1.Signal mining and analysis for adverse drug events of galcanezumab based on FAERS database
Shanshan LIU ; Guo CHEN ; Xiao LIU ; Yuzhen DONG
Chinese Journal of Pharmacoepidemiology 2024;33(8):860-868
Objective To mine the adverse drug event(ADE)signals of galcanezumab based on U.S.Food and Drug Administration Adverse Event Reporting System(FAERS)to provide reference for clinical drug safety.Methods The data from the FAERS database from the third quarter of 2018 to the fourth quarter of 2023 were extracted.After data cleaning and standardization,the duplicate data was removed using structured query language,ADE reports with galcanezumab as the main suspected drug were screened.ADE reports were standardized and categorized using the Medical Dictionary for Drug Regulatory Activities.The reporting odds ratio(ROR)method and information component(IC)method were applied for signal detection.Results A total of 60 ADE signals were detected after screening,11 system organ classes were involved,mainly general disorders and administration site conditions.The ADE signals that occurred most frequently were a variety of discomfort reactions at the injection site,consistent with the most common ADEs documented in the drug insert.The top 3 new ADE signals in order of occurrence frequency were alopecia,weight increased and constipation,and in order of ROR and IC values were injection site pustule,vertebral artery dissection and Raynaud's phenomenon.Conclusion ADE related to galcanezumab mainly involve systemic diseases and various reactions at the site of administration,among which vertebral artery dissection and Raynaud's phenomenon are stronger signals and newer ADEs.The patient's disease progression should be closely monitored during the treatment period to avoid serious consequences.
2.Ameliorating effect of calycosin regulating SIRT3/SOD2 signaling pathway on airway epithelial cell damage in mice
Jia NIE ; Yongying GUO ; Xiangyan YU ; Yuzhen PEI ; Yun LIU ; Zenglu KANG ; Yinghao SU
Tianjin Medical Journal 2024;52(11):1171-1176
Objective To investigate effects of calycosin(CA)on cigarette smoke(CS)induced airway epithelial cell damage in mice and the sirtuin 3/superoxide dismutase 2(SIRT3/SOD2)signaling pathway in mice.Methods A total of 90 mice were randomly separated into the control group,the cigarette smoke(CS)group,the CA low-dose treatment group(CA-L group),the CA high-dose treatment group(CA-H group)and the CA high-dose treatment plus SIRT3 inhibitor 3-TYP group(CA-H+3-TYP group),with 18 mice in each group.Tidal volume(TV)and peak expiratory flow rate(PEF)of lung function were detected by whole body plethysmography system.Serum levels of inflammatory factors[interleukin(IL)-6,tumor necrosis factor(TNF)-α]and oxidative stress indicators[reactive oxygen species(ROS),SOD]were detected by enzyme-linked immunosorbent assay(ELISA).The injury of airway epithelial cells in lung tissue was observed by HE staining.The expression levels of barrier related proteins(OCLN and ZO-1)in airway epithelial cells were detected by immunohistochemistry.Immunoblotting was applied to detect the expression of SIRT3/SOD2 signaling pathway related proteins.Results Compared with the control group,levels of TV,PEF,MAN and SOD and the expression levels of OCLN,ZO-1,SIRT3 and SOD2 were decreased in the CS group,while the levels of MLI,IL-6,TNF-α and ROS were increased(P<0.05).Compared with the control group,the lung tissue structure was significantly damaged,the alveolar enlargement was obvious,the surrounding alveolar was accompanied by inflammatory cell infiltration,and the airway epithelial cells were obviously shed in the CS group.Different doses of CA alleviated lung tissue destruction,improved alveolar structure,reduced inflammatory cell infiltration,reduced airway epithelial cell shedding,increased levels of TV,PEF,MAN,SOD and OCLN,ZO-1,SIRT3 and SOD2,and decreased levels of MLI,IL-6,TNF-α and ROS.The effect of high dose CA was more significant than that of low dose CA(P<0.05).SIRT3/SOD2 signaling pathway inhibitor 3-TYP partially reversed the ameliorative effect of CA on CS induced airway epithelial cell injury in mice.Conclusion CA can ameliorate CS induced airway epithelial cell damage in mice,and its mechanism is related to the activation of the SIRT3/SOD2 signaling pathway.
