Core outcome sets for myocardial infarction in clinical trials of traditional Chinese medicine and Western medicine.

BACKGROUND: Clinical trials of traditional Chinese medicine (TCM) and Western medicine showed there was heterogeneity of outcome reporting in myocardial infarction (MI). Developing a core outcome set (COS) might improve the consistency of outcome reporting in future clinical trials. METHODS: A list of outcomes was developed based on a systematic review of randomized controlled trials (RCTs) of MI and semistructured interviews with MI patients. Two rounds of Delphi survey for clinicians, researchers, journal editors, and methodologists were conducted. An online questionnaire sent to nurses. After an online consensus meeting, a COS for MI RCTs was developed. RESULTS: After extracted data from clinical trials and discussed, 216 outcomes were included in round 1 of the Delphi survey. Seventy-four participants completed round 1 of the Delphi survey. Sixty-five participants completed round 2 of the Delphi survey. Twenty-two nurses completed the online questionnaire. Fifteen participants attended the online consensus meeting, and 14 of them voted and determined the final COS. For all types of MI, it was recommended that left ventricular ejection fraction and quality of life be measured and reported. For acute MI, the participants in the consensus meeting recommended the following core outcomes: death from cardio-cerebrovascular disease, cardiogenic shock, heart failure, troponin I, troponin T, creatine kinase isoenzyme, Killip class, target vessel revascularization, and emergency CABG. For previous MI, recurrent MI, recurrent angina pectoris, and heart failure readmission were recommended. CONCLUSIONS: The COS for MI in RCTs provides recommendations for clinical trials that seek to improve outcomes for patients with MI.

Clinical evidence of three traditional Chinese medicine drugs and three herbal formulas for COVID-19: A systematic review and meta-analysis of the Chinese population.

BACKGROUND: The coronavirus disease 2019 (COVID-19) continues to spread worldwide. Integrated Chinese and Western medicine have had some successes in treating COVID-19. OBJECTIVE: This study aims to evaluate the efficacy and safety of three traditional Chinese medicine drugs and three herbal formulas (3-drugs-3-formulas) in patients with COVID-19. SEARCH STRATEGY: Relevant studies were identified from 12 electronic databases searched from their establishment to April 7, 2022. INCLUSION CRITERIA: Randomized controlled trials (RCTs), non-RCTs and cohort studies that evaluated the effects of 3-drugs-3-formulas for COVID-19. The treatment group was treated with one of the 3-drugs-3-formulas plus conventional treatment. The control group was treated with conventional treatment. DATA EXTRACTION AND ANALYSIS: Two evaluators screened and selected literature independently, then extracted basic information and assessed risk of bias. The treatment outcome measures were duration of main symptoms, hospitalization time, aggravation rate and mortality. RevMan 5.4 was used to analyze the pooled results reported as mean difference (MD) with 95% confidence interval (CI) for continuous data and risk ratio (RR) with 95% CI for dichotomous data. RESULTS: Forty-one studies with a total of 13,260 participants were identified. Our analysis suggests that compared with conventional treatment, the combination of 3-drugs-3-formulas might shorten duration of fever (MD = -1.39; 95% CI: -2.19 to -0.59; P < 0.05), cough (MD = -1.57; 95% CI: -2.16 to -0.98; P < 0.05) and fatigue (MD = -1.36; 95% CI: -2.21 to -0.51; P < 0.05), decrease length of hospital stay (MD = -2.62; 95% CI -3.52 to -1.72; P < 0.05), the time for nucleic acid conversion (MD = -2.92; 95% CI: -4.26 to -1.59; P < 0.05), aggravation rate (RR = 0.49; 95% CI: 0.38 to 0.64; P < 0.05) and mortality (RR = 0.34; 95% CI: 0.19 to 0.62; P < 0.05), and increase the recovery rate of chest computerized tomography manifestations (RR = 1.22; 95% CI: 1.14 to 1.3; P < 0.05) and total effectiveness (RR = 1.24; 95% CI: 1.09 to 1.42; P < 0.05). CONCLUSION: The 3-drugs-3-formulas can play an active role in treating all stages of COVID-19. No severe adverse events related to 3-drugs-3-formulas were observed. Hence, 3-drugs-3-formulas combined with conventional therapies have effective therapeutic value for COVID-19 patients. Further long-term high-quality studies are essential to demonstrate the clinical benefits of each formula. Please cite this article as: You LZ, Dai QQ, Zhong XY, Yu DD, Cui HR, Kong YF, Zhao MZ, Zhang XY, Xu QQ, Guan ZY, Wei XX, Zhang XC, Han SJ, Liu WJ, Chen Z, Zhang XY, Zhao C, Jin YH, Shang HC. Clinical evidence of three traditional Chinese medicine drugs and three herbal formulas for COVID-19: A systematic review and meta-analysis of the Chinese population. J Integr Med. 2023; 21(5): 441-454.

