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1.
BMC Pregnancy Childbirth ; 20(1): 580, 2020 Oct 02.
Artigo em Inglês | MEDLINE | ID: mdl-33008308

RESUMO

BACKGROUND: During the ongoing global outbreak of COVID-19, pregnant women who are susceptible to COVID-19 should be highly concerned. The issue of vertical transmission and the possibility of neonatal infection is a major concern. CASE PRESENTATION: Case 1: A 35-year-old pregnant woman with a gestational age of 37 weeks and 6 days was admitted to our hospital at the point of giving birth. Except for the abnormalities in her chest CT image, she was asymptomatic. She had an uncomplicated spontaneous vaginal delivery, and her infant was discharged home for isolation. Because of the positive result of the maternal swabs for SARS-CoV-2 obtained on the 2nd day after sampling, we transferred the mother to the designated hospital and followed up with her by telephone interviews. Luckily, it was confirmed on February 23 that the newborn did not develop any COVID-19 symptoms after observation for 14 days after birth. Case 2: Another pregnant woman, with a gestational age of 38 weeks and 2 days, was also admitted to our hospital because of spontaneous labor with cervical dilation of 5 cm. Since she had the typical manifestations of COVID-19, including cough, lymphopenia, and abnormal chest CT images, she was highly suspected of having COVID-19. Based on the experience from case 1, we helped the mother deliver a healthy baby by vaginal delivery. On the 2nd day after delivery, the maternal nasopharyngeal swab result was positive, while the infant's result was negative. CONCLUSION: There is still insufficient evidence supporting maternal-fetal vertical transmission for COVID-19-infected mothers in late pregnancy, and vaginal delivery may not increase the possibility of neonatal infection.


Assuntos
Infecções Assintomáticas , Infecções por Coronavirus/diagnóstico , Parto Obstétrico/métodos , Pulmão/diagnóstico por imagem , Pneumonia Viral/diagnóstico , Complicações Infecciosas na Gravidez/diagnóstico , Adulto , Antibacterianos/uso terapêutico , Antivirais/uso terapêutico , Betacoronavirus , Aleitamento Materno , Técnicas de Laboratório Clínico , Infecções por Coronavirus/terapia , Tosse , Medicamentos de Ervas Chinesas/uso terapêutico , Feminino , Idade Gestacional , Humanos , Linfopenia , Máscaras , Oxigenoterapia , Pandemias , Isolamento de Pacientes , Equipamento de Proteção Individual , Pneumonia Viral/terapia , Reação em Cadeia da Polimerase , Gravidez , Complicações Infecciosas na Gravidez/terapia , Testes Sorológicos , Tomografia Computadorizada por Raios X
2.
Trials ; 21(1): 827, 2020 Oct 02.
Artigo em Inglês | MEDLINE | ID: mdl-33008479

RESUMO

OBJECTIVES: We aimed to test our hypothesis that additional administration of traditional Japanese (Kampo) medicine, kakkonto (kakkon-to: KT) and shosaikotokakikyosekko (sho-saiko-to-ka-kikyo-sekko: SSKKS), is more effective in relieving symptoms and preventing the onset of severe infection in mild-to-moderate COVID-19 patients compared to those treated only with conventional treatment. TRIAL DESIGN: The study is designed as a multi-center, interventional, parallel-group, randomized (1:1 ratio), investigator-sponsored, two-arm study. PARTICIPANTS: Patients and inpatients will be recruited from 8 Japanese academic and non-academic hospitals. The inclusion and exclusion criteria are as follows: Inclusion criteria: 1. Diagnosed as positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) 2. Clinical stages of mild-to-moderate COVID-19 3. Symptomatic 4. ≥ 20 years of age 5. Male or female 6. Ability to communicate in Japanese 7. Outpatients and inpatients 8. Provided informed consent Exclusion criteria: 1. Difficulty in providing informed consent due to dementia, psychosis, or psychiatric symptoms 2. Allergic to Kampo or Western medicines used in this study 3. Pregnant and lactating 4. Unable to follow up 5. Participating in another clinical trial or interventional study 6. Hypokalemic or taking oral furosemide or steroids 7. Determined unsuitable for this study by the physician INTERVENTION AND COMPARATOR: Patients in the control group will receive conventional treatment with antipyretics, painkillers, or antitussives for symptoms that occurred after they contracted the SARS-CoV-2 infection. Patients in the Kampo group will receive 2.5 g of KT (TJ-1@TSUMURA and Co.) and 2.5 g of SSKKS (TJ-109@TSUMURA and Co.) 3 times a day, orally, for 14 days in addition to the conventional treatment as mentioned above. MAIN OUTCOMES: The number of days till at least one of the symptoms (fever, cough, sputum, malaise, shortness of breath) improves in the first 14 days of treatment. To assess the cough, sputum, malaise, and shortness of breath, a numeric rating scale will be used to define improvement in terms of a 2-point decrease in the number of days from the start of treatment for at least 2 days. Fever will be defined as an improvement when the temperature is less than 37 °C. RANDOMIZATION: Patients are randomized (1:1 ratio) to each group using the minimization method, with balancing of the arms with severity of disease stage and patient age (< 65, 65 to < 75, or ≥ 75 years). Computer-generated random numbers will be used for the minimization method. BLINDING (MASKING): Open-label with no blinding NUMBERS TO BE RANDOMIZED (SAMPLE SIZE): The main research hypothesis of this study is that the combination of Kampo medicine and conventional treatment will significantly improve the patients' symptoms (fever, fatigue, cough, sputum, and shortness of breath) during the first 14 days of treatment as compared with conventional treatment alone. Concerning the analysis of the primary endpoint, the duration of time before improvement of at least one of the common cold-like symptoms (fever, malaise, cough, sputum, and shortness of breath) will be estimated using the Kaplan-Meier method, and the survival curves will be compared between groups using the log-rank test. Assuming this method of analysis and based on previous studies reporting the efficacy of Kampo medicine for COVID-19 and H1N1 influenza patients, the median survival time in the Kampo medicine group is estimated as 3 days; this time will be 1.5 times longer in the control group. Assuming a one-sided significance level of 5%, a power of 70%, and an allocation ratio of 1:1, the required sample size is calculated as 126 cases. To compensate for a loss in follow-up, we plan to include 150 cases in both groups (Kampo group = 75, control group = 75). TRIAL STATUS: Protocol version 1.2 as of August 20, 2020 Recruitment start (expected): October 1, 2020 Recruitment finish (expected): October 31, 2023 TRIAL REGISTRATION: Japan Registry of Clinical Trials (jRCT) jRCTs021200020 . Registered on August 25, 2020 FULL PROTOCOL: The full protocol is attached as an additional file and is accessible from the Trials website (Additional file 1). In the interest of expediting the dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.


