[Integrated evidence chain: a new strategy and methodology for effectiveness e valuation of traditional Chinese medicines].

The evaluation of the effectiveness of traditional Chinese medicine(TCM) has long been a "bottleneck" issue that restricts the healthy development and internationalization of TCM. This article systematically analyzes the differences in diagnostic and treatment principles, material composition, new drug development pathways, efficacy cognition, and evaluation methodology between Chinese and Western medicine from the underlying logic of medical perspective. On this basis, it integrates the evidence elements of clinical experience, experimental research, and clinical trials, and for the first time proposes and establishes a new strategy and methodology for the evaluation of the effectiveness of TCM: the integrated evidence chain-based effectiveness evaluation of traditional Chinese medicine(iEC-Eff), forming an integrated evaluation and confirmation model of "clinical experience-experimental research-clinical trial" for the effectiveness of TCM.

Pharmacokinetics, pharmacodynamics, safety, and immunogenicity of HLX14 versus reference denosumab in healthy males: A randomized phase I study.

Denosumab is a human IgG2 monoclonal antibody against receptor activator of nuclear factor kappa-B ligand (RANKL) for the treatment of osteoporosis and bone loss. HLX14 is a proposed biosimilar of denosumab. This randomized, parallel-group, two-part, phase I study aimed to compare the pharmacokinetics, pharmacodynamics, safety, and immunogenicity of HLX14 with reference denosumab in Chinese healthy adult male participants.

Sarcopenia Is a Prognostic Factor of Adverse Effects and Mortality in Patients With Tumour: A Systematic Review and Meta-Analysis.

Background: The relationship between sarcopenia and the prognosis of patients with tumours who received radio- and/or chemotherapy still needs to be determined. In this study, we aim to investigate the relationship between sarcopenia and adverse effects and mortality in patients with tumours that received radio- and/or chemotherapy, stratified by study design, tumour category, the method sarcopenia assessed, treatment options, study location and among other factors.

Methods: PubMed, Web of Science and Embase were searched from inception to 15 August 2024, without language restrictions and with a manual search of references for additional articles retrieval.

Effects of Tanreqing injection on the gut microbiota in healthy volunteers.

Objectives: Many studies have confirmed that antibacterial agents can disrupt the human gut microbiota. In China, Tanreqing injection (TRQ) is a drug with antibacterial activity that is widely used in the treatment of respiratory infections. However, its specific influence on gut microbiota remains unclear.

Safety and efficacy of traditional Chinese manual therapy for cervicogenic dizziness: study protocol for a randomized, controlled, multicenter trial.

Background: Cervicogenic dizziness is a clinical syndrome characterized by neck pain and dizziness, which has a rising incidence in recent years. In China, manual therapy has been widely used in the treatment of cervicogenic dizziness, but there is no high-quality medical evidence to support its effectiveness and safety. The purpose of this study was to assess the safety and efficacy of Shi's manual therapy (SMT) on the treatment of cervicogenic dizziness.

Trends and challenges on inflammatory microenvironment in diabetic wound from 2014 to 2023: A bibliometric analysis.

The disturbance of the inflammatory microenvironment is a frequent pathological trait of diabetic wounds, contributing to the emergence of numerous chronic illnesses. This is crucial in both the development and recovery of wounds caused by diabetes. This study aims to perform a bibliometric analysis of research on the inflammatory microenvironment within the domain of diabetic wounds (DW) over the past 10 years.

Impact of Chinese herbal medicine on sarcopenia in enhancing muscle mass, strength, and function: A systematic review and meta-analysis of randomized controlled trials.

Sarcopenia has become important to the public health with the increase in the aging population in society. However, the therapeutic effects of conventional approaches, including pharmacotherapy, exercise, and nutritional intervention, are far from satisfactory. Chinese herbal medicine is a new treatment format with interesting possibilities in sarcopenia has been widely practiced.

Characteristics and duties of clinical research nurses: a scoping review.

Introduction: The characteristics and duties of clinical research nurses (CRNs) are constantly developing and changing with the progress of medical technology and increasing needs in patient care. With the continuous deepening and standardization of clinical trials, the importance and status of CRNs during the whole process of clinical trials are also increasingly valued.

Methods: A scoping review of studies related to the characteristics and duties of CRNs was conducted to clarify relevant roles and concepts.

A bibliometric analysis of inflammation in sarcopenia from 2007 to 2022.

Objective: In recent years, the impact of inflammation regulation on the progression of sarcopenia has garnered significant attention in research. However, there has been a lack of bibliometric analysis on the literature pertaining to inflammation in sarcopenia. This study was designed for the purpose of exploring the current research trends in this field as well as general situations and hot spots through bibliometric analysis.

Efficacy and safety of Huashi Baidu granule plus Nirmatrelvir-Ritonavir combination therapy in patients with high-risk factors infected with Omicron (B.1.1.529): A multi-arm single-center, open-label, randomized controlled trial.

Background: Huashi Baidu granule (HSBD) and Paxlovid (Nirmatrelvir-Ritonavir) are antiviral Chinese patent medicine and western medicine specially developed for treating coronavirus disease 2019 (COVID-19). Their efficacy and safety in treating COVID-19 are still under investigated.

Purpose: To assess and compare the efficacy and safety of HSBD, Paxlovid, and the combination in treating high-risk patients infected with SARS-CoV-2 Omicron.

A randomized, controlled single, and multiple ascending dose trial of the safety, pharmacokinetics and pharmacodynamics of SN1011 in healthy subjects.

