Treatment of patent ductus arteriosus in very preterm infants in China / 中华儿科杂志

Objective: To describe the current status and trends in the treatment of patent ductus arteriosus (PDA) among very preterm infants (VPI) admitted to the neonatal intensive care units (NICU) of the Chinese Neonatal Network (CHNN) from 2019 to 2021, and to compare the differences in PDA treatment among these units. Methods: This was a cross-sectional study based on the CHNN VPI cohort, all of 22 525 VPI (gestational age<32 weeks) admitted to 79 tertiary NICU within 3 days of age from 2019 to 2021 were included. The overall PDA treatment rates were calculated, as well as the rates of infants with different gestational ages (≤26, 27-28, 29-31 weeks), and pharmacological and surgical treatments were described. PDA was defined as those diagnosed by echocardiography during hospitalization. The PDA treatment rate was defined as the number of VPI who had received medication treatment and (or) surgical ligation of PDA divided by the number of all VPI. Logistic regression was used to investigate the changes in PDA treatment rates over the 3 years and the differences between gestational age groups. A multivariate Logistic regression model was constructed to compute the standardized ratio (SR) of PDA treatment across different units, to compare the rates after adjusting for population characteristics. Results: A total of 22 525 VPI were included in the study, with a gestational age of 30.0 (28.6, 31.0) weeks and birth weight of 1 310 (1 100, 1 540) g; 56.0% (12 615) of them were male. PDA was diagnosed by echocardiography in 49.7% (11 186/22 525) of all VPI, and the overall PDA treatment rate was 16.8% (3 795/22 525). Of 3 762 VPI who received medication treatment, the main first-line medication used was ibuprofen (93.4% (3 515/3 762)) and the postnatal day of first medication treatment was 6 (4, 10) days of age; 59.3% (2 231/3 762) of the VPI had been weaned from invasive respiratory support during the first medication treatment, and 82.2% (3 092/3 762) of the infants received only one course of medication treatment. A total of 143 VPI underwent surgery, which was conducted on 32 (22, 46) days of age. Over the 3 years from 2019 to 2021, there was no significant change in the PDA treatment rate in these VPI (P=0.650). The PDA treatment rate decreased with increasing gestational age (P<0.001). The PDA treatment rates for VPI with gestational age ≤26, 27-28, and 29-31 weeks were 39.6% (688/1 737), 25.9% (1 319/5 098), and 11.4% (1 788/15 690), respectively. There were 61 units having a total number of VPI≥100 cases, and their rates of PDA treatment were 0 (0/116)-47.4% (376/793). After adjusting for population characteristics, the range of standardized ratios for PDA treatment in the 61 units was 0 (95%CI 0-0.3) to 3.4 (95%CI 3.1-3.8). Conclusions: From 2019 to 2021, compared to the peers in developed countries, VPI in CHNN NICU had a different PDA treatment rate; specifically, the VPI with small birth gestational age had a lower treatment rate, while the VPI with large birth gestational age had a higher rate. There are significant differences in PDA treatment rates among different units.

A risk prediction model of cervical cancer developed based on nested case-control design / 中华流行病学杂志

Objective: To construct a cervical cancer risk prediction model based on nested case-control study design and Yinzhou Health Information Platform in Ningbo, and provide reliable reference for self-risk assessment of cervical cancer in local women. Methods: In local women aged 25-75 years old who had no history of cervical cancer registered in Yinzhou before October 31, 2018, a follow up was conducted for at least three years, the patients who developed cervical cancer during the follow up period were selected as the case group and matched with a control group at a ratio of 1∶10. The prediction indicators before the onset was used in model construction. Variables were selected by Lasso-logistic regression, the variables with non-zero β were selected to fit the logistic regression model and Bootstrap was used for internal validation. The discrimination of the model was evaluated by area under the receiver operating characteristic curve(AUROC), and the calibration was evaluated by calibration curve and Hosmer-Lemeshow test. Results: The prediction indicators included in the final model were age, smoking status, history of cervicitis, history of adenomyosis, HPV testing, and thinprep cytologic test. The AUROC calculated in the internal validation was 0.740 (95%CI:0.739-0.740), and the calibration curve was almost identical with the ideal curve, P=0.991 in Hosmer-Lemeshow test, indicating that the model discrimination and calibration were good. Conclusions: In this study, a simple and practical cervical cancer risk prediction model was developed. The model can be used in general population with strong interpretability, good discrimination and calibration in internal validation, which can provide a reference for women to assess their risk of cervical cancer.

