1.Mining and analysis of ADE signals of two camptothecin topoisomerase 1 inhibitors
Zhenjiang WU ; Jianjun LIU ; Xiangyu BAI ; Maofan YANG ; Wenhai FAN ; Pan WANG ; Junsong YANG
China Pharmacy 2024;35(9):1133-1138
OBJECTIVE To mine and analyze the adverse drug events (ADE) signals of two camptothecin topoisomerase 1 inhibitors, i.e. irinotecan and topotecan, and to provide reference for clinical medication safety. METHODS Based on the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database, ADE report data for the aforementioned two drugs were extracted from January 1, 2004 to March 31, 2023. After processing the data, signal mining was conducted by using the reporting odds ratio in conjunction with the Bayesian confidence propagation neural network, followed by analysis. RESULTS A total of 14 738 relevant ADE reports were screened, among which 11 483 were associated with irinotecan and 3 255 with topotecan. The ADE reports for irinotecan were predominantly male, whereas for topotecan, they were predominantly female; the age of patients using the two drugs mainly concentrated in 45-<75 years old. A total of 847 signals were detected, involving 24 system organ classes (SOCs). Among them, 565 signals of irinotecan were detected, involving 24 SOCs, primarily concentrating on gastrointestinal disorders, general disorders and administration site conditions, blood and lymphatic system disorders; the most frequently reported ADE was diarrhea, and the ADE with the strongest signal intensity was cholinergic syndrome. A total of 282 signals of topotecan were detected, involving 22 SOCs, primarily concentrating on general disorders and administration site conditions, investigations, blood and lymphatic system disorders, and gastrointestinal disorders; the most frequently reported ADEs were death and anemia, and the ADE with the strongest signal intensity was febrile bone marrow aplasia. ADE signals for irinotecan such as metastatic colorectal cancer, peripheral sensory neuropathy, steatohepatitis, and those for topotecan such as iris atrophy, retinal degeneration, vitreous hemorrhage, were not documented in their respective drug instruction. CONCLUSIONS ADEs of irinotecan and topotecan primarily involve the digestive and hematologic systems, warranting close clinical monitoring. Cholinergic syndrome caused by irinotecan should be concerned. In addition, patients receiving irinotecan should also be monitored for ADE such as metastatic colorectal cancer, peripheral sensory neuropathy, steatohepatitis, and proteinuria; for patients using topotecan, enhanced surveillance of ocular diseases is recommended to ensure medication safety.
2.Research on the construction of evaluation index system of internal control of medical equipment in public hospitals based on Delphi method and analytic hierarchy process
Qibo MA ; Mingzhuo DENG ; Shan LU ; Ni KANG ; Xiaochen SI ; Yu BAI ; Ming LI ; Xiangyu MENG ; Jianjun CHEN
China Medical Equipment 2024;21(5):133-137
Objective:To construct an evaluation index system of internal control medical equipment based on the internal control theory of The Committee of Sponsoring Organizations of the Treadway Commission(COSO)and combined with the current situation of medical equipment internal management in public hospitals,so as to provide reference and suggestions for the evaluation of internal control of medical equipment in public hospitals.Methods:Through literature research and expert consultation,the evaluation index system of internal control of medical equipment was preliminarily determined.Using the Delphi method,15 experts from 1 medical college and 3 tertiary hospitals in Beijing who were engaged in the use and management of medical equipment were selected to conduct two rounds of consultation on the evaluation index system of internal control of medical equipment,and the evaluation indicators were scored and screened.The analytic hierarchy process(AHP)was used to determine the index weights,and the internal control evaluation index system of medical equipment in public hospitals based on COSO was constructed.Results:The coefficient of the two rounds of expert consultation was 100%.The authority degree of consulting experts was 0.867.Finally,the evaluation index system of internal control of medical equipment in tertiary public hospitals was formed,which included 5 first-level indicators,17 second-level indicators and 50 third-level indicators.Conclusion:The evaluation index of internal control of medical equipment in public hospitals based on COSO has high expert enthusiasm,authority and coordination.The evaluation index system includes the unit level and the business level of internal control,with a wide coverage,which makes up for the limitations of traditional internal evaluation of medical equipment,which can make up for the limitations of the internal evaluation of traditional medical equipment,improve the internal control system of medical equipment in public hospitals,and optimize the medical equipment management system.