Gut microbiota and integrative traditional Chinese and western medicine in prevention and treatment of heart failure.

BACKGROUND: Heart failure (HF) is the terminal stage of multiple cardiovascular diseases, with high mortality and morbidity. More and more studies have proved that gut microbiota may play a role in the process of HF, which is expected to become a new therapeutic target. The combination of traditional Chinese and Western medicine has vast therapeutic potential of complementation against HF. PURPOSE: This manuscript expounds on the research progress of mechanisms of gut microbiota participating in the occurrence and prognosis of HF and the role of integrative traditional Chinese and Western medicine from 1987 to 2022. The combination of traditional Chinese and Western medicine in the prevention and treatment of HF from the perspective of gut microbiota has been discussed. METHODS: Studies focusing on the effects and their mechanisms of gut microbiota in HF and the role of integrative traditional Chinese and Western medicine were identified and summarized, including contributions from February 1987 until August 2022. The investigation was carried out in accordance with the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) guidelines. We searched PubMed, Embase, Cochrane Library, CNKI, Wanfang, and VIP databases up to April 2023 by using the relevant keywords and operators. RESULTS: A total of 34 articles were finally included in this review.16 RCTs and 13 basic researches, and 3 clinical research studies involving 7 relevant outcome indicators(cardiac function evaluation index, changes in gut microbiota, inflammatory factors, metabolites of gut microbiota, serum nutritional index protein, quality of life score, intestinal permeability and all-cause mortality). Compared with healthy controls, serum TNF-α and TMAO levels were significantly higher in patients with heart failure [MD = 5.77, 95%CI(4.97, 6.56), p < 0.0001; SMD = 1.92, 95%CI(1.70, 2.14), p < 0.0001]. Escherichia coli and Thick-walled bacteria increased significantly [SMD = -0.99, 95%CI(-1.38, -0.61), p < 0.0001, SMD = 2.58, 95%CI(2.23, 2.93), p < 0.0001];The number of bacteroides and lactobacillus decreased [SMD = -2.29, 95%CI(-2.54, -2.04), p < 0.0001; SMD = -1.55, 95%CI(-1.8, -1.3), p < 0.0001]. There was no difference in bifidobacterium [SMD = 0.16, 95%CI(-0.22, 0.54), p = 0.42]. In the published literature, it is not difficult to see that most of the results are studied and proved based on animal experiments or clinical trials, involving the cellular level, while the mechanism and mode of action of the molecular biology of traditional Chinese medicine are less elaborated, which is related to the characteristics of multi-components and multi-targets of traditional Chinese medicine. The above are the shortcomings of published literature, which can also be the direction of future research. CONCLUSION: Heart failure patients have decreased beneficial bacteria such as Bacillus mimics and Lactobacillus in the intestinal flora and increased harmful flora like thick-walled flora. And increase the inflammatory response of the body and the expression of trimethylamine oxide (TMAO) in the serum. And The prevention and treatment of integrative traditional Chinese and Western medicine against heart failure based on gut microbiota and its metabolites is a promising research direction.

Network pharmacology and molecular docking prediction, combined with experimental validation to explore the potential mechanism of Qishen Yiqi pills against HF-related cognitive dysfunction.

