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OBJECTIVE@#To re-evaluate the systematic review/Meta-analysis of acupuncture and moxibustion for childhood autism (CA), aiming to provide decision-making basis for clinical diagnosis and treatment.@*METHODS@#The systematic review and/or Meta-analysis of acupuncture and moxibustion for CA were searched in PubMed, EMbase, Cochrane Library, SinoMed, CNKI and Wanfang databases. The retrieval time was from the database establishment to May 5th, 2022. PRISMA (preferred reporting items for systematic reviews and Meta-analyses) was used to evaluate the report quality, and AMSTAR 2 (a measurement tool to assess systematic reviews 2) was used to evaluate the methodological quality, bubble map was used to construct the evidence map and GRADE was used to evaluate the quality of evidence.@*RESULTS@#A total of 9 systematic reviews were included. The PRISMA scores ranged from 13 to 26. The report quality was low, and there was a serious lack in the aspects of program and registration, search, other analysis and funding. The main problems in methodology included not making prespecified protocol, incomplete retrieval strategy, not providing a list of excluded literatures, and incomplete explanation on heterogeneity analysis and bias risk. The evidence map showed that 6 conclusions were valid, 2 conclusions were possible valid and 1 conclusion was uncertain valid. The overall quality of evidence was low, and the main factors leading to the downgrade were limitations, followed by inconsistency, imprecision and publication bias.@*CONCLUSION@#Acupuncture and moxibustion has a certain effect for CA, but the quality of reporting, methodology and evidence in included literature need to be improved. It is suggested to perform high-quality and standardized research in the future to provide evidence-based basis.
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Niño , Humanos , Terapia por Acupuntura/métodos , Trastorno Autístico , Moxibustión/métodos , Sesgo de Publicación , Proyectos de Investigación , Revisiones Sistemáticas como Asunto , Metaanálisis como AsuntoRESUMEN
OBJECTIVE@#To derive the Chinese medicine (CM) syndrome classification and subgroup syndrome characteristics of ischemic stroke patients.@*METHODS@#By extracting the CM clinical electronic medical records (EMRs) of 7,170 hospitalized patients with ischemic stroke from 2016 to 2018 at Weifang Hospital of Traditional Chinese Medicine, Shandong Province, China, a patient similarity network (PSN) was constructed based on the symptomatic phenotype of the patients. Thereafter the efficient community detection method BGLL was used to identify subgroups of patients. Finally, subgroups with a large number of cases were selected to analyze the specific manifestations of clinical symptoms and CM syndromes in each subgroup.@*RESULTS@#Seven main subgroups of patients with specific symptom characteristics were identified, including M3, M2, M1, M5, M0, M29 and M4. M3 and M0 subgroups had prominent posterior circulatory symptoms, while M3 was associated with autonomic disorders, and M4 manifested as anxiety; M2 and M4 had motor and motor coordination disorders; M1 had sensory disorders; M5 had more obvious lung infections; M29 had a disorder of consciousness. The specificity of CM syndromes of each subgroup was as follows. M3, M2, M1, M0, M29 and M4 all had the same syndrome as wind phlegm pattern; M3 and M0 both showed hyperactivity of Gan (Liver) yang pattern; M2 and M29 had similar syndromes, which corresponded to intertwined phlegm and blood stasis pattern and phlegm-stasis obstructing meridians pattern, respectively. The manifestations of CM syndromes often appeared in a combination of 2 or more syndrome elements. The most common combination of these 7 subgroups was wind-phlegm. The 7 subgroups of CM syndrome elements were specifically manifested as pathogenic wind, pathogenic phlegm, and deficiency pathogens.@*CONCLUSIONS@#There were 7 main symptom similarity-based subgroups in ischemic stroke patients, and their specific characteristics were obvious. The main syndromes were wind phlegm pattern and hyperactivity of Gan yang pattern.