Assuntos
Antivirais/uso terapêutico , Betacoronavirus/efeitos dos fármacos , Infecções por Coronavirus/tratamento farmacológico , Medicamentos de Ervas Chinesas/uso terapêutico , Medicina Kampo , Pneumonia Viral/tratamento farmacológico , Antivirais/efeitos adversos , Betacoronavirus/patogenicidade , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/virologia , Quimioterapia Combinada , Medicamentos de Ervas Chinesas/efeitos adversos , Feminino , Interações Hospedeiro-Patógeno , Humanos , Japão , Masculino , Estudos Multicêntricos como Assunto , Pandemias , Pneumonia Viral/diagnóstico , Pneumonia Viral/virologia , Ensaios Clínicos Controlados Aleatórios como Assunto , Índice de Gravidade de Doença , Fatores de Tempo , Resultado do Tratamento
4.
Medicine (Baltimore) ; 99(40): e22315, 2020 Oct 02.
Artigo em Inglês | MEDLINE | ID: mdl-33019407

RESUMO

INTRODUCTION: chronic obstructive pulmonary disease (COPD) is 1 of the leading causes of morbidity and mortality worldwide; its economic and social burdens are substantial and increasing. Recent years, an increasing number of study has shown the promising advantage of Erchen decoction (ECD) combined with sanziyangqin decoction (SZYQD) in treating COPD. However, due to the lack of evidence, there is no specific method or suggestion, so it is necessary to provide a protocol for a systematic review on ECD combined with SZYQD for COPD and provide effective evidence for further clinical use. METHODS AND ANALYSIS: We will conduct a Computerized literature searches in the following databases: PubMed, MEDLINE, EMBASE, Cochrane Library, China national information network, China biomedical literature database (CBM), Chinese Scientific Journals Database and wanfang database, from their inception to June 2020, without restrictions of language. Study selection, data collection, and evaluation of the quality of evidence will be performed by 2 researchers independently, risk of bias of the meta-analysis will be evaluated based on the Cochrane Handbook for Systematic Reviews of Interventions. All data analysis will be conducted by data statistics software Review Manager V.5.3. and Stata V.12.0. RESULTS: This study will systematically evaluate the effectiveness and safety of ECD combined with SZYQD for COPD. The results will be published in a peer-reviewed journal. CONCLUSION: This study will provide evidence from the current published RCTs of whether ERD combined with SZYQD is an effective and safe intervention for COPD. ETHICS AND DISSEMINATION: This study is a systematic review, the outcomes are based on the published evidence. In this study, no individual data from participants will be involved, so ethics approval is not required. OPEN SCIENCE FRAMEWORK(OSF)REGISTRATION NUMBER: August 19, 2020; osf.io/zxm24.


Assuntos
Medicamentos de Ervas Chinesas/uso terapêutico , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Quimioterapia Combinada , Medicamentos de Ervas Chinesas/administração & dosagem , Medicamentos de Ervas Chinesas/efeitos adversos , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Projetos de Pesquisa , Testes de Função Respiratória
5.
Medicine (Baltimore) ; 99(40): e22401, 2020 Oct 02.
Artigo em Inglês | MEDLINE | ID: mdl-33019415

RESUMO

BACKGROUND: A growing body of clinical trials has demonstrated that traditional Chinese medicine Shaoyao Gancao Tang may improve restlessness leg syndrome (RLS). This review aims to systematically assess its effectiveness and safety in the treatment of patients with RLS. METHODS: Eight databases will be searched from the inception to 31 August 2020, including the Chinese Biological Medicine Database, China National Knowledge Infrastructure, Wanfang Database, VIP Information Database, the Cochrane Library, PubMed, EMBASE, and the Web of Science. All published randomized controlled trials that meet the prespecified eligibility criteria will be included. The primary outcomes include the changes in the International Restless Legs Syndrome Rating Scale and the restless sensation assessed by visual analog scales, and the secondary outcomes include effective rate, adverse event rate, quality of life measures, and improvement in the sleep quality index. Study selection, data extraction, and assessment of bias risk will be conducted independently by 2 reviewers. Data synthesis will be carried out with RevMan software (V.5.3.5). Subgroup and sensitivity analysis will be performed when necessary. The strength of the evidence will be assessed by the Grading of Recommendations Assessment, Development and Evaluation System. RESULTS: A high-quality synthesis of current evidence of Shaoyao Gancao Tang's effectiveness and safety for patients with RLS will be provided. CONCLUSION: This systematic review will provide evidence of whether Shaoyao Gancao Tang is an effective and safe intervention for RLS.


