Melatonin prevents glyphosate-induced hepatic lipid accumulation in roosters via activating Nrf2 pathway.

BACKGROUND: Glyphosate (GLY) is a widely used herbicide with well-defined hepatotoxic effects, in which oxidative stress has been shown to be involved in the pathogenesis of hepatotoxicity. Melatonin (MET), an effective free radical scavenger, has been revealed to alleviate drug-induced liver damage by inhibiting oxidative stress. METHODS: In this study, a rooster model with primary chicken embryo hepatocytes was applied to elucidate the therapeutic effects of MET against GLY-induced hepatic damage and the potential mechanism. Histopathological examinations, biochemical tests and immunoblotting analysis were used to monitor the protective effects of MET on GLY-induced hepatic lipid accumulation. Molecular docking analysis was used to reveal the key reason of MET-improved hepatic lipid deposition. RESULTS: Data firstly showed that MET administration markedly improved GLY-induced hepatic injury, as evidenced by normalized liver enzymes and alleviated pathological changes of liver tissues. Moreover, MET supplementation alleviated GLY-induced hepatic lipid accumulation, which was correlated with improved serum and hepatic lipid profiles and normalized expression of lipolysis- and lipogenesis-related proteins. Notably, MET significantly inhibited vital enzymes involved in stimulating oxidative stress. Moreover, MET enhanced GLY-inhibited Nrf2 nuclear transcription and increased the expressions of its downstream target genes HO1 and NQO1. Further studies revealed that MET may interact with Nrf2 to enhance nuclear translocation of Nrf2. CONCLUSION: Collectively, our results provide the first direct evidence that MET is a novel regulator of Nrf2, highlighting that Nrf2 may be a potential therapeutic target for GLY-induced lipotoxic liver injury.

Traditional Chinese medicine for post-viral olfactory dysfunction: A systematic review.

Background: Post-viral olfactory dysfunction (PVOD) is the common symptoms of long COVID, lacking of effective treatments. Traditional Chinese medicine (TCM) is claimed to be effective in treating olfactory dysfunction, but the evidence has not yet been critically appraised. We conducted a systematic review to evaluate the effectiveness and safety of TCM for PVOD. Methods: We searched eight databases to identified clinical controlled studies about TCM for PVOD. The Cochrane risk of bias tools and GRADE were used to evaluate the quality of evidence. Risk ratio (RR), mean differences (MD), and 95 % confidence interval (CI), were used for effect estimation and RevMan 5.4.1 was used for data analysis. Results: Six randomized controlled trials (RCTs) (545 participants), two non-randomized controlled trials (non-RCTs) (112 participants), and one retrospective cohort study (30 participants) were included. The overall quality of included studies was low. Acupuncture (n = 8) and acupoint injection (n = 3) were the mainly used TCM therapies. Five RCTs showed a better effect in TCM group. Four trials used acupuncture, and three trials used acupoint injection. The results of two non-RCTs and one cohort study were not statistically significant. Two trials reported mild to moderate adverse events (pain and brief syncope caused by acupuncture or acupoint injection). Conclusions: Limited evidence focus on acupuncture and acupoint injection for PVOD and suggests that acupuncture and acupoint injection may be effective in improving PVOD. More well-designed trials should focus on acupuncture to confirm the benefit. Protocol registration: The protocol of this review was registered at PROSPERO: CRD42022366776.

Danggui Sini decoction alleviates oxaliplatin-induced peripheral neuropathy by regulating gut microbiota and potentially relieving neuroinflammation related metabolic disorder.

