1.Research on signal mining of adverse events of tizanidine based on FAERS database
Yanxin LIU ; Changjiang DONG ; Jian ZOU ; Li CHEN ; Yamin SHU ; Xucheng HE ; Pan WU
Chinese Journal of Pharmacoepidemiology 2024;33(2):166-175
Objective Based on U.S.Food and Drug Administration Adverse Event Reporting System(FAERS)database,the signal mining of tizanidine adverse drug events(ADEs)was conducted to explore the occurrence characteristics of ADE,hoping to provide references for the safe clinical application of tizanidine.Methods The reporting odds ratio(ROR)and medicines and healthcare products regulatory agency methods(MHRA)were used to analyse the ADE of tizanidine using FAERS registration data from the first quarter of 2004 to the second quarter of 2022.After valid signals were obtained,the MedDRA was used for translation and system organ classification.Results A total of 7 135 reports of tizanidine ADE were obtained,including 1 732 patients,1 304 ADE types were involved.According to the results of 2 ADE signal mining methods,at the preferred term(PT)level,177 signals were detected.There were 32 PT signals not included in the drug instructions,including potassium wasting nephropathy,cardio-respiratory arrest,and foetal growth restriction etc.In 1 732 patients,the number of ADE cases of female was 2.37 times that in male(1 057 vs.446),and the age group between 40 and 64 accounted for a large proportion(36.03%).The highest proportion(32.79%)reported by consumers.The system organ class involved mainly included various neurological diseases and psychosis.The median time to onset of tizanidine-related ADEs was 75 d(interquartile range:28-223 d),but it was necessary to be vigilant that ADE may still occur 1 year after starting the drug(13.38%).Conclusion This study aims to suggest that clinical application of tizanidin-related ADE should be paid full attention to the occurrence of ADE such as potassium-wasting nephropathy and suicidally completed,as well as key populations such as women and patients of 40-64 years old.
2.Signal Mining Study of Adverse Reaction Associated with Allopurinol and Febuxostat Based on FDA Adverse Events Reporting System(FAERS)Database
Lu WEN ; Li CHEN ; Xucheng HE ; Jia CHENG ; Yuan XU
Herald of Medicine 2024;43(4):639-647
Objective To conduct signal mining of adverse events(AEs)of allopurinol and febuxostat based on FAE-RS database,and to explore their potential drug risks and promote rational and safe clinical drug use.Methods The adverse event report data of febuxostat and allopurinol in 22 quarters from the first quarter of 2017 to the second quarter of 2022 were ex-tracted from FAERS database,and the signal mining of febuxostat and allopurinol adverse events(AE)was carried out using ROR method and PRR method.Results There were 5 060 AE reports for allopurinol,concentrated in patients aged≥60 years,in-volving 25 items of system organ classification(SOC),mainly in skin and subcutaneous tissue diseases(40.01%).It was found that 12 SOC categories were not mentioned in the instructions.For febuxostat,there were 905 AE reports,involving 17 SOC items,mainly in cardiac organ diseases(40.17%),and 2 items were not involved in the instructions.Allopurinol and febuxostat were as-sociated with infection and infectious diseases(5.51%,0.49%)and hepatobiliary diseases(5.35%,0.87%),However,these as-sociations were included in the instructions of allopurinol.Allopurinol was associated with the reproductive system and breast dis-eases(0.55%),pregnancy,puerperium and perinatal conditions(0.03%),but febuxostat was not found to be involved in the a-bove SOC.Conclusion The inclusion of adverse reactions in the instructions for allopurinol is relatively inadequate compared to buprostat,and the newly discovered involvement of systemic organs and AE can provide a reference for improving allopurinol in-structions.This study found that allopurinol and febuxostat allopurinol and febuxostat involved system differences,which can pro-vide reference for clinical individualized treatment.
