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1.
Beijing Da Xue Xue Bao Yi Xue Ban ; 52(5): 948-951, 2020 Oct 18.
Artigo em Chinês | MEDLINE | ID: mdl-33047735

RESUMO

OBJECTIVE: To assess the effects of loupes and microscope on the posture of prosthodontists when preparing the laminate veneer, and to assess the clinical value of loupes and microscope from the ergonomic aspects. METHODS: Twenty young prosthodontists from Department of Prosthodontics, Peking University School and Hospital of Stomatology were recruited into this study, which was a prospective, single blind, self-control trials. The research hypothesis was concealed and the participants were deceived about the precise purpose of the study to counterbalance the lack of direct blinding. The prosthodontists prepared laminate veneers of open window type in the artificial dental model, under routine visual field (control group), 2.5× headwear loupes (loupes group), and 8× operating microscope (microscopic group) by turning. The participants were photographed from profile view and front view. Thereafter, the subjective assessment was performed by themselves using the visual analogue score (VAS). The expert assessment was performed by two professors using modified-dental operator posture assessment instrument on the basis of photographs of the profile view and front view. RESULTS: The subjective assessment scores for the control group, loupes group and microscopic group were 4.55±1.96, 7.90±1.12, and 9.00±0.92, respectively. There was significant difference between the three groups' subjective scores (P < 0.05). The expert assessment scores for the control group, loupes group and microscopic group were 16.38±1.52, 15.15±1.30, and 13.60±0.88, respectively. There was significant difference between the three groups' expert assessment scores (P < 0.05). Specifically, the three groups' expert assessment scores were significantly different (P < 0.05) in trunk position (front to back) (1.33±0.41, 1.03±0.11, 1.00±0.00), head and neck position (front to back) (2.75±0.38, 2.13±0.36, 1.23±0.38), elbows level (1.38±0.43, 1.40±0.45, 1.13±0.22), and shoulders level (1.43±0.41, 1.23±0.34, 1.13±0.28). Thereinto, the microscopic group was better than loupes group in head and neck position (front to back) and elbows level (P < 0.05). CONCLUSION: Loupes and microscope improve the posture of the prosthodontist when preparing the laminate veneer, in which the microscope is better than loupes. Therefore, the magnification devices have clinical value from the ergonomic aspects.


Assuntos
Ergonomia , Postura , Odontólogos , Humanos , Estudos Prospectivos , Método Simples-Cego
2.
Bone Joint J ; 102-B(9): 1158-1166, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32862688

RESUMO

AIMS: The primary objective of this study was to compare migration of the cemented ATTUNE fixed bearing cruciate retaining tibial component with the cemented Press-Fit Condylar (PFC)-sigma fixed bearing cruciate retaining tibial component. The secondary objectives included comparing clinical and radiological outcomes and Patient Reported Outcome Measures (PROMs). METHODS: A single blinded randomized, non-inferiority study was conducted including 74 patients. Radiostereometry examinations were made after weight bearing, but before hospital discharge, and at three, six, 12, and 24 months postoperatively. PROMS were collected preoperatively and at three, six, 12, and 24 months postoperatively. Radiographs for measuring radiolucencies were collected at two weeks and two years postoperatively. RESULTS: The overall migration (mean maximum total point motion (MPTM)) at two years was comparable: mean 1.13 mm (95% confidence interval (CI), 0.97 to 1.30) for the ATTUNE and 1.16 mm (95% CI, 0.99 to 1.35) for the PFC-sigma. At two years, the mean backward tilting was -0.43° (95% CI, -0.65 to -0.21) for the ATTUNE and 0.08° (95% CI -0.16 to 0.31), for the PFC-sigma. Overall migration between the first and second postoperative year was negligible for both components. The clinical outcomes and PROMs improved compared with preoperative scores and were not different between groups. Radiolucencies at the implant-cement interface were mainly seen below the medial baseplate: 17% in the ATTUNE and 3% in the PFC-sigma at two weeks, and at two years 42% and 9% respectively (p = 0.001). CONCLUSION: In the first two postoperative years the initial version of the ATTUNE tibial component was not inferior with respect to overall migration, although it showed relatively more backwards tilting and radiolucent lines at the implant-cement interface than the PFC-sigma. The version of the ATTUNE tibial component examined in this study has subsequently undergone modification by the manufacturer. Level of Evidence: 1 (randomized controlled clinical trial) Cite this article: Bone Joint J 2020;102-B(9):1158-1166.


Assuntos
Artroplastia do Joelho/métodos , Cimentos para Ossos , Migração de Corpo Estranho/epidemiologia , Prótese do Joelho/efeitos adversos , Idoso , Feminino , Migração de Corpo Estranho/diagnóstico por imagem , Humanos , Masculino , Pessoa de Meia-Idade , Medidas de Resultados Relatados pelo Paciente , Desenho de Prótese , Falha de Prótese , Análise Radioestereométrica , Método Simples-Cego , Tíbia , Resultado do Tratamento
3.
Medicine (Baltimore) ; 99(33): e21670, 2020 Aug 14.
Artigo em Inglês | MEDLINE | ID: mdl-32872033

RESUMO

BACKGROUND: Total knee arthroplasty (TKA) is an established and successful surgical procedure which is the major treatment for degenerative knee joint diseases. A novel technique to address posterior knee joint pain is the infiltration of local anesthetic between the interspace between the popliteal artery and capsule of the knee (IPACK). The goal of this randomized clinical trial was to assess the efficacy and safety of adding IPACK to adductor canal block (ACB) after TKA. METHODS: This was a prospectively randomized trial that investigated the effectiveness and safety of the IPACK after TKA. Approval from Clinical Studies Ethical Committee in Qilu Hospital of Shandong University was obtained. The inclusion criteria were adult patients undergoing primary unilateral TKA and American Society of Anesthesiologists grade 1 or 2 with normal cognitive function. The patients were randomized to 1 of 2 treatment options: ACB-alone group and ACB + IPACK group. The primary outcome was the total morphine consumption during postoperative 24 hours. Secondary outcomes included postoperative pain score, time to first and total dosage of rescue morphine in postoperative 48 hours, early and late postoperative period (from postoperative day 0-3 months follow-up) performance-based test (Timed-Up and Go test, and quadriceps strength). Postoperative nausea and vomiting, length of hospital stay, patient satisfaction, and other adverse events were also evaluated. RESULTS: It was hypothesized that when combined with a control group, the IPACK block would result in a lower morphine consumption and pain score after TKA. TRIAL REGISTRATION: This study protocol was registered in Research Registry (researchregistry5765).