ETHNOPHARMACOLOGICAL RELEVANCE: Qishen Yiqi Pills (QSYQ) is a classical herbal formula for treating heart failure (HF) and has potential efficacy in improving cognitive function. The latter is one of the most common complications in patients with HF. However, there is no study on treating HF-related cognitive dysfunction by QSYQ. AIMS OF THE STUDY: The study aims to investigate the effect and mechanism of QSYQ on treating post-HF cognitive dysfunction based on network pharmacology and experimental validation. MATERIALS AND METHODS: Network pharmacology analysis and molecular docking was used to explore endogenous targets of QSYQ in treating cognitive impairment. Ligation of the anterior descending branch of the left coronary artery and sleep deprivation (SD) were used to induce HF-related cognitive dysfunction in rats. The efficacy and potential signal targets of QSYQ were then verified by functional evaluation, pathological staining, and molecular biology experiments. RESULTS: 384 common targets were identified by intersecting QSYQ 'compound targets' and 'cognitive dysfunction' disease targets. KEGG analysis showed these targets were enriched to the cAMP signal, and four marks responsible for regulating the cAMP signal were successfully docked with core compounds of QSYQ. Animal experiments demonstrated that QSYQ significantly ameliorated cardiac function and cognitive function in rats suffering from HF and SD, inhibited the reduction of cAMP and BDNF content, reversed the upregulation of PDE4 and downregulation of CREB, suppressed the loss of neurons, and restored the expression of synaptic protein PSD95 in the hippocampus. CONCLUSION: This study clarified that QSYQ could improve HF-related cognitive dysfunction by modulating cAMP-CREB-BDNF signals. It provides a rich basis for the potential mechanism of QSYQ in the treatment of heart failure with cognitive dysfunction.

Variations in dissolved oxygen and aquatic biological responses in China's coastal seas.

Coastal areas can represent an ecological transition zone with the function of biodiversity conservation, and good water quality is fundamental to maintaining this function. In this study, we analyzed data from 2011 to 2020 to reveal the variation in dissolved oxygen (DO) and the aquatic biological response in China's coastal seas. Results showed that DO in coastal waters exhibited an upward trend from 2011 to 2020 because of reduction in terrestrial anthropogenic pollutant (TAP) input. In comparison with DO in other seas, the DO content in the East China Sea was lower owing to higher TAP input, i.e., the proportion of DO of <5 mg L-1 accounted for approximately 60% of the total. Species numbers, density, and the species diversity index of phytoplankton, zooplankton, and macrobenthos were different in the different sea areas because phytoplankton, zooplankton, and macrobenthos have different responses to changes in DO. In comparison with the species numbers of zooplankton and macrobenthos, the species numbers of phytoplankton were more significantly related to DO, and showed a negative linear relationship with a better DO environment (DO ≥ 5 mg L-1; r2 = 0.39, p < 0.01) and positive correlation with a poor DO environment (DO < 3 mg L-1; r2 = 0.52, p < 0.01). A better DO environment is conducive to increased density of macrobenthos. Studies have shown that a good DO environment contributes to coastal ecosystem health, and continuous control of TAP input is an effective means of ensuring DO recovery.

Neural network aided flexible joint optimization with design of experiment method for nuclear power plant inspection robot.

Introduction: The flexible joint is a crucial component for the inspection robot to flexible interaction with nuclear power facilities. This paper proposed a neural network aided flexible joint structure optimization method with the Design of Experiment (DOE) method for the nuclear power plant inspection robot. Methods: With this method, the joint's dual-spiral flexible coupler was optimized regarding the minimum mean square error of the stiffness. The optimal flexible coupler was demonstrated and tested. The neural network method can be used for the modeling of the parameterized flexible coupler with regard to the geometrical parameters as well as the load on the base of the DOE result. Results: With the aid of the neural network model of the stiffness, the dual-spiral flexible coupler structure can be fully optimized to a target stiffness, 450 Nm/rad in this case, and a given error level, 0.3% in the current case, with regard to the different loads. The optimal coupler is fabricated with wire electrical discharge machining (EDM) and tested. Discussion: The experimental results demonstrate that the load and angular displacement keep a good linear relationship in the given load range and this optimization method can be used as an effective method and tool in the joint design process.

