Asymptomatic infection and disappearance of clinical symptoms of COVID-19 infectors in China 2022-2023: a cross-sectional study.

To explore the clinical characteristics of patients infected with SARS-CoV-2 nationwide, especially the effect factors of asymptomatic infection and disappearance of clinical symptoms. A total of 66,448 COVID-19 patients in China who have been diagnosed by nucleic acid test or rapid antigen test were surveyed online (December 24, 2022 to January 16, 2023). Our cross-sectional study used descriptive analyses and binary Logistics regression model to assess the correlation between the clinical characteristics and relative factors, including age, gender, pre-existing conditions, reinfection, vaccination and treatment. A total of 64,515 valid questionnaires were collected. Among included participants, 5969 of which were asymptomatic. The symptoms were mainly upper respiratory symptoms, including dry and itchy throat (64.16%), sore throat (59.95%), hoarseness (57.90%), nasal congestion (53.39%). In binary Logistics regression model, we found that male, no pre-existing conditions, reinfection and vaccination have positive correlations with the appearance of asymptomatic COVID-19 patients. In Cox proportional-hazards regression model, considering all clinical symptoms disappeared in 14 days as outcome, we found that ≤ 60 years old, male, no pre-existing conditions, vaccination and adopted treatment have positive correlations with rapid amelioration of clinical symptoms in COVID-19 patients. The clinical symptoms of the participants were mainly upper respiratory symptoms which were according with the infection of Omicron variant. Factors including age, gender, pre-existing conditions and reinfection could influence the clinical characteristics and prognosis of COVID-19 patients. Importantly, vaccination has positive significance for the prevention and treatment of COVID-19. Lastly, the use of Chinese medicine maybe beneficial to COVID-19 patients, however, reasonable guidance is necessary.

Development of a core outcome set for cardiac rehabilitation in patients with myocardial infarction: a study protocol.

INTRODUCTION: Heterogeneous outcome reporting is common in clinical trials focused on cardiac rehabilitation for myocardial infarction (MI); this practice often results in the exclusion of data from clinical trials in systematic reviews. Developing a core outcome set (COS) may solve this problem. METHODS AND ANALYSIS: We will first identify a preliminary list of outcomes through a systematic review. Next, we will conduct semistructured interviews with patients to explore additional potential outcomes deemed important by patients. Then, we will engage various stakeholders such as clinicians, researchers and methodologists in two Delphi survey tends to refine and prioritise the identified outcomes. Subsequently, we will gather insights directly from patients with MI by administering plain language patient surveys; patients will be involved in questionnaire development. Finally, we will hold two face-to-face consensus meetings for patients and other stakeholders to develop the final COS for cardiac rehabilitation in MI. ETHICS AND DISSEMINATION: The Ethics Committee of Dongzhimen Hospital, Beijing University of Chinese Medicine approved this study (2022DZMEC-349). The final COS will be published in a peer-reviewed journal and disseminated in conferences. TRIAL REGISTRATION: We registered this study in the Core Outcome Measures in Effectiveness Trials Initiative (COMET) platform. REGISTRATION NUMBER: 1725 (http://www.comet-initiative.org/studies/details/1725).

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.

Risk prediction models for mortality and readmission in patients with acute heart failure: A protocol for systematic review, critical appraisal, and meta-analysis.

INTRODUCTION: A considerable number of risk models, which predict outcomes in mortality and readmission rates, have been developed for patients with acute heart failure (AHF) to help stratify patients by risk level, improve decision making, and save medical resources. However, some models exist in a clinically useful manner such as risk scores or online calculators, while others are not, providing only limited information that prevents clinicians and patients from using them. The reported performance of some models varied greatly when predicting at multiple time points and being validated in different cohorts, which causes model users uncertainty about the predictive accuracy of these models. The foregoing leads to users facing difficulties in the selection of prediction models, and even sometimes being reluctant to utilize models. Therefore, a systematic review to assess the performance at multiple time points, applicability, and clinical impact of extant prediction models for mortality and readmission in AHF patients is essential. It may facilitate the selection of models for clinical implementation. METHOD AND ANALYSIS: Four databases will be searched from their inception onwards. Multivariable prognostic models for mortality and/or readmission in AHF patients will be eligible for review. Characteristics and the clinical impact of included models will be summarized qualitatively and quantitatively, and models with clinical utility will be compared with those without. Predictive performance measures of included models with an analogous clinical outcome appraised repeatedly, will be compared and synthesized by a meta-analysis. Meta-analysis of validation studies for a common prediction model at the same time point will also be performed. We will also provide an overview of critical appraisal of the risk of bias, applicability, and reporting transparency of included studies using the PROBAST tool and TRIPOD statement. SYSTEMATIC REVIEW REGISTRATION: PROSPERO registration number CRD42021256416.

