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1.
Diabetes Obes Metab ; 26(2): 548-556, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-37860884

RESUMO

AIMS: To evaluate the impact of a dual glucose-dependent insulinotropic peptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist tirzepatide (TZP), and its potential dose-response effect, on heart rate. METHODS: Articles were searched from PubMed, Web of Science, Embase, Cochrane Library, and clinical trials registries (ClinicalTrials.gov) databases. Randomized controlled trials (RCTs) comparing TZP at doses of 5, 10 and 15 mg in adults with type 2 diabetes were included. Six study arms were summarized from original research (TZP 5, 10 and 15 mg, GLP-1 receptor agonists [GLP-1RAs], insulin, placebo). The GLP-1RA and non-GLP-1RA groups were combined to form a control group. Two reviewers independently extracted data and assessed the quality of each study. Mean differences (MDs) were calculated as effect estimates for continuous outcomes. Pairwise meta-analyses and network meta-analyses were conducted. The study protocol was prospectively registered (PROSPERO ID: CRD42023418551). RESULTS: Eight articles were included in this systematic review and meta-analysis. The mean baseline heart rate ranged from 65.2 to 75.7 beats per minute. Pairwise meta-analysis showed that, compared with combined the control group, there were significantly greater increases in heart rates in the TZP group (MD 1.82, 95% confidence interval [CI] 0.75, 2.89). Similar significant rises were identified when comparing TZP with GLP-1RAs and non-GLP-1RAs (GLP-1 RAs: MD 2.29, 95% CI 1.00, 3.59; non-GLP-1RAs: MD 1.58, 95% CI 0.26, 2.91). TZP 5 mg was associated with smaller increases in heart rates compared to TZP 10 mg and TZP 15 mg (TZP 10 mg: MD -0.97, 95% CI -1.79, -0.14; TZP 15 mg: MD -2.57, 95% CI -3.79, -1.35). TZP 10 mg increased heart rate less than TZP 15 mg (MD -1.5, 95% CI -2.38, -0.82). Network meta-analysis indicated that TZP 15 mg was associated with significant increases in heart rate compared with TZP 5 mg (MD 2.53, 95% CI 1.43, 3.62), TZP 10 mg (MD 1.44, 95% CI 0.35, 2.53), GLP-1RAs (MD 3.46, 95% CI 1.67, 5.25), insulin (MD 2.86, 95% CI 1.32, 4.41) and placebo (MD 2.96, 95% CI 1.36, 4.57). CONCLUSIONS: Our study showed not only that there was a greater increase in heart rate in the TZP group than in the control, GLP-1RA and non-GLP-1RA groups, but also that the 15-mg dose of TZP had the strongest impact on increasing heart rates compared with the other five inventions, with a TZP dose-response impact on heart rate. Further research on the effects of TZP treatment-related increases in heart rate is required.


Assuntos
Diabetes Mellitus Tipo 2 , Polipeptídeo Inibidor Gástrico , Adulto , Humanos , Diabetes Mellitus Tipo 2/complicações , Polipeptídeo Inibidor Gástrico/agonistas , Peptídeo 1 Semelhante ao Glucagon/agonistas , Receptor do Peptídeo Semelhante ao Glucagon 1/agonistas , Agonistas do Receptor do Peptídeo 1 Semelhante ao Glucagon/farmacologia , Frequência Cardíaca/efeitos dos fármacos , Insulina/uso terapêutico , Metanálise em Rede
2.
BMC Public Health ; 23(1): 1361, 2023 07 15.
Artigo em Inglês | MEDLINE | ID: mdl-37454041

RESUMO

BACKGROUND: High fasting plasma glucose (HFPG) is the fastest-growing risk factor for cancer deaths worldwide. We reported the cancer mortality attributable to HFPG at global, regional, and national levels over the past three decades and associations with age, period, and birth cohort. METHODS: Data for this study were retrieved from the Global Burden of Disease Study 2019, and we used age-period-cohort modelling to estimate age, cohort and period effects, as well as net drift (overall annual percentage change) and local drift (annual percentage change in each age group). RESULTS: Over the past 30 years, the global age-standardized mortality rate (ASMR) attributable to HFPG has increased by 27.8%. The ASMR in 2019 was highest in the male population in high sociodemographic index (SDI) areas (8.70; 95% CI, 2.23-18.04). The net drift for mortality was highest in the female population in low SDI areas (2.33; 95% CI, 2.12-2.55). Unfavourable period and cohort effects were found across all SDI quintiles. Cancer subtypes such as "trachea, bronchus, and lung cancers", "colon and rectal cancers", "breast cancer" and "pancreatic cancer" exhibited similar trends. CONCLUSIONS: The cancer mortality attributable to HFPG has surged during the past three decades. Unfavourable age-period-cohort effects on mortality were observed across all SDI quintiles, and the cancer mortality attributable to HFPG is expected to continue to increase rapidly in the future, particularly in lower SDI locations. This is a grim global public health issue that requires immediate attention.