3.Trends of Incidence and Age at Onset of Uterine Corpus Cancer in Jiangsu Cancer Registration Areas from 2009 to 2019
Weiwei LI ; Jianmei DONG ; Zhaojun MA ; Lili CHAI ; Xucheng QIN ; Jinyi ZHOU ; Weigang MIAO ; Ran TAO ; Renqiang HAN
China Cancer 2024;33(12):977-982
[Purpose]To investigate the trends of incidence and age at onset of uterine corpus can-cer in Jiangsu cancer registration areas from 2009 to 2019.[Methods]The continuous monitoring data of uterine corpus cancer from 2009 to 2019 were collected from 16 cancer registries in Jiang-su Province.The crude incidence rate,the age-standardized incidence rate by Chinese standard population(ASIRC),crude and adjusted mean age,and standardized age-specific incidence composition were calculated.The average annual percentage change(AAPC)were analyzed by the Joinpoint regression model.The linear regression model was used to analyze the relationship be-tween mean age at onset and year.The standardized age-specific incidence composition in 2009 and 2019 were compared.[Results]The ASIRC of uterine corpus cancer in all registration areas and in rural areas of Jiangsu Province showed upward trends with AAPC of 1.78%and 2.38%,re-spectively(P<0.05),but not showed in the urban areas(AAPC=1.30%,P>0.05).The crude mean age at onset increased from 56.48 years old in 2009 to 58.26 years old in 2019 with an average annual growth of 0.173 years old(P=0.001).After the population structure standardized,the trends disappeared in all registration areas.[Conclusion]From 2009 to 2019,the standardized incidence rates of uterine corpus cancer were on rise in Jiangsu cancer registration areas,especially in the age group of 50 to 59 years old.
4.Disease burden of leukemia in Jiangsu Province from 1990 to 2019
MA Zhaojun ; LI Weiwei ; DONG Jianmei ; ZHOU Jinyi ; HAN Renqiang ; QIN Xucheng
Journal of Preventive Medicine 2023;35(4):282-285
Objective:
To investigate the trends in the disease burden of leukemia in Jiangsu Province from 1990 to 2019, so as to provide insights into leukemia control in Jiangsu Province.
Methods:
The prevalence, incidence, death and disability adjusted life years (DALYs) of leukemia in Jiangsu Province from 1990 to 2019 were retrieved from the 2019 Global Burden of Disease Study (GBD 2019) database, and standardized by the age structure of Chinese populations in 2000. The trends in the disease burden of leukemia in Jiangsu Province from 1990 to 2019 were analyzed using average annual percent change (AAPC).
Results :
The average annual standardized prevalence, incidence, mortality and DALY rate of leukemia were 63.63/105, 9.76/105, 4.10/105 and 194.83/105 in Jiangsu Province from 1990 to 2019, respectively. The average annual standardized prevalence (AAPC=1.420%, t=5.644, P<0.001) and incidence (AAPC=0.806%, t=3.505, P<0.001) of leukemia appeared a tendency towards a rise, while the average annual standardized mortality (AAPC=-1.589%, t=-14.714, P<0.001) and DALY rate (AAPC=-1.849%, t=-9.046, P<0.001) of leukemia appeared a tendency towards a decline in Jiangsu Province from 1990 to 2019. Higher average annual standardized prevalence (65.27/105 vs. 62.38/105, P<0.001), incidence (10.32/105 vs. 9.29/105, P<0.001), mortality (4.69/105 vs. 3.57/105, P<0.001) and DALY rate of leukemia (216.94/105 vs. 172.80/105, P<0.001) were estimated among men than among women. The crude prevalence of leukemia peaked among patients at ages of 0 to 14 years and 60 to 74 years, and the crude incidence, DALY rate and mortality of leukemia peaked at ages of 0 to 14 years and 75 years and older.
Conclusions
The mortality and DALY of leukemia appeared a tendency towards a decline and the prevalence and incidence appeared a tendency towards a rise in Jiangsu Province from 1990 to 2019; however, there were high disease burdens of leukemia among men, children and the elderly.
