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1.
Chin Med J (Engl) ; 134(16): 1920-1929, 2021 07 27.
Artigo em Inglês | MEDLINE | ID: mdl-34320566

RESUMO

BACKGROUND: The global pandemic coronavirus disease 2019 (COVID-19) has become a major public health problem and presents an unprecedented challenge. However, no specific drugs were currently proven. This study aimed to evaluate the comparative efficacy and safety of pharmacological interventions in patients with COVID-19. METHODS: Medline, Embase, the Cochrane Library, and clinicaltrials.gov were searched for randomized controlled trials (RCTs) in patients infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)/SARS-CoV. Random-effects network meta-analysis within the Bayesian framework was performed, followed by the Grading of Recommendations Assessment, Development, and Evaluation system assessing the quality of evidence. The primary outcome of interest includes mortality, cure, viral negative conversion, and overall adverse events (OAEs). Odds ratio (OR) with 95% confidence interval (CI) was calculated as the measure of effect size. RESULTS: Sixty-six RCTs with 19,095 patients were included, involving standard of care (SOC), eight different antiviral agents, six different antibiotics, high and low dose chloroquine (CQ_HD, CQ_LD), traditional Chinese medicine (TCM), corticosteroids (COR), and other treatments. Compared with SOC, a significant reduction of mortality was observed for TCM (OR = 0.34, 95% CI: 0.20-0.56, moderate quality) and COR (OR = 0.84, 95% CI: 0.75-0.96, low quality) with improved cure rate (OR = 2.16, 95% CI: 1.60-2.91, low quality for TCM; OR = 1.17, 95% CI: 1.05-1.30, low quality for COR). However, an increased risk of mortality was found for CQ_HD vs. SOC (OR = 3.20, 95% CI: 1.18-8.73, low quality). TCM was associated with decreased risk of OAE (OR = 0.52, 95% CI: 0.38-0.70, very low quality) but CQ_HD (OR = 2.51, 95% CI: 1.20-5.24) and interferons (IFN) (OR = 2.69, 95% CI: 1.02-7.08) vs. SOC with very low quality were associated with an increased risk. CONCLUSIONS: COR and TCM may reduce mortality and increase cure rate with no increased risk of OAEs compared with standard care. CQ_HD might increase the risk of mortality. CQ, IFN, and other antiviral agents could increase the risk of OAEs. The current evidence is generally uncertain with low-quality and further high-quality trials are needed.


Assuntos
COVID-19 , Humanos , Medicina Tradicional Chinesa , Metanálise em Rede , Pandemias , SARS-CoV-2
2.
Front Pharmacol ; 12: 589091, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-33732151

RESUMO

Aims: To determine the risk of liver injury associated with the use of different intravenous lipid emulsions (LEs) in large populations in a real-world setting in China. Methods: A prescription sequence symmetry analysis was performed using data from 2015 Chinese Basic Health Insurance for Urban Employees. Patients newly prescribed both intravenous LEs and hepatic protectors within time windows of 7, 14, 28, 42, and 60 days of each other were included. The washout period was set to one month according to the waiting-time distribution. After adjusting prescribing time trends, we quantify the deviation from symmetry of patients initiating LEs first and those initiating hepatic protectors first, by calculating adjusted sequence ratios (ASRs) and relevant 95% confidence intervals. Analyses were further stratified by age, gender, and different generations of LEs developed. Results: In total, 416, 997, 1,697, 2,072, and 2,342 patients filled their first prescriptions with both drugs within 7, 14, 28, 42, and 60 days, respectively. Significantly increased risks of liver injury were found across all time windows, and the strongest effect was observed in the first 2 weeks [ASR 6.97 (5.77-8.42) ∼ 7.87 (6.04-10.61)] in overall patients. In subgroup analyses, female gender, age more than 60 years, and soybean oil-based and alternative-LEs showed higher ASRs in almost all time windows. Specially, a lower risk for liver injury was observed in the first 14 days following FO-LEs administration (ASR, 3.42; 95% CI, 0.81-14.47), but the risk started to rise in longer time windows. Conclusion: A strong association was found between LEs use and liver injury through prescription sequence symmetry analysis in a real-world setting, which aligns with trial evidence and clinical experience. Differences revealed in the risks of liver injury among various LEs need further evaluation.

