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1.
Medicine (Baltimore) ; 100(15): e23736, 2021 Apr 16.
Artículo en Inglés | MEDLINE | ID: mdl-33847606

RESUMEN

BACKGROUND: Shenfu Injection (SFI) is a promising alternative treatment for heart failure (HF) in China. Many complete clinical trials have examined the efficacy of SFI combined use with conventional treatment (CT) vs CT alone. This study is to conduct a systematic review and meta-analysis of randomized clinical trials to evaluate the benefits and risks of using SFI in addition to CT for the treatment of HF. METHOD: All the trials will be searched through 4 English databases (MEDLINE via PubMed, the Cochrane Library, EMBASE, Web of Science) and 4 Chinese databases (the China Science and Technology Journal Database, Chinese Biomedical Literature Database, Wan-fang Database, the China National Knowledge Infrastructure.) from October 2005 to June 2019. Conference articles or articles with incomplete data will be removed. The primary outcome was the New York Heart Association, 6-minute walk test, hospitalization or rehospitalization. Left ventricular ejection fraction percentage, left ventricular end-diastolic dimension, Cardiac index, heart rate, N-terminal pronatriuretic peptide and other indicators were also assessed. RevMan V.5.3 Software and Stata 13.0 Statistics Software were used to calculate the data synthesis and conduct meta-analysis according to the guideline of Preferred Reporting Items for Systematic Reviews and Meta-analyses Protocols 2015. RESULTS: Mortality, New York Heart Association function classification, heart rate, 6-minute walk test, hospitalization or rehospitalization, Heart rate, systolic blood pressure, DBP, Cardiac minute volume, left ventricular ejection fractions percentage, left ventricular end-diastolic dimension (mm), N-terminal pronatriuretic peptide, etc. and adverse effects will be comprehensively assessed to evaluate the adjunctive effect of SFI through different aspects. We will perform a meta-analysis of each outcome with subgroup analysis based on the type of HF, treatment methods, and course of disease. Sensitivity analysis will be conducted with clinical factors, treatment methods, methodological characteristics, and statistical heterogeneity (if applicable). CONCLUSION: This study will assess the adjunctive effect of SFI and its safety on HF with clinical evidence. PROSPERO REGISTRATION NUMBER: PROSPERO CRD42020151856.


Asunto(s)
Medicamentos Herbarios Chinos/uso terapéutico , Insuficiencia Cardíaca/tratamiento farmacológico , Gasto Cardíaco , Terapia Combinada , Medicamentos Herbarios Chinos/administración & dosificación , Medicamentos Herbarios Chinos/efectos adversos , Insuficiencia Cardíaca/mortalidad , Insuficiencia Cardíaca/fisiopatología , Hospitalización/estadística & datos numéricos , Humanos , Inyecciones , Ensayos Clínicos Controlados Aleatorios como Asunto , Proyectos de Investigación , Índice de Severidad de la Enfermedad , Prueba de Paso
2.
Medicine (Baltimore) ; 100(15): e24531, 2021 Apr 16.
Artículo en Inglés | MEDLINE | ID: mdl-33847608

RESUMEN

BACKGROUND: As the last link in the chain of cardiovascular events, chronic heart failure (CHF) has high morbidity, high mortality, and poor prognosis. It is one of the main causes of death and disability worldwide. Shenfuqiangxin Pills (SFQX) is widely used as a Chinese herbal medicine (CHM) prescription for CHF, but there is still a lack of strict evidence-based medical evidence. Therefore, we make a protocol for evaluating the efficacy and safety of SFQX for CHF. METHODS: According to the search strategy, randomized controlled trials (RCTs) of SFQX for CHF will be retrieved from 8 databases without limitation of publication date or language. First of all, the literature was screened according to the eligibility criteria, and use the Cochrane Collaboration's tool to assess the quality of the included literature. Then, using software for traditional meta-analysis. Finally, using GRADE method to assess the strength of recommendations. RESULTS: This study will evaluate the efficacy and safety of SFQX for CHF, thereby providing more evidence support for clinical decision-making in CHF. CONCLUSION: Our research will provide more references for the clinical medication of patients with CHF. PROTOCOL REGISTRATION NUMBER: INPLASY202110019.


Asunto(s)
Medicamentos Herbarios Chinos/uso terapéutico , Insuficiencia Cardíaca/tratamiento farmacológico , Fármacos Cardiovasculares/uso terapéutico , Enfermedad Crónica , Medicamentos Herbarios Chinos/administración & dosificación , Medicamentos Herbarios Chinos/efectos adversos , Humanos , Ensayos Clínicos Controlados Aleatorios como Asunto , Proyectos de Investigación
3.
Medicine (Baltimore) ; 100(15): e25097, 2021 Apr 16.
Artículo en Inglés | MEDLINE | ID: mdl-33847614

RESUMEN

BACKGROUND: Breast cancer, a malignant disorder, occurs in the epithelial tissue of the breast gland. Chemotherapy is the standard treatment for breast cancer, however, the side effect, especially gastrointestinal dysfunction, due to chemotherapy still remain major problems. Traditional Chinese Medicine has been proven therapeutically effective on reducing adverse effects caused by chemotherapy. Shenhuang Plaster. METHODS: The study is a randomized, placebo-controlled, blind trial. A total of 160 Chinese breast cancer patients will be enrolled and randomly allocated into the experimental group and control group in a 1:1 ratio. Patients in the experimental group will be prescribed Shenhuang plaster application on shenque point (CV8) plus chemotherapy treatment. Patients in the control group will be prescribed placebo plaster application on CV8 plus chemotherapy treatment. The acupoint application will last 3 days. The primary outcome will be the form of faces every day, and the secondary outcomes the symptom score of traditional Chinese medicine, the changes of fecal bacteria and metabolites, serum motilin, gastrin and ghrelin levels. DISCUSSION: This study is to observe therapeutic effects with Shenhuang plaster application on CV8 to regulate chemotherapy-induced gastrointestinal toxicity in breast cancer patients. TRIAL REGISTRATION: Chinese Clinical Trial Registry (http://www.chictr.org.cn/showproj.aspx?proj=55262) No. ChiCTR2000034313. Registered on July 2, 2020.


