With the dissemination and popularization of EBM around the world, the evidence-based laboratory medicine has boomed gradually. However, the substantial researches in tbe field are still inadequale now. Based on the facts of hospital laboratory medicine, this article discussed the feasibility that apply the rationale and methods to orient the laboratory quality control.
Objective To compare product standards of drug and medical device made from sodium alginate and calcium alginate between domestic and abroad, and to emphases on the process parameters monitoring based on different standards. Methods Sodium alginate and calcium alginate standards of both domestic and foreign were analyzed and summarized, and the differences and commonalities of various product standards among each standard were compared. Results Differences exist in product standards of sodium alginate and calcium alginate between domestic and abroad, whether drug or medical device, but the fundamental control points are concordant. Conclusion Companies should focus on product quality control requirements combined with its own unique manufacturing process characteristics to develop reasonable and controllable quality standards, which can ensure safe and effective clinical use.
Objective To analyze and compare the domestic quality standard and foreign quality standard of sodium hyaluronate (HA), and to expatiate on the critical process monitoring parameters. Methods Different quality standards of HA were compared by translating and sorting, and some experimental data were analyzed as well as the manufacturing practice was elaborated. Results Differences exist in raw materials standard or specifications of products between domestic and foreign, but the basic control points are concordant. Conclusion The company should set up reasonable and controllable quality standard based on quality requirements and related process characteristics so as to assure the safety and effectiveness of the clinical application.
目的 建立一个规范化、标准化的肝炎病毒（HBV）感染患者和对照组标本库。 方法 通过对四川绵阳地区大型流行病调查，收集HBV感染患者捐赠的血液标本（ELISA）检测调查者血样乙肝表面抗原（HBsAg），完整记录其实验报告，临床干预及流行病学调查资料。 结果 重大专项传染病综合防治四川示范区项目启动至今共收集血液组织标本87 478份，其中HBV检出阳性标本60 571份；保留相关阴性对照标本26 907份。 结论 建立HBV 感染患者及对照组血液标本库，可为乙肝的综合防治与研究提供高质量标本及相关流行病调查信息。
目的 探讨提高临床护理质量的管理方法。 方法 利用归因理论，对2009年12月－2010年11月护理部3级综合质量检查、午夜间及节假日2级护理质量检查、科室1级护理质量自查存在的128项问题进行回顾性归因分析。 结果 危重患者护理、病房规范化管理、5年内护士、午间时段为扣分项目多发点。 结论 护理人力资源合理配置、质控归因分析会、低年资护士培训、抓重点时间段、注重人性化管理等有望改变现状。
目的 依托四川大学华西医院的临床资源，建立了一个规范化、标准化的肿瘤组织标本库，对临床医学研究提供了珍贵的资源。 方法 于2009年6月创建四川大学华西医院肿瘤组织标本库、进行质量控制、规范化管理及总结实践经验。 结果 从创建肿瘤组织标本库至2012年2月，共收集各类肿瘤（胃、食管、肝、肺、肠、乳腺、胰腺、甲状腺、纵隔、肾脏、喉、脑）组织标本44 609例，包括肿瘤组织、肿瘤旁组织（距离肿瘤组织2 cm的组织）和切缘远端非肿瘤组织（距离肿瘤组织＞5 cm的组织）。对肿瘤组织标本进行有效和科学的管理，为科研提供了便利和高质量的资源。 结论 建立了一个国际标准化、规范化、信息完善的肿瘤组织标本库，可为肿瘤的发生、发展、转移及生物标志物的研究提供高质量的标本。
【摘要】 目的 考察用乌头碱水解物、新乌头碱水解物、次乌头碱水解物的含量作为附片水煎剂及附片质量控制指标的可行性。 方法 采用高效液相色谱分析法，色谱柱为Shimpack CLC-ODS，以甲醇-乙酸铵溶液（0.2 mol/L）（200︰210）为流动相，流速1.0 mL/min，检测波长为241 nm，对乌头碱新，乌头碱、次乌头碱水解物的含量测定进行研究。 结果 3种水解物检测方法测得水解物在进样范围有良好线性关系，重现性好，稳定性好，生药提取时间宜选定为40 min，不同批号的附片中3种水解物含量差别较大。 结论 此方法简便，使用新乌头碱、乌头碱、次乌头碱的水解物作为含附片制剂的质量控制指标是可行的。【Abstract】 Objective To examine the feasibility of regarding the hydrolyzate from aconitine, new aconitine, and hypaconitine to be the decoction of radix aconite and the quality control index. Methods High performance liquid chromatographic method (HPLC) method was adopted. Shimpack CLC-ODS column with UV detection at 241 nm was used. The mobile phase consisted of (200∶210), and the flow rate was 1.0 mL/min. Results The content of the hydrolysis objects in the water decoction and toxicity were correlated with each other, and the contents of hydrolysis were significantly different among different groups of radix aconiti. Conclusion This method is simple, accurate and effective for content research of hydrolyzate from aconitine-type alkaloids in Monkshoo decoction of Radix Aconiti, and it is feasible to take it as the quality control index.
摘要:目的:总结汶川大地震中我院新生儿临时病房应急医疗实践,探讨灾难中新生儿医疗质量控制策略。方法:对“5·12”特大地震后1月(包括较大余震及唐家山堰塞湖防洪期间)我院新生儿3次转移后临时病房医疗工作的开展和质量控制过程进行回顾性分析。结果:灾害期间我院儿科新生儿病房的各项工作成效显著,其间的人员协调、院感控制、患者的转移,以及病案的管理,医疗核心制度的执行,均得到了充分的保证。结论:灾难期间,医务人员强烈的责任心和使命感、优良的职业素养和协作精神、完善的组织管理、扎实的抢救技能、妥善的转移安置,是完善医疗服务的必须。高度的质量安全意识,医疗核心制度、诊疗操作规范的严格执行,科学的应急予预案,是医疗质量安全的保障。