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Humanos , Síndrome , Accidente Cerebrovascular Isquémico , Medicina Tradicional China , Hígado , FenotipoRESUMEN
OBJECTIVE@#To explore the rule of point selection in treatment of cerebral palsy with acupuncture in preschool children.@*METHODS@#Based on the electronic medical records of Xi'an Encephalopathy Hospital of TCM, through structuring medical record text, acupuncture prescriptions were extracted. Using the data mining tools of the ancient and modern medical record cloud platform V2.2.3 and the clinical effective prescription and molecular mechanism analysis system of traditional Chinese medicine V2.0, the cluster analysis and complex network analysis were conducted on acupuncture prescriptions.@*RESULTS@#Of 1584 acupuncture prescriptions for cerebral palsy in children, there were 84 acupoints and stimulating areas of scalp acupuncture, of which, foot-motor-sensory area, balance area and Sanyinjiao (SP 6) were the top 3 acupoints with the highest use rate. With cluster analysis, 5 groups of common supplementary acupoints and stimulating areas were found, named, Weizhong (BL 40) and Waiguan (TE 5), Shousanli (LI 10), Xingjian (LR 2), Xuanzhong (GB 39) and Chengfu (BL 36), foot-motor-sensory area, balance area and Sanyinjiao (SP 6), Xuehai (SP 10) and Fenglong (ST 40), Pishu (BL 20), motor area and Yanglingquan (GB 34). With complex network analysis on core prescriptions, 13 core acupoints and stimulating areas of scalp acupuncture were obtained, including 3 core main points, i.e. Sanyinjiao (SP 6), balance area and foot-motor-sensory area and 10 sub-core points, i.e. Taichong (LR 3), motor area, Xuehai (SP 10), Ganshu (BL 18), Pishu (BL 20), Yanglingquan (GB 34), Sishencong (EX-HN 1), Baihui (GV 20), Fengchi (GB 20) and Shenshu (BL 23).@*CONCLUSION@#In treatment of acupuncture for cerebral palsy in preschool children, the core prescriptions reveal the simultaneous treatment of exterior and interior, the mutual regulation of
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Preescolar , Humanos , Puntos de Acupuntura , Terapia por Acupuntura , Parálisis Cerebral/terapia , Minería de Datos , Registros Electrónicos de SaludRESUMEN
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.
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Humanos , Antivirales/uso terapéutico , Consenso , Enfermedad de Boca, Mano y Pie , Gripe Humana/tratamiento farmacológico , Medicina Tradicional ChinaRESUMEN
Malignant pleural effusion (MPE) is one of the common complications of tumor. Acupuncture-moxibustion therapy has several advantages for treatment of MPE. Acupuncture is regarded as a complex individualized intervention, and its characteristics of TCM is difficult to be reflected by strict randomized controlled trials. The registry study provides more possibilities for the data collection of individualized diagnosis and treatment under the guidance of the overall concept and syndrome differentiation, and is more suitable for data management and collection of large samples and multi-center trials in the real-world study. It has become an opportunity to carry out real-world study of acupuncture for MPE. There are many challenges in the registry study of acupuncture for MPE. However, it is of great significance to collect real-world data of acupuncture for MPE to improve the clinical effect of MPE and provide a new clinical research method for acupuncture in tumors and related complications.
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The clinical research articles relevant with 's subcutaneous needling therapy (FSN) were retrieved from CNKI, WANFANG, CBM and PubMed databases till January 2018 since the establishment of database. According to the general international criteria of disease classification, the diseases involved in the articles were classified and summarized. In terms of the clinical application and research of FSN, the questions were extracted and commented through expert's consultation. As a result, 412 articles were included. The statistical results of disease spectrum indicated that FSN was adopted in 65 kinds of diseases in 11 systems. Of these diseases, the relevant somatic pain disorders in the musculoskeletal system were the most appropriate. Professor explained that the clinical physicians of FSN should select the muscle-related disorders as the clinical research subject and treat them with normalized manipulation of FSN. The research on FSN is still at the preliminary stage. It needs more high-quality clinical and basic researches to provide the evidences for the therapeutic effects of FSN.
