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OBJECTIVE: To assess efficacy of Chinese medicine (CM) on insomnia considering characteristics of treatment based on syndrome differentiation. METHODS: A total of 116 participants aged 18 to 65 years with moderate and severe primary insomnia were randomized to the placebo (n=20) or the CM group (n=96) for a 4-week treatment and a 4-week follow-up. Three CM clinicians independently prescribed treatments for each patient based on syndromes differentiation. The primary outcome was change in total sleep time (TST) from baseline. Secondary endpoints included sleep onset latency (SOL), wake time after sleep onset (WASO), sleep efficiency, Pittsburgh Sleep Quality Index (PSQI) and CM symptoms. RESULTS: The CM group had an average 0.6 h more (95% confidence interval (CI): 0.3-0.9, P<0.001) TST and 34.1% (10.3%-58.0%, P=0.005) more patients beyond 0.5 h TST increment than that of the placebo group. PSQI was changed -3.3 (-3.8 to -2.7) in the CM group, a -2.0 (-3.2 to -0.8, P<0.001) difference from the placebo group. The CM symptom score in the CM group decreased -2.0 (-3.3 to -0.7, P=0.003) more than the placebo group. SOL and WASO changes were not significantly different between groups. The analysis of prescriptions by these clinicians revealed blood deficiency and Liver stagnation as the most common syndromes. Prescriptions for these clinicians displayed relative stability, while the herbs varied. All adverse events were mild and were not related to study treatment. CONCLUSION: CM treatment based on syndrome differentiation can increase TST and improve sleep quality of primary insomnia. It is effective and safe for primary insomnia. In future studies, the long-term efficacy validation and the exploratory of eutherapeutic clinicians' fixed herb formulas should be addressed (Registration No. NCT01613183).
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BACKGROUND: Since adverse events during treatment affect adherence and subsequent glycemic control, understanding the safety profile of oral anti-diabetic drugs is imperative for type 2 diabetes mellitus (T2DM) therapy. AIM: To evaluate the risk of infection in patients with T2DM treated with dipeptidyl-peptidase 4 (DPP-4) inhibitors. METHODS: Electronic databases were searched. The selection criteria included randomized controlled trials focused on cardiovascular outcomes. In these studies, the effects of DPP-4 inhibitors were directly compared to those of either other active anti-diabetic treatments or placebo. Six trials involving 53616 patients were deemed eligible. We calculated aggregate relative risks employing both random-effects and fixed-effects approaches, contingent upon the context. RESULTS: The application of DPP-4 inhibitors showed no significant link to the overall infection risk [0.98 (0.95, 1.02)] or the risk of serious infections [0.96 (0.85, 1.08)], additionally, no significant associations were found with opportunistic infections [0.69 (0.46, 1.04)], site-specific infections [respiratory infection 0.99 (0.96, 1.03), urinary tract infections 1.02 (0.95, 1.10), abdominal and gastrointestinal infections 1.02 (0.83, 1.25), skin structure and soft tissue infections 0.81 (0.60, 1.09), bone infections 0.96 (0.68, 1.36), and bloodstream infections 0.97 (0.80, 1.18)]. CONCLUSION: This meta-analysis of data from cardiovascular outcome trials revealed no heightened infection risk in patients undergoing DPP-4 inhibitor therapy compared to control cohorts.
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BACKGROUND: The measurement of triceps skinfold (TSF) thickness serves as a noninvasive metric for evaluating subcutaneous fat distribution. Despite its clinical utility, the TSF thickness trajectories and their correlation with overall mortality have not been thoroughly investigated. AIM: To explore TSF thickness trajectories of Chinese adults and to examine their associations with all-cause mortality. METHODS: This study encompassed a cohort of 14747 adults sourced from the China Health and Nutrition Survey. Latent class trajectory modeling was employed to identify distinct trajectories of TSF thickness. Subjects were classified into subgroups reflective of their respective TSF thickness trajectory. We utilized multivariate Cox regression analyses and mediation examinations to explore the link between TSF thickness trajectory and overall mortality, including contributory factors. RESULTS: Upon adjustment for multiple confounding factors, we discerned that males in the 'Class 2: Thin-stable' and 'Class 3: Thin-moderate' TSF thickness trajectories exhibited a markedly reduced risk of mortality from all causes in comparison to the 'Class 1: Extremely thin' subgroup. In the mediation analyses, the Geriatric Nutritional Risk Index was found to be a partial intermediary in the relationship between TSF thickness trajectories and mortality. For females, a lower TSF thickness pattern was significantly predictive of elevated all-cause mortality risk exclusively within the non-elderly cohort. CONCLUSION: In males and non-elderly females, lower TSF thickness trajectories are significantly predictive of heightened mortality risk, independent of single-point TSF thickness, body mass index, and waist circumference.