Assuntos
Artroplastia do Joelho/métodos , Bloqueio Nervoso/métodos , Dor Pós-Operatória/prevenção & controle , Analgésicos Opioides/administração & dosagem , Anestésicos Locais/administração & dosagem , Humanos , Morfina/administração & dosagem , Artéria Poplítea , Estudos Prospectivos , Ensaios Clínicos Controlados Aleatórios como Assunto , Método Simples-Cego
4.
Medicine (Baltimore) ; 99(38): e22346, 2020 Sep 18.
Artigo em Inglês | MEDLINE | ID: mdl-32957406

RESUMO

BACKGROUND: Thyroidectomy has been considered an effective method to treat thyroid cancer. However, about 20% of patients have psychological distress before surgery. Psychological distress is considered common mental illnesses and it has been reported that the patients who suffer psychological distress have poor clinical outcomes than the patients without psychosocial disorder. Therefore, we design this randomized controlled study to explore the effect of psychological nursing intervention against quality of life and psychological distress of the patients with thyroid cancer. METHOD: The trial will be conducted from September 2020 to December 2020 at Wuhan Fourth Hospital on the basis of the International Council for Harmonisation's Good Clinical Practice Guidelines and the principles of the Helsinki Declaration. The study was authorized via the Research Ethics Committee of the Wuhan Fourth Hospital (Approval number: 20200721-046). This study is a single-center, randomized, 2-arm, evaluator-blinded clinical trial. In all, 90 patients with thyroid cancer undergoing thyroidectomy will be enrolled in this study. The inclusion criteria includes: patients aged between 20 and 60 years old; ASA I-II classification; normal platelet coagulation and count function. The exclusion criteria contains: people with the intellectual and cognitive impairment (behavioral-cognitive intervention); BMI above 35 kg/m; the history of renal and hepatic dysfunction; and patients refuse to participate in this study. Both the patients in psychological intervention group and control group should receive the routine care, while the psychological intervention group also needs to receive the additional proper psychological nursing interventions. The emotional disorders are detected with the Chinese version of Profile of Mood States-Brief. And the patients' life quality is evaluated with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core Questionnaire (QLQ-C30, version 3.0). All the data are collated into Microsoft Excel 2010 and analyzed with SPSS 12.0 (IBM). RESULTS: It is assumed that psychological nursing intervention could alleviate the psychological distress of patients with thyroid cancer and improve their quality of life. CONCLUSION: This study can provide the reliable evidence regarding the influence of psychological nursing intervention against the life quality and psychological distress of the patients with thyroid cancer. TRIAL REGISTRATION: This study protocol is registered in Research Registry (researchregistry5937).


Assuntos
Angústia Psicológica , Qualidade de Vida , Neoplasias da Glândula Tireoide/psicologia , Tireoidectomia/psicologia , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Ensaios Clínicos Controlados Aleatórios como Assunto , Método Simples-Cego , Neoplasias da Glândula Tireoide/enfermagem , Tireoidectomia/enfermagem , Adulto Jovem
5.
BMJ Open ; 10(9): e041276, 2020 09 17.
Artigo em Inglês | MEDLINE | ID: mdl-32948577

RESUMO

OBJECTIVES: To characterise current COVID-19-related research activities. DESIGN: Cross-sectional analysis. SETTING: Clinical trials registered with ClinicalTrials.gov testing interventions relevant to COVID-19. DATA SOURCES: ClinicalTrials.gov was searched for COVID-19 and related terms to identify trials registered between 1 December 2019 and 1 May 2020 that test interventions related to the COVID-19 pandemic. MAIN OUTCOME MEASURES: We classified trials according to intervention type, and report key trial characteristics including recruitment status, location, funder type, target enrolment number, intervention model (single group, randomised or sequential assignment) and projected completion date. RESULTS: Of the 630 identified clinical trials related to COVID-19, 509 (81%) involved the study of drugs or biological agents. Of these trials of drugs and biologics, 305 (60%) use an open-label design, 43 (8%) are single blinded (participant only) and 161 (32%) are double blinded (participant and investigator). 94 (18%) of the drug/biological trials are non-randomised. Either hydroxychloroquine or chloroquine is administered as part of the study protocol in 152 (30%) of the drug/biological trials. The total planned enrolment for these hydroxychloroquine/chloroquine trials is over 200 000 participants, which represents 65% of the total planned enrolment for all registered trials of drugs or biologics. There are also at least 25 registered trials of azithromycin (n=53), convalescent plasma (n=38), lopinavir/ritonavir (n=30), stem cell treatments (n=29) and tocilizumab (n=25). 142 trials were registered in the first 3 months of 2020, and 488 trials were registered between 1 April and 1 May 2020. CONCLUSIONS: These findings demonstrate a robust research response to the COVID-19 pandemic, though many of the currently planned and ongoing trials focus on a small number of potential therapies, and many also lack essential design features and power necessary to provide accurate treatment effect estimates.


Assuntos
Antivirais/uso terapêutico , Ensaios Clínicos como Assunto , Infecções por Coronavirus/terapia , Pneumonia Viral/terapia , Sistema de Registros , Transplante de Células-Tronco , Anticorpos Monoclonais Humanizados/uso terapêutico , Azitromicina/uso terapêutico , Betacoronavirus , Cloroquina/uso terapêutico , Infecções por Coronavirus/tratamento farmacológico , Método Duplo-Cego , Combinação de Medicamentos , Humanos , Hidroxicloroquina/uso terapêutico , Imunização Passiva , Lopinavir/uso terapêutico , Pandemias , Ritonavir/uso terapêutico , Método Simples-Cego
6.
Evid Based Dent ; 21(3): 96-97, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32978539

