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1.
BMC Complement Med Ther ; 21(1): 217, 2021 Aug 31.
Artigo em Inglês | MEDLINE | ID: mdl-34465313

RESUMO

BACKGROUND: Traditional Chinese medicine (TCM) has gained widespread application in treating chronic heart failure (CHF) secondary to coronary heart disease (CHD). However, the sound clinical evidence is still lacking. Corresponding clinical trials vary considerably in the outcome measures assessing the efficacy of TCM, some that showed the improvement of clinical symptoms are not universally acknowledged. Rational outcome measures are the key to evaluate efficacy and safety of each treatment and significant elements of a convincing clinical trial. We aimed to summarize and analyze outcome measures in randomized controlled trials (RCTs) of TCM in treating CHF caused by CHD, subsequently identify the present problems and try to put forward solutions. METHODS: We systematically searched databases including Embase, PubMed, Cochrane Library, CBM, CNKI, VIP and Wanfang from inception to October 8, 2018, to identify eligible RCTs using TCM interventions for treating CHF patients caused by CHD. Cochrane Database of Systematic Reviews (CDSR) was searched to include Cochrane systematic reviews (CSRs) of CHF. Two authors independently assessed the risk of bias of the included RCTs according to the Cochrane Handbook. Outcome measures of each trial were extracted and analyzed those compared with the CSRs. We also evaluated the reporting quality of the outcome measures. RESULTS: A total of 31 RCTs were included and the methodology quality of the studies was generally low. Outcome measures in these RCTs were mortality, rehospitalization, efficacy of cardiac function, left ventricular ejection fraction (LVEF), 6 min' walk distance (6MWD) and Brain natriuretic peptide (BNP), of which mortality and rehospitalization are clinical end points while the others are surrogate outcomes. The reporting rate of mortality and rehospitalization was 12.90% (4/31), the other included studies reported surrogate outcomes. As safety measure, 54.84% of the studies reported adverse drug reactions. Two trials were evaluated as high in reporting quality of outcomes and that of the other 29 studies was poor due to lack of necessary information for reporting. CONCLUSIONS: The present RCTs of TCM in treating CHF secondary to CHD did not concentrate on the clinical end points of heart failure, which were generally small in size and short in duration. Moreover, these trials lacked adequate safety evaluation, had low quality in reporting outcomes and certain risk of bias in methodology. For objective assessment of the efficacy and safety of TCM in treating CHF secondary to CHD, future research should be rigorous designed, set end points as primary outcome measures and pay more attention to safety evaluation throughout the trial.

2.
J Integr Med ; 19(5): 389-394, 2021 09.
Artigo em Inglês | MEDLINE | ID: mdl-34384714

RESUMO

Clinical trial outcome reporting differs between studies integrating traditional Chinese medicine (TCM) and Western medicine, so that some clinical trials are not eligible for inclusion in a systematic review. The excluded studies are therefore less widely disseminated, and even valid studies are less likely to yield impact. This problem may be addressed by developing core outcome sets (COSs) for integrative medicine in specific healthcare areas. The first stage of development is to define the scope of the COS for integrative medicine, the second stage is to establish the need for such a COS, and the third stage is to develop a protocol and register the COS. The final stage involves three steps: (i) development of a comprehensive list of outcomes (including efficacy outcomes and safety outcomes and TCM syndromes) using systematic review, qualitative or cross-sectional research, and reviews of package inserts and medical records; (ii) merging and grouping of outcomes within domains; (iii) conducting two rounds of Delphi survey and consensus meetings with a range of stakeholders. The final COS will include a general COS and core TCM syndrome- set. Development of COSs for clinical trials of integrative medicine may help to standardize outcome reporting and reduce publication bias in the future.


Assuntos
Medicina Tradicional Chinesa , Projetos de Pesquisa , Estudos Transversais , Técnica Delfos , Determinação de Ponto Final , Resultado do Tratamento
3.
Front Med (Lausanne) ; 8: 677068, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34026800

RESUMO

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).

4.
Zhongguo Zhong Yao Za Zhi ; 46(6): 1498-1510, 2021 Mar.
Artigo em Chinês | MEDLINE | ID: mdl-33787149

RESUMO

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.


