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.
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.
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.
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.
Objective To analyze the burden and trend of stroke attributable to metabolic risk factors in China from 1990 to 2021. Methods Data on deaths and disability-adjusted life years (DALYs) attributed to metabolic risk factors for stroke were analyzed based on the Global Burden of Disease (GBD) database 2021 in China, globally, and across different socio-demographic index (SDI) regions from 1990 to 2021. Joinpoint regression analysis was utilized to calculate the average annual percent change (AAPC) to evaluate temporal trends in disease burden. Results In 2021, the age-standardized mortality rate (ASMR) and age-standardized DALYs rate (ASDR) of stroke attributable to metabolic risk factors in China were 93.57/100 000 and 1 793.16/100 000, respectively, both higher than global and all SDI regional averages. Among metabolic-related stroke subtypes, ischemic stroke accounted for the highest disease burden, whereas subarachnoid hemorrhage had the lowest. Disease burden was greater in men compared with women. Both stroke mortality and DALYs rate increased with advancing age, with DALYs rate slightly declined only after the age of 95 years. Elevated systolic blood pressure (SBP) was identified as the leading metabolic risk factors for stroke burden. Between 1990 and 2021, the ASMR (AAPC=−1.34) and ASDR (AAPC=−1.38) attributed to metabolic risk factors of stroke in China showed decreasing trends, consistent with global and regional SDI averages, with greater reductions observed in women. Declining trends were also observed across all stroke subtypes, only stroke burden associated with high body mass index (BMI) exhibited an increasing trend. By 2031, the ASMR and ASDR are projected to decrease to 77.37/100 000 and 1 478.88/100 000, respectively. Conclusion From 1990 to 2021, the burden of stroke attributable to metabolic risk factors in China showed an overall declining trend. However, the burden remained higher compared with global and regions SDI levels, particularly among men and older adults. Future efforts should focus on enhancing metabolic factors screening and management in high-risk populations, along with optimizing individualized interventions to further reduce stroke burden.
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.
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.
Traditional Chinese medicine equipment plays an indispensable role in the prevention, diagnosis, treatment and rehabilitation of traditional Chinese medicine from the needs of people's life and health, and provides technical support for the simple, convenient, cheap and effective clinical practice of traditional Chinese medicine. The traditional Chinese medicine equipment industry has the development advantages of large demand gap, strong policy support and emerging technology empowerment. At the same time, there are also bottlenecks such as lagging standardization construction, weak industrial foundation, insufficient characteristics of traditional Chinese medicine and immature evidence-based evaluation research. The coming of the era of digital intelligence has brought new opportunities for the development and reform of the traditional Chinese medicine equipment industry. This paper provides development ideas for the transformation of traditional Chinese medicine equipment from traditional to modern from the aspects of standardization construction, digital intelligence industry upgrading, improvement of evidence-based evaluation system and in-depth international exchanges and cooperation.
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.