Epidemiological study of incidence of systematic lupus erythematosus in Yinzhou, Ningbo, 2016-2021 / 中华流行病学杂志

Objective: To characterize the incidence density of systematic lupus erythematosus (SLE) in Yinzhou District of Ningbo from 2016 to 2021, and compare the age and gender specific differences. Methods: A retrospective cohort study was conducted based on the related data from 2015 to 2021 collected from the Health Information Platform of Yinzhou. Suspected SLE cases in local residents were identified by fuzzy matching of International Classification of Diseases 10th edition code "M32" or Chinese text "lupus". The classification criteria from Systemic Lupus International Collaboration Clinics-2012 and The European League Against Rheumatism/American College of Rheumatology-2019 were used for case verification. SLE cases were identified with specific algorithm based on verification results, and new cases were identified with 1 year as the washout period. The incidence density and 95%CI were estimated by Poisson distribution. Results: From 2016 to 2021, a total of 1 551 921 permanent residents were registered in Yinzhou, in whom 51.52% were women. The M(Q1,Q3) age at enrollment was 40.38 (27.54, 53.54) years. The M(Q1,Q3) of follow-up person-years was 3.83 (0.41, 5.83) years. There were 451 new SLE cases, in which 352 were women (78.05%). The 6-year incidence density was 8.14/100 000 person-years (95%CI: 7.41/100 000 person-years-8.93/100 000 person-years) for the total population, 3.68/100 000 person-years (95%CI: 2.99/100 000 person-years-4.48/100 000 person-years) for men and 12.37/100 000 person-years (95%CI: 11.11/100 000 person-years- 13.73/100 000 person-years) for women. The incidence density in men appeared a small peak at 20-29 years old, and began to increase with age from 40 years old. The incidence density in women was highest in age group 20-29 years (16.57/100 000 person-years) and remained to be high until 30-79 years old. The incidence density of SLE in Yinzhou show no significant temporal trend from 2016 to 2021 (men: P=0.848; women: P=1.000). Conclusions: The incidence density of SLE in Yinzhou from 2016 to 2021 was similar to those of other areas in China. SLE has a high incidence in women, especially in the young and elderly, suggesting that more attention should be paid to the diagnosis and treatment of SLE in women.

Abnormal cortical surface-based spontaneous and functional connectivity in the whole brain in lifelong premature ejaculation patients / 亚洲男科学杂志(英文版)

Recent research has highlighted structural and functional abnormalities in the cerebral cortex of patients with premature ejaculation (PE). These anomalies could play a pivotal role in the physiological mechanisms underlying PE. This study leveraged functional magnetic resonance imaging (fMRI), a noninvasive technique, to explore these neural mechanisms. We conducted resting-state fMRI scans on 36 PE patients and 22 healthy controls (HC), and collected data on Premature Ejaculation Diagnostic Tool (PEDT) scores and intravaginal ejaculation latency time (IELT). Employing a surface-based regional homogeneity (ReHo) approach, we analyzed local neural synchronous spontaneous activity, diverging from previous studies that utilized a volume-based ReHo method. Areas with significant ReHo differences between PE and HC groups underwent surface-based functional connectivity (FC) analysis. Significant discrepancies in ReHo and FC across the cortical surface were observed in the PE cohort. Notably, PE patients exhibited decreased ReHo in the left triangular inferior frontal gyrus and enhanced ReHo in the right middle frontal gyrus. The latter showed heightened connectivity with the left lingual gyrus and the right orbital superior frontal gyrus. Furthermore, a correlation between ReHo and FC values with PEDT scores and IELT was found in the PE group. Our findings, derived from surface-based fMRI data, underscore specific brain regions linked to the neurobiological underpinnings of PE.

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 / 生物医学与环境科学（英文）

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.

