Efectividad

Effectividad
  • 文章类型: Journal Article
    目的:对于ST段抬高型心肌梗死(STEMI),建议行直接经皮冠状动脉介入治疗(pPCI)。各国设计了各种STEMI网络模型,以优化院外分诊,及时治疗,和患者结果。这项研究的目的是评估STEMI网络实施的有效性,包括院外分诊在改善STEMI病死率和长期死亡率方面。以及它对心力衰竭患者比例的影响,他们的缺血时间,和pPCI的时间。
    方法:系统评价和荟萃分析。搜索PubMed,Scopus,和WebofScience数据库,涵盖2000年1月至2023年12月,研究选择,数据提取由3名独立评审员完成。
    结果:共选择32篇。医院外分诊的STEMI网络实施与病死率降低了35%(95CI,-23%至-45%)相关,长期死亡率为27%(95CI,-22%至-32%),入院时KillipIII-IV患者的比例,缺血,和pPCI时间(-17%,95CI,-35%+6%;-19%,95CI,-6%至-31%;-33%,95CI,-16%至-47%,分别)。基于紧急运输系统和涉及整个卫生系统的网络,包括没有pPCI功能的初级保健中心和医院,表现出类似的效果。在城市与农村地区以及高收入与中低收入国家中,效果更高。
    结论:实施基于院外分诊的STEMI网络可有效降低STEMI病死率和长期死亡率,独立于该地区的地理和社会经济条件。紧急运输系统的参与是成功网络的关键要素。
    OBJECTIVE: Primary percutaneous coronary intervention (pPCI) is recommended for ST elevation myocardial infarction (STEMI). Countries have designed various STEMI network models to optimize out-of-hospital triage, timely treatment, and patient outcomes. The aim of this study was to evaluate the effectiveness of STEMI network implementation including out-of-hospital triage in improving STEMI case-fatality and long-term mortality, and its effect on the proportion of patients presenting with heart failure, their ischemia time, and time to pPCI.
    METHODS: Systematic review and meta-analysis. Searches of PubMed, Scopus, and Web of Science databases covering January 2000 to December 2023, study selection, and data extraction were completed by 3 independent reviewers.
    RESULTS: A total of 32 articles were selected. STEMI network implementation with out-of-hospital triage was associated with reductions of 35% in case-fatality (95%CI, -23% to -45%), 27% in long-term mortality (95%CI, -22% to -32%), and in the proportion of patients with Killip III-IV at admission, ischemia, time and time to pPCI (-17%, 95%CI, -35% +6%; -19%, 95%CI, -6% to -31%; -33%, 95%CI, -16% to -47%, respectively). Networks based on emergency transport systems and those involving the entire health system, including primary care centers and hospitals without pPCI capabilities, showed similar effectiveness. Greater effectiveness was observed in urban vs rural areas and high-income vs middle- and low-income countries.
    CONCLUSIONS: The implementation of out-of-hospital triage-based STEMI networks is effective in reducing STEMI case-fatality and long-term mortality, independently of the geographic and socioeconomic conditions of the region. Participation of the emergency transport system is the key element of successful networks.
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  • 文章类型: Journal Article
    背景:免疫缺陷患者的SARS-CoV-2死亡率较高,他们是接受暴露前预防的附属机构。这项研究的目的是评估tixagevimab/cilgavimab(Evusheld)预防SARS-CoV-2感染的有效性,免疫功能低下患者的住院率和死亡率。
    方法:119名符合Evushold治疗条件的18岁免疫受损者随访6个月。既往有SARS-CoV-2感染或疫苗接种方案不完整的人被排除在外。共有19名接受Evushold的人与倾向得分相匹配,使用1:1的比例,还有19个人没有收到Evusheld。社会人口统计学,纳入了与SARS-CoV-2危险因素相关以及与免疫抑制变量相关的因素.因变量是感染,住院治疗,和死亡率与SARS-CoV-2有关。使用SPSSStatistics19.0、STATA11.0和R统计软件包进行统计分析。
    结果:总计,Evushold组4人,对照组11人感染SARS-CoV-2,发病率为每100人个月3.87和13.62,分别。SARS-CoV-2感染的HR(危险比)为0.29(95%CI=0.09-0.90),0.37(0.07-1.92)用于SARS-CoV-2住院治疗,与对照组相比,Evusheld组的SARS-CoV-2死亡率为0.23(0.03-2.09)。
    结论:这项研究表明Evusheld减少了SARS-CoV-2感染。
    BACKGROUND: Inmunocompromised people have higher SARS-CoV-2 morbi-mortality and they are subsidiary to receive pre-exposure prophylaxis. The objective of this study is to evaluate the effectiveness of tixagevimab/cilgavimab (Evusheld) in preventing SARS-CoV-2 infections, hospitalizations and mortality in immunocompromised patients.