Asunto(s)
Antineoplásicos/efectos adversos , Neoplasias de la Mama/tratamiento farmacológico , Medicamentos Herbarios Chinos/uso terapéutico , Enfermedades Gastrointestinales/inducido químicamente , Enfermedades Gastrointestinales/tratamiento farmacológico , Administración Tópica , Adulto , Antineoplásicos/uso terapéutico , China , Método Doble Ciego , Medicamentos Herbarios Chinos/administración & dosificación , Medicamentos Herbarios Chinos/efectos adversos , Femenino , Humanos , Persona de Mediana Edad
4.
Medicine (Baltimore) ; 100(14): e25360, 2021 Apr 09.
Artículo en Inglés | MEDLINE | ID: mdl-33832116

RESUMEN

INTRODUCTION: Hepatocellular carcinoma (HCC) is the most common type of primary liver cancer, and most patients in China are diagnosed at the intermediate or later stages, which is not suitable for the first line therapies. Transarterial chemoembolization (TACE) is a commonly selected therapeutic option for intermediate and later stage HCC in China, but patients often suffer from postembolization syndrome (PES), manifesting as fever, liver area pain, nausea, vomiting, paralyzed intestinal obstruction, and abdominal pain after TACE. We try to conduct a double blinded, randomized, placebo-controlled clinical trial to observe whether Chaihu Guizhi decoction (CGD), a classic traditional Chinese formula, could prophylactically alleviate the incidence of PES in HCC patients after TACE. METHODS: Patients will be randomly assigned sequentially in a 1:1 ratio by using preformed randomization envelopes. After TACE procedures, patients in the treatment group will be administrated with Chinese herbal formula CGD, and patients in the control group with CGD simulations, twice a day, continuously for 7 days. The outcomes are the incidence of PES hospitalization and, complications. SPSS version 22 (IBM, Chicago, IL) will be used for the data, and a P < .05 will be considered statistically significant. CONCLUSIONS: The findings will explore the prophylactic effect of CGD in alleviating the incidence of PES following TACE in HCC patients. TRIAL REGISTRATION: OSF Registration number: DOI 10.17605/OSF.IO/FKRSN.


Asunto(s)
Quimioembolización Terapéutica/efectos adversos , Quimioembolización Terapéutica/métodos , Medicamentos Herbarios Chinos/administración & dosificación , Fiebre/prevención & control , Neoplasias Hepáticas/terapia , Náusea/prevención & control , Vómitos/prevención & control , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Método Doble Ciego , Medicamentos Herbarios Chinos/efectos adversos , Femenino , Fiebre/etiología , Humanos , Masculino , Persona de Mediana Edad , Náusea/etiología , Proyectos de Investigación , Síndrome , Vómitos/etiología , Adulto Joven
5.
Medicine (Baltimore) ; 100(16): e25476, 2021 Apr 23.
Artículo en Inglés | MEDLINE | ID: mdl-33879680

RESUMEN

BACKGROUND: Knee osteoarthritis (KOA) is a chronic and degenerative bone and joint disease, with KOA, cartilage degeneration, destruction and subchondral bone remodeling as the main pathological features. Its clinical symptoms are knee pain, swelling, limited activity, and long course of disease can cause joint deformities. At present, the early treatment of Western medicine is mainly the use of nonsteroidal drugs for anti-inflammation and removing pain, but because the efficacy of these drugs is unstable, the disease is easy to repeat after treatment, and the clinical effect is not good. Although Biqi capsule has advantages in the treatment of KOA, there is a lack of standard clinical studies to verify it, so the purpose of this randomized controlled study is to evaluate the efficacy and safety of Biqi capsule in the treatment of KOA. METHODS: This is a prospective randomized controlled trial to study the efficacy and safety of Biqi capsule in the treatment of KOA. The patients were randomly divided into a treatment group and a control group according to 1:1. Among them, treatment group: Biqi capsule combined with diclofenac sodium sustained release tablets; Control group: Diclofenac sodium sustained-release tablets alone. Both groups were treated with standard treatment for 2 weeks and were followed up for 30 days to pay attention to the efficacy and safety indexes. Observation indicators included: the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Hospital for Special Surgery Knee Score (HSS), liver and kidney function, adverse reactions, and so on. SPSS 25.0 software is used for data analysis. DISCUSSION: This study will evaluate the efficacy and safety of Biqi capsule in the treatment of KOA, and the results of this experiment will provide a clinical basis for Biqi capsule in the treatment of KOA. TRIAL REGISTRATION: OSF Registration number: DOI 10.17605/OSF.IO/6HB9D.


Asunto(s)
Artralgia/tratamiento farmacológico , Diclofenaco/administración & dosificación , Medicamentos Herbarios Chinos/administración & dosificación , Osteoartritis de la Rodilla/tratamiento farmacológico , Adulto , Artralgia/diagnóstico , Artralgia/etiología , Cápsulas , Preparaciones de Acción Retardada/administración & dosificación , Preparaciones de Acción Retardada/efectos adversos , Diclofenaco/efectos adversos , Quimioterapia Combinada , Medicamentos Herbarios Chinos/efectos adversos , Femenino , Estudios de Seguimiento , Humanos , Articulación de la Rodilla/efectos de los fármacos , Masculino , Osteoartritis de la Rodilla/complicaciones , Osteoartritis de la Rodilla/diagnóstico , Dimensión del Dolor/estadística & datos numéricos , Estudios Prospectivos , Ensayos Clínicos Controlados Aleatorios como Asunto , Proyectos de Investigación , Comprimidos , Resultado del Tratamiento
6.
Medicine (Baltimore) ; 100(14): e25355, 2021 Apr 09.
Artículo en Inglés | MEDLINE | ID: mdl-33832115