Assuntos
Medicamentos de Ervas Chinesas/uso terapêutico , Síndrome das Pernas Inquietas/tratamento farmacológico , Medicamentos de Ervas Chinesas/administração & dosagem , Medicamentos de Ervas Chinesas/efeitos adversos , Humanos , Medicina Tradicional Chinesa , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Projetos de Pesquisa , Sono/fisiologia
6.
Medicine (Baltimore) ; 99(40): e22404, 2020 Oct 02.
Artigo em Inglês | MEDLINE | ID: mdl-33019416

RESUMO

BACKGROUND: Systemic lupus erythematosus (SLE), known as lupus, is a chronic autoimmune disease and there is no cure for SLE. The western medication can improve syndromes to some extent; however, severe adverse drug reactions appear at the same time. Recently, it is confirmed that Chinese medicine also can have an excellent clinical efficacy on SLE. METHODS AND ANALYSIS: The following databases will be searched for relevant information before July 2020: PubMed, Embase, Cochrane Library, Web of Science, and China National Knowledge Infrastructure. MAJOR RESULTS: levels of total remission rate, SLEDAI. Secondary results: The laboratory index about C3 levels, Hb levels, white blood cell levels, and adverse event. Data will be collected independently by 2 researchers, and the risk of bias in meta analysis will be evaluated according to "Cochrane Handbook for Systematic Reviews of Interventions." All data analysis will be conducted using Review Manager V.5.3. and Stata V.12.0. RESULTS: The curative effect and safety of Chinese herbal compound prescription treatment for SLE patients will be evaluated systematically. CONCLUSION: The systematic review of this study will summarize the currently published evidence of Chinese herbal compound prescription treatment for SLE to further guide its promotion and application. ETHICS AND DISSEMINATION: The private information from individuals will not be published. This systematic review also will not involve endangering participant rights. Ethical approval is not required. The results may be published in a peer-reviewed journal or disseminated in relevant conferences. OPEN SCIENCE FRAMEWORK (OSF)REGISTRATION NUMBER:: https://osf.io/wvfrx/.


Assuntos
Medicamentos de Ervas Chinesas/uso terapêutico , Lúpus Eritematoso Sistêmico/tratamento farmacológico , Medicamentos de Ervas Chinesas/administração & dosagem , Medicamentos de Ervas Chinesas/efeitos adversos , Hemoglobinas/análise , Humanos , Contagem de Leucócitos , Ensaios Clínicos Controlados Aleatórios como Assunto , Indução de Remissão , Projetos de Pesquisa
7.
Medicine (Baltimore) ; 99(40): e22517, 2020 Oct 02.
Artigo em Inglês | MEDLINE | ID: mdl-33019454

RESUMO

BACKGROUND: Hepatic encephalopathy (HE) is one of the common complications of many serious liver diseases. Western medicine treatment is mainly symptomatic treatment such as neutralizing blood ammonia and protecting liver, which has poor curative effect, easy repetition and high mortality. Retention enema with traditional Chinese medicine (TCM) has been used on treatment of HE in China for many years. And it has been clinically proved that retention enema with TCM is effective and safe. But there is absent convincing evidence-based medicine to confirm the efficacy of retention enema with TCM for HE. Thus, we aimed to conduct this meta-analysis to summarize the efficacy of retention enema with TCM in patients with HE. METHODS: The study only selects clinical randomized controlled trials of retention enema with TCM for HE. We will search each database from the built-in until December 31, 2020. The English literature mainly searches Cochrane Library, Pubmed, EMBASE, and Web of Science. While the Chinese literature comes from CNKI, CBM, VIP, and Wanfang database. Meanwhile, we will retrieve clinical trial registries and gray literature. Two researchers worked independently on literature selection, data extraction and quality assessment. The dichotomous data is represented by relative risk (RR), and the continuous is expressed by mean difference (MD) or standard mean difference (SMD), eventually the data is synthesized using a fixed effect model (FEM) or a random effect model (REM) depending on the heterogeneity. The total effective rate, blood ammonia and the total bilirubin were evaluated as the main outcomes. While several secondary outcomes were also evaluated in this study. The statistical analysis of this Meta-analysis was conducted by RevMan software version 5.3. RESULTS: This study will synthesize and provide high-quality evidence based on the data of the currently published retention enema with TCM for the treatment of HE. CONCLUSION: This meta-analysis aims to evaluate the benefits of retention enema with TCM for the treatment of HE reported in randomized controlled trials, and provide more options for clinicians and patients with HE. REGISTRATION NUMBER: INPLASY202080107.