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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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Terapia por Acupuntura , Trastorno Autístico , Moxibustión , Niño , Humanos , Terapia por Acupuntura/métodos , 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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Accidente Cerebrovascular Isquémico , Humanos , Síndrome , Medicina Tradicional China , Hígado , FenotipoRESUMEN
To compare the clinical efficacy among different acupuncture and moxibustion therapies on stable angina pectoris (SAP) of coronary heart disease by means of network Meta-analysis. The articles of randomized controlled trial (RCT) for SAP of coronary heart disease treated with acupuncture and moxibustion therapies were searched from PubMed, Web of Science, Cochrane Library, CNKI, Wanfang database and VIP database from May 1, 2002 to May 1, 2022. The quality of them was assessed with the risk of bias assessment tool of Cochrane 5.3, and the network Meta-analysis was undertaken with Stata 13.1 software. A total of 29 articles were included with the acupuncture and moxibustion therapies involved, e.g. acupuncture, acupoint application and moxibustion. In comparison with the simple routine western medication, the effective rate was better on SAP treated with the combined treatments, in which, acupoint application, moxibustion, acupuncture and intradermal needling were combined with routine western medication (P<0.05). Of those combined treatments, the combination of the acupoint application with routine western medication had high probability, suggesting the optimal regimen (area under the curve [SUCRA]=0.711, P<0.05). The effective rate of acupuncture combined with routine western medication for ECG improvement was better than that of routine western medication (P<0.05), and such combined treatment was high in probability, underlying its optimal treatment (SUCRA=0.800, P<0.05). Combined with routine western medication, acupuncture, acupoint application, moxibustion and intradermal needling all improve the clinical efficacy on SAP of coronary heart disease. But, with different outcomes considered, the optimal treatments may be different. It needs more multi-central and large-sample randomized controlled trials to validate these results.
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Enfermedad Coronaria , Humanos , Metaanálisis en Red , Enfermedad Coronaria/terapiaRESUMEN
OBJECTIVE: To estimate the minimal clinically important difference (MCID) of the frequency of bowel movement for the patients with chronic severe functional constipation treated with acupuncture so as to provide the evidence for the clinical decision. METHODS: In this study, 813 patients with chronic severe functional constipation treated with acupuncture in two previous randomized controlled trials were included. Through the anchor-based method (anchored by the item 28 "satisfaction with previous treatment" of the patient assessment of constipation-quality of life [PAC-QOL]) and the distribution-based method, the MCID of the weekly frequency of complete spontaneous bowel movement (CSBM) and spontaneous bowel movement (SBM) was analyzed statistically in the patients. RESULTS: The MCID of the mean weekly frequency of CSBM and SBM was 1.3 times and 1.6 times in patients with chronic severe functional constipation treated with acupuncture, respectively. CONCLUSION: The mean increase of the weekly CSMB is ≥ 1.3 times and that of SBM is ≥ 1.6 times after treatment when compared with the baseline respectively, suggesting the clinical significance.
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Terapia por Acupuntura , Calidad de Vida , Humanos , Diferencia Mínima Clínicamente Importante , Resultado del Tratamiento , Estreñimiento/terapiaRESUMEN
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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Enfermedad de Boca, Mano y Pie , Gripe Humana , Antivirales/uso terapéutico , Consenso , Humanos , Gripe Humana/tratamiento farmacológico , Medicina Tradicional China , Guías de Práctica Clínica como AsuntoRESUMEN
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 yin and yang and the combination of acupoints with stimulating ares of scalp acupuncture for both encephalopathy and paralysis.
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Terapia por Acupuntura , Parálisis Cerebral , Puntos de Acupuntura , Parálisis Cerebral/terapia , Preescolar , Minería de Datos , Registros Electrónicos de Salud , HumanosRESUMEN
BACKGROUND: Germinoma is a type of germ cell tumor that most frequently arises in the midline axis of the brain. Impaired vision is a clinical manifestation of germinnoma. Although rare, intracranial germinoma seeding to the perioptic arachnoid space is one cause of visual acuity decrease. CASE SUMMARY: An 11yearold girl who presented with polyuria and polydipsia and subsequently developed diminution of vision. Imaging showed bilateral heterogeneous enhancement of the optic nerve sheaths and atrophy of the optic nerve, and transsphenoidal biopsy revealed a germinoma. The patient experienced poor visual recovery following chemotherapy and radiotherapy. Germinomas are rare and they are mostly identified in children and adolescents. The manifestations include diabetes insipidus, pituitary dysfunction, visual complaints, etc. The mechanisms that lead to visual loss include intracranial hypertension, compression of optic chiasma, and tumor invasion. A literature review was performed to summarize the cases with a tumor infiltrating the optic nerve. Most of the reported patients were adolescents and presented with anterior pituitary hormone deficiency. Enhancement of optic nerve sheaths and optic disc pallor could be identified in most of the cases. The purpose of this report is to provide awareness that in cases where a germinoma is associated with visual loss, though rare, perioptic meningeal seeding should be taken into consideration. CONCLUSION: The case report suggests that children with diabetes insipidus need a complete differential diagnosis.