3.
Am J Hematol ; 96(5): 561-570, 2021 05 01.
Artigo em Inglês | MEDLINE | ID: mdl-33606900

RESUMO

Globally, postpartum hemorrhage (PPH) is the leading cause of maternal death. Women with immune thrombocytopenia (ITP) are at increased risk of developing PPH. Early identification of PPH helps to prevent adverse outcomes, but is underused because clinicians do not have a tool to predict PPH for women with ITP. We therefore conducted a nationwide multicenter retrospective study to develop and validate a prediction model of PPH in patients with ITP. We included 432 pregnant women (677 pregnancies) with primary ITP from 18 academic tertiary centers in China from January 2008 to August 2018. A total of 157 (23.2%) pregnancies experienced PPH. The derivation cohort included 450 pregnancies. For the validation cohort, we included 117 pregnancies in the temporal validation cohort and 110 pregnancies in the geographical validation cohort. We assessed 25 clinical parameters as candidate predictors and used multivariable logistic regression to develop our prediction model. The final model included seven variables and was named MONITOR (maternal complication, WHO bleeding score, antepartum platelet transfusion, placental abnormalities, platelet count, previous uterine surgery, and primiparity). We established an easy-to-use risk heatmap and risk score of PPH based on the seven risk factors. We externally validated this model using both a temporal validation cohort and a geographical validation cohort. The MONITOR model had an AUC of 0.868 (95% CI 0.828-0.909) in internal validation, 0.869 (95% CI 0.802-0.937) in the temporal validation, and 0.811 (95% CI 0.713-0.908) in the geographical validation. Calibration plots demonstrated good agreement between MONITOR-predicted probability and actual observation in both internal validation and external validation. Therefore, we developed and validated a very accurate prediction model for PPH. We hope that the model will contribute to more precise clinical care, decreased adverse outcomes, and better health care resource allocation.


Assuntos
Hemorragia Pós-Parto/etiologia , Complicações Hematológicas na Gravidez , Púrpura Trombocitopênica Idiopática/complicações , Adulto , Área Sob a Curva , China/epidemiologia , Estudos de Coortes , Suscetibilidade a Doenças , Registros Eletrônicos de Saúde , Feminino , Seguimentos , Previsões , Geografia Médica , Humanos , Imunoglobulinas Intravenosas/uso terapêutico , Imunossupressores/uso terapêutico , Recém-Nascido , Modelos Logísticos , Modelos Teóricos , Hemorragia Pós-Parto/epidemiologia , Hemorragia Pós-Parto/prevenção & controle , Prednisona/uso terapêutico , Gravidez , Resultado da Gravidez , Prognóstico , Púrpura Trombocitopênica Idiopática/tratamento farmacológico , Púrpura Trombocitopênica Idiopática/terapia , Estudos Retrospectivos , Fatores de Risco , Centros de Atenção Terciária/estatística & dados numéricos
4.
Biomed Environ Sci ; 33(1): 37-47, 2020 Jan 20.
Artigo em Inglês | MEDLINE | ID: mdl-32029057

RESUMO

Objective: To evaluate the effects of incretin-based therapies on body weight as the primary outcome, as well as on body mass index (BMI) and waist circumference (WC) as secondary outcomes. Methods: Databases including Medline, Embase, the Cochrane Library, and clinicaltrials.gov (www.clinicaltrials.gov) were searched for randomized controlled trials (RCTs). Standard pairwise meta-analysis and network meta-analysis (NMA) were both carried out. The risk of bias (ROB) tool recommended by the Cochrane handbook was used to assess the quality of studies. Subgroup analysis, sensitivity analysis, meta-regression, and quality evaluation based on the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) were also performed. Results: A total of 292 trials were included in this study. Compared with placebo, dipeptidyl-peptidase IV inhibitors (DPP-4Is) increased weight slightly by 0.31 kg [95% confidence interval ( CI): 0.05, 0.58] and had negligible effects on BMI and WC. Compared with placebo, glucagon-like peptide-1 receptor agonists (GLP-1 RAs) lowered weight, BMI, and WC by -1.34 kg (95% CI: -1.60, -1.09), -1.10 kg/m 2 (95% CI: -1.42, -0.78), and -1.28 cm (95% CI: -1.69, -0.86), respectively. Conclusion: GLP-1 RAs were more effective than DPP-4Is in lowering the three indicators. Overall, the effects of GLP-1 RAs on weight, BMI, and WC were favorable.


