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1.
Zhongguo Zhong Xi Yi Jie He Za Zhi ; 36(11): 1304-1307, 2016 Nov.
Artigo em Zh | MEDLINE | ID: mdl-30641620

RESUMO

Objective To observe changing laws of syndrome types of Chinese medicine (CM) in dyslipidemia patients. Methods Totally 439 dyslipidemia patients were recruited. Their syndrome types of CM and blood lipids were.observed at the baseline (at the first visit) , 1st interview (at week 4), 2nd interview (at week 8), and 3rd interview (at week 12), respectively. Analyses of multilayer latent class analysis model were performed in the 4 interviews. Changes of syndrome types of CM were sum- marized as well. Results Asymptomatic patients accounted for 49. 7% of the total number (218/439) at the baseline. Among symptomatic patients, yin deficiency yang predominance syndrome occupied the top (28.2%, 124/439), and followed by sputum turbidity obstruction syndrome (13. 7%, 60/439). At 1st interview there were still 134 asymptomatic patients. Among symptomatic patients, yin deficiency yang predominance syndrome occupied the top (23. 5%, 103/439), and followed by sputum turbidity obstruc- tion syndrome (17. 3% , 76/439). And 70 patients were lost. At 2nd interview blood stasis phlegm stagna- tion syndrome (21. 4%, 79/369) and yin deficiency yang predominance syndrome (19. 5% , 72)369) were main syndrome types. And 64 patients were lost. At 3rd interview sputum turbidity obstruction syndrome (11. 8%, 36)305) and qi-yin deficiency syndrome (11. 1%, 34)305) were main syndrome types. And 50 patients were lost. Conclusions Syndrome types of CM in dyslipidemia patients showed changing and unstable state along with the prolongation of dyslipidemia. It was insufficient to take syndrome types of CM as main therapeutic indicators for clinical research on dyslipidemia.


Assuntos
Dislipidemias , Medicina Tradicional Chinesa , Deficiência da Energia Yin , Yin-Yang , Dislipidemias/classificação , Dislipidemias/diagnóstico , Humanos , Síndrome
2.
Front Pharmacol ; 15: 1351871, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-39015370

RESUMO

Introduction: Fuqi Guben Gao (FQGBG) is a botanical drug formulation composed of FuZi (FZ; Aconitum carmichaelii Debeaux [Ranunculaceae; Aconiti radix cocta]), Wolfberry (Lycium barbarum L. [Solanaceae; Lycii fructus]), and Cinnamon (Neolitsea cassia (L.) Kosterm. [Lauraceae; Cinnamomi cortex]). It has been used to clinically treat nocturia caused by kidney-yang deficiency syndrome (KYDS) for over 30 years and warms kidney yang. However, the pharmacological mechanism and the safety of FQGBG in humans require further exploration and evaluation. Methods: We investigated the efficacy of FQGBG in reducing urination and improving immune organ damage in two kinds of KYDS model rats (hydrocortisone-induced model and natural aging model), and evaluated the safety of different oral FQGBG doses through pharmacokinetic (PK) parameters, metabonomics, and occurrence of adverse reactions in healthy Chinese participants in a randomized, double-blind, placebo-controlled, single ascending dose clinical trial. Forty-two participants were allocated to six cohorts with FQGBG doses of 12.5, 25, 50, 75, 100, and 125 g. The PKs of FQGBG in plasma were determined using a fully validated LC-MS/MS method. Results: FQGBG significantly and rapidly improved the symptoms of increased urination in both two KYDS model rats and significantly resisted the adrenal atrophy in hydrocortisone-induced KYDS model rats. No apparent increase in adverse events was observed with dose escalation. Major adverse drug reactions included toothache, thirst, heat sensation, gum pain, diarrhea, abdominal distension, T-wave changes, and elevated creatinine levels. The PK results showed a higher exposure level of benzoylhypaconine (BHA) than benzoylmesaconine (BMA) and a shorter half-life of BMA than BHA. Toxic diester alkaloids, aconitine, mesaconitine, and hypaconitine were below the lower quantitative limit. Drug-induced metabolite markers primarily included lysophosphatidylcholines, fatty acids, phenylalanine, and arginine metabolites; no safety-related metabolite changes were observed. Conclusion: Under the investigated dosing regimen, FQGBG was safe. The efficacy mechanism of FQGBG in treating nocturia caused by KYDS may be related to the improvement of the hypothalamus-pituitary-adrenal axis function and increased energy metabolism. Clinical Trial Registration: https://www.chictr.org.cn/showproj.html?proj=26934, identifier ChiCTR1800015840.

