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Prophylaxis and treatment of acute intraocular pressure rise after cataract surgery: considerations to aid in decision-making. 白内障手术后急性眼压升高的预防和治疗:辅助决策的考虑因素。
IF 4.3 3区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2024-11-01 Epub Date: 2024-11-11 DOI: 10.1080/17512433.2024.2427104
Eitan A Katz, Shivani Majmudar, Ahmad A Aref
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引用次数: 0
SGLT2i and GLP1RA effects in patients followed in a hospital diabetology consultation. SGLT2i 和 GLP1RA 对医院糖尿病咨询随访患者的影响。
IF 4.3 3区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2024-11-01 Epub Date: 2024-10-27 DOI: 10.1080/17512433.2024.2421872
António Cabral Lopes, Olga Lourenço, Manuel Morgado

Background: We aimed to investigate the effects of sodium-glucose cotransporter 2 inhibitors (SGLT2i) and glucagon-like peptide-1 receptor agonists (GLP1RA) in patients with type 2 diabetes mellitus (T2DM) in clinical practice.

Research design and methods: A total of 340 patients were included. Data on age, gender, antidiabetic medications, and bioanalytical parameters were collected at baseline and one year later. Were analyzed estimated glomerular filtration rate (eGFR), blood sodium and potassium levels, blood pressure, weight, cardiovascular risk, and glycated hemoglobin (HbA1c).

Results: Patients treated with SGLT2i exhibited a significant improvement in eGFR at the endpoint compared to baseline (p = 0.006). Both treatment groups experienced reductions in systolic blood pressure at the endpoint; especially patients treated with SGLT2i (p = 0.0002). GLP1RA treatment resulted in a statistically significant weight reduction from baseline to endpoint (p < 0.0001), with a higher percentage of patients achieving ≥ 5% weight loss compared to the non-GLP1RA group (33.6% vs. 19.8%). Both SGLT2i and GLP1RA treatments significantly reduced cardiovascular risk scores (p = 0.004 and p = 0.002, respectively). Additionally, both treatments were associated with a significant reduction in HbA1c levels at the endpoint (p = 0.010 and p = 0.002, respectively).

Conclusions: Our findings suggest that SGLT2i and GLP1RA offer beneficial effects in patients with T2DM.

背景:我们旨在研究钠-葡萄糖共转运体 2 抑制剂(SGLT2i)和胰高血糖素样肽-1 受体激动剂(GLP1RA)在临床实践中对 2 型糖尿病(T2DM)患者的影响:共纳入 340 例患者。研究设计和方法:共纳入 340 名患者,收集基线和一年后的年龄、性别、抗糖尿病药物和生物分析参数数据。对估计肾小球滤过率(eGFR)、血钠和血钾水平、血压、体重、心血管风险和糖化血红蛋白(HbA1c)进行了分析:结果:接受 SGLT2i 治疗的患者在终点时的 eGFR 与基线相比有显著改善(p = 0.006)。两个治疗组在终点时收缩压都有所下降,尤其是接受 SGLT2i 治疗的患者(p = 0.0002)。GLP1RA 治疗使患者体重从基线到终点均有显著下降(分别为 p = 0.004 和 p = 0.002)。此外,两种治疗方法在终点都能显著降低 HbA1c 水平(分别为 p = 0.010 和 p = 0.002):我们的研究结果表明,SGLT2i 和 GLP1RA 可为 T2DM 患者带来益处。
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引用次数: 0
Type II RAF inhibitor tovorafenib for the treatment of pediatric low-grade glioma. 治疗小儿低级别胶质瘤的 II 型 RAF 抑制剂托伐非尼。
IF 4.3 3区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2024-11-01 Epub Date: 2024-10-19 DOI: 10.1080/17512433.2024.2418405
Tianqiao Zhang, Bo Xu, Fan Tang, Zunbo He, Jiecan Zhou

Introduction: Pediatric low-grade glioma (pLGG) is the most prevalent childhood brain tumor group, currently regarded as a chronic disease. On 23 April 2024, the U.S. FDA approved a new type II RAF inhibitor, tovorafenib (OJEMDATM), previously known as DAY101, for the treatment of patients aged 6 months and older with relapsed or refractory (R/R) pLGG harboring a BRAF fusion or rearrangement, or BRAF V600E mutation.