BACKGROUND: Danggui Sini decoction (DSD), a traditional Chinese medicine formula, has the function of nourishing blood, warming meridians, and unblocking collaterals. Our clinical and animal studies had shown that DSD can effectively protect against oxaliplatin (OXA)-induced peripheral neuropathy (OIPN), but the detailed mechanisms remain uncertain. Multiple studies have confirmed that gut microbiota plays a crucial role in the development of OIPN. In this study, the potential mechanism of protective effect of DSD against OIPN by regulating gut microbiota was investigated. METHODS: The neuroprotective effects of DSD against OIPN were examined on a rat model of OIPN by determining mechanical allodynia, biological features of dorsal root ganglia (DRG) as well as proinflammatory indicators. Gut microbiota dysbiosis was characterized using 16S rDNA gene sequencing and metabolism disorders were evaluated using untargeted and targeted metabolomics. Moreover the gut microbiota mediated mechanisms were validated by antibiotic intervention and fecal microbiota transplantation. RESULTS: DSD treatment significantly alleviated OIPN symptoms by relieving mechanical allodynia, preserving DRG integrity and reducing proinflammatory indicators lipopolysaccharide (LPS), IL-6 and TNF-α. Besides, DSD restored OXA induced intestinal barrier disruption, gut microbiota dysbiosis as well as systemic metabolic disorders. Correlation analysis revealed that DSD increased bacterial genera such as Faecalibaculum, Allobaculum, Dubosiella and Rhodospirillales_unclassified were closely associated with neuroinflammation related metabolites, including positively with short-chain fatty acids (SCFAs) and sphingomyelin (d18:1/16:0), and negatively with pi-methylimidazoleacetic acid, L-glutamine and homovanillic acid. Meanwhile, antibiotic intervention apparently relieved OIPN symptoms. Furthermore, fecal microbiota transplantation further confirmed the mediated effects of gut microbiota. CONCLUSION: DSD alleviates OIPN by regulating gut microbiota and potentially relieving neuroinflammation related metabolic disorder.

Influence of Modified Shashen Maidong Decoction Combined with Camrelizumab Immunotherapy Plus Chemotherapy on the Efficacy,Survival Status,and Serum CYFRA21-1 and NSE Levels in Patients with Advanced Non-Small Cell Lung Cancer / 广州中医药大学学报

Objective To investigate the influence of modified Shashen Maidong Decoction combined with Camrelizumab immunotherapy plus chemotherapy on the efficacy,survival status and serum cytokeratin 19 fragment(CYFRA21-1)and neuron-specific enolase(NSE)levels in patients with advanced non-small cell lung cancer(NSCLC).Methods Forty patients with advanced NSCLC of lung-stomach yin deficiency with intense heat-toxin type were randomly divided into a control group and a study group,with 20 patients in each group.The patients in the control group were given Camrelizumab immunotherapy plus chemotherapy,and the patients in the study group were given modified Shashen Maidong Decoction combined with Camrelizumab immunotherapy plus chemotherapy,with 21 days as a course of treatment and for a total of 4 courses of treatment.The changes of serum NSE and CYFRA21-1 levels in the two groups before and after treatment were observed,and the clinical efficacy,survival status and the incidence of toxic and side effects were compared between the two groups.Results(1)After 4 courses of treatment,the total effective rate of the study group was 70.00%(14/20),which was significantly higher than that of the control group(9/20,45.00%),but the intergroup comparison(tested by chi-square test)showed that the difference was not statistically significant(P＞0.05).(2)After 2 years of follow-up,the overall survival(OS),time to progression(TTP),and progression-free survival(PFS)of the patients in the study group were significantly prolonged compared with those in the control group(P＜0.01).(3)After treatment,the serum NSE and CYFRA21-1 levels of the patients in the two groups were decreased compared with those before treatment(P＜0.05),and the decrease of serum NSE and CYFRA21-1 levels in the study group was significantly superior to that in the control group(P＜0.01).(4)The incidence of toxic and side effects in the study group was 25.00%(5/20),which was significantly lower than that of 65.00%(13/20)in the control group,and the intergroup comparison showed that the difference was statistically significant(P＜0.05).Conclusion Modified Shashen Maidong Decoction combined with Camrelizumab immunotherapy plus chemotherapy has satisfactory therapeutic effect on patients with advanced NSCLC,which can reduce the toxic and side effects of chemotherapy,lower the level of serum tumor markers,and prolong the survival period and time to progression(TTP)of the patients.

Constructing a nomogram based on the distribution of thyroid nodules and suspicious lateral cervical lymph nodes in fine-needle aspiration biopsies to predict metastasis in papillary thyroid carcinoma.