RESUMEN

BACKGROUND: Ulcerative colitis (UC) is a kind of chronic non-specific ulcerative colitis, which is characterized by repeated abdominal pain, diarrhea, and mucus purulent stool. The disease is more recurrent, easy to delay, and canceration, seriously affect the quality of life, increase the economic burden of patients and society, treatment is more difficult, the World Health Organization as one of the modern refractory diseases. Shenling Atractylodes Powder in the treatment of ulcerative colitis showed a strong advantage, the effect is accurate. Therefore, this paper will systematically evaluate and meta-analyze the efficacy and safety of heat-sensitive moxibustion in the treatment of ulcerative colitis. METHODS: Eight electronic databases were searched, including the PubMed, Embase, Web of Science, Cochrane Library, China National knowledge Infrastructure, China Science and Technology Journal Database, Wanfang Database, and China Biomedical Literature Database. We will search in the above electronic database from early 2021 to December without any language restrictions. Outcome indicators, including colonic mucosal symptom score Mayo colonoscopy grading, total effective rate, total incidence of adverse reactions, clinical symptom score, recurrence rate, laboratory indicators: IL-6, IL-9, TNF-α, IL-4, IL-10 inflammation-related factor levels. Rev Man5.3 software will be used for statistical analysis. The efficacy and safety results of Shenling Atractylodes Powder in the treatment of ulcerative colitis will be used as the average difference between the risk ratio of dichotomy data and the 95% co-card interval of continuous data. RESULTS: When this research program is completed, the relevant results can be obtained. ETHICS AND DISSEMINATION: This article does not need to pass the ethics committee review, because this article does not involve the ethics question, only collates the related literature research. The results of this study will be disseminated in the form of a paper to help better guide the clinical practice of heat-sensitive moxibustion in the treatment of ulcerative colitis. REGISTRATION NUMBER: INPLASY202120018.


Asunto(s)
Atractylodes , Colitis Ulcerosa/tratamiento farmacológico , Medicamentos Herbarios Chinos/uso terapéutico , Colitis Ulcerosa/patología , Medicamentos Herbarios Chinos/administración & dosificación , Medicamentos Herbarios Chinos/efectos adversos , Humanos , Mediadores de Inflamación/metabolismo , Polvos , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto , Proyectos de Investigación , Índice de Severidad de la Enfermedad
7.
Medicine (Baltimore) ; 100(12): e25158, 2021 Mar 26.
Artículo en Inglés | MEDLINE | ID: mdl-33761688

RESUMEN

BACKGROUND: Diabetic retinopathy is not only the most common complication of diabetes, but also 1 of the main causes of blindness, which seriously affects the physical and mental health of patients. Panretinal photocoagulation is a common method for the treatment of diabetic retinopathy, but it has some defects. Qiming granule has advantages in the treatment of diabetic retinopathy, but there is a lack of standard clinical research to verify it. Therefore, the purpose of this randomized controlled trial is to evaluate the efficacy and safety of qiming granule combined with laser in the treatment of diabetic retinopathy. METHODS: This is a prospective randomized controlled trial to study the efficacy and safety of Qiming granule combined with laser in the treatment of diabetic retinopathy. Approved by the Clinical Research Society of our hospital. The patients are randomly divided into a treatment group (Qiming granule combined with laser treatment group) or control group (simple laser treatment group). The patients are followed up for 12 months after 6 months of treatment. Observation indexes include total effective rate, corrected visual acuity, macular fovea thickness, adverse reactions and so on. Data are analyzed using the statistical software package SPSS version 18.0 (Chicago, IL). DISCUSSION: This study will evaluate the clinical efficacy and safety of qiming granule combined with laser in the treatment of diabetic retinopathy. The experimental results of this study will provide a reliable reference basis for clinical use of qiming granule combined with laser in the treatment of diabetic retinopathy. TRIAL REGISTRATION: OSF Registration number: DOI 10.17605/OSF.IO/ZEQPB.


Asunto(s)
Retinopatía Diabética/tratamiento farmacológico , Retinopatía Diabética/cirugía , Medicamentos Herbarios Chinos/efectos adversos , Medicamentos Herbarios Chinos/uso terapéutico , Coagulación con Láser/efectos adversos , Coagulación con Láser/métodos , Terapia Combinada , Humanos , Estudios Prospectivos , Resultado del Tratamiento
8.
Medicine (Baltimore) ; 100(12): e25197, 2021 Mar 26.
Artículo en Inglés | MEDLINE | ID: mdl-33761702

RESUMEN

BACKGROUND: Type 2 diabetes mellitus (T2D) and osteoporosis (OP) often coexist, and both are systemic metabolic diseases and seriously increase the risk of fragility fracture. However, there is no specific Western medicine for the treatment of T2D with OP (T2DOP). As reported in clinical and experimental studies, traditional Chinese medicine (TCM) based on principle of tonifying-kidney, strengthening-spleen, and invigorating blood circulation (Bushen-Jianpi-Huoxue) (BSJPHX) has significant efficacy against T2DOP. This protocol will be designed for a systematic review and meta-analysis to assess the efficacy and safety of TCM BSJPHX principle in the treatment of T2DOP. METHODS: All relevant randomized controlled trials (RCTs) related to TCM therapies conducted in BSJPHX principle for T2DOP will be searched in the 8 electronic databases: PubMed, Cochrane Library, Wed of Science, EMBASE, Chinese National Knowledge Infrastructure Database (CNKI), Chinese Biomedical Literatures Database (CBM), Chinese Scientific Journal Database (VIP), Wanfang Database, from inception to October 2020. The main outcomes will contain: fasting blood glucose (FPG), 2 hours postprandial blood glucose (2hPG), glycosylated hemoglobin (HbA1c), serum calcium, bone mineral density (BMD), TCM syndrome integral, and the additional outcomes will consist of visual analog scale (VAS), and adverse events. Two reviewers will independently carry out literature search, data selection and synthesis, and literature quality assessment. In case of any dispute, it will be settled by group discussion. Assessment of risk of bias, reporting bias, and data synthesis would be performed with Review Manager software (Rev-Man 5.3). RESULT: This study will collate and summarize the various current evidences of TCM BSJPHX principle for T2DOP. CONCLUSION: This study will offer convincing evidence for judging the efficacy and safety of TCM BSJPHX principle for T2DOP. PROSPERO REGISTRATION NUMBER: CRD42020218877.