Assuntos
Glicemia , Neoplasias , Humanos , Masculino , Feminino , Anos de Vida Ajustados por Qualidade de Vida , Carga Global da Doença , Fatores de Risco , Saúde Global , Jejum , Estudos de Coortes
3.
J Interv Cardiol ; 2022: 6361398, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35185397

RESUMO

OBJECTIVE: To evaluate the correlation between the TIMI frame count, IMR, and CFR in coronary microvascular disease (slow flow phenomenon). METHODS: TFC and IMR were recorded in the nitroglycerin and ATP administration states, and the relationship between TFC, IMR, and CFR in specific states was analyzed. RESULTS: A total of 41 patients with baseline TFC >25 frames on coronary angiography were enrolled, and nitroglycerin reduced TFC by 50% from baseline in 24 (58.54%) patients; 16 of the remaining 17 patients were able to achieve a 50% reduction in TFC by further intracoronary ATP injection. 10 patients were further tested for IMR, and the results showed significant correlations between baseline TFC and IMR (r = 0.775, P=0.008), TFC and IMR after nitroglycerin (r = 0.875, P=0.001), and the minimal TFC and IMR that could be obtained with nitroglycerin or ATP administration (r = 0.890, P=0.001). There was also a significant correlation between the proportional improvement in TFC and CFR before and after nitroglycerin injection (r = 0.685, P=0.029). In addition, we observed a lower IMR measured after nitroglycerin than after ATP in three patients, suggesting that CMD may be dominated by NO-sensitive vascular such as prearterioles and that an extensive analysis of the target site of CMD may be achieved by stepwise drug administration. CONCLUSION: Induction of TFC in different states by a stepwise drug approach may serve as a potential primary screening method for coronary microcirculatory dysfunction, thereby reducing the need for further IMR or CFR testing.


Assuntos
Nitroglicerina , Fenômeno de não Refluxo , Angiografia Coronária , Circulação Coronária , Vasos Coronários/diagnóstico por imagem , Humanos , Microcirculação , Nitroglicerina/uso terapêutico
4.
Ann Intern Med ; 174(10): 1357-1366, 2021 10.
Artigo em Inglês | MEDLINE | ID: mdl-34399062

RESUMO

BACKGROUND: Acupuncture has promising effects on chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), but high-quality evidence is scarce. OBJECTIVE: To assess the long-term efficacy of acupuncture for CP/CPPS. DESIGN: Multicenter, randomized, sham-controlled trial. (ClinicalTrials.gov: NCT03213938). SETTING: Ten tertiary hospitals in China. PARTICIPANTS: Men with moderate to severe CP/CPPS, regardless of prior exposure to acupuncture. INTERVENTION: Twenty sessions of acupuncture or sham acupuncture over 8 weeks, with 24-week follow-up after treatment. MEASUREMENTS: The primary outcome was the proportion of responders, defined as participants who achieved a clinically important reduction of at least 6 points from baseline on the National Institutes of Health Chronic Prostatitis Symptom Index at weeks 8 and 32. Ascertainment of sustained efficacy required the between-group difference to be statistically significant at both time points. RESULTS: A total of 440 men (220 in each group) were recruited. At week 8, the proportions of responders were 60.6% (95% CI, 53.7% to 67.1%) in the acupuncture group and 36.8% (CI, 30.4% to 43.7%) in the sham acupuncture group (adjusted difference, 21.6 percentage points [CI, 12.8 to 30.4 percentage points]; adjusted odds ratio, 2.6 [CI, 1.8 to 4.0]; P < 0.001). At week 32, the proportions were 61.5% (CI, 54.5% to 68.1%) in the acupuncture group and 38.3% (CI, 31.7% to 45.4%) in the sham acupuncture group (adjusted difference, 21.1 percentage points [CI, 12.2 to 30.1 percentage points]; adjusted odds ratio, 2.6 [CI, 1.7 to 3.9]; P < 0.001). Twenty (9.1%) and 14 (6.4%) adverse events were reported in the acupuncture and sham acupuncture groups, respectively. No serious adverse events were reported. LIMITATION: Sham acupuncture might have had certain physiologic effects. CONCLUSION: Compared with sham therapy, 20 sessions of acupuncture over 8 weeks resulted in greater improvement in symptoms of moderate to severe CP/CPPS, with durable effects 24 weeks after treatment. PRIMARY FUNDING SOURCE: China Academy of Chinese Medical Sciences and the National Administration of Traditional Chinese Medicine.


Assuntos
Terapia por Acupuntura , Dor Pélvica/terapia , Prostatite/terapia , Terapia por Acupuntura/métodos , Adulto , Doença Crônica , Humanos , Masculino , Medição da Dor , Dor Pélvica/etiologia , Prostatite/complicações
5.
Am J Gastroenterol ; 116(5): 1024-1035, 2021 05 01.
Artigo em Inglês | MEDLINE | ID: mdl-33273258

RESUMO

INTRODUCTION: This multicenter, randomized, noninferiority trial compared electroacupuncture with prucalopride for the treatment of severe chronic constipation (SCC). METHODS: Participants with SCC (≤ 2 mean weekly complete spontaneous bowel movements [CSBMs]) were randomly assigned to receive either 28-session electroacupuncture over 8 weeks with follow-up without treatment over 24 weeks or prucalopride (2 mg/d before breakfast) over 32 weeks. The primary outcome was the proportion of participants with ≥3 mean weekly CSBMs over weeks 3-8, based on the modified intention-to-treat population, with -10% as the noninferior margin. RESULTS: Five hundred sixty participants were randomized, 280 in each group. Electroacupuncture was noninferior to prucalopride for the primary outcome (36.2% vs 37.8%, with a difference of -1.6% [95% confidence interval, -8% to 4.7%], P < 0.001 for noninferiority); almost the same results were found in the per-protocol population. The proportions of overall CSBM responders through weeks 1-8 were similar in the electroacupuncture and prucalopride groups (24.91% vs 25.54%, with a difference of -0.63% [95% confidence interval, -7.86% to 6.60%, P = 0.864]). Except during the first 2-week treatment, no between-group differences were found in outcomes of excessive straining, stool consistency, and quality of life. Adverse events occurred in 49 (17.69%) participants in the electroacupuncture group and 123 (44.24%) in the prucalopride group. One non-treatment-related serious adverse event was recorded in the electroacupuncture group. DISCUSSION: Electroacupuncture was noninferior to prucalopride in relieving SCC with a good safety profile. The effects of 8-week electroacupuncture could sustain for 24 weeks after treatment. Electroacupuncture is a promising noninferior alternative for SCC (see Visual Abstract, http://links.lww.com/AJG/B776).