Variable importance for projection (VIP) scores for analyzing the contribution of risk factors in severe adverse events to Xiyanping injection.

BACKGROUND: Age and herb-drug combination are risk factors for the severity of Xiyanping injection (XYP) associated adverse events (AEs). OBJECTIVE: To analyze risk factors contributing to the severity of XYP's AEs using a variable importance for projection (VIP) method. METHODS: AEs related to the use of XYP were extracted from the China National Adverse Drug Reaction Monitoring Information System (2004-2017) and classified as general or severe. Data were analyzed with respect to age and 12 herb-drug combinations, including ribavirin (RB), ceftriaxone, penicillin sodium, ambroxol hydrochloride (AH), clindamycin, cefoxitin sodium, azithromycin (AZM), ceftazidime, amoxicillin sodium/potassium clavulanate, levofloxacin hydrochloride, sodium cefazolin pentahydrate, and acyclovir according to VIP scores and correlation coefficient (Coeff). RESULTS: A total of 21,714 AEs (general 20,660; severe 1054) related to XYP combinations were included. Using XYP alone tended to produce general AEs (All VIP = 3.124; 1.329; 1.857; 2.169; 2.400, Coeff < 0). For all set, 0-6 years old patients tend to have general AEs (VIP = 2.425, Coeff < 0), while those > 41 years old patients tend to have severe AEs (VIP = 1.180; 2.323, Coeff > 0). For 0-40 years old patients, XYP-RB combination had a greater impact on the severity of AEs (VIP = 1.158; 1.360; 1.147, Coeff > 0). For 7-17 years old patients, XYP-AZM combination tended to produce general AEs (VIP = 1.502, Coeff < 0). In individuals > 65 years old, XYP-AH combination tended to result in severe AEs (VIP = 1.232, Coeff > 0). CONCLUSIONS: VIP method was expected to effectively analyze risk factors in affecting the severity of AEs and control AEs more effectively. Age is the key factor contributing to the severity of AEs, and there are different influence directions. It is recommended that clinicians pay closer attention to the metabolic characteristics of different age groups. It is safe to use XYP alone and strictly implementing standardized operations such as medication interval and flushing will avoid undesired AEs.

[Concept and method of evidence-based toxicology of traditional Chinese medicine from origin and development of evidence-based toxicology].

Advances in science and technology promote the rapid development of toxicological detection technologies. However, there is still a lack of decision-making tools for toxicological risk assessment, such as the lack of transparent schemes to evaluate current toxicological research and practice and the lag of toxicological testing tools to evaluate toxicity, resulting in difficulties in toxicity verification and hindering the transformation of toxicological research paradigm. Some scholars have proposed to integrate the concept of evidence-based medicine with the toxicological practice to improve the technical methods of toxicological research concept and risk assessment decision-making. With the promotion of relevant scholars and academic organizations, the concept and connotation of evidence-based toxicology have gradually become clear and a framework for research and practice has been initially formed. Although there are still many challenges, it also provides a new idea for the toxicity risk assessment and safe medication decision-making of traditional Chinese medicine(TCM). The era of digital intelligence has brought new opportunities and broad space for the development of TCM evidence-based toxicology. The exploration of TCM evidence-based toxicology from concept to method is an important embodiment of the development of TCM evidence-based toxicology, and will also promote the continuous enrichment and improvement of the research and practice system of TCM evidence-based toxicology.