腹腔镜辅助下圆球阴道前庭黏膜上提法行阴道成型术15例

目的探讨腹腔镜辅助下圆球阴道前庭黏膜上提法行阴道成型术治疗先天性无阴道的临床效果。方法对15例先天性无阴道患者采用腹腔镜辅助下圆球阴道前庭黏膜上提法行阴道成型术。结果15例患者手术均获成功,手术后成型阴道深约8—12cm,人工阴道弹性好,黏膜湿润粉红,患者术后感觉满意。结论腹腔镜下圆球阴道前庭黏膜上提法行阴道成型术是治疗先天性无阴道的微创有效的方法之一。     

美容切口联合胸锁乳突肌瓣在腮腺良性肿瘤手术中的应用(附18例临床报告)

目的尝试改良的腮腺手术切口,并结合胸锁乳突肌瓣填塞创腔,使腮腺肿瘤患者术后面部外形更加美观。方法对18例腮腺良性肿瘤患者(多形性腺瘤13例,腺淋巴瘤4例,腮腺囊肿1例),采用耳屏内侧缘切口向下至耳垂后延伸至发际并沿发际延伸的改良切口行腮腺区肿瘤及浅叶或部分浅叶切除+面神经解剖术,并切取近乳突处的胸锁乳突肌瓣填塞创腔,术后负压引流3～5 d。结果随访6～24个月,18例患者切口愈合良好,无感染,无涎瘘。3例患者出现暂时性面瘫,于术后3个月内恢复正常,其余患者未出现神经损伤症状。1例患者术后5个月出现Frey综合征,无术后复发病例。切口隐蔽,无明显凹陷,所有患者对术后切口美观满意。结论改良的腮腺手术切口用于腮腺浅叶良性肿瘤及浅叶或部份浅叶的切除较传统的"S"形切口更加美观、隐蔽,术中以胸锁乳突肌瓣填塞创腔对避免术区凹陷及预防Frey综合征有较好的作用。     

经肛门手术治疗低位直肠类癌15例临床分析

目的探讨经肛门手术治疗低位直肠类癌的临床疗效。方法回顾性分析经证实为低位直肠类癌15例患者的临床资料,全部病例均经肛门手术切除,其中1例行常规切除后有肿瘤残留而改为经腹行Dixon根治手术。结果全部病例无并发症,切口无感染,伤口I期愈合,术后5～8 d出院。结论经肛门手术治疗低位直肠类癌,可彻底清除肿瘤,手术创伤小,患者恢复快,疗效好。     

Recommendations for the validation of cell-based assays used for the detection of neutralizing antibody immune responses elicited against biological therapeutics

The administration of biological therapeutics may result in the development of anti-drug antibodies (ADAs) in treated subjects. In some cases, ADA responses may result in the loss of therapeutic efficacy due to the formation of neutralizing ADAs (NAbs). An important characteristic of anti-drug NAbs is their direct inhibitory effect on the pharmacological activity of the therapeutic. Neutralizing antibody responses are of particular concern for biologic products with an endogenous homolog whose activity can be potentially dampened or completely inhibited by the NAbs leading to an autoimmune-type deficiency syndrome. Therefore, it is important that ADAs are detected and characterized appropriately using sensitive and reliable methods. The design, development and optimization of cell-based assays used for detection of NAbs have been published previously by Gupta et al. 2007 [1]. This paper provides recommendations on best practices for the validation of cell-based NAb assay and suggested validation parameters based on the experience of the authors.     

The Short Time Exposure (STE) test for predicting eye irritation potential: Intra-laboratory reproducibility and correspondence to globally harmonized system (GHS) and EU eye irritation classification for 109 chemicals