Assuntos
Peso Corporal/efeitos dos fármacos , Diabetes Mellitus Tipo 2/tratamento farmacológico , Inibidores da Dipeptidil Peptidase IV/uso terapêutico , Incretinas/uso terapêutico , Adulto , Idoso , Feminino , Humanos , Hipoglicemiantes/uso terapêutico , Masculino , Pessoa de Meia-Idade , Metanálise em Rede
5.
Zhongguo Zhong Yao Za Zhi ; 44(20): 4350-4353, 2019 Oct.
Artigo em Chinês | MEDLINE | ID: mdl-31872644

RESUMO

Kangfu Xiaoyan Suppository is widely used in the treatment of gynecological inflammatory diseases. Long-term clinical application and a certain amount of research evidences show that Kangfu Xiaoyan Suppository can alleviate the clinical symptoms of pelvic inflammatory diseases,reduce the recurrence rate,and relieve sequelae,with a better safety and economic characteristics. As a type of nationally protected traditional Chinese medicine and type B medicine included in medical insurance,it has been selected as a Chinese patent medicine for rectal administration. It was included in the Guidelines for diagnosis and treatment of common gynecological diseases of traditional Chinese medicine published by the Chinese Academy of Traditional Chinese Medicine in 2012,the Pelvic inflammatory diseases diagnosis and treatment guidelines issued by the Infectious Diseases Collaborative Group of the Obstetrics and Gynecology Branch of the Chinese Medical Association in 2014,and the group standard of Single use of traditional Chinese medicine/combined antibiot guidelines for clinical practice-pelvic inflammatory diseases of the Chinese Academy of Traditional Chinese Medicine in 2017. To further enhance clinicians' understanding of the drug and better guide its rational clinical use,experts from the field of gynecology of traditional Chinese and Western medicine were invited to develop and compile this expert consensus. This consensus takes full account of clinical evidences and expert clinical experience,and form recommendations for clinical problems based on evidences and consensus recommendations for clinical problems without evidence by nominal grouping method. The expert consensus is mainly formed in the consideration of six factors: quality of evidence,economy,efficacy,adverse reactions,patient acceptability and others. Based on clinical research evidences and expert experience,this consensus provides a preliminary reference for the clinical use of the drug in a concise and clear format. However,evidence-based support is still required in a large number of high-quality studies,and this consensus will be revised in the future according to new clinical problems and the update of evidence-based evidence in practical application.


Assuntos
Consenso , Medicamentos de Ervas Chinesas/uso terapêutico , Medicina Tradicional Chinesa , Doença Inflamatória Pélvica/tratamento farmacológico , Feminino , Humanos , Medicamentos sem Prescrição , Supositórios
6.
Zhongguo Zhong Yao Za Zhi ; 44(14): 2896-2901, 2019 Jul.
Artigo em Chinês | MEDLINE | ID: mdl-31602831

RESUMO

In 2013,China pharmaceutical regulatory department issued guiduance on postmarketing drug safety monitoring for industry. It aimed to encourage industry to carry out postmarketing drug safety monitoring including hospital-based intensive monitoring of postmarketing Chinese patent medicine. Subsequently,more and more such kind of studies have been performed all over China. However,in view of the current situation in this field,the development of hospital-based intensive monitoring of postmarketing Chinese patent medicine lacks standardization,such as unreasonable design,omission of reports about adverse drug reactions,inadequate process of quality control,non-standardized interpretation of adverse reactions,etc. Therefore,it is necessary to formulate relevant technical specifications to guide this area. The developing of this technical specification refered to the international post-marketing safety monitoring model and advanced design concepts and methods. We developed it under the guidance of relevant laws,regulations and technical documents in China. Meanwhile the characteristics of Chinese patent medicines and the real situation in this area were considered. The aim of this technical specification is to obtain the incidence,type,degree and clinical manifestation of adverse drug reactions of Chinese patent medicines,to find new risk signals of adverse reactions,to identify risk factors,and to provide a basis for the formulation of risk management and control plans. This specification has been approved by China association of Chinese medicine which is numbered T/CACM011-2016.


Assuntos
Medicina Tradicional Chinesa , Medicamentos sem Prescrição , Vigilância de Produtos Comercializados , Sistemas de Notificação de Reações Adversas a Medicamentos , China , Hospitais
7.
Zhongguo Zhong Yao Za Zhi ; 44(14): 2926-2931, 2019 Jul.
Artigo em Chinês | MEDLINE | ID: mdl-31602834

RESUMO

Diemailing~® Kudiezi Injection( DKI) is widely used in the treatment of cerebral infarction,coronary heart disease and angina pectoris. Long-term clinical application and related research evidence showed that DKI has a good effect in improving the clinical symptoms of cardiovascular and cerebrovascular diseases. However,this injection has not been included in any clinical practice guideline. It has been found that the use of DKI is in wrong way in clinical practice in recent years. Therefore,clinical experts from the field of cardiovascular and cerebrovascular diseases nationwide are invited to compile this expert consensus in order to guide clinicians.GRADE system is used to grade the quality of evidence according to different outcomes according to degrading factors. Then it forms the recommendation or consensus suggestion through the nominal group method. The formation of expert consensus mainly considers six factors: quality of evidence,economy,efficacy,adverse reactions,patient acceptability and others. Based on these six aspects,if the evidence is sufficient,a " recommendation" supported by evidence is formed,and GRADE grid voting rule is adopted. If the evidence is insufficient,a " consensus suggestions" will be formed,using the majority voting rule. In this consensus,the clinical indications,efficacy,safety evidences and related preliminary data of DKI were systematically and comprehensively summarized in a concise and clear format,which could provide valuable reference for the clinical use of DKI. This consensus has been approved by China association of Chinese medicine which is numbered GS/CACM 202-2019.