RESUMO

Design A single-blinded, randomised controlled trial. The experimental group received 24 personalised text messages each week, disseminating tailored preventive advice using the multifactorial model for individual caries risk assessment: Cariogram. The same frequency of text messaging was delivered to the control group; however, these were non-personalised messages and did not factor the Cariogram.Sample selection One hundred and ninety-one participants were assessed for eligibility by eight calibrated, volunteer dental practitioners in County Cork, Ireland. Six different inclusion criteria were detailed, including the requirement for medical card holders, serving as an indicator for economically underprivileged status. Other criteria included: aged between 19-70 years; competent with text messaging services; have a minimum of 20 teeth present; not pregnant; and prepared to give consent. Failure to return a baseline food diary or possess a mobile phone saw the exclusion of 20 participants. Following stratified and blocked randomisation, 85 and 86 participants were allocated in the test and control group, respectively. The study received ethical approval by the Clinical Research Ethics Committee of the Cork Teaching Hospitals.Data analysis One hundred and eleven participants attended the follow-up examination, 26 weeks after randomisation, where the 'chance of avoiding new cavities' was determined as a numerical index for caries risk. The secondary aim was to measure individual changes to seven Cariogram risk factors between the baseline assessment and the re-examination. The ANCOVA intention-to-threat (ITT) protocol and the per-protocol method were adhered to for analyses of outcome measures. Statistical analysis was performed using SAS 9.4, in adherence to a pre-defined significance level of 5% (two-sided).Results Both analytic techniques confirmed no statistically significant difference (p >0.05) between the groups regarding the 'chance of avoiding new cavities'. Of the risk parameters assessed, only saliva secretion demonstrated a positive effect in the intervention group (p = 0.036, OR = 0.3, 95% CI = 0.1, 0.9). Predictive modelling techniques were not reliable due to the limited sample size of per-protocol analysis.Conclusions The failure to conclude statistical significance between the groups validates the null hypothesis. Accordingly, no difference can be established between the personalised nor non-personalised mobile text messaging intervention on the caries risk of underprivileged adults in Ireland. The authors address the value of further studies exploring the potential for caries risk reduction through mobile phone communications.


Assuntos
Telefone Celular , Cárie Dentária , Envio de Mensagens de Texto , Adulto , Idoso , Cárie Dentária/prevenção & controle , Odontólogos , Feminino , Humanos , Irlanda , Pessoa de Meia-Idade , Gravidez , Papel Profissional , Método Simples-Cego , Adulto Jovem
7.
Int J Oral Maxillofac Implants ; 35(5): 1022-1036, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32991655

RESUMO

PURPOSE: This 3-year study aimed to evaluate hard and soft tissue modification around a two-piece implant characterized by a transmucosal hyperbolic neck in healthy consecutive patients with a need for single-tooth replacement. MATERIALS AND METHODS: Two-piece implants (n = 66) were placed with a flapless technique in 56 patients (27 men; 29 women; mean age 55 ± 9 years): 16 immediately after root extraction (immediate group), 20 after 8 to 12 weeks (early group), and 30 after 10 or more months (delayed group). The transmucosal hyperbolic neck was exposed 1 to 1.5 mm above gingival level. Customized abutments were positioned 3 months later with the implant-abutment connection located approximately 1 to 1.5 mm above soft tissue level. Provisional cemented resin crowns were designed with the finishing line at the hyperbolic neck and then positioned to avoid excessive compression of soft tissue, to guide gingival contours. Twenty days later, a definitive metal-ceramic crown was cemented. In all patients, the gingival biotype (thin or thick) was also evaluated. The primary outcomes were as follows: 36-month implant survival rate, peri-implant marginal bone level (MBL, in mm) changes observed in single-blind on radiographs at 1, 3, 6, 12, 24, and 36 months (T1, T3, T6, T12, T24, and T36), and pink esthetic score (PES) at T6, T12, and T36 to analyze soft tissue adaptation after loading and crown application. The secondary outcomes were as follows: plaque score and bleeding on probing (BOP). Linear regression models and multilevel mixed logistic regression were used to detect any statistical difference of MBL according to operative parameters. Kruskal-Wallis one-way analysis of variance (ANOVA) on ranks was performed to assess statistical differences of PES at T6, T12, and T36. RESULTS: The survival rate was 100%. The dropout rate was 1.79%. No infections, mucositis, or peri-implantitis were reported. Implants placed in thick-biotype tissues showed a statistically different lower bone loss at 36 months with respect to the thin biotype (P < .05). At 36 months, the early group showed lower bone loss compared with the delayed group (P < .05). Multilevel mixed logistic regression revealed that gingival biotype was the parameter that was most related to MBL variations (P = .025). The PES value (mean ± SD) at T6 was 10.76 ± 1.19 (median: 11; range: 8 to 13; IQR: 10 to 12). The values statistically increased at T12 and T36, where the mean values were 11.76 ± 1.10 (median: 12; range: 9 to 13; IQR: 11 to 12) and 11.83 ± 1.03 (median: 12; range: 9 to 14; IQR: 11 to 13). CONCLUSION: MBL and soft tissue clinical parameters measured around two-piece hyperbolic-neck implants were stable during the 3-year follow-up and free from complications. The exposure of the hyperbolic neck for 1.0 to 1.5 mm allowed a flapless one-stage surgery, which supported fast adaptation of the soft tissues, evidenced by high PES values and low percentages of BOP. The results from the study imply a new simple approach in the clinical management of gingival and bone tissue.


Assuntos
Implantes Dentários para Um Único Dente , Implantação Dentária Endo-Óssea/efeitos adversos , Estética Dentária , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Método Simples-Cego
8.
Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi ; 34(9): 1130-1135, 2020 Sep 15.
Artigo em Chinês | MEDLINE | ID: mdl-32929906