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Humanos , Analgesia por Acupuntura , Puntos de Acupuntura , Terapia por Acupuntura , Dolor Nociceptivo , TerapéuticaRESUMEN
OBJECTIVE@#To systematically review the current status of application of acupuncture in low back pain guidelines.@*METHODS@#The computer retrieval was conducted in PubMed, Cochrane Library, EMbase, China Journal Full Text Database (CNKI), China Biomedical Literature Database (CBM), VIP, Wanfang, guidelines databases, and the official websites of WHO and academic organizations (American Pain Society, American College of Physicians, etc.). After screening, the basic information and acupuncture-related issues in the guidelines that met the inclusion criteria were extracted and compared by using Excel software.@*RESULTS@#A total of 35 low back pain guidelines were included. ① One guideline was published before 2000, 16 guidelines were published from 2000 to 2010, and 18 guidelines were published from 2011 to 2017; 17 guidelines were published by the United States, 4 by Canada and China, 2 by New Zealand, the United Kingdom, and Europe, and 1 by Netherlands, Philippines, Denmark and Italy. ② Twenty-three guidelines were evidence-based guidelines, which was developed mainly by system review, meta-analysis and expert consultation, involving diagnosis, treatment, primary care of low back pain. ③ Acupuncture was mentioned in 23 guidelines, of them, 7 guidelines recommended acupuncture, 6 guidelines indicated that acupuncture might be considered under certain conditions such as combined with other therapies or patients were interested in acupuncture, however, 10 guidelines did not recommended acupuncture for low back pain.@*CONCLUSION@#The guidelines of low back pain are mainly developed by Europe countries and the United States, and the majority is published in the last 20 years. Among them, 20% of the guidelines have recommend acupuncture for low back pain.
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Humanos , Terapia por Acupuntura , China , Europa (Continente) , Dolor de la Región Lumbar , Terapéutica , Países Bajos , Nueva Zelanda , Guías de Práctica Clínica como Asunto , Reino UnidoRESUMEN
OBJECTIVE@#To develop an improved version of the Quality-of-Life Assessment instrument for Lung Cancer Patients Based on Traditional Chinese Medicine (QLASTCM-Lu) and to evaluate its psychometric property.@*METHODS@#The structured group method and the theory in developing rating scale were employed to revise the preliminary scale. The psychometric property (reliability, validity, and responsiveness) of the established QLASTCM-Lu (modified) were evaluated by quality of life data measured in 100 lung cancer patients. Statistical analyses were made accordingly by way of correlation analysis, factor analysis and paired t-test.@*RESULTS@#The internal consistency reliability of the overall scale and all domains was from 0.80 to 0.94. Correlation and factor analyses demonstrated that the scale was good in construct validity. The criterion validity was formed with European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire-Lung Cancer (EORTC QLQ-LC43) as the criterion. Statistically significant changes were found apart from such domain as "mental condition" and "social function", with the standardized response means being close to those of QLQ-LC43.@*CONCLUSION@#QLASTCM-Lu (modified) could be used to measure the quality of life of lung cancer patients with good reliability, validity and a certain degree of responsiveness.
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<p><b>OBJECTIVE</b>To determine whether patterns of enterovirus 71 (EV71)-associated hand, foot, and mouth disease (HFMD) were classified based on symptoms and signs, and explore whether individual characteristics were correlated with membership in particular pattern.</p><p><b>METHODS</b>Symptom-based latent class analysis (LCA) was used to determine whether patterns of EV71-HFMD existed in a sample of 433 cases from a clinical data warehouse system. Logistic regression was then performed to explore whether demographic, and laboratory data were associated with pattern membership.</p><p><b>RESULTS</b>LCA demonstrated a two-subgroup solution with an optimal fit, deduced according to the Bayesian Information Criterion minima. Hot pattern (59.1% of all patients) was characterized by a very high fever and high endorsement rates for classical HFMD symptoms (i.e., rash on the extremities, blisters, and oral mucosa lesions). Non-hot pattern (40.9% of all patients) was characterized by classical HFMD symptoms. The multiple logistic regression results suggest that white blood cell counts and aspartate transaminase were positively correlated with the hot pattern (adjust odds ratio=1.07, 95% confidence interval: 1.006-1.115; adjust odds ratio=1.051, 95% confidence interval: 1.019-1.084; respectively).</p><p><b>CONCLUSIONS</b>LCA on reported symptoms and signs in a retrospective study allowed different subgroups with meaningful clinical correlates to be defined. These findings provide evidence for targeted prevention and treatment interventions.</p>
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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.