Assuntos
Benzofuranos/uso terapêutico , Constipação Intestinal/terapia , Eletroacupuntura/métodos , Laxantes/uso terapêutico , China , Doença Crônica , Estudos de Equivalência como Asunto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade
6.
Med Educ ; 55(3): 293-308, 2021 03.
Artigo em Inglês | MEDLINE | ID: mdl-32881047

RESUMO

CONTEXT: Synchronous distance education (SDE) has been widely used for health science students in recent years. This study examined the effectiveness and acceptance of SDE compared with traditional education for health science students and explored the potential moderators that could impact the pooled results. METHODS: A systematic review and meta-analysis was conducted of randomised controlled trials (RCTs) from January 2000 to March 2020 searched on nine electronic databases, including Web of Science, PubMed, Cochrane Library, Scopus, EMBASE, CINAHL, ERIC, PsycINFO, and ProQuest Dissertations and Theses. The outcomes measured were knowledge, skills with objective assessments and overall satisfaction with subjective evaluations. The pooled results were calculated using random-model effects, and moderators were explored through meta-regression. RESULTS: A total of seven RCTs with 594 participants were included. At the post-test level, the pooled effect size of knowledge acquisitions (SMD 0.12, 95% CI -0.07-0.32) showed insignificant difference between the SDE and traditional education groups (P = .207), with low heterogeneity (I2  = 17.6%). Subgroup analyses observed no factors that significantly impacted the pooled results of knowledge acquisition at the post-test levels (P for interaction > 0.05). Knowledge gains from pretest to post-test in SDE groups also did not differ significantly between groups (SMD 0.15, 95% CI -0.22-0.53; P = .428). The pooled effect size of skills (SMD 0.02, 95% CI -0.24-0.28; P = .735) was similarly insignificant. The pooled effect size of overall satisfaction (SMD 0.60, 95% CI 0.38-0.83; P < .001) significantly favoured SDE over traditional education. Incorporating two-group studies without randomisations did not significantly change the overall results of knowledge acquisition at the post-test level (SMD -0.002, 95% CI -0.11-0.10; P = .994), with moderate heterogeneity (I2  = 61.9%). CONCLUSIONS: Synchronous distance education was not significantly different from traditional education in effectiveness and had higher satisfaction ratings. Our findings might provide indications for adoptions of online remote education in health science education centres.


Assuntos
Educação a Distância , Educação Médica , Ensaios Clínicos Controlados Aleatórios como Assunto , Estudantes de Ciências da Saúde , COVID-19 , Humanos
7.
Zhongguo Zhong Yao Za Zhi ; 46(9): 2304-2308, 2021 May.
Artigo em Zh | MEDLINE | ID: mdl-34047134

RESUMO

Antiviral Oral Liquid is modified on the basis of Baihu Decoction in Treatise on Febrility Diseases by ZHANG Zhongjing and Qingwen Baidu Yin in Qing Dynasty, with effects in clearing toxic heat, repelling dampness and cooling blood. It is widely used in clinical treatment of common colds, influenza and upper respiratory tract infection, mumps, viral conjunctivitis and hand-foot-mouth disease, with a good clinical efficacy and safety. Based on a questionnaire survey of clinicians and a systematic review of study literatures on Antiviral Oral Liquid, the international clinical practice guidelines development method was adopted to analyze the optimal available evidences and expert experiences in the "evidence-based, consensus-based and experience-based" principles. The consensus was jointly reached by more than 30 multidisciplinary experts nationwide, including clinical experts of traditional Chinese and Western medicine in the field of respiratory diseases and infectious diseases, and methodological experts. In the study, literatures were retrieved based on clinical problems in the clinical survey as well as PICO clinical problems. The GRADE system was used for the classification and evaluation of evidence, and fully combined with clinical expert experience, so as to reach expert consensus by the nominal grouping method. This expert consensus recommended or suggested indications, usage and dosage, course of treatment, intervention time for treatment, and the safety and precautions of Antiviral Oral Liquid for treatment of influenza, and can provide reference for the rational use of this drug in clinical practice.