RESUMO

Objective: To analyze the effectiveness of percutaneous injection of autologous concentrated bone marrow aspirate (cBMA) combined with platelet-rich plasma (PRP) in the treatment of delayed fracture healing. Methods: A prospective, randomized, controlled, single-blind case study was conducted. Between March 2016 and July 2018, 66 patients who met the inclusion and exclusion criteria for delayed fracture healing but had solid internal fixation of the fracture end were randomly divided into control group (31 cases, treated with percutaneous autogenous bone marrow blood injection) and study group (35 cases, treated with percutaneous autogenous cBMA+PRP injection). General data such as gender, age, body mass index, site of delayed fracture healing, length of bone defect at fracture end, and preoperative radiographic union score for tibia (RUST) showed no significant difference between the two groups ( P>0.05). Before injection, Kirschner wire was used in both groups to stimulate the fracture end and cause minor injury. The fracture healing time, treatment cost, and adverse reactions were recorded and compared between the two groups. Visual analogue scale (VAS) score was used to evaluate pain improvement. The tibial RUST score was extended to the tubular bone healing evaluation. Results: No infection of bone marrow puncture needle eyes occurred in both groups. In the control group, local swelling was obvious in 5 cases and pain was aggravated at 1 day after operation in 11 cases. In the study group, postoperative swelling and pain were not obvious, but 2 cases presented local swelling and pain. All of them relieved after symptomatic treatment. Patients in both groups were followed up, the follow-up time of the control group was 16-36 months (mean, 21.8 months), and the study group lasted 14-33 months (mean, 23.2 months). The amount of bone marrow blood was significantly lower in the study group than in the control group ( t=4.610, P=0.000). The degree of postoperative pain in the study group was less than that in the control group, and the treatment cost was higher than that in the control group. But the differences between the two groups in VAS score at 1 day after operation and treatment cost were not significant ( P>0.05). Fracture healing was achieved in 19 cases (61.3%) in the control group and 30 cases (85.7%) in the study group. The difference in fracture healing rate between the two groups was significant ( χ 2=5.128, P=0.024). Fracture healing time and RUST score at last follow-up were significantly better in the study group than in the control group ( P<0.05). At last follow-up, RUST scores in both groups were significantly improved when compared with those before operation ( P<0.05). Conclusion: Autogenous cBMA combined with PRP percutaneous injection can provide high concentration of BMSCs and growth factors, and can improve the fracture healing rate and shorten the fracture healing time better than autogenous bone marrow blood injection.


Assuntos
Consolidação da Fratura , Plasma Rico em Plaquetas , Medula Óssea , Fixação Interna de Fraturas , Humanos , Estudos Prospectivos , Método Simples-Cego , Resultado do Tratamento
9.
Medicine (Baltimore) ; 99(33): e21586, 2020 Aug 14.
Artigo em Inglês | MEDLINE | ID: mdl-32872011

RESUMO

INTRODUCTION: With the rapid development of social economy, peoples dependence on computers and mobile phones is increasing day by day. This causes people to often overuse. Therefore, the incidence of Ocular muscle spasm has been increasing year by year in recent years. The disease usually starts and hides, which seriously affects the patients social image, daily life, and work. METHODS/DESIGN: We will compare the clinical efficacy of thunder-fire moxibustion combined with acupressure with pure thunder-fire moxibustion on Ocular muscle spasm using random control method. DISCUSSION: We aim to find a simple, safe, simple and effective Chinese medicine nursing technology that relieves Ocular muscle spasm. TRIAL REGISTRATION: ClinicalTrials.gov,ChiCTR2000034187, Registered on 27 June 2020.


Assuntos
Acupressão/métodos , Olho , Moxibustão/métodos , Espasmo/terapia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Terapia Combinada , Face , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Reserpina/análogos & derivados , Método Simples-Cego , Adulto Jovem
10.
PLoS Med ; 17(9): e1003355, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32991589

RESUMO

BACKGROUND: Secondhand smoke can cause adverse pregnancy outcomes, yet there is a lack of effective smoking cessation interventions targeted at expectant fathers. We examined the effectiveness of a video-based smoking cessation intervention focusing on maternal and child health in promoting quitting among expectant fathers. METHODS AND FINDINGS: A single-blind, 3-arm, randomized controlled trial was conducted at the obstetrics registration centers of 3 tertiary public hospitals in 3 major cities (Guangzhou, Shenzhen, and Foshan) in China. Smoking expectant fathers who registered with their pregnant partners were invited to participate in this study. Between 14 August 2017 to 28 February 2018, 1,023 participants were randomized to a video (n = 333), text (n = 322), or control (n = 368) group. The video and text groups received videos or text messages on the risks of smoking for maternal and child health via instant messaging. The control group received a leaflet with information on smoking cessation. Follow-up visits were conducted at 1 week and at 1, 3, and 6 months. The primary outcome, by intention to treat (ITT), was validated abstinence from smoking at the 6-month follow-up. The secondary outcomes included 7-day point prevalence of abstinence (PPA) and level of readiness to quit at each follow-up. The mean age of participants was 32 years, and about half of them were first-time expectant fathers. About two-thirds of participants had completed tertiary education. The response rate was 79.7% (815 of 1,023) at 6 months. The video and text groups had higher rates of validated abstinence than the control group (video group: 22.5% [75 of 333], P < 0.001; text group: 14.9% [48 of 322], P = 0.02; control group: 9.2% [34 of 368]) with adjusted odds ratios (ORs) of 2.80 (95% confidence interval [CI]: 1.79-4.37, P < 0.001) in the video group and 1.70 (95% CI: 1.06-2.74, P = 0.03) in the text group. The video and text groups differed in the rates of validated abstinence (22.5% versus 14.9%, P = 0.008; adjusted OR: 1.64, 95% CI: 1.10-2.46, P = 0.02). The video and text groups had higher rates of 7-day PPA than the control group at 6 months (video group: 24.6% [82 of 333] versus 11.4% [42 of 368], P < 0.001; text group: 17.4% [56 of 333] versus 11.4% [42 of 368], P = 0.02). The video and text groups also differed in the rates of 7-day PPA (24.6% versus 17.4%, P = 0.02). Excluding the quitters, the video and text groups had higher levels of readiness to quit than the control group at 6 months (video group: 43.5% [109 of 251] versus 31.6% [103 of 326], P = 0.002; text group: 40.6% [108 of 266] versus 31.6% [103 of 326], P = 0.01), No such difference was detected between the video and text groups (43.5% versus 40.6%, P = 0.29). The study was limited in that the long-term effectiveness of the intervention is uncertain. CONCLUSIONS: This smoking cessation intervention for expectant fathers that focused on explaining the ramifications of smoking on maternal and child health was effective and feasible in promoting quitting, and video messages were more effective than texts in delivering the information. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03236025.