Assuntos
Medicamentos de Ervas Chinesas/uso terapêutico , Encefalopatia Hepática/tratamento farmacológico , Medicina Tradicional Chinesa/métodos , Medicamentos de Ervas Chinesas/efeitos adversos , Enema , Humanos , Medicina Tradicional Chinesa/efeitos adversos , Ensaios Clínicos Controlados Aleatórios como Assunto , Projetos de Pesquisa
8.
Medicine (Baltimore) ; 99(40): e22455, 2020 Oct 02.
Artigo em Inglês | MEDLINE | ID: mdl-33019432

RESUMO

BACKGROUND: Cerebral small vessel disease (CSVD) is the most common etiology of vascular cognitive impairment (VCI). VCI in CSVD (CSVD-VCI) shows a progressive course with multiple stages and is also associated with dysfunctions such as gait, emotional and behavioral, and urinary disturbances, which seriously affect the life quality of elderly people. In mainland China, Chinese herbal medicine (CHM) is clinically used for CSVD-VCI and presenting positive efficacy, but the evidence revealed in relevant clinical trials has not been systematically evaluated. The purpose of this study is to assess the current evidence available for the clinical efficacy and safety of CHM for CSVD-VCI. METHODS: A literature search of published RCTs up to April 30, 2020, has been conducted in the following 7 electronic databases: PubMed, Embase, the Cochrane Library, Chinese National Knowledge Infrastructure Database (CNKI), Chinese Science and Technology Journals Database (VIP), Wanfang Database, and Chinese Biomedical Literature Service System (SinoMed). For unpublished studies, 2 clinical trial online registration websites will be searched: ClinicalTrials.gov and Chinese Clinical Trial Registry (ChiCTR). Only randomized controlled trials (RCTs) using CHM in the treatment of patients with CSVD-VCI, which compares CHM with no treatment, placebo, or other conventional treatments, will be included in this systematic review. Primary outcomes will be set as acknowledged scales measuring cognitive function. Secondary outcomes will involve activities of daily living, behavioral, and psychological symptoms, global performance of dementia, neurological function, biological markers of endothelial dysfunction, the clinical effective rate, and adverse events. After screening studies and extracting data, the Cochrane Collaborations tool for assessing risk of bias will be applied to assess the methodological quality of included RCTs. Review Manager Version 5.3 software will be used for data synthesis and statistical analysis. Subgroup analyses, sensitivity analyses, and meta-regression will be conducted to detect potential sources of heterogeneity. The funnel plot and Eggers test will be developed to evaluate publication bias, if available. We will perform the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system to appraise the quality of evidence. RESULTS: Evidence exhibited in this systematic review will provide practical references in the field of CHM treating CSVD-VCI. Moreover, our detailed appraisals of methodological deficiencies of relevant RCTs will offer helpful advice for researchers who are designing trials of CHMs in the treatment of CSVD-VCI. CONCLUSION: The conclusion about the clinical efficacy and safety of CHM for CSVD-VCI will be provided for clinical plans, decisions, and policy developments in the full version of this systematic review. SYSTEMATIC REVIEW REGISTRATION: INPLASY202080120.


Assuntos
Doenças de Pequenos Vasos Cerebrais/tratamento farmacológico , Demência Vascular/tratamento farmacológico , Medicamentos de Ervas Chinesas/uso terapêutico , Doenças de Pequenos Vasos Cerebrais/complicações , Demência Vascular/etiologia , Humanos , Metanálise como Assunto , Revisões Sistemáticas como Assunto
9.
Medicine (Baltimore) ; 99(40): e22457, 2020 Oct 02.
Artigo em Inglês | MEDLINE | ID: mdl-33019433

RESUMO

INTRODUCTION: Ulcerative Colitis is a chronic nonspecific inflammatory disease of the colon and rectum, which is of global concern. It has the characteristics of a long course of disease and repeated attacks, which seriously affects the quality of life and economic and social development of the affected population. The treatment of UC by herb Huanglian and compound prescription contain Huanglian have been proved. However, due to the lack of evidence, there is no specific method or suggestion, it is necessary to systematically evaluate coptidis so as to provide effective evidence for further research. METHODS AND ANALYSIS: The following databases will be searched from their inception to June 2020: Electronic databases included PubMed, Embase, Cochrane Library, Web of Science, Nature, Science Online, WanFang China Biomedical Database, VIP Medical Information, CNKI (Knowledge Infrastructure of China). MAIN OUTCOMES: Colonoscopy, improved condition (tenesmus), stool routine. Additional outcomes: Electrocardiogram (ECG), erythrocyte (RBC), leukocyte (WBC), platelet (PLT). Data will be extracted by 2 researchers independently, risk of bias of the meta-analysis will be evaluated based on the Cochrane Handbook for Systematic Reviews of Interventions. All data analysis will be conducted by data statistics software Review Manager V.5.3. and Stata V.12.0. RESULTS: The results of this study will systematically evaluate the efficacy and safety of rhizoma coptidis intervention in patients with Ulcerative Colitis. CONCLUSION: Through the systematic review of this study, the published evidence of rhizoma coptidis on the treatment of UC is summarized so as to further guide its promotion and application. ETHICS AND COMMUNICATION: This study is a systematic review, the outcomes are based on the published evidence, so examination and agreement by the ethics committee are not required in this study. We intend to publish the study results in a journal or conference presentations. OPEN SCIENCE FRA MEWORK (OSF) REGISTRATION NUMBER: August 27, 2020. osf.io/7nh3k (https://osf.io/7nh3k).