Areas covered: This article aims to review the pharmacological properties of tovorafenib and evaluate its efficacy and safety in the treatment of R/R pLGG. We conducted a systematic search of PubMed and Web of Science databases for English-language publications related to tovorafenib, including journal articles and conference abstracts, up through 20 August 2024.

Expert opinion: As the first and only FDA-approved medicine for children with BRAF fusions or rearrangements, which are the most common molecular alteration in pLGG, tovorafenib shows superior central nervous system penetration without the paradoxical activation of the MAPK pathway reported for type I BRAF inhibitors. Phase 1 and the pivotal phase 2 trials have demonstrated that tovorafenib monotherapy is generally well-tolerated and exhibits encouraging signs of meaningful, rapid and sustained clinical activity in children and young adults with BRAF-altered pLGG.

简介小儿低级别胶质瘤(pLGG)是发病率最高的儿童脑肿瘤,目前被视为一种慢性疾病。2024 年 4 月 23 日,美国 FDA 批准了一种新型 II 型 RAF 抑制剂--托伐非尼(OJEMDATM)(之前名为 DAY101),用于治疗年龄在 6 个月及以上、携带 BRAF 融合或重排或 BRAF V600E 突变的复发或难治性(R/R)pLGG 患者:本文旨在回顾托伐非尼的药理特性,并评估其治疗R/R pLGG的有效性和安全性。我们在PubMed和Web of Science数据库中系统检索了截至2024年8月20日与沃拉非尼相关的英文出版物,包括期刊论文和会议摘要:作为首个也是唯一一个获得FDA批准的治疗儿童BRAF融合或重排(pLGG中最常见的分子改变)的药物,tovorafenib显示出卓越的中枢神经系统穿透力,而不会出现I型BRAF抑制剂所报道的MAPK通路激活的矛盾现象。1 期和关键的 2 期试验表明,托伐非尼单药治疗的耐受性普遍良好,而且在患有 BRAF 改变的 pLGG 的儿童和年轻成人中显示出令人鼓舞的有意义、快速和持续的临床活性。
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引用次数: 0
An overview on disease modifying and symptomatic drug treatments for multiple sclerosis. 多发性硬化症的改病和对症药物治疗概述。
IF 3.6 3区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2024-10-08 DOI: 10.1080/17512433.2024.2410393
Gloria Dalla Costa, Letizia Leocani, Mariaemma Rodegher, Luca Chiveri, Alessandro Gradassi, Giancarlo Comi

Introduction: Multiple sclerosis (MS) is an inflammatory and degenerative autoimmune condition, resulting frequently in a disabling condition. Significant improvements of long-term prognosis have been recently achieved with an early and more aggressive use of disease modifying therapies (DMTs). Addressing the complexity of managing its progressive forms remains a significant challenge.

Areas covered: This review provides an update on DMTs for relapsing-remitting MS (RRMS) and progressive MS and their efficacy, safety, and mechanism of action, emphasizing the critical role of biomarkers in optimizing treatment decisions. Moreover, some key information on drugs used to manage symptoms such as pain, fatigue, spasticity and urinary problems will be provided. The literature search was conducted using PubMed, Embase, and Cochrane Library databases covering the period from January 2000 to January 2024.

Expert opinion: Major advances have been achieved in the treatment of RRMS. Treatment should start immediately as soon as the neurologist is confident with the diagnosis and its choice should be based on the prognostic profile and on the patient's propensity to accept drug-related risks. The therapeutic landscape for progressive MS is quite disappointing and necessitates further innovation. Personalized medicine, leveraging biomarker insights, holds promise for refining treatment efficacy and patient outcomes.