Assuntos
Saúde da Criança , Pai , Abandono do Hábito de Fumar , Fumar/efeitos adversos , Adulto , Terapia Comportamental/métodos , China , Feminino , Humanos , Masculino , Motivação/fisiologia , Método Simples-Cego , Fumar/epidemiologia , Envio de Mensagens de Texto , Poluição por Fumaça de Tabaco/efeitos adversos
11.
N Engl J Med ; 383(14): 1305-1316, 2020 10 01.
Artigo em Inglês | MEDLINE | ID: mdl-32865375

RESUMO

BACKGROUND: Despite improvements in the management of atrial fibrillation, patients with this condition remain at increased risk for cardiovascular complications. It is unclear whether early rhythm-control therapy can reduce this risk. METHODS: In this international, investigator-initiated, parallel-group, open, blinded-outcome-assessment trial, we randomly assigned patients who had early atrial fibrillation (diagnosed ≤1 year before enrollment) and cardiovascular conditions to receive either early rhythm control or usual care. Early rhythm control included treatment with antiarrhythmic drugs or atrial fibrillation ablation after randomization. Usual care limited rhythm control to the management of atrial fibrillation-related symptoms. The first primary outcome was a composite of death from cardiovascular causes, stroke, or hospitalization with worsening of heart failure or acute coronary syndrome; the second primary outcome was the number of nights spent in the hospital per year. The primary safety outcome was a composite of death, stroke, or serious adverse events related to rhythm-control therapy. Secondary outcomes, including symptoms and left ventricular function, were also evaluated. RESULTS: In 135 centers, 2789 patients with early atrial fibrillation (median time since diagnosis, 36 days) underwent randomization. The trial was stopped for efficacy at the third interim analysis after a median of 5.1 years of follow-up per patient. A first-primary-outcome event occurred in 249 of the patients assigned to early rhythm control (3.9 per 100 person-years) and in 316 patients assigned to usual care (5.0 per 100 person-years) (hazard ratio, 0.79; 96% confidence interval, 0.66 to 0.94; P = 0.005). The mean (±SD) number of nights spent in the hospital did not differ significantly between the groups (5.8±21.9 and 5.1±15.5 days per year, respectively; P = 0.23). The percentage of patients with a primary safety outcome event did not differ significantly between the groups; serious adverse events related to rhythm-control therapy occurred in 4.9% of the patients assigned to early rhythm control and 1.4% of the patients assigned to usual care. Symptoms and left ventricular function at 2 years did not differ significantly between the groups. CONCLUSIONS: Early rhythm-control therapy was associated with a lower risk of adverse cardiovascular outcomes than usual care among patients with early atrial fibrillation and cardiovascular conditions. (Funded by the German Ministry of Education and Research and others; EAST-AFNET 4 ISRCTN number, ISRCTN04708680; ClinicalTrials.gov number, NCT01288352; EudraCT number, 2010-021258-20.).


Assuntos
Antiarrítmicos/uso terapêutico , Fibrilação Atrial/tratamento farmacológico , Fibrilação Atrial/cirurgia , Doenças Cardiovasculares/prevenção & controle , Ablação por Cateter , Síndrome Coronariana Aguda/epidemiologia , Idoso , Antiarrítmicos/efeitos adversos , Fibrilação Atrial/complicações , Doenças Cardiovasculares/mortalidade , Feminino , Seguimentos , Insuficiência Cardíaca/epidemiologia , Hospitalização/estatística & dados numéricos , Humanos , Incidência , Tempo de Internação , Masculino , Risco , Prevenção Secundária , Método Simples-Cego , Função Ventricular Esquerda/efeitos dos fármacos
13.
PLoS Med ; 17(9): e1003282, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32903262

RESUMO

BACKGROUND: Endothelial dysfunction is a crucial step in atherosclerosis development, and its severity is determinant for the risk of cardiovascular recurrence. Diet may be an effective strategy to protect the endothelium, although there is no consensus about the best dietary model. The CORonary Diet Intervention with Olive oil and cardiovascular PREVention (CORDIOPREV) study is an ongoing prospective, randomized, single-blind, controlled trial in 1,002 coronary heart disease (CHD) patients, whose primary objective is to compare the effect of 2 healthy dietary patterns (low-fat versus Mediterranean diet) on the incidence of cardiovascular events. Here, we report the results of one secondary outcome of the CORDIOPREV study: to evaluate the effect of these diets on endothelial function, assessed by flow-mediated dilation (FMD) of the brachial artery. METHODS AND FINDINGS: From the total participants taking part in the CORDIOPREV study, 805 completed endothelial function study at baseline and were randomized to follow a Mediterranean diet (35% fat, 22% monounsaturated fatty acids [MUFAs], and <50% carbohydrates) or a low-fat diet (28% fat, 12% MUFAs, and >55% carbohydrates), with endothelial function measurement repeated after 1 year. As secondary objectives and to explore different underlying mechanisms in the modulation of endothelial function, we quantified endothelial microparticles (EMPs) and endothelial progenitor cells (EPCs) and evaluated, in 24 preselected patients, in vitro cellular processes related to endothelial damage (reactive oxygen species, apoptosis, and senescence) and endothelial repair (cell proliferation and angiogenesis), as well as other modulators (micro-RNAs [miRNAs] and proteins). Patients who followed the Mediterranean diet had higher FMD (3.83%; 95% confidence interval [CI]: 2.91-4.23) compared with those in the low-fat diet (1.16%; 95% CI: 0.80 to 1.98) with a difference between diets of 2.63% (95% CI: 1.89-3.40, p = 0.011), even in those patients with severe endothelial dysfunction. We observed higher EPC levels (group difference: 1.64%; 95% CI: 0.79-2.13, p = 0.028) and lower EMPs (group difference: -755 EMPs/µl; 95% CI: -1,010 to -567, p = 0.015) after the Mediterranean diet compared with the low-fat diet in all patients. We also observed lower intracellular reactive oxygen species (ROS) production (group difference: 11.1; 95% CI: 2.5 to 19.6, p = 0.010), cellular apoptosis (group difference: -20.2; 95% CI: -26.7 to -5.11, p = 0.013) and senescence (18.0; 95% CI: 3.57 to 25.1, p = 0.031), and higher cellular proliferation (group difference: 11.3; 95% CI: 4.51 to 13.5, p = 0.011) and angiogenesis (total master segments length, group difference: 549; 95% CI: 110 to 670, p = 0.022) after the Mediterranean diet than the low-fat diet. Each dietary intervention was associated with distinct changes in the epigenetic and proteomic factors that modulate biological process associated with endothelial dysfunction. The evaluation of endothelial function is a substudy of the CORDIOPREV study. As in any substudy, these results should be treated with caution, such as the potential for false positives because of the exploratory nature of the analyses. CONCLUSIONS: Our results suggest that the Mediterranean diet better modulates endothelial function compared with a low-fat diet and is associated with a better balance of vascular homeostasis in CHD patients, even in those with severe endothelial dysfunction. CLINICAL TRIAL REGISTRATION: URL, http://www.cordioprev.es/index.php/en. clinicaltrials.gov number NCT00924937.


