RESUMO
This study aimed to systematically evaluate the effectiveness and safety of Tanreqing Injection in the treatment of severe pneumonia in the elderly. Eighteen randomized controlled trials(RCTs) involving 1 457 elderly patients with severe pneumonia were included in the study after conducting searches in both Chinese and English databases as well as clinical trial registration platforms. The quality of the included studies was assessed using the Cochrane risk of bias assessment tool. Meta-analysis were conducted using RevMan 5.4 and Stata 17 software, and trial sequential analysis(TSA) was performed using TSA 0.9.5.10 beta software. Meta-analysis results showed that compared with conventional western medicine treatment, Tanreqing Injection + conventional western medical significantly improved the clinical effectiveness in elderly patients with severe pneumonia(RR=1.26, 95%CI[1.20, 1.32], P<0.000 01), arterial oxygen partial pressure(SMD=6.23, 95%CI[3.29, 9.18], P<0.000 1), oxygenation index(SMD=11.72, 95%CI[4.41, 19.04], P=0.002), reduce procalcitonin(SMD=-6.16, 95%CI[-8.10,-4.21], P<0.000 01), C-reactive protein(SMD=-8.50, 95%CI[-11.05,-5.96], P<0.000 01), white blood cell count(SMD=-4.56, 95%CI[-5.73,-3.39], P<0.000 01), and shortened the duration of fever(SMD=-3.12, 95%CI[-4.61,-1.63], P<0.000 1), cough(SMD=-4.84, 95%CI[-6.90,-2.79], P<0.000 01), lung rales(SMD=-0.99, 95%CI[-1.54,-0.44], P=0.000 4), and mechanical ventilation time(SMD=-3.26, 95%CI[-5.03,-1.50], P=0.000 3), increase CD4~+ T-cell levels(SMD=6.73, 95%CI[5.23, 8.23], P<0.000 01) and CD8~+ T-cell levels(SMD=7.47, 95% CI[5.32, 9.61], P<0.000 01) with no significant adverse reactions. TSA confirmed the stability and reliability of the results related to clinical effectiveness. This study suggests that Tanreqing Injection, as a Chinese medicinal preparation, has a significant therapeutic effect and good safety profile in the treatment of severe pneumonia in elderly patients. Due to the limited quality of the included studies, high-quality RCT is still needed to provide evidence support for the above conclusions.
Assuntos
Medicamentos de Ervas Chinesas , Pneumonia , Idoso , Humanos , Tosse/induzido quimicamente , Medicamentos de Ervas Chinesas/efeitos adversos , Pneumonia/tratamento farmacológico , Reprodutibilidade dos Testes , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
BACKGROUND: Stable angina pectoris (SAP) is a clinical condition characterized by reversible and temporary myocardial ischemia and hypoxia. A majority of SAP patients also experience depressive disorders, which adversely affect their disease prognosis and overall quality of life. However, the clinical utility of existing antidepressants is constrained by their side effects. Ginkgo biloba dropping pill (GBDP), a Chinese patented medication, has demonstrated efficacy in the treatment of both coronary heart disease and mental disorders. This prospective, randomized, double-blind, multicenter clinical trial aimed to assess the effectiveness and safety of GBDP as an adjuvant therapy for SAP complicated by depression. METHODS: Participants were randomly assigned in a 1:1 ratio to receive either GBDP or a placebo (5 pills, three times a day) in addition to standard therapy for a duration of 12 weeks. The Seattle Angina Questionnaire (SAQ) was administered every 4 weeks during the treatment, and angina event frequency was assessed weekly. The 36-item Short-Form (SF-36) and Hamilton Depression Scale (HAMD) scores were measured both before and after the treatment. RESULTS: Out of the 72 patients, 68 (n = 34 per group) completed the entire study. At the first visit (4 weeks ± 3 days), the SAQ-Angina Stability score in the GBDP group was significantly higher than that in the placebo group (p < 0.05). While the average weekly frequency of angina episodes in the placebo group notably increased after 12 weeks of treatment (p < 0.05), it displayed an improving trend in the GBDP group (p > 0.05). By the endpoint, each subcategory score of SF-36 in the GBDP group exhibited significant improvement compared to baseline (p < 0.05). The comparison of score improvement between the two groups revealed that the SF-PCS score of the GBDP group was higher than that of the placebo group (p < 0.05). HAMD scores in both groups significantly increased after treatment (p < 0.05). No discernible difference in the incidence of adverse reactions was observed between the two groups (p > 0.05). CONCLUSION: In patients with SAP complicated by depression, GBDP, when combined with standard treatment, rapidly and safely alleviates angina pectoris symptoms. It demonstrates therapeutic potential in enhancing the quality of life and alleviating depressive symptoms.