Methodology progress and challenges on assessing the appropriateness of real-world data / 中华流行病学杂志

From the perspective of data users, ensuring the relevance and reliability of big data in healthcare and medicine via assessments on data appropriateness is a prerequisite for generating high-quality real-world evidence, which could guarantee good representativeness and generalizability of real-world studies. This review summarized the quality dimensions, definitions, evaluation indexes and calculating methods of assessment on the appropriateness of real-world data (RWD) according to guidance from different countries and international organizations, as well as exploring the opportunities and challenges for better assessing RWD appropriateness.

Progress in research of economic evaluation of COVID-19 vaccination strategies / 中华流行病学杂志

Objective: To understand the research progresses of economic evaluation of COVID-19 vaccination strategies both at home and abroad, and provide reference for the economic evaluation of COVID-19 vaccination strategies using real word data in China. Methods: Literature retrieval was conducted for related papers published from January, 2020 to December, 2021 in Chinese and English databases, including the economic evaluation of COVID-19 vaccination, and the results of the related literatures were narratively integrated. Results: A total of 16 English literatures (including 3 reviews) were included, and it was found that the COVID-19 vaccination was cost-effective or cost-saving regardless of the vaccine types, while the cost-effectiveness in different population and under different vaccination dose strategies varied due to vaccine efficacy, vaccine price, duration of natural immunity, duration of vaccination campaign, vaccine supply, and vaccination pace. Conclusions: China lacks suitable evidences of economic evaluation of COVID-19 vaccination strategies based on real-world data in the context of long-term epidemic. Therefore, further researches of suitable strategies of booster COVID-19 vaccination are needed.

Artificial intelligence-based literature data warehouse for vaccine safety / 中华流行病学杂志

Objective: To establish a sustainable updated literature data warehouse for global vaccine safety assessment, and provide data support for evidence-based vaccine safety assessment. Methods: Semi-automated construction and updating of a literature data warehouse were achieved through the continuous integration of standard operating steps of evidence-based reviews with artificial intelligence technologies. Following the standard procedure of a systematic literature review, the literatures about vaccine safety assessment published before November 29, 2020 were retrieved from 9 databases including OVID, Scopus, Web of Science, Cochrane Library, and ClinicalTrails.org in English and Wanfang, CNKI, VIP, and SinoMed in Chinese. Literatures were screened for two rounds in a semi-automatic manner (by artificial intelligence literature processing system and manual work) according to the inclusion/exclusion criteria. Furthermore, the literatures were classified according to the types of vaccines and adverse events. The updating strategy was established, and the literature data warehouse was updated regularly. Experts were organized to select specific vaccine safety topics and carry out special demonstration studies. Results: More than 0.41 million articles were retrieved. According to the inclusion/exclusion criteria, 23 304 articles were included after two rounds of screening. At present, we have selected and completed three prior topics as demonstration studies, including the systematic review of "DPT (diphtheria, pertussis and tetanus) vaccine and encephalopathy/encephalitis", and the classified management of literatures about allergic purpura and brachial plexus neuritis. Conclusions: The sustainable updated literature data warehouse of vaccine safety can provide high-quality research data for vaccine safety research, including evidence support for immunization related policy-making and adjustment and vaccine safety-related methodological research or clinical tool development; and further demonstration studies can provide references for building a new methodological framework system for timely and efficient completion of the evidence-based assessment of vaccine safety.

How to report adaptive design randomized trials-A interpretation of international reporting guideline ACE / 中华流行病学杂志

Concerns has been raised in improving the quality of adaptive design randomized trials reports. Based on the CONSORT 2010 (Consolidated Standards of Reporting Trials), The Adaptive designs CONSORT Extension (ACE) has developed items and reporting specifications for adaptive design trials. This paper presents a brief explanation of the extension and new items of ACE and introduces the applications of ACE checklist with examples.