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The effective quality control in clinical practices is an effective guarantee for the authenticity and scientificity of the findings. The post-marketing reevaluation for traditional Chinese medicines (TCM) focuses on the efficacy, adverse reaction, combined medication and effective dose of drugs in the market by expanded clinical trials, and requires a larger sample size and a wider range of patients. Therefore, this increases the difficulty of quality control in clinical practices. With the experience in quality control in clinical practices for the post-marketing reevaluation for Kangbingdu oral for cold, researchers in this study reviewed the study purpose, project, scheme design and clinical practice process from an overall point of view, analyzed the study characteristics of the post-marketing reevaluation for TCMs and the quality control risks, designed the quality control contents with quality impacting factors, defined key review contents and summarized the precautions in clinical practices, with the aim to improve the efficiency of quality control of clinical practices. This study can provide reference to clinical units and quality control-related personnel in the post-marketing reevaluation for TCMs.
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Humanos , Medicamentos Herbarios Chinos , Economía , Usos Terapéuticos , Medicina Tradicional China , Vigilancia de Productos Comercializados , Métodos , Control de Calidad , Ensayos Clínicos Controlados Aleatorios como Asunto , Infecciones del Sistema Respiratorio , QuimioterapiaRESUMEN
<p><b>BACKGROUND</b>Coronary artery perforation (CAP) is a rare but severe complication of percutaneous coronary intervention (PCI). The aim of our study was to evaluate the effect and safety of transcatheter embolization by autologous fat particles in the treatment of CAP.</p><p><b>METHODS</b>Once the CAP was confirmed, a little autologous subcutaneous fatty tissue was obtained from the groin of the patient and then was made into 1 mm × 1 mm fat particles. The perforated vessel was embolized by fat particles via a micro-catheter. There were eight patients undergoing transcatheter embolization by autologous fat particles in the treatment of CAP during PCI in Peking University Third Hospital from February 2009 to June 2014, and the clinical data of these patients were collected and analyzed retrospectively.</p><p><b>RESULTS</b>The lesion morphology of the patients was classified based on the American College of Cardiology/American Heart Association Task Force classification, there were one patient with Class B2 lesion and seven patients with Class C lesions (there were five patients with chronic total occlusion lesions). According to the Ellis classification of CAP, there were six patients with Class II perforations and two patients with Class III perforations. The causes of perforation included that seven patients induced by guide wire and one patient by balloon predilation. Three patients had pericardial effusion. All of the eight patients with CAP underwent transcatheter embolization by autologous fat particles. Coronary angiography confirmed that all of them were embolized successfully. There was no severe complication after the procedure. The coronary angiography of one patient at 1 week and another patient at 2 years after the embolization showed that the embolized arteries had recanalized. The median follow-up time was 20.3 months (8.8-50.2 months), the event-free survival rate was 100%.</p><p><b>CONCLUSIONS</b>Transcatheter embolization by autologous fat particles was an effective, safe, cheap, and easy way to treat the perforation of small vessels during PCI.</p>
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Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Enfermedad de la Arteria Coronaria , Cirugía General , Terapéutica , Vasos Coronarios , Cirugía General , Embolización Terapéutica , Intervención Coronaria Percutánea , Métodos , Estudios RetrospectivosRESUMEN
Treatment determination based on syndrome differentiation is the key of Chinese medicine. A feasible way of improving the clinical therapy effectiveness is needed to correctly differentiate the syndrome classifications based on the clinical manifestations. In this paper, a novel data mining method based on manifold ranking (MR) is proposed to explore the relation between syndromes and symptoms for viral hepatitis. Since MR could take the symptom data with expert differentiation and the symptom data without expert differentiation into the task of syndrome classification, the clinical information used for modeling the syndrome features is greatly enlarged so as to improve the precise of syndrome classification. In addition, the proposed method of syndrome classification could also avoid two disadvantages in previous methods: linear relation of the clinical data and mutually exclusive symptoms among different syndromes. And it could help exploit the latent relation between syndromes and symptoms more effectively. Better performance of syndrome classification is able to be achieved according to the experimental results and the clinical experts.