导言:多发性硬化症(MS)是一种炎症性和变性的自身免疫性疾病,经常导致残疾。最近,通过早期和更积极地使用改变疾病疗法(DMTs),多发性硬化症的长期预后得到了显著改善。但如何应对渐进形式的复杂病情仍然是一项重大挑战:本综述提供了有关治疗复发性多发性硬化症(RRMS)和进展性多发性硬化症的 DMTs 及其疗效、安全性和作用机制的最新信息,强调了生物标志物在优化治疗决策中的关键作用。此外,还将提供一些用于控制疼痛、疲劳、痉挛和泌尿系统问题等症状的药物的关键信息。我们使用 PubMed、Embase 和 Cochrane Library 数据库对 2000 年 1 月至 2024 年 1 月期间的文献进行了检索:RRMS 的治疗已取得重大进展。一旦神经科医生确信诊断结果,就应立即开始治疗,治疗方案的选择应基于预后情况和患者接受药物相关风险的倾向。进展期多发性硬化症的治疗前景令人失望,需要进一步创新。利用生物标志物洞察力的个性化医疗有望改善治疗效果和患者预后。
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引用次数: 0
Tirzepatide, a novel, dual glucose-dependent insulinotropic polypeptide/glucagon-like peptide-1 receptor agonist for the ongoing diabesity epidemic: the dawn of a new era? 新型双重葡萄糖依赖性促胰岛素多肽/胰高血糖素样肽-1 受体激动剂 Tirzepatide:新时代的曙光?
IF 3.6 3区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2024-10-04 DOI: 10.1080/17512433.2024.2408753
Imran Rangraze, Dimitrios Patoulias, Paschalis Karakasis, Mohamed El-Tanani, Manfredi Rizzo
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引用次数: 0
Clozapine for persons with neurodevelopmental disorders: a systematic review and expert recommendations for clinical practice. 用于神经发育障碍患者的氯氮平:系统综述和临床实践专家建议。
IF 3.6 3区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2024-10-03 DOI: 10.1080/17512433.2024.2410395
Hélène Verdoux, Clélia Quiles, Jose de Leon

Introduction: We aimed to synthesize the information on the risks and benefits of clozapine prescription for resistant challenging behavior in persons with neurodevelopmental disorders.

Methods: Articles were identified with MEDLINE, Web of Sciences, and PsycINFO search from inception through January 2024. The review was restricted to persons with intellectual disability (ID) and/or autism spectrum disorder (ASD) without comorbid psychotic or affective disorder. Data were synthesized narratively.

Results: We identified 24 articles (13 case reports, eight chart studies, two controlled studies, one pharmaco-epidemiological study) including 296 patients with ID (n = 222) or ASD (n = 74) (10% aged ≤ 18 years). After clozapine initiation, a decreased frequency of challenging behavior persisting over time was reported in most participants included in clinical studies, and a significant reduction in the number of admissions in the population-based two-year mirror-image study. Adverse drug reactions were those commonly observed with clozapine, i.e. constipation, sedation, and weight gain.

Conclusions: Since only four participants were included in the controlled studies, the benefits of clozapine in neurodevelopmental disorders are supported by a body of evidence exclusively drawn from observational studies. Further studies are required to clarify the indications of clozapine with respect to the unmet need induced by resistant challenging behavior.

Registration: PROSPERO database registration number CRD42024522343.

简介我们旨在综合有关氯氮平处方治疗神经发育障碍患者耐受性挑战行为的风险和益处的信息:通过MEDLINE、Web of Sciences和PsycINFO检索发现了从开始到2024年1月的文章。研究对象仅限于智力障碍(ID)和/或自闭症谱系障碍(ASD)患者,且不合并精神病或情感障碍。对数据进行了叙述性综合:我们发现了 24 篇文章(13 篇病例报告、8 篇图表研究、2 篇对照研究、1 篇药物流行病学研究),其中包括 296 名智障患者(n = 222)或自闭症谱系障碍患者(n = 74)(10% 年龄小于 18 岁)。据报道,在开始使用氯氮平之后,大多数参与临床研究的患者在一段时间内持续出现挑战性行为的频率有所降低,而在为期两年的人群镜像研究中,入院人数也显著减少。药物不良反应是氯氮平常见的不良反应,如便秘、镇静、体重增加等:由于只有四名参与者参与了对照研究,因此氯氮平对神经发育障碍的益处得到了大量证据的支持,这些证据完全来自观察性研究。还需要进一步的研究,以明确氯氮平在抵抗性挑战行为引起的未满足需求方面的适应症:PROSPERO数据库注册号为CRD42024522343。
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引用次数: 0
Effectiveness of ulinastatin in critical care patients in real world: a retrospective multi-center study. 乌利那他汀在重症监护患者中的实际疗效:一项多中心回顾性研究。
IF 3.6 3区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2024-10-03 DOI: 10.1080/17512433.2024.2402433
Deduo Xu, Yi Shan, Qinghua Liu, Pei Liang, Xin Hao, Jinyuan Zhang, Ze Yu, Wenfang Li, Fei Gao, Xia Tao, Qin Gu, Yabin Ma, Wansheng Chen

Objectives: Ulinastatin has been applied in various diseases associated with inflammation, but its effectiveness lacks real-world evidence. We aimed to evaluate the effectiveness of ulinastatin based on a real-world database in the intensive care unit (ICU) patients.

