正患病率(aPR) = 1.11;p = .04]接受性传播感染4 ~ 8次检测(aPR = 2.21;p < 0.001), 9倍以上aPR = 3.42;P < 0.001)与基于门户的信息披露的流行率显著相关。结论:研究结果表明,患者门户网站可能是MSM社区预防性传播感染的可行工具,特别是在性传播感染易感性增加的人群中。解决门户访问方面的差异并解释患者门户的功能,可能会增强数字卫生在减少男男性行为者社区间性传播感染方面的作用。
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引用次数: 0
High unmet needs for cervical cancer screening among women living with HIV in six African countries: A population-based study. 六个非洲国家感染艾滋病毒的妇女对宫颈癌筛查的高度未满足需求:一项基于人口的研究。
IF 1.4 4区 医学 Q4 IMMUNOLOGY Pub Date : 2025-01-21 DOI: 10.1177/09564624251315787
Annabelle D Alpar, Cathy Ndiaye, Dominique Guillaume, Rupali J Limaye, Joseph G Rosen

Background: Cisgender women living with HIV (WLWH) are disproportionately impacted by cervical cancer. Nevertheless, disparities in uptake and implementation of cervical cancer services persist in sub-Saharan Africa, where population-level estimates of screening coverage remain scarce.

Methods: We pooled data from nationally representative Population-based HIV Impact Assessment (PHIA) surveys conducted in Ethiopia, Malawi, Rwanda, Tanzania, Zambia, and Zimbabwe (2015-2019). After estimating the prevalence of self-reported lifetime cervical cancer screening (overall and by country), survey-weighted multivariable log-binomial regression identified socio-demographic and clinical correlates of screening uptake among WLWH aged 25-64 years.

Results: Overall, 6933 WLWH (mean age: 39.6 years) were included in the multi-country sample. The pooled prevalence of lifetime cervical cancer screening was 18.5% (range: 8.5% [Rwanda] to 25.3% [Zambia]). Screening uptake varied by HIV clinical status, with serostatus-aware (21.3% vs 9.0%), antiretroviral therapy-experienced (22.0% vs 10.5%), and virally suppressed (22.1% vs 11.6%) WLWH, respectively, reporting significantly (p < 0.001) higher screening rates. Screening was especially low among WLWH aged <35 years (14.7%), with no formal education (12.1%), in the poorest households (7.9%), and residing in rural areas (14.0%).

Conclusions: Fewer than one-fifth of WLWH had ever screened for cervical cancer, suggesting expanded availability and access to tailored, integrated services are critically needed.

背景:感染艾滋病毒的顺性别妇女(WLWH)患宫颈癌的比例过高。然而,在撒哈拉以南非洲,在接受和实施宫颈癌服务方面仍然存在差距,在那里,对筛查覆盖率的人口水平估计仍然很少。方法:我们汇集了2015-2019年在埃塞俄比亚、马拉维、卢旺达、坦桑尼亚、赞比亚和津巴布韦进行的具有全国代表性的基于人口的艾滋病毒影响评估(PHIA)调查的数据。在估计了自我报告的终生宫颈癌筛查的流行率(总体和按国家)之后,调查加权的多变量对数二项回归确定了25-64岁的WLWH接受筛查的社会人口统计学和临床相关性。结果:总体而言,6933名WLWH(平均年龄:39.6岁)被纳入多国样本。终生宫颈癌筛查的总患病率为18.5%(范围:8.5%[卢旺达]至25.3%[赞比亚])。筛查率因HIV临床状态而异,血清状态意识(21.3% vs 9.0%)、抗逆转录病毒治疗经历(22.0% vs 10.5%)和病毒抑制(22.1% vs 11.6%)的WLWH分别报告了显著(p < 0.001)更高的筛查率。结论:不到五分之一的妇女曾接受过宫颈癌筛查,这表明迫切需要扩大定制的综合服务的可得性和可及性。
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引用次数: 0
Pneumocystis jirovecii pneumonia co-infection with cytomegalovirus pneumonia in a patient with acquired immunodeficiency syndrome: A case report and literature review. 乙肝肺囊虫肺炎合并巨细胞病毒肺炎一例获得性免疫缺陷综合征病例报告并文献复习。
IF 1.4 4区 医学 Q4 IMMUNOLOGY Pub Date : 2025-01-20 DOI: 10.1177/09564624251314567
Tanyanop Techasupaboon, Worapong Nasomsong