5.Trends in incidence of stroke in Lianyungang City from 2014 to 2020
Weiwei ZHANG ; Xucheng QIN ; Weiwe LI ; Zhaojun MA ; Jianmei DONG
Journal of Preventive Medicine 2022;34(9):932-936
Objective:
To investigate the incidence and trends in incidence of stroke among residents in Lianyungang City, Jiangsu Province from 2014 to 2020, so as to provide insights into stroke control.
Methods:
The stroke morbidity data in Lianyungang City from 2014 to 2020 were captured from Lianyungang Municipal System for Monitoring of Cardiovascular and Cerebrovascular Diseases, and standardized by the sixth national population census data in China in 2010. The trends in stroke incidence were evaluated using average annual percentage change (AAPC), and the gender-, age-, region- and disease type-specific incidence and trends in incidence of stroke were descriptively analyzed.
Results:
Totally 162 423 new stroke cases were diagnosed in Lianyungang City from 2014 to 2020 new case, and the annual mean crude and standardized incidence rates were 435.32/105 and 357.28/105, which both appeared a tendency towards a rise (AAPC=12.61%, t=39.098, P<0.001; AAPC=9.91%, t=6.123, P<0.001) . The standardized incidence of stroke was significantly higher in men than in women (389.63/105 vs. 327.17/105; χ2=4.056, P=0.044). The crude incidence of stroke appeared a tendency towards a rise with age among residents (χ2trend=258.219, P<0.001), and appeared a tendency towards a rise among residents at ages of <35 (AAPC=22.52%, t=6.723, P<0.001), 35 to 64 (AAPC=9.78%, t=7.867, P<0.001) and 65 years and older (AAPC=10.24%, t=5.156, P<0.001). The crude incidence was higher in rural areas than in urban areas (437.72/105 vs. 425.31/105; χ2=20.709, P<0.001). Ischemic stroke was the predominant type (139 680 cases, 86.00% of all cases), and both the crude and standardized incidence appeared a tendency towards a rise (AAPC=13.79%, t=16.865, P<0.001; AAPC=10.88%, t=5.128, P<0.001).
Conclusion
The incidence of stroke appeared a tendency towards a rise among residents living in Lianyungang City from 2014 to 2020. Men, middle-age and elderly residents and rural residents are high-risk populations for stroke control.
6.Analysis of related factors of epilepsy secondary to aneurysmal subarachnoid hemorrhage in the elderly
Jun ZHANG ; Hanyong LI ; Weidong LUO ; Yan XIONG ; Can YU ; Xucheng LI
Chinese Journal of Primary Medicine and Pharmacy 2020;27(15):1849-1852
Objective:To explore the related factors of epilepsy secondary to aneurysmal subarachnoid hemorrhage in the elderly.Methods:From January 2015 to January 2019, 213 elderly patients with aneurysmal subarachnoid hemorrhage admitted to Wuhan Hospital of Traditional Chinese Medicine were divided into epilepsy group(46 cases) and non-epilepsy group(167 cases) according to whether secondary epilepsy.Univariate analysis was used to analyze the related factors affecting epilepsy secondary to aneurysmal subarachnoid hemorrhage in the elderly, and multivariate logistic regression was used to analyze the risk factors of epilepsy secondary to aneurysmal subarachnoid hemorrhage in the elderly.The investigation factors included sex, age, hypertension, diabetes mellitus, smoking history, location of responsible aneurysms, number of aneurysms, intracranial hematoma, hydrocephalus and neurological sequelae.Results:Univariate analysis showed that there were no statistically significant differences in sex, age, history of diabetes mellitus and smoking between the two groups(all P>0.05). There were statistically significant differences between the epilepsy group and non epilepsy group in hypertension(15 cases vs.22 cases), location of responsible aneurysms in middle cerebral artery(22 cases vs.24 cases), number of aneurysms(23 cases vs.41 cases), intracranial hematoma(15 cases vs.26 cases), hydrocephalus(15 cases vs.21 cases) and neurological sequelae(14 cases vs.20 cases)(χ 2=9.491, 23.840, 11.113, 6.737, 10.306, 9.161, all P<0.05). The results of multivariate analysis showed that hypertension, middle cerebral artery, multiple aneurysms, intracranial hematoma, hydrocephalus and neurologic sequelae were risk factors for epilepsy secondary to aneurysmal subarachnoid hemorrhage in the elderly[ OR(95% CI)2.361(1.476-3.421), 3.012(1.935-1.845), 1.494(1.027-1.845), 2.785(1.684-3.982), 1.920(1.283-2.984), 1.637(1.171-2.316)]. Conclusion:There are many factors influencing secondary epilepsy in elderly patients with aneurysmal subarachnoid hemorrhage.In order to reduce the incidence of secondary epilepsy, preventive measures should be taken against the above risk factors.