Assuntos
Colite Ulcerativa/tratamento farmacológico , Medicamentos de Ervas Chinesas/uso terapêutico , Humanos , Metanálise como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto , Revisões Sistemáticas como Assunto
10.
Medicine (Baltimore) ; 99(40): e22462, 2020 Oct 02.
Artigo em Inglês | MEDLINE | ID: mdl-33019437

RESUMO

PURPOSE: To review the literature on the efficacy and safety of Chaihu Longgu Muli decoction (CLMD) for insomnia. METHODS: A systematic literature search was performed for five databases up to May of 2019 to identify randomized control trials involving CLMD for patients with insomnia. The experimental group was CLMD monotherapy or CLMD plus conventional treatment. Comparators were placebo, no treatment, or conventional medicine. The main comparison was CLMD against conventional drugs. The primary outcome was sleep quality (assessed using the Pittsburgh Sleep Quality Index, PSQI). The secondary outcomes were clinical effectiveness rate, total sleep time, and adverse event rate. RevMan 5.3 software was used for meta-analysis with effect estimate presented as relative risk (RR) and mean difference (MD) with 95% confidence interval (CI). RESULTS: A total of 22 studies involving 2029 patients were included. All the included studies presented some risk of bias, especially risks of performance, and detection bias. The main meta-analysis showed that CLMD alone was more effective than conventional medications by reducing PSQI (MD = -2.80, 95% CI [-5.48, -0.13], P = .04), improving the clinical effectiveness rate (RR = 1.23, 95% CI [1.16, 1.31], P < .00001), and prolonging total sleep time (MD = 1.01, 95% CI [0.19, 1.83], P = .002). The adverse event rate in the CLMD group was lower than that of the control group (RR = 0.22, 95% CI [0.09, 0.51], P = .0005). CLMD also improved sleep quality better than conventional medications as an adjunct therapy (P < .05). The funnel plot was symmetrical, representing a low risk of publication bias. CONCLUSION: CLMD presented better efficacy and safety than conventional medications and had the potential to become an alternative to conventional medications for the treatment of insomnia. However, as the included studies showed significant risks of bias, these results will need to be confirmed by future double-blind randomized controlled trials. PROSPERO REGISTRATION NUMBER: CRD42019133103.


Assuntos
Medicamentos de Ervas Chinesas/uso terapêutico , Distúrbios do Início e da Manutenção do Sono/tratamento farmacológico , Humanos
11.
Medicine (Baltimore) ; 99(41): e22454, 2020 Oct 09.
Artigo em Inglês | MEDLINE | ID: mdl-33031277

RESUMO

BACKGROUND: The combined therapy of Chinese herbal formula and western medicine against gastroesophageal reflux disease (GERD) could significantly improve the clinical effect, reduce the recurrence rate and the side effects of western medicine, and even reduce the dosage and course of treatment of western medicine. This study tried to systematically evaluate the efficacy and safety traditional Chinese herbal formula combined with western medicine in the treatment of GERD. METHODS: Randomized controlled trials of traditional Chinese herbal formula combined with western medicine for GERD patients will be systematically searched using the PubMed, Embase, Medline, Cochrane Library, China National Knowledge Infrastructure (CNKI), Wanfang database, Chongqing VIP Chinese Science and Technology Periodical Database, and Chinese Biological and Medical database (CMB) until Aug. 28, 2020. Two researchers will perform data extraction and risk of bias assessment independently. Statistical analysis will be conducted in RevMan 5.3. RESULTS: This study will summarize the present evidence by exploring the efficacy and safety of traditional Chinese herbal formula combined with western medicine in the treatment of GERD. CONCLUSIONS: The findings of the study will help to determine potential benefits of traditional Chinese herbal formula combined with western medicine against GERD. ETHICS AND DISSEMINATION: The private information from individuals will not be published. This systematic review also will not involve endangering participant rights. Ethical approval is not required. The results may be published in a peer-reviewed journal or disseminated in relevant conferences. OSF REGISTRATION NUMBER: DOI 10.17605/OSF.IO/RSAVF.


Assuntos
Antiácidos/uso terapêutico , Medicamentos de Ervas Chinesas/uso terapêutico , Refluxo Gastroesofágico/tratamento farmacológico , Antagonistas dos Receptores Histamínicos H2/uso terapêutico , Inibidores da Bomba de Prótons/uso terapêutico , Antiácidos/efeitos adversos , Quimioterapia Combinada , Medicamentos de Ervas Chinesas/efeitos adversos , Antagonistas dos Receptores Histamínicos H2/efeitos adversos , Humanos , Metanálise como Assunto , Inibidores da Bomba de Prótons/efeitos adversos , Ensaios Clínicos Controlados Aleatórios como Assunto , Projetos de Pesquisa , Revisões Sistemáticas como Assunto
12.
Medicine (Baltimore) ; 99(41): e22515, 2020 Oct 09.
Artigo em Inglês | MEDLINE | ID: mdl-33031290

RESUMO

BACKGROUND: Alopecia areata (AA) is a common, inflammatory, nonscarring type of hair loss that is characterized by depression, anxiety and social isolation. In recent years, Plum-blossom needle plus Chinese herbal medicine has gradually shown its clinical advantages and been more and more widely used in China. Whereas, there has been no systematic review and meta-analysis. The purpose of this study is to estimate the safety and effectiveness of Plum-blossom needle plus Chinese herbal medicine in AA treatment. METHODS: Seven databases as following: PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure (CNKI), Chinese Scientific Journal Database (VIP), and Chinese Biomedical Literatures Database (CBM) will be searched from their inception to August 2020. Two reviewers (LBL and ZYZ) will respectively regulate research selection, data extraction, and risk of bias assessment. A third reviewer will be settled to consulting, if necessary. Review Manager Software 5.4 will be implemented for this study. RESULTS: The results will be published in a peer-reviewed medical journal. This meta-analysis will provide a synthetic review of the credible evidence for the treatment of Plum-blossom needle plus Chinese herbal medicine with AA. CONCLUSIONS: This systematic review and meta-analysis expects to provide high-quality evidence regarding the synergistic effect of Plum-blossom needle plus Chinese herbal medicine treatment for AA.