    METHODS: 119 immunocompromised people>18 years old eligible of receiving Evusheld were followed for 6 months. People with previous SARS-CoV-2 infection or incomplete vaccination regimen were exluded. A total of 19 people who received Evusheld were matched by propensity score, using a 1:1 ratio, with another 19 people who did not receive Evusheld. Sociodemographic, related to SARS-CoV-2 risk factors and related to immunosuppression variables were included. The dependent variables were infection, hospitalization, and mortality related to SARS-CoV-2. Statistical analyzes were performed using SPSS Statistics 19.0, STATA 11.0, and the R statistical package.
    RESULTS: In total, 4 people in the Evusheld group and 11 in the control group had SARS-CoV-2 infection, showing an incidence rate of 3.87 and 13.62 per 100 person-months, respectively. The HR (Hazard Ratio) was 0.29 (95% CI=0.09-0.90) for SARS-CoV-2 infection, 0.37 (0.07-1.92) for SARS-CoV-2 hospitalization and, 0.23 (0.03-2.09) for SARS-CoV-2 mortality in the Evusheld group compared to control group.
    CONCLUSIONS: This study demonstrates that Evusheld reduces the SARS-CoV-2 infections.
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  • 文章类型: Journal Article
    Most protected area impact research that uses counterfactuals draws heavily on quantitative methods, data, and knowledge types, making it valuable in producing generalizations but limited in temporal scope, historical detail, and habitat diversity and coverage of ecosystem services. We devised a methodological pluralistic approach, which supports social science qualitative methods, narratives, mixed methods, and interdisciplinarity, to fully unlock the potential of counterfactuals in ensuring a place-based and detailed understanding of the socioecological context and impacts of protected areas. We applied this approach to derive possible counterfactual conditions for the impact of a montane protected area on 40 years of vegetation change in the Cape Floristic Region-a global biodiversity hotspot and UNESCO World Heritage Site in South Africa. We incorporated diverse methods, knowledge, and information sources, drawing on before-after protected area comparisons for inside and outside the protected area. A significant increase in shrubland vegetation (17-30%) was observed and attributed primarily to a decline in frequent burning for grazing. This also occurred outside the protected area and was driven by socioeconomic drivers and not by concerns over biodiversity conservation or land degradation. Had the protected area not been established the area would have seen intensification of cultivation and increased road networks, buildings, and water storage in dams. Our approach increased historical temporal coverage of socioecological change and contextualized assumptions around causality. Protected area impact evaluation should reengage in place-based research that fully incorporates pluralism in methodologies for constructing counterfactuals in a way that builds regional and global understanding from the local level upward. We devised 10 key principles for deriving counterfactuals grounded in methodological pluralism, covering aspects of collaboration, cocreation, inter- and transdisciplinarity, diverse values and lived experiences, multiple knowledge types, multiple possible causal mechanisms, social science qualitative methods, perceptions, perspectives, and narratives.