3.
Zhongguo Zhong Xi Yi Jie He Za Zhi ; 32(8): 1117-20, 2012 Aug.
Artigo em Zh | MEDLINE | ID: mdl-23173265

RESUMO

With the active encouragement of the Chinese government, all domestic clinical research institutes pay more attention to the human research protect program (HRPP) during the process of clinical trials, and actively follow the regulations of medical ethical practice. We could make fully preparation for the accreditation by the correlated international organizations only by further analyzing the Association for Accreditation of Human Research Protection Program (AAHRPP) from a whole and in each accreditation field at different levels, thus having a clear understanding the difference in acknowledging the difference between China's hospitals and America's hospitals.


Assuntos
Acreditação , Ensaios Clínicos como Assunto/legislação & jurisprudência , Política Pública , China , Humanos , Estados Unidos
4.
Zhong Xi Yi Jie He Xue Bao ; 10(10): 1092-8, 2012 Oct.
Artigo em Zh | MEDLINE | ID: mdl-23073192

RESUMO

OBJECTIVE: To develop a patient-reported outcome instrument for chronic gastrointestinal diseases and to select items by analyzing the data from clinical investigation. METHODS: The instrument was developed by establishing the item pool through reviewing the literature on subject of chronic gastrointestinal diseases, interviewing typical cases, focus group discussion and referring to related instruments, and then the processes of selecting and optimizing items, forming primary instrument and testing in a small sample pilot survey. A clinical investigation was conducted in 4 hospitals in Beijing. The data of 274 effective respondents with chronic gastrointestinal diseases were obtained and analyzed for selecting items using SPSS 16.0 software by applying methods such as Cronbach's α coefficient, correlation coefficient, t test, dispersion logistic regression and factor analysis. RESULTS: In the patient-reported outcome instrument, 35 items were selected from investigation. Among the 35 items, 2 items were deleted, and 6 items were modified for further investigation. CONCLUSION: The results of item selection provide a good reference for the primary instrument, which still needs further modification, and lots of work needed to be done, at the base of large sample size.


Assuntos
Gastroenteropatias , Avaliação de Resultados em Cuidados de Saúde , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Doença Crônica , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Projetos Piloto , Inquéritos e Questionários , Adulto Jovem
5.
Zhong Xi Yi Jie He Xue Bao ; 10(1): 39-47, 2012 Jan.
Artigo em Zh | MEDLINE | ID: mdl-22237273