Assuntos
Doença de Mão, Pé e Boca , Influenza Humana , Antivirais/uso terapêutico , Consenso , Humanos , Influenza Humana/tratamento farmacológico , Medicina Tradicional Chinesa , Guias de Prática Clínica como Assunto
8.
Pharmacol Res ; 161: 105127, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-32791263

RESUMO

We formulated a traditional Chinese medicine (TCM) prescription, Hanshiyi Formula (HSYF), which was approved and promoted by the Wuhan Municipal Health Commission for treating mild and moderate coronavirus disease 2019 (COVID-19). We aimed to evaluate the effect of HSYF on the progression to severe disease in mild and moderate COVID-19 patients. We conducted a retrospective cohort study of patients with mild and moderate COVID-19 in a quarantine station in Wuchang District, Wuhan. Using the real-time Internet information collection application and Centers for Disease Control for the Wuchang District, patient data were collected through patient self-reports and follow-ups. HSYF intervention was defined as the exposure. The primary outcome was the proportion of patients who progressed to a severe disease status, and a stratification analysis was performed. Univariate and multivariate regression analyses were performed to identify influencing factors that may affect the outcome. Further, we used propensity score matching (PSM) to assess the effect of HSYF intervention on the conversion of mild and moderate to a severe disease status. Totally, 721 mild and moderate COVID-19 patients were enrolled, including 430 HSYF users (exposed group) and 291 non-users (control group). No cases in the exposed group and 19 (6.5 %, P < 0.001) cases in the control group progressed to severe disease, and the difference between the two groups (exposed group-control group) was -6.5 % [95 % confidence interval (CI): (-8.87 %, -4.13 %)]. Univariate regression analysis revealed sex (male), age, fever, cough, and fatigue as risk factors for progression to severe disease. After PSM, none of the HSYF users and 7 (4.7 %, P = 0.022) non-users transitioned to severe disease, and the difference between the two groups (exposed group-control group) was -4.7 % [95 % CI: (-8.2 %, -1.2 %)]. Multivariate regression analysis revealed that sex (male) [OR: 3.145; 95 % CI: 1.036-9.545; P = 0.043] and age (> 48 years) [odds ratio (OR): 1.044; 95 % CI: 1.001-1.088; P = 0.044] were independent risk factors for conversion to severe disease. Therefore, HSYF can significantly reduce the progression to severe disease in patients with mild and moderate COVID-19, which may effectively prevent and treat the disease. However, further larger clinical studies are required to verify our results.


Assuntos
Tratamento Farmacológico da COVID-19 , Medicamentos de Ervas Chinesas/uso terapêutico , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , COVID-19/epidemiologia , Criança , Pré-Escolar , China , Estudos de Coortes , Progressão da Doença , Feminino , Humanos , Lactente , Recém-Nascido , Masculino , Pessoa de Meia-Idade , Fatores de Risco , Fatores Sexuais , Resultado do Tratamento , Adulto Jovem
9.
BMC Med Inform Decis Mak ; 20(1): 264, 2020 10 15.
Artigo em Inglês | MEDLINE | ID: mdl-33059709

RESUMO

BACKGROUND: Syndrome differentiation aims at dividing patients into several types according to their clinical symptoms and signs, which is essential for traditional Chinese medicine (TCM). Several previous works were devoted to employing the classical algorithms to classify the syndrome and achieved delightful results. However, the presence of ambiguous symptoms substantially disturbed the performance of syndrome differentiation, This disturbance is always due to the diversity and complexity of the patients' symptoms. METHODS: To alleviate this issue, we proposed an algorithm based on the multilayer perceptron model with an attention mechanism (ATT-MLP). In particular, we first introduced an attention mechanism to assign different weights for different symptoms among the symptomatic features. In this manner, the symptoms of major significance were highlighted and ambiguous symptoms were restrained. Subsequently, those weighted features were further fed into an MLP to predict the syndrome type of AIDS. RESULTS: Experimental results for a real-world AIDS dataset show that our framework achieves significant and consistent improvements compared to other methods. Besides, our model can also capture the key symptoms corresponding to each type of syndrome. CONCLUSION: In conclusion, our proposed method can learn these intrinsic correlations between symptoms and types of syndromes. Our model is able to learn the core cluster of symptoms for each type of syndrome from limited data, while assisting medical doctors to diagnose patients efficiently.


Assuntos
Síndrome da Imunodeficiência Adquirida/diagnóstico , Diagnóstico por Computador/métodos , Medicina Tradicional Chinesa/métodos , Redes Neurais de Computação , Algoritmos , Atenção , Humanos
11.
BMC Cancer ; 19(1): 276, 2019 Mar 28.
Artigo em Inglês | MEDLINE | ID: mdl-30922256

RESUMO

BACKGROUND: The efficacy of bevacizumab combined with erlotinib (B + E) for the treatment of advanced hepatocellular carcinoma, especially for sorafenib-refractory patients, has been observed and evaluated in several trials. We conducted this single arm meta-analysis to generally assess the benefit and risk with B + E for advanced hepatocellular carcinoma. METHODS: The PubMed, Cochrane Library, Embase, ScienceDirect, Web of Science and Scopus databases were searched for related studies. The main outcomes were objective response rate (ORR), disease control rate (DCR), overall survival (OS), progression-free survival (PFS) and adverse effects (AEs). RESULTS: Eight phase II clinical trials including 342 hepatocellular carcinoma patients were analyzed. The pooled ORR was 12.6% (95% CI: 6.3-19.0%), and the pooled DCR was 54.5% (95% CI: 48.9-66.8%). The 16-week PFS rate was 50.2% (95% CI: 38.2-62.2%). The 6- and 12-month OS rates were 77.8% (95% CI: 71.3-84.2%) and 44.9% (95% CI: 36.8-53.0%). The main grade 3-4 AEs were fatigue (11.9%), diarrhea (9.0%), hypertension (6.7%), acne (5.8%) and hemorrhage (5.3%). The only RCT showed that the B + E regimen had a consistent response and equable median OS but fewer toxicities (grade 3-4 AEs: 19% vs. 27%) than sorafenib. Subgroup analysis showed that as a second-line treatment, the B + E regimen had substantial value with a favorable PFS-16w (P = 0.012), OS-12 m (P = 0.048) and a favorable tendency of ORR (P = 0.089), but obvious toxicities in the second-line setting could not be neglected. CONCLUSION: Bevacizumab combined with erlotinib is effective for treating hepatocellular carcinoma patients, especially sorafenib-refractory patients. More well-designed and large-scale RCTs are warranted to prove our findings.