Assuntos
Angina Estável , Humanos , Angina Estável/tratamento farmacológico , Ginkgo biloba , Qualidade de Vida , Estudos Prospectivos , Depressão , Método Duplo-Cego , Extratos Vegetais/efeitos adversos , Resultado do TratamentoRESUMO
BACKGROUND: Coronary heart disease(CHD) with stable angina pectoris is a common cardiovascular disease. It has been reported that 10%-81.4% of these patients suffer from psychological conditions,such as depression, which has been associated with more frequent angina, lower treatment satisfaction and lower perceived quality of life. Ginkgo biloba extract (GBE), the raw material of Ginkgo biloba dropping pills (GBDPs), is widely used to treat various conditions, including cardiovascular disease, ischaemic cerebrovascular disease, and depression. This clinical trial aimed to examine the efficacy and safety of GBDPs in improving the frequency of angina pectoris and the life quality of patients with stable angina pectoris and depression symptoms. METHODS: This randomised, double-blind, placebo-controlled, parallel-group and multicentre clinical trial will be conducted in four medical centres in China. We aim to recruit approximately 72 participants aged 18-75 years with depression and coronary heart disease with stable angina pectoris. Based on conventional drug treatment, participants will be randomly assignedto the treatment group (GBDPs group; n=36) or the control group (placebo group; n=36) at a 1:1 allocation ratio. After randomisation,follow-up will be done at 4 weeks, 8 weeks and 12 weeks (±3 days). Additionally, 30 healthy individuals will be enrolled to investigate the underlying pharmacological mechanisms of the effects of GBE. The primary outcomes will be the Seattle Angina Questionnaire score and the frequency of angina pectoris-related symptoms each week. The secondary outcomes will include the 36-item Short Form Health Survey quality-of-life scale, Hamilton Depression Scale and composite endpoint incidence of major adverse cardiovascular events. ETHICS AND DISSEMINATION: This trial has been approved by the Research Ethics Committee of the First Affiliated Hospital of Guangzhou University of Chinese Medicine, China (approval number: ZYYECK [2020]030). Written informed consent will be obtained from all participants. The results of this trial will be publicly shared through academic conferences and peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT04529148 and ChiCTR2200066908.
Assuntos
Angina Estável , Doença das Coronárias , Medicamentos de Ervas Chinesas , Humanos , Angina Estável/tratamento farmacológico , Ginkgo biloba , Medicamentos de Ervas Chinesas/farmacologia , Grupos Controle , Depressão/tratamento farmacológico , Qualidade de Vida , Resultado do Tratamento , Método Duplo-Cego , Doença das Coronárias/complicações , Doença das Coronárias/tratamento farmacológico , Ensaios Clínicos Controlados Aleatórios como Assunto , Estudos Multicêntricos como AssuntoRESUMO
BACKGROUND: Xinyin Tablet (XYT) has been widely used in the treatment of CHF, Which helping to improve the clinical symptoms, enhance exercise, and even may improve the long-term prognosis of patients. However, the exact effectiveness and safety of XYT for CHF has not be comprehensively researched, so we want to generalize the effectiveness and safety of XYT for CHF through the meta-analysis, which may benefit the design of future clinical trials and provide valuable references. METHODS: This protocol complies with the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols. From the inception until September 2020, a systematic and comprehensive electronic search about Relevant randomized controlled trials will be conducted in 4 English literature databases and 4 Chinese literature databases. The registration number: INPLASY2020100015. 2 investigators will be arranged to deal with the study selection and data extraction independently. The New York Heart Function Classification, traditional Chinese medicine (TCM) symptom scores, the scores of quality of life, 6-min walk distance (6MWD), etc. will be systematically measured as outcomes. At last, the data will be handled by Review Manager 5.3 and Stata 15.0. RESULTS AND CONCLUSION: This study is hoping to provide a high-level evidence to prove the therapeutic effect of XYT on CHF, which may enhance the application of Chinese medicine.