Assuntos
Angina Pectoris/tratamento farmacológico , Infarto Cerebral/tratamento farmacológico , Doença das Coronárias/tratamento farmacológico , Medicamentos de Ervas Chinesas/uso terapêutico , China , Consenso , Humanos , Injeções , Medicina Tradicional Chinesa
8.
Zhongguo Zhong Yao Za Zhi ; 44(14): 2932-2936, 2019 Jul.
Artigo em Chinês | MEDLINE | ID: mdl-31602835

RESUMO

Xiyanping Injection is a commonly used medicine in clinical treatment,which is recommended by many pediatric disease guidelines/consensus. However,the instraction is relatively simple and lack of guidance for clinical application,which affects the efficacy and brings safety risks. Therefore,more detailed clinical guidance is urgently needed. This consensus is formulated by clinical experts of traditional Chinese medicine and Western medicine in pediatrics. This consensus follows Manual for the clinical experts consensus of Chinese patent medicine which published by China Association of Chinese Medicine. The study identified clinical problems using clinical investigation,searched the literature based on PICO clinical problems,using GRADE system to carry out evidences evaluation,classification and recommendation,and adopted the nominal grouping method to reach expert consensus. The consensus combines evidence-based evidence with expert experience,sufficient evidence of clinical problems would lead to " recommendations",and clinical problems with insufficient evidence will lead to " consensus suggestions". This expert consensus recommends the indications,intervention time for treatment,route of drug administration,dose conversion,the indications of being used alone,suitability and taboos of medicine combination,and introduces the safety and clinical application,to provide reference for clinical using.


Assuntos
Medicamentos de Ervas Chinesas/uso terapêutico , Criança , China , Consenso , Humanos , Injeções , Medicina Tradicional Chinesa , Medicamentos sem Prescrição , Pediatria
9.
Zhongguo Zhong Yao Za Zhi ; 44(14): 2943-2946, 2019 Jul.
Artigo em Chinês | MEDLINE | ID: mdl-31602837

RESUMO

Hugan Tablets is a Chinese patent medicine,it has the function of anti-inflammation and reducing transaminase. Based on questionnaire investigation of doctors and a systematic review of research literature on Hugan Tablets,using international clinical practice guidelines' developing methods,with the best available evidence and fully combining expert experience,and following the principle of " evidence-based,consensus-based and experience-based",Expert consensus statement on Hugan Tablets in clinical practice was developed by more than 30 multidisciplinary experts from the nationwide,aimed at guiding and standardizing the rational use of Hugan Tablets by clinicians and to improve clinical efficacy and safety. The expert consensus adopts internationally recognized recommendation criteria for classification of evidence: GRADE. The formation of expert consensus adopts the nominal group technique. Six main considerations are quality of evidence,curative effect,safety,economical efficiency,patient acceptability and other factors. If there is sufficient evidence,a " recommendation" is formed,using GRADE grid voting rule. If there isn' t sufficient evidence,a " consensus opinion" is formed,using majority counting rule. Focus on the indication,usage and dosage,drug use in special population and safety of Hugan Tablets,two recommendations and eight consensus opinions were put forward. Through expert meetings and correspondence,a nationwide consultation and peer review was conducted. This consensus applies to clinicians in hospitals and grass-roots health services,to provide guidance and reference for the rational use of Hugan Tablets.


Assuntos
Medicamentos de Ervas Chinesas/uso terapêutico , Inflamação/tratamento farmacológico , Consenso , Humanos , Medicamentos sem Prescrição , Comprimidos
10.
Front Pharmacol ; 10: 1523, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31998127