Assuntos
Doença das Coronárias/dietoterapia , Endotélio/metabolismo , Idoso , Doenças Cardiovasculares/prevenção & controle , Dieta com Restrição de Gorduras , Dieta Mediterrânea , Gorduras na Dieta , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Azeite de Oliva , Estudos Prospectivos , Proteômica , Método Simples-Cego
14.
West J Emerg Med ; 21(5): 1067-1075, 2020 Aug 17.
Artigo em Inglês | MEDLINE | ID: mdl-32970556

RESUMO

INTRODUCTION: Pulmonary opacities in COVID-19 increase throughout the illness and peak after ten days. The radiological literature mainly focuses on CT findings. The purpose of this study was to assess the diagnostic and prognostic value of chest radiographs (CXR) for coronavirus disease 2019 (COVID-19) at presentation. METHODS: We retrospectively identified consecutive reverse transcription polymerase reaction-confirmed COVID-19 patients (n = 104, 75% men) and patients (n = 75, 51% men) with repeated negative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) tests. Two radiologists blindly and independently reviewed the CXRs, documented findings, assigned radiographic assessment of lung edema (RALE) scores, and predicted the patients' COVID-19 status. We calculated interobserver reliability. The score use for diagnosis and prognosis of COVID-19 was evaluated with the area under the receiver operating characteristic curve. RESULTS: The overall RALE score failed to identify COVID-19 patients at presentation. However, the score was inversely correlated with a COVID-19 diagnosis within ≤2 days, and a positive correlation was found six days after symptom onset.Interobserver agreement with regard to separating normal from abnormal CXRs was moderate (k = 0.408) with low specificity (25% and 27%). Definite pleural effusion had almost perfect agreement (k = 0.833) and substantially reduced the odds of a COVID-19 diagnosis. Disease distribution and experts' opinion on COVID-19 status had only fair interobserver agreement. The RALE score interobserver reliability was moderate to good (intraclass correlation coefficient = 0.745). A high RALE score predicted a poor outcome (intensive care unit hospitalization, intubation, or death) in COVID-19 patients; a score of ≥5 substantially increased the odds of having a poor outcome. CONCLUSION: Chest radiography was found not to be a valid diagnostic tool for COVID-19, as normal or near-normal CXRs are more likely early in the disease course. Pleural effusions at presentation suggest a diagnosis other than COVID-19. More extensive lung opacities at presentation are associated with poor outcome in COVID-19 patients. Thus, patients with more than minimal opacities should be monitored closely for clinical deterioration. This clinical application of CXR is its greatest strength in COVID-19 as it impacts patient care.


Assuntos
Betacoronavirus , Regras de Decisão Clínica , Técnicas de Laboratório Clínico/métodos , Infecções por Coronavirus/diagnóstico por imagem , Pulmão/diagnóstico por imagem , Pneumonia Viral/diagnóstico por imagem , Adulto , Idoso , Idoso de 80 Anos ou mais , Área Sob a Curva , Betacoronavirus/isolamento & purificação , Estudos de Casos e Controles , Infecções por Coronavirus/diagnóstico , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Variações Dependentes do Observador , Pandemias , Prognóstico , Curva ROC , Radiografia Torácica , Reprodutibilidade dos Testes , Estudos Retrospectivos , Método Simples-Cego
15.
Medicine (Baltimore) ; 99(37): e22178, 2020 Sep 11.
Artigo em Inglês | MEDLINE | ID: mdl-32925788

RESUMO

INTRODUCTION: Postmenopausal osteoporosis (PMOP), which is a common and frequently occurring age-related metabolic bone disease in perimenopausal women, severely affects patients living quality. Modern medicine therapies for PMOP have several problems such as side reactions, low compliance, and high costs. Thus, nonpharmacological modality is urgently needed. Although acupoint thread embedding treatment is widely used in clinical practice, there is no persuasive evidence of its effect on increasing bone mass for PMOP. This experiment aims to investigate the efficacy and safety of acupoint thread embedding on PMOP and elucidate the correlations among brain neural activation, bone mineral density (BMD), and clinical outcomes with magnetic resonance evidence, thus to explore its neural mechanism. METHODS: This parallel designed, exploratory randomized, controlled, assessor-statistician-blinded, positive medicine clinical trial will include 70 participants with PMOP recruited from 2 traditional Chinese Medicine hospitals. These participants will be randomly allocated to a treatment group (Group Embedding) and a control group (Group Medication) in a 1:1 ratio. Participants in the treatment group will receive acupoint thread embedding treatment once 2 weeks in the following predefined acupoints: Shenshu (BL23), Sanyinjiao (SP6), Guanyuan (RN4), Ganshu (BL18), Dazhu (BL11), Xuanzhong (GB39), Zusanli (ST36), and Pishu (BL20). Meanwhile, the participants in the control group will take 0.3 mg Climen tablet orally, 1 tablet/day; every month has a schedule of the 21-day-continuous-taking-medicine period, and 7-day tablet-free period. There is a study period of 3 months and a follow-up period of 1 month for each group. The primary outcomes will be the following therapeutic indexed: Short-Form of McGill Pain Questionnaire (SF-MPQ), Osteoporosis Symptom Score during the observation period and follow-up period. The secondary outcomes will be Osteoporosis Quality of Life Scale (OQOLS), 16-item Assessment of Health-Related Quality of Life in Osteoporosis. In addition, functional magnetic resonance imaging (fMRI) scans and bone density test will be done before and after the observation period to show cranial neuroimaging changes. All the outcomes will be evaluated before and after treatment. The safety of interventions will be assessed at every visit. DISCUSSION: We present study design and rationale to explore the effectiveness and neural mechanism of acupoint thread embedding for PMOP through these outcomes. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR-INR-17011491.