Evaluation of water quality at national scale from 2011 to 2021: Advances and challenges.

More environmental policies and larger investments in protecting the aquatic environment in China have been made in the last decade than previously. It is important to assess how this will affect river water quality. Here, changes in water quality in China between 2011 and 2021 are assessed. Water bodies meeting class III or better defined in the Chinese Environmental Quality Standards for Surface Water (GB3838-2002) were labeled WQI, water bodies meeting class V or better but below class III were labeled WQII, and water bodies below class V were labeled WQIII. The percentage of WQI water bodies increased from 66.1 % in 2011 to 81.0 % in 2021, and the percentages of WQII and WQIII water bodies decreased between 2011 and 2021. The percentage of WQI water bodies increased more quickly and the percentage WQIII water bodies decreased more quickly after 2017 than between 2011 and 2016. The percentages of WQI water bodies in the Northwest River Basin (RB), Pearl RB, Southeast RB, Southwest RB, and Yangtze RB were >80 %, and were higher than the percentages of WQI water bodies in the other five RBs. The percentages of WQI and WQII water bodies increased but the percentage of WQIII water bodies decreased in the Hai RB. The percentage of WQI water bodies increased but the percentages of WQII and WQIII water bodies decreased in the Huai RB, Liao RB, Yangtze RB, and Yellow RB. The river monitoring capacity increased and pollution sources, particularly point sources, became more controlled, and this improved river water quality. River management in China has passed the first stage of controlling pollution sources after 10 years of centralized management. The next stage should be focused on strengthening control of non-point sources of pollution and rehabilitating ecological systems to improve river health.

Evidence of improvements in the water quality of coastal areas around China.

Coastal areas are huge carbon stores and hotspots for marine carbon fixation. Changes in the water quality of coastal areas are closely linked to their carbon fixation function. In this study, monitoring data were analyzed to identify how the water quality in China's coastal areas changed from 2001 to 2020. The results showed that the water quality in the coastal areas had improved gradually since 2001. The proportion of water quality in Class II and above gradually increased from 41.4% in 2001 to 77.4% in 2020, meanwhile, the proportion of water quality less than Class II, decreased from 58.6% to 22.6%, respectively. Of the four sea areas, the water quality was best in the Yellow Sea, and was poor in the East China Sea. The water quality varied between the different coastal provinces and cities and was good in coastal areas of Hainan, Guangxi, Shandong, and other provinces and cities, but was poor in Shanghai, Zhejiang, and Tianjin. Terrestrial anthropogenic pollutants were the main influence on the water quality in the coastal areas. As a hotspot for fixing blue carbon, the continuous improvement of the water quality of coastal areas laid a foundation for the health of the blue carbon ecosystems.

Dissolved oxygen variation in the North China Plain river network region over 2011-2020 and the influencing factors.

The 2011-2020 data of dissolved oxygen (DO) and nutrients-total phosphorus (TP), solution reactive phosphorus (SRP), total nitrogen (TN), ammoniacal nitrogen (NH3-N), and chemical oxygen demand (CODCr)-in the North China Plain river network region were analyzed. Moreover, the DO variation trend and the influencing factors were investigated. The results showed that between 2011 and 2020, the DO concentration steadily increased from <3 mg L-1 to >5 mg L-1. Negative relationships were observed between the DO and CODCr (R = -0.34, p < 0.01), TN (R = -0.41, p < 0.01), NH3-N(R = -0.40, p < 0.01), TP (R = -0.28, p < 0.01), and SRP (R = -0.19, p < 0.01), indicating that a reduction in the nutrient input promoted the increase in the DO concentration in the past decade. The DO concentration in the rainy season was lower than that in the dry season, which suggests that nonpoint-source pollution caused by heavy storm runoff was the main factor affecting the water quality. The average DO concentration in the suburban rivers (4.88 mg L-1) was higher than that in urban rivers (3.41 mg L-1). Furthermore, comprehensive analysis indicated that the loss of riparian buffer, river solidification, pollutant input, and sluice dam operations are the main factors affecting DO concentration decrease and water quality deterioration. Finally, measures for water improvement and DO recovery in the river network region, namely pollutant input control, reduction in the impact of water conservancy projects, and river ecological restoration, were examined. Overall, this study shows that water quality has improved over the past decade. The study results provide a reference for the continuous improvement of water quality and the continuous recovery of DO in river network regions.