RESUMO

Background: Tanreqing injection (TRQ) is a traditional Chinese medicine commonly used in China to treat pulmonary diseases presenting as phlegm-heat syndrome. Robust data on the safety of TRQ from real-world observational cohorts are currently lacking. Objective: To evaluate as the incidence, type, and predictors of adverse events (AEs) and adverse drug reactions (ADRs) of TRQ in clinical practice in China. Methods: We conducted a population-based cohort, multicenter study to evaluate the incidence, manifestation, outcomes, and risk factors of AEs and ADRs following TRQ use in China. Between April 2014 and May 2015 a total of 30,322 consecutive inpatients/emergency attendance patients from 90 hospitals across China administrated TRQ were followed-up for 7 days. Odds ratios (ORs) with 95% confidence intervals (CIs) were estimated using logistic regression to identify predictors of ADRs. Results: The incidence of AEs and ADRs was 1.4 and 0.3%, respectively. Skin and subcutaneous tissue disorders were the most common ADRs. All ADRs were mild or moderate in severity, except for one serious case of anaphylactic reaction. The majority of ADRs (72.8%) occurred in the first 2 h after TRQ administration. Two-thirds of patients (66.1%) in the study were prescribed TRQ off-label, including infants aged ≤24 months. A history of food allergy (OR 4.50, 95% CI: 1.35-15.00), drug allergy (OR 2.77, 95% CI: 1.56-4.94), and fast infusion speed (off-label use) (OR 2.10, 95% CI: 1.27-3.50) were associated with an increased risk of ADRs. Conclusion: TRQ is well tolerated in the general population, yet off-label use is prevalent. Efforts are required to educate prescribers to adhere to the drug label in order to minimize potential patient harm.

11.
Zhongguo Zhong Yao Za Zhi ; 44(24): 5282-5286, 2019 Dec.
Artigo em Chinês | MEDLINE | ID: mdl-32237369

RESUMO

Xiyanping Injection is widely used in the treatment of respiratory infectious diseases. However,its package insert is still less instructive for physicians in understanding the specific clinical application of Xiyanping Injection. To discover potential clinical advantages of Xiyanping Injection,the team invited clinical experts of traditional Chinese medicine and western medicine from the field of respiratory diseases,pharmacists and methodologists of evidence-based medicine to compile the consensus. The consensus was based on a combination of clinical research evidence and expert experience,involving recommendations for clinical problems supported by clini-cal evidence as well as consensus suggestions for clinical problems with no clinical evidence. The consensus recommended the indication,timing of intervention,usage,dosage,course of treatment,combined medication of Xiyanping Injection used for adults,and introduced the safety and precautions of its clinical application. It is suitable for guiding clinical medical workers to rationally use Xiyanping Injection in the treatment of adult's respiratory infectious diseases.


Assuntos
Medicamentos de Ervas Chinesas/uso terapêutico , Medicina Tradicional Chinesa , Infecções Respiratórias/tratamento farmacológico , Adulto , Consenso , Humanos
12.
Zhongguo Zhong Yao Za Zhi ; 44(24): 5291-5293, 2019 Dec.
Artigo em Chinês | MEDLINE | ID: mdl-32237371

RESUMO

Xiaoke Pills are Chinese and Western medicine compound preparations with effects of nourishing kidney and Yin,and supplementing Qi and promoting fluid. It is widely used in clinical treatment of type 2 diabetes( Qi and Yin deficiency syndrome),and continuously included in 2010,2013 and 2017 editions of Chinese prevention guide for type 2 diabetes. For the purpose of accurate positioning and rational use in clinic,it is necessary to further define the curative effect,indications,medication precautions and contraindications of Xiaoke Pills,in order to improve medication safety. This consensus was reached by reference of international clinical guidelines and expert consensus approach based on clinical evidence-based evidence,expert experience and standard specification. The evidence-based evaluation was oriented to clinical problems summarized by no less than 200 front-line clinical physicians in two rounds.GRADE system was adopted for quality classification and evaluation of the evidences,and then the nominal group method was used to form consensus recommendations or suggestions. This consensus defined the curative effect advantages,target users,dosage,administration method,contraindications and precautions of Xiaoke Pills,and provided valuable reference for the clinical use of the drug. Thisconsensus still needs to be updated and revised based on new clinical problems and evidence-based evidence in practical application in the future.


Assuntos
Diabetes Mellitus Tipo 2/tratamento farmacológico , Medicamentos de Ervas Chinesas/uso terapêutico , Consenso , Humanos , Medicina Tradicional Chinesa , Deficiência da Energia Yin
13.
Neuropsychiatr Dis Treat ; 15: 1-19, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30587993