RESUMO

BACKGROUND: Chronic lung diseases, including bronchial asthma, chronic obstructive pulmonary disease (COPD), chronic bronchitis, allergic rhinitis and repeated respiratory tract infection (RRTL) in infants, exacerbate frequently in winter because of respiratory viral infections and low temperature. Summer acupoint application therapy (SAAT) is thought to be effective in reducing exacerbation frequency of chronic lung diseases in winter. It is a kind of therapy using a herbal mixture for external application on special acupoints during summer. The herbal mixture basically contains Semen Sinapis Albae, Herba Asari, Radix Euphorbiae Kansui and Rhizoma Corydalis. The acupoints include Feishu (BL13), Dazhui (GV14) and Danzhong (CV17). Through a large-scale multicenter trial based on three years of clinical observation, and retrospective and prospective analyses, this study aims to explore the efficacy of SAAT. METHODS AND DESIGN: In this clinical observation trial, patients who have been diagnosed with bronchial asthma, COPD, chronic bronchitis, allergic rhinitis or RRTL will be enrolled from 13 centers. All patients enrolled will be treated with SAAT over a two-year period by medical practitioners. After this, an initial case report form (CRF) will be completed and forwarded to the central study site (China Academy of Chinese Medical Sciences, Beijing, China). The CRF is designed to investigate patients' history of medical treatment (including SAAT) and chronic lung disease exacerbation, also self-reported health condition. For retrospective analyses, the authors will focus on those who have accepted SAAT before enrollment and will collect their SAAT history and chronic lung disease exacerbation history, to evaluate the effects of SAAT. For prospective analyses, medical students will follow up with patients by phone interviews in winter once a year. The primary outcome is frequency of chronic lung disease exacerbation in winter. The secondary outcomes include conditions of lung disease recovery, non-SAAT therapy, and a self health report. DISCUSSION: The authors aim to collect 7 400 patients from July 2008 to August 2009. The final follow-up has been completed in December 2010. To reduce the selection bias, a total of 13 clinical centers from different areas of China have participated in this study. The results from this study will provide a high-quality evidence base for evaluating the efficacy of SAAT in reducing exacerbation frequency of chronic lung diseases in winter. TRIAL REGISTRATION NUMBER: This trial has been registered in Chinese Clinical Trial Registry (Identifier: ChiCTR-TNRC-10001292).


Assuntos
Pontos de Acupuntura , Pneumopatias/terapia , Medicina Tradicional Chinesa/métodos , Asma/terapia , Doença Crônica , Estudos de Coortes , Feminino , Humanos , Masculino , Doença Pulmonar Obstrutiva Crônica/terapia , Recidiva , Infecções Respiratórias/terapia , Tamanho da Amostra
6.
Zhongguo Zhen Jiu ; 42(3): 241-9, 2022 Mar 12.
Artigo em Zh | MEDLINE | ID: mdl-35272398

RESUMO

OBJECTIVE: To observe the influence of acupoint application on the use of antibiotics in primary clinic practice, and explore the effect of acupoint application and its influence on the use of antibiotics based on common diseases in primary clinic (fever, cough, diarrhea, sore throat). METHODS: With the help of the internet electronic diagnosis and treatment platform (the main TCM suitable technology promoted by this platform is acupoint application therapy), the diagnosis and treatment data of 1.23 million patients in 2 000 primary clinics from August 24, 2020 to March 31, 2021 were collected. The patients were divided into an application group (acupoint application treatment) and a non-application group (non-acupoint application treatment), and the proportion of antibiotic use in the two groups was compared. The propensity score was used to match age, gender, concomitant symptoms, diagnosed diseases and other confounding factors of treatment, and the disappearance rate of symptoms (fever, cough, diarrhea, sore throat) and the time to first disappearance of symptoms were compared between the two groups. RESULTS: A total of 1 230 923 patients were analyzed, including 1 048 382 cases in the application group, accounting for 85.2%; 182 541 cases in the non-application group, accounting for 14.8%. The most patients who used acupoint application treatment were 0-2 years old, followed by 3-6 years old, and the patients over 15 years old who did not use acupoint application treatment were the most. The proportion of antibiotic use in the application group was 2.4%, lower than that in the non-application group (44.2%, P<0.001). The proportion of antibiotic use in all ages of patients in the application group was lower than that in the non-application group (P<0.001). Among the common diseases in primary clinic (fever, cough, diarrhea and sore throat), the proportion of antibiotic use in the application group was lower than that in the non-application group (P<0.01); the disappearance rate of symptoms in the application group was higher than that in the non-application group, and the time to first disappearance of symptoms was shorter than that in the non-application group (P<0.001). CONCLUSION: Acupoint application has a certain influence on the use of antibiotics in primary clinic patients. In the treatment of common diseases, patients treated with acupoint application have better curative effect and lower proportion of antibiotic use.


