Global burden of hip fracture: The Global Burden of Disease Study.

This study is the first to measure global burden of hip fracture in patients aged 55 years and older across 204 countries and territories from 1990 to 2019. Our study further proved that the global burden of hip fracture is still large. Hip fractures among males are perhaps underestimated, and older adults should be given more attention. PURPOSE: Hip fracture is a tremendous universal public health challenge, but no updated comprehensive and comparable assessment of hip fracture incidence and burden exists for most of the world in older adults. METHODS: Using data from the Global Burden of Diseases (GBD) 2019, we estimated the number and rates of the incidence, prevalence, and years lived with disability (YLD) of hip fracture across 204 countries and territories in patients aged 55 years and older from 1990 to 2019. RESULTS: In 2019, the incidence, prevalence, and YLDs rates of hip fracture in patients aged 55 years and older were 681.35 (95% UI 508.36-892.27) per 100000 population, 1191.39 (95% UI 1083.80-1301.52) per 100000 population, and 130.78 (95% UI 92.26-175.30) per 100000 population. During the three decades, the incidence among people aged below 60 years showed a downward trend, whereas it showed a rapid upward trend among older adults. All the numbers and rates of hip fractures among females were higher than those among males and increased with age, with the highest number and rate in the highest age group. Notably, the male to female ratio of the incidence for people aged over 55 years increased from 0.577 in 1990 to 0.612 in 2019. Falls were the leading cause among both sexes and in all age groups. CONCLUSIONS: The incidence and the number of hip fractures among patients aged 55 years and older increased over the past three decades, indicating that the global burden of hip fracture is still large. Hip fractures among males are perhaps underestimated, and older adults should be given more attention.

Global burden of influenza lower respiratory tract infections in older people from 1990 to 2019.

BACKGROUND: Infections with influenza viruses cause severe illness, substantial number of hospitalization and death, especially in older adults. However, few studies have focused on the burden of influenza lower respiratory tract infections (LRTIs) solely in older adults, particularly in low-resource settings. AIMS: We aimed to estimate the mortality and DALYs of influenza LRTIs for people aged 55 years and older in 204 countries and territories from 1990 to 2019. METHODS: The Global Burden of Disease (GBD) 2019 study was used to obtain data on mortality and DALYs of influenza LRTIs at the global, regional, and country levels. RESULTS: In 2019, the global rates for mortality and DALYs of influenza LRTIs were 6.46 per 100,000 [95% uncertainty interval (UI): 2.37-12.62] and 97.39 per 100,000 (95% UI: 34.70-187.03). Although the rates for mortality and DALYs in people aged 55 years and older decreased from 1990 to 2019, the absolute numbers for both increased by 85.84% and 66.56%, respectively. Both the absolute numbers and rates of deaths and DALYs of influenza LRTIs were higher in male than in female in all age groups. Although low-socio-demographic index (SDI) regions experienced the largest declines for the rates of mortality and DALYs of influenza LRTIs over the past three decades, they still had the highest rates for mortality and DALYs in all age groups. Moreover, the absolute numbers and rates of deaths and DALYs of influenza LRTIs showed an increasing trend with age, reaching the peak in the people over 85 years old. DISCUSSION: Burden of influenza LRTIs in older adults is still high and could continue to grow along with global aging. CONCLUSION: Efforts to improve vaccination for influenza are needed for preparedness of another influenza pandemic, especially in low-SDI regions.

Incidence and cost of vertebral fracture in urban China: a 5-year population-based cohort study.

