Objective To explore and appraise the representation of samples in clinical trials of hypertension medications. Methods Four databases (MEDLINE, CBM, CNKI and VIP )were searched systematically. All RCTs of hypertension medication run in China from January 1996 to December 2006 were collected, and then appraised by a quality assessment checklist. Those RCTs with 3 or more grading score were enrolled for critical appraisal of representation of samples. Results A total of 164 RCTs on hypertension were targeted and reviewed systematically. 122 (74.4%) RCTs selected secondary or tertiary cares as their trial settings. 81 (49.4%) RCTs described the source of samples, in which 86.3% were hospitalized patients. 16.7% patients in 12 (7.3%) RCTs were excluded in run-in periods, 24.6% patients were ineligible for inclusion criteria in 8 (4.9%) RCTs. 8.4% eligible patients were non-enrolled in 3 RCTs. 89.4% subjects were mild to moderate essential hypertension. The proportions of women and the patients aged 65 years or older were 41.1% and 16.9%, respectively, and were markedly lower than that in community (Plt;0.001). Conclusion Representation of samples in clinical trials of hypertension medications was not good and the influencing factors of representation were not reported sufficiently. These would undermine the efforts to provide evidence-based care to all hypertensive patients.
Retrospective chart review (RCR) is a type of research that answers specific research questions based on the existing patient medical records or related databases through a series of research processes including data extraction, data collation, statistical analysis, etc. Relying on the development of medical big data, as well as the relatively simple implementation process and low cost of information acquisition, RCR is increasingly used in the medical research field. In this paper, we conducted the visual analysis of high-quality RCR published in the past five years, and explored and summarized the current research status and hotspots by analyzing the characteristics of the number of publications, national/regional and institutional cooperation networks, author cooperation networks, keyword co-occurrence and clustering networks. We further systematically combed the methodological core of this kind of research from eight aspects: research question and hypothesis, applicability of chart, study design, data collecting, statistical analysis, interpretation of results, and reporting specification. By summarizing the shortcomings, unique advantages and application prospects of RCR, providing guidance and suggestions for the standardized application of RCR in the medical research field in the future.
Objective To explore the change of particles of Shuanghuanglian Injection (SHLI) admixed with different infusion solutions, and provide a reference for selecting rational menstruum. Methods A comprehensive literature search was executed to collect all the studies on the compatibility of SHLI with different infusion solutions. The reporting quality of the included studies was assessed; particles-related data were extracted and analyzed systematically. Results A total of 338 studies were identified, and 24 studies were included after screening. The quality of the included studies were poor and had heterogeneous outcomes. Generally, the particles of mixture increased dramatically, and there were significant differences among different pharmaceuticals, drug batches and infusion solutions. The pH of solvent had a greater impact on the particles, and the concentration and storage time of prepared liquor were other important factors. The particles of SHLI admixed with Normal Saline were less than 5%, 10% glucose injection and other solvents. Conclusion The particles of SHLI admixed with Normal Saline are the fewest, and commonly can be the preferred solvent. Factors on rational drug use are worthy of further studies; and more attention is needed for the scientificalness of study design.
Objective Shuanghuanglian injection (SHLI) is a typical Chinese medicine injection which has been used for more than 20 years. This study aims to investigate the compatibility of SHLI with western intravenous agents. Methods An extensive literature search was executed to identify all experimental tests and clinical reports on the topics. Data on the types of infusion solutions and western medical injections, usage and dosage, outcome measures for physical and chemical properties, and changes of drug effect were searched for. The included data was analyzed and described by the category of included western drugs. Compatibility was tested through integrating the evaluations of physical properties, chemical composition, drug metabolism, and safety. Results Sixty articles (38 experimental tests and 22 clinical reports) were included after screening. Fifty–three western medical injections were identified from all the included articles. Most of the research was about the compatibility of SHLI with different types of antibiotics, including β-lactam, aminoglycoside, and quinolone etc. Thirty-one western medical injections were not recommended to be combined with SHLI. The quality of the experimental test design was low because of unbalanced evaluation indicators: more attention to physical changes than drug metabolism, effect, and safety. Conclusions A broad incompatibility exists in the combination of SHLI with western medical injections. Some results are still uncertain, but the combinations should still be avoided until researched clearly. The compatibility and interaction of Chinese herbal injections and western medicines is still a weak area. The pharmaceutical sector should strengthen post-market research to update evidence and improve its distribution.
Traditional Chinese Medicine (TCM) clinical practice guidelines play essential roles in the development of TCM. However, the existing TCM guidelines are not effectively used in clinic. Based on this phenomenon, this article addresses the characteristics of clinical practice guidelines of TCM, and analyzes its status, problems and resolutions, providing feasible suggestions for the development of high-quality clinical practice guidelines of TCM which are in accordance with clinical practice.
It is very important to develop and revise expert panel consensus on Chinese patent medical clinical application. The contents of the expert panel consensus include determination of the subject, clarity of the application scope, indications, dosage and administration, and safety of Chinese patent medicine. In the process, clinical researchers establish project team, formulate clinical management questions, select the outcome index, retrieve and make the evidence, and develop expert consensus with consensus methods strictly according to the requirements of methodology.