Safety evaluation of surgical materials by cytotoxicity testing

The cytotoxicity of three kinds of commercially available absorbable hemostats [oxidized cellulose (Surgicel, gauze and cotton types), microfibrillar collagen (Avitene), and cotton-type collagen (Integran)] and one adhesion barrier [sodium hyaluronate and carboxymethyl-cellulose membrane (Seprafilm)] were comparatively assessed by a colony assay using V79 cells and a minimum essential medium (MEM) elution assay in combination with a neutral red assay using L929 cells. Strong cytotoxicity was detected for Surgicel by both the MEM elution assay and the colony assay. For Avitene, both methods revealed weak cytotoxicity. For Seprafilm, no cytotoxicity was detected by the MEM elution assay, while a moderate degree of cytotoxicity was observed in the colony assay. For Integran cytotoxicity was not detected by either the MEM elution or the colony assay. The results of the different methods showed some inconsistency in terms of the degree of cytotoxicity of the materials. It is proposed that the combination of two or more sensitive cytotoxicity testing methods for the evaluation of biomaterials is necessary to avoid false-negative results for biomaterials at the preclinical stage. Furthermore, investigation of the correlation between the cytotoxicity and the extraction period of the surgical materials is helpful for predicting the effect of prolonged in vivo use of biomaterials on surrounding cells, tissues, and organs.     

Performance of platinum stimulating electrodes,mapped on the limitvoltage plane

The paper introduces the electrode limit-voltage plane (ELVP)—a useful tool for describing in electrical terms what a polarisable electrode is doing under a particular set of conditions. The ELVP is then used to consider the charge-injection capability of a platinum stimulating electrode.     

Neuroleptic malignant syndrome during low dosed neuroleptic medication in first-episode psychosis: a case report

 Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal side-effect of antipsychotic drug therapy, especially of dopamine receptor antagonists. As a dose relationship has been postulated, low dose neuroleptization would be expected to help to avoid this side-effect. In contrast, we report on a 21-year-old female following low dose fluphenazine treatment with 2.5 mg/day. The patient recovered from NMS after 3 days of dantrolene administration. Eventually, remission from psychotic symptoms was achieved with clozapine. At 8-month follow-up, psychopathology remained stable and there were no more signs of NMS. Received: 8 July 1998 / Final version: 6 November 1998     

医院用药经济分析的基本方法

本文简要介绍了医院药品经济分析的基本方法，包括购药分析、处方分析、质量控制和相关文献。     

医用臭氧安全性的研究进展

臭氧治疗方兴未艾,临床应用结果表明医学臭氧治疗很多疾病具有显著的优越性,得到医生不同程度的认可,但是为何在我国迟迟未能真正推广呢?其中有个重要的原因是人们对医用臭氧治疗的安全性存在一定的质疑。在一定的程度上影响患者对臭氧治疗的接受程度,成为医用臭氧治疗推广应用的一个阻碍。本文对目前医用臭氧安全性相关研究进行综述,以期对医用臭氧的安全应用有所借鉴。     

重庆地区市民用药习惯调查分析

  目的  了解河南省居民安全用药情况,为维护居民健康提供基础研究,提升居民用药安全水平。  方法  2016年7 — 9月,采用简单随机抽样法抽取河南省郑州、新乡、焦作等15个市的2 146名居民为研究对象,使用自行设计的调查问卷进行调查,利用SPSS 22.0软件对数据进行统计分析。  结果  居民安全用药意识不高,仅有748人（34.86 %）经常关注药物说明书,关注度大致随着文化程度的增加逐渐增高,差异有统计学意义（χ² = 71.065 1,P < 0.05）。当服用药物后出现不良反应时,有85.00 %的人表示会选择立即停药咨询医生。自行购药比例较高,有88.77 %的人有过自行购药的经历,其中 ≥ 60岁居民经常自行购药的比例最高（35.42 %）,差异有统计学意义（χ² = 62.693 3 ,P < 0.05）。不良用药习惯最常见的是不按时服药,其次为稍有好转就停药、自行增减药量、自行调快输液速度等。  结论  居民安全用药意识有待提高,正确了解用药知识,合理安全使用药品,对市民促进身体健康水平、事业发展和生活质量都有着十分重要的意义。     

