婴幼儿青霉素过敏试验判断标准探讨

介绍了５０例３岁以下住院患儿青霉素过敏试验的观察和分析。按本组判断标准确定结果，阳性率为８％。阴性者用药后无１例发生过敏反应。本标准组与习用标准组对比（χ２＝６．７８，Ｐ＜０．０１），差异明显。认为婴幼儿青霉素过敏试验的操作方法及其判断标准因其皮肤的解剖生理特点及小儿免疫生理状况的特异性而应该与成人有所差别。     

国外药典与中国药典的无菌检查用真菌培养基的灵敏度比对

微生物培养基是微生物生长繁殖需要的一种生物营养物质。无菌试验用培养基是药品无菌检验的重要手段，中国药典无菌检查法中检查真菌用的培养基改良马丁培养基是用于检查样品是否污染真菌。而BP、EP、USP、JP等国家药典用大豆-酪蛋白消化培养基检查此项。进口药品的药品标准及厂报标准大多都参照国外药典制定，为了与国际接轨，了解大豆-酪蛋白消化培养基能否替代改良马丁培养基，我们参照中国药典培养基灵敏度检查法对中国药典改良马丁培养基与大豆-酪蛋白消化培养基进行了比对试验。现报告如下.     

Is the pattern of solid‐phase gastric emptying different between genders?

BACKGROUND: In the 13C-octanoate breath test, the shape of the 13CO2 excretion curve in the ascending portion reflects a pattern of gastric emptying (GE). Recent scintigraphic studies have revealed an overall delay in solid GE in fertile women compared with men. However, it remains unknown whether women have a different GE pattern compared with men. As a symptomatic delay in solid GE is specific to the female gender, it could be hypothesized that the 13CO2 excretion curve is different in shape between genders. MATERIALS AND METHODS: Because the ascending gradient of the 13CO2 excretion curve is often biphasic, the dual function of y(t) = ( a1 . tb1 + a2 . tb2) e(-K.t) was applied to fit the breath data, where a1, b1, a2, b2, and K are constants. Assessed on the 4 h-based breath samples obtained after ingestion of a 320-kcal muffin containing 100 mg 13C-octanoate, the time versus 13CO2 excretion curve was created from 31 adult volunteers (15 men and 16 women). The curve shape was characterized by the dual function, and was compared between genders. RESULTS: In both genders, the ascending gradient exhibited the biphasic feature, characterized by an initial steep rise and the subsequent blunted increase, while the descending gradient followed the monotonous decay. The initial rise was steeper and the subsequent increase was more blunted in women than in men. CONCLUSION: Women exhibit a gender-specific pattern of the 13CO2 excretion profile. A possible explanation for this gender difference is that the post-gastric feedback regulation is more potent in women than in men.     

丹参胶囊在欧盟药品注册中的可读性测试研究和实践

药品说明书是载明药品信息的法定文件,对指导公众合理用药起着至关重要的作用。在欧美药品的申报体系和指南中,均要求申请者在药品上市前必须完成药品说明书可读性测试研究,以保证说明书内容通俗易懂,指导公众合理安全用药,避免用药不当可能导致的风险。由于审评理念和标准的差距,目前中国在新药评审的过程中缺乏药品说明书可读性测试研究的要求、法规和指南。以国内申报欧盟成功的品种丹参胶囊注册上市实践为案例,分析欧盟对于药品说明书可读性测试研究的要求,以期为我国建立和实施药品说明书可读性研究的管理思路提供借鉴和参考。     

Impact of Early Salvage Radiation Therapy in Patients with Persistently Elevated or Rising Prostate-specific Antigen After Radical Prostatectomy

Background

Salvage radiation therapy (SRT) is a recommended treatment option for biochemical recurrence after radical prostatectomy (RP). However, its effectiveness may be limited to specific categories of patients.