Assuntos
Bevacizumab/administração & dosagem , Carcinoma Hepatocelular/tratamento farmacológico , Cloridrato de Erlotinib/administração & dosagem , Neoplasias Hepáticas/tratamento farmacológico , Protocolos de Quimioterapia Combinada Antineoplásica/administração & dosagem , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Bevacizumab/efeitos adversos , Ensaios Clínicos Fase II como Assunto , Cloridrato de Erlotinib/efeitos adversos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Análise de Sobrevida , Resultado do Tratamento
12.
Med Sci Monit ; 25: 2032-2042, 2019 Mar 19.
Artigo em Inglês | MEDLINE | ID: mdl-30886134

RESUMO

BACKGROUND This systematic review of the literature and meta-analysis aimed to review the evaluation and monitoring of superoxide dismutase (SOD) activity and its clinical significance in gastric cancer. MATERIAL AND METHODS Systematic review involved searching the PubMed, Embase, Ovid, and the China National Knowledge Infrastructure (CNKI) databases. Search terms included 'superoxide dismutase,' and 'gastric cancer.' Studies that included measurements of SOD activity in peripheral blood samples in patients with SOD activity compared with healthy controls. The study was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. RESULTS Ten controlled clinical studies were identified that included six studies that measured SOD in serum, three in erythrocytes, and one study that measured SOD on whole blood. Meta-analysis, using the standardized mean difference (SMD) and the 95% confidence interval (CI), showed that patients with gastric cancer had significantly decreased SOD activity when compared with the healthy controls (SMD, -0.840; 95% CI, -1.463 to -0.218; p=0.008). Subgroup analysis was conducted on SOD distribution in the blood (erythrocyte: SMD, -1.773; 95% CI, -2.504 to -1.042; p=0.000) (serum SMD, -0.322; 95% CI, -1.006-0.361; p=0.355) (whole blood: SMD, -1.251; 95% CI, -1.731 to -0.771; p=0.000) and for male subjects (SMD, -2.090; 95% CI, -2.725 to -1.456; p<0.001). CONCLUSIONS Meta-analysis showed that SOD measurements from blood samples, especially in erythrocytes, had potential as a diagnostic and monitoring parameter in patients with gastric cancer.


Assuntos
Neoplasias Gástricas/enzimologia , Superóxido Dismutase/metabolismo , Biomarcadores Tumorais/sangue , Feminino , Humanos , Masculino , Neoplasias Gástricas/sangue , Superóxido Dismutase/sangue , Superóxido Dismutase-1/sangue , Superóxido Dismutase-1/metabolismo
13.
BMC Musculoskelet Disord ; 20(1): 488, 2019 Oct 27.
Artigo em Inglês | MEDLINE | ID: mdl-31656194

RESUMO

OBJECTIVE: Acupuncture therapy for chronic low back pain (CLBP) has received increasing attention. Nevertheless, the evidence of efficacy and safety of random controlled trials (RCTs) remains controversial. Acupuncture as a complex intervention influenced by many factors, its effectiveness in treating chronic low back pain in the real world is unknown. We will develop a network-based registry study to evaluate the effectiveness and safety of acupuncture for the treatment of chronic low back pain and explore key factors affecting efficacy in the real world. METHODS: A prospective, multi-center and dynamic registry study. All acupuncture related information will be collected through a high-quality structured network platform. Patients with CLBP included in the study met the following criteria: age from 16 to 80 years, using acupuncture as a main therapy and voluntarily signing the informed consent. At least 2000 patients, 27 acupuncturist, and 9 medical centers will be recruited under actual clinical settings at the first stage. Numeric rating scale (NRS), Oswestry Disability Index (ODI) and Effective rate will be measured in pain and functional disability assessment, respectively, as the primary outcome. Evaluation index will be collected at the baseline and follow-up in 1, 4, 12 weeks after the last visit. Hierarchical models and regression analysis will be used to explore the key factors affecting acupuncture effectiveness. Effects between propensity matching groups (Traditional Chinese acupuncture style vs Microacupuncture style, Local acupoint selection vs Non-local acupoint selection, Single Acupuncture vs Combined therapy) will be compared. DISCUSSION: This study will be conducted based on the characteristics of acupuncture therapy in the "Real World". Fundamental factors affecting the clinical effectiveness of acupuncture and the preferred acupuncture regimen in the treatment of CLBP will be identified. Reliable acupuncture evidence for the treatment of CLBP through the registry will be a significant supplement to the RCTs. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR-OOC-17010751 and Acupuncture-Moxibustion Clinical Trial Registry, AMCTR-OOO-17000045 . Registered date on 3 December 2016.