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Humanos , Hepatitis Viral Humana , Clasificación , Medicina Tradicional ChinaRESUMEN
Publication biases and collection limitations are the main disadvantages of a traditional meta-analysis based on aggregate patient data (APD) from published articles. Individual patient data (IPD) meta-analysis, as the gold standard of systematic review, is a possible alternative in this context. However, the publications relative to IPD meta-analyses are still rare compared with the traditional ones, especially in the research oriented to Chinese medicine (CM). In this article, the strengths and detailed functioning of IPD meta-analysis are described. Furthermore, the need for IPD meta-analysis to assess the treatments based on CM was also discussed. Compared with the traditional APD meta-analysis, the IPD meta-analysis might give a more accurate and unbiased assessment and is worth to be recommended to CM researchers.
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Humanos , Investigación Biomédica , PacientesRESUMEN
To effectively guarantee quality of randomized controlld trial (RCT) of acupuncture and develop reasonable content and checklist of on-site quality control, influencing factors on quality of acupuncture RCT are analyzed and scientificity of quality control content and feasibility of on-site manipulation are put into overall consideration. Based on content and checklist of on-site quality control in National 11th Five-Year Plan Project Optimization of Comprehensive Treatment Plan for TCM in Prevention and Treatment of Serious Disease and Clinical Assessment on Generic Technology and Quality Control Research, it is proposed that on-site quality control of acupuncture RCT should be conducted with PICOST (patient, intervention, comparison, out come, site and time) as core, especially on quality control of interveners' skills and outcome assessment of blinding, and checklist of on-site quality control is developed to provide references for undertaking groups of the project.
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Humanos , Terapia por Acupuntura , Estándares de Referencia , China , Control de Calidad , Ensayos Clínicos Controlados Aleatorios como Asunto , Estándares de Referencia , Proyectos de Investigación , Estándares de ReferenciaRESUMEN
Differences and relations between effects of acupuncture therapy and sham acupuncture are systematically analyzed in this article through the influential factors of acupuncture effect. And it is held that sham acupuncture effect is not exactly equal to placebo effect. The effects of both acupuncture and sham acupuncture are composed by specific effects and non-specific effects, and the differences of non-specific effects between acupunc ture and sham acupuncture can be minimized furthest with blinding and randomized method. Therefore, the difference of acupuncture and sham acupuncture treatment rests with the degree of differences of the specific effects. Only when both of the specific effect of acupuncture and the effect of acupuncture are minimized, can it be applied as the ideal placebo control. Consequently when placebo acupunture are setted up, factors such as the body condition, site of stimulation and stimulation parameters which can influence the specific effect of acupuncture should be taken into consideration to produce the relatively minimum specific effect.
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Humanos , Terapia por Acupuntura , Psicología , Ensayos Clínicos Controlados como Asunto , Métodos , Psicología , Efecto Placebo , Proyectos de Investigación , Resultado del TratamientoRESUMEN
HIV/AIDS patients in high prevalence areas with different routes of infection (sexually transmitted 878 cases, 527 cases of intravenous drug user, paid blood donor 652 cases) were choosen for traditional Chinese medicine (TCM) syndrome investigation for one-year clinical follow-up. This paper primarily concluded the nature, location and pathogenesis of AIDS diseases. Deficiency of Yang and Yin, combining deficiency of Qi are the basic deficiency syndromes, while stagnation of dampness, toxic fire are the excess syndromes; the disease location of HIV infector is spleen, main syndrome is deficiency of spleen Qi; the disease location of AIDS patient is kidney, main syndrome is deficiency of spleen and kidney Yang. The pathogenic development tendency is from deficiency of Qi to combining stagnation of dampness and toxic fire, finally to deficiency of Qi and Yin, deficiency of Yang.