Assuntos
Alopecia em Áreas/terapia , Medicamentos de Ervas Chinesas/uso terapêutico , Medicina Tradicional Chinesa/métodos , Agulhas , Terapia Combinada , Humanos , Medicina Tradicional Chinesa/instrumentação , Metanálise como Assunto , Satisfação do Paciente , Projetos de Pesquisa , Revisões Sistemáticas como Assunto , Resultado do Tratamento
13.
Medicine (Baltimore) ; 99(41): e22516, 2020 Oct 09.
Artigo em Inglês | MEDLINE | ID: mdl-33031291

RESUMO

BACKGROUND: Xihuang pill, a famous traditional Chinese medicine formulation, is a broad-spectrum anti-tumor drug and has been widely used for the treatment of lung cancer in China. The aim of this study is to systematically investigate the efficacy and safety of Xihuang pill for the treatment of lung cancer. METHODS: We will perform the comprehensive literature search in the following databases from their inceptions to August 2020 for data extraction: PubMed, the Cochrane Library, Embase, the China National Knowledge Infrastructure, Wanfang Database, Chinese Science and Technology Periodical Database, and Chinese Biomedical Literature Database. Cochrane Risk of Bias tool will be used to assess the risk of bias of included studies. The RevMan 5.4 and Stata 16.0 software will be applied for statistical analyses. Statistical heterogeneity will be computed by I tests. Sensitivity analysis will be conducted to evaluate the stability of the results. The publication bias will be evaluated by funnel plots and Egger test. The quality of evidence will be assessed by the Grading of Recommendations Assessment, Development and Evaluate system (GRADE) system. RESULTS: The results of our research will be published in a peer-reviewed journal. CONCLUSION: The conclusion of this study will provide evidence to show whether Xihuang pill is an effective intervention for patient with lung cancer. OSF REGISTRATION NUMBER: 10.17605/OSF.IO/W2GHN.


Assuntos
Antineoplásicos/uso terapêutico , Medicamentos de Ervas Chinesas/uso terapêutico , Neoplasias Pulmonares/tratamento farmacológico , Administração Oral , Antineoplásicos/administração & dosagem , Antineoplásicos/efeitos adversos , Medicamentos de Ervas Chinesas/administração & dosagem , Medicamentos de Ervas Chinesas/efeitos adversos , Humanos , Metanálise como Assunto , Projetos de Pesquisa , Revisões Sistemáticas como Assunto , Comprimidos
14.
Medicine (Baltimore) ; 99(41): e22565, 2020 Oct 09.
Artigo em Inglês | MEDLINE | ID: mdl-33031303

RESUMO

BACKGROUND: Kangai injection, a well-known insect-derived traditional Chinese medicine preparation, has been widely applied as a promising adjunctive drug for hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC). However, its exact clinical efficacy and safety is still not well investigated. In this study, we aimed to summarize the efficacy and safety of Kangai injection for patients with HBV-related HCC through the meta-analysis. METHODS: All available randomized controlled trials (RCTs) and high-quality prospective cohort studies that investigated the efficacy and safety of Kangai injection for patients with HBV-related HCC were searched from ten electronic databases including Google Scholar, PubMed, Excerpt Medica Database (Embase), Cochrane Library, Medline, Web of Science (WOS), China National Knowledge Infrastructure (CNKI), China Scientific Journal Database (CSJ) Chinese, Biomedical Literature Database (CBM) and Wanfang Database. Papers in Chinese or English published from January 2000 to September 2020 will be included without any restrictions.Study selection and data extraction will be performed independently by 2 researchers. The clinical outcomes including overall response rate (ORR), disease control rate (DCR), quality of life (QoL), clinical symptoms, virological indicators, immune function and adverse events, were systematically evaluated. Review Manager 5.3 and Stata 14.0 were used for data analysis, and the quality of the literatures was also evaluated. RESULTS: The results of this study will be published in a peer-reviewed journal, and provide a helpful evidence for clinicians to formulate the best postoperative adjuvant treatment strategy for HBV-related HCC patients. CONCLUSION: Our study will draw an objective conclusion of the efficacy of Kangai injection on curative effect (ORR and DCR), clinical symptoms, virological indicators, QoL, and immune function in patients with HBV-related HCC. INPLASY REGISTRATION NUMBER: INPLASY202090014.