Assuntos
Pontos de Acupuntura , Faringite , Adolescente , Antibacterianos/uso terapêutico , Criança , Pré-Escolar , Tosse/tratamento farmacológico , Diarreia , Humanos , Lactente , Recém-Nascido , Faringite/tratamento farmacológico
7.
Zhongguo Zhen Jiu ; 42(4): 390-6, 2022 Apr 12.
Artigo em Zh | MEDLINE | ID: mdl-35403397

RESUMO

OBJECTIVE: To explore the effectiveness on exogenous fever and the characteristics of effective population, as well as the specialties of prescription of acupoint application. METHODS: Using the internet electronic diagnosis and treatment platform (Spring Broadcast Wanxiangyun Clinic Database, and the main TCM suitable technology promoted by this platform is acupoint application therapy), from August 24, 2020 to November 5, 2020, the patients complained with fever and diagnosed as common cold, with a record of initial visit and at least one return visit, were included as the subjects. According to whether acupoint application therapy was received or not, the subjects were divided into an exposure group (with acupoint application therapy, 26 664 cases) and a non-exposure group (without acupoint application therapy, 515 cases). Using the propensity score, the mixed factors, e.g. age and sex, were matched between the two groups. The disappearance rate of fever (within 2 days) and the time for the first fever disappearance were taken as the effect indexes. The association rules extraction was adopted to analyze the characteristics of effective population and acupoint application prescription in treatment of exogenous fever. RESULTS: After propensity score matching, there were 1 229 cases in the application group and 423 cases in the non-application group. The disappearance rate of fever in the application group was 1.82 times as high as that in the non-application group (P<0.05). The time for the first fever disappearance in the application group was shorter than the non-application group (P<0.01). A total of 5 370 cases were effective with acupoint application therapy, of which, the median age was 2 years old and the proportion of children patients under 6 years old was relatively high. In the effective crowd, the most commonly-used acupoints were Shenque (CV 8), Dazhui (GV 14), Yongquan (KI 1) and Tiantu (CV 22), etc. Shenque (CV 8) and Dazhui (GV 14) were highly associated and the support was 62.57%. The most common herbal materials in the acupoint application therapy included Radix et Rhizoma Rhei, Natrii Sulfas, Radix Scutellariae, Herba Ephedrae and Radix Bupleuri, etc. Radix et Rhizoma Rhei and Natrii Sulfas were most commonly used at Shenque (CV 8) and the supports were 57.49% and 57.21% respectively. Herba Ephedrae was most commonly applied to Shenque (CV 8) and Dazhui (GV 14) and the supports were 48.21% and 43.91% respectively. Radix Bupleuri was the most common herb at Dazhui (GV 14) with the support of 46.61%. Besides, the most commonly combined western drugs included cefixime and keteling in the acupoint application therapy and the supports were 13.07% and 12.72% respectively. CONCLUSION: Acupoint application is effective on exogenous fever. The common therapy refers to Radix et Rhizoma Rhei and Natrii Sulfas plaster at Shenque (CV 8), while Herba Ephedrae and Radix Bupleuri at Dazhui (GV 14).


Assuntos
Pontos de Acupuntura , Medicamentos de Ervas Chinesas , Criança , Pré-Escolar , Medicamentos de Ervas Chinesas/uso terapêutico , Febre/terapia , Humanos , Estudos Retrospectivos , Estações do Ano
8.
Front Med (Lausanne) ; 9: 1025833, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36438030