7.Cross-sectional study on obesity and central obesity among 35-75 year-old people in Jiangsu Province
Weiwei ZHANG ; Tonghao WU ; Jin MA ; Jianmei DONG ; Weiwei LI ; Xucheng QIN ; Zhaojun MA ; Jian SU ; Lan CUI ; Jinyi ZHOU ; Yu QIN
Journal of Preventive Medicine 2019;31(9):886-890
Objective:
To investigate the prevalence and related factors of obesity and central obesity among 35-75 year-old population in Jiangsu Province.
Methods:
During 2015-2017,83 530 eligible subjects aged 35-75 years from six study sites of Jiangsu Province were interviewed and examined. The data of demography,lifestyles,disease history,height,weight and waistline were collected. Logistic regression analysis was conducted for the influencing factors for obesity and central obesity.
Results:
A total of 83 393 residents completed the study,with a response rate of 99.84%. The prevalence of overweight,obesity and central obesity was 43.35%(standardized rate:35.90%),20.02%(19.48%)and 59.93%(57.03%). The results of multivariate logistic regression analysis showed that females(OR=0.822,95%CI:0.786-0.859;OR=0.900,95%CI:0.851-0.952;OR=1.130,95%CI:1.083-1.179),45-75 years old(OR:1.120-1.731,95%CI:1.102-1.881),graduating from high school or above(OR:0.767-0.902,95%CI:0.721-0.943),living in urban areas(OR:1.530-2.077,95%CI:1.284-3.007),smoking(OR:0.724-0.855,95%CI:0.678-0.898),drinking (OR:1.125-1.179,95%CI:1.076-1.235),hypertension(OR:1.884-3.461,95%CI:1.821-3.613),diabetes(OR:1.363-1.758,95%CI:1.305-1.851), dyslipidemia(OR:1.478-1.870,95%CI:1.429-1.851)were associated with overweight,obesity and central obesity.
Conclusion
The standardized prevalence rates of overweight,obesity and central obesity among 35-75 year-old population in Jiangsu Province are 35.90%,19.48% and 57.03%,respectively. Gender,age,education,residence,smoking,drinking,hypertension,diabetes and dyslipidemia are related factors.
