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Evaluating real-world data in COVID-19 antigen and PCR testing. 评估COVID-19抗原和PCR检测的真实数据。
IF 0.8 4区 医学 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2023-04-01 DOI: 10.5414/CP204338
Olaf Rose, Emina Obarcanin, Susanne Erzkamp
OBJECTIVE COVID-19 testing is an important pillar in fighting the SARS-CoV-2 pandemic. Even though billions of tests have been conducted, little is known on performance of testing sites. This is a retrospective observational study with real-world data from a pharmacist-led COVID-19 testing center in Germany during the Omicron subvariant BA.4 and BA.5 wave in June 2022. MATERIALS The rapid antigen tests employed were purchased from Anbio Biotechnology (Xiamen, China). The RT-PCR was performed on Egens YS-qPCR-1 real-time system with Kewei multiple real-time PCR kits for detection of SARS-CoV-2 (Beijing Kewei Clinical Diagnostic Reagent Inc., Beijing, China). METHODS The study followed the STARD 2015 guideline. In this retrospective cohort study, the performance of testing sites was compared. RESULTS During the study period, 7,112 patients were tested by rapid antigen tests and 1,025 RT-PCR tests conducted. Included were 233 patients who were referred by other testing sites for confirmation of positive results. A positive predictive value of 99.6% was calculated for the antigen tests in the pharmacist-led testing center. Referred positive patients from non-medical sites were antigen and RT-PCR negative in 16 cases, which led to a positive predictive value of 88.8%. Difference between site performance was statistically significant (p < 0.05). CONCLUSION Results indicate that nucleic acid amplification confirmation is crucial in the context of the current testing strategy in Germany. Higher standards in antigen-testing, however, can make nucleic acid amplification in active COVID-19 infections unnecessary and testing cost efficient. This study provides the first data in the world on COVID-19 testing performance, and how it can be optimized.
目的:COVID-19检测是抗击新冠肺炎大流行的重要支柱。尽管已经进行了数十亿次测试,但人们对测试站点的性能知之甚少。这是一项回顾性观察性研究,使用了2022年6月Omicron亚变异BA.4和BA.5浪潮期间德国药剂师领导的COVID-19检测中心的真实数据。材料:所用快速抗原试验购自中国厦门安比奥生物技术有限公司。RT-PCR采用Egens s - qpcr -1实时检测系统,采用科微多重实时PCR试剂盒检测SARS-CoV-2(北京科微临床诊断试剂有限公司,北京,中国)。方法:本研究遵循STARD 2015指南。在这项回顾性队列研究中,比较了检测地点的性能。结果:在研究期间,7112例患者进行了快速抗原检测,1025例进行了RT-PCR检测。其中包括233名由其他检测机构转诊确认阳性结果的患者。在药剂师主导的检测中心,抗原检测的阳性预测值为99.6%。非医疗场所转诊阳性患者抗原阴性、RT-PCR阴性16例,阳性预测值为88.8%。两组现场表现差异有统计学意义(p < 0.05)。结论:结果表明,在德国目前的检测策略背景下,核酸扩增确认至关重要。然而,抗原检测标准的提高,可能会使活动性COVID-19感染的核酸扩增变得不必要,从而降低检测成本。这项研究提供了世界上第一个关于COVID-19检测性能以及如何优化检测性能的数据。
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引用次数: 0
Persistence with first-line antihypertensive therapy in Germany: A retrospective cohort study with 2,801,469 patients. 德国一线降压治疗的持续性:一项包含 2,801,469 名患者的回顾性队列研究。
IF 0.8 4区 医学 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2023-03-05 DOI: 10.5414/CP204358
Karel Kostev, Balaji Yakkali, Saket Chaudhari, Swati Upadhyaya, Christian Tanislav, Marcel Konrad, Mark Luedde

Background: The goal of this retrospective cohort study was to investigate 3-year persistence with antihypertensive drug therapy and the association between antihypertensive drug classes and therapy discontinuation risk in Germany.

Materials and methods: The present retrospective cohort study was based on the IQVIA longitudinal prescription database (LRx) and included adult outpatients (≥ 18 years) with an initial prescription of antihypertensive monotherapy alone including diuretics (DIU), β-blockers (BB), calcium channel blockers (CCB), ACE inhibitors (ACEi), and angiotensin II receptor blockers (ARB) in Germany between January 2017 and December 2019 (index date). A Cox proportional hazards regression model was also used to assess the relationship between antihypertensive drug classes and non-persistence adjusted for age and sex.

Results: This study included 2,801,469 patients. Patients on ARB monotherapy exhibited the highest persistence within 1 year (39.4%) and 3 years (21.7%) after the index date. Patients on DIU monotherapy showed the lowest persistence (16.5% after 1 year, 6.2% 3 years after the index date). In the overall population, initial monotherapy with DIU (HR: 1.48) was positively associated with monotherapy discontinuation, whereas ARB monotherapy was (HR = 0.74) negatively associated with monotherapy discontinuation compared to BB. However, in the age group > 80, there was a slight negative association between DIU intake and monotherapy discontinuation (HR = 0.91).

Conclusion: This large cohort study reveals significant differences in 3-year persistence with antihypertensives, which were strongest for ARB and weakest for DIU. However, the differences also depended on age, with much better DIU persistence in the elderly.