RESUMO

Background: Diabetic Foot (DF) is one of the most common complications of diabetes, and it is characterized by high morbidity, disability, lethality and low cure rate. Traditional Chinese medicine treatment has certain characteristics and advantages in diabetic foot. Due to selective reporting bias and heterogeneity of research results, on the one hand, relevant clinical studies are of low quality and poor practicability, and on the other hand, similar studies cannot be included in meta-analysis to form high-quality evidence-based evidence and evaluate the value of studies. Therefore, the development of a core set of outcomes (COS-TCM-DF) for traditional Chinese medicine for the treatment of diabetic foot is an important way to address these issues. Methods: The COS-TCM-DF project will refer to the developed COS methodology and the steps are divided into four stages: (1) a scoping review and analysis of enrolled research protocols to collect and analyze all existing outcomes that have been used in trials on the prevention or treatment of diabetic foot with Chinese Medicine; (2) qualitative interviews with Diabetic foot patient and attendants to Collect additional outcomes related to them; (3) Gather opinionest and obtain initial consensus from key stakeholders, including patients, clinicians, researchers, and pharmaceutical company staff, through a Delphi survey; (4) a consensus meeting was held to develop the final COS-TCM-DF. Discussion: Currently, there is no COS on measuring or monitoring diabetic foot with TCM in trials or clinical practice. The COS-TCM-DF will be developed to advance the synthesis of evidence regarding the prevention and treatment of diabetic foot in TCM and to promote the standardized and consistent application of results in future studies in this field. Trial registration: Registered with the Core Outcome Measures in Effectiveness Trials (COMET) database, December 2019 https://www.comet-initiative.org/Studies/Details/1553.

9.
Zhongguo Zhen Jiu ; 42(12): 1431-8, 2022 Dec 12.
Artigo em Zh | MEDLINE | ID: mdl-36484199

RESUMO

To compare the clinical efficacy among different acupuncture and moxibustion therapies on stable angina pectoris (SAP) of coronary heart disease by means of network Meta-analysis. The articles of randomized controlled trial (RCT) for SAP of coronary heart disease treated with acupuncture and moxibustion therapies were searched from PubMed, Web of Science, Cochrane Library, CNKI, Wanfang database and VIP database from May 1, 2002 to May 1, 2022. The quality of them was assessed with the risk of bias assessment tool of Cochrane 5.3, and the network Meta-analysis was undertaken with Stata 13.1 software. A total of 29 articles were included with the acupuncture and moxibustion therapies involved, e.g. acupuncture, acupoint application and moxibustion. In comparison with the simple routine western medication, the effective rate was better on SAP treated with the combined treatments, in which, acupoint application, moxibustion, acupuncture and intradermal needling were combined with routine western medication (P<0.05). Of those combined treatments, the combination of the acupoint application with routine western medication had high probability, suggesting the optimal regimen (area under the curve [SUCRA]=0.711, P<0.05). The effective rate of acupuncture combined with routine western medication for ECG improvement was better than that of routine western medication (P<0.05), and such combined treatment was high in probability, underlying its optimal treatment (SUCRA=0.800, P<0.05). Combined with routine western medication, acupuncture, acupoint application, moxibustion and intradermal needling all improve the clinical efficacy on SAP of coronary heart disease. But, with different outcomes considered, the optimal treatments may be different. It needs more multi-central and large-sample randomized controlled trials to validate these results.


Assuntos
Doença das Coronárias , Humanos , Metanálise em Rede , Doença das Coronárias/terapia
10.
Chin J Integr Med ; 28(12): 1059-1062, 2022 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-35851942

RESUMO

In recent years, the real-world studies (RWS) have attracted extensive attention, and the real-world evidence (RWE) has been accepted to support the drug development in China and abroad. However, there is still a lack of standards for the evaluation of the quality of RWE. It is necessary to formulate a quality evaluation and reporting specification for RWE especially in traditional Chinese medicine (TCM). To this end, under the guidance of China Association of Chinese Medicine, the Quality Evaluation and Reporting Specification for Real-World Evidence of Traditional Chinese Medicine (QUERST) Group, including 24 experts (clinical epidemiologists, clinicians, pharmacologists, ethical reviewer and statisticians), was established to develop the specification. This specification contains the listing of classification of RWS design and RWE, the general principles and methods of RWE quality evaluation (26 tools or scales), 25 types of bias in RWS, the special considerations in evaluating the quality of RWE of TCM, and the 19 reporting standards of RWE. This specification aims to propose the quality evaluation principles and key points of RWE, and provide guidance for the proper use of RWE in the development of TCM new drugs.