BACKGROUND: Osteoporotic vertebral fractures cause pain and disability, which result in a heavy socioeconomic burden. However, the incidence and cost of vertebral fractures in China are unknown. We aimed to assess the incidence and cost of clinically recognized vertebral fractures among people aged 50 years and older in China from 2013 to 2017. MATERIALS AND METHODS: This population-based cohort study was conducted by using Urban Employee Basic Medical Insurance (UEBMI) and Urban Resident Basic Medical Insurance (URBMI) data in China from 2013 to 2017, which covered more than 95% of the Chinese population in urban areas. Vertebral fractures were identified by the primary diagnosis (i.e. International Classification of Diseases code or text of diagnosis) in UEBMI and URBMI. The incidence and medical cost of these clinically recognized vertebral fractures in urban China were calculated. RESULTS: A total of 271 981 vertebral fractures (186 428, 68.5% females and 85 553, 31.5% males) were identified, with a mean age of 70.26 years. The incidence of vertebral fractures among patients aged 50 years and over in China increased ~1.79-fold during the 5 years, from 85.21 per 100 000 person-years in 2013 to 152.13 per 100 000 person-years in 2017. Medical costs for vertebral fractures increased from US$92.74 million in 2013 to US$505.3 million in 2017. Annual costs per vertebral fracture case increased from US$3.54 thousand in 2013 to US$5.35 thousand in 2017. CONCLUSION: The dramatic increase in the incidence and cost of clinically recognized vertebral fractures among patients aged 50 and over in urban China implies that more attention should be given to the management of osteoporosis to prevent osteoporotic fractures.

Association between Serum Uric Acid and the Early Marker of Kidney Function Decline among Chinese Middle-Aged and Older Population: Evidence from the China Health and Retirement Longitudinal Study.

Objective: To evaluate the association between serum uric acid (SUA) and kidney function decline. Methods: Data was obtained from the China Health and Retirement Longitudinal Study on the Chinese middle-aged and older population for analysis. The kidney function decline was defined as an annual estimated glomerular filtration rate (eGFR) decrease by > 3 mL/min per 1.73 m 2. Multivariable logistic regression was applied to determine the association between SUA and kidney function decline. The shape of the association was investigated by restricted cubic splines. Results: A total of 7,346 participants were included, of which 1,004 individuals (13.67%) developed kidney function decline during the follow-up of 4 years. A significant dose-response relation was recorded between SUA and the kidney function decline ( OR 1.14, 95% CI 1.03-1.27), as the risk of kidney function decline increased by 14% per 1 mg/dL increase in SUA. In the subgroup analyses, such a relation was only recorded among women ( OR 1.22, 95% CI 1.03-1.45), those aged < 60 years ( OR 1.22, 95% CI 1.05-1.42), and those without hypertension and without diabetes ( OR 1.22, 95% CI 1.06-1.41). Although the dose-response relation was not observed in men, the high level of SUA was related to kidney function decline ( OR 1.83, 95% CI 1.05-3.17). The restricted cubic spline analysis indicated that SUA > 5 mg/dL was associated with a significantly higher risk of kidney function decline. Conclusion: The SUA level was associated with kidney function decline. An elevation of SUA should therefore be addressed to prevent possible kidney impairment and dysfunction.

Higher Prevalence of Generalized Pustular Psoriasis in Asia? A Population-Based Study Using Claim Data in China and a Systematic Review.

BACKGROUND: Few studies have reported the burden of generalized pustular psoriasis (GPP), a severe and potentially life-threatening skin disease, especially at a national level. OBJECTIVES: The aim of this study is to estimate the nationwide burden of GPP in China and make a systemic review of the published data. METHODS: We conducted a population-based study using Urban Basic Medical Insurance in China from 2012 to 2016. GPP cases were identified by primary diagnoses including the international classification of Diseases codes (ICD-10: L40.1 and ICD-9: 694.3). A systematic review was conducted using relevant databases up to January 2022. RESULTS: The crude prevalence and incidence of GPP in 2016 were 1.403 (95% confidence interval [CI]: 1.115-1.691) and 0.629 (95% CI: 0.483-0.775) per 100,000 person-years, respectively. The rates were higher in males than in females for both prevalence (1.429 vs. 1.135) and incidence (0.635 vs. 0.520). The prevalence and incidence showed a bimodal age distribution, with the first peak occurring in the 0- to 3-year age-group and the second peak occurring in the 30- to 39-year age-group. The per capita total cost per year for 1 patient with GPP was 609.26 (± 45.77) US dollars. Seven studies were identified in a systematic review, according to which the prevalence (per 100,000) of GPP tended to be higher in Asian countries (0.746-8.178 in Japan and 12.230 in Korea) than in France (0.176), Sweden (6.25), and Brazil (0.7). CONCLUSIONS: This is the largest study concerning the disease burden of GPP, and in this study, the prevalence seemed to be higher in Asia. Although the direct economic burden of GPP did not seem high during the study period, the future usage of biologics and the humanistic burden should also be considered for policy-related decision-making.