Introduction of a tool to assess Risk of Bias in Non-randomized Studies-of Environmental Exposure (ROBINS-E) / 中华流行病学杂志

This paper summaries the Risk of Bias in Non-randomized Studies-of Environmental Exposure (ROBINS-E), a tool for evaluating risk of bias about non-randomized studies of exposures (NRSE), and introduces the application of ROBINS-E in a published NRSE. According to the characteristics of NRSE, evaluation fields and signaling questions were designed in ROBINS-E to provide essential information about risk of bias for NRSE included in systematic reviews and GRADE. ROBINS-E is the tool in assessment of risk of bias in observational studies and quasi-randomized studies. Although the tool has been used in practice to some extent, but it still needs further improvement. Attention should be paid to its update and progress.

Epidemiological study on the incidence of inflammatory bowel disease in Yinzhou District, Ningbo City from 2011 to 2020 / 北京大学学报(医学版)

OBJECTIVE@#To describe the distribution characteristics of inflammatory bowel disease among permanent residents in Yinzhou District, Ningbo City, and to understand the disease burden and development trend of inflammatory bowel disease in this area.@*METHODS@#Using the retrospective cohort design, we collected the registration information of all permanent residents in the residents' health files of the Yinzhou Regional Health Information Platform from 2010 to 2020, and used electronic medical records to follow up their inflammatory bowel disease visits. A one-year wash-out period was set, and the patients who were diagnosed with the primary diagnosis for the first time after one year of registration were re-garded as new cases. The incidence density and 95% confidence interval (CI) of inflammatory bowel disease were estimated by Poisson distribution.@*RESULTS@#From 2011 to 2020, a total of 1 496 427 permanent residents in Yinzhou District were included, of which 729 996 were male (48.78%). The total follow-up person-years were 8 081 030.82, and the median follow-up person-years were 5.41 [interquartile range (IQR): 5.29]. During the study period, there were 1 217 new cases of inflammatory bowel disease, of which males (624 cases, 51.27%) were more than females (593 cases, 48.73%). The total incidence density was 15.06/100 000 person-years (95%CI: 14.23, 15.93). Among all new cases, there were 1 106 cases (90.88%) of ulcerative colitis, with an incidence density of 13.69 per 100 000 person-years (95%CI: 12.89, 14.52); 70 cases (5.75%) of Crohn's disease, with an incidence density of 0.87 per 100 000 person-years (95%CI: 0.68, 1.09); and 41 cases (3.37%) of indeterminate colitis, with an incidence density of 0.51 per 100 000 person-years (95%CI: 0.36, 0.69). The median age of onset of ulcerative colitis was 50.82 years old (IQR: 18.77), with the highest proportion (15.01%) in the 45-49 years group. The incidence density of ulcerative colitis gradually increased with age, reaching a relatively high level in the 45-49 years group (20.53/100 000 person-years; 95%CI: 17.63, 23.78), followed by a slight increase. And the incidence density in the 65-69 years group was the highest (25.44/100 000 person-years; 95%CI: 20.85, 30.75), with a rapid decrease in the 75-79 years group. The median age of onset of Crohn's disease was 44.34 years (IQR: 33.41), with the highest proportion (12.86%) in the 25-29 years group. Due to the small number of new cases of Crohn's disease, the age distribution fluctuated greatly, with peaks both in young and old people. From 2011 to 2020, the incidence density of inflammatory bowel disease in Yinzhou District was at a low level from 2011 to 2013, and showed a rapid upward trend from 2014 to 2016, reaching a peak of 24.62 per 100 000 person-years in 2016 (95%CI: 21.31, 28.30), and slightly decreased in 2017-2020.@*CONCLUSION@#The incidence density of inflammatory bowel disease in Yinzhou District from 2011 to 2020 was at a relatively high level, and medical institutions and health departments need to pay attention to the burden of disease caused by it.

Clinical research progress and implications of therapeutic vaccines for cervical cancer and precancerous lesions: a qualitative systematic review / 中华肿瘤杂志