Assuntos
Medicina Tradicional Chinesa , China
11.
J Tradit Chin Med ; 31(2): 136-40, 2011 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-21977815

RESUMO

OBJECTIVE: To study which items need the formulation of national standards and which standards should be first formulated. METHODS: Apply the method of the questionnaire survey to collect data, and the statistical analysis adopt the frequency and weighted average method. RESULTS: Propose the items of acupuncture and moxibustion which need the urgent formulation of standards and the sequence in the formulation of standard items. CONCLUSION: Provid important bases for the follow-up report of national standard items and avoid temporary formulation of standards without plan.


Assuntos
Terapia por Acupuntura , Química Farmacêutica/normas , Moxibustão , Humanos
12.
Phytomedicine ; 61: 152828, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31055046

RESUMO

BACKGROUND: Alstonia scholaris (Apocynaceae) was reported to be a rich source of indole alkaloids, which exhibited remarkably bioactivities. The leaf of A. scholaris has been used in 'dai' ethno-medicine for treatment of respiratory diseases, and the defined indole alkaloids from leaf of A. scholaris has been registered as investigational new botanical drug (No. 2011L01436) and was approved for phase I/II clinical trials by China Food and Drug Administration (CFDA). PURPOSE: The aim of the trial is to evaluate the safety and explore the relationship of dosing frequency and pharmacokinetics after oral administration of capsule of alkaloids from leaf of A. scholaris (CALAS) at different doses. METHODS: In this randomized, open-labelled, single-center clinical trial, the safety and pharmacokinetics of CALAS were assessed in eligible healthy Chinese volunteers after oral administration of different doses. Each volunteer (n = 10 per group) received single dose of CALAS from 20 mg, 40 mg, 80 mg to 120 mg orally. The pharmacokinetics of CALAS was investigated in healthy Chinese subjects' plasma by a fully-validated LC-MS/MS method. Safety was assessed biochemically and clinically throughout the study, and drug re-excitation research was conducted to verify the correlation between investigational product and minor adverse events. The trial was registered on August 26, 2015 (http://www.chictr.org.cn/showproj.aspx?proj=11736), number ChiCTR-IPR-15006976. RESULTS: 40 subjects completed the study, and as a result, vallesamine had the highest concentration in plasma of healthy volunteers, and the AUC exposure level in each compounds in turn is vallesamine > scholaricine > 19-epischolaricine > picrinine. For the safety evaluation of CALAS, two cases of minor adverse events were observed during the trial, but the drug re-excitation research indicated that these two adverse events were related to the individual's physiological variation. CONCLUSION: Pharmacokinetic characteristics of each ingredient showed different patterns. 19-epischolaricine, vallesamine and picrinine were match to the linear pharmacokinetic characteristics, but scholaricine conformed to the characteristics of nonlinear pharmacokinetics. The CALAS was safe in healthy subjects under the current dose regimen.


Assuntos
Alcaloides/administração & dosagem , Alcaloides/farmacocinética , Alstonia/química , Administração Oral , Adulto , Alcaloides/efeitos adversos , Alcaloides/sangue , Área Sob a Curva , Povo Asiático , Cromatografia Líquida , Feminino , Voluntários Saudáveis , Humanos , Alcaloides Indólicos/sangue , Masculino , Folhas de Planta/química , Reprodutibilidade dos Testes , Espectrometria de Massas em Tandem
13.
Zhong Xi Yi Jie He Xue Bao ; 6(11): 1101-4, 2008 Nov.
Artigo em Zh | MEDLINE | ID: mdl-18990333

RESUMO

Clinical evaluation proceedings from patient-reported outcomes (PRO) are being concerned increasingly. Based on the concept of PRO, the report discusses the findings in the research recently made at home and abroad. PRO from apoplexy patients with spastic paralysis was taken as an example in the exploration of how to evaluate the curative effects in clinical practice on the basis of PRO.