Assuntos
Medicamentos de Ervas Chinesas , Medicina , Intervenção Coronária Percutânea , Medicamentos de Ervas Chinesas/efeitos adversos , Humanos , Intervenção Coronária Percutânea/efeitos adversos , Qualidade de Vida , Volume Sistólico , Função Ventricular Esquerda
5.
J Evid Based Med ; 14(1): 65-74, 2021 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-33615709

RESUMO

It has been over 20 years since the introduction of evidence-based medicine (EBM) into the research of traditional Chinese medicine (TCM). The development of evidence-based TCM research has profoundly influenced the process of clinical research and decision-making, impelling researchers to pay attention to raise evidence quality, accumulate data, and explore appropriate evaluation methods adaptive to TCM original theories and knowledge. In this paper, the authors aim to summarize and review the existing work and seek promising research interests in this field, expecting to inspire more thoughts leading to breakthroughs in the near future.


Assuntos
Medicamentos de Ervas Chinesas , Medicina Tradicional Chinesa , Medicina Baseada em Evidências
6.
Antiviral Res ; 185: 104985, 2021 01.
Artigo em Inglês | MEDLINE | ID: mdl-33271272

RESUMO

APE1 is a multi-functional protein with a redox function in its N-terminal domain and an apurinic/apyrimidinic endonuclease activity in the C-terminal domain. APE1 redox function plays an important role in regulating cell proliferation and survival through activating specific transcriptional activators. APE1 redox function is also found to be associated with some cancer occurrence. In this study, we demonstrated that APE1 redox function is essential for Epstein-Barr virus (EBV) lytic replication as the silencing of APE1 expression or treatment with APE1 redox inhibitors C10 and E3330 can inhibit EBV lytic replication and virion production. Furthermore, C10 and E3330 also inhibit MHV-68 replication in vitro and in vivo. C10 and E3330 were able to significantly reduce the loss of pulmonary alveoli and thickening of alveolar septa in mice caused by MHV-68 infection. Altogether, (i) APE1 redox function is validated as a new antiviral target; (ii) APE1 redox inhibitors, especially C10, have potentials to be used for the treatment of γ-herpesvirus infection and associated diseases; (iii) MHV-68 is validated to be a surrogate for the study of the pathogenesis and therapy of EBV and KSHV infection in vivo.


Assuntos
DNA Liase (Sítios Apurínicos ou Apirimidínicos)/antagonistas & inibidores , Inibidores Enzimáticos/farmacologia , Inibidores Enzimáticos/uso terapêutico , Herpesviridae/efeitos dos fármacos , Replicação Viral/efeitos dos fármacos , Animais , Benzoquinonas/farmacologia , Benzoquinonas/uso terapêutico , Linhagem Celular Tumoral , Feminino , Células HEK293 , Herpesviridae/classificação , Herpesviridae/patogenicidade , Infecções por Herpesviridae/tratamento farmacológico , Infecções por Herpesviridae/virologia , Humanos , Pulmão/efeitos dos fármacos , Pulmão/virologia , Camundongos , Camundongos Endogâmicos BALB C , Células NIH 3T3 , Oxirredução , Propionatos/farmacologia , Propionatos/uso terapêutico
7.
Chin J Integr Med ; 27(1): 54-61, 2021 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-32445018

RESUMO

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.

8.
J Mater Chem B ; 9(2): 404-409, 2021 01 21.
Artigo em Inglês | MEDLINE | ID: mdl-33283827

RESUMO

Montmorillonite (MMT), as a naturally sourced and FDA-approved biomaterial, has attracted considerable attention due to its extensive application in biomedical areas, such as intestinal ailments, drug delivery, and additive manufacturing. In this work, two-dimensional montmorillonite (2D-MMT) ultrathin nanosheets were successfully prepared from sodium montmorillonite (Na-MMT) by utilizing a freeze-drying assisted method. Possessing a large specific surface area and increased number of exposed hydroxyl groups, 2D-MMT nanosheets exhibited better antibacterial ability than the original Na-MMT. More strikingly, we found that both 2D-MMT nanosheets and Na-MMT could generate reactive oxygen species (ROS) upon visible light illumination, which could promote their antibacterial efficiency. As a result, 2D-MMT nanosheets showed efficient antibacterial performance in the presence of light towards Escherichia coli with a simultaneous enhancement of surface adsorption and photodynamic ablation. What's more, a possible mechanism for ROS generation by MMT upon light illumination was first proposed in this work. The combination of the increased physical adsorption capacity and ROS generation ability of 2D-MMT nanosheets would help inspire the development of MMT as a promising antimicrobial candidate in the future.