Objective: To systematically summarize and analyze the clinical research progress of therapeutic vaccines for cervical cancer or precancerous lesions. Methods: English databases (PubMed, Embase, Web of Science, Cochrane library, Proquest, and ClinicalTrails.gov) and Chinese databases (SinoMed, CNKI, WanFang, and VIP Database) were systematically searched to collect literature on therapeutic vaccines for cervical cancer or precancerous lesions from inception to February 18, 2021. After screening, we evaluated the risk of bias of included studies, and combed the basic information of the literature, research designs, information of vaccines, study patients, outcome indicators and so on, qualitatively summarized the clinical research progress. Results: A total of 71 studies were included in this systematic review, including 14 random controlled trials, 15 quasi-random controlled trials, 4 cohort studies, 1 case-control study, 34 case series studies and 3 case reports. The study patients included women aged 15~79 with cervical cancer or precancerous lesions in 18 countries from 1989 to 2021. On the one hand, there were 40 studies on therapeutic vaccines for cervical precancerous lesions (22 867 participants), involving 21 kinds of vaccines in 6 categories. Results showed 3 marketed vaccines (Cervarix, Gardasil, Gardasil 9) as adjuvant immunotherapies were significant effective in preventing the recurrence of precancerous lesions compared with the conization only. In addition, MVA E2 vaccine had been in phase Ⅲ clinical trials as a specific therapeutic vaccine, with relative literature showing it could eliminate most high-grade precancerous lesions. Therapeutic vaccines for precancerous lesions all showed good safety. On the other hand, there were 31 studies on therapeutic vaccines for cervical cancer (781 participants), involving 19 kinds of vaccines in 7categories, with none had been marketed. 25 studies were with no control group, showing the vaccines could effectively eliminate solid tumors, prevent recurrence, and prolong the median survival time. However, the vaccines effectiveness couldn't be statistically calculated due to the lack of a control group. As for the safety of therapeutic vaccines for cervical cancer, 9 studies showed that patients experienced serious adverse events after treatments, where 7 studies reported that serious adverse events occurred in patients couldn't be ruled out as the results of therapeutic vaccines. Conclusions: The literature review shows that the literature evidence for the therapeutic vaccines for cervical precancerous lesions is relatively mature compared with the therapeutic vaccines for cervical cancer. The four kinds of vaccines on the market are all therapeutic vaccines for precancerous lesions, but they are generally used as vaginal infection treatments or adjuvant immunotherapies for cervical precancerous lesions, not used for the specific treatments of cervical precancerous lesions. Other specific therapeutic vaccines are in the early stage of clinical trials, mainly phase Ⅰ/Ⅱ clinical trials with small sample size. The effectiveness and safety data are limited, and further research is still needed.

Strengthening the Reporting of Pharmacogenetic Studies (STROPS) guideline / 中华流行病学杂志

Pharmacogenetic studies are designed to investigate the associations between genetic variation and treatment response for a particular drug in terms of both efficacy and adverse events and have high sample size requirements. To improve the quality of pharmacogenetic studies and facilitate the Meta-analyses to investigate statistically significant associations, Strengthening the Reporting of Pharmacogenetic Studies (STROPS) guideline was developed in 2020 based on the Strengthening the Reporting of Genetic Association Studies (STREGA) statement. The objective of this article is to present a brief introduction to the STROPS guideline and an interpretation of the key points in some items with examples for the better understanding and application.

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 / 中华医学杂志(英文版)

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.

Self-Care Skills between Institutionalised and Home Dwelling Older Adults: A Preliminary Study Kajian Rintis Kemahiran Penjagaan Diri Warga Tua di antara institusi dan rumah kediaman / Jurnal Sains Kesihatan Malaysia

@#Self-care is defined as activities performed by individuals, families, and communities to enhance their health, prevent diseases, limit illnesses, and restore health. Previous research has mainly focused on self-care skills of older adults in either institution or residential homes separately but limited studies have compared between both these settings. This study aimed to compare the self-care skills between institutionalised and home dwelling older adults at selected area in Malaysia. A total of 43 participants aged 60 years old and above were recruited in our study; (23 participants were home-dwelled older adults and 19 participants were recruited from institutionalised older adults located in Kuala Lumpur). The Malay Version of Performance Assessment of Self-Care Skills (M-PASS-HOME) 4.0 was used focusing on four main subtests of self-skills; oral hygiene, trimming toenails, house mobility and shower mobility. The differences in self-care skills between institutionalised and home dwelling older adults are statistically significant (p<0.01) in the aspects of independency for all self-care activities. The results of this study revealed that home dwelling older adults group are more independent in self-care activities of oral hygiene, trimming toenails, house mobility and shower mobility compared to institutionalised group.