Assuntos
Terapia por Acupuntura , Dor Crônica/terapia , Dor Lombar/terapia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Dor Crônica/diagnóstico , Avaliação da Deficiência , Feminino , Humanos , Dor Lombar/diagnóstico , Masculino , Pessoa de Meia-Idade , Estudos Multicêntricos como Assunto , Medição da Dor , Sistema de Registros/estatística & dados numéricos , Resultado do Tratamento , Adulto Jovem
14.
BMC Complement Altern Med ; 19(1): 300, 2019 Nov 06.
Artigo em Inglês | MEDLINE | ID: mdl-31694613

RESUMO

BACKGROUND: Both doctors' and patients' opinions are important in the process of treatment and healthcare of Chinese medicine. This study is to compare patients' and doctors' treatment satisfaction over the course of two visits in a Chinese medicine outpatient setting, and to explain their respective views. METHODS: Patients' chief complaints were collected prior to the outpatient encounter. The doctor was then asked (through a questionnaire) to state what complaints he or she was prioritizing during the process of diagnosing disease and making a prescription for herbal medicine or acupuncture treatment. On the next visit, both the patient and the doctor completed a questionnaire assessing satisfaction with the treatment of Chinese medicine prescribed in the first visit and administered by the patient at home. A 5-point Likert scales was used to assess the patients' and doctors' satisfaction with treatment. The timing of the follow-up appointment was determined by the doctor. One chief specialist, one associate chief specialist and one attending practitioner in Chinese medicine, and 60 patients having a follow-up appointment with one of the doctors, participated in the study. RESULTS: For 11 patients, their most urgent complaint was different from what the doctor's choose to focus on in his or her treatment. And only one patient refused to comply due to his or her dissatisfaction with the treatment focus of the doctor. Overall, 59 patients completed the satisfaction assessment, and 53 patients visited their doctors for a follow-up appointment. Patients' total satisfaction was higher than their doctors' (mean 3.55 vs. 3.45), and correlation of patients' and doctors' treatment satisfaction was moderate (r = 0.63, P < 0.01). Both of the patients' and doctors' satisfaction ratings were correlated with treatment adherence (P < 0.001). The predictors of their treatment satisfaction were different. Doctors' satisfaction with treatment was a significant factor in the process of making further clinical decisions. CONCLUSION: Patients and doctors form their opinion about the treatment effects in different ways. When evaluating treatment satisfaction, doctor's opinions are also an important indicator of positive or negative clinical effects and affect the subsequent decisions-making.


Assuntos
Assistência Ambulatorial/psicologia , Medicina Tradicional Chinesa/psicologia , Pacientes Ambulatoriais/psicologia , Satisfação do Paciente , Médicos/psicologia , Adulto , Idoso , Tomada de Decisões , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Inquéritos e Questionários , Adulto Jovem
15.
J Stroke Cerebrovasc Dis ; 28(5): 1388-1399, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-30826129

RESUMO

BACKGROUND: Reflex sympathetic dystrophy (RSD) is the common complication among stroke and cerebral injury patients, which is lack of safe and effective treatment. Electroacupuncture (EA) may potentially be a reliably therapy, but the evidence is insufficiency. METHODS: Cochrane Library, MEDLINE, Embase, Chinese National Knowledge Infrastructure, Wan Fang Data, the Chinese Biology Medicine disc, etc., were searched, until July 20, 2018. We included random control trials that contrast EA with conventional rehabilitation therapy for the treatment of RSD. Main outcomes were visual analog scale score and Fugl-Meyer upper limb motor function scoring scale, other outcomes such as Barthel index, and hand swelling score were also collected. Data in included studies were extracted into an excel and pooled by Stata/MP 14.1. RESULTS: We incorporated 13 studies involving 1040 RSD patients and outcomes were from 2 to 6 weeks' follow-up. The analgesic effect between 2 groups had statistically significant difference (weighted mean difference [WMD] = -1.122, 95% confidence interval [CI] [-1.682 to -.562], P = .000], a statistical difference existed in improving dysfunction between 2 groups: (WMD = 6.039, 95% CI [2.231-.916], P = .000). EA groups had a better effect on improving activities of daily life abilities (WMD = 12.170, 95% CI [6.657-17.682], P < .00011] and better detumescence effect (WMD = -.800, 95% CI [-1.972 to -.212], P = .000] contrast to conventional rehabilitation therapy. CONCLUSIONS: This meta-analysis supports that EA has a positive effect on alleviating pain, improving limb dysfunction, and promoting activities of daily living. On account of moderate-quality random control trials and high heterogeneity, further high-quality studies are imperative to optimize the EA treatment program.


Assuntos
Eletroacupuntura , Distrofia Simpática Reflexa/terapia , Reabilitação do Acidente Vascular Cerebral/métodos , Acidente Vascular Cerebral/terapia , Atividades Cotidianas , Adulto , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Ensaios Clínicos Controlados Aleatórios como Assunto , Recuperação de Função Fisiológica , Distrofia Simpática Reflexa/diagnóstico , Distrofia Simpática Reflexa/fisiopatologia , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/fisiopatologia , Fatores de Tempo , Resultado do Tratamento
16.
Am J Obstet Gynecol ; 219(4): 373.e1-373.e10, 2018 10.
Artigo em Inglês | MEDLINE | ID: mdl-30125529