Assuntos
Antibacterianos/metabolismo , Bentonita/química , Nanotecnologia/métodos , Fotoquimioterapia/métodos , Humanos , Espécies Reativas de Oxigênio
9.
Artigo em Inglês | MEDLINE | ID: mdl-33005202

RESUMO

Background: Non-ST segment elevation acute coronary syndrome has been one of the most serious diseases threatening human health. Long-term cardiac rehabilitation and secondary prevention is the essential method to control the recurrence and mortality of the disease. Traditional Chinese medicine has proved the efficiency on the treatment of non-ST segment elevation acute coronary syndrome, but there is a lack of appropriate methodological design to reflect the characteristics of individualized diagnosis and treatment of it. Therefore, this study used the evidenced-based Goal Attainment Scale to evaluate the clinical effectiveness of traditional Chinese medicine on the treatment of non-ST segment elevation acute coronary syndrome. Method: This is observational research with the prospective feature. A total of 200 patients will be recruited and observed in the three months by telephone or door visit, collecting the individualized intervention of traditional Chinese medicine and evaluating through the method of evidence-based Goal Attainment Scale. Participants will be included according to the inclusion and exclusion criteria. Any reasons for loss to follow-up and adverse events will be recorded strictly. Discussion. The evidence-based Goal Attainment Scale provides a personalized method of evaluation based on the Goal Attainment Scale and combined with evidence-based medicine, which can better reflect the characteristics and superiority of individualized and dynamic intervention for traditional Chinese medicine on the long-term prevention and treatment of non-ST segment elevation acute coronary syndrome than other methods of design. It is of great significance to explore and promote this method of design in the future.

10.
ESC Heart Fail ; 7(5): 3124-3133, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32567238

RESUMO

AIMS: We aim to assess the effect of a lyophilized herbal injection on 90 day mortality and readmission rates in patients with acute heart failure (AHF). METHODS AND RESULTS: The AUGUST-AHF study is a multicentre, randomized, double-blind, placebo-controlled trial enrolling 1270 hospitalized patients for AHF. Patients are randomized to receive YiqiFumai lyophilized injection (5.2 g/day) or placebo for 10 days, in addition to standard therapy, using a 1:1 ratio via an interactive web response system. The primary endpoint is the 90 day all-cause mortality or AHF readmission rates. Secondary endpoints include 180 day all-cause mortality or heart failure readmission rates, length of hospital stay for the indexed AHF, 90 day cardiac-specific mortality rate, occurrence of worsening heart failure through Day 10, changes in the Minnesota Living with Heart Failure Quality of Life scale score through Day 180, and 90 day major adverse cardiac events. Additional secondary endpoints include change in dyspnoea via visual analogue scale (VAS) and Likert 7-point comparator scale, N terminal pro-B-type natriuretic peptide value and New York Heart Association functional class, and the total amount of diuretics for the indexed AHF hospitalization. Study recruitment is expected to be completed by March 2021, and follow-up will end in September 2021. In an optional sub-study, patients will be followed up for 3 years. CONCLUSIONS: To our best knowledge, AUGUST-AHF is the first study assessing the efficacy of a Chinese herbal injection in patients with AHF. The results will be valuable to guide clinicians in using YiqiFumai lyophilized injection, which was included in the latest Chinese Health Insurance Catalog.


Assuntos
Insuficiência Cardíaca , Qualidade de Vida , Doença Aguda , Diuréticos , Insuficiência Cardíaca/tratamento farmacológico , Humanos , Resultado do Tratamento
11.
Front Pharmacol ; 11: 781, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32574235

RESUMO

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.