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Adolescente , Adulto , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Adulto Joven , Estudios de Seguimiento , Infecciones por VIH , Diagnóstico , Medicina Tradicional China , MétodosRESUMEN
<p><b>BACKGROUND</b>Impaired coronary flow reserve (CFR) in patients with hypertension may be caused by epicardial coronary stenosis or microvascular dysfunction. Antihypertensive treatment has been shown to improve coronary microvascular dysfunction. The aim of this study was to evaluate the impact of uncontrolled blood pressure (BP) on diagnostic accuracy of CFR for detecting significant coronary stenosis.</p><p><b>METHODS</b>A total of 98 hypertensive patients scheduled for coronary angiography (CAG) due to chest pain were studied. Of them, 45 patients had uncontrolled BP (defined as the office BP ≥ 140/90 mmHg (1 mmHg = 0.133 kPa) in general hypertensive patients, or ≥ 130/80 mmHg in hypertensive individuals with diabetes mellitus), and the remaining 53 patients had well-controlled BP. CFR was measured in the left anterior descending coronary artery (LAD) during adenosine triphosphate-induced hyperemia by non-invasive transthoracic Doppler echocardiography (TTDE) within 48 hours prior to CAG. Significant LAD stenosis was defined as > 70% luminal narrowing. Diagnostic accuracy of CFR for detecting significant coronary stenosis was analyzed with a receiver operating characteristic analysis.</p><p><b>RESULTS</b>CFR was significantly lower in patients with uncontrolled BP than in those with well-controlled BP (2.1 ± 0.6 vs. 2.6 ± 0.9, P < 0.01). Multivariate linear regression analysis of the study showed that the value of CFR was independently associated with the angiographically determined degree of LAD stenosis (β = -0.445, P < 0.0001) and the presence of uncontrolled BP (β = -0.272, P = 0.014). With a receiver operating characteristic analysis, CFR < 2.2 was the optimal cut-off value for detecting LAD stenosis in all hypertensive patients (AUC 0.83, 95%CI 0.75 - 0.91) with a sensitivity of 75%, a specificity of 78%, and an accuracy of 77%. A significant reduction of diagnostic specificity was observed in patients with uncontrolled BP compared with those with well-controlled BP (67% vs. 93%, P = 0.031).</p><p><b>CONCLUSIONS</b>CFR measurement by TTDE is valuable in the diagnosis of significant coronary stenosis in hypertensive patients. However, the diagnostic specificity is reduced in patients with uncontrolled BP.</p>
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Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Presión Sanguínea , Fisiología , Circulación Coronaria , Fisiología , Estenosis Coronaria , Diagnóstico , HipertensiónRESUMEN
The clinical application of Chinese patent medicines has suffered sever problems and required guidelines for clinical practices. Currently, the expert consensus method is more suitable for formulating clinical practice guidelines of Chinese patent medicines than the evidence-based method. However, there remain problems in the application of the expert consensus method. This study proposed a derivative expert consensus method--a method for formulating clinical practice guidelines of common Chinese patent medicines based on clinical practices, and introduced the method in terms of research thought, methodology and implementation procedure.
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Humanos , Medicina Basada en la Evidencia , Estándares de Referencia , Medicamentos sin Prescripción , Estándares de ReferenciaRESUMEN
Data authenticity is the basic requirement of clinical studies. In actual clinical conditions how to establish formatted case report forms (CRF) in line with the requirement for data authenticity is the key to ensure clinical data quality. On the basis of the characteristics of clinical data in actual clinical conditions, we determined elements for establishing formatted case report forms by comparing differences in data characteristics of CRFs in traditional clinical studies and in actual clinical conditions, and then generated formatted case report forms in line with the requirement for data authenticity in actual clinical conditions. The data of formatted CRFs generated in this study could not only meet the requirement for data authenticity of clinical studies in actual clinical conditions, but also comply with data management practices for clinical studies, thus it is deemed as a progress in technical methods.