Healing in peri‐implant gap with BMP‐2 and systemic bisphosphonate is dependent on BMP‐2 dose—A canine study

The bone–implant interface of cementless orthopedic implants can be described as a series of uneven sized gaps with discontinuous areas of direct bone–implant contact. Bridging these voids and crevices by addition of an anabolic stimulus to increase new bone formation can potentially improve osseointegration of implants. Bone morphogenetic protein 2 (BMP‐2) stimulates osteoblast formation to increase new bone formation but also indirectly stimulates osteoclast activity. In this experiment, we investigate the hypothesis that osseointegration, defined as mechanical push‐out and histomorphometry, depends on the dose of BMP‐2 when delivered as an anabolic agent with systemic administration of the anti‐resorptive agent zoledronate to curb an increase in osteoclast activity. Four porous coated titanium implants (one with each of three doses of surface‐applied BMP‐2 (15 µg; 60 µg; 240 µg) and untreated) surrounded by a 0.75 mm empty gap, were inserted into the distal femurs of each of twelve canines. Zoledronate IV (0.1 mg/kg) was administered 10 days into the observation period of 4 weeks. Bone–implant specimens were evaluated by mechanical push‐out test and histomorphometry. The 15 µg implants had the best fixation on all mechanical parameters and largest surface area covered with new bone compared to the untreated, 60 and 240 µg implants, as well as the highest volume of new bone in the implant gap compared to 60 and 240 µg implants. The results in a canine implant model demonstrated that a narrow range of BMP‐2 doses have opposite effects in bridging an empty peri‐implant gap with bone, when combined with systemic zoledronate. © 2017 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 36:1406–1414, 2018.

     

Effect of Maximal Oxygen Pulse on Patients with Chronic Obstructive Pulmonary Disease

ObjectiveThis study evaluated the effect of maximal oxygen pulse (O₂P_max) on patients with chronic obstructive pulmonary disease (COPD) and confirmed the predictive effect on acute exacerbations of COPD (AECOPD).MethodsThis retrospective study included 91 participants who underwent cardiopulmonary exercise testing (CPET), lung function testing, a dyspnea scale assessment, and a 3-year follow-up. The participants were divided into two groups according to the O₂P_max value. Exercise capacity, ventilatory conditions, gas exchange efficiency, and dyspnea symptoms were compared, and the correlations between O₂P_max and these indices were evaluated. The ability of O₂P_max to predict AECOPD was examined.ResultsExercise capacity, ventilatory conditions, and gas exchange efficiency were lower, and dyspnea symptom scores were higher in the impaired O₂P_max group (P < 0.05). O₂P_max was positively correlated with forced vital capacity (FVC)%, forced expiratory volume in 1 sec (FEV-₁)%, FEV₁/FVC%, anaerobic threshold (AT), work rate (WR)%, aximal oxygen uptake (VO_2max)%, VO₂/kg_max, VO₂/kg_max%, WR_AT, WR_max, VO_2AT, VO_2max, and V_Emax, and was negatively correlated with EqCO_2AT, and EqCO_2max (P < 0.05). Most importantly, O₂P_max could be used to predict AECOPD, and the best cut-off value was 89.5% (area under the curve, 0.739; 95% CI, 0.609–0.869).ConclusionO₂P_max reflected exercise capacity, ventilation capacity, gas exchange capacity, and dyspnea symptoms in patients with COPD and may be an independent predictor of AECOPD.     

Are hemoglobin levels really lower in faecal immunochemical test positive patients with colorectal cancer?

Introduction

Faecal immunochemical test (FIT) is advocated in many colorectal cancer-screening programs. A positive FIT translates to the need for a colonoscopy. However, waiting times for diagnostic colonoscopy is long. The aim of our study is to determine the correlation of hemoglobin levels in patients with a positive FIT who were subsequently diagnosed with colorectal cancer, and to compare them with patients with only colonic adenomas and those with normal colonoscopy with the intention of determining if hemoglobin levels could be used to stratify the urgency of colonoscopy.