3.The role of DNA hypomethylation in the promoter region of EphA2 and its relationship with pyroptosis in invasive breast cancer
Yuzhen JIE ; Ying ZHU ; Fengying GUO ; Li NA ; Yideng JIANG ; Ligang WU ; Shengchao MA
Tumor 2023;43(12):960-970
Objective:To investigate the correlation of the expression of Ephrin A receptor 2(EphA2)and its promoter region DNA hypomethylation with the occurrence of pyroptosis in invasive breast cancer. Methods:The expression level of pyroptosis-related protein EphA2 in normal breast tissue,paracancerous tissues and cancer tissues from 42 breast cancer patients was examined by Immunofluorescence staining and Western blotting.The expression level of pyroptosis related protein nucleotide-binding oligomerization domain-like receptor protein 3(NLRP3)was analyzed by immunofluorescence staining and Western blotting.The expression levels of apoptosis related proteins Caspase 1 and inflammatory cytokine interleukin-1β(IL-1 β)were studied by Western blotting.The DNA methylation level in the promoter region of EphA2 was investigated by nested methylation-specific PCR(nMS-PCR).The expression levels of DNA methyltransferase 1(DNMT1)and DNA methyltransferase 3a(DNMT3a)were examined by Western blotting.The correlation of the protein expression and methylation level of EphA2 in cancer tissues with the expression NLRP3,Caspase 1,IL-1 β,DNMT1 and DNMT3a was analyzed by Pearson correlation coefficient. Results:Compared with normal breast tissues and paracancerous tissues,the expression level of EphA2 protein was significantly increased(P<0.01),while that of NLRP3,Caspasel and IL-1 βwas significantly decreased(P<0.05)in breast cancer tissues.Meanwhile,compared with normal breast tissues and paracancerous tissues,the DNA methylation level of EphA2 promoter in breast cancer tissues was significantly decreased(P<0.05),the expression level DNMT3a protein was significantly decreased(P<0.01,P<0.05),and the difference in the expression level of DNMT1 protein was not statistically significant.Pearson correlation analysis showed that the expression level of EphA2 protein is negatively correlated with that of NLRP3(r=-0.651 2,P<0.05),Caspasel(r=-0.571 2,P<0.05),IL-1β(r=-0.654 6,P<0.05)or DNMT3a(r=-0.537 4,P<0.05),while the methylation level of EphA2 was positively correlated with the protein expression level of NLRP3(r=0.634 1,P=0.026 8),Caspase1(r=0.672 8,P=0.01 6 5),IL-1 β(r=0.694 0,P=0.01 2 3)and DNMT3a(r=0.687 1,P=0.01 3 6). Conclusion:The expression of EphA2 protein is upregulated in breast cancer tissues is negatively correlated with pyroptosis.DNMT3a may be involved in the process of DNA hypomethylation in the promoter region of EphA2.
4.Application and Analysis of High-quality Evaluation for Jianwei Xiaoshi Tablets
Anyi ZHAO ; Lukun XIAO ; Sha CHEN ; Cong GUO ; Yuzhen LIU ; Zhiguang WANG ; Yan LIU ; An LIU
Chinese Journal of Experimental Traditional Medical Formulae 2022;28(21):138-146
Jianwei Xiaoshi tablets, as a common variety of Chinese patent medicine with "one product with many manufacturers", have many manufacturers and huge market sales. However, the phenomenon about uneven quality and discrepant price is prominent. Based on this, this study was carried out for the quality evaluation of Jianwei Xiaoshi tablets by applying the high-quality evaluation criteria with the quality as core for Chinese patent medicine, which was based on the full production cycle, from the multi-dimension including raw material selection, production process, quality control, post-marketing research and so on. The evaluation results showed that the quality evaluation scores of Jianwei Xiaoshi tablets from different manufacturers varied greatly (ranging from 35 to 66), indicating that the quality was significantly different. In the actual production, generally inadequate attention was paid to the quality of raw materials, and the quality of raw materials was insufficient with the score ratio of 43%, especially the poor consistency control of them. The role of good manufacturing practice was obvious, and the scores of production process were generally high with the average score ratio of 62%, and the maximum up to 80%. The technological advancement of the manufacturer was outstanding. The score ratio of quality control was only 31% that the internal quality standard of each manufacture almost stayed at the qualified line, which was equal to the national standard, and the consistency of products was insufficient. The post-marketing research was lacking with the score ratio of 37%. Manufacturers with high brand awareness and market share were upper scores, while the others lagged far behind. The results of this evaluation are in line with the overall prediction, which can provide a reference for the high-quality evaluation of Chinese patent medicine, and supply the scientific data for high-quality and high-price application.