Development of a Core Outcome Set for the Benefits and Adverse Events of Acute Heart Failure in Clinical Trials of Traditional Chinese Medicine and Western Medicine: A Study Protocol.

Aims: To identify a minimum set of efficacy and adverse events for patients with acute heart failure (AHF) among different stakeholders in clinical trials of traditional Chinese medicine and Western medicine. Methods and Analysis: First, we will develop a preliminary long list of outcomes that includes efficacy and adverse events/reactions via three steps: (i) systematic reviews of efficacy and safety outcomes for clinical trials of AHF; (ii) drugs included in the National Medical Insurance Catalog, the National Essential Medicines Catalog, and the WHO Essential Medicines List will be collected and safety outcomes extracted from the package inserts; and (iii) patients' or caregivers' semi-structured interviews will be carried out to add new viewpoints to the list. Second, after merging outcomes and grouping them under different outcome domains, questionnaires for health professionals and patients will be separately developed. Further, two rounds of Delphi survey for health professionals and a survey for patients and the public will be carried out. Third, different stakeholders will discuss and determine the final core outcome set (COS) for AHF in a consensus meeting. Ethics and Dissemination: The entire project has been approved by the Ethics Committee of the main institution. After the final COS is developed, it will be published and discussed widely in conferences. Clinical Trial Registration: This study is registered with the Core Outcome Measures in Effectiveness Trials database as study 1566 (available at: https://www.cometinitiative.org/Studies/Details/1566).

[Meta-analysis of effect of Qishen Yiqi Dripping Pills combined with Western medicine on adverse cardiovascular events and quality of life after percutaneous coronary intervention].

To systemically evaluate the effect of Qishen Yiqi Dripping Pills combined with Western medicine on adverse cardiovascular events and quality of life after percutaneous coronary intervention(PCI). A total of 7 Chinese and English databases including CNKI, Wanfang, VIP, SinoMed, PubMed, Cochrane Library and Web of Science were searched by computer to collect the randomized controlled trials(RCTs) on Qishen Yiqi Dripping Pills combined with Western medicine in the treatment of patients with coronary heart disease after PCI with the retrieval time from the database establishment to April 1, 2020. Two researchers independently conducted li-terature screening, data extraction and bias risk assessment. Then, Meta-analysis was performed by using RevMan 5.3 software. A total of 31 RCTs were included, involving 3 537 patients. The results of Meta-analysis showed that in terms of major adverse cardiovascular events(MACE) after PCI, the combination of Qishen Yiqi Dripping Pills could significantly reduce the recurrence of angina pectoris, incidence of arrhythmia, heart failure and re-revascularization, and the effect was better than that of Western medicine treatment alone. However, there was no significant difference between the two groups in the improvement of non-fatal myocardial infarction, cardiac death, stent restenosis, stroke and other adverse cardiovascular events. In terms of improving left ventricular ejection fraction(LVEF), 6 min walking test(6 MWT), high-sensitivity C-reactive protein(hs-CRP) and Seattle angina pectoris scale(SAQ), the combination of Qishen Yiqi Dripping Pills and Western medicine treatment had obvious advantages over Western medicine treatment alone in increasing LVEF, 6 MWT and SAQ, and reducing the level of hs-CRP, with statistically significant differences. There were few adverse reactions in both groups, and there was no significant difference between the two groups. The main manifestations were gastrointestinal reactions, rash, gingiva and other small bleeding, and no serious adverse reactions occurred. The above reactions could disappear after drug withdrawal or symptomatic treatment. The application of Qishen Yiqi Dripping Pills combined with Western medicine in the treatment of patients after PCI could reduce the occurrence of MACE, improve the clinical efficacy, quality of life and prognosis in a safe and reliable manner. However, due to the quantity and quality limitations of included studies, more standardized, rigo-rous and high-quality clinical studies are still needed to further verify the above conclusions.