Utilizing social media data in post-market safety surveillance / 北京大学学报(医学版)

Post-marketing surveillance is the principal means to ensure drug use safety. The spontaneous report is the essential method of post-marketing surveillance for drug safety. Often, most spontaneous reports come from medical staff and sometimes come from patients who use the drug. The posts published by individuals on social media platforms that contain drugs and related adverse reaction content have gradually been seen as a new data source similar to spontaneous reports from drug users in recent years. Those user-generated posts potentially provide researchers and regulators with new opportunities to conduct post-marketing surveillance for drug safety from patients' perspectives mostly rather than medical professionals and can afford the possibility theoretically to discover drug-related safety issues earlier than traditional methods. Social media data as a new data source for safety signal detection and signal reinforcement have the unique advantages, such as population coverage, type of drugs, type of adverse reactions, data timeliness and quantity. Most of the social media data used in post-marketing surveillance research for drug safety are still text data in English, and even multiple languages are used by different people worldwide on several social media platforms. Unfortunately, there is still a controversy in the academic circles whether social media data can be used as reliable data sources for routine post-marketing surveillance for drug safety. A couple of obstacles of data, methods and ethics must be overcome before leveraging social media data for post-marketing surveillance. The number of Chinese social media users is large, and the social media data in the Chinese language is rapidly snowballing, which can be employed as the potential data source for post-marketing surveillance for drug safety. However, due to the Chinese language's specific characteristics, the text's diversity is different from the English text, and there is not enough accepted corpus in medical scenarios. Besides, the lack of domestic laws and regulations on privacy and security protection of social media data poses more challenges for applying Chinese social media data for post-market surveillance. The significance of social media data to post-marketing surveillance for drug safety is undoubtedly significant. It will be an essential development direction for future research to overcome the challenges of using social media data by developing new technologies and establishing new mechanisms.

Epidemiological and etiological characteristics of hand, foot and mouth disease among children aged 5 years and younger in Ningbo (2016 to 2019) / 北京大学学报(医学版)

OBJECTIVE@#To describe the epidemiological and etiological characteristics of hand, foot and mouth disease (HFMD) among children aged 5 years and younger in Ningbo after the access of entero-virus-A71 vaccine (2016 to 2019).@*METHODS@#A retrospective cohort study were performed in children aged 5 years and younger in Ningbo from 2016 to 2019. Data for incidence of HFMD was collected from the National Notifiable Disease Surveillance Reporting System and the Electronic Medical Records (EMRs) System, while the demographic information was derived from the Immunization Information System. Speci-mens were detected by real-time fluorescence quantitative PCR and the Wilson method was used to estimate the incidence rate and 95% confidence interval.@*RESULTS@#From 2016 to 2019, a total of 1 044 800 residential children were observed in this population-based cohort. In the study, 102 471 cases of HFMD were diagnosed in 2 651 081 person-years, revealing an overall incidence density of 3 865.25/100 000 person-years. There was no significant decline in the number of the cases after the vaccine was available. The number of the patients of hand foot mouth disease during the four years was 93 421, of whom 84 875 (90.85%) had only one incident record, while 8 946 (9.15%) had 2 or more cases in this period; there were 69 771 (66.06%) patients who only needed to see a doctor once for each disease, 19.92% of the patients needed to be treated twice, and 14 801 (14.02%) patients needed to go to the hospital or clinic three times or more. The incidence of HFMD showed obvious seasonality and periodicity, which mainly concentrated in April to July each year, and the epidemic cycle was 2 years; most of the cases were 1 to 3-year old children, with more cases in male. The incidence density varied across the region, with the highest density observed in Ninghai (4 524.76/100 000 person-years), followed by Xiangshan (3 984.22/100 000 person-years). In 3 748 library-conformed cases, 2 834(75.61%) were detected positive, among which enterovirus-A71, Cox-A16 and other enteroviruses accounted for 9.03%, 31.55% and 59.42%, respectively. During the study period, the cumulative coverage of enterovirus-A71 vaccine increased year by year, with the proportion of enterovirus-A71 and severe cases both gradually decreasing.@*CONCLUSION@#The current status of hand, foot and mouth disease in Ningbo is still serious. Children under 3-year old (especially male children aged 1 year) were the key population for prevention and control. Vaccination might lead to changes in major pathogenic virus type, of which more attention should be paid to the potential impact on disease surveillance, prevention and control.