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OBJECTIVE: To establish and promote the non-contact doctor-patient interactive diagnosis and treatment mode based on mobile internet for the treatment of coronavirus disease 2019 (COVID-19) with moxibustion therapy, and to observe the feasibility and effectiveness of the model in the pandemic. METHODS: A total of 43 first-line medical staff and 149 suspected and confirmed cases with COVID-19 [18 cases in medical observation period, 17 cases of mild type (cold dampness and stagnation in the lung), 24 cases of ordinary type (cold-dampness accumulated in the lung) and 90 cases in recovery period (qi deficiency of spleen and lung)] were included. A non-contact doctor-patient interactive diagnosis and treatment platform was established for the treatment of COVID-19 with indirect moxibustion plaster based on mobile internet. By the platform, the patients were instructed to use indirect moxibustion plaster in treatment. For the first-line medical staff and patients in the medical observation period, Zusanli (ST 36), Qihai (CV 6) and Zhongwan (CV 12) were selected. For the mild cases (cold dampness and stagnation in the lung) and the cases of ordinary type (cold-dampness accumulated in the lung), Hegu (LI 4), Taichong (LR 3), Zusanli (ST 36) and Guanyuan (CV 4) were selected. In the recovery period (qi deficiency of spleen and lung), Dazhui (GV 14), Feishu (BL 13), Geshu (BL 17), Zusanli (ST 36) and Kongzui (LU 6) were used. The treatment was given once daily for 40 min each time. The intervention lasted for 10 days. After intervention, the infection rate and the improvement in the symptoms and psychological status of COVID-19 were observed in clinical first-line medical staff and COVID-19 patients. RESULTS: In 10 days of intervention with indirect moxibustion plaster, there was "zero" infection among medical staff. Of 43 first-line physicians and nurses, 33 cases had some physical symptoms and psychological discomforts, mainly as low back pain, poor sleep and anxiety. After treatment, regarding the improvements in the symptoms and psychological discomforts, the effective rate was 78.8% (26/33) and the curative rate was 36.4% (12/33). Regarding the improvements in psychological discomforts, the effective rate was 58.3% (14/24) and the curative rate was 37.5 (9/24). Of 149 patients, 133 cases had the symptoms and psychological discomforts. After treatment, regarding the improvements in the symptoms and psychological discomforts, the effective rate was 81.2% (108/133) and the curative rate was 34.6% (46/133). Regarding the improvements in psychological discomforts, the effective rate was 76.5% (52/68) and the curative rate was 57.4 % (39/68). CONCLUSION: It is feasible to apply the indirect moxibustion plaster technique based on mobile internet to the treatment COVID-19. This mode not only relieves the symptoms such as cough and fatigue, improves psychological state, but also possibly prevents the first-line medical staff from COVID-19.
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Infecciones por Coronavirus/prevención & control , Infecciones por Coronavirus/terapia , Moxibustión , Pandemias/prevención & control , Neumonía Viral/prevención & control , Neumonía Viral/terapia , Consulta Remota , Puntos de Acupuntura , Betacoronavirus , COVID-19 , Personal de Salud , Humanos , SARS-CoV-2RESUMEN
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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Terapia por Acupuntura , Moxibustión , Derrame Pleural Maligno/terapia , Sistema de Registros , Humanos , Medicina Tradicional China , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
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. â 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. â¡ 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. ⢠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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Terapia por Acupuntura , Dolor de la Región Lumbar/terapia , China , Europa (Continente) , Humanos , Países Bajos , Nueva Zelanda , Guías de Práctica Clínica como Asunto , Reino UnidoRESUMEN
The clinical research articles relevant with Fu'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 FU Zhong-hua 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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Analgesia por Acupuntura , Terapia por Acupuntura , Dolor Nociceptivo , Puntos de Acupuntura , Humanos , Dolor Nociceptivo/terapiaRESUMEN
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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Neoplasias Pulmonares/psicología , Medicina Tradicional China/métodos , Psicometría/métodos , Calidad de Vida , Encuestas y Cuestionarios , Adulto , Anciano , Emociones , Femenino , Humanos , Neoplasias Pulmonares/diagnóstico , Neoplasias Pulmonares/epidemiología , Masculino , Persona de Mediana Edad , Psicometría/normas , Mejoramiento de la Calidad , Reproducibilidad de los Resultados , Factores SocioeconómicosRESUMEN
OBJECTIVE: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.
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Enterovirus/fisiología , Enfermedad de Boca, Mano y Pie/terapia , Enfermedad de Boca, Mano y Pie/virología , Medicina Tradicional China , Niño , Preescolar , Femenino , Humanos , Masculino , Modelos Biológicos , Estudios Retrospectivos , Factores de RiesgoRESUMEN
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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Medicina Tradicional China/normas , Vigilancia de Productos Comercializados , China , Consenso , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Medicamentos Herbarios Chinos/efectos adversos , Medicamentos Herbarios Chinos/normas , Humanos , Inyecciones , Control de CalidadRESUMEN
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.