Assuntos
Protocolos Clínicos , Insuficiência Cardíaca/tratamento farmacológico , Medicina Tradicional Chinesa/normas , Insuficiência Cardíaca/fisiopatologia , Humanos , Medicina Tradicional Chinesa/métodos , Medicina Tradicional Chinesa/tendências , Metanálise como Assunto , Peptídeo Natriurético Encefálico/análise , Qualidade de Vida/psicologia , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Revisões Sistemáticas como Assunto , Ultrassonografia/métodosRESUMO
INTRODUCTION: Unstable angina (UA), referred to as acute coronary syndrome (ACS), causes unexpected chest pain. Xueshuantong injection (lyophilised) (XST) is a traditional Chinese herbal injection having the potential to treat ACS. However, no clinical trial has been performed in this field. This clinical trial aims to examine the efficacy and safety of XST. METHODS AND ANALYSIS: This is a randomised, parallel-arm, controlled, double-blind and multicentre clinical trial. A total of 1200 participants with UA will be enrolled in a 1:1 ratio, with 600 patients included in the XST treatment group and 600 with 1/20th dose in the control group. The efficacy assessment and major adverse cardiovascular events will be observed, and the frequency of angina attack, angina pectoris will be examined at the start and end of the run-in period. All adverse events will be recorded, regardless of the severity, to assess the safety of XST. The baseline characteristics of patients will be summarised and compared using the t test or non-parametric statistical test. Qualitative data will be analysed using the χ2 or Fisher exact tests, Cochran-Mantel-Hasenszel test and Wilcoxon test. ETHICS AND DISSEMINATION: This trial has been approved by the Research Ethics Committee of The First Affiliated Hospital of Guangzhou University of Chinese Medicine, China (approval number: ZYYEC [2017] 0021). Written informed consent will be obtained from all participants. The results of this trial will be disseminated to the public through academic conferences and peer-reviewed journals. TRIAL REGISTRATION: This study was registered on the Chinese Clinical Trial Registry (http://www.chictr.org.cn/) with the ID ChiCTR1800015911.
Assuntos
Angina Instável , Inibidores da Agregação Plaquetária , Angina Instável/tratamento farmacológico , Angina Instável/epidemiologia , China/epidemiologia , Método Duplo-Cego , Medicamentos de Ervas Chinesas , Humanos , Incidência , Estudos Multicêntricos como Assunto , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
Luteolin, a natural flavonoid exists in various medicinal plants, has strong anti-inflammatory effect. However, anti-inflammatory mechanism of luteolin has not been fully explored. Hence, we systematically investigated druggability and anti-inflammatory mechanism of luteolin based on network pharmacology and in vitro experiments. The absorption, distribution, metabolism and excretion of luteolin were evaluated by TCMSP server. Targets associated with luteolin and inflammation were collected from public databases, and the overlapping targets between luteolin and inflammation were analyzed by Draw Venn diagram. Then the protein-protein interaction network of luteolin against inflammation was constructed. Further, gene function and pathway enrichment analysis were performed. Finally, in vitro experiments were carried out to estimate the accuracy of predicted target genes. ADME results indicated that luteolin has great potential to be developed into a drug. 226 overlapping targets were screened by matching 280 targets of luteolin with 9015 targets of inflammation. 9 core targets of luteolin against inflammation were identified, including MMP9, MAPK1, HSP90AA1, CASP3, ALB, EGFR, SRC, HRAS and ESR1. Gene function were mainly involved in metabolism, energy pathways and signal transduction. Metabolic pathways, pathways in cancer, PI3K-AKT signaling pathway, Ras signaling pathway and so on might be the critical pathways of luteolin against inflammation. RT-qPCR and ELISA results indicated that luteolin decreased the expression of most of core genes at protein and mRNA levels (MMP9, MAPK1, HSP90AA1, EGFR, SRC and HRAS). Luteolin is expounded to have great potential to be developed into a drug and target various genes and pathways to perform anti-inflammatory effect.