Effect of Text Messaging Parents of School-Aged Children on Outdoor Time to Control Myopia: A Randomized Clinical Trial.

Importance: Myopia in school-aged children is a public health issue worldwide; consequently, effective interventions to prevent onset and progression are required. Objective: To investigate whether SMS text messages to parents increase light exposure and time outdoors in school-aged children and provide effective myopia control. Design, Setting, and Participants: This randomized clinical trial was conducted in China from May 2017 to May 2018, with participants observed for 3 years. Of 528 965 primary school-aged children from Anyang, 3113 were randomly selected. Of these, 268 grade 2 schoolchildren were selected and randomly assigned to SMS and control groups. Data were analyzed from June to December 2021. Interventions: Parents of children in the SMS group were sent text messages twice daily for 1 year to take their children outdoors. All children wore portable light meters to record light exposure on 3 randomly selected days (2 weekdays and 1 weekend day) before and after the intervention. Main Outcomes and Measures: The co-primary outcomes were change in axial length (axial elongation) and change in spherical equivalent refraction (myopic shift) from baseline as measured at the end of the intervention and 3 years later. A secondary outcome was myopia prevalence. Results: Of 268 grade 2 schoolchildren, 121 (45.1%) were girls, and the mean (SD) age was 8.4 (0.3) years. Compared with the control group, the SMS intervention group demonstrated greater light exposure and higher time outdoors during weekends, and the intervention had significant effect on axial elongation (coefficient, 0.09; 95% CI, 0.02-0.17; P = .01). Axial elongation was lower in the SMS group than in the control group during the intervention (0.27 mm [95% CI, 0.24-0.30] vs 0.31 mm [95% CI, 0.29-0.34]; P = .03) and at year 2 (0.39 mm [95% CI, 0.35-0.42] vs 0.46 mm [95% CI, 0.42-0.50]; P = .009) and year 3 (0.30 mm [95% CI, 0.27-0.33] vs 0.35 mm [95% CI, 0.33-0.37]; P = .005) after the intervention. Myopic shift was lower in the SMS group than in the control group at year 2 (-0.69 diopters [D] [95% CI, -0.78 to -0.60] vs -0.82 D [95% CI, -0.91 to -0.73]; P = .04) and year 3 (-0.47 D [95% CI, -0.54 to -0.39] vs -0.60 D [95% CI, -0.67 to -0.53]; P = .01) after the intervention, as was myopia prevalence (year 2: 38.3% [51 of 133] vs 51.1% [68 of 133]; year 3: 46.6% [62 of 133] vs 65.4% [87 of 133]). Conclusions and Relevance: In this randomized clinical trial, SMS text messages to parents resulted in lower axial elongation and myopia progression in schoolchildren over 3 years, possibly through increased outdoor time and light exposure, showing promise for reducing myopia prevalence. Trial Registration: Chinese Clinical Trial Registry Identifier: ChiCTR-IOC-17010525.

Prevalence and incidence of pseudomyxoma peritonei in urban China: A nationwide retrospective cohort study.