RESUMO

Objective: To evaluate the efficacy, safety and economics of levetiracetam (LEV) for epilepsy. Materials and methods: PubMed, Scopus, the Cochrane Library, OpenGrey.eu and ClinicalTrials.gov were searched for systematic reviews (SRs), meta-analyses, randomized controlled trials (RCTs), observational studies, case reports and economic studies published from January 2007 to April 2018. We used a bubble plot to graphically display information of included studies and conducted meta-analyses to quantitatively synthesize the evidence. Results: A total of 14,803 records were obtained. We included 30 SRs/meta-analyses, 34 RCTs, 18 observational studies, 58 case reports and 2 economic studies after the screening process. The included SRs enrolled patients with pediatric epilepsy, epilepsy in pregnancy, focal epilepsy, generalized epilepsy and refractory focal epilepsy. Meta-analysis of the included RCTs indicated that LEV was as effective as carbamazepine (CBZ; treatment for 6 months: 58.9% vs 64.8%, OR=0.76, 95% CI: 0.50-1.16; 12 months: 54.9% vs 55.5%, OR=1.24, 95% CI: 0.79-1.93), oxcarbazepine (57.7% vs 59.8%, OR=1.34, 95% CI: 0.34-5.23), phenobarbital (50.0% vs 50.9%, OR=1.20, 95% CI: 0.51-2.82) and lamotrigine (LTG; 61.5% vs 57.7%, OR=1.22, 95% CI: 0.90-1.66). SRs and observational studies indicated a low malformation rate and intrauterine death rate for pregnant women, as well as low risk of cognitive side effects. But psychiatric and behavioral side effects could not be ruled out. LEV decreased discontinuation due to adverse events compared with CBZ (OR=0.52, 95% CI: 0.41-0.65), while no difference was found when LEV was compared with placebo and LTG. Two cost-effectiveness evaluations for refractory epilepsy with decision-tree model showed US$ 76.18 per seizure-free day gained in Canada and US$ 44 per seizure-free day gained in Korea. Conclusion: LEV is as effective as CBZ, oxcarbazepine, phenobarbital and LTG and has an advantage for pregnant women and in cognitive functions. Limited evidence supports its cost-effectiveness. Registered number: PROSPERO (No CRD 42017069367).

14.
Br J Ophthalmol ; 103(6): 768-774, 2019 06.
Artigo em Inglês | MEDLINE | ID: mdl-30072437

RESUMO

PURPOSE: To determine prevalence of refractive (RA), corneal (CA) and internal astigmatism (IA), including variation with gender and spherical equivalent refraction (SE), in a population of 12-year-old Chinese children. METHODS: A total of 1783 students with a mean age of 12.7 years (range 10.0-15.6 years) completed comprehensive eye examinations in the Anyang Childhood Eye Study. Data of cycloplegic refraction and corneal curvature were analysed. RESULTS: Prevalences of RA, CA and IA ≥1.0 D were 17.4% (95%CI 15.6% to 19.2%), 52.8% (50.5% to 55.1%)%) and 20.9% (19.0% to 22.8%), respectively. With different limits of astigmatism axes classification, including ±15°, ±20° and ±30°, RA and CA axes were mainly 'with-the-rule' (WTR) (ie, correcting axis of negative cylinders at or near 180°), while those for IA axes were mainly 'against-the-rule' (ATR) (ie, correcting axis of negative cylinders at or near 90°). RA was not different between the genders, but girls had higher prevalence and greater means of CA and IA. RA and CA increased in students with higher ametropia (more myopia and more hyperopia) and were the highest in a high myopic group (SE≤-6 D), while IA was stable across refraction groups. Children with RA higher than 0.50 D were more likely to have lens corrections (51%, 57%, 61% and 69% for magnitudes of ≥0.50 D, ≥0.75 D, ≥1.0 D and ≥1.5 D, respectively). CONCLUSIONS: Prevalence of RA in the Chinese 12-year-old children was relatively high compared with other studies. RA and CA had mainly 'WTR' astigmatism, while IA was mainly ATR and partially compensated for CA. Girls had greater means and prevalences of CA and IA than did boys. Both RA and CA, but not IA, increased with refractive errors away from emmetropia.


Assuntos
Astigmatismo/epidemiologia , Refração Ocular/fisiologia , Acuidade Visual , Adolescente , Astigmatismo/fisiopatologia , Criança , China/epidemiologia , Estudos Transversais , Feminino , Seguimentos , Humanos , Incidência , Masculino , Prevalência , Fatores de Tempo
15.
Int J Qual Health Care ; 31(7): 568-574, 2019 Aug 01.
Artigo em Inglês | MEDLINE | ID: mdl-30388240

RESUMO

QUALITY PROBLEM OR ISSUE: Chinese medical institutions need clinical guidelines to improve healthcare quality. Unfamiliarity with clinical methodology and procedures leads to poor quality. INITIAL ASSESSMENT: This study examined 327 clinical guidelines made in China during the period of 2006-10 and found these clinical guidelines have many problems in terms of guideline making procedures-compliant process, conflicts of interest disclosure. CHOICE OF SOLUTION: Chinese Medical Association organized a working group in 2014 to make a national [Guideline for Clinical Guidelines Constitution/Amendment] and invited multidiscipline experts to prove its possibility. IMPLEMENTATION: Experts investigated and reviewed numerous domestic and foreign published literature within the past 2 years, concluded that a clinical guideline should have following seven components: I. Objective; II. General Principle; III. Procedure and Methodology; IV. Confirmation, Publication and Dissemination; V. Update and Amendment; VI. Implementation and Outcome Validation; VII. Reference. EVALUATION: The [Guideline for Clinical Guidelines Constitution/Amendment] will improve the quality of Chinese clinical guidelines and regulate applications, as well as outcome evaluations of clinical guidelines in China. LESSONS LEARNED: Standardized methodology and procedures are important for constituting high-quality clinical guidelines.