Diagnostic endoscopic ultrasonography: Assessment of safety and prevention of complications

Endoscopic ultrasonography (EUS) has gained wide acceptance as an important, minimally invasive diagnostic tool in gastroenterology, pulmonology, visceral surgery and oncology. This review focuses on data regarding risks and complications of non-interventional diagnostic EUS and EUS-guided fine-needle biopsy (EUS-FNB). Measures to improve the safety of EUS und EUS-FNB will be discussed. Due to the specific mechanical properties of echoendoscopes in EUS, there is a low but noteworthy risk of perforation. To minimize this risk, endoscopists should be familiar with the specific features of their equipment and their patients’ specific anatomical situations (e.g., tumor stenosis, diverticula). Most diagnostic EUS complications occur during EUS-FNB. Pain, acute pancreatitis, infection and bleeding are the primary adverse effects, occurring in 1% to 2% of patients. Only a few cases of needle tract seeding and peritoneal dissemination have been reported. The mortality associated with EUS and EUS-FNB is 0.02%. The risks associated with EUS-FNB are affected by endoscopist experience and target lesion. EUS-FNB of cystic lesions is associated with an increased risk of infection and hemorrhage. Peri-interventional antibiotics are recommended to prevent cyst infection. Adequate education and training, as well consideration of contraindications, are essential to minimize the risks of EUS and EUS-FNB. Restricting EUS-FNB only to patients in whom the cytopathological results may be expected to change the course of management is the best way of reducing the number of complications.     

男性慢性乙型肝炎患者服用阿德福韦酯期间妻子妊娠安全性的研究

如何评判男性慢性乙型肝炎患者在服用阿德福韦酯期间对孕妇及胎儿的影响,是医生和患者必须面对的问题,我们对收治的26例孕妇进行随访及对照研究,现报道如下.一、资料与方法1.研究对象:26例男性慢性乙型肝炎患者为2006年1月至2009年3月南京市第二医院门诊患者,诊断均符合2005年《慢性乙型肝炎防治指南》诊断标准[l].年龄26-34岁(中位数30岁),服药前患者HBsAg均为阳性,HBeAg为阳性或阴性,HBV DNA>104拷贝/ml.同时半年内未服过其他抗病毒药物,服用阿德福韦酯的时间为6 - 47个月(中位数26个月),入组时HBV DNA均已下降至＜500拷贝/ml、肝功能正常.26名孕妇年龄为23 - 32岁(中位数27岁).     

Pharmacokinetic modeling as an approach to assessing the safety of residual formaldehyde in infant vaccines

Formaldehyde is a one-carbon, highly water-soluble aldehyde that is used in certain vaccines to inactivate viruses and to detoxify bacterial toxins. As part of the manufacturing process, some residual formaldehyde can remain behind in vaccines at levels less than or equal to 0.02%. Environmental and occupational exposure, principally by inhalation, is a continuing risk assessment focus for formaldehyde. However, exposure to formaldehyde via vaccine administration is qualitatively and quantitatively different from environmental or occupational settings and calls for a different perspective and approach to risk assessment. As part of a rigorous and ongoing process of evaluating the safety of biological products throughout their lifecycle at the FDA, we performed an assessment of formaldehyde in infant vaccines, in which estimates of the concentrations of formaldehyde in blood and total body water following exposure to formaldehyde-containing vaccines at a single medical visit were compared with endogenous background levels of formaldehyde in a model 2-month-old infant. Formaldehyde levels were estimated using a physiologically-based pharmacokinetic (PBPK) model of formaldehyde disposition following intramuscular (IM) injection. Model results indicated that following a single dose of 200 μg, formaldehyde is essentially completely removed from the site of injection within 30 min. Assuming metabolism at the site of injection only, peak concentrations of formaldehyde in blood/total body water were estimated to be 22 μg/L, which is equivalent to a body burden of 66 μg or <1% of the endogenous level of formaldehyde. Predicted levels in the lymphatics were even lower. Assuming no adverse effects from endogenous formaldehyde, which exists in blood and extravascular water at background concentrations of 0.1 mM, we conclude that residual, exogenously applied formaldehyde continues to be safe following incidental exposures from infant vaccines.