BACKGROUND: Pseudomyxoma peritonei (PMP) is an extremely rare condition. Information regarding the disease burden of PMP in developing countries is limited. This study aimed to determine the epidemiology of PMP in China. METHODS: PMP data were extracted from the national databases of Urban Basic Medical Insurance. All cases were identified using the International Classification of Diseases (ICD) codes and Chinese diagnostic terms. The national prevalence from 2012 to 2016 and incidence in 2016 were estimated. RESULTS: In total, 153 patients with PMP were identified. The crude prevalence of PMP in 2016 was 2.47 (95% confidence interval [CI] 1.71 to 3.23) per million person-year, with a higher prevalence in females than males. Prevalence increased with age, with the first peak in those aged 15-29 years and the highest in those aged >80 years. The crude incidence of PMP in 2016 was 1.19 (95% CI 0.59 to 1.78) per million person-years. Similar to the prevalence, the rates were higher in women than in men. The incidence also increased with age, with the highest prevalence in those aged >80 years. Besides, the most frequent comorbidities before and after the first diagnosis of PMP were unspecified secondary malignancies and malignancies of unspecified sites, followed by abdominal malignant tumours. CONCLUSIONS: The rate of PMP was lower in mainland China than in European countries and increased with advancing age. Women were more likely to have PMP than men. Furthermore, an insufficient understanding of this rare disease presents a major challenge in accurately evaluating the disease burden.

Prednisone plus IVIg compared with prednisone or IVIg for immune thrombocytopenia in pregnancy: a national retrospective cohort study.

Background: The responses of intravenous immunoglobulin (IVIg) or corticosteroids as the initial treatment on pregnancy with ITP were unsatisfactory. This study aimed to assess the safety and effectiveness of prednisone plus IVIg versus prednisone or IVIg in pregnant patients with immune thrombocytopenia (ITP). Methods: Between 1 January 2010 and 31 December 2020, 970 pregnancies diagnosed with ITP at 19 collaborative centers in China were reviewed in this observational study. A total of 513 pregnancies (52.89%) received no intervention. Concerning the remaining pregnancies, 151 (33.04%) pregnancies received an initial treatment of prednisone plus IVIg, 105 (22.98%) pregnancies received IVIg alone, and 172 (37.64%) pregnancies only received prednisone. Results: Regarding the maternal response to the initial treatment, no differences were found among the three treatment groups (41.1% for prednisone plus IVIg, 33.1% for prednisone, and 38.1% for IVIg). However, a significant difference was observed in the time to response between the prednisone plus IVIg group (4.39 ± 2.54 days) and prednisone group (7.29 ± 5.01 days; p < 0.001), and between the IVIg group (6.71 ± 4.85 days) and prednisone group (p < 0.001). The median prednisone duration in the monotherapy group was 27 days (range, 8-195 days), whereas that in the combination group was 14 days (range, 6-85 days). No significant differences were found among these three treatment groups in neonatal outcomes, particularly concerning the neonatal platelet counts. The time to response in the combination treatment group was shorter than prednisone monotherapy. The duration of prednisone application in combination group was shorter than prednisone monotherapy. The combined therapy showed a lower predelivery platelet transfusion rate than IVIg alone. Conclusion: These findings suggest that prednisone plus IVIg may represent a potential combination therapy for pregnant patients with ITP.

Comparative effectiveness and safety of 32 pharmacological interventions recommended by guidelines for coronavirus disease 2019: a systematic review and network meta-analysis combining 66 trials.

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.

Risk of Liver Injury Associated with Intravenous Lipid Emulsions: A Prescription Sequence Symmetry Analysis.

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.

Prediction of postpartum hemorrhage in pregnant women with immune thrombocytopenia: Development and validation of the MONITOR model in a nationwide multicenter study.

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.

Effects of Incretin-based Therapies on Weight-related Indicators among Patients with Type 2 Diabetes: A Network Meta-analysis.

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.

[Expert consensus statement on Kangfu Xiaoyan Suppository in treatment of pelvic inflammatory in clinical practice].

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.

[Technical specifications for hospital-based intensive monitoring of post-marketing Chinese patent medicine].

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.

[Expert consensus statement on Diemailing~® Kudiezi Injection in clinical practice].

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.

[Experts consensus statement on Xiyanping Injection in clinical practice(children)].

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.

[Expert consensus statement on Hugan Tablets in clinical practice].

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.

Astigmatism and its components in 12-year-old Chinese children: the Anyang Childhood Eye Study.

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.

Guideline for [Clinical Guidelines Constitution/Amendment] in China.

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.

Levetiracetam for epilepsy: an evidence map of efficacy, safety and economic profiles.

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).