Traditional Chinese medicine (TCM) has some unique advantages in the prevention and treatment of cancer. Due to different ideas and mechanism of between TCM and biomedicine in the prevention and treatment of cancer, the clinial effect evaluation approches of biomedicine could not be used as a beneficial method to scientifically evaluate the effects of TCM. From three angles, this article analyzes the key issues regardsing the evaluation methods of TCM as an adjuvant therapy of cancer. It draws lessons from the idea of quality-adjusted survival (QAS), proposes Two-in-One (TIO) method to evaluate the effects of TCM as adjuvant therapy of cancer, which reflects the combined value of the individual patient dynamic information and provides methodological support for the effect evaluation of TCM.
With the implementation of “Good Clinical Practice”, the quality of clinical trials in China has increased constantly and more importance has been attached to the protection of the subject. Large scale clinical trials are primarily featured by long-term intervention, large sample size, many participant organizations, different levels of investigators, long test periods, and lots of adverse events. Consequently, the protection of subject is full of extensive complexities and difficulties and currently there is little experience to refer to. Hence, the article introduces the subject’s protection method adopted in the National Program Subject of Secondary Prevention Clinical Trial about Effect of Qi Shen Tonifying Qi on Myocardial Infarction (MISPS-TCM).
To aim directly at the individualized character and tendency about clinical assessment of Traditional Chinese Medicine (TCM), we draw off a new pathway which is evidence-based goal attainment scale(EBGAS) in the text. i.e., we will develop clinical individualized assessment method of TCM on account of GAS by the approach of evidence based medicine.
ObjectiveTo systematically review studies on evaluating the quality evaluation index and the transformation application effect evaluation index of domestic related scientific and technological achievements, to analyze and identify the key elements of evaluating the " production-transformation” of scientific and technological achievements, and to provide the methodological support for the establishment of evaluation system for the transformation and application of domestic scientific and technological achievements.MethodsWe searched CNKI, WanFang Data, SinoMed and VIP databases from inception to December 2016. In addition, manual retrieval and tracing references were also used to collect researches. Two reviewers screened literatures, extracted data, and descriptive analysis was performed to assess the results.ResultsA total of 18 studies on the production quality of the technological achievements and 12 studies on the transformation and application effect of the technological achievements were included. The results of systematic reviews showed that: the evaluation of production quality of technological achievements were mainly established from the benefits, characteristics, value, effect and source, and input of technological achievements; the evaluation of transformation and application of technological achievements were mainly established from researching and development ability, transforming ability and transformation effect of technological achievements.ConclusionsThe evaluation of technological achievements covers 2 key links: the production quality, transformation and application effect of technological achievements that are mutually complementary to each other. At the same time, the value elements are found in the production quality, transformation and application of technological achievements, namely scientific value, discipline value, economic value and social value. Therefore it is necessary to establish the evaluation of production quality, transformation and application effect of technological achievements based on the value.
ObjectivesTo systematically review the risk factors associated with prediabetes, and to provide reference for prevention and treatment of diabetes mellitus and health education.MethodsPubMed, EMbase, SinoMed, CNKI, WanFang Data and VIP databases were electronically searched to collect case-control studies on the risk factors associated with prediabetes from inception to February 20th, 2018. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies, then, meta-analysis was performed by using RevMan 5.3 software.ResultsA total of 13 studies involving 49 168 patients were included. The results of meta-analysis showed that: drinking (OR=1.31, 95%CI 1.04 to 1.65, P=0.02), hypertension (OR=1.75, 95%CI 1.11 to 2.76, P=0.02), abdominal obesity (OR=1.26, 95%CI 1.12 to 1.42, P=0.000 1), and waist to hip ratio (OR=1.77, 95%CI 1.27 to 2.45, P=0.000 6) might be the risk factors for prediabetes. However, dyslipidemia, smoking, physical activity, family history of diabetes, body mass index and waist circumference might not be risk factors for prediabetes.ConclusionsCurrent evidence shows that drinking, hypertension, abdominal obesity and waist-hip ratio may be the influencing factors of pre-diabetes, while other related risk factors are required to be further studied. Due to limited quality and quantity of the included studies, more high quality studies are required to verify above conclusions.
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.
Based on evidence-based medicine (EBM) and from the viewpoint of providing scientific evidence for clinical application, we found that Traditional Chinese Medicine (TCM) was short of adequate evidence to support its therapeutic effects due to lack of high quality clinical research. Data management plays a very important role in clinical research. Lack of adequate data management may lead to low quality clinical research. Thus, it is of great importance to establish a set of standards for data management so as to improve the quality of clinical research. Based on the real practice in Myocardial Infarction Secondary Prevention Study in TCM (MISPS-TCM), this article introduces methods on data audit in clinical trials of TCM.