背景:这项回顾性队列研究的目的是调查德国降压药物治疗的 3 年持续性以及降压药物类别与治疗中断风险之间的关联:本回顾性队列研究以IQVIA纵向处方数据库(LRx)为基础,纳入了2017年1月至2019年12月(索引日期)期间德国首次处方单纯降压单药治疗的成人门诊患者(≥18岁),包括利尿剂(DIU)、β受体阻滞剂(BB)、钙通道阻滞剂(CCB)、ACE抑制剂(ACEi)和血管紧张素II受体阻滞剂(ARB)。此外,还采用 Cox 比例危险度回归模型评估了抗高血压药物类别与非持久性之间的关系,并对年龄和性别进行了调整:本研究共纳入 2,801,469 名患者。接受 ARB 单一疗法的患者在指数日期后 1 年内(39.4%)和 3 年内(21.7%)的持续率最高。接受 DIU 单一疗法的患者的持续率最低(1 年后为 16.5%,指数日期后 3 年后为 6.2%)。在总体人群中,与 BB 相比,DIU 的初始单药治疗(HR:1.48)与单药治疗的终止呈正相关,而 ARB 单药治疗(HR = 0.74)与单药治疗的终止呈负相关。然而,在年龄大于 80 岁的人群中,DIU 摄入量与单药治疗停药之间存在轻微的负相关(HR = 0.91):这项大型队列研究显示,服用降压药的 3 年持续率存在显著差异,其中 ARB 的差异最大,DIU 的差异最小。然而,差异还取决于年龄,老年人的 DIU 持续性要好得多。
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引用次数: 0
Comparative pharmacokinetics of two formulations of 2.5-mg rivaroxaban in healthy Korean subjects. 韩国健康受试者体内 2.5 毫克利伐沙班两种制剂的药代动力学比较。
IF 0.8 4区 医学 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2023-03-05 DOI: 10.5414/CP204335
Seol Ju Moon, Yunjeong Kim, Sun-Young Kim, Ji-Young Jeon, Eunji Song, Yeji Lim, Min-Gul Kim

Objective: Rivaroxaban is a direct factor Xa inhibitor used for the prevention and treatment of thromboembolic disorders. The objective of this study was to compare the pharmacokinetic profiles of two rivaroxaban formulations after a single dose of rivaroxaban (2.5-mg tablet) in healthy Korean subjects.

Materials and methods: This study was a randomized, open-label, single-dose, two-period, crossover study that included 34 healthy adult subjects under fasting conditions. The test drug (Yuhan rivaroxaban tablet) or reference drug (Xarelto tablet) was administered in each period. Serial blood samples were collected up to 36 hours post-dose. Plasma concentrations were measured by LC-MS/MS. Pharmacokinetic parameters, including maximum plasma concentration (Cmax) and area under the plasma concentration-time curve from time zero to the last measurable concentration (AUCt), were determined by non-compartmental analysis. The 90% confidence intervals (CIs) for the ratio of the geometric means of Cmax and AUCt for the test drug/reference drug were calculated to evaluate pharmacokinetic equivalence.

Results: A total of 28 subjects were included in the pharmacokinetic analysis. The geometric mean ratios (90% CI) of the test drug/reference drug for rivaroxaban were 1.0140 (0.9794 - 1.0499) for AUCt and 0.9350 (0.8797 - 0.9939) for Cmax. All adverse events (AEs) were mild, and there was no significant difference in the incidence of AEs between the formulations.

Conclusion: The pharmacokinetic parameters of rivaroxaban were compared between the test and reference drug, and both formulations were bioequivalent. The newly developed rivaroxaban tablet is safe and well tolerated as the reference drug (ClinicalTrials.gov identifiers: NCT05418803).

目的:利伐沙班是一种直接的 Xa 因子抑制剂,用于预防和治疗血栓栓塞性疾病。本研究旨在比较韩国健康受试者单剂量服用利伐沙班(2.5 毫克片剂)后两种利伐沙班制剂的药代动力学特征:本研究是一项随机、开放标签、单剂量、两阶段、交叉研究,包括 34 名空腹条件下的健康成年受试者。每个阶段服用试验药物(Yuhan rivaroxaban 片剂)或参比药物(Xarelto 片剂)。连续采集血样,直至用药后 36 小时。血浆浓度由 LC-MS/MS 测定。药代动力学参数,包括最大血浆浓度(Cmax)和从零时到最后可测量浓度的血浆浓度-时间曲线下面积(AUCt),均通过非室分析法确定。计算受试药物/参照药物 Cmax 和 AUCt 几何平均比值的 90% 置信区间 (CI),以评估药代动力学等效性:共有 28 名受试者参加了药代动力学分析。利伐沙班的试验药物/参照药物的几何平均比(90% CI)分别为:AUCt 1.0140(0.9794 - 1.0499),Cmax 0.9350(0.8797 - 0.9939)。所有不良事件(AEs)均为轻微,且不同制剂之间的不良事件发生率无显著差异:结论:比较了利伐沙班的药代动力学参数,两种制剂具有生物等效性。新开发的利伐沙班片剂与参比药物一样安全且耐受性良好(ClinicalTrials.gov identifiers: NCT05418803)。
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引用次数: 0
Extremely high unbound flucloxacillin concentrations in a patient with acute septic renal failure during continuous venovenous hemofiltration: Therapeutic drug monitoring to optimize treatment. 一名急性脓毒症肾衰竭患者在持续静脉血液滤过过程中出现极高的非结合氟氯西林浓度:治疗药物监测以优化治疗。
IF 0.8 4区 医学 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2023-03-05 DOI: 10.5414/CP204313
Evine M Appelman, Elisabeth A Wammes van-der-Heijden, Sjoerd D Meenks, Paddy K C Janssen, Jos L M L le Noble