Epidemiological study of infantile epilepsy incidence density among infants under 36 months of age in Ningbo City from 2015 to 2019 / 北京大学学报(医学版)

OBJECTIVE@#To describe the distribution and trend of infantile epilepsy among infants under 36 months in Ningbo, Zhejiang Province.@*METHODS@#Using the birth cohort design, we retrospectively collected the local born infants in Ningbo national health information platform from 2015 to 2019, and took the first visit of epilepsy in the electronic medical record of the platform as the new case. The incidence density and 95% confidence interval (CI) of epilepsy were estimated by Poisson distribution.@*RESULTS@#From 2015 to 2019, a total of 294 900 children were born in Ningbo, with male accounting for 51.92%. The total person-years of observation were 595 300, while the median follow-up person-years was 2.31 [interquartile range (IQR): 1.90]. There were 575 new onset epilepsy patients during the whole observation period. The total number of visits was 2 599, with an average of 4.52. The total incidence density was 96.59/100 000 person-years (95%CI: 88.85-104.82). The median age of onset was 13 months (IQR: 15), 0-12 months old infants had the highest incidence density (102.18/100 000 person-years), 25-36 months old infants had the lowest incidence density (89.68/100 000 person-years), and the difference was not statistically significant (P>0.05). The incidence density of male was 97.58/100 000 person-years, female was 95.53/100 000 person-years, and the difference was not statistically significant (P>0.05). Fenghua was the highest (130.54/100 000 person-years, 95%CI: 94.47-175.83) and Ninghai was the lowest (66.44/100 000 person-years, 95%CI: 47.02-91. 19), with significant difference (P < 0.05). There was no significant difference in the incidence density in different birth years (P>0.05). There was significant difference in the incidence density between 0-12 months old infants in different calendar years (Ptrend < 0.05). In this age group, the incidence density was the lowest in 2015 (69.41/100 000 person-years, 95%CI: 41.79-108.39), and the highest in 2019 (225.61/100 000 person-years, 95%CI: 186.10-271.03). There was no significant difference in the incidence density between 13-24 and 25-36 months old infants in different calendar years (P>0.05).@*CONCLUSION@#The incidence density of epilepsy in 0-36 months old infants in Ningbo City from 2015 to 2019 was low as a whole, and there was no difference in age group, gender, and year of birth. The incidence density of 0-12 months old infants increased with the year.

Accuracy of Xpert® MTB/RIF for the detection of tuberculosis and rifampicin-resistance tuberculosis in China: A systematic review and meta-analysis / 北京大学学报(医学版)

OBJECTIVE@#To systematically review the diagnostic accuracy of Xpert® Mycobacterium tuberculosis/rifampicin (Xpert® MTB/RIF) for the detection of active tuberculosis (TB) and rifampicin-resistance TB in Chinese patients.@*METHODS@#Four Chinese databases (SinoMed, CNKI, WanFang database, and VIP) and three English databases (PubMed, Embase, and The Cochrane Library) were searched from January 1, 2000 to September 15, 2017, to identify diagnostic tests about the accuracy of Xpert® MTB/RIF in Chinese patients. Two investigators screened the articles and extracted the information independently, and then the quality of each included study was evaluated by Quality Assessment of Diagnostic Accuracy Studies (QUADAS)-2. Bivariate random-effects meta-analysis was conducted to pool the sensitivity and specificity. In addition, subgroup analyses were performed based on patient type (TB patient and TB suspected patient), sample type (sputum, bronchoalveolar lavage fluid and others). All statistical analyses were conducted with Stata version 13.0.@*RESULTS@#A total of 47 articles were included in this systematic review. Most of them (38 articles) were in Chinese and only 9 articles were in English. All the articles were published during 2014 to 2017, and the sample size ranged from 31 to 3 151. Forty articles including 42 comparisons about TB were finally included with the pooled sensitivity of 0.94 (95%CI: 0.92, 0.95) and the pooled specificity of 0.87 (95%CI: 0.84, 0.91). Subgroup analysis showed that different patient and specimen types had no significant differences on sensitivity, but the specificity of sputum group was higher than that of bronchoalveolar lavage fluid. As for the detection of rifampicin-resistant TB, 33 articles (38 comparisons) were analyzed, the pooled sensitivity and specificity were 0.92 (95%CI: 0.89, 0.94) and 0.98 (95%CI: 0.97, 0.99) respectively. There were no significant differences between the patient and specimen in the subgroup analyses. The Deeks funnel plot showed a possible publication bias for detecting active tuberculosis (P=0.08) and no publication bias for rifampicin-resistant TB (P=0.24). The likelihood ratio scatter gram showed that in clinical applications, Xpert® MTB/RIF had a good diagnostic ability for detecting active tuberculosis, and it had good clinical diagnostic value in detecting rifampicin-resistant TB.@*CONCLUSION@#Xpert® MTB/RIF has good sensitivity and specificity in detecting TB and rifampicin-resistant TB in Chinese people. In particular, it has good clinical value in diagnosing rifampicin-resistance TB.

