Compared with traditional clinical trials, the real-world studies set higher requirements on the authenticity (reality), applicability, and timeliness of the evidence obtained. In this paper, we brought up a hypothesis that creating synergies between observational and experimental studies may meet these requirements. And then it was discussed in three aspects including providing evidence, research design and execution. In addition, data analysis facilitated generating efficient and robust evidence which was in support of decision making. Finally, some enlightenment may be offered for Traditional Chinese Medicine evaluation methods based on the synergies of both study types.
ObjectivesTo systematically review the efficacy of traditional Chinese medicine for arrhythmia caused by anthracycline drugs.MethodsPubMed, EMbase, The Cochrane Library, CBM, CNKI, WanFang Data databases were electronically searched to collect randomized controlled trials (RCTs) on the efficacy of traditional Chinese medicine for arrhythmia caused by anthracycline drugs from inception to October 2017. Two reviewers independently screened literature, extracted data and evaluated risk of bias of included studies. Meta-analysis was then performed by Revman 5.3 software.ResultsA total of 4 RCTs involving 312 patients were included. The results of meta-analysis showed that: the incidence of tachycardia in the Wenxin granule treatment group was lower than that in the control group (RR=0.35, 95%CI 0.18 to 0.67, P=0.002). Baoxinkang was more effective than antioxidant western medicine in protecting myocardial SOD activity (RR=2.25, 95%CI 1.74 to 2.76, P<0.000 01). But there was no significant difference between two groups on the incidence of atrial premature beats (RR=0.40, 95%CI 0.15 to 1.08,P=0.07), premature ventricular contractions (RR=0.56, 95%CI 0.23 to 1.34, P=0.19) and atrial fibrillation (RR=0.41, 95%CI 0.11 to 1.53, P=0.18). In addition, there was no significant difference between Wenxin granules and amiodarone in treating arrhythmia induced by anthracycline. The addition of Wenxin granules on the basis of anthracycline antitumor chemotherapy regimens was not effective in delaying disease progression compared with anthracycline alone. Wenxin granules could not change the SOD level of breast cancer patients with cardiotoxicity caused by anthracycline chemotherapy, compared with chemotherapy and basic treatment.ConclusionsThe current evidence shows that Wenxin granules can prevent and reduce anthracycline-induced tachycardia, but its efficacy in improving the overall efficiency, preventing and reducing atrial premature beats, premature ventricular contractions, atrial fibrillation, and SOD levels are unclear. Baoxinkang can protect myocardial SOD activity. Due to limited quality and quantity of the included studies, more high quality studies are required to verify above conclusions.
In order to mediate the contradiction between the high quantity and low quality of Traditional Chinese Medicine (TCM) clinical research, to avoid blind research and waste of resources, and to promote the benign development of TCM clinical research, we proposed carrying out health research priority setting on the TCM clinical research. This paper defined the main content of TCM clinical research and briefly introduced the research status of priority setting methods. We described a five-step process of the TCM priority setting research: setting the research scope and plan, establishing the working group, mapping the research field, identifying priority research areas, reporting, evaluating and updating the research. It is expected that this area will receive the attention of relevant researchers, policy makers and research funders.
In continuous renal replacement therapy (CRRT), the combination of medicine and engineering is propelling advancements in therapeutic technology. By enhancing the biocompatibility and specific adsorption capabilities of the blood adsorption materials, the therapeutic efficacy of CRRT is augmented, leading to a reduction in adverse reactions for patients. Moreover, the application of big data and artificial intelligence in CRRT is continually being developed. Utilizing intelligent devices, data analysis, and machine learning, the initiation, monitoring, and formulation of CRRT treatment plans are optimized, providing clinical patients with more efficient and secure therapeutic options, thereby further improving clinical outcomes.
Objective To systemically evaluate the accuracy of f/t-PSA for diagnosing prostate cancer with a t-PSA level of 4-10ng/mL through meta-analysis. Methods A literature search of CBM, VIP, CNKI and Wanfang Data from 1999 to 2009 was performed. Related journals were also searched manually. Two reviewers independently assessed trial quality according to QUADAS items. Heterogenous studies and meta-analysis were conducted by Meta-Disc1.4 software. The analysis was based on different critical values of f/t-PSA (0.1, 0.15, 0.2, 0.25, and 0.3). Results Total 18 studies involving 2217 subjects were included. No threshold effect was found. But there was heterogeneity due to other factors. The meta–analysis showed that, the sensitivity of f/t-PSA with the critical value of 0.15 for the diagnosis of prostate cancer with a t-PSA level of 4-10ng/mL was 75% (95%CI 70%-79%), and the specificity was 81% (95%CI 78%-84%). The area under SROC curve was 0.883 5, and the Q index was 0.814 0. Conclusion The f/t-PSA is a better index for diagnosing prostate cancer with t-PSA levels between 4 and 10ng/mL. And it is reasonable to consider 0.15 as a more suitable critical value.