Asunto(s)
Diabetes Mellitus Tipo 2/tratamiento farmacológico , Medicamentos Herbarios Chinos/uso terapéutico , Metaanálisis como Asunto , Osteoporosis/tratamiento farmacológico , Revisiones Sistemáticas como Asunto , Glucemia/metabolismo , Densidad Ósea , Calcio/sangre , Diabetes Mellitus Tipo 2/sangre , Diabetes Mellitus Tipo 2/complicaciones , Medicamentos Herbarios Chinos/efectos adversos , Hemoglobina A Glucada/metabolismo , Humanos , Insulina/sangre , Resistencia a la Insulina , Osteoporosis/sangre , Osteoporosis/complicaciones , Proyectos de Investigación
9.
Zhongguo Zhong Yao Za Zhi ; 46(6): 1523-1536, 2021 Mar.
Artículo en Chino | MEDLINE | ID: mdl-33787151

RESUMEN

To systematically evaluate the efficacy and safety of Yangxue Qingnao Granules combined with conventional Western medicine in the treatment of essential hypertension and its accompanying symptoms. PubMed, EMbase, Cochrane Library, VIP, CNKI, Wanfang, and China biomedical database(CBD) were searched to screen out from the establishment of the database to April 2020 about the clinical randomized controlled trials of Yangxue Qingnao Granules combined with conventional Western medicine in the treatment of essential hypertension and accompanying symptoms. The articles were selected according to the inclusion and exclusion criteria. RevMan 5.3 software was used for Meta-analysis. TSA 0.9.5.10 Beta software was used for sequential analysis, and GRADE 3.6 was used for evidence quality evaluation. A total of 4 532 patients were included in 34 randomized controlled trials. Meta-analysis results showed that: Yangxue Qingnao Granules combined with conventional anti-hypertensive agents reduced systolic blood pressure(MD=-10.56, 95%CI[-13.63,-7.50], P<0.000 01) and diastolic blood pressure(MD=-8.21, 95%CI[-10.84,-5.59], P<0.000 01), improved total effective rate(RR=1.21, 95%CI[1.14, 1.29], P<0.000 01), improved patients dizziness(RR=1.29, 95%CI[1.21, 1.37], P<0.000 01), insomnia(RR=1.66, 95%CI[1.44, 1.91], P<0.000 01), headache(RR=1.32, 95%CI[1.21, 1.43], P<0.000 01), chest distress(RR=1.26, 95%CI[1.12, 1.42], P=0.000 1), memory loss(RR=1.24, 95%CI[1.10, 1.40], P=0.000 4), palpitation(RR=1.28, 95%CI[1.17, 1.41], P<0.000 01), and improved traditional Chinese medicine symptom scores(MD=-4.24, 95%CI[-5.25,-3.23], P<0.000 01) and headache symptom improvement scores(MD=-2.02, 95%CI[-2.51,-1.53], P<0.000 01) as compared with Western medicine group alone. Subgroup analysis results showed that Yang-xue Qingnao Granules combined with ACEI drug had more obvious effects in lowering systolic blood pressure and diastolic blood pressure. There was no statistically significant difference in the incidence of adverse reactions, and no abnormal liver and kidney function was observed in each study. Trial sequential analysis showed that the total effective rate was cumulative across the traditional and TSA thresholds, further confirming its clinical efficacy. The evidence level was mostly low or extremely low in GRADE evaluation. The clinical application of Yangxue Qingnao Granules combined with conventional Western medicine in the treatment of essential hypertension and its accompanying symptoms is clear and safe, so it is recommended for clinical application.


Asunto(s)
Medicamentos Herbarios Chinos , Antihipertensivos/efectos adversos , China , Medicamentos Herbarios Chinos/efectos adversos , Hipertensión Esencial , Humanos , Medicina China Tradicional , Ensayos Clínicos Controlados Aleatorios como Asunto
10.
Medicine (Baltimore) ; 100(13): e25341, 2021 Apr 02.
Artículo en Inglés | MEDLINE | ID: mdl-33787633

RESUMEN

BACKGROUND: Idiopathic thrombocytopenic purpura (ITP) is a common immune system and blood system disease in clinical practice, and it is a hemorrhagic disease caused by immune factors causing platelet destruction and decreasing number of platelets. There is currently no effective treatment plan for ITP. At this stage, glucocorticoid and gamma globulin are mostly used in the treatment of ITP, and some patients use splenectomy to achieve therapeutic purposes, but the various treatment methods are inadequate. At this stage, a large number of randomized controlled studies have reported that Chinese herbal medicine has achieved good curative effect in the treatment of ITP. However, due to the variety of Chinese herbal medicine, there has been no evidence of the effectiveness and safety of Chinese herbal medicine in the treatment of ITP. Because of the above reasons, this study uses the network meta-analysis method based on Bayesian method to compare the clinical efficacy and safety of different kinds of Chinese herbal medicine in the treatment of ITP through direct and indirect comparison, in order to provide evidence-based medical support for the treatment of ITP with Chinese herbal medicine. METHODS: This study uses the method of combining free words with theme words, and using computer to retrieve PubMed, EMbase, The Cochrane Library, WANFANG Database, CNKI, and VIP Database, etc, to collect the randomized control studies on Chinese herbal medicine in the treatment of ITP. The retrieval time is from the establishment of each database to January 2021, and the retrieval languages are Chinese and English. Two researchers independently read the title, abstract and full text of the article to determine whether it is included in the literature; In the event of a disagreement, a third researcher will join the discussion to resolve the disagreement; For the literature that lacks information, trying to contact the original author of the document to supplement it. The literature quality evaluation carried out by using the Stata 14.0 software to draw network and funnel plots, in accordance with the quality evaluation criteria of version 5.1.0 of the Cochrane System Evaluation Manual. Statistical analysis is performed by using ADDIS 1.16.8 software based on the Bayesian model. RESULTS: This study will compare the clinical efficacy and safety of different types of Chinese herbal medicine in the treatment of idiopathic thrombocytopenic purpura through the method of network meta-analysis, and rank the different types of Chinese herbal medicine according to their effectiveness, and the results will be published in a peer-reviewed, high-quality academic journal. CONCLUSION: This study will find effective and safe Chinese herbal medicine for clinical treatment of ITP from the perspective of evidence-based medicine, and benefit more ITP patients.