5.Molecular biological characteristics of the 2019 novel Coronavirus in Shijiazhuang
Huixia GAO ; Lin YANG ; Yun GUO ; Yicong WANG ; Yuzhen LIU ; Yue TANG ; Zhang HE ; Xinming LIANG ; Shunkai HUANG ; Peng GAO ; Ying HUANG ; Muwei DAI ; Zhi ZHANG ; Qian HU ; Yuling WANG ; Fang CHEN ; Erhei DAI ; Ping JIANG ; Yutao DU
Chinese Journal of Laboratory Medicine 2022;45(6):637-641
Objective:To analyze the molecular epidemiological characteristics of the Corona virus disease 2019 (COVID-19) cases in Shijiazhuang, which can reveal the origin of the outbreak and provide a scientific basis for COVID-19 prevention and control.Methods:From January 2 to January 8, 2021, a total of 404 samples from 170 COVID-19 cases were collected from the Shijiazhuang Fifth Hospital. The consensus sequence of 2019 novel Coronavirus(2019-nCoV) was obtained through multiplex polymerase chain reaction-based sequencing. The sequences of 170 COVID-19 cases were analyzed by the PANGOLIN, and the data were statistically analyzed by T-test.Results:Among the 404 COVID-19 samples, a total of 356 samples obtained high quality genome sequences (>95%,100×sequencing depth). The whole genome sequences of 170 COVID-19 cases were obtained by eliminating repeated samples. All 170 sequences were recognized as lineage B1.1 using PANGOLIN. The number of single nucleotide polymorphism arrange from 18-22 and most of the single nucleotide polymorphism were synonymous variants. All of 170 genomes could be classified into 48 sub-groups and most of the genomes were classified into 2 sub-groups (66 and 31, respectively).Conclusions:All cases in this study are likely originated from one imported case. The viruses have spread in the community for a long time and have mutated during the community transmission.
6.Efficacy comparison of standardized incision and conventional incision for reduction and internal fixation of multiple rib fracture
Zhiming SONG ; Jianming CHEN ; Jing ZHONG ; Junhua GUO ; Xiaoping YU ; Songlin CHEN ; Weibin CAI ; Yuzhen ZHENG ; Yunfeng YI
Chinese Journal of Trauma 2022;38(11):977-984
Objective:To compare the efficacy of standardized incision and conventional incision for reduction and internal fixation of multiple rib fracture.Methods:A retrospective cohort study was conducted to analyze the clinical data of 192 patients with multiple rib fracture treated in 909th Hospital of Joint Logistics Support Force (Affiliated Dongnan Hospital of Xianmen University Medical College) from January 2020 to January 2022. There were 101 males and 91 females; aged 32-94 years [(51.5±16.6)years]. The patients underwent open reduction and internal fixation with nickel-titanium shape memory alloy embracer via standard incision such as anterior axillary longitudinal incision (standard incision group, n=96) or conventional incision such as posterolateral incision (conventional incision group, n=96). The incision length, operation time, intraoperative blood loss, number of fixed fractures, indwelling time of closed thoracic drainage tube, postoperative thoracic drainage volume, postoperative spontaneous ambulation time and length of hospital stay were compared in the two groups. The visual analogue scale (VAS) was used to evaluate pain at 1 month after operation. Postoperative complications were recorded. Results:All patients were followed up for 1-16 months [4.0(3.0, 10.5)months]. The operation time, intraoperative blood loss, indwelling time of closed thoracic drainage tube, postoperative thoracic drainage volume, postoperative spontaneous ambulation time, length of hospital stay and VAS at postoperative 1 month in standard incision group [(12.1±1.6)cm, (51.4±13.0)minutes, (191.5±16.8)ml, (2.8±0.6)days, (568.9±109.0)ml, (4.1±0.7)days, (11.4±1.7)days, (2.5±0.7)points] were better than those in conventional incision group [(13.7±1.9)cm, (62.0±8.8)minutes, (248.9±65.4)ml, (4.8±1.1)days, (655.9±121.9)ml, (5.2±0.9)days, (15.3± 1.7)days, (3.5±0.7)points] ( P<0.05 or 0.01). There was no statistical difference in the number of fixed fractures between standard incision group and conventional incision group (5.1±0.8 vs. 5.4±0.9) ( P>0.05). In standard incision group, there were 3 patients with poor wound healing, 5 with pulmonary infection, 3 with atelectasis and 3 with small pleural effusion. In conventional incision group, there were 11 patients with poor wound healing, 9 with pulmonary infection, 7 with atelectasis and 7 with small pleural effusion. The incidence of postoperative complications was 14.6% (14/96) in standard incision group and 35.4% (34/96) in conventional incision group ( P<0.01). Conclusion:For multiple rib fracture, standard incision is superior to conventional incision reduction in shortening the incision length, operation time, indwelling time of drainage tube, postoperative spontaneous ambulation time and length of hospital stay, reducing the intraoperative blood loss and postoperative thoracic drainage volume, alleviating the pain and reducing the postoperative complications.
