各国生物类似药沟通交流机制及生物类似药可互换性对比研究及建议

药品注册中的沟通交流对于控制风险、提高研发注册效率具有重要作用。对美国、欧盟、日本、韩国等国家生物类似药沟通交流机制进行对比研究,结合我国沟通交流的现状,问卷调研和专家研讨,提出完善我国生物类似药沟通交流机制的建议。各国对生物类似药的"可互换性"有着不同的界定和管理。对美欧等国家生物类似药的"可互换性"进行研究,结合问卷调研和专家研讨,提出完善我国生物类似药可互换性的建议。     

Managing invasive aspergillosis in haematological patients in the era of resistance polymerase chain reaction and increasing triazole resistance: A modelling study of different strategies

Objectives

Triazole resistance in Aspergillus spp. is emerging and complicates prophylaxis and treatment of invasive aspergillosis (IA) worldwide. New polymerase chain reaction (PCR) tests on broncho-alveolar lavage (BAL) fluid allow for detection of triazole resistance at a genetic level, which has opened up new possibilities for targeted therapy. In the absence of clinical trials, a modelling study delivers estimates of the added value of resistance detection with PCR, and which empiric therapy would be optimal when local resistance rates are known.

Characterization and Management of Arrhythmic Events in Young Patients With Brugada Syndrome

Background

Information on young patients with Brugada syndrome (BrS) and arrhythmic events (AEs) is limited.

Associations of metabolically healthy obesity with prevalence and progression of coronary artery calcification: Results from the Heinz Nixdorf Recall Cohort Study

Background and aims

There is controversy on the potentially benign nature of metabolically healthy obesity (MHO), i.e., obese persons with few or no metabolic abnormalities. So far, associations between MHO and coronary artery calcification (CAC), a measure of subclinical atherosclerosis, have mainly been studied cross-sectionally in Asian populations. We assessed cross-sectional and longitudinal MHO CAC associations in a Caucasian population.

济南市手足口病重症病例危险因素的病例对照研究

目的 探讨济南市手足口病重症病例发病的危险因素,为早期识别重症病例,降低手足口病重症病例的发生提供科学依据。 方法 采用病例对照研究方法,病例组为86例手足口病重症病例,对照组为86例手足口病轻症病例,用问卷调查收集病例组和对照组的社会人口学特征、接触史、就诊史、临床症状、实验室诊断等信息,对重症病例危险因素分析采用单因素和多因素非条件logistic回归分析。 结果 单因素结果显示发病到就诊日期、初诊单位类型为村级、患儿出现发热、足部皮疹、口腔疱疹、臀部皮疹、咳嗽、呕吐、有病例接触史、EV71阳性在两组间差异有统计学意义。多因素非条件Logistic回归分析结果显示,患儿出现发热(OR=89.38)、口腔疱疹(OR=22.28)、臀部皮疹(OR=234.81)、呕吐(OR=23.90)、有病例接触史(OR=31.48)和EV71阳性(OR=71.65)是手足口病重症病例发病的危险因素。 结论 早期识别发热、口腔疱疹、臀部皮疹、呕吐等症状的患儿,对降低手足口病重症病例的发生具有一定的参考意义。提高EV71手足口病疫苗的接种率,可降低由EV71导致的重症手足口病病例的发生率。     

国产氨磺必利与丙咪嗪治疗迟滞性抑郁症的临床对照研究

目的探讨国产氨磺必利治疗迟滞性抑郁症的疗效和安全性。方法将162例迟滞性抑郁患者随机分为观察组(国产氨磺必利)和对照组(丙咪嗪),治疗12周后对疗效、不良反应发生率、治疗依从性及随访1年复发率等数据进行组间比较及统计学分析。结果观察组研究对象的痊愈率和总有效率分别为39.0%和91.4%与对照组的38.3%和88.9%进行组间比较,观察组具有一定优势,但差异无统计学意义(P>0.05);随访1年复发率的比较中,观察组优于对照组,且差异有统计学意义(P<0.05);观察组研究对象的不良发应率为14.8%,低于对照组的23.5%,且差异有统计学意义(P<0.05);在治疗依从性的比较中,观察组显著高于对照组,且差异有统计学意义(P<0.05)。结论国产氨磺必利在迟滞性抑郁症的治疗中具有疗效显著,安全性高,复发率低,治疗依从性高等优势,具有重要的临床价值,适于临床推广使用。     

Port Wine “Caviar”: Product Development,Sensorial Analysis,and Marketing Evaluation

The aim of this work was to develop a new product, port wine “caviar,” consisting of products based on red and white port wines used in different concentrations. Sample R+ consisted of red port wine at a concentration of 90%, sample R- was red port at 75%, sample W+ was white port at 90%, and sample W- was white port at 75%, all (m/m). The use of two types of port is related to different colors and the two concentrations related to the intensity. The results from the sensory analysis showed that the red port “caviar” at 90% was the best among the products tested, either in the preference test or in the evaluation of the individual characteristics. Furthermore, the market study revealed that this product can be successfully commercialized, particularly for the gourmet kitchen, which is one the main usages identified by the respondents.