A 75-year-old female orthopedic patient with spondylodiscitis was admitted to the intensive care unit, where she developed severe acute renal injury (AKI) due to a Staphylococcus aureus bloodstream infection. Continuous venovenous hemofiltration (CVVH) was initiated as renal replacement therapy. According to physician experience and based on (inter)national guidelines and the severity of the infection, treatment with intravenous (IV) flucloxacillin at an initial continuous dose of 9 g/24h was started. The dose was increased to 12 g/24h because endocarditis could not be excluded. Therapeutic drug monitoring (TDM) was used to monitor flucloxacillin levels which are related to antibiotic efficacy and toxicity. Total and unbound flucloxacillin concentrations were measured following 24 hours of continuous infusion at three time points before regional citrate anticoagulation (RCA)-CVVH was initiated, at three time points in plasma, pre-filter, and post-filter, and in ultrafiltrate samples during RCA-CVVH treatment and 1 day following cessation of CVVH treatment. Extremely high total (up to 299.8 mg/L) and unbound (up to 155.1 mg/L) flucloxacillin concentrations were found in the plasma. This led to a dose decrease to 6 g/24h and subsequently to 3 g/24h. Antimicrobial target attainment against S. aureus was achieved by dosing IV flucloxacillin based on TDM. Based on these findings, we conclude that current dosing guidelines for flucloxacillin during renal replacement therapy need revision. We suggest a starting dose of 4 g/24h, which should be adjusted based on the TDM of the unbound flucloxacillin concentration.

重症监护病房收治了一名患有脊柱盘炎的 75 岁女性骨科患者,她因金黄色葡萄球菌血流感染而出现了严重的急性肾损伤 (AKI)。作为肾脏替代疗法,她开始接受连续静脉血液滤过(CVVH)治疗。根据医生的经验和(国际)国家指南以及感染的严重程度,开始静脉注射氟氯西林,初始连续剂量为 9 克/24 小时。由于无法排除心内膜炎的可能性,剂量增至 12 克/24 小时。治疗药物监测(TDM)用于监测与抗生素疗效和毒性相关的氟氯西林水平。在开始区域性枸橼酸盐抗凝(RCA)-CVVH治疗前的三个时间点、RCA-CVVH治疗期间和CVVH治疗停止后1天的三个时间点,连续输注24小时后的血浆、滤过前、滤过后和超滤液样本中测量了氟氯西林的总浓度和未结合浓度。在血浆中发现了极高的氟氯西林总浓度(高达 299.8 mg/L)和未结合浓度(高达 155.1 mg/L)。这导致剂量降至 6 克/24 小时,随后又降至 3 克/24 小时。根据 TDM 给药静脉滴注氟氯西林可达到抗金黄色葡萄球菌的目标。基于这些研究结果,我们认为目前肾脏替代治疗期间氟氯西林的用药指南需要修订。我们建议起始剂量为 4 克/24 小时,并根据非结合氟氯西林浓度的 TDM 调整剂量。
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引用次数: 0
Effects of reduced edoxaban administration on bleeding risk and D-dimer levels in patients wearing elastic stockings after total hip arthroplasty: A retrospective cohort study. 减少服用依多沙班对全髋关节置换术后穿弹力袜患者出血风险和 D-二聚体水平的影响:一项回顾性队列研究。
IF 0.8 4区 医学 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2023-03-05 DOI: 10.5414/CP204359
Akihiro Uchiike, Dai Tsurusaki, Norikazu Kikuchi, Toru Imai, Susumu Otsuka, Kyoko Motoyoshi, Motoki Arakawa, Shinji Hidaka

Objective: Edoxaban is sometimes given at reduced doses when used concomitantly with physical prophylaxis to prevent symptomatic venous thromboembolism (VTE) after total hip arthroplasty (THA). This study aimed to evaluate the safety of reduced doses of edoxaban administered independent of the dose-reduction criteria and their effects on D-dimer levels after THA in Japanese patients.

Materials and methods: This study enrolled 22 patients who received edoxaban 30 mg/day and 45 patients who received edoxaban 15 mg/day with dose adjustment as a standard-dose group, and 110 patients who received edoxaban 15 mg/day without dose adjustment as a low-dose group. The incidence of bleeding events was then compared between groups with patients wearing elastic stockings. Multivariate regression analysis was also performed to examine the effect of edoxaban administration on D-dimer levels after THA.