Assuntos
Guias de Prática Clínica como Assunto/normas , China
16.
Int J Cancer ; 142(6): 1209-1217, 2018 03 15.
Artigo em Inglês | MEDLINE | ID: mdl-29119548

RESUMO

This prospective study included 68,759 Chinese male adults from Kailuan cohort of China who had a standardized medical examination between 2006 and 2007 and were followed up for approximately 8 years until occurrence of ASCVD, cancer or death or until December 31, 2014. Subjects were divided into four categories based on the quartiles of TC, LDL-C and non-HDL-C. Cox regression models were used to estimate hazard ratios (HRs) and their 95% confidence intervals (CIs). During follow-up, 2,916 males developed ASCVD and 1,884 developed cancer. Compared with the lowest quartile, the upper-most quartiles of TC, LDL-C and non-HDL-C were all associated with increased ASCVD risk (HR 1.53; HR 1.16; HR 1.55); however, the upper-most quartiles of TC, LDL-C and non-HDL-C were all negatively associated with cancer (HR0.84; HR 0.82; HR 0.80) and these associations were present after exclusion of incident cancers during the first 4 years of follow-up. In a word, we report that high TC, LDL-C and non-HDL-C concentrations increased ASCVD incidence in a male population and that these lipid profiles were inversely associated with total cancer and several individual cancers.


Assuntos
Aterosclerose/epidemiologia , Colesterol/sangue , Neoplasias/epidemiologia , Adulto , Idoso , Aterosclerose/sangue , China/epidemiologia , Seguimentos , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Neoplasias/sangue , Estudos Prospectivos , Fatores de Risco
17.
PLoS One ; 12(1): e0170182, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28125608

RESUMO

BACKGROUND: Salvia Miltiorrhiza Depside Salt for Infusion (SMDS) is made of a group of highly purified listed drugs. However, its safety data is still reported limitedly. Compared with the clinical trials, its safety in the real world setting is barely assessed. OBJECTIVE: To investigate the safety issues, including adverse events (AEs), adverse events related to SMDS (ADEs), and adverse drug reactions (ADRs) of the SMDS in the real world clinical practice. METHODS: This is a prospective, multicenter, pharmacist-led, cohort study in the real world setting. Consecutive patients prescribed with SMDS were all included in 36 sites. Pharmacists were well trained to standardized collect the patients information, including demographics, medical history, prescribing patterns of SMDS, combined medications, adverse events, laboratory investigations, outcomes of the treatment when discharge, and interventions by pharmacists. Adverse events and adverse drug reactions were collected in details. Multivariate possion regression analysis was applied to identify risk factors associated with ADEs using the significance level (α) 0.05. ClinicalTrials.gov Identifier: NCT01872520. RESULTS: Thirty six hospitals were participated in the study and 30180 consecutive inpatients were included. The median age was 62 (interquartile range [IQR], 50-73) years, and male was 17384 (57.60%) among the 30180 patients. The incidences of the AEs, ADEs and ADRs were 6.40%, 1.57% and 0.79%, respectively. There were 9 kinds of new ADEs which were not on the approved label found in the present study. According to the multivariate analysis, male (RR = 1.381, P = 0.009, 95%CI [1.085~1.759]), more concomitant medications (RR = 1.049, P<0.001, 95%CI [1.041~1.057]), longer duration of SMDS therapy (RR = 1.027, P<0.001, 95%CI [1.013~1.041]), higher drug concentration (RR = 1.003, P = 0.014, 95%CI [1.001~1.006]), and resolvent unapproved (RR = 1.900, P = 0.002, 95%CI [1.260~2.866]) were the independent risk factors of the ADEs. Moreover, following the approved indication (RR = 0.655, P<0.001, 95%CI [0.532~0.807]) was associated with lower incidence of ADEs. CONCLUSIONS: SMDS was well tolerated in the general population. The incidences of the AEs, ADEs and ADRs were 6.40%, 1.57% and 0.79%, respectively. Several risk factors of its ADEs have been identified. It is recommended to follow the instructions when prescribing and administrating SMDS in the real world clinical practice.


