EMA对药用辅料右旋糖酐新的安全性评价

欧洲药品局（EMA）于2018年11月发布了"人用药品辅料右旋糖酐的包装说明书资料"，该文件引用大量文献全面评价了右旋糖酐的安全性，特别指出含有右旋糖酐辅料的注射和吸入制剂的疫苗与药品，应在说明书中描述有关其过敏反应信息的新要求。介绍该文件的主要内容，期望对我国这类药品说明书的撰写和监管有所帮助。     

Factors influencing choice of medical vs. surgical treatment of pediatric appendicitis

PurposeTo examine what proportion of caregivers, if given a choice, would choose medical versus surgical treatment of appendicitis and what factors would be important in their decision.MethodsA survey was devised and given to the caregivers of children presenting to the pediatrician for a routine visit in community and academic pediatric clinics. The survey presented a summary of outcomes after medical (non-operative) and surgical treatment of uncomplicated appendicitis. Participants were then asked to choose medical versus surgical treatment if their child were to develop appendicitis. They were also asked to rate the importance of certain factors in their decision ? 1 being “not important” and 5 being “very important”.ResultsFour hundred surveys were distributed with an 86.2% (345/400) response rate. Six percent (21/342) of respondents reported a history of appendicitis and 49.4% (168/340) reported having known someone who had appendicitis. The majority of respondents, 85.3% (284/333), were mothers. A minority of respondents, 41.7% (95% CI: 36.7, 47.0), chose medical treatment over surgery for appendicitis. There was no statistical difference in the proportion of mothers (41.6%) versus fathers who chose medical treatment (41.3%). Caregivers who chose medical treatment were more likely to rate time in hospital (p = .008) and time out of school (p = 05) as important in decision making when compared with those who chose surgery. Those who chose surgical treatment were more likely to rate risk of recurrent appendicitis (p < .001) as important to decision making. In the multivariate analysis, those who rated time in hospital as very important had more than twice the odds of choosing medical therapy (OR 2.20, p = 0.02) when compared with those who rated it as less important. Not knowing someone who has had appendicitis was significantly associated with choosing medical therapy when compared with those who do know someone who has had appendicitis, OR 2.3, p = .002. Rating pain as very important was also significantly associated with choosing medical therapy, when compared to those rating pain 1–3, OR 3.38, p = .03.ConclusionsIn this survey of caregivers of children presenting for routine care, 41.7% would choose medical, or non-operative, therapy for their children with acute appendicitis. The risk of recurrence, time in hospital, and time out of school, pain, and knowing someone who has had appendicitis were all important factors that families may consider when making a decision. These data may be useful for surgeons counseling patients on which treatment to pursue.     

Cuantificación y tratamiento de la congestión en insuficiencia cardíaca: una visión clínica y fisiopatológica

Renal sodium and water retention with resulting extracellular volume expansion and redistribution are hallmark features of heart failure syndromes. However, congestion assessment, monitoring, and treatment represent a real challenge in daily clinical practice. This document reviewed historical and contemporary evidence of available methods for determining volume status and discuss pharmacological aspects and pathophysiological principles that underlie diuretic use.     

Systematic review of drug–drug interactions between rifamycins and anticoagulant and antiplatelet agents and considerations for management

Rifamycins (rifampin, rifabutin, and rifapentine) play an essential role in the treatment of mycobacterial and some nonmycobacterial infections. They also induce the activity of various drug transporting and metabolizing enzymes, which can impact the concentrations and efficacy of substrates. Many anticoagulant and antiplatelet (AC/AP) agents are substrates of these enzymes and have narrow therapeutic indices, leading to risks of thrombosis or bleeding when coadministered with rifamycins. The objective of this systematic review was to evaluate the effects on AC/AP pharmacokinetics, laboratory markers, and clinical safety and efficacy of combined use with rifamycins. A systematic review following the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidance was performed. The PubMed, Embase, and Web of Science databases were queried for English-language reports on combination use of rifamycins and AC/AP agents from database inception through August 2021. The 29 studies identified examined warfarin (n = 17), direct oral anticoagulants (DOACs) (n = 8), and antiplatelet agents (n = 4) combined with rifampin (n = 28) or rifabutin (n = 1). Eleven studies were case reports or small case series; 14 reported on pharmacokinetic or laboratory markers in healthy volunteers. Rifampin-warfarin combinations led to reductions in warfarin area under the curve (AUC) of 15%–74%, with variability by warfarin isomer and study. Warfarin dose increases of up to 3–5 times prerifampin doses were required to maintain coagulation parameters in the therapeutic range. DOAC AUCs were decreased by 20%–67%, with variability by individual agent and with rifampin versus rifabutin. The active metabolite of clopidogrel increased substantially with rifampin coadministration, whereas prasugrel was largely unaffected and ticagrelor saw decreases. Our review suggests most combinations of AC/AP agents and rifampin are problematic. Further studies are required to determine whether rifabutin or rifapentine could be safe alternatives for coadministration with AC/AP drugs.     

Perceptions About the Efficacy and Acceptability of Telephone and Video-Delivered Allied Health Care for Adults With Disabilities During the COVID-19 Pandemic: A Cross-sectional National Survey

ObjectiveTo investigate and compare perceptions about the efficacy and acceptability of allied health care delivered via telephone and video call for adults with disabilities during the COVID-19 pandemic.DesignCross-sectional national survey.SettingParticipants who accessed occupational therapy, physiotherapy, psychology, or speech pathology care via telephone or via video call from June to September 2020.ParticipantsFive hundred eighty-one adults with permanent or significant disabilities, or their carers, partners, or family members, who were funded by the Australian National Disability Insurance Scheme.InterventionsNot applicable.Main Outcome MeasuresExperiences (eg, safety, efficacy, ease of use) with telephone and video-delivered care. Data were analyzed by calculating response proportions and chi-square tests to evaluate differences in experiences between allied health professions and between telephone and video modalities.ResultsResponses were obtained for 581 adults with disabilities. There was no evidence of differences between experiences with telephone or video-delivered services or across allied health professions. Overall, 47%-56% of respondents found telehealth technology easy to use (vs 17%-26% who found it difficult), 51%-55% felt comfortable communicating (vs 24%-27% who felt uncomfortable), 51%-67% were happy with the privacy and/or security (vs 6%-9% who were unhappy), 74% were happy with the safety (vs 5%-7% who were unhappy), and 56%-64% believed the care they received was effective (vs 17% who believed it was ineffective). Despite this, 48%-51% were unlikely to choose to use telephone or video consultations in the future (vs 32%-36% who were likely).ConclusionsAdults with disabilities in Australia had generally positive experiences receiving allied health care via telehealth during the COVID-19 pandemic, although some experienced difficulties using and communicating via the technology. Findings indicated no differences between satisfaction with telephone or video modalities, or between physiotherapy, speech pathology, occupational therapy, or psychology services.