Results: The incidence of bleeding events after THA did not differ significantly between groups. In the multivariate model, dose reduction of edoxaban did not correlate with D-dimer levels on postoperative days 7 and 14, but higher D-dimer levels at postoperative days 7 and 14 correlated significantly with longer duration of surgery (odds ratio (OR) 1.66, 95% confidence interval (CI) 1.20 - 2.29, p = 0.002; OR 1.63, 95% CI 1.17 - 2.29, p = 0.004, respectively).

Conclusion: These results suggest that information on the duration of surgery may be useful in the pharmaceutical management in edoxaban drug prophylaxis combined with physical prophylaxis after THA in Japanese patients.

目的:为预防全髋关节置换术(THA)后出现症状性静脉血栓栓塞症(VTE),在使用物理预防的同时有时会减量服用埃多沙班。本研究旨在评估日本患者在接受全髋关节置换术(THA)后独立于减量标准使用减量剂量依多沙班的安全性及其对 D-二聚体水平的影响:该研究招募了22名接受埃多沙班30毫克/天治疗的患者和45名接受埃多沙班15毫克/天治疗并调整剂量的患者作为标准剂量组,以及110名接受埃多沙班15毫克/天治疗但未调整剂量的患者作为低剂量组。然后比较了两组穿弹力袜患者的出血事件发生率。此外,还进行了多变量回归分析,以研究服用埃多沙班对 THA 后 D-二聚体水平的影响:结果:各组间 THA 术后出血事件的发生率无明显差异。在多变量模型中,依多沙班剂量的减少与术后第7天和第14天的D-二聚体水平没有相关性,但术后第7天和第14天较高的D-二聚体水平与较长的手术持续时间显著相关(几率比(OR)分别为1.66,95%置信区间(CI)为1.20 - 2.29,P = 0.002;OR分别为1.63,95%置信区间(CI)为1.17 - 2.29,P = 0.004):这些结果表明,关于手术持续时间的信息可能有助于日本患者 THA 术后伊多沙班药物预防与物理预防相结合的药物管理。
{"title":"Effects of reduced edoxaban administration on bleeding risk and D-dimer levels in patients wearing elastic stockings after total hip arthroplasty: A retrospective cohort study.","authors":"Akihiro Uchiike, Dai Tsurusaki, Norikazu Kikuchi, Toru Imai, Susumu Otsuka, Kyoko Motoyoshi, Motoki Arakawa, Shinji Hidaka","doi":"10.5414/CP204359","DOIUrl":"10.5414/CP204359","url":null,"abstract":"<p><strong>Objective: </strong>Edoxaban is sometimes given at reduced doses when used concomitantly with physical prophylaxis to prevent symptomatic venous thromboembolism (VTE) after total hip arthroplasty (THA). This study aimed to evaluate the safety of reduced doses of edoxaban administered independent of the dose-reduction criteria and their effects on D-dimer levels after THA in Japanese patients.</p><p><strong>Materials and methods: </strong>This study enrolled 22 patients who received edoxaban 30 mg/day and 45 patients who received edoxaban 15 mg/day with dose adjustment as a standard-dose group, and 110 patients who received edoxaban 15 mg/day without dose adjustment as a low-dose group. The incidence of bleeding events was then compared between groups with patients wearing elastic stockings. Multivariate regression analysis was also performed to examine the effect of edoxaban administration on D-dimer levels after THA.</p><p><strong>Results: </strong>The incidence of bleeding events after THA did not differ significantly between groups. In the multivariate model, dose reduction of edoxaban did not correlate with D-dimer levels on postoperative days 7 and 14, but higher D-dimer levels at postoperative days 7 and 14 correlated significantly with longer duration of surgery (odds ratio (OR) 1.66, 95% confidence interval (CI) 1.20 - 2.29, p = 0.002; OR 1.63, 95% CI 1.17 - 2.29, p = 0.004, respectively).</p><p><strong>Conclusion: </strong>These results suggest that information on the duration of surgery may be useful in the pharmaceutical management in edoxaban drug prophylaxis combined with physical prophylaxis after THA in Japanese patients.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":" ","pages":""},"PeriodicalIF":0.8,"publicationDate":"2023-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10853144","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"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
A pharmacokinetic analysis of amisulpride in adult Chinese patients with schizophrenia: Impact of creatinine clearance. 氨磺必利在中国成年精神分裂症患者中的药代动力学分析:肌酐清除率的影响。
IF 0.8 4区 医学 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2023-03-05 DOI: 10.5414/CP204334
Wei Liu, Jingqi Zhou, Minjuan Cao, Fangming Zhang, Xiaoming Sun

Objective: To develop a stable population pharmacokinetic (PPK) model of amisulpride and to investigate the effects of covariates on the pharmacokinetic parameters in adult Chinese patients with schizophrenia.

Materials and methods: This retrospective study was carried out using 168 serum samples from 88 patients collected during routine clinical monitoring. Covariates recorded included demographic parameters (gender, age, weight), clinical parameters (serum creatinine, creatinine clearance), and intake of co-medications. The amisulpride PPK model was established using a nonlinear mixed effects modeling (NONMEM) approach. Goodness-of-fit (GOF) plots, bootstrap validation (1,000 runs), and normalized prediction distribution error (NPDE) were used in the evaluation of the final model.

