Data mining for signals in spontaneous reporting databases: proceed with caution

PURPOSE: To provide commentary and points of caution to consider before incorporating data mining as a routine component of any Pharmacovigilance program, and to stimulate further research aimed at better defining the predictive value of these new tools as well as their incremental value as an adjunct to traditional methods of post-marketing surveillance. METHODS/RESULTS: Commentary includes review of current data mining methodologies employed and their limitations, caveats to consider in the use of spontaneous reporting databases and caution against over-confidence in the results of data mining. CONCLUSIONS: Future research should focus on more clearly delineating the limitations of the various quantitative approaches as well as the incremental value that they bring to traditional methods of pharmacovigilance.     

光动力疗法治疗中心性渗出性脉络膜视网膜病变疗效观察

目的观察光动力疗法(PDT)治疗中心性渗出性脉络膜视网膜病变(CEC)的临床疗效及安全性。方法回顾28例经眼底检查、荧光素眼底血管造影(FFA)及光相干断层扫描(OCT)确诊的CEC患者28只患眼PDT治疗前后的临床资料,对比分析治疗前后的视力、眼底像、FFA及OCT检查结果,统计重复治疗的次数,观察治疗的安全性。28例患者平均年龄31.5岁,就诊时最佳矫正视力0.02~0.8。28只眼共治疗38次,其中,22只眼治疗1次,3只眼治疗2次,2只眼治疗3次,1只眼治疗4次。PDT治疗后平均随访时间26个月。结果PDT治疗后末次随访时,视力提高≥2行的视力明显改善者21只眼,占75.00%;视力波动在1行以内的视力稳定者5只眼,占17.86%;视力下降≥2行的视力下降者2只眼,占7.14%。FFA检查显示:21只眼CNV完全闭合,占75.00%;3只眼CNV部分闭合,占10.71%;4只眼CNV未闭合或CNV扩大,占14.29%。有6只眼出现视网膜色素上皮损害,占21.43%。结论PDT治疗CEC对于大多数患者是安全有效的,对于小病变,可以适当减小光斑治疗;对于一次治疗效果不佳的患者,重复治疗应考虑其病因。     

溃疡性结肠炎的中医药治疗进展

文章对近年来中医药治疗溃疡性结肠炎从病因病机、治疗方法,包括分型论治,以基础方加减,成药治疗及治则进行了文献综述,并对存在的问题及发展前景作了阐述。     

温肺散寒化痰定喘法治疗小儿寒性哮喘临床研究

目的：探讨温肺散寒化痰定喘法治疗小儿寒性哮喘的临床疗效。方法：将254例小儿患者随机分为两组,治疗组130例,采用温肺散寒化痰定喘法治疗,方用小青龙汤合三子养亲汤（方药组成：麻黄、桂枝、细辛、干姜、半夏、五味子、白芍、白芥子、紫苏子、莱菔子）治疗;对照组124例,采用西药抗生素配合口服氨茶碱、酮替酚及特布他林气雾吸入,均以7d为1个疗程。结果：治疗组有效率89．23％,对照组有效率79．03％,经χ2检验,两组差异有统计学意义（P〈0．05）。结论：温肺散寒化痰定喘法治疗小儿寒性哮喘有良好效果。     

白藜芦醇的制备方法研究进展

白藜芦醇是一种含有芪类结构的非黄酮类多酚化合物,在医药和食品工业中应用广泛,需求量大幅增加。本文综述了白藜芦醇的制备方法研究进展,包括天然植物提取法、化学合成法、生物工程技术法等,为进一步开发利用白藜芦醇提供依据。     

Statistical Methods for the Analysis of Food Composition Databases: A Review

Evidence-based knowledge of the relationship between foods and nutrients is needed to inform dietary-based guidelines and policy. Proper and tailored statistical methods to analyse food composition databases (FCDBs) could assist in this regard. This review aims to collate the existing literature that used any statistical method to analyse FCDBs, to identify key trends and research gaps. The search strategy yielded 4238 references from electronic databases of which 24 fulfilled our inclusion criteria. Information on the objectives, statistical methods, and results was extracted. Statistical methods were mostly applied to group similar food items (37.5%). Other aims and objectives included determining associations between the nutrient content and known food characteristics (25.0%), determining nutrient co-occurrence (20.8%), evaluating nutrient changes over time (16.7%), and addressing the accuracy and completeness of databases (16.7%). Standard statistical tests (33.3%) were the most utilised followed by clustering (29.1%), other methods (16.7%), regression methods (12.5%), and dimension reduction techniques (8.3%). Nutrient data has unique characteristics such as correlated components, natural groupings, and a compositional nature. Statistical methods used for analysis need to account for this data structure. Our summary of the literature provides a reference for researchers looking to expand into this area.     

Development and content validity of the Experienced Patient‐Centeredness Questionnaire (EPAT)—A best practice example for generating patient‐reported measures from qualitative data

IntroductionTo effectively foster patient‐centeredness (PC), it is crucial to measure its implementation. So far, there is no German measure to assess PC comprehensively. The aim of this study is to develop and select items for the Experienced Patient‐Centeredness (EPAT) Questionnaire, a patient‐reported experience measure (PREM). The EPAT intends to assess PC from the perspective of adult patients treated for different chronic diseases in inpatient and outpatient settings in Germany. Furthermore, we aim at providing a best‐practice example for developing PREMs from qualitative data.MethodsThe development process comprised a three‐phase mixed‐method design: (1) preparation, (2) item generation and (3) item selection and testing of content validity. We generated items using qualitative content analysis based on information from focus groups, key informant interviews and literature search. We selected items using relevance rating and cognitive interviews. Participants were patients from four chronic disease groups (cancer, cardiovascular disease, mental disorder, musculoskeletal disorder) and healthcare experts (e.g., clinicians, researchers, patient representatives).ResultsWe conducted six focus groups with a total of 40 patients, key informant interviews with 10 experts and identified 48 PREMs from international literature. After team discussion, we reached a preliminary pool of 152 items. We conducted a relevance rating with 32 experts and 34 cognitive interviews with 21 patients. We selected 125 items assessing 16 dimensions of PC and showed high relevance and comprehensibility.ConclusionsThe EPAT questionnaire is currently undergoing psychometric testing. The transparent step‐by‐step report provides a best practice example that other researchers may consider for developing PREMs. Integrating literature and experts with a strong focus on patient feedback ensured good content validity. The EPAT questionnaire will be helpful in assessing PC in routine clinical practice in inpatient and outpatient settings for research and quality improvement.Patient or Public ContributionPatients were not involved as active members of the research team. While developing the funding proposal, we informally reached out to several patient organizations who all gave us positive feedback on the study aims, thereby confirming their relevance. Those patient organizations endorsed the funding proposal with formal letters of support and supported recruitment by disseminating advertisements for study participation.