3.Clinical efficacy of semaglutide in the treatment of type 2 diabetes mellitus combined with non-alco-holic fatty liver disease and its effect on oxidative stress and inflammatory factors
Xiangyu MENG ; Liwei BAI ; Qingfeng YIN ; Beiyan LIU ; Xuehui CHEN ; Yun XU ; Di WANG ; Xu WANG ; Ruina GENG ; Qiujun LIU
Journal of Xinxiang Medical College 2024;41(5):443-448
Objective To explore the efficacy of semaglutide in the treatment of type 2 diabetes mellitus(T2DM)com-bined with non-alcoholic fatty liver disease(NAFLD)and its effect on oxidative stress and inflammatory factors.Methods Totally 80 patients with T2DM accompanied by NAFLD admitted to the First Affiliated Hospital of Xinxiang Medical University from July 2021 to December 2022 were selected and randomly assigned to the observation group and the control group,with 40 patients in each group.Patients in the control group were treated with pioglitazone metformin and dapagliflozin,while patients in the observation group were treated with pioglitazone metformin,dapagliflozin,and semaglutide.The levels of glycated hemoglobin(HbA1c),fasting blood glucose(FBG),2-hour postprandial blood glucose(2hPG),body mass,body mass index(BMI),waist circumference,alanine aminotransferase(ALT),aspartate aminotransferase(AST),gamma-glutamyl transferase(GGT),controlled attenuation parameter(CAP),liver stiffness measurement(LSM),malondialdehyde(MDA),glutathione peroxidase(GSH-PX),lipid peroxide(LPO),tumor necrosis factor-α(TNF-α),interleukin-6(IL-6),and interleukin-10(IL-10)before and after the treatment were compared.Results After 24 weeks of treatment,the overall response rate(ORR)in the observation group and control group was 92.5%(37/40)and 72.5%(29/40),respectively;and the ORR in the observation group was significantly higher than that in the control group(x2=5.541,P<0.05).Before treatment,there was no statistically significant difference in the body mass,BMI,waist circumference,HbA1c,FBG,2hPG,ALT,AST,GGT,CAP,LSM,MDA,GSH-PX,LPO,TNF-α,IL-6,and IL-10 of patients between the 2 groups(P>0.05);after 24 weeks of treatment,the body mass,BMI,waist circumference,HbA1c,FBG,2hPG,ALT,AST,GGT,CAP,LSM,MDA,LPO,TNF-α,IL-6,and IL-10 were significantly lower than before treatment,while GSH-PX was significantly higher than before treatment(P<0.05);after 24 weeks of treatment,the body mass,BMI,waist circumference,HbA1c,FBG,2hPG,ALT,AST,GGT,CAP,LSM,MDA,LPO,TNF-α,IL-6,and IL-10 of patients in the observation group were significantly lower than those in the control group,and GSH-PX was significantly higher than that in the control group(P<0.05).The incidence of adverse reactions in the observation group and the control group during the treatment period was 17.5%(7/40)and 12.5%(5/40),respectively;and the difference in the incidence of adverse reactions between the two groups was not statistically significant(P>0.05).Conclusion Semaglutide significantly downregulates the levels of FBG,2hPG and HbA1c in patients with T2DM combined with NAFLD and reduces the body mass,waist circumference,liver enzyme level,hepatic fat content,hepatic fibrosis,oxidative stress,and inflammatory indicators.