Results: A one-compartment model with first-order absorption and elimination was developed. The population estimates for apparent clearance (CL/F) and apparent volume of distribution (V/F) were 32.6 L/h and 391 L, respectively. Estimated creatinine clearance (eCLcr) was a significant covariate for CL/F. The established model was: CL/F = 32.6 × (eCLcr/114.3)0.485 (L/h). The stability of the model was confirmed using GOF plots, bootstrap, and NPDE.

Conclusion: Creatinine clearance is a major covariate which is positively correlated with CL/F. Therefore, additional dose adjustments of amisulpride may be required on the basis of eCLcr. An ethnic difference may exist in the pharmacokinetics of amisulpride, but further research is needed in order to confirm this possibility. The PPK model of amisulpride for adult Chinese schizophrenic patients established here using NONMEM, is potentially an important tool for individualizing drug dosage and therapeutic drug monitoring.

摘要建立稳定的阿米舒必利群体药代动力学(PPK)模型,并研究共变量对中国成年精神分裂症患者药代动力学参数的影响:这项回顾性研究使用了在常规临床监测中收集的 88 名患者的 168 份血清样本。记录的协变量包括人口统计学参数(性别、年龄、体重)、临床参数(血清肌酐、肌酐清除率)和联合用药情况。采用非线性混合效应建模(NONMEM)方法建立了阿米舒必利 PPK 模型。在评估最终模型时使用了拟合优度(GOF)图、引导验证(1,000 次运行)和归一化预测分布误差(NPDE):结果:建立了一个具有一阶吸收和消除的单室模型。表观清除率(CL/F)和表观分布容积(V/F)的人群估计值分别为 32.6 升/小时和 391 升。估计肌酐清除率(eCLcr)是 CL/F 的重要协变量。建立的模型为CL/F = 32.6 × (eCLcr/114.3)0.485 (L/h)。该模型的稳定性通过 GOF 图、bootstrap 和 NPDE 得到证实:结论:肌酐清除率是与 CL/F 呈正相关的主要协变量。因此,可能需要根据 eCLcr 调整阿米舒必利的剂量。氨磺必利的药代动力学可能存在种族差异,但需要进一步研究才能证实这种可能性。本文利用NONMEM建立的中国成年精神分裂症患者氨磺必利的PPK模型可能是个体化用药和治疗药物监测的重要工具。
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引用次数: 0
Hypovitaminosis D in infants: Evidence that increased intake of vitamin D reduces the incidence of allergic and respiratory disorders. 婴儿维生素D缺乏症:证据表明增加维生素D摄入量可减少过敏和呼吸系统疾病的发生率。
IF 0.8 4区 医学 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2023-03-01 DOI: 10.5414/CP204093
Katerina Dajic, Bojko Bjelakovic, Andrijana Kostic, Ana Vujic, Slobodan Jankovic, Jasmina Milovanovic, Sandra Matovic, Predrag Sazdanovic, Andjelka Stojkovic

Aim: The study assessed the relationship between vitamin D status in infants and the presence of allergic and/or respiratory disorders.

Materials and methods: The study cohort comprised 81 hospitalized infants presenting at the Pediatric Clinic, University Clinical Center Kragujevac, Serbia, between January 2011 and June 2016.

Results: The age of the infants ranged from 29 days to 12 months. All infants received prophylactic doses of vitamin D3 of 400 IU/daily until the end of the first year of life regardless of whether they are fed with adapted infant formula (n = 20) or breast milk (n = 37) or concurrently both (n = 24), up to the 5th month of life. The mean level of plasma 25(OH)D was 29.65 ng/mL. Hypovitaminosis D (mean serum level of 25(OH)D < 30 ng/mL) was found in n = 38 infants of which 6 presented with severe vitamin D deficiency (level below 10 ng/mL), 13 presented with vitamin D deficiency (level between 10 and 20 ng/mL) and 19 had vitamin D insufficiency (levels between 20 and 30 ng/mL). The median vitamin D serum level in infants with allergic disease (n = 16) was 32.35 ng/mL and in infants with respiratory disease (n = 65) 28.99 ng/mL.

Conclusion: Daily vitamin D3 supplementation with 400 IU in infants until the end of the first year of life is too low to provide optimal defense against respiratory and/or allergic conditions.

目的:本研究评估婴儿体内维生素D水平与过敏和/或呼吸系统疾病之间的关系。材料和方法:研究队列包括2011年1月至2016年6月期间在塞尔维亚克拉古耶瓦茨大学临床中心儿科诊所就诊的81名住院婴儿。结果:患儿年龄29天~ 12个月不等。所有婴儿都接受400 IU/天的维生素D3预防剂量,直到一岁结束,无论他们是用适应婴儿配方奶粉喂养(n = 20)还是母乳喂养(n = 37)或同时喂养(n = 24),直到生命的第五个月。血浆25(OH)D平均水平为29.65 ng/mL。在n = 38例婴儿中发现维生素D缺乏症(25(OH)D平均血清水平< 30 ng/mL),其中6例为严重维生素D缺乏症(水平低于10 ng/mL), 13例为维生素D缺乏症(水平在10 ~ 20 ng/mL之间),19例为维生素D不足症(水平在20 ~ 30 ng/mL之间)。过敏性疾病患儿(n = 16)血清维生素D水平中位数为32.35 ng/mL,呼吸道疾病患儿(n = 65)血清维生素D水平中位数为28.99 ng/mL。结论:婴儿在一岁前每天补充400国际单位的维生素D3不足以提供对呼吸和/或过敏状况的最佳防御。
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引用次数: 0
Prevalence and risk factors of non-adherence to antipsychotic medications in Saudi Arabia. 沙特阿拉伯抗精神病药物不依从性的患病率和危险因素
IF 0.8 4区 医学 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2023-03-01 DOI: 10.5414/CP204300
Bshra A Alsfouk, Jouri A Alsamnan, Mariam M Alamri, Nouf Z Alshammari, Raghad A Madkhali, Ali Garatli, Muhammad Salman Bashir, Aisha A Alsfouk

Purpose: To evaluate the rate and determinants of non-adherence to antipsychotic medications in Saudi Arabia.