Assuntos
Avaliação de Resultados em Cuidados de Saúde , Humanos , Paraparesia Espástica/terapia , Satisfação do Paciente , Qualidade de Vida , Acidente Vascular Cerebral/terapia , Inquéritos e Questionários
14.
Chin J Integr Med ; 24(8): 573-578, 2018 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-29790064

RESUMO

OBJECTIVE: To investigate the efficacy of integrated Chinese and Western medicine (IM) in the treatment of metastatic colorectal cancer (mCRC) in a cohort study. METHODS: The survival outcome of patients receiving IM was compared with that of patients receiving Western medicine alone. The study design was adopted with "continuous administration of Chinese medicine for ⩾ 3 months" as the exposure factor. Patients who met this exposure factor were assigned to the IM cohort (Group A, 110 patients). Patients who did not meet this exposure factor were assigned to the Western medicine cohort (Group B, 225 patients). The overall survival (OS), progression-free survival (PFS), and 1st year, 2nd year, and 3rd year survival in the two cohorts were compared. RESULTS: The median OS in Group A and B were 18 months [95% confidence interval (CI) 15-21] and 16 months (95% CI 14-18), respectively, and the median PFS in Group A and B were 6 months (95% CI 4-7) and 5 months (95% CI 4-6), respectively. No statistically significant differences were observed between the groups (P=0.186, P=0.223). Group A demonstrated significantly longer OS and PFS than Group B in the following subgroups: female patients, patients with lesions in the right half of the colon, and those who received first-line treatment (P<0.05). In the subgroup of elderly patients (age>65 years), the OS in Group A was longer than that in Group B (P<0.05). CONCLUSION: IM could prolong the survival of patients with mCRC. (Registry No. ChiCTR-IOR-17010497).


Assuntos
Antineoplásicos/uso terapêutico , Neoplasias Colorretais/tratamento farmacológico , Neoplasias Colorretais/patologia , Medicamentos de Ervas Chinesas/uso terapêutico , Medicina Integrativa , Idoso , Estudos de Coortes , Neoplasias Colorretais/mortalidade , Intervalo Livre de Doença , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Prognóstico , Taxa de Sobrevida
15.
Trials ; 17: 412, 2016 08 18.
Artigo em Inglês | MEDLINE | ID: mdl-27538952

RESUMO

BACKGROUND: The risk of cardiovascular events remains high in patients with coronary heart disease (CHD) after successful percutaneous coronary intervention (PCI). Panax quinquefolius saponin, a major component of Xinyue capsule, has been used to treat patients with CHD. The aim of this study is to evaluate the efficacy and safety of Xinyue capsules in patients with CHD after PCI. METHODS/DESIGN: This study is a multicenter, placebo-controlled, double-blind, randomized controlled clinical trial. A total of 1100 participants are randomly allocated to two groups: the intervention group and a placebo group. The intervention group receives Xinyue capsules plus conventional treatment, and the placebo group receives placebo capsules plus conventional treatment. The patients receive either Xinyue or placebo capsules three times daily (1.8 g/day) for up to 24 weeks. The primary outcome measure is the time from randomization to the first occurrence of major adverse cardiovascular events. The secondary outcome measure is the time from randomization to the first occurrence of stroke, pulmonary embolism, and peripheral vascular events, as well as death due to any cause. All outcome measures will be assessed at 12, 24, 36, and 48 weeks after randomization. Adverse events will be monitored during the trial. DISCUSSION: The aim of this study is to evaluate the effects of Xinyue capsules on patients with CHD after interventional treatment. The results of this trial will provide critical evidence regarding Chinese herbal medicine treatment for CHD. TRIAL REGISTRATION: Chinese Clinical Trials Registry identifier ChiCTR-IPR-14005475. Registered on 10 November 2014.