Methods: This was a retrospective cohort study. ICU patient data from multi-centers in China were collected. Propensity score matching (PSM) was applied. The effectiveness of ulinastatin was evaluated by mortality, length of stay in the ICU and mechanical ventilation duration. Kaplan-Meier method was used to estimate the hazard ratio and plot the survival curve.

Results: A total of 2036 patients were analyzed after PSM. Mortality was significantly lower in the ulinastatin group than in the non-ulinastatin group (hazard ratio for death: 0.77; 95% confidence interval: 0.62-0.96; p = 0.018). Ulinastatin significantly reduced mortality at 28 days (10.0% vs. 13.6%), 60 days (13.9% vs. 18.2%) and 90 days (14.7% vs. 18.5%), length of stay in the ICU (median 8.0 d vs. 13.0 d), and mechanical ventilation duration (median 24.0 h vs. 25.0 h; p < 0.05).

Conclusions: Ulinastatin was beneficial for patients in the ICU, mainly by reducing mortality, length of ICU stay, and mechanical ventilation duration. This study provides evidence of the clinical effectiveness of ulinastatin.

研究目的乌利那他汀已被应用于多种与炎症相关的疾病,但其有效性缺乏真实世界的证据。我们的目的是根据重症监护室(ICU)患者的实际数据库评估乌利那他汀的疗效:这是一项回顾性队列研究。方法:这是一项回顾性队列研究,收集了来自中国多个中心的 ICU 患者数据。采用倾向得分匹配法(PSM)。通过死亡率、ICU住院时间和机械通气时间评估乌利那他汀的疗效。采用卡普兰-梅耶法估算危险比并绘制生存曲线:结果:共分析了 2036 名 PSM 患者。乌利那他汀组的死亡率明显低于非乌利那他汀组(死亡危险比:0.77;95% 置信区间:0.62-0.96;P = 0.018)。乌利那他汀能明显降低28天(10.0% vs. 13.6%)、60天(13.9% vs. 18.2%)和90天(14.7% vs. 18.5%)的死亡率、重症监护室住院时间(中位数8.0天 vs. 13.0天)和机械通气时间(中位数24.0小时 vs. 25.0小时;P 结论:乌利那他汀能明显降低重症监护室住院时间(中位数8.0天 vs. 13.0天)和机械通气时间(中位数24.0小时 vs. 25.0小时):乌利那他汀对重症监护病房的患者有益,主要是降低了死亡率、缩短了重症监护病房的住院时间和机械通气时间。这项研究为乌利那他汀的临床疗效提供了证据。
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引用次数: 0
Pharmacokinetic interaction of quetiapine and lamotrigine - victim and perpetrator? 喹硫平与拉莫三嗪的药代动力学相互作用--受害者还是肇事者?
IF 3.6 3区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2024-10-03 DOI: 10.1080/17512433.2024.2410400
Florian Gilleßen, Arnim Johannes Gaebler, Ekkehard Haen, Georgios Schoretsanitis, Justyna Wozniak, Julia C Stingl, Michael Paulzen

Objective: We aimed to investigate the ambiguous findings of earlier research regarding the reduction of quetiapine plasma levels when combined with lamotrigine, most likely via UDP-glucuronosyltransferase induction by lamotrigine.

Methods: One thousand one hundred and fifty samples, divided into four groups of patients receiving either quetiapine immediate- (IR) or extended-release (XR) without or in combination with lamotrigine were compared regarding absolute and dose-adjusted plasma concentrations. Furthermore, samples of intra-individual controls were analyzed.

Results: Patients receiving quetiapine IR in combination with lamotrigine showed 31% lower plasma (p = 0.002) and 23% lower dose-adjusted plasma concentrations (p = 0.004) compared to those receiving IR monotherapy. The proportion of patients with quetiapine plasma concentrations below the lower limit of the therapeutic reference range was 50% and 30% in the combination group and in patients receiving monotherapy, respectively (p = 0.03). However, no significant differences regarding plasma concentration (p = 0.13) and dose-adjusted plasma concentration (p = 0.42) were observed in patients with combination vs. monotherapy with the XR formulation of quetiapine. In the intra-individual controls, no trends could be identified, possibly due to insufficient number of samples (p > 0.05).