Purpose: Elevated concentrations of thyroglobulin eluent is a risk factor for lateral cervical lymph node metastasis (LLNM) in patients with papillary thyroid cancer (PTC). We aimed to develop a practical nomogram based on the distribution of thyroid nodules and the presence of suspicious lateral cervical lymph nodes in fine-needle aspiration biopsies (LN-FNABs), including the cytopathology and the suspicious lateral cervical lymph node (LLN) thyroglobulin eluent (Tg), to predict the possibility of LLNM preoperatively in patients with PTC. Methods: The clinical data of PTC patients who were admitted to the Third Affiliated Hospital of Soochow University from January 2022 to May 2023 to undergo fine-needle aspiration biopsy (FNAB) were included in this study. A total of 208 patients in 2022 served as the training set (70%), and 89 patients in 2023 served as the validation set (30%). The clinical characteristics and LN-FNAB results were collected to determine the risk factors of LLNM. A preoperative nomogram was developed for predicting LLNM based on the results of the univariate and multivariate analyses. Internal calibration, external calibration, and decision curve analysis (DCA) were performed for these models. Results: The multivariate logistic regression analysis showed that the maximum thyroid nodule diameter (Odds Ratio (OR) 2.323, 95% CI 1.383 to 3.904; p = 0.001), Tg level (OR 1.007, 95% CI 1.005 to 1.009; p = 0.000), Tg divided by serum thyroglobulin, (Tg/sTg) [odds ratio (OR) 1.005, 95% CI 1.001 to 1.008; p = 0.009], and cytopathology (OR 9.738, 95% CI 3.678 to 25.783; p = 0.000) (all p < 0.05) had a significant impact on the LLNM of patients with suspicious LLNs. The nomogram showed a better predictive value in both the training cohort [area under the curve, (AUC) 0.937, 95% CI 0.895 to 0.966] and the validation cohort (AUC 0.957, 95% CI 0.892 to 0.989). The nomogram also showed excellent internal and external calibration in predicting LLNM. According to the DCA, the diagnostic performance of this model was dependent on the following variables: maximum thyroid nodule diameter, Tg level, Tg/sTg, and cytopathology. Conclusion: Based on the aforementioned risk factors, we believe that it is necessary to establish a personalized LLNM model for patients with PTC. Using this practical nomogram, which combines clinical and Tg risk factors, surgeons could accurately predict the possibility of LLNM preoperatively. The nomogram will also help surgeons to establish personalized treatment plans before surgery.

A novel and alternative therapy for persistent allergic rhinitis via intranasal acupuncture: a randomized controlled trial.