RESUMO

BACKGROUND: Acupuncture has been used for women during menopause transition, but evidence is limited. OBJECTIVE: We sought to evaluate the efficacy of electroacupuncture on relieving symptoms of women during menopause transition. STUDY DESIGN: We conducted a prospective, multicenter, randomized, participant-blinded trial in China mainland. Subjects were randomized to receive 24 treatment sessions of electroacupuncture at traditional acupoints or sham electroacupuncture at nonacupoints over 8 weeks with 24 weeks' follow-up. Primary outcome was the change from baseline in the total score of Menopause Rating Scale at week 8. Secondary outcomes included the changes from baseline in the average 24-hour hot flash score, the Menopause Rating Scale subscale scores, the total score of Menopause-Specific Quality of Life Questionnaire and its subscales, and serum female hormones. All analyses were performed with a 2-sided P value of < .05 considered significant based on the intention-to-treat principle. RESULTS: A total of 360 women (180 in each group) with menopause-related symptoms during menopause transition were enrolled from June 9, 2013, through Dec 28, 2015. At week 8, the reduction from baseline in the Menopause Rating Scale total score was 6.3 (95% confidence interval, 5.0-7.7) in the electroacupuncture group and 4.5 (95% confidence interval, 3.2-5.8) in the sham electroacupuncture group with a between-group difference of 1.8 (95% confidence interval, 0.9-2.8; P = .0002), less than the minimal clinically important difference of 5 points' reduction. For secondary outcomes, the between-group differences for the decrease in the mean 24-hour hot flash score were significant at weeks 8, 20, and 32, but all were less than the minimal clinically important difference in previous reports. Interestingly, the between-group differences for the Menopause-Specific Quality of Life Questionnaire total score reduction were 5.7 at week 8, 7.1 at week 20, and 8.4 at week 32, greater than the minimal clinically important difference of 4 points. Changes from baseline in follicle-stimulating hormone, luteinizing hormone, and estradiol levels at weeks 8 and 20 (P > .05 for all), with the exception of follicle-stimulating hormone/luteinizing hormone ratios (P = .0024 at week 8 and .0499 at week 20), did not differ between groups. CONCLUSION: Among women during menopause transition, 8 weeks' electroacupuncture treatment did not seem to relieve menopausal symptoms, even though it appeared to improve their quality of life. Generalizability of the trial results may be limited by mild baseline menopausal symptoms in the included participants.


Assuntos
Terapia por Acupuntura , Fogachos/terapia , Menopausa , China , Feminino , Fogachos/psicologia , Humanos , Pessoa de Meia-Idade , Estudos Prospectivos , Qualidade de Vida , Método Simples-Cego , Inquéritos e Questionários , Resultado do Tratamento
17.
Ann Intern Med ; 165(11): 761-769, 2016 Dec 06.
Artigo em Inglês | MEDLINE | ID: mdl-27618593

RESUMO

BACKGROUND: Acupuncture has been used for chronic constipation, but evidence for its effectiveness remains scarce. OBJECTIVE: To determine the efficacy of electroacupuncture (EA) for chronic severe functional constipation (CSFC). DESIGN: Randomized, parallel, sham-controlled trial. (ClinicalTrials.gov: NCT01726504). SETTING: 15 hospitals in China. PARTICIPANTS: Patients with CSFC and no serious underlying pathologic cause for constipation. INTERVENTION: 28 sessions of EA at traditional acupoints or sham EA (SA) at nonacupoints over 8 weeks. MEASUREMENTS: The primary outcome was the change from baseline in mean weekly complete spontaneous bowel movements (CSBMs) during weeks 1 to 8. Participants were followed until week 20. RESULTS: 1075 patients (536 and 539 in the EA and SA groups, respectively) were enrolled. The increase from baseline in mean weekly CSBMs during weeks 1 to 8 was 1.76 (95% CI, 1.61 to 1.89) in the EA group and 0.87 (CI, 0.73 to 0.97) in the SA group (between-group difference, 0.90 [CI, 0.74 to 1.10]; P < 0.001). The change from baseline in mean weekly CSBMs during weeks 9 to 20 was 1.96 (CI, 1.78 to 2.11) in the EA group and 0.89 (CI, 0.69 to 0.95) in the SA group (between-group difference, 1.09 [CI, 0.94 to 1.31]; P < 0.001). The proportion of patients having 3 or more mean weekly CSBMs in the EA group was 31.3% and 37.7% over the treatment and follow-up periods, respectively, compared with 12.1% and 14.1% in the SA group (P < 0.001). Acupuncture-related adverse events during treatment were infrequent in both groups, and all were mild or transient. LIMITATIONS: Longer-term follow-up was not assessed. Acupuncturists could not be blinded. CONCLUSION: Eight weeks of EA increases CSBMs and is safe for the treatment of CSFC. Additional study is warranted to evaluate a longer-term treatment and follow-up. PRIMARY FUNDING SOURCE: Ministry of Science and Technology of the People's Republic of China through the Twelfth Five-Year National Science and Technology Pillar Program.


Assuntos
Constipação Intestinal/terapia , Eletroacupuntura , Idoso , China , Doença Crônica , Constipação Intestinal/fisiopatologia , Defecação , Eletroacupuntura/efeitos adversos , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Resultado do Tratamento
18.
BMC Complement Altern Med ; 17(1): 269, 2017 May 18.
Artigo em Inglês | MEDLINE | ID: mdl-28521826