    Importancia del pluralismo metodológico en la derivación de situaciones contrafactuales para la conservación basada en evidencias Resumen La mayoría de las investigaciones sobre el impacto de las áreas protegidas que usan situaciones contrafactuales se basan en gran medida en métodos cuantitativos, datos y tipos de conocimiento, por lo que son muy valiosas para producir generalizaciones, pero limitadas en el enfoque temporal, el detalle histórico y la diversidad de hábitats y cobertura de los servicios ambientales. Diseñamos una estrategia metodológica pluralista, la cual apoya los métodos cualitativos de las ciencias sociales, narrativas, métodos mixtos e interdisciplinarios para utilizar por completo el potencial de las situaciones contrafactuales para asegurar un conocimiento detallado y basado en el lugar del contexto socio ecológico y el impacto de las áreas protegidas. Aplicamos esta estrategia para derivar las posibles condiciones contrafactuales del impacto de un área protegida montañosa sobre 40 años de cambio de vegetación en el reino florístico del Cabo – un punto caliente de biodiversidad y Sitio de Patrimonio Mundial de la UNESCO en Sudáfrica. Incorporamos varios métodos, conocimientos y fuentes de información a partir de las comparaciones antes‐después dentro y fuera del área protegida. Observamos un incremento significativo en la vegetación del matorral (17‐30%), el cual atribuimos principalmente en la disminución de la quema frecuente para el pastoreo. Esto también ocurrió fuera del área protegida y fue causado por factores socioeconómicos y no por preocupación por la conservación de la biodiversidad o por la degradación del suelo. De no haberse establecido el área protegida, la zona habría sufrido una intensificación de cultivos y un incremento de carreteras, edificios y almacenamiento de agua en presas. Nuestra estrategia incrementó la cobertura histórica temporal del cambio socio‐ecológico y contextualizó las suposiciones sobre la causalidad. La evaluación del impacto del área protegida debe volver a la investigación basada en el lugar que incorpora de lleno el pluralismo en la metodología para construir situaciones contrafactuales de una forma que genere conocimiento regional y global a partir del nivel local y hacia arriba. Diseñamos diez principios clave para derivar las situaciones contrafactuales basados en el pluralismo metodológico, la cobertura de los aspectos de colaboración, creación conjunta, inter‐ y transdisciplinariedad, valores diversos y experiencias vividas, varios tipos de conocimiento, diferentes mecanismos causales posibles, métodos cualitativos de las ciencias sociales, percepciones, perspectivas, historias y narrativas.
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  • 文章类型: Journal Article
    目的:比较常规穿刺与超声引导穿刺在成人动脉血气采样中的疗效。
    方法:开发了一种搜索协议,并将其应用于三个数据库(Medline,科克伦,和Dialnet)。2013年1月至2023年1月之间以西班牙语或英语发表的临床试验,被考虑。结果是第一次尝试成功,直到成功的尝试次数,时间,自我报告的医源性疼痛,收集患者或专业经验。评估每个纳入研究的偏倚风险。
    结果:选择了五个随机临床试验,样本量范围从50到238名在紧急情况下接受治疗的成年患者。四分之三的研究显示,使用超声波时,首次尝试成功率更高,4项研究中有2项报告医源性疼痛减少。在所花费的时间和成功所需的尝试次数方面,研究中观察到了不同的发现。
    结论:尽管目前的证据有限,研究结果也不相同,与常规穿刺相比,超声引导下的动脉穿刺在首次成功和减少医源性疼痛方面可能具有优势.
    OBJECTIVE: To compare the efficacy of conventional puncture versus ultrasound-guided puncture for arterial blood gas sampling in adults.
    METHODS: A search protocol was developed and applied to three databases (Medline, Cochrane, and Dialnet). Clinical trials published between January 2013 and January 2023, in Spanish or English, were considered. Outcomes in terms of first-attempt success, number of attempts until success, time taken, self-reported iatrogenic pain, and patient or professional experience were collected. The risk of bias for each included study was assessed.
    RESULTS: Five randomized clinical trials were selected, with sample sizes ranging from 50 to 238 adult patients treated in emergency settings. Three out of four studies showed higher first-attempt success rates when using ultrasound, and 2 out of 4 studies reported a decrease in iatrogenic pain. Discrepant findings were observed among the studies in terms of time taken and the number of attempts required for success.
    CONCLUSIONS: Although current evidence is limited and the findings are heterogeneous, ultrasound-guided arterial puncture may have advantages over conventional puncture in terms of first-attempt success and in reducing iatrogenic pain.