BACKGROUND: Acupuncture is used to treat allergic rhinitis (AR) in traditional Chinese medicine, and the ST2 and ST36 acupoints are generally selected in clinical practice. We report a new intranasal acupuncture method at the Neiyingxiang (EX-HN9) and Biqiu points for the treatment of persistent AR (PAR). Here, the efficacy and safety of this method were evaluated. METHODS: A total of 120 patients diagnosed with PAR were randomly allocated (2:1 ratio) to intranasal acupuncture or Western medicine groups, the basic principle of random grouping is SAS random grouping method. The applicator held a nasal endoscope and a 0.30 × 75 mm filiform needle in their left and right hands, respectively. When aiming at the Neiyingxiang or Biqiu point, the applicator quickly inserted the needle to a 20-mm depth as parallel as possible to the inferior turbinate or middle turbinate, without special reinforcing and reducing techniques (the needle remained for 20 min). The intranasal acupuncture groups received acupuncture treatment three times per week for 2 weeks. The Western medicine group was treated with budesonide nasal spray (two sprays/nostril, twice/day) and loratadine (one tablet/night) for 2 weeks. Visual analog scale (VAS) scores were the primary outcome. Quality of life, medication dosages and adverse events were secondary outcomes measured using the Rhinoconjunctivitis Quality-of-Life Questionnaire (RQLQ). Confidence assessments were performed to evaluate data from the treatment and follow-up periods. RESULTS: The results were as follows: (1) VAS and RQLQ scores were significantly lower in the intranasal acupuncture group than in the Western medicine group on day 1 (i.e., first treatment) (P < 0.05; 95% CI - 13.1 to - 9.6 VAS points) (P < 0.05; 95% CI - 20.27 to - 12.28 RQLQ points). Overall symptoms (95% CI - 2.86 to - 1.86 points), nasal obstruction (95% CI - 6.33 to - 5.36 points), olfactory function (95% CI - 2.91 to - 1.75 points), sleep (95% CI - 5.05 to - 3.57 points), actual problems (95% CI - 2.03 to - 0.06 points), nasal symptoms (95% CI - 6.62 to - 4.5 points), and emotional problems (95% CI - 5.05 to - 3.5 points) were significantly improved. (2) VAS and RQLQ scores in the two groups were significantly improved at week 2; however, there were no significant group differences in the VAS (P > 0.05; 95% CI - 1.21 to - 1.38 points) and RQLQ (P > 0.05; 95% CI - 0.33 to - 3.46 points) scores. Olfactory function symptoms were significantly improved (95% CI - 1.58 to - 0.21 points). (3) During the follow-up period, there was a significant difference between the two groups (P < 0.05) with higher RQLQ and VAS scores in the intranasal acupuncture group than in the Western medicine group. VAS scores on rhinobyon symptoms, nasal itch, rhinorrhea and olfactory function and RQLQ scores for activities, non-nasal/eye symptoms, actual problems, nasal symptoms, and eye symptoms were significantly improved. (4) No adverse events were observed in either group during treatment. CONCLUSIONS: Intranasal acupuncture has good efficacy and safety in the treatment of PAR. Moreover, VAS and RQLQ scores were much lower in the intranasal acupuncture group than in the Western medicine group, and acupuncture had an immediate impact, especially for improving nasal congestion, olfactory function and sleep.

Analysis of Chinese Medical Syndrome Features of Ischemic Stroke Based on Similarity of Symptoms Subgroup.

OBJECTIVE: To derive the Chinese medicine (CM) syndrome classification and subgroup syndrome characteristics of ischemic stroke patients. METHODS: By extracting the CM clinical electronic medical records (EMRs) of 7,170 hospitalized patients with ischemic stroke from 2016 to 2018 at Weifang Hospital of Traditional Chinese Medicine, Shandong Province, China, a patient similarity network (PSN) was constructed based on the symptomatic phenotype of the patients. Thereafter the efficient community detection method BGLL was used to identify subgroups of patients. Finally, subgroups with a large number of cases were selected to analyze the specific manifestations of clinical symptoms and CM syndromes in each subgroup. RESULTS: Seven main subgroups of patients with specific symptom characteristics were identified, including M3, M2, M1, M5, M0, M29 and M4. M3 and M0 subgroups had prominent posterior circulatory symptoms, while M3 was associated with autonomic disorders, and M4 manifested as anxiety; M2 and M4 had motor and motor coordination disorders; M1 had sensory disorders; M5 had more obvious lung infections; M29 had a disorder of consciousness. The specificity of CM syndromes of each subgroup was as follows. M3, M2, M1, M0, M29 and M4 all had the same syndrome as wind phlegm pattern; M3 and M0 both showed hyperactivity of Gan (Liver) yang pattern; M2 and M29 had similar syndromes, which corresponded to intertwined phlegm and blood stasis pattern and phlegm-stasis obstructing meridians pattern, respectively. The manifestations of CM syndromes often appeared in a combination of 2 or more syndrome elements. The most common combination of these 7 subgroups was wind-phlegm. The 7 subgroups of CM syndrome elements were specifically manifested as pathogenic wind, pathogenic phlegm, and deficiency pathogens. CONCLUSIONS: There were 7 main symptom similarity-based subgroups in ischemic stroke patients, and their specific characteristics were obvious. The main syndromes were wind phlegm pattern and hyperactivity of Gan yang pattern.

Efficient Aerobic Oxidative Coupling of Methyl Heteroarenes with Indoles.