12.
Artigo em Inglês | MEDLINE | ID: mdl-32508947

RESUMO

Introduction: TCMI with the effect of Liqihuoxue and Yiqihuoxue has been applied as complementary therapies during the perioperative period of PCI for patients with ACS, while the recommended time points and plans of TCMI are still short of the support of evidence-based medicine. Methods: A systematic review and meta-analysis was conducted to evaluate the clinical efficacy and safety of TCMI on patients with ACS during the perioperative period of PCI. RCTs were searched based on standardized searching rules in seven medical databases from the inception up to August 2019. Two reviewers conducted the study selection, data extraction, and quality analysis independently. Data were analysed with the support of software RevMan and Stata. Results: A total of 68 articles with 6,043 patients were enrolled. The result of meta-analysis showed that the TCMI combined with western medicine was superior to the western medicine alone on clinical efficiency (before the PCI, before and after the PCI, or overall, P < 0.05), the occurrence of MACE (myocardial infarction and stenocardia: before the PCI, before and after the PCI, or overall, P < 0.05; arrhythmia: before and after the PCI, P < 0.05), and the level of inflammatory factors (hs-CRP: before the PCI, before and after the PCI, or overall, P < 0.05; IL-6: after the PCI, P < 0.05). The TCMI with the effect of Liqihuoxue obtained more support compared with Yiqihuoxue based on the result of meta-analysis. Conclusions: TCMI with the effect of Liqihuoxue or Yiqihuoxue combined with western medicine generally showed the potential advantage on the treatment of ACS during the perioperative period of PCI. However, the optimal time point of intervention and recommended plan based on the effect still needs more clinical evidence. We consider that the research of precise and standardized application of TCMI will be a promising direction for TCM in the future.

13.
J Biol Chem ; 295(21): 7431-7441, 2020 05 22.
Artigo em Inglês | MEDLINE | ID: mdl-32312752

RESUMO

Lytic replication of Epstein-Barr virus (EBV) is not only essential for its cell-to-cell spread and host-to-host transmission, but it also contributes to EBV-induced oncogenesis. Thus, blocking EBV lytic replication could be a strategy for managing EBV-associated diseases. Previously, we identified a series of natural lignans isolated from the roots of Saururus chinensis (Asian lizard's tail) that efficiently block EBV lytic replication and virion production with low cytotoxicity. In this study, we attempted to elucidate the molecular mechanism by which these lignans inhibit EBV lytic replication. We found that a representative compound, CSC27 (manassantin B), inhibits EBV lytic replication by suppressing the expression of EBV immediate-early gene BZLF1 via disruption of AP-1 signal transduction. Further analysis revealed that manassantin B specifically blocks the mammalian target of rapamycin complex 2 (mTORC2)-mediated phosphorylation of AKT Ser/Thr protein kinase at Ser-473 and protein kinase Cα (PKCα) at Ser-657. Using phosphoinositide 3-kinase-AKT-specific inhibitors for kinase mapping and shRNA-mediated gene silencing, we validated that manassantin B abrogates EBV lytic replication by inhibiting mTORC2 activity and thereby blocking the mTORC2-PKC/AKT-signaling pathway. These results suggest that mTORC2 may have utility as an antiviral drug target against EBV infections and also reveal that manassantin B has potential therapeutic value for managing cancers that depend on mTORC2 signaling for survival.


Assuntos
Furanos/farmacologia , Herpesvirus Humano 4/fisiologia , Alvo Mecanístico do Complexo 2 de Rapamicina/metabolismo , Transdução de Sinais/efeitos dos fármacos , Serina-Treonina Quinases TOR/antagonistas & inibidores , Ativação Viral/efeitos dos fármacos , Linhagem Celular Tumoral , Humanos , Proteína Quinase C/metabolismo , Proteínas Proto-Oncogênicas c-akt/metabolismo , Serina-Treonina Quinases TOR/metabolismo , Transativadores/metabolismo , Fator de Transcrição AP-1/metabolismo
14.
Biomed Pharmacother ; 125: 109992, 2020 May.
Artigo em Inglês | MEDLINE | ID: mdl-32084700

RESUMO

Oxidative stress is recognized as a common pathology that affects up to half of all men infertile. Fucoxanthin possesses antioxidant activity, and several investigators have reported anti-inflammatory action. This study extracted powder of Sargassum glaucescens by acetone to obtained fucoxanthin rich-brown algae extract (FXE). The objective of this study was to evaluate the ameliorative effects of fucoxanthin extract from Sargassum glaucescens on lipopolysaccharide-induced inflammation in RAW264.7 macrophage cells and its protective effects of against Cisplatin (CP)-induced reproductive damage in hamsters. Eighty male Syrian hamsters were injected with and without CP, then daily oral gavage with various concentrations of fucoxanthin for 5 days. Treatment with FXE reduced the level of reactive oxygen species and malondialdehyde in RAW 264.7 cells and the rats' testis as well as protective effects on mitochondrial membrane potential. The FXE administration also improved testosterone level and alpha-glucosidase activity. The sperm count also increased after treated with FXE, whereas sperm abnormality was reduced. Histopathological analysis showed that FXE successfully improved the seminiferous tubules morphology. According to these findings, fucoxanthin extract from Sargassum glaucescens can be used as an alternative for the treatment of testicular damage.


