ObjectiveTo study the effects of recombinant human growth hormone (rhGH) on proliferation of human rectal cancer cell in vitro. MethodsThe experiment was divided into control group,rhGH group,Oxaliplatin (LOHP) group and rhGH+LOHP group. The double proliferation time of cells,cell inhibition rate,cell cycle, proliferation index (PI) and DNA inhibition rate of human rectal cancer line,HR8348,were studied by cell culture, MTT assay and flow cytometry on different concentration of rhGH. ResultsIn vitro the markedly accelerated effects of rhGH on multiplication of HR8348 cell line were not found: there was no statistical significance as compared rhGH group with control group or compared rhGH+LOHP group and LOHP group （Pgt;0.05）. The double proliferation time of cells was markedly lengthened, cell inhibition rate and the cells arrested in G0-G1 phase were obviously increased, meanwhile, the cells in S phase （P＜0.05） and G2-M phase and PI were markedly decreased and DNA inhibition rate was obviously risen as compared rhGH+LOHP group with control group or rhGH+LOHP group and rhGH group （P＜0.01）.ConclusionIn vitro rhGH does not accelerate the multiplication of human rectal cancer cells.
Objective To analyze the current status of studies related to motherwort——a traditional Chinese herb medicine, and its application in prevention and treatment of diseases. Methods We searched CBM, CNKI, WanFang Data, EMbase and Ovid (MEDLINE) from inception up to August 26th, 2016. Two reviewers independently screened literature. Then the included studies were categorized by publication time, published journals and research topics, and a descriptive analysis was conducted. Results 7 040 studies were included, of which 4 653 were on decoction pieces, 1017 on motherwort patent formula, 648 on herbal medicine and 722 on animal studies. A “triple-stage” increasing tendency was found in numbers of published studies. The top twelve journals publishing papers about motherwort were all Chinese journals. The top three high-frequently used prescription forms were electuary/granule, injection, and capsule. 263 papers about Chinese patent medicine mentioned motherwort injection, in which 48 were fundamental studies that reported the effects such as promoting uterus contraction, reducing whole-blood viscosity, improving myocardial ischemia, reperfusion injury and lymphatic microcirculation and 211 were clinical studies about the effectiveness and safety of motherwort injection on postpartum hemorrhage, post-abortion hemorrhage, coronary heart disease, cerebral infarction, heart failure and myocardial ischemia. Conclusion Studies on motherwort patent formula are fewer than that on decoction. Electuary/granule and injection are ascendant formulation of motherwort in clinical practice. The common indication of motherwort injection is postpartum hemorrhage. Motherwort injection was found to have multiple pharmacological effects but the levels and quality of evidence are low. More high-quality studies are required to provide strong evidence for clinical application of motherwort injection in future.
Real world data (RWD) and real world evidence (RWE) have increasingly received wide attention. Patient registry study is an important part of real-world studies using observational design. In this paper, we introduce the concept, classification and application of patient registries, and discuss the planning for a patient registry study and development of registry database, and provide methodological guidance for developing high-quality patient registry studies.
Retrospective database study is an important type of real world study that employ observational designs, which has received wide attention. However, misunderstandings and inappropriate conduct of retrospective database studies are very common. We systematically introduced the concept, features and applications of retrospective database study, as well as discussed the methods to plan a retrospective database study and how to develop a research database. This article is expected to offer guidance for the quality production and appropriate use of retrospective database study.
ObjectiveTo investigate the effects of single-disease quota payment in Chengdu.MethodsThe data of medical insurance in Chengdu from 2009 to 2013 were used to compare changes of average hospitalization expenses, hospitalization days, re-admission rate and so on by establishing a difference-in-difference (DID) model.ResultsThe quota payment policy effectively controlled the overall medical expenses. Drug fee and examination fee were significantly affected (P<0.01). However, the re-admission rate was significantly improved (P<0.10).ConclusionThe implementation of single-disease quota payment in Chengdu controlled the medical expanses growth effectively, but it is necessary to prevent its side effects.
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.
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.
A patient registry database is an important source of real-world data, and has been widely used in the assessment of drug and medical devices, as well as disease management. As the second part of the serial technical guidance for real-world data and studies, this paper introduces the concept and scope of potential uses of patient registry databases, proposes recommendations for planning and developing a patient registry database, and compares existing health and medical databases. This paper further develops essential quality indicators for developing a patient registry database, in expect to guide future studies.