Conclusions: The combination of quetiapine IR with lamotrigine is associated with significantly lower drug concentrations of quetiapine, potentially impacting quetiapine effectiveness. For quetiapine ER, a significant interaction is less likely.

研究目的我们旨在研究早期研究中关于喹硫平与拉莫三嗪合用时血浆中喹硫平水平降低的模糊结论,这很可能是通过拉莫三嗪诱导UDP-葡萄糖醛酸转移酶所致:将接受喹硫平即释(IR)或缓释(XR)治疗但不与拉莫三嗪合用或与拉莫三嗪合用的患者分成四组,对一千一百五十份样本的绝对血浆浓度和剂量调整血浆浓度进行了比较。此外,还分析了个体内对照样本:结果:与接受IR单药治疗的患者相比,接受喹硫平IR联合拉莫三嗪治疗的患者血浆浓度低31%(p = 0.002),剂量调整后血浆浓度低23%(p = 0.004)。联合用药组和单药治疗组中,喹硫平血浆浓度低于治疗参考范围下限的患者比例分别为50%和30%(p = 0.03)。然而,在接受喹硫平XR制剂联合治疗与单药治疗的患者中,未观察到血浆浓度(p = 0.13)和剂量调整血浆浓度(p = 0.42)方面的明显差异。在个体内部对照中,可能由于样本数量不足(p > 0.05),未发现任何趋势:结论:喹硫平IR与拉莫三嗪合用时,喹硫平的药物浓度明显降低,可能会影响喹硫平的疗效。对于喹硫平 ER 而言,发生显著相互作用的可能性较小。
{"title":"Pharmacokinetic interaction of quetiapine and lamotrigine - victim and perpetrator?","authors":"Florian Gilleßen, Arnim Johannes Gaebler, Ekkehard Haen, Georgios Schoretsanitis, Justyna Wozniak, Julia C Stingl, Michael Paulzen","doi":"10.1080/17512433.2024.2410400","DOIUrl":"10.1080/17512433.2024.2410400","url":null,"abstract":"<p><strong>Objective: </strong>We aimed to investigate the ambiguous findings of earlier research regarding the reduction of quetiapine plasma levels when combined with lamotrigine, most likely via UDP-glucuronosyltransferase induction by lamotrigine.</p><p><strong>Methods: </strong>One thousand one hundred and fifty samples, divided into four groups of patients receiving either quetiapine immediate- (IR) or extended-release (XR) without or in combination with lamotrigine were compared regarding absolute and dose-adjusted plasma concentrations. Furthermore, samples of intra-individual controls were analyzed.</p><p><strong>Results: </strong>Patients receiving quetiapine IR in combination with lamotrigine showed 31% lower plasma (<i>p</i> = 0.002) and 23% lower dose-adjusted plasma concentrations (<i>p</i> = 0.004) compared to those receiving IR monotherapy. The proportion of patients with quetiapine plasma concentrations below the lower limit of the therapeutic reference range was 50% and 30% in the combination group and in patients receiving monotherapy, respectively (<i>p</i> = 0.03). However, no significant differences regarding plasma concentration (<i>p</i> = 0.13) and dose-adjusted plasma concentration (<i>p</i> = 0.42) were observed in patients with combination vs. monotherapy with the XR formulation of quetiapine. In the intra-individual controls, no trends could be identified, possibly due to insufficient number of samples (<i>p</i> > 0.05).</p><p><strong>Conclusions: </strong>The combination of quetiapine IR with lamotrigine is associated with significantly lower drug concentrations of quetiapine, potentially impacting quetiapine effectiveness. For quetiapine ER, a significant interaction is less likely.</p>","PeriodicalId":12207,"journal":{"name":"Expert Review of Clinical Pharmacology","volume":" ","pages":"1-8"},"PeriodicalIF":3.6,"publicationDate":"2024-10-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142364958","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Is therapeutic drug monitoring a dancing partner for TNF-α inhibitors in real-world practice? Answers from an updated systematic review and meta-analysis. 治疗药物监测是 TNF-α 抑制剂在实际应用中的舞伴吗?最新系统综述和荟萃分析给出的答案。
IF 3.6 3区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2024-10-01 Epub Date: 2024-09-21
Yang Hu, Zaiwei Song, Yuan Gao, Dan Jiang, Yiwen Ran, Yi Ma, Huibo Li, Rongsheng Zhao

Introduction: This systematic review aimed to determine the effect of therapeutic drug monitoring (TDM) for tumor necrosis factor-α inhibitors (TNF-αI) in immune-mediated inflammatory diseases (IMIDs) based on real-world evidence, as results from published meta-analyses based on randomized controlled trials (RCTs) may not fully capture the nuances of clinical practice due to strict criteria.