Assuntos
Produtos Biológicos/administração & dosagem , Cisplatino/farmacologia , Suplementos Nutricionais , Feófitas/química , Testículo/efeitos dos fármacos , Testículo/metabolismo , Xantofilas/administração & dosagem , Animais , Antioxidantes/administração & dosagem , Produtos Biológicos/isolamento & purificação , Biomarcadores , Sobrevivência Celular/efeitos dos fármacos , Células Cultivadas , Cricetinae , Masculino , Potencial da Membrana Mitocondrial/efeitos dos fármacos , Camundongos , Estresse Oxidativo/efeitos dos fármacos , Substâncias Protetoras/administração & dosagem , Células RAW 264.7 , Espécies Reativas de Oxigênio/metabolismo , Túbulos Seminíferos/metabolismo , Xantofilas/isolamento & purificação
15.
Trials ; 21(1): 48, 2020 Jan 08.
Artigo em Inglês | MEDLINE | ID: mdl-31915046

RESUMO

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.


Assuntos
Medicamentos de Ervas Chinesas/administração & dosagem , Intervenção Coronária Percutânea , Infarto do Miocárdio com Supradesnível do Segmento ST/terapia , Tempo para o Tratamento , Adolescente , Adulto , Idoso , Circulação Coronária/efeitos dos fármacos , Medicamentos de Ervas Chinesas/efeitos adversos , Eletrocardiografia , Feminino , Humanos , Masculino , Microcirculação/efeitos dos fármacos , Pessoa de Meia-Idade , Estudos Multicêntricos como Assunto , Período Pós-Operatório , Período Pré-Operatório , Estudos Prospectivos , Ensaios Clínicos Controlados Aleatórios como Assunto , Infarto do Miocárdio com Supradesnível do Segmento ST/diagnóstico , Fatores de Tempo , Resultado do Tratamento , Adulto Jovem
16.
Chin J Integr Med ; 26(3): 227-234, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-31093877

RESUMO

OBJECTIVE: To systematic review the effect of Chinese medicine (CM) on no or slow reflow after percutaneous coronary intervention (PCI) in myocardial infarction (MI) patients. METHODS: The PubMed, EMBASE databases, Cochrane Central Register of Controlled Trials (CENTRAL), Web of Science, China National Knowledge Infrastructure (CNKI), Chinese BioMedical Literature Database (CBM), Wanfang Knowledge Service Platform (Wanfang Database) and Chinese Scientific Journal Database (VIP) were searched up to December 2017. Randomized controlled trials (RCTs) which evaluated the effect of CM therapies on no or slow reflow after PCI in MI patients were included. The primary outcome was the effect of reperfusion. Secondary outcomes were left ventricular ejection fraction, incidence of major adverse cardiovascular events and adverse effect. RESULTS: Ten RCTs covering 814 patients were included. Two studies revealed that the incidence of no or slow reflow was less in Shenmai Injection () group than in the control group measured by thrombolysis in myocardial infarction (TIMI) ⩽ 2 (risk ratio=0.55, 95% confidence interval 0.38 to 0.81, P=0.003, I2=37%). Two studies indicated that Salvianolate Injection showed no additional benefit on no or slow reflow measured by corrected TIMI frame count compared with the conventional treatment (mean difference -4.24, 95% confidence interval -13.03 to 4.54, P=0.34, I2=86%). In addition, Tongxinluo Capsules (), Danhong Injection () and Xuesaitong Injection () may have the potential to reduce no or slow reflow measured during or after PCI in individual studies. CONCLUSIONS: Current evidence from RCTs are not sufficient to evaluate the effect of CM adjuvant therapies on no or slow reflow after PCI for MI patients. The included studies are limited by small sample size and unclear baseline conditions. Further rigorously designed researches and verification studies with sufficient number of patients are warranted.