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  • 文章类型: English Abstract
    背景:25.9%的西班牙人患有慢性疼痛。一个综合的,建议采用跨学科方法,药物和非药物治疗,让病人参与他们的自我保健。
    目的:评估短期和中期非肿瘤性慢性疼痛非药物治疗方案的有效性和对资源的影响。
    方法:准实验前后研究,随访3-6个月,测量:疼痛,幸福,生活质量,自尊,弹性,焦虑/抑郁(验证量表);研讨会对疼痛管理影响的患者报告结果,习惯和情绪;ED和办公室访问;药物消费和就业状况。
    结果:142名患者完成了该计划;131名(92.3%)是女性,年龄:56.0。减少:疼痛(量表0-10)(开始:6.0;车间结束:4.0;3个月:5.0);焦虑(12.9;10.4;8.8)和抑郁(12.3;7.23;6.47)(量表0-21)。他们增加了:幸福感(量表0-10)(4.0;6.0;4.0);生活质量(量表0-1)(0.418;0.580;0.536);健康状况(量表0-100)(47.5;60.0;60.0);自尊(量表9-36)(24.1;27.5;26.7);韧性(量表6-30)(14.8;17.4;18.6)。在研讨会结束时,136例患者进行了患者报告的结果,在3个月时进行了79例:疼痛减轻(程序结束:104,76.5%;3个月:66,83.5%);药物减少(96,76.2%;60,78.9%);习惯改善(112,88.2%;69,90.8%)。四十名病人(37.4%)减少到急诊室就诊,40人(37.4%)减少了预定的访问。总体满意度:10人中有9.8人。
    结论:患者学会减轻疼痛,参与他们的自我保健,提高他们的生活质量,自尊和情绪状态。效果持续3-6个月。
    BACKGROUND: 25.9% of Spanish people suffer from chronic pain. An integrated, interdisciplinary approach is recommended, with pharmacological and non-pharmacological therapies, involving patients in their self-care.
    OBJECTIVE: To evaluate the effectiveness and impact on resources of a program with non-pharmacological therapies in the control of non-oncological chronic pain in the short and medium term.
    METHODS: Quasi-experimental before-after study, follow-up 3-6 months, measuring: pain, well-being, quality of life, self-esteem, resilience, anxiety/depression (validated scales); patient-reported outcomes of workshop impact on pain management, habits and mood; ED and office visits; drug consumption and employment status.
    RESULTS: One hundred and forty-two patients completed the program; 131 (92.3%) were women, age: 56.0. Decreased: pain (scale 0-10) (start: 6.0; end of workshop: 4.0; 3 months: 5.0); anxiety (12.9; 10.4; 8.8) and depression (12.3; 7.23; 6.47) (scales 0-21). They increased: well-being (scale 0-10) (4.0; 6.0; 4.0); quality of life (scale 0-1) (0.418; 0.580; 0.536); health status (scale 0-100) (47.5; 60.0; 60.0); self-esteem (scale 9-36) (24.1; 27.5; 26.7); resilience (scale 6-30) (14.8; 17.4; 18.6). Patient-reported outcomes were performed by 136 patients at the end of the workshop and 79 at 3 months: pain decreased (end of program: 104, 76.5%; 3 months: 66, 83.5%); medication decreased (96, 76.2%; 60, 78.9%); habits improved (112, 88.2%; 69, 90.8%). Forty patients (37.4%) reduced visits to the emergency room, 40 (37.4%) reduced scheduled visits. Overall satisfaction: 9.8 out of 10.
    CONCLUSIONS: Patients learn to mitigate their pain, participate in their self-care and improve their quality of life, self-esteem and emotional state. The effects remained for 3-6 months.
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  • 文章类型: Observational Study
    目的:在风险分担协议(RSA)的背景下,提供塞托珠单抗(CZP)在中度至重度斑块状银屑病(PsO)成年患者实际临床实践中的有效性的证据。
    方法:基于RSA中收集的变量进行回顾性观察研究,用于中重度斑块PsO的成年患者的CZP治疗。实施RSA的十家西班牙医院参加了会议。评估了在随访(第16周)时达到RSA目标临床反应的患者百分比:生物学初治人群的绝对银屑病面积和严重程度指数(PASI)值≤3,和≤5的情况下,以前失败的单一生物药物。此外,分析了研究中包括的其他量表评分的改善情况:体表面积(BSA),皮肤病生活质量指数(DLQI)医师全球评估(PGA),和指甲牛皮癣严重程度指数(NAPSI)。对总人口和患者亚组进行了描述性分析(幼稚与对生物学不幼稚,男性vs.女性,和与不中断)。
    结果:纳入66例患者,男12人,女54人。90.9%达到目标临床反应,平均减少8个(-78.4%)绝对PASI点。在BSA中观察到改善,PGA,NAPSI,和DLQI,减少11.3(-80.6%),1.9(-65.5%),3.3(-30.7%),和9.0(-66.4%)绝对值点,分别。尽管6名患者(9%)未达到RSA中设定的治疗目标(药物的成本由实验室承担),只有2例(3%)停止治疗.