Direct oxidative coupling of inert C(sp3 )-H bond has been a great challenge. Herein, an environmentally friendly aerobic oxidative coupling of α-methyl substituted N-heteroarenes with indoles is reported. A variety of diheteroaryl ketones were prepared in good yields (up to 72 %). This protocol features simple operation and broad substrates scope (26 examples). Significantly, a plausible mechanism about catalytic cycle was proposed, and two key intermediates were confirmed by high resolution mass spectrometry.

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.

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.

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.

Present situation and development suggestions of blood transfusion warmer / 医疗卫生装备

The main products and performance characteristics of non-portable and portable blood transfusion warmers in the world were introduced.The problems of the blood transfusion warmer were analyzed,and some suggestions were put forward accordingly.It's pointed out the intelligent and portable blood transfusion warmer with the functions of heating,pressurization and speed control would be the main direction of future development.

Analysis of research hotspots based on the International Conference on Pharmacoepidemiology and Therapeutic Risk Management from 2021 to 2022 / 药物流行病学杂志

Objective To describe the research hotspots and authors'cooperative relationships in the field of pharmacoepidemiology mentioned in the 2022 International Conference on Pharmacoepidemiology and Therapeutic Risk Management(ICPE),and compare with those result of ICPE 2021.Methods Taking the 2021-2022 ICPE abstracts as the data source,we used Python to extract literature information.R software networkD3 package was used to draw network diagrams of cooperative relationships among authors and organizations.Term frequency-inverse document frequency technology in tidytext package was used to conduct weighted statistics on the frequency of tokens to identify hotspot diseases,drugs,databases,etc.Results 2 086 ICPE abstracts were included.Between 2021 and 2022,the number of abstracts,authors,and organizations increased by 58.8%,42.3%,and 24.9%respectively.In 2022,there were a total of 387 core authors(including 14 from China,all from Hong Kong and Taiwan district),forming 26 close cooperation groups(including 2 Chinese groups).161 core organizations(including 8 in China),constituted 18 close cooperation groups(including 1 Chinese-foreign group and 1 Chinese domestic group).The topic of COVID-19,type 2 diabetes,and rheumatoid arthritis have always been deeply discussed,meanwhile,the discussion popularity of breast cancer,Parkinson's disease and dementia have increased significantly.Opioids,sodium-glucose transporters 2 inhibitors,and antipsychotics have always been popular drugs,and the popularity of antidepressants,COVID-19 vaccines and antihypertensive drugs have increased markedly.The hotspot databases included Clinical Practice Research Datalink,IBM MarketScan Commercial Claims and Encounters,and Food and Drug Administration Adverse Event Reporting System,etc.Conclusion From 2021 to 2022,the scale of ICPE has expanded,and academic cooperation has become more extensive and in-depth.However,there is still a big gap between the participation and cooperation scale of scholars from Chinese mainland and foreign countries.Breast cancer,Parkinson's disease,dementia,antidepressants,and COVID-19 vaccines are new hot topics at ICPE 2022.The research hotspots and cooperation networks displayed in this article have certain reference values for Chinese pharmacoepidemiologists in selecting future research topics and partners.

The C(sp3)-H bond functionalization of thioethers with styrenes with insight into the mechanism.

A metal-free inactive C(sp3)-H bond functionalization of thioethers with styrenes using TBHP as an initiator and DBU as a base has been developed. This transformation has broken through the low activity of thioethers and realized moderate yields. Herein extended experiments were conducted to confirm the radical relay process, reaction energy and intermediate transformations.

Copper-Catalyzed Aldehyde Exchanged Amidation.

The synthesis of bioactive amides has been the pursuit of chemists. Herein secondary amides incorporated with an aldehyde group were first generated using aldehydes and secondary amines. Various (hetero)aryl aldehydes and even aliphatic aldehydes (>40 examples) were converted into the desired products in moderate to excellent yields (up to 89%). A plausible mechanism involving a Cu(I/II/III) catalytic cycle combined with radical rearrangement was proposed and confirmed with four key intermediates detected by high-resolution mass spectrometry.

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.

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.

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.

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.

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.