Preventing Adverse Drug Reactions After Hospital Discharge (PADR-AD): Protocol for a randomised-controlled trial in older people

BackgroundAdverse drug reactions (ADRs) and adverse drug events (ADEs) in older people contribute to a significant proportion of hospital admissions and are common following discharge. Effective interventions are therefore required to combat the growing burden of preventable ADRs. The Prediction of Hospitalisation due to Adverse Drug Reactions in Elderly Community Dwelling Patients (PADR-EC) score is a validated risk score developed to assess the risk of ADRs in people aged 65 years and older and has the potential to be utilised as part of an intervention to reduce ADRs.ObjectivesThis trial was designed to investigate the effectiveness of an intervention to reduce ADR incidence in older people and to obtain further information about ADRs and ADEs in the 12–24 months following hospital discharge.MethodsThe study is an open-label randomised-controlled trial to be conducted at the Royal Hobart Hospital, a 500-bed public hospital in Tasmania, Australia. Community-dwelling patients aged 65 years and older with an unplanned overnight admission to a general medical ward will be recruited. Following admission, the PADR-EC ADR score will be calculated by a research pharmacist, with the risk communicated to clinicians and discussed with participants. Following discharge, nominated general practitioners and community pharmacists will receive the risk score and related medication management advice to guide their ongoing care of the patient. Follow-up with participants will occur at 3 and 12 and 18 and 24 months to identify ADRs and ADEs. The primary outcome is moderate-severe ADRs at 12 months post-discharge, and will be analysed using the cumulative incidence proportion, survival analysis and Poisson regression.SummaryIt is hypothesised that the trial will reduce ADRs and ADEs in the intervention population. The study will also provide valuable data on post-discharge ADRs and ADEs up to 24 months post-discharge.     

FDA“治疗等效性评价供企业用指导原则”（草案）介绍

美国食品药品管理局（FDA）于2022年7月发布了"治疗等效性评价供企业用指导原则"（草案）。该指导原则阐明了FDA治疗等效性的标准以及治疗等效性编码系统，目的是准确评价仿制药与参比制剂的治疗等效性并通过治疗等效性代码，在"橙皮书"中迅速检索到治疗等效的仿制药。而中国目前尚无类似的指导原则，详细介绍FDA该指导原则主要内容，期望对中国加强仿制药的治疗等效性评价和加速完善和实施符合国情的治疗等效性编码系统有所帮助。     

集束化干预联合闭环管理对ICU多重耐药菌感染的防控效果

目的 探讨集束化干预策略联合闭环管理模式对ICU多重耐药菌感染的防控效果。方法选取2020年1~12月EICU住院患者275例作为对照组，实施常规管理；2021年1~10月EICU住院患者239例作为观察组，在常规管理基础上实施集束化干预策略联合闭环管理。结果实施后，观察组多重耐药菌感染发生率明显低于对照组；患者住院日显著低于对照组，4项护理措施执行率(隔离标识、手卫生、环境消毒、医务人员相关知识知晓)、病原学送检率显著高于对照组（均P<0.05）。结论集束化干预联合信息化闭环管理可有效降低EICU多重耐药菌感染发生率。     

Co-precipitates of lumefantrine-Eudragit E PO for dissolution improvement

1. Download : Download high-res image (204KB)
2. Download : Download full-size image

     

多发性骨髓瘤中表观遗传学修饰的研究进展北大核心

多发性骨髓瘤(multiple myeloma,MM)是一种病因不明,目前仍无法治愈的恶性血液系统性疾病。研究显示MM是一种复杂的表观遗传学修饰所驱动的恶性肿瘤,表观遗传学修饰是改变MM发病进展的重要机制,并影响治疗及预后。本文将对表观遗传学异常调控在MM的发生发展过程中的作用及相关耐药机制和治疗的现状进行综述。     

Synthesis and characterization of photosensitive gelatin-based hydrogels for photodynamic therapy in HeLa-CCL2 cell line

BackgroundHydrogel systems are increasingly gaining visibility involving biomedicine, tissue engineering, environmental treatments, and drug delivery systems. These systems have a three-dimensional network composition and high-water absorption capacity, are biocompatible, allowing them to become an option as photosensitizer carriers (PS) for applications in Photodynamic Therapy (PDT) protocols.MethodsA nanohydrogel system (NAHI), encapsulated with chloroaluminium phthalocyanine (ClAlPc) was synthesized for drug delivery.. NAHI was synthesized using gelatin as based polymer by the chemical cross-linking technique. The drug was encapsulated by immersing the hydrogel in a 1.0 mg.mL⁻¹ ClAlPc solution. The external morphology of NAHI was examined by scanning electron microscopy (SEM). The degree of swelling of the synthesized system was evaluated to determine the water absorption potential. The produced nanohydrogel system was characterized by photochemical, photophysical and photobiologial studies.ResultsThe images from the SEM analysis showed the presence of three-dimensional networks in the formulation. The swelling test demonstrated that the nanohydrogel freeze-drying process increases its water holding capacity. All spectroscopic results showed excellent photophysical parameters of the drug studied when served in the NAHI system. The incorporation efficiency was 70%. The results of trypan blue exclusion test have shown significant reduction (p < 0.05) in the cell viability for all groups treated with PDT, in all concentrations tested. In HeLa cells, PDT mediated by 0,5 mg.mL⁻¹ ClAlPc encapsulated in NAHI showed a decrease in survival close to 95%. In the internalization cell study was possible to observe the internalization of phthalocyanine after one hour of incubation, at 37 °C, with the the accumulation of PS in the cytoplasm and inside the nucleus at both concentrations tested.ConclusionsGiven the peculiar performance of the selected system, the resulting nanohydrogel is a versatile platform and display potential applications as controlled delivery systems of photosensitizer for photodynamic therapy application.     

Implementation of a Semistructured Clinical Event Documentation Tool for Acute Adverse Contrast Reactions

PurposeTo improve the efficiency and accuracy of clinicians documenting acute clinical events related to contrast agent administration using a web browser–based semistructured documentation support tool.MethodsA new tool called Contrast Incident Support and Reporting (CISaR) was developed to enable radiologists responding to contrast reactions to document inciting contrast class, type of event, severity of contrast reaction, and recommendation for future contrast use. Retrospective analysis was conducted of all CT and MRI examinations performed between February 2018 and December 2019 across our hospital system with associated contrast reaction documentation. Time periods were defined as before tool deployment, early adoption, and steady-state deployment. The primary outcome measure was the presence of event documentation by a radiologist. The secondary outcome measure was completeness of the documentation parameters.ResultsA total of 431 CT and MRI studies with reactions were included in the study, and 50% of studies had radiologist documentation during the pre-CISaR period. This increased to 66% during the early adoption period and 89% in the post-CISaR period. It took approximately 9 months from the introduction of CISaR to reach full adoption and become the main method for adverse contrast reaction documentation. The percentage of radiologist documentation that detailed provoking contrast agent class, severity of reaction, reaction type, and future contrast agent recommendation all significantly increased (P < .0001), with greater than 95% inclusion of each element.ConclusionThe implementation of a semistructured electronic application for adverse contrast reaction reporting significantly increased radiologist documentation rate and completeness of the documentation.