Asunto(s)
Medicamentos Herbarios Chinos/administración & dosificación , Púrpura Trombocitopénica Idiopática/tratamiento farmacológico , Teorema de Bayes , Medicamentos Herbarios Chinos/efectos adversos , Medicina Basada en la Evidencia/métodos , Humanos , Metaanálisis en Red , Revisiones Sistemáticas como Asunto , Resultado del Tratamiento
11.
Medicine (Baltimore) ; 100(13): e25383, 2021 Apr 02.
Artículo en Inglés | MEDLINE | ID: mdl-33787645

RESUMEN

INTRODUCTION: Diastolic heart failure (DHF) is an important pathological type of heart failure, that involves multiple organ dysfunction and multiple complications. The prevalence of DHF is high, and effective treatments are lacking. Chinese herbs are an alternative therapy for DHF. Shen'ge formula (SGF) is a classical formula from which patients can benefit, but convincing evidence of its efficacy is lacking. Therefore, we designed this randomized controlled trial protocol. METHODS/DESIGN: This randomized, double-blind, placebo-controlled clinical trial will evaluate the efficacy and safety of SGF in the treatment of DHF. A total of 130 patients with DHF will be enrolled in the trial and treated with SGF granules or placebo for 12 weeks and followed up for 12 weeks. The primary outcome measurement will be to changes in plasma N-terminal brain natriuretic peptide precursor before versus after treatment, while the second primary outcome measurement will be changes in heart function before versus after treatment and the 12-week follow-up period. It will also include echocardiography, a cardiopulmonary exercise test, cardiac function grading, traditional Chinese medicine syndrome score, and the Minnesota Heart Failure Quality of Life Scale. Adverse events will be evaluated throughout the trial. DISCUSSION: The results of this trial will demonstrate whether SGF could alleviate symptoms, improve cardiac function, reduce readmission rates, and improve quality of life of patients with DHF. TRIAL REGISTRATION: Chinese Clinical Trial Register, ChiCTR2000036533, registered on August 24, 2020.


Asunto(s)
Medicamentos Herbarios Chinos/administración & dosificación , Insuficiencia Cardíaca Diastólica/tratamiento farmacológico , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Método Doble Ciego , Medicamentos Herbarios Chinos/efectos adversos , Ecocardiografía , Prueba de Esfuerzo , Femenino , Estudios de Seguimiento , Insuficiencia Cardíaca Diastólica/sangre , Insuficiencia Cardíaca Diastólica/complicaciones , Insuficiencia Cardíaca Diastólica/diagnóstico , Humanos , Masculino , Persona de Mediana Edad , Péptido Natriurético Encefálico/sangre , Placebos/administración & dosificación , Placebos/efectos adversos , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto , Resultado del Tratamiento , Adulto Joven
12.
Zhongguo Zhong Yao Za Zhi ; 46(3): 694-702, 2021 Feb.
Artículo en Chino | MEDLINE | ID: mdl-33645037

RESUMEN

To evaluate the efficacy and safety of Compound Glycyrrhizin Injection(CGI) in improving liver damage in chronic hepatitis B(CHB). PubMed, Web of Science, SinoMed, CNKI, Wanfang and VIP databases were retrieved from their inception to February 10, 2020. The randomized controlled trial(RCT) of CGI in the treatment of CHB was included. Data were independently extracted by two authors, and the methodological quality was evaluated using the Cochrane bias risk assessment tool by other two authors. Statistical analysis was performed using RevMan 5.3 software. A total of 18 two-armed RCTs were included, involving 1 915 participants. The methodological quality of all studies included was generally low. In the comparison between CGI and diammonium glycyrrhizinate, the results showed that CGI was superior to the control group in improving the overall clinical effectiveness, but there was no statistical difference between the two groups in increasing ALT normalization rate, reducing ALT and AST level. In the comparison between CGI and diammonium glycyrrhizinate+other general hepatoprotective drugs, the results showed that CGI was superior to the control group in reducing AST level, while there was no statistical difference between the two groups in reducing ALT level and increasing overall clinical effectiveness. In the comparison between CGI+other commonly used drugs(including energy mixture, glutathione, vitamins, potassium magnesium aspartate) and diammonium glycyrrhizinate+other commonly used drugs, the results showed that CGI combined with other commonly used drugs was better than the control group in reducing ALT and AST level and improving the clinical total effective rate, and there was no statistical difference between the two groups in increasing the rate of ALT normalization. In the comparison between CGI+other commonly used drugs and other commonly used drugs, the results showed that CGI combined with other commonly used drugs was superior to the control group in reducing ALT and AST level and improving the overall clinical effectiveness. In the comparison between CGI+vitamins and diammonium glycyrrhizinate+potassium magnesium aspartate+vitamins, the results showed no statistical difference between the two groups in reducing AST level. A small number of studies included reported that CGI caused mild adverse reactions when used alone or in combination with other drugs. Based on the results, CGI has a certain effect in improving CHB liver damage, but the evidence is not enough to prove that CGI would cause serious adverse events. In the future, more well-designed and strictly-enforced RCT with an adequate sample size are needed to further evaluate the effect CGI in alleviating CHB liver damage.