Assuntos
Anti-Inflamatórios/farmacologia , Luteolina/farmacologia , Proteoma/efeitos dos fármacos , Transcriptoma/efeitos dos fármacos , Animais , Anti-Inflamatórios/farmacocinética , Anti-Inflamatórios/uso terapêutico , Caspase 3/metabolismo , Biologia Computacional , Bases de Dados Genéticas , Bases de Dados de Produtos Farmacêuticos , Receptores ErbB/metabolismo , Receptor alfa de Estrogênio/metabolismo , Proteínas de Choque Térmico HSP90/metabolismo , Inflamação/tratamento farmacológico , Inflamação/genética , Luteolina/farmacocinética , Luteolina/uso terapêutico , Metaloproteinase 9 da Matriz/metabolismo , Camundongos , Proteína Quinase 1 Ativada por Mitógeno/metabolismo , Mapas de Interação de Proteínas , Proteínas Proto-Oncogênicas p21(ras)/metabolismo , Proteínas Proto-Oncogênicas pp60(c-src)/metabolismo , Células RAW 264.7 , Albumina Sérica/metabolismo , Transdução de Sinais/efeitos dos fármacosRESUMO
BACKGROUND: Chronic obstructive pulmonary disease (COPD) has the characteristics of high incidence, mortality, disability rate, and heavy economic burden. Symptomatic measures such as anti-inflammatory, antispasmodic and anti-asthmatic are widely used in the treatment of COPD, and pulmonary rehabilitation has not been fully utilized. It is reported that up to 10 different kinds of Traditional Chinese exercises (TCEs) are often used for treating stable COPD. There are many randomized controlled trials (RCTs) and systematic reviews that have evaluated the efficacy of various TCEs for COPD. However, most of these studies were designed in comparison with conventional western medicine or health education. There are rarely studies to compare different TCEs head to head. Therefore, there remains uncertainty regarding the comparative efficacy among different TCEs. Thus, we plan to conduct a systematic review and Network meta-analysis (NMA) to compare the efficacy among 5 different TCEs and rank their benefits relative to each other. It is hoped that the findings of this study will facilitate the management and application of TCEs in the treatment of COPD. METHODS: A systematic and comprehensive literature search will be performed from inception to April 2019 in both English and Chinese databases, involving Medline, Cochrane Library, Embase, China National Knowledge Infrastructure Database, Wanfang Database, China Biomedical Literature Database, and Chongqing VIP information. RCTs related to TCE in the treatment of COPD will be included. Quality of included trials will be assessed according to the risk of bias tool of Cochrane Handbook 5.1.0. The GRADE approach will be used to rate the certainty of the evidence of estimates derived from NMA. Data analysis will be conducted by using STATA 14.0. RESULTS: This systematic review and NMA aims to summarize the direct and indirect evidence for different kinds of TCEs and to rank these TCEs. The findings of this NMA will be reported according to the PRISMA-NMA statement. The results of the NMA will be submitted to a peer-reviewed journal once completed. CONCLUSION: Using NMA, this study will provide an evidence profile which will be helpful to inform the selection of TCE for treating patients with COPD. The results will inform clinicians, bridge the evidence gaps, and identify promising TCE for future trials. PROSPERO REGISTRATION NUMBER: PROSPERO CRD 42019132970.