Methods: We searched PubMed, Embase, and the Cochrane Library up to 1 August 2023. Cohort studies comparing TDM (proactive and reactive) with empirical management were included. Primary outcome was effectiveness [for IBDs: clinical remission; for rheumatic diseases: clinical remission or low disease activity], with certainty of evidence appraised using the GRADE approach. Secondary outcomes included treatment failure, serious adverse events (SAEs), IMIDs-related surgeries or hospitalizations, and anti-drug antibodies (ADAs) development risk.

Results: Twenty-four cohort studies were included and almost all were on infliximab. For IBDs, compared with empirical management, proactive TDM significantly improved clinical remission (RR = 1.15, 95% CI = 1.04-1.28), reduced IBDs-related surgeries (RR = 0.46, 95% CI = 0.26-0.81), hospitalizations (RR = 0.60, 95% CI = 0.43-0.83), SAEs (RR = 0.23, 95% CI = 0.07-0.76), and ADAs development risk (RR = 0.34, 95% CI = 0.19-0.60). Reactive TDM significantly lowered hospitalization rates and might be cost-effective. Proactive TDM outperformed reactive TDM in secondary outcomes. For rheumatic diseases, benefits of TDM were inconclusive due to limited evidence.

Conclusions: Real-world evidence supports proactive TDM of TNF-αI (particularly infliximab) in IBDs to improve effectiveness, safety, and immunogenicity. However, benefits of TDM for different TNF-αI in other IMIDs remain uncertain.

Protocol registration: www.crd.york.ac.uk/ PROSPERO identifier is CRD42022370846.

导言:由于基于随机对照试验(RCT)的已发表荟萃分析的结果可能因严格的标准而无法完全反映临床实践的细微差别,因此本系统综述旨在根据现实世界的证据确定肿瘤坏死因子-α抑制剂(TNF-αI)治疗药物监测(TDM)在免疫介导的炎症性疾病(IMIDs)中的效果:我们检索了截至 2023 年 8 月 1 日的 PubMed、Embase 和 Cochrane 图书馆。方法:我们检索了截至 2023 年 8 月 1 日的 PubM、Embase 和 Cochrane 图书馆,纳入了比较 TDM(主动和被动)与经验性管理的队列研究。主要结果为有效性[对于IBD:临床缓解;对于风湿性疾病:临床缓解或低疾病活动性],采用GRADE方法评估证据的确定性。次要结果包括治疗失败、严重不良事件(SAEs)、IMIDs相关手术或住院以及抗药抗体(ADAs)发展风险:结果:共纳入了 24 项队列研究,几乎所有研究都涉及英夫利西单抗。对于 IBDs,与经验性治疗相比,主动性 TDM 可显著改善临床缓解(RR = 1.15,95% CI = 1.04-1.28),减少 IBDs 相关手术(RR = 0.46,95% CI = 0.26-0.81)、住院(RR = 0.60,95% CI = 0.43-0.83)、SAEs(RR = 0.23,95% CI = 0.07-0.76)和 ADAs 发展风险(RR = 0.34,95% CI = 0.19-0.60)。反应性 TDM 能明显降低住院率,可能具有成本效益。在次要结果方面,主动式TDM优于被动式TDM。对于风湿性疾病,由于证据有限,TDM的益处尚无定论:真实世界的证据支持对IBD患者的TNF-αI(尤其是英夫利西单抗)进行主动TDM,以提高有效性、安全性和免疫原性。然而,TDM对其他IMIDs中不同TNF-αI的益处仍不确定。协议注册:www.crd.york.ac.uk/ PROSPERO标识符为CRD42022370846。
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引用次数: 0
Amylin analogs for the treatment of obesity without diabetes: present and future. 用于治疗无糖尿病肥胖症的淀粉类似物:现状与未来。
IF 3.6 3区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2024-09-30 DOI: 10.1080/17512433.2024.2409403
Theodoros Panou, Evanthia Gouveri, Djordje S Popovic, Nikolaos Papanas

Introduction: Obesity is a pandemic, linked with increased morbidity including diabetes mellitus (DM) and certain cancer types. Amylin is a major regulatory hormone for satiation and food intake perception in humans. Amylin analogs (pramlintide and cagrilintide) are emerging as promising anti-obesity agents in non-DM subjects.