Asunto(s)
Medicamentos Herbarios Chinos , Hepatitis B Crónica , Medicamentos Herbarios Chinos/efectos adversos , Ácido Glicirrínico , Hepatitis B Crónica/tratamiento farmacológico , Humanos
13.
Zhongguo Zhong Yao Za Zhi ; 46(3): 712-721, 2021 Feb.
Artículo en Chino | MEDLINE | ID: mdl-33645039

RESUMEN

This study aimed to comprehensively analyze and compare the differences of different clinical study types currently published in the safety evaluation of Xuebijing Injection. Six databases, namely the Cochrane Library, PubMed, EMbase, CNKI, VIP and Wanfang database, were electronically retrieved to collect all types of studies on the safety of Xuebijing Injection, including randomized controlled trials, case-controlled studies, cohort studies, systematic reviews, and centralized monitoring studies of clinical safety(hospital), in order to comprehensively and objectively evaluate the safety of Xuebijing Injection, and analyze the differences of different research results. A total of 211 literatures were included, involving a total of 46 384 patients treated with Xuebijing Injection, and 423 adverse reactions(ADRs) occurred. They included 191 randomized controlled trials, 3 cohort studies, 15 systematic reviews, and 2 centralized monitoring studies of clinical safety(hospital), and the incidence of adverse reactions was 2.54%(common), 2.31%(common), 0.95%(occasionally), and 0.50%(occasionally). More than half of the 423 cases of ADRs occurred in skin and adnexal system(151 cases) and gastrointestinal system(65 cases), including such manifestations as rash, skin itching, nausea and vomiting, diarrhea. The degree of ADRs was mild. Randomized controlled trials showed that the incidence of ADR was the highest when Xuebijing Injection was used for malignant tumor and multiple organ failure. And the systematic evaluation showed that the incidence of ADR was the highest when Xuebijing Injection was used for spontaneous peritonitis of liver cirrhosis. In conclusion, different study types could lead to significant differences in the results of drug safety evaluation. Sample size, study type, and quality control are the main factors for biased results. Due to large sample size and high-quality, centralized monitoring studies become the better clinical safety evaluation model of drugs at present, and full life cycle management could more objectively reflect drug safety and guide clinical rational drug use.


Asunto(s)
Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Medicamentos Herbarios Chinos , Estudios de Casos y Controles , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Medicamentos Herbarios Chinos/efectos adversos , Humanos , Inyecciones
14.
Zhongguo Zhong Yao Za Zhi ; 46(1): 214-224, 2021 Jan.
Artículo en Chino | MEDLINE | ID: mdl-33645073

RESUMEN

To systemically evaluate the efficacy and safety of sinomenine combined with methotrexate(SIN+MTX) in the treatment of rheumatoid arthritis(RA). Literature databases of Wanfang, CNKI, VIP, SinoMed, PubMed, Cochrane Library and Web of Science were retrieved comprehensively for relevant clinical trials. The literature retrieval time was from database establishment to February 4, 2020. The quality of literatures was assessed by the Cochrane Evaluation Handbook 5.1.0, and qualified literature was reviewed and analyzed by using the RevMan 5.3 statistical software. Twenty randomized controlled trials met the inclusion criteria, and were enrolled in the Meta-analysis. The results showed that SIN+MTX remarkably reduced DAS28(MD=-0.85, 95%CI[-1.03,-0.67], P<0.000 01), and improved total efficiency(P<0.000 01). SIN+MTX could inhibit swollen joint count(MD=-1.19, 95%CI[-1.75,-0.63], P<0.000 1), tender joint count(MD=-1.58, 95%CI[-2.89,-0.28], P=0.02) and reduce morning stiffness time(MD=-8.44, 95%CI[-11.82,-5.07], P<0.000 01) compared with control group. The results showed that SIN+MTX was equal to control group in grip strength(SMD=0.20,95%CI[-1.11,1.51],P=0.77). SIN+MTX remarkably alleviated the erythrocyte sedimentation rate(MD=-9.87, 95%CI[-14.52,-5.22], P<0.000 1), C-reactive protein(SMD=-0.30, 95%CI[-0.51,-0.09], P=0.005), and rheumatoid factor(MD=-11.23,95%CI[-13.81,-8.65],P<0.000 01). The frequency of adverse reactions were reduced compared with that in the control group(P<0.000 01). Current clinical studies demonstrate that the efficacy and safety of SIN+MTX in the treatment of RA were superior to control group. However, due to the low quality and quantity of the included studies, high-quality randomized controlled trials are necessary to support the clinical evidences.


Asunto(s)
Antirreumáticos , Artritis Reumatoide , Medicamentos Herbarios Chinos , Antirreumáticos/efectos adversos , Artritis Reumatoide/tratamiento farmacológico , Medicamentos Herbarios Chinos/efectos adversos , Humanos , Metotrexato/efectos adversos , Morfinanos
15.
Zhongguo Zhong Yao Za Zhi ; 46(1): 247-252, 2021 Jan.
Artículo en Chino | MEDLINE | ID: mdl-33645076

RESUMEN

To evaluate the efficacy and safety of Compound Danshen Injection combined with Western medicine in the treatment of vascular dementia. Databases of Cochrane Library, PubMed, EMbase, CNKI, SinoMed, VIP, Wanfang Data were electronically retrieved for collecting randomized controlled trial(RCT)about vascular dementia treated with Western medicine alone or combined with Compound Danshen Injection from the year of database establishment to January 2020. Two researchers independently screened out li-teratures, extracted data, and evaluated the risk of bias for inclusion in the study. Meta-analysis was conducted using RevMan 5.3 software. A total of 5 RCTs were included, involving 588 patients, with 299 in treatment group and 289 in control group. Meta-analysis results showed that compared with Western medicine alone, Compound Danshen Injection combined with Western medicine was better in the effective rate(RR=1.23,95%CI[1.14,1.33],P<0.000 01), MMSE score(MD=3.54,95%CI[3.01,4.06],P<0.000 01), ADL score(MD=11.49,95%CI[8.05,14.93],P<0.000 01), the level of CRP(MD=-0.72,95%CI[-1.25,-0.20],P=0.007) and the level of IL-6(MD=-7.64,95%CI[-9.65,-5.63],P<0.000 01). Adverse reactions mainly included rash and skin prick, which did not affect the treatment effect. Based on the findings, the combination of Compound Danshen Injection in the treatment of vascular dementia could improve the effective rates, relieve the mental state damage and improve the daily living ability, with mild adverse reactions and a low incidence. However, due to the low quality of the included literatures, high-quality and large-scale randomized controlled trials are needed for further verification.