RESUMO

BACKGROUND: There are no generally accepted standards for evaluation of treatment outcomes in traditional Chinese medicine (TCM). Pattern differentiation and individual treatments are recognized as the most distinguishing features of TCM. Therefore, how practitioners determine curative effects is an issue worthy of research, though little has been done in this area up to this point. This study examines perceptions of the effectiveness of TCM treatments and the means of evaluating clinical outcomes from the practitioners' perspective. METHODS: Qualitative analysis of semi-structured interviews. RESULTS: A total of nine TCM practitioners from three university-affiliated hospitals and two scientific institutions participated in the interviews in August 2013. Participants reported evaluation of periodical treatment as an important part of the process of individual treatment based on pattern differentiation. Themes included (1) ways of evaluating treatment outcomes; (2) relationships between treatment outcomes and pathological transformation; and (3) distinguishing manifestations of the healing process from true adverse reactions. These considerations helped determine the optional treatment principles for further follow-up. An additional theme emerged related to the characteristics of diagnosis and treatment in TCM. CONCLUSIONS: Health professionals considered all of the following as important ways of evaluating TCM treatment outcomes: patients' input and subjective experience, physicians' intake and examination, laboratory tests and medical device measurements. Pathological conditions were determined based on all the above factors, and no single factor determined the effectiveness from the practitioners' perspectives. If the patients felt no significant beneficial effects, then it was necessary to judge the effectiveness from adverse effect. The follow-up measures were usually based on the previous treatment, and physicians' satisfaction with each phase of TCM treatment was a significant factor in the process of making further decisions.


Assuntos
Atitude do Pessoal de Saúde , Medicina Tradicional Chinesa/psicologia , Médicos/psicologia , Tomada de Decisões , Estudos de Avaliação como Assunto , Humanos , Masculino , Pessoa de Meia-Idade , Resultado do Tratamento
19.
JAMA ; 317(24): 2493-2501, 2017 06 27.
Artigo em Inglês | MEDLINE | ID: mdl-28655016

RESUMO

Importance: Electroacupuncture involving the lumbosacral region may be effective for women with stress urinary incontinence (SUI), but evidence is limited. Objective: To assess the effect of electroacupuncture vs sham electroacupuncture for women with SUI. Design, Setting, and Participants: Multicenter, randomized clinical trial conducted at 12 hospitals in China and enrolling 504 women with SUI between October 2013 and May 2015, with data collection completed in December 2015. Interventions: Participants were randomly assigned (1:1) to receive 18 sessions (over 6 weeks) of electroacupuncture involving the lumbosacral region (n = 252) or sham electroacupuncture (n = 252) with no skin penetration on sham acupoints. Main Outcomes and Measures: The primary outcome was change from baseline to week 6 in the amount of urine leakage, measured by the 1-hour pad test. Secondary outcomes included mean 72-hour urinary incontinence episodes measured by a 72-hour bladder diary (72-hour incontinence episodes). Results: Among the 504 randomized participants (mean [SD] age, 55.3 [8.4] years), 482 completed the study. Mean urine leakage at baseline was 18.4 g for the electroacupuncture group and 19.1 g for the sham electroacupuncture group. Mean 72-hour incontinence episodes were 7.9 for the electroacupuncture group and 7.7 for the sham electroacupuncture group. At week 6, the electroacupuncture group had greater decrease in mean urine leakage (-9.9 g) than the sham electroacupuncture group (-2.6 g) with a mean difference of 7.4 g (95% CI, 4.8 to 10.0; P < .001). During some time periods, the change in the mean 72-hour incontinence episodes from baseline was greater with electroacupuncture than sham electroacupuncture with between-group differences of 1.0 episode in weeks 1 to 6 (95% CI, 0.2-1.7; P = .01), 2.0 episodes in weeks 15 to 18 (95% CI, 1.3-2.7; P < .001), and 2.1 episodes in weeks 27 to 30 (95% CI, 1.3-2.8; P < .001). The incidence of treatment-related adverse events was 1.6% in the electroacupuncture group and 2.0% in the sham electroacupuncture group, and all events were classified as mild. Conclusions and Relevance: Among women with stress urinary incontinence, treatment with electroacupuncture involving the lumbosacral region, compared with sham electroacupuncture, resulted in less urine leakage after 6 weeks. Further research is needed to understand long-term efficacy and the mechanism of action of this intervention. Trial Registration: clinicaltrials.gov Identifier: NCT01784172.


Assuntos
Eletroacupuntura/métodos , Incontinência Urinária por Estresse/terapia , Pontos de Acupuntura , Adulto , Idoso , China , Eletroacupuntura/efeitos adversos , Eletroacupuntura/estatística & dados numéricos , Feminino , Humanos , Incidência , Região Lombossacral , Pessoa de Meia-Idade , Fatores de Tempo , Resultado do Tratamento , Incontinência Urinária por Estresse/epidemiologia
20.
Zhongguo Zhong Yao Za Zhi ; 42(1): 6-9, 2017 Jan.
Artigo em Zh | MEDLINE | ID: mdl-28945018

RESUMO

Along with the increase of clinical application, the safety of traditional Chinese medicine gained more and more attentions. In particular, the safety evaluation of Chinese medical injections has become a mandatory task should be completed by pharmaceutical companies under the supervision of China Food and Drug Administration(CFDA). Due to the weak foundation of previous studies, the safety issues of Chinese medical injections have not been fully understood, and lack of scientific and rational risk management programs. Clinical safety centralized monitoring(CSCM) is an important method for post-market safety evaluation of Chinese medicine. Due to the lack of appropriate norms and procedures, the quality of similar research is uneven, and the results vary. Combined with practical experience with experts' suggestions, we developed this expert consensus on the design and implementation of CSCM from three stages (design, implementation and report) with 20 technical points, which will provide technical support for future CSCM studies.


Assuntos
Medicina Tradicional Chinesa/normas , Vigilância de Produtos Comercializados , China , Consenso , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Medicamentos de Ervas Chinesas/efeitos adversos , Medicamentos de Ervas Chinesas/normas , Humanos , Injeções , Controle de Qualidade
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