7.Practices in British blood services: A comparatve study with Chinese status
Tianning SI ; Wusheng LI ; Xibiao GUO ; Tianhui HE ; Saipeng ZHAO ; Lei ZHAO ; Xinli JIN ; Yuzhen LIU
Chinese Journal of Blood Transfusion 2021;34(1):91-94
The blood donation, component preparation and manufacturing, laboratory, issuing and quality control were studied and compared between the UK and China, in order to learn British experience in the clinical practice and blood services. The age limits of blood donors, blood collection units, donation times per year, laboratory items, and the types(volumes) of component preparation and manufacturing in the UK are more superior than those in China. In addition, the blood quality monitoring and regarding indicators are more scientific and reasonable in the UK. The full reimbursement of clinical blood expenses for patients has been realized in the UK. The British experience in continuous safeguard of the blood safety and balance of requirement and availability contributes to the constant and scientific development of British blood services over the years, and is worthy of references.
8.Analysis of trend of low vision of students in the middle and high school entrance examination in Beijing from 2009 to 2018
LI Weiming, GUO Xiuhua, SONG Yuzhen, WU Lijuan, TAO Lixin, DUAN Jiali
Chinese Journal of School Health 2020;41(9):1292-1294
Objective:
To investigate the status and trend of low vision of junior and senior high school students in Beijing from 2009 to 2018, and to provide evidence for myopia prevention.
Methods:
Data came from the results of physical examination of eyesight in 2009-2018 in Beijing, which were cdlected among juncor and senior high school students in March every year. Detection rate of low vision of students and the difference across different districts and counties were analyzed.
Results:
From 2009 to 2018, the rate of low vision of high school and college entrance examination students in Beijing was on the rise, with the average rate of low vision of 86.07% and 76.36% respectively. Similar trend was found in the rate of high myopia(16.39% and 18.64%,respectively), while that of light and medium myopia tends to be stable. The highest rate of low vision among junior middle school students was in Xicheng (84.75%) District and Chaoyang District (84.03%), and for high middle school students,the highest rate of myopia was found in Fengtai District (91.17%) and Dongcheng District (89.92%).
Conclusion
In Beijing, the detection rate of low vision of middle school and college entrance examination students increased steadily, especially the high myopia. The health education of eyesight protection is of great significance to students. It is necessary to strengthen the extensive intervention of eyesight protection in middle and college entrance examination students.