Status Quo and Analysis of the Cardiovascular Clinical Practice Guidelines/Expert Consensuses of Chinese and Integrative Medicine: A Systematic Review.

OBJECTIVE: To describe and analyze the status quo of cardiovascular clinical practice guidelines or expert consensuses including both Chinese medicine (CM) and integrative medicine, through systematic literatures searching and quality assessment. METHODS: Data bases including Chinese Biomedical Literature Database, the China National Knowledge Infrastructure, Wanfang Data, China Science and Technology Journal Database were searched for published CM or integrative cardiovascular clinical practice guidelines or expert consensuses. The website www. medlive.cn was also retrieved as supplementary. The clinical practice evaluation tool AGREE II was used to assess the quality of included guidelines or consensuses. RESULTS: A total of 31 relevant clinical practice guidelines or expert consensuses were included, covering diagnosis, treatment, Chinese patent and patient fields. Common cardiovascular diseases like coronary heart diseases, heart failure and arrhythmia were also involved. Through analysis it was found that both the quantity and quality of included guidelines have been improved year by year. A total of 4 evidence-based clinical practice guideline has been found, one of which was a guideline project plan. Except that, the remaining 27 reports were all consensus-based guidelines. The scores of each field, from highest to lowest, were clarity of presentation (58%), scope and purpose (54%), stakeholder involvement (28%), rigor of development (21%), applicability (13%) and editorial independence (8%). CONCLUSIONS: Although clinical practice guidelines in cardiovascular domain of Chinese have gained increasing concern, with both quantity and quality improved, there is still huge gap in methodology and reporting standards between CM guidelines and international ones. On the one hand, it is essential to improve and standardize the methodology of developing CM guidelines. On the other hands, the evaluation system of evidence and recommendation with CM characters should be developed urgently.

Core Outcome Set for Clinical Trials of COVID-19 Based on Traditional Chinese and Western Medicine.

BACKGROUND: Development of a core outcome set (COS) for clinical trials for COVID-19 is urgent because of the pandemic wreaking havoc worldwide and the heterogeneity of outcomes in clinical trials. METHODS: A preliminary list of outcomes was developed after a systematic review of protocols of clinical trials for COVID-19. Then, two rounds of the Delphi survey were conducted. Stakeholders were traditional Chinese medicine (TCM) experts, Western medicine (WM) experts, nurses, and the public. Patients with confirmed COVID-19 were also invited to participate in a questionnaire written in understandable language. Then different stakeholders participated in a consensus meeting by video conference to vote. RESULTS: Ninety-seven eligible study protocols were identified from 160 clinical trials. Seventy-six outcomes were identified from TCM clinical trials and 126 outcomes were identified from WM clinical trials. Finally, 145 outcomes were included in the first round of the Delphi survey. Then, a COS for clinical trials of TCM and WM was developed. The COS included clinical outcomes (recovery/improvement/progression/death), etiology (SARS-CoV-2 nucleic-acid tests, viral load), inflammatory factor (C-reactive protein), vital signs (temperature, respiration), blood and lymphatic-system parameters (lymphocytes, virus antibody), respiratory outcomes (pulmonary imaging, blood oxygen saturation, PaO2/FiO2 ratio, arterial blood gas analysis, mechanical ventilation, oxygen intake, pneumonia severity index), clinical efficacy (prevalence of preventing patients with mild-to-moderate disease progressing to severe disease), and symptoms (clinical symptom score). Outcomes were recommended according to different types of disease. Outcome measurement instruments/definitions were also recommended. CONCLUSION: Though there are some limitations for the research, such as insufficient patients and the public involvement, and the unbalanced stakeholders' region, the COS for COVID-19 may improve consistency of outcome reporting in clinical trials. It also should be updated with research progression.