Assuntos
Depsídeos/efeitos adversos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Medicina Tradicional Chinesa/efeitos adversos , Salvia miltiorrhiza/química , Idoso , China , Estudos de Coortes , Depsídeos/uso terapêutico , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/fisiopatologia , Feminino , Hospitalização , Humanos , Masculino , Pessoa de Meia-Idade , Cloreto de Sódio na Dieta/uso terapêutico
19.
Clin Exp Ophthalmol ; 44(8): 701-709, 2016 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-27082378

RESUMO

BACKGROUND: To report the thickness of the peripapillary retinal nerve fibre layer (pRNFL) in Chinese children and examine its association with refractive error, axial length (AL) and optic disc parameters. DESIGN: Population-based cross-sectional study. PARTICIPANTS: A total of 2893 seven-year-old children from 11 randomly selected primary schools in Anyang, central China. METHODS: Participants underwent ophthalmic examinations including optical biometry, cycloplegic autorefraction and spectral-domain ocular coherence tomography. MAIN OUTCOME MEASURES: Retinal nerve fibre layer thickness in 16 radial sections, cycloplegic spherical equivalent, AL. RESULTS: The mean (SD) average RNFL thickness was 102.01(8.02) µm. The average RNFL thickness decreased with smaller disc area (r = 0.18, R2 = 0.03, P < 0.0001), bigger cup area (r = -0.11, R2 = 0.01, P < 0.0001), smaller rim area (r = 0.28, R2 = 0.08, P < 0.0001), smaller nerve head volume (r = 0.27, R2 = 0.07, P < 0.0001), longer AL (r = -0.15, R2 = 0.02, P < 0.0001) and a negative spherical equivalent (r = 0.11, R2 = 0.01, P < 0.0001). Hyperopic children had a thicker RNFL than emmetropic children [102.45(8.13) µm vs. 100.81 (7.18) µm, P < 0.001]. Myopic children had thinner RNFL than emmetropic children [99.17 (7.69) µm vs. 100.81 (7.18) µm, P < 0.05]. CONCLUSION: Retinal nerve fibre layer thickness decreased with increasing AL, higher myopia, bigger cup area, smaller disc and rim area, and a smaller nerve head volume, but the coefficient of determination for all these associations was small. The RNFL in myopes was significantly thinner than emmetropes or hyperopes, but with small absolute differences. The study provides RNFL values for healthy 7-year-old Chinese children. Follow up of this cohort to observe the change of RNFL thickness with myopia and possible change in detected associations with age is planned.


Assuntos
Hiperopia/fisiopatologia , Miopia/fisiopatologia , Fibras Nervosas/patologia , Células Ganglionares da Retina/patologia , Grupo com Ancestrais do Continente Asiático/etnologia , Comprimento Axial do Olho , Biometria , Criança , Pré-Escolar , China/epidemiologia , Estudos Transversais , Emetropia/fisiologia , Feminino , Humanos , Hiperopia/etnologia , Masculino , Miopia/etnologia , Disco Óptico/patologia , Refração Ocular/fisiologia , Tomografia de Coerência Óptica
20.
Sci Rep ; 6: 20243, 2016 Feb 01.
Artigo em Inglês | MEDLINE | ID: mdl-26832228

RESUMO

To analyze the components of young Chinese eyes with special attention to differences in corneal power, anterior segment length and lens power. Cycloplegic refractions and ocular biometry with LENSTAR were used to calculate lens power with Bennett's method. Mean refraction and mean values for the ocular components of five different refractive groups were studied with ANOVA and post-hoc Scheffé tests. There were 1889 subjects included with full data of refraction and ocular components. As expected, mean axial length was significantly longer in myopic eyes compared to emmetropes. Girls had steeper corneas, more powerful lenses and shorter eyes than boys. Lens power was lower in boys and also lower in myopic eyes. Lens thickness was the same for both genders but was lower in myopic eyes. Although cornea was steeper in myopic eyes in the whole sample, this was a gender effect (more girls in the myopic group) as this difference disappeared when the analysis was split by gender. Anterior segment length was longer in myopic eyes. In conclusion, myopic eyes have lower lens power and longer anterior segment length, that partially compensate their longer axial length. When analyzed by gender, the corneal power is not greater in low and moderate myopic eyes.


Assuntos
Segmento Anterior do Olho/anatomia & histologia , Córnea/fisiologia , Cristalino/fisiologia , Fenômenos Fisiológicos Oculares , Vigilância em Saúde Pública , Emetropia , Feminino , Humanos , Masculino , Miopia/epidemiologia , Refração Ocular
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