Areas covered: Pramlintide, the first amylin analog, initially used for the treatment of both type 1 and type 2 DM, has demonstrated weight-lowering action. Clinical trials confirmed a weight loss exceeding 3% in the study period without major untoward effects, which was maintained beyond the follow-up period. Recently, cagrilintide, a long-lasting synthetic amylin analog has been introduced. Cagrilintide has achieved adequate weight loss, reaching even more than 10% of the total weight in early clinical trials. However, adverse gastrointestinal effects, particularly nausea, were more frequent compared with pramlintide. Clinical trials have also confirmed the effectiveness of cagrilintide in comparison with glucagon-like peptide 1 receptor agonists.

Expert opinion: Amylin analogs will certainly enrich the growing therapeutic armamentarium aimed at tackling obesity. The most exciting future research venue could be the development of their combinations with other weight-lowering drugs, especially dual and triple incretin-based co-agonists, thus potentially providing massive weight-loss effects.

导言:肥胖症是一种大流行病,与糖尿病(DM)和某些癌症类型等发病率增加有关。淀粉样蛋白是人体饱腹感和食物摄入感的主要调节激素。淀粉样蛋白类似物(普拉林肽和卡格列林肽)正在非糖尿病患者中成为有前景的抗肥胖药物:普拉林肽是第一种淀粉类似物,最初用于治疗 1 型和 2 型糖尿病,已证明具有降低体重的作用。临床试验证实,在研究期间体重下降超过 3%,且无重大不良反应,随访期后仍能保持。最近,一种长效合成淀粉样蛋白类似物卡格列汀(cagrilintide)问世。在早期临床试验中,卡格列林肽的减重效果很好,甚至达到了总重量的 10%以上。然而,与普拉林肽相比,胃肠道的不良反应,尤其是恶心更为频繁。临床试验还证实,与胰高血糖素样肽 1 受体激动剂相比,卡格列净的疗效更好:专家观点:淀粉类似物必将丰富日益增长的肥胖症治疗手段。未来最令人兴奋的研究方向可能是开发淀粉类似物与其他减重药物的组合,特别是与双重和三重胰高血糖素类联合受体激动剂的组合,从而可能产生巨大的减重效果。
{"title":"Amylin analogs for the treatment of obesity without diabetes: present and future.","authors":"Theodoros Panou, Evanthia Gouveri, Djordje S Popovic, Nikolaos Papanas","doi":"10.1080/17512433.2024.2409403","DOIUrl":"https://doi.org/10.1080/17512433.2024.2409403","url":null,"abstract":"<p><strong>Introduction: </strong>Obesity is a pandemic, linked with increased morbidity including diabetes mellitus (DM) and certain cancer types. Amylin is a major regulatory hormone for satiation and food intake perception in humans. Amylin analogs (pramlintide and cagrilintide) are emerging as promising anti-obesity agents in non-DM subjects.</p><p><strong>Areas covered: </strong>Pramlintide, the first amylin analog, initially used for the treatment of both type 1 and type 2 DM, has demonstrated weight-lowering action. Clinical trials confirmed a weight loss exceeding 3% in the study period without major untoward effects, which was maintained beyond the follow-up period. Recently, cagrilintide, a long-lasting synthetic amylin analog has been introduced. Cagrilintide has achieved adequate weight loss, reaching even more than 10% of the total weight in early clinical trials. However, adverse gastrointestinal effects, particularly nausea, were more frequent compared with pramlintide. Clinical trials have also confirmed the effectiveness of cagrilintide in comparison with glucagon-like peptide 1 receptor agonists.</p><p><strong>Expert opinion: </strong>Amylin analogs will certainly enrich the growing therapeutic armamentarium aimed at tackling obesity. The most exciting future research venue could be the development of their combinations with other weight-lowering drugs, especially dual and triple incretin-based co-agonists, thus potentially providing massive weight-loss effects.</p>","PeriodicalId":12207,"journal":{"name":"Expert Review of Clinical Pharmacology","volume":" ","pages":"1-9"},"PeriodicalIF":3.6,"publicationDate":"2024-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142344307","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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Expert Review of Clinical Pharmacology
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