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.     

Identification of volatile organic compounds in muscle tissues of different species based on Headspace-Gas-Chromatography Ion-Mobility spectrometry

Species identification of unknown biological samples is crucial for forensic applications, especially in cases of explosion, disaster accidents, and body mutilation after murdering, as well as poaching, illegal trade in endangered animals, and meat food fraud. In this study, we identified 60 volatile organic compounds (VOCs) in fresh skeletal muscle tissues of seven different animal species (cattle, sheep, pigs, rabbits, rats, chickens and carp) and a human dead body by headspace-gas-chromatography ion-mobility spectrometry (HS-GC-IMS), and compared their differences by retention time, drift time and molecular weight. The results showed that these VOCs formed different gallery plot fingerprints in the skeletal muscle tissues of the human dead body and seven animal species. Principal component analysis (PCA) showed significantly different fingerprints between these species, and these fingerprints maintained good stability between the species and within the same species. Some VOCs have high species specificity, while VOCs of human fresh muscle tissues from different individual sources have little difference, demonstrating that all tested muscle tissue samples could be distinguished based on different VOCs. HS-GC-IMS has proved to be a rapid, high-throughput, highly sensitive and specific species identification method, which can be used for forensic species identification in criminal cases and disaster accidents, as well as detection in the field of food safety, such as meat fraud and adulteration.     

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。     

情绪释放技术对乳腺癌术后化疗患者预期性悲伤的影响

目的 探讨情绪释放技术对改善乳腺癌术后化疗患者预期性悲伤的效果。方法 采用便利抽样法选取乳腺癌术后化疗患者60例为研究对象,采用随机数字表法将其分为对照组和干预组,各30例。对照组给予常规护理,干预组在对照组的基础上实施情绪释放干预疗法。比较干预前后2组心理痛苦程度和预期性悲伤得分水平。结果 干预后,干预组心理痛苦程度低于对照组(t=-17.930,P＜0.001);预期性悲伤总分及各维度得分均低于对照组(P＜0.001)。结论 对乳腺癌术后化疗患者应用情绪释放技术进行护理干预,可以减轻患者心理痛苦程度,降低患者预期性悲伤,值得临床推广应用。     

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

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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.