Assuntos
Medicina Tradicional Chinesa , Infarto do Miocárdio/terapia , Fenômeno de não Refluxo/tratamento farmacológico , Intervenção Coronária Percutânea , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Volume Sistólico/efeitos dos fármacos
17.
BMJ Open ; 9(12): e032256, 2019 12 03.
Artigo em Inglês | MEDLINE | ID: mdl-31796484

RESUMO

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).


Assuntos
Ensaios Clínicos como Assunto/métodos , Determinação de Ponto Final/normas , Medicina Tradicional Chinesa/métodos , Infarto do Miocárdio/tratamento farmacológico , Ensaios Clínicos como Assunto/normas , Consenso , Humanos , Entrevistas como Assunto , Medicina Tradicional Chinesa/normas , Infarto do Miocárdio/fisiopatologia , Projetos de Pesquisa , Revisões Sistemáticas como Assunto , Resultado do Tratamento
18.
Complement Ther Med ; 46: 180-188, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31519276

RESUMO

BACKGROUND: N-of-1 trial is a desired and appropriate approach to assessing the efficacy and safety of traditional Chinese medicine (TCM) interventions. There have been an increasing number of N-of-1 trials for TCM published. However, a lack of preferred reporting guidance led in the general poor reporting quality of these trials. Due to the unique characteristics of TCM, the working group developed this CONSORT Extension for reporting N-of-1 Trials for Traditional Chinese Medicine (CENT for TCM) to assist TCM researchers in reporting N-of-1 trials for TCM. METHODS: We registered CENT for TCM at the EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network (available at equator-network.org). The development was a comprehensive process through collection of the initial reporting items, two-round scientific Delphi consensus survey with 17 panelists, revision and formation of the final reporting checklist. RESULTS: The checklist includes 25 items within six domains, eight items in which were extended and elaborated on the items of the CENT 2015 checklist. Explanation of the items were listed adequately considering the nature of TCM, introducing the concept of TCM syndrome differentiation and TCM interventions. CONCLUSIONS: CENT for TCM can be used to assess the completeness of the reporting of N-of-1 trials for TCM. The working group expect that CENT for TCM could be a practical tool to enhance the comprehensiveness and transparency of the design, implementation and reporting of N-of-1 trials for TCM.


Assuntos
Ensaios Clínicos como Assunto/normas , Medicina Tradicional Chinesa/normas , Relatório de Pesquisa/normas , Lista de Checagem/normas , Humanos , Projetos de Pesquisa/normas
19.
BMJ Open ; 9(8): e028803, 2019 08 30.
Artigo em Inglês | MEDLINE | ID: mdl-31471437

RESUMO

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.


Assuntos
Antiarrítmicos/uso terapêutico , Anticoagulantes/uso terapêutico , Fibrilação Atrial/tratamento farmacológico , Ecocardiografia , Determinação de Ponto Final/estatística & dados numéricos , Avaliação de Resultados em Cuidados de Saúde/estatística & dados numéricos , Fibrilação Atrial/complicações , Pressão Sanguínea , Isquemia Encefálica/etiologia , Frequência Cardíaca , Humanos , Medicina Tradicional Chinesa , Estudos Observacionais como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto , Recidiva , Acidente Vascular Cerebral/etiologia
20.
PeerJ ; 7: e7001, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31179188

RESUMO

Tree peony is a perennial deciduous shrub with great ornamental and medicinal value. A limitation of its current functional genomic research is the lack of effective molecular genetic tools. Here, the first application of a Tobacco rattle virus (TRV)-based virus-induced gene silencing (VIGS) in the tree peony species Paeonia ostii is presented. Two different approaches, leaf syringe-infiltration and seedling vacuum-infiltration, were utilized for Agrobacterium-mediated inoculation. The vacuum-infiltration was shown to result in a more complete Agrobacterium penetration than syringe-infiltration, and thereby determined as an appropriate inoculation method. The silencing of reporter gene PoPDS encoding phytoene desaturase was achieved in TRV-PoPDS-infected triennial tree peony plantlets, with a typical photobleaching phenotype shown in uppermost newly-sprouted leaves. The endogenous PoPDS transcripts were remarkably down-regulated in VIGS photobleached leaves. Moreover, the green fluorescent protein (GFP) fluorescence was detected in leaves and roots of plants inoculated with TRV-GFP, suggesting the capability of TRV to silence genes in various tissues. Taken together, the data demonstrated that the TRV-based VIGS technique could be adapted for high-throughput functional characterization of genes in tree peony.

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