摘要:目的:了解2007~2008年成都地区17家医院生物制品及生化药品的使用状况。方法:采用限定日剂量(DDD)的方法,对成都地区2007~2008年17家医院生物制品及生化药品的销售金额、用药频度(DDDs)等进行统计分析。结果:2007年、2008年成都地区17家医院生物制品及生化药品销售总额分别为7338万元、9786万元;分别占总销售额的4.83%、5.00%。销售金额进入总销售额排名前100位的生物制品及生化药品有:人血白蛋白、胸腺肽、丙种球蛋白、促白细胞生长素和环磷腺苷。环磷腺苷在生物制品及生化药品中的DDDs最高。结论:生物制品及生化药品的价格及供给对其临床使用有较大的限制。Abstract: Objective: To evaluate the current situation and the trend of biological products and biochemical drugs used in Chengdu city in 2007 to 2008. Methods: Consumption of biological products and biochemical drugs used in 17 hospitals of Chengdu city in 2007 to 2008 were analyzed by the way of sum DDD and DDDs ranking. Results: The total cost of the biological products and biochemical drugs used in Chengdu city in was 73.38 and 97.86 million yuan in 2007 to 2008, it accounted for 4.83% and 5.00% of the total cost. Human serum albumin, thymosin, gamma globulin, interleukin promoting growth hormone and adenosine cyclophosphate were the drugs in the first 100 cost list. The DDDs of adenosine cyclophosphate was highest among biological products and biochemical drugs. Conclusion: The cost and supply of biological products and biochemical drugs were great limitations of their clinical application.
ObjectiveTo explore the effect of quality control circle (QCC) on the management of hospital medication. MethodsAccording to the existing problems between December 2013 and January 2014, we put forward a series of continuous improvement plans, strengthened the nurses training, and intensified the supervision methods from February to May 2014. ResultsAfter the implementation of QCC, the incidence of leakage from drugs significantly decreased from 15.8% to 0.0%; the nurse-related drug management knowledge rate increased from 64.1% to 92.3%. Withdrawal process execution rate increased from 71.8% to 100.0%, and the difference was statistically significant (P<0.05) from February to May 2014. ConclusionQCC activity improves the hospital medication management, increases the nurses' sense of responsibility, and ensures the medical security of hospitalized patients.
Drug administration is an extremely important aspect in the design and conduct of randomized controlled trials, which can influence the reliability and quality of the trials’ results. This topic covers issues such as blinding, preparation, packaging, labeling, shipping, dispensing and returning of test articles. Good drug administration procedures should ensure the smooth implementation of large-scale multi-center randomized controlled trials and increase their reliability and usefulness.
Objective To learn the current status, publication standards, formats, and contents of medical advertisements published in journals in China, and to discuss the possibility of evidence-based evaluation and standards for advertisement publication. Methods We handsearched Issue One, 2008 of 222 core medical journals indexed by A Guide to the Core Journals of China (2004 version) and the most important databases to index top 20% academic journals to identify basic journal information and the content of their advertisements. The general and trade name of the drugs, and the advertisements and production license number of the drugs and devices were collected. We used EXCEL software for data input and SPSS 13.0 for statistical analyses. Results Two-hundred and eighteen journals were handsearched and evaluated. The other 4 journals were excluded because the print version could not be found. A total of 1,201 advertisements were published in 159 (72.9%) of the journals, with the average of 5.5 (range of 1-37) for each journal. Of the advertisements, 910 (75.8%) were related to medical drugs or devices, including 598 (49.8%) drug and 312 (26.0%) medical device advertisements. Most of them were published in clinical and special medical journals. There were 518 (86.6%) drug advertisements which had both advertisement license and production license number, but only 116 (36.1%) medical device advertisements stated the advertisement license and production license number. Conclusion The medical drug advertisements published in core medical journals in China lack sufficient publication standards, and medical device advertisements are even worse. We cannot conclude the efficacy, safety, and cost-effectiveness of advertisement production according to the current limited, unclear, and highly-commercialized advertisements.
Real-world evidence represents critical evidence to support post-marketing drug monitoring, assessment and policy decisions, and has received extensive attentions. However, an explicit over-arching design and conceptual framework for this specific area is lacking. Divergent opinions on the production of real world evidence are often present among researchers; and understanding about their implications also differ among policy makers and evidence users. In this article, we have proposed, from the regulatory and clinical perspectives, a conceptual framework on the use of real world data for post-marketing drug studies, assessment and policy decisions.
In recent years, real-world evidence data (RWD) and real-world evidence (RWE) have gained substantial attentions from healthcare practitioners and health authorities worldwide. In particular, the needs from regulatory bodies have promoted the production and use of real-world evidence. In the context of drug and device evaluation and regulation decisions, the pattern for using real world evidence may differ. This article aimed to discuss the potential uses of RWE for pre-approval clinical evaluation, post-approval monitoring and evaluation, and associated regulatory decisions, which may ultimately improve the production and use of RWE for regulatory decisions.
目的 分析上海市奉贤区中心医院2008年－2010年门、急诊麻醉药品的使用情况，促进麻醉药品使用的合理化和规范化。 方法 对2008年－2010年门急诊麻醉药品处方共5 461张进行统计分析，包括不合理处方比例及存在的问题、各年度处方总数、临床使用分布、各类麻醉药品的用药总量、各类麻醉药品的处方比例和等。对非癌痛处方以用药频率、药物利用指数为指标，癌症处方以用药天数和平均日剂量为指标进行分析、评价。 结果 门急诊的麻醉药品有9种，盐酸吗啡缓释片的总用量居首位，盐酸吗啡针在急诊处方中比例最高，药物利用指数＜1，不合理处方共770张，占14.10%。 结论 该院门急诊麻醉药品使用基本合理，但需对部分医师加强麻醉药品使用培训。
Objective To investigate the methodological characteristics of observational studies on the correlation between drug exposure during pregnancy and birth defects. Methods The PubMed database was searched from January 1, 2020 to December 31, 2020 to identify observational studies investigating the correlation between drug use during pregnancy and birth defects. Literature screening and data extraction were conducted by two researchers and statistical analysis was performed using R 3.6.1 software. Results A total of 40 relevant articles were identified, of which 8 (20.0%) were published in the four major medical journals and their sub-journals, 21 (42.5%) were conducted in Europe and the United States, and 4 were conducted (10.0%) in China. Cohort studies (30, 75.0%) and case-control studies (10, 25%) were the most commonly used study designs. Sixteen studies (40.0%) did not specify how the databases were linked. Sixteen studies (40.0%) did not report a clear definition of exposure, while 17 studies (42.5%) defined exposure as prescribing a drug that could not be guaranteed to have been taken by the pregnant women, possibly resulting in misclassification bias. Six studies (15.0%) did not report the diagnostic criteria for birth defects and 18 studies (45.0%) did not report the types of birth defects. In addition, 33 studies (82.5%) did not control for confounding factors in the study design, while only 19 studies (47.5%) considered live birth bias. Conclusion Improvements are imperative in reporting and conducting observational studies on the correlation between drug use during pregnancy and birth defects. This includes the methods for linking data sources, definition of exposure and outcomes, and control of confounding factors. Methodological criteria are needed to improve the quality of these studies to provide higher quality evidence for policymakers and researchers.