中医药临床实践指南适用性评价建议清单及解读

指南的制定不仅要满足严谨的方法学要求,还要确保指南推荐意见应用于临床时的可信性或可实施性。基于建立一个完善的适用于中医药领域的指南评价体系的构想,笔者认为一个完整的中医药领域临床实践指南评价体系分为质量评价、适用性评价及临床应用性调查3部分。其中,适用性评价指的是评价指南与临床的贴合程度,即指南是否具有良好的可读性和临床适用性,以促进临床的应用。评价人员是中医药相关专业领域的临床专家。一个逻辑清晰、详细全面的指南适用性评价清单将为中医药指南制订小组人员提供好的评价工具,对于指南的质量以及推广应用起到重要的促进作用。笔者主要参考国际上适用性评价工具的制订流程及方法,以及通过权威的中医药临床专家及方法学家的论证,制订出适用于中医药领域的临床实践指南适用性评价建议清单。该文介绍了整个适用性评价建议清单的条目,并对每个条目给予详细解读,希望为将来中医药临床实践指南制订过程的规范化提供借鉴和参考。     

头孢匹胺无菌检查方法的建立

目的 建立抗生素类固体原料药头孢匹胺的无菌检查方法。方法 以碳酸钠溶液作为稀释液，采用薄膜过滤法去除头孢匹胺的抗菌活性，按照《中国药典》2015年版无菌检查法进行方法的建立和验证。结果 药典规定的6种标准菌株均在规定时间内正常生长。结论 该方法能有效去除头孢匹胺的抗菌活性，对其相关产品的无菌检查起到较好的参考作用。     

Assaying embryotoxicity in the test tube: Current limitations of the embryonic stem cell test (EST) challenging its applicability domain

Testing for embryotoxicity in vitro is an attractive alternative to animal experimentation. The embryonic stem cell test (EST) is such a method, and it has been formally validated by the European Centre for the Validation of Alternative Methods. A number of recent studies have underscored the potential of this method. However, the EST performed well below the 78% accuracy expected from the validation study using a new set of chemicals and pharmaceutical compounds, and also of toxicity criteria, tested to enlarge the database of the validated EST as part of the Work Package III of the ReProTect Project funded within the 6th Framework Programme of the European Union. To assess the performance and applicability domain of the EST we present a detailed review of the substances and their effects in the EST being nitrofen, ochratoxin A, D-penicillamine, methylazoxymethanol, lovastatin, papaverine, warfarin, β-aminopropionitrile, dinoseb, furosemide, doxylamine, pravastatin, and metoclopramide. By delineation of the molecular mechanisms of the substances we identify six categories of reasons for misclassifications. Some of these limitations might also affect other in vitro methods assessing embryotoxicity. Substances that fall into these categories need to be included in future validation sets and in validation guidelines for embryotoxicity testing. Most importantly, we suggest conceivable improvements and additions to the EST which will resolve most of the limitations.     

空肠管饲的研究及其护理进展

从空肠管饲适用范围、主要置管途径、不同置管途径喂养的特点、空肠管喂护理方面综述了空肠管饲的护理进展,提出空肠管喂中存在的问题,有待在临床实践中不断完善.     

2种医院制剂微生物限度检查方法学适用性研究

目的：建立微生物限度检查方法,保证微生物限度检查结果的准确性。方法：依据《中国药典》2015年版四部通则1105及1106对制剂中需氧菌总数、霉菌和酵母菌总数计数法及控制菌检查方法进行适用性验证。结果：宣肺止嗽丸需氧菌总数计数检查采用培养基稀释法,霉菌和酵母菌总数计数及控制菌检查采用常规法。消炎栓需氧菌、霉菌和酵母菌总数计数及控制菌检查均需采用供试液稀释法。结论：医院制剂微生物检验方法应该按照药典规定进行升级,完成方法学验证后进行检验。     

Pooling sera to reduce the cost of HIV surveillance: a feasibility study in a rural Kenyan district

Summary Seroprevalence studies are crucial in HIV control programs but too expensive at district level. We evaluated the applicability of pooling sera and how it can reduce cost and affect accuracy at district level. 740 samples collected from antenatal clinic attendants for a sentinel survey in a rural Kenyan district were screened individually and in pools of 10. The seroprevalence when measured individually was 7.30%, while the calculated seroprevalence from pooled testing was 7.49%. Pooling was practicable and reduced costs by 62% for a marginal loss of accuracy. It is a useful tool in increasing the affordability of surveillance at district level. A pool size of 8 would have resulted in optimal cost reduction at minimal loss of accuracy.     

Scanning Microscopy of Colonic Mucin during Carcinogenesis: Is It Clinically Applicable?

The integrity of the colonic mucin layer has been reported to be altered during carcinogenesis in both humans and rodents. Prior to attempting scanning microscopic techniques on colonic mucosa of patients at high risk to develop colorectal cancer, these procedures were performed on colonic mucosa from rats with chemically induced colon cancers. Substantial technical difficulties in preparation and serious subjectivity in interpretation of the scanning micrographs were encountered. The major technical problem was the unpredictable retention of the mucin layer upon both normal and cancerous mucosae. Visual interpretation of the integrity or disruption of the mucin layer with the scanning electron microscope revealed variable fenestration and fraying of the mucin in both normal and cancerous colons. Our findings suggest that scanning electron microscopy of colonic mucin may not be a reliable screening procedure for (pre)cancerous changes in human colonic mucosae.     

葛根素超滤适用性研究

目的：研究葛根素的超滤适用性。方法：以丙二醇的浓度、温度、药液浓度、超滤膜截留分子量四因素进行正交设计,成分含量为检测指标,测定超滤前后药液成分的浓度,计算透过率来观察葛根素溶液超滤前后的含量变化。结果：葛根素不被膜吸附,透过率高。超滤膜相对截留分子量因素对葛根素的吸附率有显著影响（P〈0.05）。结论：葛根素在超滤过程中溶液浓度变化小,有较好的超滤适用性。