Assuntos
Doença das Coronárias/cirurgia , Morte Súbita Cardíaca/prevenção & controle , Medicamentos de Ervas Chinesas/uso terapêutico , Infarto do Miocárdio/prevenção & controle , Intervenção Coronária Percutânea , Saponinas/uso terapêutico , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Cápsulas , Relação Dose-Resposta a Droga , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estatísticas não Paramétricas , Fatores de Tempo
16.
Chin J Integr Med ; 2015 Nov 23.
Artigo em Inglês | MEDLINE | ID: mdl-26597284

RESUMO

A clinical practice guideline of acupuncture for depression was compiled according to the grading of recommendations assessment, development and evaluation (GRADE) method, including the clinical characteristics, diagnosis, treatment and other information about depression, while several acupuncture treatments of depression, severe depression, depression after stroke were recommended.

17.
Zhongguo Zhen Jiu ; 30(12): 1038-40, 2010 Dec.
Artigo em Zh | MEDLINE | ID: mdl-21290847

RESUMO

Based on the optimum clinical evidence, consulting the international guide, the outstanding guidelines of acupuncture clinical practices is formulated in order to promote the process of acupuncture modernization and internationalization. According to consensus of experts, using the questionnaire method, integrating the characteristics and requirements for acupuncture clinical practices, the guidelines reflect the characteristics of acupuncture, for instance, applicability, inheritance, holism, and the discipline characteristics. Thus, the guidelines will standardize the treatments in acupuncture clinical practices, strengthen medical service quality management, control medical costs, and promote the process of acupuncture modernization and internationalization.


Assuntos
Terapia por Acupuntura/normas , Humanos , Guias de Prática Clínica como Assunto , Padrões de Prática Médica/normas
18.
Zhongguo Zhen Jiu ; 30(8): 647-52, 2010 Aug.
Artigo em Zh | MEDLINE | ID: mdl-20942281

RESUMO

Based on ZhangShi YiTong written by ZHANG Lu of Qing dynasty, and the record that external application of Baijiezi (seeds of Brassica Alba) for treating asthma of cold syndrome, retrospective study is conducted to modern literature of treating winter diseases in summer with acupoint sticking therapy for preventing and treating chronic cough and asthma. Learning from thoughts and methods of evidence-based medicine, and according to subject characteristics of TCM and acupuncture, acupoints and point-selecting discipline of prescription for preventing and treating chronic cough and asthma in summer with acupoint sticking are analyzed. The results show that the top ten common acupoints used for acupoint sticking therapy of treating winter diseases in summer are Feishu (BL 13), Dingchuan (EX-B 1), Xinshu (BL 15), Geshu (BL 17), Danzhong (CV 17), Shenshu (BL 23), Gaohuang (BL 43), Dazhui (GV 14), Pishu (BL 20), Tiantu (CV 22), most of which belong to the Bladder Meridian of Foot-Taiyang, Conception Vessel and Governor Vessel or extra-meridian points. It refers that the core acupoints of acupoint sticking therapy are Feishu (BL 13), Dingchuan (EX-B 1), Xinshu (BL 15), Geshu (BL 17), Danzhong (CV 17), and adjunct points can be selected by syndrome, disease different stage, disease or symptoms.


Assuntos
Pontos de Acupuntura , Asma/prevenção & controle , Tosse/prevenção & controle , Medicamentos de Ervas Chinesas/uso terapêutico , Asma/tratamento farmacológico , Ensaios Clínicos como Assunto , Tosse/tratamento farmacológico , Prescrições de Medicamentos , Humanos , Estações do Ano
19.
Zhongguo Zhen Jiu ; 29(9): 755-8, 2009 Sep.
Artigo em Zh | MEDLINE | ID: mdl-19803248

RESUMO

Based on the literatures about the optimized effectiveness of the acupoint sticking therapy for diseases which are attacked in winter but are treated in summer, the main constituent elements of plaster, acupoints, the dose and the application time are reviewed and analyzed. It is suggested that the stepwise procedures are adoped to accumulate clinical evidence, standardize the technique instructions based on the clinical evidences, and perform high quality clinical trials.


Assuntos
Pontos de Acupuntura , Tratamento Farmacológico/métodos , Medicamentos de Ervas Chinesas/uso terapêutico , Ensaios Clínicos como Assunto , Tratamento Farmacológico/normas , Humanos , Estações do Ano , Resultado do Tratamento
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