Cytomegalovirus (CMV) pneumonia is an uncommon presentation of CMV among patients with HIV/AIDS, particularly in co-infection with Pneumocystis jirovecii pneumonia (PCP). A case was reported with a literature review, and a comprehensive literature search was performed using the PubMed/MEDLINE and Scopus databases. We report a 52-year-old male with AIDS presenting with progressively worsening dyspnea over 1 week. One month earlier, he had completed a 21-day course of PCP treatment, showed improvement and was discharged. Two weeks before presentation, he started antiretroviral therapy (ART), but his dyspnea worsened significantly 1 week later. Chest radiography showed bilateral ground glass opacities. Bronchoscopy and lung biopsy revealed nuclear enlargement with prominent intranuclear inclusions and marginated chromatin of alveolar cells on H&E staining, along with positive immunohistochemistry for CMV. Grocott's methenamine silver staining identified 3-5 μm irregular yeast-like organisms resembling crushed ping-pong balls, consistent with P. jirovecii. He was treated with intravenous ganciclovir for a total of 21 days, and his clinical and radiologic findings completely resolved. CMV pneumonia co-infection with PCP is extremely rare and should be considered among patients with severely immunocompromise with interstitial pneumonitis unresponsive to PCP treatment or recurring after treatment.

巨细胞病毒(CMV)肺炎在HIV/AIDS患者中是一种罕见的巨细胞病毒表现,特别是在合并感染基罗氏肺囊虫肺炎(PCP)时。报告1例病例并进行文献综述,使用PubMed/MEDLINE和Scopus数据库进行全面的文献检索。我们报告一名52岁男性爱滋病患者,在1周内出现渐进式恶化的呼吸困难。一个月前,他完成了21天的PCP治疗,病情有所改善并出院。发病前两周,他开始抗逆转录病毒治疗(ART),但1周后他的呼吸困难明显恶化。胸片显示双侧磨玻璃影。支气管镜检查和肺活检显示核增大,核内包涵体明显,H&E染色肺泡细胞染色质边缘,CMV免疫组化阳性。Grocott的甲基苯丙胺银染色鉴定出3-5 μm的不规则酵母样生物,类似于压碎的乒乓球,与p.j roveci一致。他静脉注射更昔洛韦共21天,他的临床和放射学表现完全解决。巨细胞病毒肺炎合并PCP极为罕见,在对PCP治疗无反应或治疗后复发的严重免疫功能低下的间质性肺炎患者中应予以考虑。
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引用次数: 0
Increasing incidence of Mycoplasma genitalium is driven by people living with HIV and PrEP users. 生殖器支原体发病率的增加是由艾滋病毒感染者和PrEP使用者推动的。
IF 1.4 4区 医学 Q4 IMMUNOLOGY Pub Date : 2025-01-20 DOI: 10.1177/09564624251315782
Roberto Rossotti, Alice Nava, Federico D'Amico, Chiara Baiguera, Diana Fanti, Elvira Inglese, Alessandro Raimondi, Nicholas Brian Bana, Federico Spelzini, Maurizio Bini, Chiara Vismara, Massimo Puoti

Background: Mycoplasma genitalium (MG) is responsible for non-gonococcal urethritis. Our aim is to describe MG positivity rate and incidence in specific populations.

Methods: Retrospective, surveillance study included all samples collected from 2018 to 2022. All samples were tested with Anyplex II STI7 (Seegene). Incidence rate (IR) was calculated, incidence rate ratios (IRRs) were assessed using Poisson regression model.

Results: The study included 13,504 samples belonging to 7,692 individuals. Overall positivity rate was 2.9% (95%CI 2.6-3.2). Subgroups showed significant differences: 13.6% in PrEP users, 5.2% in STI clinic, 4.6% in people living with HIV (PLWH), 1.2% in Gynecology/Obstetrics Department, 0.5% in Fertility clinic, and 0.5% in the "Other" group (p < .001). A significant increasing temporal trend was registered for PLWH. Over a cumulative follow up of 2,554 years, 293 incident infections were registered with an IR of 11.5 per 100PYFU. Departments showed diverse IRs: 7.9 per 100PYFU for PLWH, 30.1 per 100PYFU for PrEP users, 22.7 per 100PYFU for STI clinic. Poisson regression model found a significant increase in incident rates over time in the overall study population driven by PLWH and PrEP users.

Conclusions: MG is uncommon in the general population with stable trends, while PLWH and PrEP users exhibit increasing positivity rate and incidence.