8.Correlation analysis of serum cardiac troponin Ⅰ and clinical efficacy observation of Wushen decoction for treatment of patients with sepsis heart failure
Xucheng LI ; Dong ZHANG ; Jun ZHANG ; Can YU ; Yu GAO ; Shujing YU ; Quanli PAN ; Liping YU
Chinese Journal of Integrated Traditional and Western Medicine in Intensive and Critical Care 2017;24(1):10-13
Objective To investigate the effect of Wushen decoction on levels of serum cardiac troponin Ⅰ (cTnI),cardiac muscle enzyme and clinical parameters in patients with sepsis heart failure,and to analyze the correlations between cTnI and myocardial enzyme level and clinical parameters.Methods Forty-two patients diagnosed as sepsis admitted to Wuhan Hospital of Traditional Chinese Medicine from March 2014 to March 2016 were enrolled,and they were divided into a Wushen decoction treatment group and a control group by principle of single blind complete randomized method,21 cases in each group.The patients in control gToup were treated by conventional western medicine,while the patients in Wushen decoction treatment group,on the basis of conventional western medicine,they were treated additionally by Wushen decoction (composed of ginseng,radix sophorae flavescentis,radix glehniae,radix adenophorae,salvia,astragalus,notoginseng radix,rosewood,etc.),one dose a day,the therapeutic course in both groups being 7 days.The changes of biochemical indicators [cTnI,creatine kinase (CK),CK isoenzyme (CK-MB)],haemodynamics parameters [cardiac index (CI),central venous pressure (CVP),extravascular lung water index (ELWI),global ejection fraction (GEF),mean arterial pressure (MAP),heart rate (HR)],treatment condition and prognostic parameters [vasoactive drug dosage index,acute physiology and chronic health evaluation Ⅱ (APACHE Ⅱ) score,duration of mechanical ventilation,the length of stay in intensive care unit (ICU) and total hospitalization time] were compared before and after treatment for 7 days in the two groups.The correlations between the level of cTnI on admission before treatment and CK,CK-MB,APACHE Ⅱ,vasoactive drug dosage index,duration of mechanical ventilation,the length of stay in ICU and total hospitalization time were analyzed.Results The levels of cTnI,CK,CK-MB,CVP,ELWI,HR,vasoactive drug dosage index,APACHE Ⅱ score in two groups after treatment were obviously lower than those before treatment,the levels of CI,GEF,MAP were markedly higher than those before treatment,the duration of mechanical ventilation,the length of stay in ICU and total hospitalization time were significantly shorter than those before treatment,and the changes of above indexes were more remarkable in Wushen decoction group than those in control group [cTnI (mg/L):0.94-± 0.29 vs.1.30 ± 0.67,CK (U/L):96.00 ± 24.30 vs.101.38 ± 24.55,CK-MB (U/L):31.14 ± 6.78 vs.36.48 ± 8.17,CI (mL· s-1 · m-2):64.51 ± 5.83 vs.53.34 ± 4.67,CVP (cmH2O,1 cmH2O =0.098 kPa):10.56 ± 1.84 vs.11.94--2.16,ELWI (mL/kg):8.81±1.61 vs.11.66±2.30,GEF:(33.62±3.88)% vs.(27.14±4.55)%,MAP (mmHg,1 mmHg =0.133 kPa):84.67 ± 5.58 vs.79.52 ± 5.74,HR (bpm):87.86 ± 9.02 vs.82.95 ± 5.26,vasoactive drug dosage index:2.44 ± 0.53 vs.2.89 ± 0.68,APACHE Ⅱ score:10.66 ± 1.66 vs.14.43 ± 1.82,duration of mechanical ventilation (days):1.67 ± 2.11 vs.2.10 ± 2.26,the length of stay in ICU (days):8.86 ± 2.59 vs.10.67 ± 2.96,total hospitalization time (days):13.24 ± 4.53vs.16.76 ± 5.04,all P < 0.05].On admission before treatment,the correlations between the level of cTnI and CK,APACHE Ⅱ score,vasoactive drug dosage index,duration of mechanical ventilation and the length of stay in ICU were all positive (r =0.322,0.335,0.327,0.328,0.338,P =0.038,0.030,0.030,0.034,0.029).Conclusions The elevation of cTnI level may reflect the degree of myocardial damage in patients with sepsis cardiac failure,and it can be used as an indicator to predict the prognosis of the disease;the changes of many biochemical and clinical indexes suggest that the addition of Wushen decoction might elevate the clinical efficacy for treatment of patients with sepsis heart failure.