Assuntos
Carcinoma Hepatocelular/terapia , Carcinoma Hepatocelular/virologia , Quimioembolização Terapêutica , Medicamentos de Ervas Chinesas/uso terapêutico , Vírus da Hepatite B , Neoplasias Hepáticas/terapia , Neoplasias Hepáticas/virologia , Projetos de Pesquisa , Humanos , Metanálise como Assunto
15.
Medicine (Baltimore) ; 99(41): e22692, 2020 Oct 09.
Artigo em Inglês | MEDLINE | ID: mdl-33031339

RESUMO

BACKGROUND: Chronic hepatitis B liver fibrosis is significant public concern. Ganshuang granules (GSG) are used to treat liver fibrosis for a long time. The aim of this study is to synthesize related data to explore efficacy and safety of GSG as an adjuvant treatment for chronic hepatitis B liver fibrosis. METHODS: Electronic database were used to identify related studies. We chose PubMed, China Knowledge Network Infrastructure, China Biomedical Database, Wan Fang Data, VIP Database, EMBASE, and Cochrane Library as retrieval tool. Two independent individuals conducted the publication selection, data extraction, data assessment. Any problems between 2 researchers will be resolved by a third reviewer through negotiation. RevMan 5.3 (The Cochrane Collaboration, Copenhagen, Denmark) software will be used for data analysis. RESULTS: This study will systematically detect the efficacy and safety of GSG for treating chronic hepatitis B liver fibrosis. CONCLUSION: This study will provide scientific evidence to explorer whether GSG are efficacy and safety in treating chronic hepatitis B liver fibrosis. PROSPERO REGISTRATION NUMBER: INPLASY202090027.


Assuntos
Medicamentos de Ervas Chinesas/uso terapêutico , Hepatite B Crônica/complicações , Cirrose Hepática/tratamento farmacológico , Fitoterapia , Humanos , Cirrose Hepática/virologia , Metanálise como Assunto , Revisões Sistemáticas como Assunto
16.
Medicine (Baltimore) ; 99(41): e22732, 2020 Oct 09.
Artigo em Inglês | MEDLINE | ID: mdl-33031344

RESUMO

BACKGROUND: It is extremely easy for rectal prolapse to relapse with surgery alone. Clinical practice indicates that Buzhong Yiqi decoction combined with surgery has certain therapeutic advantages, while there is a lack of evidence-based medicine support. This study aimed to systematically investigate the efficacy and safety of Buzhong Yiqi decoction combined with surgery in the treatment of rectal prolapse. METHODS: The English databases (PubMed, Embase, Web of Science, the Cochrane Library) and Chinese databases (China National Knowledge Infrastructure [CNKI], Wanfang, China Science and Technology Journal Database [VIP], China Biology Medicine disc) were searched by computer. In addition, Baidu Scholar and Google Scholar were searched manually. A randomized controlled clinical study of Buzhong Yiqi decoction combined with surgery in the treatment of rectal prolapse was performed from the establishment of databases to September 2020. Two investigators independently conducted data extraction and assessed the literature quality of the included studies. The Revman5.3 software was used for meta-analysis of the included literature. RESULTS: The efficacy and safety of Buzhong Yiqi decoction combined with surgery in the treatment of rectal prolapse were evaluated in terms of efficiency, symptom score, recurrence rate, adverse reaction rate, and so on. CONCLUSIONS: Thisstudy provides reliable evidence-based support for the clinical application of Buzhong Yiqi decoction combined with surgery in the treatment of rectal prolapse. OSF REGISTRATION NUMBER: DOI: 10.17605/OSF.IO/K3PJX.


Assuntos
Medicamentos de Ervas Chinesas/uso terapêutico , Prolapso Retal/tratamento farmacológico , Humanos , Medicina Tradicional Chinesa , Prolapso Retal/cirurgia , Resultado do Tratamento
17.
Medicine (Baltimore) ; 99(35): e21929, 2020 Aug 28.
Artigo em Inglês | MEDLINE | ID: mdl-32871932

RESUMO

BACKGROUND: Cerebral infarction (CI) is a common disease with high morbidity and disability. Shuxuetong (SXT) injection is a Chinese Materia Medica standardized product used in the treatment of CI. Currently, there is a lack of high-quality evidence to support the effectiveness and safety of SXT on patients with CI. This systematic review protocol aims at describing a meta-analysis to evaluate the efficacy of SXT for the treatment of CI. METHODS: We will search the databases of PubMed, MEDLINE, Embase, Cochrane Library Central Register of Controlled Trials, China national knowledge infrastructure database (CNKI), Wan fang database, Chongqing VIP information, and SinoMed from their inception to Jun 2020. Two reviewers will independently screen Randomized controlled trials of SXT for the treatment of CI. The meta-analysis will be conducted using RevMan V.5.3 software. RESULTS: The results of this study will be published in a peer-reviewed journal. CONCLUSION: The conclusion of our systematic review will provide evidence to judge whether SXT is an effective intervention for patients with CI. TRIAL REGISTRATION NUMBER: 10.17605/OSF.IO/3F6ZH.


Assuntos
Infarto Cerebral/tratamento farmacológico , Medicamentos de Ervas Chinesas/uso terapêutico , Metanálise como Assunto , Revisões Sistemáticas como Assunto , Adulto , Medicamentos de Ervas Chinesas/efeitos adversos , Humanos , Injeções , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento
18.
Medicine (Baltimore) ; 99(35): e21932, 2020 Aug 28.
Artigo em Inglês | MEDLINE | ID: mdl-32871934