Initiate Danhong Injection before or after percutaneous coronary intervention for microvascular obstruction in ST-elevation myocardial infarction (DIRECTION): study protocol for a randomized controlled trial.

BACKGROUND: No treatment has convincingly been proven to be beneficial for microvascular obstruction (MVO) in patients with ST-elevation myocardial infarction (STEMI). Several studies have described the effects of Danhong Injection. However, evidence of a rigorously designed verification study is still lacking, and the intervention timing of Danhong Injection is uncertain. METHODS: The DIRECTION study is a multicenter, prospective, randomized, evaluator-blind study. A total of 336 patients with STEMI receiving percutaneous coronary intervention (PCI) will be randomly assigned to conventional treatment, the preoperative Danhong Injection, or the postoperative Danhong Injection. The primary outcome is rate of ST-segment resolution (STR) ≥ 70% at 90 min after PCI. The secondary outcomes are the degree of STR, Thrombolysis in Myocardial Infarction (TIMI) flow grade, TIMI myocardial perfusion grade, left ventricular ejection fraction, N-terminal prohormone brain natriuretic peptide, high-sensitivity C-reactive protein, and infarct size expressed as area under the curve for cardiac troponin I (cTnI) and for creatine kinase MB. The major adverse cardiovascular events and hospital readmission events will be recorded. Health quality will be assessed with the 12-item Short Form Health Survey. The safety outcomes include bleeding events, adverse events, and abnormal changes in routine blood tests. Psychological status and dietary patterns will be evaluated using Hamilton Depression Rating Scale and Food Frequency Questionnaire as the relevant indicators. DISCUSSION: This trial will evaluate the efficacy and safety of Danhong Injection, as well as its optimal timing of intervention to prevent MVO in patients with STEMI. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR1900021440. Registered on February 21, 2019.

Development of a core outcome set for myocardial infarction in clinical trials of traditional Chinese medicine: a study protocol.

INTRODUCTION: Myocardial infarction (MI) is the most dangerous complication in patients with coronary heart disease. In China, there is an increasing number of randomised controlled trials (RCTs) of traditional Chinese medicine (TCM) for treating MI. However, the inconsistency of outcome reporting means that a large number of clinical trials cannot be included in systematic reviews to provide the best evidence for clinical practice. The aim of this study is to develop a core outcome set (COS) for future TCM clinical trials of MI, which may improve the consistency of outcome reporting and facilitate the synthesis of data across studies in systematic reviews. METHODS AND ANALYSIS: We will conduct a systematic review of MI clinical trials with any intervention. Semistructured interviews will be conducted to obtain the perspectives of patients with MI. The outcomes from the systematic review and semistructured interviews will be grouped and used to develop a questionnaire. The questionnaire will be developed as a supplement for the TCM syndromes of MI and will be constructed from the results of a systematic review, existing medical records and a cross-sectional study. Then two rounds of the Delphi survey will be conducted with different stakeholders (TCM experts and Western medicine experts in cardiovascular disease, methodologists, magazine editors and patients) to determine the importance of the outcomes. Only the TCM experts will need to response to the questionnaire for core TCM syndromes. A face-to-face consensus meeting will be conducted to create a final COS and recommend measurement time for each outcome. ETHICS AND DISSEMINATION: This project has been approved by the Ethics Committee of Dongzhimen Hospital, Beijing University of Chinese Medicine. The final COS will be published and freely available. TRIAL REGISTRATION NUMBER: This study is registered with the Core Outcome Measures in Effectiveness Trials database as study 1243 (available at: http://www.comet-initiative.org/studies/details/1243).

Outcome reporting from clinical trials of non-valvular atrial fibrillation treated with traditional Chinese medicine or Western medicine: a systematic review.