Asunto(s)
Demencia Vascular , Medicamentos Herbarios Chinos , Medicina , Salvia miltiorrhiza , Demencia Vascular/tratamiento farmacológico , Medicamentos Herbarios Chinos/efectos adversos , Humanos , Inyecciones
16.
Zhongguo Zhong Yao Za Zhi ; 46(4): 1000-1009, 2021 Feb.
Artículo en Chino | MEDLINE | ID: mdl-33645106

RESUMEN

To systematically evaluate the clinical efficacy and safety of Lianhua Qingwen in the treatment of adult pneumonia. The randomized controlled trial of Lianhua Qingwen combined with conventional Western medicine in the treatment of pneumonia were retrieved from PubMed, EMbase, Wanfang database, VIP database, and CNKI from the establishment of database to March 2020. Two researchers independently conducted literature screening and data extraction, and the third researcher was in charge of arbitration in case of any disagreement. Outcome indicators included total clinical effective rate, symptom improvement time, and incidence of adverse events. R 3.6.1 was used for Meta-analysis, and RevMan 5.3 was used for quality evaluation. Twenty-two studies were included, with a total of 2 007 patients, including 1 017 patients in the experimental group and 990 patients in the control group. The results showed that the total clinical effective rate of the experimental group was higher than that of the control group(RR=1.11, 95%CI[1.08, 1.15], P<0.001), and the antifebrile time(MD=-1.81, 95%CI[-2.42,-1.21], P<0.001), cough duration(MD=-2.32, 95%CI[-2.89,-1.76], P<0.001), rale duration(MD=-2.19, 95%CI[-2.74,-1.63], P<0.001), imaging recovery time(MD=-2.17, 95%CI[-2.76,-1.58], P<0.001) and post-treatment CRP(MD=-4.07, 95%CI[-6.39,-1.75], P<0.001] were all significantly lower than those of the control group. However, it did not proved that the experimental group was safer than the control group(RR=0.84, 95%CI[0.57, 1.24], P=0.382). The results confirmed that Lianhua Qingwen combined with conventional Western medicine in the treatment of pneumonia could improve the clinical treatment efficiency, shorten the time of fever, cough, rale disappearance and imaging recovery, improve CRP index and accelerate the recovery of pneumonia patients. However, the literatures included in this study had a low quality, and the conclusions still need to be further confirmed by more high-quality, multi-center, rigorously designed randomized controlled trial.


Asunto(s)
Medicamentos Herbarios Chinos , Neumonía , Adulto , Tos , Medicamentos Herbarios Chinos/efectos adversos , Humanos , Neumonía/tratamiento farmacológico , Resultado del Tratamiento
17.
Medicine (Baltimore) ; 100(8): e24528, 2021 Feb 26.
Artículo en Inglés | MEDLINE | ID: mdl-33663059

RESUMEN

BACKGROUND: Functional dyspepsia (FD) is a common and frequently-occurring disease in internal medicine. It is known that Liujunzi decoction and acupuncture are widely used in the treatment of FD, but there are few studies on the combination of Liujunzi decoction and acupuncture in the treatment of FD, and its safety and efficacy are still controversial. Therefore, the purpose of this study is to evaluate the efficacy and safety of acupuncture combined with Liujunzi decoction in the treatment of FD. METHODS: We designed a prospective randomized controlled trial. The study protocol was approved by the Clinical Research Ethics Committee of our hospital. Patients with FD were randomly assigned to the treatment group of acupuncture combined with Liujunzi Decoction (the experimental group) and the treatment group of Liujunzi Decoction (the control group) in a ratio of 1:1. Outcome indicators were Nepean Dyspepsia Index, the MOS item short from health survey, and adverse reactions. Finally, SPSS 18.0 software would be used for statistical analysis of the data. DISCUSSION: This study will evaluate the efficacy and safety of acupuncture combined with Liujunzi Decoction in the treatment of FD and provide clinical basis for the use of acupuncture combined with Liujunzi Decoction in the treatment of FD. OSF REGISTRATION NUMBER: DOI 10.17605/OSF.IO/67GKN.


Asunto(s)
Terapia por Acupuntura/métodos , Medicamentos Herbarios Chinos/uso terapéutico , Dispepsia/terapia , Adolescente , Adulto , Anciano , Terapia Combinada , Medicamentos Herbarios Chinos/administración & dosificación , Medicamentos Herbarios Chinos/efectos adversos , Dispepsia/tratamiento farmacológico , Humanos , Persona de Mediana Edad , Estudios Prospectivos , Calidad de Vida , Proyectos de Investigación , Adulto Joven
18.
Medicine (Baltimore) ; 100(8): e24576, 2021 Feb 26.
Artículo en Inglés | MEDLINE | ID: mdl-33663065

RESUMEN

BACKGROUND: Diabetes is a chronic metabolic disease characterized by elevated blood glucose levels due to insulin resistance and ß-cell dysfunction. In China, Huangyusang decoction (HYS) has been widely used to treat Type 2 diabetes. However, there is no systematic review found. In order to evaluate the efficacy and safety of HYS in the treatment of Type 2 diabetes, we need to conduct a meta-analysis and systematic evaluation. METHODS: We will enroll the randomized controlled trials (RCTs) evaluating the effectiveness and safety of HYS in the treatment of Type 2 diabetes. Data come mainly from 4 Chinese databases (CNKI, Wanfang, CBM, and VIP Database) and 4 English databases (PubMed, Embase, Cochrane Library, and Web of science). The enrollment of RCTs is from the starting date of database establishment till January 30, 2021. Fasting blood glucose is considered as the main indicator of the dyslipidemia, while the body mass index, glycated hemoglobin, fasting insulin, triglycerides, and cholesterol are regarded as the secondary indicators. There are safety indicators including liver enzyme and kidney function. The work such as selection of literature, data collection, quality evaluation of included literature, and assessment of publication bias will be conducted by 2 independent researchers. Meta-analysis will be performed by RevMan 5.0 software. RESULTS: This study will provide high-quality evidence for the effectiveness and safety of HYS in the treatment of type 2 diabetes. CONCLUSION: The results of the study will help us determine whether HYS can effectively treat type 2 diabetes. ETHICS AND DISSEMINATION: This study does not require ethical approval. We will disseminate our findings by publishing results in a peer-reviewed journal. OSF REGISTRATION NUMBER: DOI 10.17605/OSF.IO/AXBRV.