Materials and methods: This was a cross-sectional study that included a questionnaire, interview, and data extraction from medical records of adult patients on antipsychotic medications. The study was conducted at outpatient clinics at the psychological care department at King Fahad Medical City, Riyadh, Saudi Arabia, between October 25 and November 26, 2020. Data collection included three parts: patients' sociodemographic characteristics; antipsychotic medications used and patients' clinical characteristics; and adherence to antipsychotic medications measured by the Medication Adherence Rating Scale (MARS).

Results: Out of 220 patients, 122 (55.5%) were considered non-adherent (MARS scores 6 or less). The MARS items contributing most to non-adherence were "the medication makes me feel tired and sluggish" and "forget to take the medication", 55 and 40.9%, respectively. Additionally, adverse drug effect significantly increased the risk of poor adherence in regression analysis (odds ratio = 1.97, p = 0.028). The model also showed that female sex, low income, cigarette smoking, substance abuse, uncontrolled disease, comorbidity, and use of Ruqyah religious therapy were associated with increased risk of poor adherence, but were however not statistically significant (p < 0.05).

Conclusion: This study showed high non-adherence rate to antipsychotic medications. Adverse drug effects and forgetting to take medications were the main patient-reported barriers to adherence. Likewise, sociodemographic, clinical, and spiritual factors affected medication adherence. Knowing these predictors helps in early identification of patients who are predisposed to medication non-adherence and allows personalized interventions that improve adherence and treatment outcomes.

目的:评估沙特阿拉伯抗精神病药物不依从性的比率和决定因素。材料和方法:这是一项横断面研究,包括问卷调查、访谈和从服用抗精神病药物的成年患者的医疗记录中提取数据。该研究于2020年10月25日至11月26日在沙特阿拉伯利雅得法赫德国王医疗城心理护理部门的门诊进行。数据收集包括三部分:患者的社会人口学特征;抗精神病药物使用情况及患者临床特点;通过药物依从性评定量表(MARS)测量抗精神病药物的依从性。结果:在220例患者中,122例(55.5%)被认为是非依从性(MARS评分6分或以下)。MARS项目中对不依从性贡献最大的是“药物使我感到疲倦和迟缓”和“忘记服药”,分别占55%和40.9%。此外,在回归分析中,药物不良反应显著增加依从性差的风险(优势比= 1.97,p = 0.028)。该模型还显示,女性、低收入、吸烟、药物滥用、疾病不受控制、合并症和使用Ruqyah宗教疗法与不良依从性风险增加相关,但无统计学意义(p < 0.05)。结论:本研究显示抗精神病药物的不依从率较高。药物不良反应和忘记服药是患者报告的主要障碍。同样,社会人口学、临床和精神因素也会影响药物依从性。了解这些预测因素有助于早期识别易患药物依从性的患者,并允许个性化干预以改善依从性和治疗结果。
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引用次数: 0
Metformin alone and in combination with sitagliptin induces depression and impairs quality of life in type 2 diabetes mellitus patients: An observational study. 单用二甲双胍和联合西格列汀可诱导2型糖尿病患者抑郁并损害生活质量:一项观察性研究
IF 0.8 4区 医学 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2023-03-01 DOI: 10.5414/CP204288
Mohammed Athar, Aakriti Garg, Mohd Ashif Khan, Rizwana Parveen, Sunil Kohli, Divya Vohora, Nidhi

Background: Various studies have reported the association of cognition and depression with diabetes. Literature suggests that metformin and sitagliptin used to control hyperglycemia in type 2 diabetes mellitus (T2DM) possess a beneficial effect on neurological symptoms associated with diabetes. However, there are scarce data in the clinical setting. Thus, this study aims to compare depression, cognitive impairment, and quality of life (QoL) of newly diagnosed T2DM patients with those of healthy individuals. Further, the impact of metformin alone or in combination with dipeptidyl peptidase-4 inhibitors on cognition, depression, and QoL of T2DM patients was also compared with newly diagnosed T2DM patients.

Materials and methods: This was a prospective observational study in 120 subjects. The subjects were equally divided into four groups: healthy controls, newly diagnosed T2DM patients, and T2DM patients taking either metformin alone or in combination with sitagliptin. We assessed cognition using Mini-Mental State Examinations (MMSE), depression using Hamilton Depression Rating Scale (HAM-D), and health status using Short-Form Health Survey-36 (SF-36).