OBJECTIVES: To examine variation in outcomes, outcome measurement instruments (OMIs) and measurement times in clinical trials of non-valvular atrial fibrillation (NVAF) and to identify outcomes for prioritisation in developing a core outcome set (COS) in this field. DESIGN: This study was a systematic review. DATA SOURCES: Clinical trials published between January 2015 and March 2019 were obtained from PubMed, the Cochrane Library, Web of Science, Wanfang Database, the China National Knowledge Infrastructure and SinoMed. ELIGIBILITY CRITERIA: Randomised controlled trials (RCTs) and observational studies were considered. Interventions included traditional Chinese medicine and Western medicine. The required treatment duration or follow-up time was ≥4 weeks. The required sample size was ≥30 and≥50 in each group in RCTs and observational studies, respectively. We excluded trials that aimed to investigate the outcome of complications of NVAF, to assess the mechanisms or pharmacokinetics, or for which full text could not be acquired. DATA EXTRACTION AND SYNTHESIS: The general information and outcomes, OMIs and measurement times were extracted. The methodological and outcome reporting quality were assessed. The results were analysed by descriptive analysis. RESULTS: A total of 218 articles were included from 25 255 articles. For clinical trials of antiarrhythmic therapy, 69 outcomes from 16 outcome domains were reported, and 28 (31.82%, 28/88) outcomes were reported only once; the most frequently reported outcome was ultrasonic cardiogram. Thirty-one outcomes (44.93%, 31/69) were provided definitions or OMIs; the outcome measurement times ranged from 1 to 20 with a median of 3. For clinical trials of anticoagulation therapy, 82 outcomes from 18 outcome domains were reported; 38 (29.23%, 38/130) outcomes were reported only once. The most frequently reported outcome was ischaemic stroke. Forty (48.78%, 40/82) outcomes were provided OMIs or definitions; and the outcome measurement times ranged from 1 to 27 with a median of 8. CONCLUSION: Outcome reporting in NVAF is inconsistent. Thus, developing a COS that can be used in clinical trials is necessary.

The Role of Traditional Chinese Medicine in the Regulation of Oxidative Stress in Treating Coronary Heart Disease.

Oxidative stress has been closely related with coronary artery disease. In coronary heart disease (CHD), an excess of reactive oxygen species (ROS) production generates endothelial cell and smooth muscle functional disorders, leading to a disequilibrium between the antioxidant capacity and prooxidants. ROS also leads to inflammatory signal activation and mitochondria-mediated apoptosis, which can promote and increase the occurrence and development of CHD. There are several kinds of antioxidative and small molecular systems of antioxidants, such as ß-carotene, ascorbic acid, α-tocopherol, and reduced glutathione (GSH). Studies have shown that antioxidant treatment was effective and decreased the risk of CHD, but the effect of the treatment varies greatly. Traditional Chinese medicine (TCM) has been utilized for thousands of years in China and is becoming increasingly popular all over the world, especially for the treatments of cardiovascular diseases. This review will concentrate on the evidence of the action mechanism of TCM in preventing CHD by modulating oxidative stress-related signaling pathways.

Anticancer Therapy-Induced Atrial Fibrillation: Electrophysiology and Related Mechanisms.

Some well-established immunotherapy, radiotherapy, postoperation, anticancer drugs such as anthracyclines, antimetabolites, human epidermal growth factor receptor 2 blockers, tyrosine kinase inhibitors, alkylating agents, checkpoint inhibitors, and angiogenesis inhibitors, are significantly linked to cardiotoxicity. Cardiotoxicity is a common complication of several cancer treatments. Some studies observed complications of cardiac arrhythmia associated with the treatment of cancer, including atrial fibrillation (AF), supraventricular arrhythmias, and cardiac repolarization abnormalities. AF increases the risk of cardiovascular morbidity and mortality; it is associated with an almost doubled risk of mortality and a nearly 5-fold increase in the risk of stroke. The occurrence of AF is also usually researched in patients with advanced cancer and those undergoing active cancer treatments. During cancer treatments, the incidence rate of AF affects the prognosis of tumor treatment and challenges the treatment strategy. The present article is mainly focused on the cardiotoxicity of cancer treatments. In our review, we discuss these anticancer therapies and how they induce AF and consequently provide information on the precaution of AF during cancer treatment.