Asunto(s)
Diabetes Mellitus Tipo 2/tratamiento farmacológico , Medicamentos Herbarios Chinos/uso terapéutico , Glucemia , Índice de Masa Corporal , Medicamentos Herbarios Chinos/administración & dosificación , Medicamentos Herbarios Chinos/efectos adversos , Hemoglobina A Glucada , Humanos , Pruebas de Función Renal , Lípidos/sangre , Pruebas de Función Hepática , Ensayos Clínicos Controlados Aleatorios como Asunto , Proyectos de Investigación
19.
Medicine (Baltimore) ; 100(8): e24591, 2021 Feb 26.
Artículo en Inglés | MEDLINE | ID: mdl-33663069

RESUMEN

BACKGROUND: Thyroid nodules (TN) are discrete lesions within the thyroid gland and are a common clinical problem detected in 19% to 68% of people. TN are more common as age increases and occur more frequently in women. TN can cause pressure symptoms, cosmetic complaints, and thyroid dysfunction. Treatment for benign thyroid nodules includes thyroid hormone therapy, surgery, radioiodine treatment, percutaneous ethanol injection therapy, and laser or radiofrequency treatment to shrink nodules. In China and many other countries, doctors use Chinese herbal medicines (CHM) to treat TN. However, systematic review and meta-analysis has not been found to assess the effects and safety of CHM in curing TN at present. Hence, the systematic review is conducted to scientifically and methodically evaluate the value of its effectiveness and safety of CHM on TN. METHODS: Literatures related to CHM for TN from the establishment of the database to November 2020 will be retrieved from the following databases: PubMed, Excerpta Medica Database (EMBASE), MEDLINE, Web of Science, Cochrane Library, SpringerLink, WHO International Clinical Trials Registry Platform (ICTRP), Wanfang Database, China National Knowledge Infrastructure (CNKI), Chinese Biomedical Literature Database (CBM), and Chinese Scientific Journal Database (VIP). There are no language restrictions for retrieving literatures. Case reports, animal studies, editorials, expert opinions, reviews without original data, and studies on pediatric population were excluded. Eligible randomized clinical trials (RCTs) evaluating the effectiveness and safety of CHM in TN patients will be put in the study including nodule volume reduction ≥50%, pressure symptoms, cosmetic complaints, quality of life, and adverse events. By scanning the titles, abstracts and full texts, 2 reviewers will independently select studies, extract data, and assess the quality of study. Meta-analysis of RCTs will be conducted using Review Manager 5.1 software. The results will be presented as risk ratio for dichotomous data, and standardized or weighted mean difference for continuous data. RESULT: This study will provide high-quality available evidence for the treatment of TN with CHM based on nodule volume reduction ≥50%, pressure symptoms, cosmetic complaints, quality of life, and adverse events. CONCLUSION: The systematic review will to evaluate the efficacy of CHM in treating benign thyroid nodules in adults and provide evidence for clinicians. INPLASY REGISTRATION NUMBER: INPLASY2020120093.


Asunto(s)
Medicamentos Herbarios Chinos/uso terapéutico , Nódulo Tiroideo/tratamiento farmacológico , Medicamentos Herbarios Chinos/administración & dosificación , Medicamentos Herbarios Chinos/efectos adversos , Humanos , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto , Proyectos de Investigación , Pruebas de Función de la Tiroides
20.
Medicine (Baltimore) ; 100(8): e24663, 2021 Feb 26.
Artículo en Inglés | MEDLINE | ID: mdl-33663075

RESUMEN

BACKGROUND: Varicose veins of the lower extremities are common chronic venous diseases in the clinic. Although Western medicine has various surgical methods to treat varicose veins in the lower extremities, there are still a variety of complications. Some studies have shown that Buyang Huanwu decoction treatment of varicose veins of the lower extremities has a certain effect, and can reduce the occurrence of postoperative complications, but there is no evidence of evidence-based medicine. The research carried out in this scheme is to systematically evaluate the efficacy and safety of Buyang Huanwu decoction in the treatment of varicose veins in the lower extremities, and to provide reliable evidence for guiding clinical practice. METHODS: This is a randomized, double-blind, placebo-controlled, parallel-group clinical trial, which studies the effectiveness and safety of Buyang Huanwu decoction in the treatment of varicose veins of the lower extremities. The patients are randomly and evenly divided into treatment group and control group, the former one is given Buyang Huanwu decoction and the latter one is given placebo. The study will last 49 days, including a 7-day washout period, 14-day intervention and 28-day follow-up, focusing on its efficacy and safety indicators. Observation indicators include: TCM syndrome score, Venous Clinical Severity Score (VCSS), Venous Disability Scote (VDS), Aberdeen Varicose Vein Questionnaire (AVVQ), Hemorheology Indicators, Adverse Reactions, etc. Data analysis is performed using SPSS 25.0 software. DISCUSSION: This study will evaluate the effectiveness and safety of Buyang Huanwu decoction and provide clinical evidence for the treatment of varicose veins of the lower extremities. TRIAL REGISTRATION: OSF Registration number: DOI 10.17605/OSF.IO/WGJXT.


Asunto(s)
Medicamentos Herbarios Chinos/uso terapéutico , Várices/tratamiento farmacológico , Adulto , Anciano , Método Doble Ciego , Medicamentos Herbarios Chinos/administración & dosificación , Medicamentos Herbarios Chinos/efectos adversos , Femenino , Humanos , Extremidad Inferior , Masculino , Persona de Mediana Edad , Proyectos Piloto , Índice de Severidad de la Enfermedad , Adulto Joven
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