    结论:我们的研究表明,CZP在中重度斑块PsO患者的实际临床实践中有效,随着绝对PASI和DLQI的改进,以及其他尺度,对于总人口和分析的亚组。近91%的患者达到了RSA中固定的治疗目标。实施这种类型的协议可以为参与该过程的所有代理商提供直接或间接的好处,为决策提供有价值的信息。
    OBJECTIVE: To provide evidence of the effectiveness of certolizumab pegol (CZP) in real clinical practice in adult patients with moderate-to-severe plaque psoriasis (PsO) in the context of a risk-sharing agreement (RSA).
    METHODS: Retrospective observational study based on variables collected in the RSA for treatment with CZP of adult patients with moderate-severe plaque PsO. Ten Spanish hospitals where the RSA was implemented participated. The percentage of patients who achieved the target clinical response of the RSA at the follow-up visit (week 16) was evaluated: absolute Psoriasis Area and Severity Index (PASI) value ≤3 for biologic naïve population, and ≤5 in case of previous failure to a single biologic drug. In addition, the improvement in the scores of other scales included in the study was analysed: Body Surface Area (BSA), Dermatology Life Quality Index (DLQI), Physician\'s Global Assessment (PGA), and Nail Psoriasis Severity Index (NAPSI). A descriptive analysis was performed for the total population and by patient subgroups (naive vs. non-naive to biologic, male vs. female, and with vs. without discontinuation).
    RESULTS: Sixty-six patients were included, 12 men and 54 women. 90.9% achieved the target clinical response, with a mean reduction of 8 (-78.4%) absolute PASI points. Improvement was observed in BSA, PGA, NAPSI, and DLQI, with a reduction of 11.3 (-80.6%), 1.9 (-65.5%), 3.3 (-30.7%), and 9.0 (-66.4%) absolute value points, respectively. Despite not achieving the therapeutic target set in the RSA in 6 patients (9%) (the cost of the drug was assumed by the laboratory), only 2 (3%) discontinued treatment.
    CONCLUSIONS: Our study shows that CZP is effective in real clinical practice in patients with moderate-severe plaque PsO, with an improvement in absolute PASI and DLQI, as well as other scales, both for the total population and in the subgroups analysed. Nearly 91% of patients reached the therapeutic target fixed in the RSA. Implementing this type of agreement can provide a direct or indirect benefit for all the agents involved in the process, providing valuable information for decision-making.
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  • 文章类型: Systematic Review
    背景:经皮乙醇注射(PEI)已被证明是甲状腺结节病理和转移性宫颈腺病的有价值的治疗方法。
    目的:为了评估有效性,安全,PEI在甲状腺结节病理和转移性宫颈腺病中的成本效益。
    方法:使用荟萃分析对PEI的有效性和安全性进行了系统评价(SR)。还进行了关于成本效益的SR。SRs是根据CochraneCollaboration制定的方法进行的,并根据PRISMA声明进行报告。使用决策树模型进行了成本最小化分析。假设两种微创技术(PEI和射频消融(RFA))的有效性相同,该模型从西班牙国家卫生系统的角度比较了六个月替代方案的成本。
    结果:搜索确定了三个RCT(n=157),用于评估诊断为良性甲状腺结节的患者的PEI和RFA:96例主要为囊性结节的患者和61例实性结节的患者。没有发现其他技术或甲状腺结节病理学的证据。PEI和RFA在体积减少(%)方面没有观察到统计学上的显著差异,症状评分,化妆品评分,治疗成功和主要并发症。没有确定经济评估。成本最小化分析估计PEI手术每位患者的成本为326欧元,而RFA为4781欧元。这意味着-4455欧元的增量差额。
    结论:PEI和RFA在安全性和有效性方面没有差异,但是经济评估确定前一种选择更便宜。
    BACKGROUND: Percutaneous ethanol injection (PEI) has been shown to be a valuable treatment for thyroid nodular pathology and metastatic cervical adenopathies.
    OBJECTIVE: To evaluate the effectiveness, safety, and cost-effectiveness of PEI in thyroid nodular pathology and metastatic cervical adenopathies.
    METHODS: A systematic review (SR) using meta-analysis was conducted on the effectiveness and safety of PEI. A SR on cost-effectiveness was also performed. The SRs were conducted according to the methodology developed by the Cochrane Collaboration with reporting in accordance with the PRISMA statement. A cost-minimization analysis was carried out using a decision tree model. Assuming equal effectiveness between two minimally invasive techniques (PEI and radiofrequency ablation (RFA)), the model compared the costs of the alternatives with a horizon of six months and from the perspective of the Spanish National Health System.