Assuntos
Pontos de Acupuntura , Terapia por Acupuntura/métodos , Categute , Osteoporose Pós-Menopausa/terapia , Idoso , Biomarcadores , Densidade Óssea , Acetato de Ciproterona/uso terapêutico , Combinação de Medicamentos , Estradiol/análogos & derivados , Estradiol/uso terapêutico , Feminino , Humanos , Pessoa de Meia-Idade , Osteoporose Pós-Menopausa/tratamento farmacológico , Qualidade de Vida , Método Simples-Cego
16.
Trials ; 21(1): 799, 2020 Sep 17.
Artigo em Inglês | MEDLINE | ID: mdl-32943115

RESUMO

OBJECTIVES: The Bacille Calmette-Guérin (BCG) vaccine against tuberculosis is associated with non- specific protective effects against other infections, and significant reductions in all-cause morbidity and mortality have been reported. We aim to test whether BCG vaccination may reduce susceptibility to and/or the severity of COVID-19 and other infectious diseases in health care workers (HCW) and thus prevent work absenteeism.The primary objective is to reduce absenteeism due to illness among HCW during the COVID-19 pandemic. The secondary objectives are to reduce the number of HCW that are infected with SARS-CoV-2, and to reduce the number of hospital admissions among HCW during the COVID-19 pandemic. HYPOTHESIS: BCG vaccination of HCW will reduce absenteeism by 20% over a period of 6 months. TRIAL DESIGN: Placebo-controlled, single-blinded, randomised controlled trial, recruiting study participants at several geographic locations. The BCG vaccine is used in this study on a different indication than the one it has been approved for by the Danish Medicines Agency, therefore this is classified as a phase III study. PARTICIPANTS: The trial will recruit 1,500 HCW at Danish hospitals.To be eligible for participation, a subject must meet the following criteria: Adult (≥18 years); Hospital personnel working at a participating hospital for more than 22 hours per week.A potential subject who meets any of the following criteria will be excluded from participation in this study: Known allergy to components of the BCG vaccine or serious adverse events to prior BCG administration Known prior active or latent infection with Mycobacterium tuberculosis (M. tuberculosis) or other mycobacterial species Previous confirmed COVID-19 Fever (>38 C) within the past 24 hours Suspicion of active viral or bacterial infection Pregnancy Breastfeeding Vaccination with other live attenuated vaccine within the last 4 weeks Severely immunocompromised subjects. This exclusion category comprises: a) subjects with known infection by the human immunodeficiency virus (HIV-1) b) subjects with solid organ transplantation c) subjects with bone marrow transplantation d) subjects under chemotherapy e) subjects with primary immunodeficiency f) subjects under treatment with any anti-cytokine therapy within the last year g) subjects under treatment with oral or intravenous steroids defined as daily doses of 10 mg prednisone or equivalent for longer than 3 months h) Active solid or non-solid malignancy or lymphoma within the prior two years Direct involvement in the design or the execution of the BCG-DENMARK-COVID trial Intervention and comparator: Participants will be randomised to BCG vaccine (BCG-Denmark, AJ Vaccines, Copenhagen, Denmark) or placebo (saline). An adult dose of 0.1 ml of resuspended BCG vaccine (intervention) or 0.1 ml of sterile 0.9% NaCl solution (control) is administered intradermally in the upper deltoid area of the right arm. All participants will receive one injection at inclusion, and no further treatment of study participants will take place. MAIN OUTCOMES: Main study endpoint: Days of unplanned absenteeism due to illness within 180 days of randomisation.Secondary study endpoints: The cumulative incidence of documented COVID-19 and the cumulative incidence of hospital admission for any reason within 180 days of randomisation.Randomisation: Randomisation will be done centrally using the REDCap tool with stratification by hospital, sex and age groups (+/- 45 years of age) in random blocks of 4 and 6. The allocation ratio is 1:1.Blinding (masking): Participants will be blinded to treatment. The participant will be asked to leave the room while the allocated treatment is prepared. Once ready for injection, vaccine and placebo will look similar, and the participant will not be able to tell the difference.The physicians administering the treatment are not blinded.Numbers to be randomised (sample size): Sample size: N=1,500. The 1,500 participants will be randomised 1:1 to BCG or placebo with 750 participants in each group.Trial Status: Current protocol version 5.1, from July 6, 2020.Recruitment of study participants started on May 18, 2020 and we anticipate having finished recruiting by the end of December 2020. TRIAL REGISTRATION: The trial was registered with EudraCT on April 16, 2020, EudraCT number: 2020-001888-90, and with ClinicalTrials.gov on May 1, 2020, registration number NCT04373291.Full protocol: The full protocol is attached as an additional file, accessible from the Trialswebsite (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.


Assuntos
Vacina BCG/administração & dosagem , Betacoronavirus/patogenicidade , Infecções por Coronavirus/prevenção & controle , Pessoal de Saúde , Saúde do Trabalhador , Pandemias/prevenção & controle , Pneumonia Viral/prevenção & controle , Vacinação , Absenteísmo , Vacina BCG/efeitos adversos , Betacoronavirus/imunologia , Infecções por Coronavirus/imunologia , Infecções por Coronavirus/transmissão , Infecções por Coronavirus/virologia , Dinamarca , Feminino , Humanos , Masculino , Estudos Multicêntricos como Assunto , Admissão do Paciente , Pneumonia Viral/imunologia , Pneumonia Viral/transmissão , Pneumonia Viral/virologia , Ensaios Clínicos Controlados Aleatórios como Assunto , Licença Médica , Método Simples-Cego , Fatores de Tempo , Resultado do Tratamento
17.
JAMA ; 324(9): 848-858, 2020 09 01.
Artigo em Inglês | MEDLINE | ID: mdl-32870298

RESUMO

Importance: In patients who undergo mechanical ventilation during surgery, the ideal tidal volume is unclear. Objective: To determine whether low-tidal-volume ventilation compared with conventional ventilation during major surgery decreases postoperative pulmonary complications. Design, Setting, and Participants: Single-center, assessor-blinded, randomized clinical trial of 1236 patients older than 40 years undergoing major noncardiothoracic, nonintracranial surgery under general anesthesia lasting more than 2 hours in a tertiary hospital in Melbourne, Australia, from February 2015 to February 2019. The last date of follow-up was February 17, 2019. Interventions: Patients were randomized to receive a tidal volume of 6 mL/kg predicted body weight (n = 614; low tidal volume group) or a tidal volume of 10 mL/kg predicted body weight (n = 592; conventional tidal volume group). All patients received positive end-expiratory pressure (PEEP) at 5 cm H2O. Main Outcomes and Measures: The primary outcome was a composite of postoperative pulmonary complications within the first 7 postoperative days, including pneumonia, bronchospasm, atelectasis, pulmonary congestion, respiratory failure, pleural effusion, pneumothorax, or unplanned requirement for postoperative invasive or noninvasive ventilation. Secondary outcomes were postoperative pulmonary complications including development of pulmonary embolism, acute respiratory distress syndrome, systemic inflammatory response syndrome, sepsis, acute kidney injury, wound infection (superficial and deep), rate of intraoperative need for vasopressor, incidence of unplanned intensive care unit admission, rate of need for rapid response team call, intensive care unit length of stay, hospital length of stay, and in-hospital mortality. Results: Among 1236 patients who were randomized, 1206 (98.9%) completed the trial (mean age, 63.5 years; 494 [40.9%] women; 681 [56.4%] undergoing abdominal surgery). The primary outcome occurred in 231 of 608 patients (38%) in the low tidal volume group compared with 232 of 590 patients (39%) in the conventional tidal volume group (difference, -1.3% [95% CI, -6.8% to 4.2%]; risk ratio, 0.97 [95% CI, 0.84-1.11]; P = .64). There were no significant differences in any of the secondary outcomes. Conclusions and Relevance: Among adult patients undergoing major surgery, intraoperative ventilation with low tidal volume compared with conventional tidal volume, with PEEP applied equally between groups, did not significantly reduce pulmonary complications within the first 7 postoperative days. Trial Registration: ANZCTR Identifier: ACTRN12614000790640.