Short Time Exposure (STE) test is an easy in vitro eye irritation test that assesses cytotoxicity in SIRC cells (rabbit corneal cell line) following a 5 min dose treatment. To assess intra-laboratory reproducibility, medium control, three vehicles (saline, saline containing 5% (w/w) dimethyl sulfoxide, and mineral oil) and three standard chemicals (sodium lauryl sulfate, calcium thioglycolate, and Tween 80) were evaluated. Assessments were repeated 30 times for vehicles and 18 times for standard chemicals; resulting in almost the same cell viability and a low coefficient of variation value. In addition, the STE eye irritation rankings of three standard chemicals, as calculated on the cell viabilities in 5% and 0.05% solutions were in agreement in all tests. Based on these results, high intra-laboratory reproducibility was confirmed.In addition, the irritation category (irritant and non-irritant) was evaluated for 109 chemicals with STE test, globally harmonized system (GHS) classification, and European Union (EU) classification. The results of the evaluation found the STE classification to have an accuracy with GHS classification of 87% and with EU classification of 83%, which confirmed the excellent correspondence.The correspondence of STE rankings (1, 2, and 3) based on the prediction model by STE test with the eye irritation rankings by GHS (non-irritant, categories 2 and 1) and EU (non-irritant, R36, and R41) was 76% and 71%, respectively.Based on the above results, STE test was considered to be a promising alternative method for assessing eye irritation that has high intra-laboratory reproducibility as well as an excellent predictability of eye irritation.     

Report from the EPAA workshop: In vitro ADME in safety testing used by EPAA industry sectors

There are now numerous in vitro and in silico ADME alternatives to in vivo assays but how do different industries incorporate them into their decision tree approaches for risk assessment, bearing in mind that the chemicals tested are intended for widely varying purposes? The extent of the use of animal tests is mainly driven by regulations or by the lack of a suitable in vitro model. Therefore, what considerations are needed for alternative models and how can they be improved so that they can be used as part of the risk assessment process? To address these issues, the European Partnership for Alternative Approaches to Animal Testing (EPAA) working group on prioritisation, promotion and implementation of the 3Rs research held a workshop in November, 2008 in Duesseldorf, Germany. Participants included different industry sectors such as pharmaceuticals, cosmetics, industrial- and agro-chemicals. This report describes the outcome of the discussions and recommendations (a) to reduce the number of animals used for determining the ADME properties of chemicals and (b) for considerations and actions regarding in vitro and in silico assays. These included: standardisation and promotion of in vitro assays so that they may become accepted by regulators; increased availability of industry in vivo kinetic data for a central database to increase the power of in silico predictions; expansion of the applicability domains of in vitro and in silico tools (which are not necessarily more applicable or even exclusive to one particular sector) and continued collaborations between regulators, academia and industry. A recommended immediate course of action was to establish an expert panel of users, developers and regulators to define the testing scope of models for different chemical classes. It was agreed by all participants that improvement and harmonization of alternative approaches is needed for all sectors and this will most effectively be achieved by stakeholders from different sectors sharing data.     

治疗2型糖尿病药物研究新进展

目的介绍近年来应用于2型糖尿病的新型药物GLP-1类似物、DPP-IV阻断剂及作用于ECS的药物。方法归纳总结国外相关文献,介绍其作用机制、临床实践、不良反应、权威使用指南。结果与结论此类药物具有一定应用前景,但仍存在较多问题,需要进一步探讨和研究。     

皮肤科门诊H1受体阻断剂应用分析

目的:分析重庆市某三甲医院皮肤科门诊H1受体阻断剂的应用情况,为临床合理用药提供参考。方法:收集该院2009年皮肤科门诊处方,统计所用H1受体阻断剂的种类、销售金额、用药频度(DDDs)、日均费用(DDC)及药物利用指数(DUI)等进行回顾性统计分析。结果:在皮肤科门诊抽查的3 586张处方中,H1受体阻断剂使用率为32.46%,应用最多的是第2代H1受体阻断剂,DDDs排序前3位的依次是氯雷他定、地氯雷他定、依巴斯汀。结论:该院皮肤科门诊H1受体阻断剂的应用较为合理,但仍存在大剂量、高频次用药、处方书写欠规范等现象,合理用药水平有待进一步提高。     

某医学院校学生负担调查分析及对策研究

诠释了学生负担的内涵,以某医学院校为案例,调查分析了大学生负担的来源,讨论了减负的基本原则和对策。     

医学免疫学多层次教学模式的实践和探讨

医学免疫学是一门理论抽象、知识点更新迅速、研究方法独特的综合学科,需要科学合理地选择不同的教学方法,才能有效培养和激发学生对医学免疫学的兴趣和科研能力。本文结合学科特点与学生需求及具体实践,从课堂教学、第二课堂及本科生导师制三个逐步提升的层次对医学免疫学的教学模式进行了探讨。