背景:生殖道支原体(MG)是导致非淋球菌性尿道炎的原因。我们的目的是描述MG在特定人群中的阳性率和发病率。方法:回顾性监测研究纳入2018 - 2022年收集的所有样本。所有样品均采用Anyplex II STI7 (Seegene)进行检测。计算发病率(IR),采用泊松回归模型评估发病率比(IRRs)。结果:该研究包括7692个人的13504个样本。总阳性率为2.9% (95%CI 2.6 ~ 3.2)。亚组差异显著:PrEP使用者占13.6%,STI诊所占5.2%,HIV感染者(PLWH)占4.6%,妇产科占1.2%,生育诊所占0.5%,“其他”组占0.5% (p < 0.001)。PLWH在时间上有显著的增加趋势。在2,554年的累计随访中,登记了293例事件感染,IR为11.5 / 100PYFU。各科室表现出不同的IRs:公共卫生部门为7.9 / 100PYFU, PrEP使用者为30.1 / 100PYFU,性传播感染诊所为22.7 / 100PYFU。泊松回归模型发现,在PLWH和PrEP使用者驱动的总体研究人群中,随着时间的推移,事故率显著增加。结论:MG在普通人群中少见,呈稳定趋势,而PLWH和PrEP使用者的阳性率和发病率呈上升趋势。
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引用次数: 0
Emerging sexually transmitted infections outbreak: Dermatophytosis among men who have sex with men in Milan, Italy. 新出现的性传播感染爆发:意大利米兰男男性行为者中的皮肤真菌病。
IF 1.4 4区 医学 Q4 IMMUNOLOGY Pub Date : 2025-01-09 DOI: 10.1177/09564624241312731
Chiara Maci, Angelo Roberto Raccagni, Riccardo Lolatto, Emanuela Messina, Diana Canetti, Chiara Tassan Din, Maria Del Carmen Garcia Martearena, Golnaz Torkjazi, Martina Bottanelli, Caterina Candela, Antonella Castagna, Silvia Nozza

Background: Dermatophytosis is an infection of the skin or adnexa, which is extremely widespread in the environment. Sexually transmitted infections (STIs) are an increasing global public health threat, especially among men who have sex with men (MSM). This study aims to describe an outbreak of sexually transmitted dermatophytosis among MSM in our cohort between April 2022 and October 2023.

Methods: This is a retrospective monocentric study including outpatients who were diagnosed with at least one episode of dermatophytosis between March 2010 and October 2023 at the Infectious Diseases Unit of San Raffaele Scientific Institute, Milan, Italy. Mycosis diagnosis was mainly clinical following the medical visit and physical examination.

Results: Overall, 107 people were diagnosed with dermatophytosis between March 2010 and October 2023. All 56 cases observed since April 2022 included 55 MSM and 1 female; compared to before 2022 there was a total diagnosis of 51 cases.

Conclusions: These results highlight the evident increase in the incidence of mycotic infections among MSM, followed in our center. We are dealing with a new entity of sexually transmissible infections, in addition to the existing diseases that are being studied.

背景:皮肤真菌病是一种皮肤或附件的感染,在环境中极为普遍。性传播感染是一个日益严重的全球公共卫生威胁,特别是在男男性行为者中。本研究旨在描述2022年4月至2023年10月期间MSM人群中性传播性皮肤癣的爆发。方法:这是一项回顾性单中心研究,纳入2010年3月至2023年10月在意大利米兰圣拉斐尔科学研究所传染病科诊断为至少一次皮肤癣发作的门诊患者。真菌病的诊断主要以临床就诊和体格检查为主。结果:总体而言,2010年3月至2023年10月期间,107人被诊断为皮肤癣。自2022年4月以来观察到的56例病例包括55例男男性行为者和1例女性;与2022年之前相比,总共诊断了51例。结论:这些结果突出了MSM中真菌感染的发生率明显增加,在我中心也是如此。除了正在研究的现有疾病之外,我们正在处理一种新的性传播感染。
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引用次数: 0
A case of acquired syphilis in an infant through mouth-to-mouth transmission of prechewed food. 通过咀嚼过的食物口对口传播的婴儿获得性梅毒病例。
IF 1.4 4区 医学 Q4 IMMUNOLOGY Pub Date : 2025-01-08 DOI: 10.1177/09564624241312950
Sen Feng, Qing Zhu, Mingyuan Ren, Guoying Miao, Guoqiang Zhang

Background: Patients with syphilis are the only source of infection, which can be transmitted through sexual contact and mother-to-child and blood transmission, and rarely through contaminants. The clinical manifestations of syphilis are complex and variable, and can be easily misdiagnosed. This article reports a case of syphilis in a child with "psoriasis"-like lesions who was fed pre-chewed food.

Case presentation: An 18-month-old girl presented with mung bean to peanut-sized erythema and papules scattered on both lower limbs and perianal area; some of the erythema was covered with scales, with clear boundaries and no fusion. The case was misdiagnosed as "psoriasis" in the local hospital until the child and her mother tested positive for syphilis in the outpatient clinic of our hospital. The girl's mother had a habit of chewing food in her mouth before feeding it to her child.

Conclusions: Consumption of food chewed by a person with syphilis can lead to infection, and attention should be paid to the possible ways and means of being infected.