Assuntos
Pneumopatias/prevenção & controle , Respiração com Pressão Positiva/métodos , Complicações Pós-Operatórias/prevenção & controle , Procedimentos Cirúrgicos Operatórios , Volume de Ventilação Pulmonar , Adulto , Feminino , Humanos , Incidência , Cuidados Intraoperatórios , Pneumopatias/epidemiologia , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/epidemiologia , Período Pós-Operatório , Método Simples-Cego , Procedimentos Cirúrgicos Operatórios/efeitos adversos
18.
Medicine (Baltimore) ; 99(36): e21852, 2020 Sep 04.
Artigo em Inglês | MEDLINE | ID: mdl-32899014

RESUMO

INTRODUCTION: Chronic heart failure has become one of the main diseases endangering human health in the 21st century. It is characterized by high morbidity and high mortality. With the continuous in-depth study of Traditional Chinese medicine, the treatment of heart failure by Tradional Chinese medicine has made significant progress, especially in improving the clinical symptoms of patients, controlling the development of the disease, and improving the quality of life of patients. METHODS/DESIGN: This will be a retrospective, single-blind clinical observational study. All participants will receive chronic heart failure routine treatment and care. The researcher will fill in the case information collection form and collect multiple clinical diagnosis and treatment information. DISCUSSION: At present, there is very little research on the elements of chronic heart failure syndrome, and more exploration and excavation in this area are needed. So we designed this program. We aim to explore the distribution characteristics of Traditional Chinese medicine syndrome elements and combinations of chronic heart failure patients, and analyze the relationship between syndrome elements and related influencing factors. TRIAL REGISTRATION: ClinicalTrials.gov,ChiCTR2000034555, Registered on 18 May 2020.


Assuntos
Medicamentos de Ervas Chinesas/uso terapêutico , Insuficiência Cardíaca/tratamento farmacológico , Medicina Tradicional Chinesa , Estudos Clínicos como Assunto , Insuficiência Cardíaca/classificação , Humanos , Estudos Observacionais como Assunto , Estudos Retrospectivos , Método Simples-Cego
19.
Medicine (Baltimore) ; 99(36): e21958, 2020 Sep 04.
Artigo em Inglês | MEDLINE | ID: mdl-32899031

RESUMO

INTRODUCTION: Wake up stroke starts in sleep and is a more common form of ischemic stroke. At present, it is still controversial whether wake up stroke can be treated with thrombolytic therapy. Therefore, this study will combine imaging techniques to assess the onset time of wake up stroke patients, and to analyze the imaging characteristics of wake up stroke patients and patients suitable for thrombolytic therapy within the time window. METHODS/DESIGN: This study will be a single-blinded, randomized controlled trial with 2 parallel groups. It will be conducted at North China University of science and technology affiliated hospital. DISCUSSION: There is no consistent conclusion about the pathogenesis of wake up stroke. Wake up stroke is more likely to manifest as small vessel disease. The incidence of wake up stroke patients is relatively high, and the effectiveness and safety of intravenous thrombolysis under the guidance of multimode imaging therapy in wake up stroke need to be further explored by prospective, large-scale studies. TRIAL REGISTRATION: ClinicalTrials.gov, ChiCTR2000034402, Registered on 05 July 2020.


Assuntos
Fibrinolíticos/administração & dosagem , Acidente Vascular Cerebral/tratamento farmacológico , Ativador de Plasminogênio Tecidual/administração & dosagem , Administração Intravenosa , Feminino , Fibrinolíticos/efeitos adversos , Humanos , Masculino , Ensaios Clínicos Controlados Aleatórios como Assunto , Método Simples-Cego , Ativador de Plasminogênio Tecidual/efeitos adversos
20.
Medicine (Baltimore) ; 99(36): e22056, 2020 Sep 04.
Artigo em Inglês | MEDLINE | ID: mdl-32899069

RESUMO

INTRODUCTION: With the development of social economy, transportation and various infrastructures have also developed, but it has objectively increased the number of patients with head injury. Although the current craniocerebral medicine technology continues to advance, long-term bed rest and other complications have led to an insignificant decrease in the mortality rate of coma patients. It is not uncommon for patients with disturbance of consciousness caused by head injury in major hospitals. METHODS/DESIGN: This will be a retrospective, single-blind clinical observational study. We will select 50 cases that meet the subject's selection criteria. According to whether they received acupuncture treatment or not, they will be randomly divided into 2 groups, namely treatment group and control group. The control group will be given conventional Western medicine treatment, and the treatment group will be given acupuncture method of removing-stasis and resuscitating treatment on the basis of the control group. DISCUSSION: Our purpose is to observe the role of acupuncture method of removing-stasis and resuscitating in promoting the recovery of patients with severe head injury. We aim to provide more evidence-based medical evidence for acupuncture treatment of this disease. TRIAL REGISTRATION: ClinicalTrials.gov, ChiCTR2000034732, Registered on 19 July 2020.


Assuntos
Terapia por Acupuntura/métodos , Lesões Encefálicas Traumáticas/complicações , Coma/terapia , Estado Vegetativo Persistente/terapia , Ressuscitação/métodos , Adulto , Estudos de Casos e Controles , Coma/etiologia , Coma/mortalidade , Terapia Combinada , Estado de Consciência , Feminino , Escala de Coma de Glasgow , Humanos , Masculino , Pessoa de Meia-Idade , Medicamentos sob Prescrição , Estudos Retrospectivos , Índice de Gravidade de Doença , Método Simples-Cego
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