    RESULTS: The search identified three RCTs (n=157) that evaluated PEI versus RFA in patients diagnosed with benign thyroid nodules: ninety-six patients with predominantly cystic nodules and sixty-one patients with solid nodules. No evidence was found on other techniques or thyroid nodular pathology. No statistically significant differences were observed between PEI and RFA in volume reduction (%), symptom score, cosmetic score, therapeutic success and major complications. No economic evaluations were identified. The cost-minimization analysis estimated the cost per patient of the PEI procedure at €326 compared to €4781 for RFA, which means an incremental difference of -€4455.
    CONCLUSIONS: There are no differences between PEI and RFA regarding their safety and effectiveness, but the economic evaluation determined that the former option is cheaper.
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  • 文章类型: English Abstract
    背景:在医院环境中应用精益方法可以帮助改善跨专业交流并减少非增值活动(浪费)。
    目的:为了确定实施可视化管理工具的有效性,减少旅行次数的能力,在医院内转移(ITH)和出院过程中实时确定患者的位置。
    方法:在医院内科进行的前后研究。检测到由于不必要的转移而造成的若干时间浪费。成立了一个多专业小组,以设计可视化管理工具来解决这些已发现的问题。评估了专业人员对该工具的意见,并在实施前后测量了工作人员流离失所和工具完成的变量。
    结果:对相关人员进行了培训。随着时间的推移,工具的完成情况有所改善,无论是在HIT还是在放电中,减少旅行次数。
    结论:视觉管理工具在护理过程中的应用,包括所有相关人员都是有效的,节省了浪费。
    BACKGROUND: The application of Lean methodology in the hospital environment can help to improve interprofessional communication and reduce non-value adding activities (waste).
    OBJECTIVE: To determine the effectiveness of the implementation of a visual management tool, in the ability to reduce the number of trips, to determine the location of patients in real time in the process of intra-hospital transfers (ITH) and discharges in a hospital.
    METHODS: Before-after study in a hospital internal medicine unit. Several time wastes due to unnecessary transfers were detected. A multiprofessional group was formed to design a visual management tool for the resolution of these identified problems. The opinion of the professionals on the tool was evaluated and variables of staff displacement and completion of the tool were measured before and after its implementation.
    RESULTS: The personnel involved was trained. Completion of the tool improved over time, both in HIT and in discharges, reducing the number of trips.
    CONCLUSIONS: The application of a visual management tool in care processes, including all the personnel involved is effective and saves waste.
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  • 文章类型: Journal Article
    背景:炎症性风湿性疾病通常影响使用生物药物治疗的育龄妇女。然而,缺乏关于妊娠期生物疾病改善药物的疗效和毒性的文献.这项研究的目的是在现实世界的数据集中确定使用bDMARDs治疗的怀孕患者的存在,并在西班牙患者注册中检查怀孕和哺乳对风湿性疾病演变的影响。
    方法:这是一项具有真实世界背景的多中心前瞻性研究。信息来自BIOBADASER注册表。患者包括从19个风湿病单位怀孕到2020年11月的妇女。我们进行了比例,means,和标准偏差(SD)来描述研究人群和治疗方法的使用。T检验和卡方检验用于评估组间差异。
    结果:登记了90例妊娠病例(n=68例足月妊娠;n=22例自然流产)。大多数病例在怀孕期间停止bDMARDs(78.9%),但13例在怀孕期间继续治疗,主要使用赛托珠单抗pegol。这些病例得到更好的治疗风湿病,尽管差异无统计学意义[DAS28-CRP,2.9(标准差:1.6)与2.0(1.2)、p=.255;DAS28-ESR,2.2(1.0)与1.7(.5),p=0.266]。在怀孕和哺乳期间未报告严重不良事件。
    结论:在风湿性疾病和使用bDMARDs的患者中,怀孕仍然是一种罕见的情况。我们的结果表明,在继续服用bDMARDs的患者中,风湿病在怀孕期间倾向于更好地发展。
    BACKGROUND: Inflammatory rheumatic diseases usually affect women of childbearing age treated with biologic drugs. However, there is a lack of literature on the efficacy and toxicity of biologic disease-modifying drugs during pregnancy. The aim of this study was to determine the presence of pregnant patients treated with bDMARDs in a real-world dataset and to examine the impact of pregnancy and lactation on the evolution of rheumatic disease in a registry of Spanish patients.