9.Cognitive status of Chinese acne patients and its influencing factors
Shuyun YANG ; Ying TU ; Jianting YANG ; Rong JIN ; Yanni GUO ; Xinyu LIN ; Ying QIU ; Hongxia LIU ; Yao XIE ; Yuzhen LI ; Leihong XIANG ; Bo YU ; Xianyu ZENG ; Changchun XU ; Fengyan LU ; Xing LI ; Hua DU ; Xiangfei LIN ; Yuedong QIU ; Feifei ZHU ; Yufu FANG ; Mingfen LYU ; Ruina ZHANG ; Xinlin HU ; Linjun JIAO ; Hongxia FENG ; Xiaodong BI ; Min ZHANG ; Biwen LIN ; Qiao LIU ; Yonghong LU ; Li HE
Chinese Journal of Medical Aesthetics and Cosmetology 2019;25(5):403-410
Objective To indentify the cognitive status of Chinese patients to acne and the influencing factors to theirs' cognitive status,so as to provide solid evidences for the prevention and treatment of acne.Methods A self-designed questionnaire was made to conduct this survey of 16,156 acne patients,who seeked to the treatment in the dermatological departments from 112 hospitals in China.The survey consisted of several parts,including the general status of patients,the patients' cognition of occurrence,development and risk factors of acne,whether the first choice was seeking treatment at the hospital when the patients had acne and the condition of selection of skin care products.The factors were analyzed,which could impact the cognition of the patients' behavior of treatment,how did the patients' cognition to influence their medical behavior and skin care as well as the consistency of assessment of the severity of acne by doctors and patients themselves.Results The acne patients studied had the best knowledge of "acne is a skin disease","it not only occurs in the period of adolescence" and "the disease can be prevented and cured",which accordingly accounted for 80.65%,69.16% and 65.49% of the total patients respectively.However,the awareness of acne patients to heredity,high sugar and dairy products as risk factors for acne was insufficient,which accounted for 48.72%,42.40% and 18.25% of the total patients,respectively.Gender,age,educational level,occupation and health knowledge were the main factors affecting the cognitive level of patients;the survey also found that men,patient with educational level of junior high or even lower educational condition,occupation of labor workers or farmers and patients were lack of health education with poor knowledge of the genetics and dietary were risk factors for acne;patients with age over 36 years or with mild illness had poor knowledge of dietary risk factors for acne;the difference was statistically significant (P<0.05).The analysis of the influence of cognitive status on medical treatment behavior and skin care showed that the better the cognition,the higher the probability of patients would choose medical treatment as the first choice as well as choosing functional skin care products;the difference was statistically significant (P<0.05).The consistency of assessment of the severity of acne by doctors and patients was poor (Kappa value <0.4),and the assessment of severity of acne by patients was more serious than doctors' assessment.Conclusions Patient's cognitive status will affect their medical behavior and skin care,and there is also a phenomenon that patients have a more serious assessment of their acne condition.It is suggested that health education for acne patients should be strengthened in clinical medicine so as to improve their knowledge of acne as well as preventing from acne effectively.
10. Investigation of the dog-biting events and molecular evolution characteristics of rabies virus strains in Shuangbai county of Yunnan province
Xingxiang GUO ; Weihong YANG ; Yun FENG ; Yuzhen ZHANG ; Fen ZHOU ; Yingjin LI ; Hailin ZHANG
Chinese Journal of Experimental and Clinical Virology 2018;32(3):237-241
Objective:
To illustrate the epidemical characteristics of the dog-biting events and molecular evolution of rabies virus (RV) strains prevalent in Shuangbai county of Yunnan province, China.
Methods:
Epidemical investigation on the dog-biting events and human cases were conducted and the brain tissues of the biting dogs and human cases were sampled post-mortem. Nucleoprotein (N) genes of the RVs were sequenced. Homology and phylogenetic analysis were performed using the relevant bioinformatics software.
Results:
A total of 12 dog-biting events took place between 2011-2017 in Shuangbai county and 35 persons were bitten. Of the 12 events, 11 were investigated in time and 32 bitten persons received proper wound management and a full post-exposure vaccination course. Rabies has not developed in these wounded cases until now. However, due to failure to receive medical intervention and post-exposure treatment in time, 1 of 3 bitten persons in a single event died of rabies. RV N genes from 5 dogs and 1 person were sequenced. Phylogenetic tree showed that RV strains prevalent in Shuangbai county were closely related with the ones found in neighboring counties/cities such as Chuxiong, Lufeng, Jingdong and Xiangyun. All these strains were related to the ones denoted as clade China-I and prevalent in Sichuan province. Homology analysis showed 99.6%-100% homology in nucleotide and amino acid among the 6 RVs prevalent in Shuangbai county and those prevalent in Chuxiong, Lufeng, Xiangyun and clade China-I of Sichuan province. Compared with the China-I strains prevalent in Chuxiong, Zhaotong and Qujing prefectures between 2006-2007, the homology of nucleotide and amino acid were 97.1%-99.3% and 99.1%-99.6%, respectively.
Conclusions
Surveillance on the dog-biting events can prevent rabies in humans effectively. RV strains prevalent in Shuangbai county belong to clade China-I and have a close relationship with those of neighboring prefectures, cities, counties and the ones prevalent in Sichuan province.


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