4.Comparison of the therapeutic effects of different doses of radioactive iodine-131 in the treatment of hyperthyroidism
Xuehui CHEN ; Liwei BAI ; Xiangyu MENG ; Yun XU ; Huiling DUAN ; Xu WANG ; Ruina GENG
Journal of Xinxiang Medical College 2024;41(5):467-471
Objective To explore the therapeutic effects of different doses of radioactive iodine-131 on patients with hyperthyroidism.Methods A total of 574 patients with hyperthyroidism treated in the First Affiliated Hospital of Xinxiang Medical University from April 2020 to April 2023 were sampled for this study and were divided evenly into the observation group and the control group by a random number table,with 287 patients in each group.The control group was treated with high-dose radioactive iodine-131(>10-15 mCi),while the observation group was provided with low-dose radioactive iodine-131(5-10 mCi).The therapeutic effects were estimated six months after treatment.Data of the two groups of patients before treatment and 3 and 6 months after treatment were compared,including the levels of thyroid hormone(FT4),free triiodothyronine(FT3),and thyroid-stimulating hormone(TSH),which were measured through the fluorescence immunochromatography of serum(obtained by centrifugation of 3 mL fasting venous blood),and the tumor necrosis factor-α(TNF-α),transforming growth factor-β1(TGF-β1),interleukin-6(IL-6),and IL-1,which were measured through the enzyme-linked immunosorbent assay of serum.The salivary gland uptake index and salivary gland secretion index of the patients before treatment and 3 and 6 months after treatment were measured through radionuclide imaging.The incidence of adverse reactions during treatment was documen-ted.The incidence of hypothyroidism in both groups was evaluated 6 months after treatment.Results The total effective rate of the observation group and the control group was 83.27%(234/281)and 92.88%(261/281),respectively,and that of the observation group was significantly higher(x2=12.353,P<0.05).The FT4,FT3,and TSH levels of the two groups before treatment showed no statistical discrepancy(P>0.05).According to data collected 3 and 6 months after treatment,FT4 and FT3 levels of both groups significantly decreased,while TSH increased(P<0.05)compared to corresponding pre-treatment levels;FT4 and FT3 levels of both groups observed 6 months after treatment were significantly lower than those observed 3 months before,in contrast to the growing TSH trend(P<0.05).At 3 and 6 months after treatment,FT4 and FT3 levels of the observation group were significantly lower than those of the control group,while TSH levels were significantly higher(P<0.05).The salivary gland uptake index and salivary gland secretion index between the two groups before treatment showed no statistical discrepancy(P>0.05).At 3 and 6 months after treatment,such indexes of both groups obviously decreased(P<0.05).However,those observed 6 months after treatment were higher than three months before(P<0.05).At 3 months after treatment,the salivary gland uptake index and salivary gland secretion index of the observation group were notably higher than the control group(P<0.05);at 6 months after treatment,no statistical discrepancy was observed between the two groups in terms of the two indexes(P>0.05).Before treatment,there was no statistical difference in TNF-α,TGF-β1,IL-6,and IL-1 levels between the two groups(P>0.05).At 3 and 6 months after treatment,the TNF-α,TGF-β1,IL-6,and IL-1 levels of both groups decreased significantly from pre-treatment levels(P<0.05),and the data observed 6 months after treatment were still lower than those observed 3 months after treatment(P<0.05).At 3 months after treatment,the TNF-α,TGF-β1,IL-6,and IL-1 levels of the observation group were significantly lower than those of the control group(P<0.05);at 6 months after treatment,no statistical difference was observed between the two groups(P>0.05).The incidence of adverse reactions during treatment in the control group and the observation group was 16.38%(47/287)and 8.01%(23/287),respectively,and that of the observation group was significantly lower than the other group(x2=8.457,P<0.05).At 6 months after treatment,the incidence of hypothyroidism in the control group and the observation group was 12.46%(35/281)and 3.56%(10/281),respectively,and that of the observation group was significantly lower than that in the control group(x2=15.098,P<0.05).Conclusion Low doses of radioactive iodine-131 work better in the treatment of hyperthyroidism and can effectively alleviate inflammation and salivary gland dysfunction,with less risk of inducing hypothyroidism and adverse reactions.