    METHODS: This was a multicentre prospective study with a real-world setting. Information was obtained from BIOBADASER registry. Patients included are women who got pregnant until November 2020 from 19 rheumatology units. We conducted proportions, means, and standard deviations (SD) to describe the study population and the use of treatments. T-test and Chi-square test were applied to assess differences between groups.
    RESULTS: Ninety cases of pregnancy were registered (n=68 full-term pregnancies; n=22 spontaneous miscarriages). Most of the cases discontinued bDMARDs during pregnancy (78.9%) but 13 cases continued treatment during pregnancy, mainly using certolizumab pegol. These cases were obtaining better management of rheumatic disease, although the differences were not statistically significant [DAS28-CRP, 2.9 (SD: 1.6) vs. 2.0 (1.2), p=.255; DAS28-ESR, 2.2 (1.0) vs. 1.7 (.5), p=.266]. No serious adverse events were reported during pregnancy and lactation.
    CONCLUSIONS: Being pregnant is still an uncommon condition in patients with rheumatic diseases and using bDMARDs. Our results show that rheumatic disease tended to progress better during pregnancy in patients who continued to take bDMARDs.
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  • 文章类型: Journal Article
    目的:球囊血管成形术后展开的低剖面可视化腔内支持(LVIS)支架在治疗颅内动脉粥样硬化性狭窄中的性能未知,本研究旨在探讨LVIS支架治疗大脑中动脉M1段颅内动脉粥样硬化性狭窄的安全性和有效性。
    方法:纳入35例M1段动脉粥样硬化狭窄患者。16例患者的狭窄率约为75%,15中的80%,其余四个中的90%。LVIS支架用于治疗这些患者。
    结果:支架置入成功率为97.1%。一名患者由于术中狭窄(75%)段的解剖,支架置入术失败。导致30天的围手术期并发症发生率为2.9%(1/35)。在植入支架之前,狭窄率为75%-90%(平均78.9%±4.7%),支架植入后,支架段的直径显着(P<0.0001)增加到正常动脉直径的1.5-3.4mm(平均2.1±0.32mm),范围为68.2%-100%(平均94.0%±5.8%),残余狭窄范围为0-31.8%(中位数为4.8%,IQR2.4%-7.3%)。支架置入后6-20个月(平均8.5)进行随访。1例(2.9%)支架M1段闭塞,无症状,两名患者(5.7%)在M1段有轻度无症状的瞬时狭窄(40%),术后再狭窄和闭塞率为8.6%(3/35)。
    结论:编织LVIS支架可以安全地用于颅内大脑中动脉粥样硬化性狭窄的治疗,支架置入后即刻及随访时具有良好的安全性和有效性。
    OBJECTIVE: The performance of the Low-Profile Visualized Intraluminal Support (LVIS) stent deployed following balloon angioplasty is unknown in treating intracranial atherosclerotic stenosis, and this study was to investigate the safety and efficacy of the LVIS stent in treating intracranial atherosclerotic stenosis in the middle cerebral artery M1 segment.
    METHODS: Thirty-five patients were enrolled with 35 atherosclerotic stenoses at the M1 segment. The stenosis was about 75% in 16 patients, 80% in 15, and 90% in the rest four. The LVIS stent was used to treat these patients.
    RESULTS: The success rate of stenting was 97.1%. The stenting procedure was failed in one patient because of intraprocedural dissection of the stenotic (75%) segment, resulting in a 30-day periprocedural complication rate of 2.9% (1/35). Before stenting, the stenosis rate ranged 75%-90% (mean 78.9%±4.7%), and after stenting, the diameter of the stented segment was significantly (P<0.0001) increased to 1.5-3.4mm (mean 2.1±0.32mm) ranging 68.2%-100% (mean 94.0%±5.8%) of the normal arterial diameter, with the residual stenosis ranging 0-31.8% (median 4.8%, IQR 2.4%-7.3%). Follow-up was performed at 6-20 months (mean 8.5) after stenting. One patient (2.9%) had occlusion of the stented M1 segment with no symptoms, and two patients (5.7%) had slight asymptomatic instent stenosis (40%) at the M1 segment, with the instent restenosis and occlusion rate of 8.6% (3/35).
    CONCLUSIONS: The braided LVIS stent can be safely applied for treatment of intracranial atherosclerotic stenosis in the middle cerebral artery with good safety and efficacy immediately after stenting and at follow-up.
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