背景:梅毒患者是唯一的感染源,可通过性接触、母婴传播和血液传播,很少通过污染物传播。梅毒的临床表现复杂多变,易误诊。这篇文章报告了一例梅毒的儿童与“牛皮癣”样病变谁被喂食预先咀嚼的食物。病例介绍:一名18个月大的女婴,双下肢和肛周有绿豆到花生大小的红斑和丘疹;部分红斑被鳞片覆盖,边界清晰,无融合。该病例在当地医院被误诊为“牛皮癣”,直到患儿及其母亲在我院门诊梅毒检测呈阳性。这个女孩的母亲有一个习惯,在给她的孩子喂食之前,先在嘴里咀嚼食物。结论:梅毒患者咀嚼食物可导致感染,应注意可能的感染途径和途径。
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引用次数: 0
Effectiveness, safety, and patient-reported outcomes of bictegravir/emtricitabine/tenofovir alafenamide in routine clinical care in Italy: 12-Month results from the BICSTaR cohort. BICSTaR队列研究的12个月结果:比替格拉韦/恩曲他滨/替诺福韦阿拉那胺在意大利常规临床护理中的有效性、安全性和患者报告的结果
IF 1.4 4区 医学 Q4 IMMUNOLOGY Pub Date : 2025-01-08 DOI: 10.1177/09564624241308372
Andrea Antinori, Giulia Marchetti, Vincenzo Esposito, Stefano Rusconi, Diana Canetti, Eugenia Quiros-Roldan, Bianca Candelaresi, Annalisa Saracino, Massimo Andreoni, Andrea Marongiu, Tali Cassidy, David Thorpe, Laura Albini, Roberto Caldera, Gabriele Forcina, Giovanni Di Perri

Background: BICSTaR is a multi-national, observational cohort evaluating the effectiveness, safety, and patient-reported outcomes (PROs) in treatment-naïve (TN) and -experienced (TE) people with HIV-1 receiving bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in routine clinical care. We present the 12-month (M12) outcomes of the Italian BICSTaR cohort.

Methods: Participants initiating B/F/TAF in routine care were prospectively followed. Outcomes included virological and immunologic effectiveness, drug-related adverse events (DRAEs), treatment persistence, and PROs using the HIV Symptom Index (HIV-SI) and the HIV Treatment Satisfaction Questionnaires (HIVTSQ).

Results: N = 201 were included (29 TN, 172 TE), 83% male, median age 38 years in TN, 48 years in TE. At baseline, 94% of TE had an HIV-1 RNA <50 cp/mL, 92% switched to B/F/TAF for simplification. Overall, 69% reported comorbidities (TN: 59%, TE: 70%). At M12, 88% (23/26) of TN and 96% (152/159) of TE had an HIV-1 RNA <50 cp/mL in the discontinuation = failure analysis (without emergence of resistance to B/F/TAF). Median CD4 count changes were +296 cells/µL (interquartile range [IQR], 118, 383) in TN, and +23 cells/µl (-137, 114) in TE. DRAEs were reported for 5% and led to discontinuation in 1%. M12 persistence on B/F/TAF was 97%. TN had a median HIV-SI bothersome symptom count decrease of -1.5 (IQR, -5.0, 0.0). Median treatment satisfaction change score was +29.0 (21, 30) in TE indicating an improvement.

Conclusions: In this real-world Italian cohort of mostly treatment-experienced people switching for simplification, B/F/TAF demonstrated high effectiveness and persistence over 12 months and confirmed the favourable safety profile shown in clinical trials.

Trial registration: European cohort: EUPAS22185.

背景:BICSTaR是一项多国观察性队列研究,旨在评估treatment-naïve (TN)和有经验(TE)的HIV-1感染者在常规临床护理中接受比替替韦/恩曲他滨/替诺福韦α胺(B/F/TAF)治疗的有效性、安全性和患者报告的结局(PROs)。我们介绍了意大利BICSTaR队列的12个月(M12)结果。方法:对在常规护理中开始B/F/TAF治疗的参与者进行前瞻性随访。结果包括病毒学和免疫学有效性、药物相关不良事件(DRAEs)、治疗持续性和PROs(使用HIV症状指数(HIV- si)和HIV治疗满意度问卷(HIVTSQ))。结果:纳入N = 201例(TN 29例,TE 172例),男性83%,TN中位年龄38岁,TE中位年龄48岁。在基线时,94%的TE患者有HIV-1 RNA。结论:在这个现实世界的意大利队列中,大多数治疗经验丰富的患者改用简化治疗,B/F/TAF显示出高有效性和持续12个月,并证实了临床试验中显示的良好安全性。试验注册:欧洲队列:EUPAS22185。
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International Journal of STD & AIDS
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