The purpose of this study was to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SN1011, a novel Bruton tyrosine kinase (BTK) inhibitor, and food effects in healthy subjects. In this phase I trial, subjects received single ascending doses (SADs) of SN1011 (100 to 800 mg), multiple ascending doses (MADs) of SN1011 (200 to 600 mg), or placebo q.d.

Effectiveness of Traditional Chinese Medicine on coronavirus disease 2019 in 92 patients: a retrospective study.

Objective: To investigate the antipyretic effect of early treatment with Traditional Chinese Medicine (TCM) on coronavirus disease 2019 (COVID-19) patients.

Methods: We retrospectively analyzed 369 patients from January 26th, 2020 to April 15th, 2020, who had been diagnosed with COVID-19. Among 92 eligible cases, 45 cases were identified as treatment group Ⅰ ( 45) and 47 cases were identified as treatment group Ⅱ.

Efficacy and safety of Tuina (Chinese Therapeutic Massage) for knee osteoarthritis: A randomized, controlled, and crossover design clinical trial.

Background: Knee osteoarthritis (KOA) is a highly prevalent joint disease among the middle-aged and elderly population that can lead to pain, functional impairment, decreased quality of life, and a large number of medical expenses. Physical therapy is one of the main treatment methods for KOA. In China, Tuina has been widely used in the treatment of KOA, but up to now, there is no high-quality medical evidence to support its effectiveness and safety.

[Technical points of human use experience of ethnic medicine].

Ethnic medicine has a rich history of application. Because of the large number of ethnic groups, wide geographical distribution, and unique medical systems in China, the research on the human use experience(HUE) of ethnic medicine should combine the characteristics of ethnic medicine, be based on practical experience, and respect folk practice and tradition. The clinical positioning of ethnic medicine should consider three factors, i.

[Guideline for clinical comprehensive evaluation of Chinese patent medicine (2022 version)].

Currently,the research or publications related to the clinical comprehensive evaluation of Chinese patent medicine are increasing,which attracts the broad attention of all circles. According to the completed clinical evaluation report on Chinese patent medicine,there are still practical problems and technical difficulties such as unclear responsibility of the evaluation organization,unclear evaluation subject,miscellaneous evaluation objects,and incomplete and nonstandard evaluation process. In terms of evaluation standards and specifications,there are different types of specifications or guidelines with different emphases issued by different academic groups or relevant institutions.

Efficiency and Safety of Baofei Granules in Chronic Obstructive Pulmonary Disease (Lung and Spleen Qi Deficiency Syndrome): A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial.

Background: Baofei Granules (BFGs) have been extensively applied in the clinical treatment of chronic obstructive pulmonary disease (COPD) and significantly have affected COPD patients with lung and spleen qi deficiency syndrome. However, the data from previous small-sample clinical trials are limited. This trial aimed to estimate the efficiency and safety of BFGs in COPD with lung and spleen qi deficiency syndrome.

Test reliability and comparability of paper and Chinese electronic version of the western Ontario and McMaster University osteoarthritis index: protocol for a randomised controlled clinical trial.

Introduction: The Western Ontario and McMaster University osteoarthritis index (WOMAC) is the most commonly used indicator of disease-specific outcome in knee osteoarthritis for its convenience and reliability. It has two formats the paper-based WOMAC (p-WOMAC) and the electronic WOMAC (e-WOMAC). In China, the p-WOMAC has been widely used though e-WOMAC is yet untested.

Clinical efficacy of Jingyin granules, a Chinese patent medicine, in treating patients infected with coronavirus disease 2019.

Background: Jingyin granules (JY), one patented Chinese herbal formula, have been advised for treating coronavirus disease 2019 (COVID-19) in China. As of now, the safety and effectiveness of JY in treating COVID-19 patients were still to be evaluated.

Purpose: To investigate the safety and clinical effectiveness of JY in treating mild COVID-19 patients.

[Relevant thoughts on development of traditional Chinese medicine industry in new era].

Since the 18th National Congress of the Communist Party of China(CPC), the CPC and the government have highligh-ted the development of traditional Chinese Medicine(TCM) and issued a series of policies, such as the Plan for Protection and Deve-lopment of Chinese Medicinal Materials(2015-2020) forwarded by the General Office of the State Council in 2015, the Plan for Healthy Development of Traditional Chinese Medicine(2015-2020) released by the General Office of the State Council in the same year, the Healthy China 2030 Plan published by the CPC Central Committee and the State Council in 2016, the Law of the People's Republic of China on Traditional Chinese Medicine which took effect on July 2017, On the Preservation and Innovative Development of Traditional Chinese Medicine promulgated by CPC Central Committee and the State Council in 2019, and Plan for the Development of Traditional Chinese Medicine during the 14th Five-Year Plan Period of China released by the General Office of the State Council in March 2022, to promote the development of the TCM industry, which have brought historical opportunities to the TCM industry. However, TCM industry faces various challenges in the development. In terms of drug development in TCM, the current studies mainly focused on the chemical research and technical requests, which neglected TCM characteristics and cased in conformity between new drug transformation of TCM and clinical practice.

Study on the efficacy and safety of the combination of Shi's manual therapy and percutaneous endoscopic lumbar diskectomy for lumbar disc herniation with radiculopathy: study protocol for a multicenter randomized controlled trial.

Background: Lumbar disc herniation (LDH) is a common chronic musculoskeletal disorder that seriously affects quality of life. The percutaneous endoscopic lumbar diskectomy (PELD) technique was developed to address spinal nerve root compression through direct visualization of pathological findings while minimizing tissue destruction upon exposure. It is an effective and safe treatment for LDH.