RESUMO

BACKGROUND: Xiaoaiping injection, extracted from the Chinese herb Marsdenia tenacissima (Roxb.) Wight et Arn., is a broad-spectrum anti-tumor drug and has been widely used for the treatment of breast cancer in China. The aim of this study is to systematically investigate the efficacy and safety of Xiaoaiping injection for the treatment of breast cancer. METHODS: We will perform the comprehensive literature search in the following databases from their inceptions to August 2020 for data extraction: PubMed, the Cochrane Library, Embase, the China National Knowledge Infrastructure, Wanfang Database, Chinese Science and Technology Periodical Database, and Chinese Biomedical Literature Database. Cochrane Risk of Bias tool will be used to assess the risk of bias of included studies. The RevMan 5.4 and Stata 16.0 software will be applied for statistical analyses. Statistical heterogeneity will be computed by I2 tests. Sensitivity analysis will be conducted to evaluate the stability of the results. The publication bias will be evaluated by funnel plots and Egger's test. The quality of evidence will be assessed by the GRADE system. RESULTS: The results of our research will be published in a peer-reviewed journal. CONCLUSION: The conclusion of this study will provide evidence to show whether Xiaoaiping injection is an effective intervention for patient with breast cancer. OSF REGISTRATION NUMBER: 10.17605/OSF.IO/4ZUXC.


Assuntos
Neoplasias da Mama/tratamento farmacológico , Medicamentos de Ervas Chinesas/efeitos adversos , Medicamentos de Ervas Chinesas/uso terapêutico , Metanálise como Assunto , Revisões Sistemáticas como Assunto , Feminino , Humanos , Injeções , Ensaios Clínicos Controlados Aleatórios como Assunto
19.
Medicine (Baltimore) ; 99(35): e21808, 2020 Aug 28.
Artigo em Inglês | MEDLINE | ID: mdl-32871901

RESUMO

BACKGROUND: Viral pneumonia is a common respiratory disease that leads to high mortality around the world. Tanreqing (TRQ) injection has been widely used to treat viral pneumonia in China. However, the efficiency and safety of TRQ injection for viral pneumonia have not been scientifically and methodically evaluated up to now. Thus, this protocol describes a plan of performing a systematic review and meta-analysis to evaluate the efficacy and safety of TRQ injection on patients with viral pneumonia. METHODS: Only randomized controlled trials will be enrolled in our study, and we will search eligible studies in the following electronic databases: PubMed, Embase, Cochrane Central Register of Controlled Trials, Clinical Trials, China National Knowledge Infrastructure, the Wanfang database, the Chinese Scientific Journal Database, and the Sinomed. The total effective rate of clinical efficacy will be used as primary outcome. Time to relieve symptoms, incidence of adverse reactions, and the laboratory parameters will be used as secondary outcomes. Any side effects and adverse events will be recorded and assessed as safety outcomes. Study inclusion, data extraction, and quality assessment will be performed independently by 2 reviewers, and any disagreement will be resolved by a third reviewer. After that, data synthesis and subgroup analysis will be conducted with the Review Manager V.5.3.3 software. RESULTS: This review will provide a high-quality synthesis to assess the effectiveness and safety of TRQ injection for viral pneumonia patients. CONCLUSION: Our study will provide comprehensive evidence to decide whether TRQ injection is effective and safe for viral pneumonia patients. PROSPERO REGISTRATION NUMBER: PROSPERO CRD42020164164.


Assuntos
Medicamentos de Ervas Chinesas/uso terapêutico , Metanálise como Assunto , Pneumonia Viral/tratamento farmacológico , Revisões Sistemáticas como Assunto , Humanos , Injeções , Medicina Tradicional Chinesa , Projetos de Pesquisa
20.
Medicine (Baltimore) ; 99(35): e21858, 2020 Aug 28.
Artigo em Inglês | MEDLINE | ID: mdl-32871910

RESUMO

INTRODUCTION: These years, due to dissatisfaction with western medicine treatments, traditional Chinese medicine (TCM) becomes a main treatment for bronchial asthma patients. Lung and kidney yang deficiency syndrome is a common type of asthma and the Chinese herbal medicine formula modified Mahuang-Fuzi-Xixin (MFX) decoction is prescribed for mild bronchial asthma patients with acute exacerbation syndrome. However, there is not obvious evidence to support the efficacy and safety of modified MFX decoction the efficacy and safety to treat mild bronchial asthma and the mechanism of this disease is still unclear. METHODS: A double-blind, placebo-controlled, randomized clinical trial was proposed by us. After a 10-day run-in period, 180 eligible objects will be recruited in this study. These subjects will be allocated to the experimental group or control group in a 1:1 ratio. Patients in the experimental group will take modified MFX decoction. At the same time, patients in the control group will receive a matched placebo. The budesonide inhalation powder will be used as a western medicine treatment for both groups. All subjects will receive 14 days of treatment and another 6 months of follow-up. The primary outcome is the mean change in peak expiratory flow rate from the baseline to 14 days in this research. The secondary outcome includes forced expiratory volume in one second, asthma control test score, Asthma Quality of Life Questionnaire score, curative effect of TCM syndrome, and salbutamol dosage. This trial will also explore the association between the change of immunoglobulin E and modified MFX decoction treatment. Any side effects of the treatment will be recorded. DISCUSSION: The results of this trial will provide the evidence for the effect of modified MFX decoction in patients with mild bronchial asthma during acute exacerbation. It also will explore the mechanism of this formula in the treatment of bronchial asthma, which will provide another treatment option for patients with mild bronchial asthma.


Assuntos
Antiasmáticos/uso terapêutico , Asma/tratamento farmacológico , Medicamentos de Ervas Chinesas/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Humanos , Pico do Fluxo Expiratório
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