Dyspnea is the most common symptom in patients with acute heart failure syndrome (AHFS), and relieving dyspnea is an important goal in clinical practice, clinical trials and new drug regulatory approval. However, in clinical and scientific research, there is still no consensus on how to evaluate dyspnea, and there is still a lack of unified measurement methods. This article introduces the pathophysiological mechanism of dyspnea in acute heart failure, the measuring time of dyspnea, the posture of patients during measurement, the measuring conditions, and the common measurement methods of dyspnea in clinical trials and their advantages and disadvantages, so as to provide references for the selection of measurement methods of dyspnea in clinical trials of acute heart failure.
【摘要】 目的 探讨常规MRI扫描及胰胆管造影（MRCP）对胆管梗阻性疾病的临床诊断价值。 方法 2006年4月-2010年6月，对59例胆管梗阻性疾病患者行常规MRI及MRCP检查，其中18例行动态增强扫描，并与临床诊断或手术、病理结果对照分析。MRCP采用不屏气厚层快速自旋回波（FSE）序列重度T2WI扫描，原始图像以最大信号强度投影（MIP）法进行三维重建。 结果 MRI及MRCP对胆管梗阻程度的判断和定位诊断准确率为100.0%，定性诊断准确率为91.5%，其中MRCP诊断胆管结石和恶性胆管梗阻的准确率分别为96.8%和86.9%。 结论 MRCP对胆管梗阻的定位诊断准确，结合3D原始图像、常规MRI扫描及动态增强扫描，对胆管结石和恶性胆管梗阻的定性诊断有很高的准确性。【Abstract】 Objective To evaluate the clinical diagnosis value of MRI and cholangiopancreatography (MRCP) in diagnosis of biliary obstructive disease. Methods Routine MRI and MRCP were performed on 59 patients between April 2006 and June 2010, in which dynamic enhance scan was performed on 18 patients. The results were compared with clinical diagnosis or surgical findings and pathological examination. Non-breath-hold thick slices heavy T2 weighted TSE sequence was used. The original images were reconstructed by using three-dimensional maximum-intensity-projection (MIP) algorithm. Results The accuracy of MRI and MRCP in the detection of the degree and level of bile duct obstruction was 100.0 % and the accuracy for evaluating the causes of obstruction was 91.5 %. In the diagnosis of bile duct stone and malignant biliary obstruction, the diagnostic rate of MRCP was 96.8 % and 86.9%. Conclusion Routine MRI and MRCP examination can accurately define the level of bile duct obstruction. Combining with the original images and routine images and dynamic enhance scan, the specificity for the diagnosis of bile duct stone and malignant biliary obstruction is high.
ObjectiveTo systematically review the efficacy and safety of pericarpium trichosanthis injection combined with conventional western medicine for angina pectoris.MethodsDatabases including CBM, CNKI, WanFang Data, VIP, PubMed, The Cochrane Library and Web of Science were searched from inception to February 20th 2017 to collect randomized controlled trials (RCTs) about pericarpium trichosanthis injection combined with conventional western medicine for angina pectoris. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Then, meta-analysis was performed using RevMan 5.3 software.ResultsA total of 10 RCTs involving 1 004 patients were included. The results of meta-analysis showed that: the effective rate of angina symptoms (RR=1.24, 95%CI 1.15 to 1.33, P<0.000 01) and resting ECG (RR=1.30, 95%CI 1.15 to 1.45, P<0.000 1) in pericarpium trichosanthis injection combined with conventional western medicine group were superior to the conventional western medicine group. And the adverse reaction was rare and could be more tolerated in pericarpium trichosanthis injection combined with conventional western medicine group.ConclusionPericarpium trichosanthis injection combined with conventional western medicine can improve the symptoms of angina pectoris and objective indicator of ECG. However, due to the low quality of included studies and lack of evidence, the above results are needed to be validated by further well-designed multicenter, large scale, double blind RCTs.
Evidence-based medicine (EBM) provides a reliable evidence decision-making model for the medical field. The concepts and methods of EBM are gradually extended to other disciplines. At present, the paradigm of evidence-based science (EBS) is formally proposed, which is not only based on a methodological cooperation between different disciplines, but also a deeper potential driving force in optimizing the operation process of knowledge. The advantages of EBS helps promote its extension to other disciplines through standardization concepts and systematic methods, through which the common theories and supporting organization of EBS are formed. Under the guideline of EBS, the evidence-based concepts and methods will play a supportive role in scientific development.
The prominent feature and form of clinical diagnosis and treatment of traditional Chinese medicine is individualization, which has generated difficulty for clinical evaluation and has restricted the production of high-level evidence for traditional Chinese medicine for a long time. Based on the complexity and dynamics of individualized information under the characteristics of time and space, this paper references the theory of space-time of system science to analyze the individualized data of diagnosis and treatment of traditional Chinese medicine and summarizes the concept of the long time course for clinical evaluation. Based on the concept of the long time course, this paper starts with the origin of clinical evaluation, which is the construction of clinical problem elements named PICO, introduces dynamic evaluation factors, explores the construction of individualized dynamic evaluation method of traditional Chinese medicine, and provides demonstration and examples for the design and implementation of individualized clinical research in future.