Results: No significant change in MMSE score was observed among the groups. However, a significant increase in the HAM-D score of newly diagnosed patients (p < 0.001), T2DM patients receiving metformin alone (p < 0.05), and in combination with sitagliptin (p < 0.001) was observed as compared to healthy controls (p < 0.001). Also, a statistically significant increase in HAM-D score was observed in patients receiving sitagliptin in combination with metformin as compared to metformin alone (p < 0.01). A decrease in SF-36 scores was observed in all groups as compared to healthy controls.

Conclusion: To conclude, this preliminary study indicates that T2DM patients are most likely to suffer from depression and impaired QoL. Moreover, both the conventional and recent antidiabetic agents might lead to neurobehavioral complications and adverse impact on the QoL of these patients. Thus, we warrant the assessment of cognitive functions, depression, and QoL in patients receiving metformin and sitagliptin.

背景:各种研究报道了认知和抑郁与糖尿病的关系。文献表明,用于控制2型糖尿病(T2DM)高血糖的二甲双胍和西格列汀对与糖尿病相关的神经系统症状有有益的作用。然而,在临床环境中缺乏数据。因此,本研究旨在比较新诊断T2DM患者与健康个体的抑郁、认知障碍和生活质量(QoL)。此外,还比较了二甲双胍单独或联合二肽基肽酶-4抑制剂对T2DM患者认知、抑郁和生活质量的影响。材料和方法:本研究为前瞻性观察性研究,纳入120名受试者。受试者被平均分为四组:健康对照组、新诊断的T2DM患者和单独服用二甲双胍或联合西格列汀的T2DM患者。我们使用简易精神状态检查(MMSE)评估认知,使用汉密尔顿抑郁评定量表(HAM-D)评估抑郁,使用简短健康调查-36 (SF-36)评估健康状况。结果:各组间MMSE评分无明显变化。结论:本初步研究提示T2DM患者最容易出现抑郁和生活质量下降。此外,常规和近期的降糖药均可能导致神经行为并发症,并对患者的生活质量产生不利影响。因此,我们保证对接受二甲双胍和西格列汀治疗的患者的认知功能、抑郁和生活质量进行评估。
{"title":"Metformin alone and in combination with sitagliptin induces depression and impairs quality of life in type 2 diabetes mellitus patients: An observational study.","authors":"Mohammed Athar,&nbsp;Aakriti Garg,&nbsp;Mohd Ashif Khan,&nbsp;Rizwana Parveen,&nbsp;Sunil Kohli,&nbsp;Divya Vohora,&nbsp;Nidhi","doi":"10.5414/CP204288","DOIUrl":"https://doi.org/10.5414/CP204288","url":null,"abstract":"<p><strong>Background: </strong>Various studies have reported the association of cognition and depression with diabetes. Literature suggests that metformin and sitagliptin used to control hyperglycemia in type 2 diabetes mellitus (T2DM) possess a beneficial effect on neurological symptoms associated with diabetes. However, there are scarce data in the clinical setting. Thus, this study aims to compare depression, cognitive impairment, and quality of life (QoL) of newly diagnosed T2DM patients with those of healthy individuals. Further, the impact of metformin alone or in combination with dipeptidyl peptidase-4 inhibitors on cognition, depression, and QoL of T2DM patients was also compared with newly diagnosed T2DM patients.</p><p><strong>Materials and methods: </strong>This was a prospective observational study in 120 subjects. The subjects were equally divided into four groups: healthy controls, newly diagnosed T2DM patients, and T2DM patients taking either metformin alone or in combination with sitagliptin. We assessed cognition using Mini-Mental State Examinations (MMSE), depression using Hamilton Depression Rating Scale (HAM-D), and health status using Short-Form Health Survey-36 (SF-36).</p><p><strong>Results: </strong>No significant change in MMSE score was observed among the groups. However, a significant increase in the HAM-D score of newly diagnosed patients (p < 0.001), T2DM patients receiving metformin alone (p < 0.05), and in combination with sitagliptin (p < 0.001) was observed as compared to healthy controls (p < 0.001). Also, a statistically significant increase in HAM-D score was observed in patients receiving sitagliptin in combination with metformin as compared to metformin alone (p < 0.01). A decrease in SF-36 scores was observed in all groups as compared to healthy controls.</p><p><strong>Conclusion: </strong>To conclude, this preliminary study indicates that T2DM patients are most likely to suffer from depression and impaired QoL. Moreover, both the conventional and recent antidiabetic agents might lead to neurobehavioral complications and adverse impact on the QoL of these patients. Thus, we warrant the assessment of cognitive functions, depression, and QoL in patients receiving metformin and sitagliptin.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":"61 3","pages":"102-110"},"PeriodicalIF":0.8,"publicationDate":"2023-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9489399","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"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
Application of low-dose etomidate combined with oxycodone and midazolam in endoscopic injection sclerotherapy. 小剂量依托咪酯联合羟考酮、咪达唑仑在内镜注射硬化治疗中的应用。
IF 0.8 4区 医学 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2023-03-01 DOI: 10.5414/CP204341
Jie Yao, Shuai Hao, Chen Zhou, YingHao Cao, ZheFeng Quan

Objective: To evaluate the adverse effects and particularly the anesthetic effect of low-dose etomidate combined with oxycodone and midazolam in endoscopic injection sclerotherapy.