Safety of biological valves for aortic valve replacement: A systematic review and meta-analysis / 北京大学学报(医学版)

OBJECTIVE@#To provide a comprehensive and contemporary overview of the long-term safety outcomes after aortic valve replacements (AVR) with conventional biological heart valve (stented or stentless).@*METHODS@#English databases (Medline, Embase, Web of Science, CENTRAL, and ClinicalTrial.gov) and Chinese databases (CNKI, VIP, WanFang, and SinoMed) were searched systemically from January 1, 2000 to January 26, 2019. Eligible randomized controlled trials, non-randomized clinical trials, cohort studies (retrospective or prospective), and unselected case series were included. Strict screening of the obtained literature was conducted to extract relevant data by two reviewers. Other inclusion criteria were studied reporting on outcomes of AVR with biological valves (stented or stentless), with or without coronary artery bypass grafting (CABG) or valve repair procedure, with mean follow-up length equal to or longer than 5 years. We excluded studies that reported only a specific patient group (e.g., patients with renal failure, or pregnancy), without the report of biological valve type, or with study population size less than 100. The meta-analysis was performed using Stata 14.0 software.@*RESULTS@#In this study, 53 papers (in total 57 study groups) involving 47 803 patients were included. (1) The all-cause mortality was 6.33/100 patient-years (95%CI: 5.85-6.84). Subgroup analysis showed that the mortality rates of porcine and bovine valve prostheses were 5.69/100 patient-years (95%CI: 5.05-6.41) and 7.29/100 patient-years (95%CI: 6.53-8.13), respectively. The all-cause mortality rates for stented and stentless valve were 6.69/100 patient-years (95%CI: 6.12-7.30) and 5.21/100 patient-years (95%CI: 4.43-6.14), respectively. (2) The incidence rate of thromboembolism was 1.16/100 patient-years (95%CI: 0.96-1.40), the incidence rate of permanent pacemaker (PPM) implantation was 1.08/100 patient-years (95%CI: 0.75-1.54), the incidence rate of stroke was 0.74/100 patient-years (95%CI: 0.51-1.06), the incidence rate of structural valve dysfunction (SVD) was 0.73/100 patient-years (95%CI: 0.59-0.91), the incidence rate of major bleeding was 0.52/100 patient-years (95%CI: 0.41-0.65), the incidence rate of endocarditis was 0.38/100 patient-years (95%CI: 0.33-0.44), and the incidence rate of non-structural valve dysfunction (NSVD) was 0.20/100 patient-years (95%CI: 0.13-0.31). The total reoperation rate for biological aortic valve was 0.77/100 patient-years (95%CI: 0.65-0.91), and the SVD related reoperation rate was 0.46/100 patient-years (95%CI: 0.36-0.58).@*CONCLUSION@#The all-cause mortality for conventional biological AVR was 6.33/100 patient-years. Thromboembolism, PPM implantation, reoperation, stroke, and SVD were major long term complications.