Assuntos
Terapia por Exercício , Medicina Tradicional Chinesa , Doença Pulmonar Obstrutiva Crônica/reabilitação , China , Humanos , Metanálise como AssuntoRESUMO
BACKGROUND: Chinese medicine injections (CMIs) are extensively applied to the therapy of acute exacerbation of chronic obstructive pulmonary disease (AECOPD) in mainland China. Up to 13 different kinds of CMIs are reportedly often used for treating chronic obstructive pulmonary disease, yet, rarely head to head comparison of tests are used to decide the relative consequent among the distinct CMIs. Network meta-analysis (NMA) will be performed to further compare the effects of 13 different CMI, including direct and indirect comparisons of different CMI. METHODS: From now until April 2019, a systematic and comprehensive literature search will be conducted in both English and Chinese databases, including Medline, Embase, Cochrane library, Chongqing VIP information, Wanfang Database, China national knowledge infrastructure database, and Sino Med. Randomized controlled trials will be included related to CMI therapy for AECOPD. We will assess the quality of the included trials in accordance with the risk of bias tools in Cochrane manual 5.1.0. We will use the grading of recommendations assessment development, and evaluation method to assess the certainty of the estimated evidence from the NMA. STATA 14.0 will be used for data analysis. RESULTS: The purpose of this systematic evaluation and NMA was to summarize and rank the direct and indirect evidence for 8 different types of CMI. The NMA's findings will be reported in accordance with preferred reporting items for systematic reviews and meta analyses-NMA statement. Upon completion, NMA results will be submitted to a peer-reviewed journal. CONCLUSION: With NMA, this study will provide evidence for the selection of CMI for patients with AECOPD. The results will provide information to clinicians, bridge the evidence gap and identify promising CMI targets for future trials. PROSPERO REGISTRATION NUMBER: PROSPERO CRD 42019132955.
Assuntos
Medicamentos de Ervas Chinesas/uso terapêutico , Metanálise em Rede , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Revisões Sistemáticas como Assunto , Humanos , Injeções , Projetos de PesquisaRESUMO
The randomized controlled trials( RCTs) about modified Sanzi Yangqin Decoction in the treatment of patients with exacerbation of chronic obstructive pulmonary disease( AECOPD) were collected from 7 databases( PubMed,CNKI,etc.) till December25,2018 from their inception. All the studies searched were strictly evaluated and independently screened by two researchers according to the inclusion and exclusion criteria,and the methodological quality of included studies was evaluated. In order to systematically review the efficacy and safety of modified Sanzi Yangqin Decoction for treating AECOPD,the Meta-analysis and trial sequential analysis were conducted by using Stata/SE 14. 0 and TSA 0. 9. 5. 10 Beta,respectively. A total of 22 RCTs involving 2 012 patients were included. The results of Meta-analysis suggested that: as compared with the control group,the clinical symptoms in AECOPD patients were improved( RR = 1. 19,95%CI[1. 15,1. 24],P = 0); the pulmonary functions including forced expiratory volume in one second( FEV_1)( SMD= 0. 96,95%CI[0. 39,1. 52],P= 0. 001),the percentage of forced expiratory volume in one second( FEV_1%)( SMD =0. 80,95%CI[0. 20,1. 41],P = 0. 009),forced vital capacity( FVC)( SMD = 0. 69,95% CI[0. 06,1. 31],P = 0. 032),first seconds breathing volume percentage of forced vital capacity( FEV_1/FVC) were improved( SMD = 0. 81,95%CI[0. 64,0. 97],P = 0);the arterial oxygen partial pressure( PaO_2) was improved( SMD= 0. 87,95%CI[0. 41,1. 32],P= 0); the arterial partial pressure of carbon dioxide( PaCO_2) was decreased( SMD =-0. 91,95%CI[-1. 33,-0. 49],P = 0) in the trial group. In addition,the incidence of adverse reactions in the experimental group was low,and there were no serious adverse events. The trial sequential analysis( TSA) showed that the studies included in the improvement of clinical efficacy had passed the conventional and TSA threshold at the same time,further confirming the efficacy of trial group. This research showed that,conventional Western medicine treatment,combined with modified Sanzi Yangqin Decoction in treating acute exacerbation patients with chronic obstructive pulmonary disease could improve the clinical efficiency and pulmonary functions,improve the PaO_2,decrease the PaCO_2,with a high safety. However,the quality of existing research is low,requiring more high quality clinical trials for further validation.