Materials and methods: We herein report a prospective, double-blind, randomized controlled trial. It included patients with liver cirrhosis (age, 18 - 65 years; BMI, 18 - 25 kg/m2) who were treated with endoscopic injection sclerotherapy, and the patients were randomly assigned to the propofol group or the etomidate group. The incidence of respiratory depression was the primary outcome measure. The occurrence of various adverse effects and endoscopist satisfaction score were the secondary outcome measures.

Results: In this study, we enrolled a total of 96 patients. The incidence of respiratory depression in the propofol group was 19%, while that in the etomidate group was only 4% (9/47 vs. 2/49; p = 0.026). Regarding the secondary outcome measures, the incidence of hypoxia in the propofol group was 15%, while that in the etomidate group was only 2% (7/47 vs. 1/49; p = 0.029). Injection-site pain occurred in 0% and 23% of the patients in the etomidate group and propofol group, respectively (p < 0.001). Endoscopist satisfaction scores were classified as "poor", "fair", "good", and "very good". The scores were 17% higher (46/49 vs. 36/47; p = 0.026) for the "very good" level and 15% lower (3/49 vs. 10/47; p = 0.038) for the "good" level in the etomidate group than in the propofol group.

Conclusion: Low-dose etomidate combined with oxycodone and midazolam for endoscopic injection sclerotherapy could reduce the incidence of hypoxia without increasing the incidence of complications.

目的:评价小剂量依托咪酯联合羟考酮、咪达唑仑用于内镜注射硬化治疗的不良反应,特别是麻醉效果。材料和方法:我们在此报告一项前瞻性、双盲、随机对照试验。包括肝硬化患者(年龄18 - 65岁;BMI, 18 - 25kg /m2),经内镜注射硬化治疗的患者,随机分为异丙酚组和依托咪酯组。呼吸抑制的发生率是主要的结局指标。各种不良反应的发生和内窥镜医师满意度评分是次要的观察指标。结果:本研究共纳入96例患者。异丙酚组呼吸抑制发生率为19%,而依托咪酯组仅为4% (9/47 vs 2/49;P = 0.026)。次要结局指标方面,异丙酚组缺氧发生率为15%,而依托咪酯组缺氧发生率仅为2% (7/47 vs 1/49;P = 0.029)。依托咪酯组和异丙酚组分别有0%和23%的患者出现注射部位疼痛(p < 0.001)。内窥镜医师满意度评分分为“差”、“一般”、“好”和“非常好”。得分高出17%(46/49比36/47;P = 0.026)为“非常好”水平,低于15%(3/49比10/47;P = 0.038)的“良好”水平在依托咪酯组比在异丙酚组。结论:小剂量依托咪酯联合羟考酮、咪达唑仑用于内镜注射硬化治疗可降低缺氧发生率,且不增加并发症发生率。
{"title":"Application of low-dose etomidate combined with oxycodone and midazolam in endoscopic injection sclerotherapy.","authors":"Jie Yao,&nbsp;Shuai Hao,&nbsp;Chen Zhou,&nbsp;YingHao Cao,&nbsp;ZheFeng Quan","doi":"10.5414/CP204341","DOIUrl":"https://doi.org/10.5414/CP204341","url":null,"abstract":"<p><strong>Objective: </strong>To evaluate the adverse effects and particularly the anesthetic effect of low-dose etomidate combined with oxycodone and midazolam in endoscopic injection sclerotherapy.</p><p><strong>Materials and methods: </strong>We herein report a prospective, double-blind, randomized controlled trial. It included patients with liver cirrhosis (age, 18 - 65 years; BMI, 18 - 25 kg/m<sup>2</sup>) who were treated with endoscopic injection sclerotherapy, and the patients were randomly assigned to the propofol group or the etomidate group. The incidence of respiratory depression was the primary outcome measure. The occurrence of various adverse effects and endoscopist satisfaction score were the secondary outcome measures.</p><p><strong>Results: </strong>In this study, we enrolled a total of 96 patients. The incidence of respiratory depression in the propofol group was 19%, while that in the etomidate group was only 4% (9/47 vs. 2/49; p = 0.026). Regarding the secondary outcome measures, the incidence of hypoxia in the propofol group was 15%, while that in the etomidate group was only 2% (7/47 vs. 1/49; p = 0.029). Injection-site pain occurred in 0% and 23% of the patients in the etomidate group and propofol group, respectively (p < 0.001). Endoscopist satisfaction scores were classified as \"poor\", \"fair\", \"good\", and \"very good\". The scores were 17% higher (46/49 vs. 36/47; p = 0.026) for the \"very good\" level and 15% lower (3/49 vs. 10/47; p = 0.038) for the \"good\" level in the etomidate group than in the propofol group.</p><p><strong>Conclusion: </strong>Low-dose etomidate combined with oxycodone and midazolam for endoscopic injection sclerotherapy could reduce the incidence of hypoxia without increasing the incidence of complications.</p>","PeriodicalId":13963,"journal":{"name":"International journal of clinical pharmacology and therapeutics","volume":"61 3","pages":"122-128"},"PeriodicalIF":0.8,"publicationDate":"2023-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9191452","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"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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International journal of clinical pharmacology and therapeutics
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