9.Changes in the composition of hospitalization of thyroid disease in Lianyungang City of Jiangsu Province from 2002 to 2010
Jianmei DONG ; Weiwei LI ; Xucheng QIN
Chinese Journal of Endemiology 2015;34(3):208-212
Objective To analyze the changes in the composition of hospitalization of thyroid disease in Lianyungang City from 2002 to 2010,to learn the impact of iodine intake on thyroid disease in Lianyungang City after implementing universal salt iodization (USI),and to get epidemiologic evidence for prevention and control of iodine deficiency disorders scientifically.Methods Medical reports of the patients with thyroid disease were collected from hospitals at county level and above institutions in Lianyungang City from 2002 to 2010.Monitoring results of household iodized salt were also collected from five counties (districts) in Lianyungang City.The changes in the composition of hospitalization of thyroid disease were analyzed,and the relationship between thyroid disease and iodized salt was studied.Results ① A total of 3 559 patients with thyroid disease were enrolled in the study,the ratio between male and female was 1 ∶ 3.36.Mean age was (46.81 ± 14.94) years old and the peak age was from 40 to 60 years old.② Among the hospitalized patients with thyroid disease,the proportion of goiter patients,hyperthyroidism patients,thyroiditis patients,hypothyroidism and other thyroid disorders was 41.64% (1 482/3 559),40.07% (1 426/3 559),6.83% (243/3 559),6.21% (221/3 559) and 5.25% (187/3 559),respectively.③In 2002-2010,the hospitalization rate of thyroid disease showed an upward trend (x2 =460.12,P< 0.01),and the hospitalization rates of hypothyroidism,goiter,hyperthyroidism,thyroiditis and other thyroid disorders were all increased year by year (x2 =50.54,281.91,85.15,19.51 and 65.01,all P < 0.01).④From 2002 to 2006,among the patients with thyroid disease,the proportion of hyperthyroidism was the highest,and the range of values was from 42.03% (124/295) to 53.02% (114/215).Followed by goiter,and the range of values was from 34.55% (142/411) to 39.25% (73/186).From 2007 to 2010,the proportion of goiter became the highest,and the range of values was from 42.11% (232/551) to 49.57% (291/587).Followed by hyperthyroidism,and the range of values was from 33.05% (194/587) to 40.47% (223/551).⑤From 2002 to 2010,the coverage of iodized salt and the consumption rate of qualified iodized salt both increased year by year (x2 =183.75,211.99,all P < 0.01).⑥There were positive correlations between the hospitalization rates of thyroid disease,hypothyroidism,goiter,other thyroid disorders and the coverage of iodized salt,and the consumption rate of qualified iodized salt (rs =0.83,0.93,0.82,0.87,0.83,0.93,0.74 and 0.91,all P < 0.05).⑦There was a positive correlation between the hospitalization rate of hyperthyroidism and the consumption rate of qualified iodized salt (rs =0.72,P < 0.05).Conclusions There are some changes in the composition of hospitalization of thyroid disease in Lianyungang city from 2002 to 2010.Iodine intake may affect the hospitalization rate of thyroid disease.
10.Therapeutic effect of plasmapheresis in treatment of hyperlipidemic acute pancreatitis
Clinical Medicine of China 2012;28(3):279-281
Objective To investigate the clinical effect of plasmapheresis in the treatment of hyperlipidemic acute pancreatitis.Methods Twenty four patients with hyperlidemic acute pancreatitis were treated with plasmapheresis combined with the conventional therapeutic measures.The clinical symptoms,serum levels of lipids (triglycerides,cholesterol)and the prognosis of patients were observed and compared before and after the treatment of plasmpheresis.Results One case underwent plasmapheresis after surgery,one case with extremely severe symptoms underwent surgical treatment after plasmapheresis,twenty two cases didn't underwent surgical treatment.After the plasmapheresis treatment the clinical symptoms of twenty four patients were alleviated and the blood lipid levels decreased significantly.The triglyceride concentrations decreased significantly from(24.55 ± 10.76) mmol/L to ( 3.85 ± 3.02 ) mmol/L ( t =7.099,P < 0.01 ) and the cholesterol concentrations decreased significantly from ( 10.82 ± 5.06 ) mmol/L to ( 3.43 ± 1.28 ) mnol/L ( t =5.826,P <0.01 ).Twenty four cases of patients were cured and discharged.Conclusion It is safe and effective of plasmapheresis in treatmeat of hyperlipidemic acute pancreatitis.


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