5.Development of clinical decision support system for insulin titration and validation of its effectiveness and safety
Xiangyu MENG ; Liwei BAI ; Beiyan LIU ; Xuehui CHEN ; Yun XU ; Di WANG ; Xu WANG ; Ruina GENG ; Qiujun LIU
Journal of Xinxiang Medical College 2024;41(6):566-570
Objective To develope a clinical decision support system(CDSS)on insulin titration and validate its effectiveness and safety.Methods Eighty patients with type 2 diabetes mellitus treated at the Department of Endocrinology of the First Affiliated Hospital of Xinxiang Medical University from January 2021 to July 2023,who had difficulty in achieving glycemic control on the basis of lifestyle interventions and oral hypoglycemic drug treatments,were selected for the study.The patients were divided into the observation group and the control group using a random number table,with 40 cases in each group.Patients in both groups received oral metformin extended-release tablets,subcutaneous insulin degludec before bedtime,and subcutaneous aspartate insulin injection before three meals for glycemic control.Patients in the observation group were given insulin titration using the CDSS,and patients in the control group were given insulin titration using the conventional method.The retrospective continuous glucose monitoring system was used to monitor time in range(TIR)for glucose,mean amplitude of glycemic excursion(MAGE),mean blood glucose(MBG),standard deviation of blood glucose(SDBG),and the coefficient of variation(CV)of blood glucose.Fasting blood glucose(FBG),2-hour postprandial glucose(2hPG),length of hospitalization,time to achieve standard blood glucose control,and incidence of hypoglycemia of patients were recorded before and after treatment in the two groups.Results There was no significant difference in FBG and 2hPG of patients between the two groups before treat-ment(P>0.05).The FBG and 2hPG levels of patients in the two groups were significantly lower than those before treatment(P<0.05).The FBG and 2hPG levels of patients in the observation group were significantly lower than those in the control group after treatment(P<0.05).TIR of patients in the observation group was significantly higher than that in the control group,while MAGE,MBG,SDBG,and CV were significantly lower than those in the control group after treatment(P<0.05).The length of hospitalization was 9.0(7.3,10.0)days and 11.0(8.3,12.0)days of patients in the observation group and control group,respectively;and the length of hospitalization of patients in the control group was significantly longer than that in the observation group(Z=-2.408,P<0.05).The time required to achieve glycemic control was 6.5(5.0,8.8)days and 7.5(6.0,10.0)days of patients in the observation group and control group,respectively;and the time required to achieve glycemic control of patients in the control group was significantly longer than that in the observation group(Z=-2.019,P<0.05).The incidence of hypoglycemia of patients in the observation group and control group was 20.0%(8/40),12.5%(5/40),respectively;there was no significant difference in the incidence of hypoglycemia between the observation group and the control group(x2=0.827,P>0.05).Conclusion Compared with the conventional titration of insulin,the application of CDSS can provide decision support during the implementation of a basal-meal insulin regimen,which can lead to more effective glycemic control,improved glucose TIR,reduced glycemic fluctuations,shorter time required for patients to achieve glycemic control,and shorter hospital stays without increasing the risk of hypoglycemia.
6.Construction of clinical training content system for master of nursing specialist
Xiangyu SUN ; Yule LI ; Jing JIAO ; Jiamin LI ; Xiaoming ZHANG ; Yunfeng BAI ; Xinjuan WU
Chinese Journal of Modern Nursing 2023;29(2):203-208
Objective:To construct the clinical training content system for master of nursing specialist (MNS) in China.Methods:The first draft of clinical training content system for MNS was constructed through literature review, national status survey and semi-structured interview. Delphi expert consultation was used to form the final draft, and analytic hierarchy process was used to determine the weight of indicators at all levels.Results:Two rounds of consultation were conducted among 20 experts. The questionnaire recovery rate was 100% and the expert authority coefficient was 0.93. The Kendall concordance coefficients of the two rounds were 0.499 and 0.387, respectively, with a statistically significant difference ( P<0.001) . The average assigned value of importance of indicators at all levels was 4.60 to 5.00. The final version of the clinical training content system for MNS included 6 first-level items, 17 second-level items and 24 third-level items. Conclusions:The clinical training content system for MNS has good practicability, scientificity and reliability, which can provide reference and guidance for MNS clinical training.
7.Feasibility study of optical surface imaging assisted postmastectomy radiotherapy set-up
Dashuang LUO ; Zhibin LI ; Xiangyu ZHANG ; Haiping HE ; Guangjun LI ; Sen BAI
Chinese Journal of Radiological Medicine and Protection 2022;42(11):871-876
Objective:To investigate the performance of optical surface imaging (OSI) in the postmastectomy radiotherapy setup and to assess the effects of 3D printed silicone bolus on OSI detection precision.Methods:A retrospective analysis was conducted for 16 patients treated with left-sided postmastectomy radiotherapy (PMRT) in West China Hopital, Sichuan University from January to April, 2021. The setup errors of 16 patients without bolus detected using OSI (OSI no-bolus, OSI n) were obtained before error correction was conducted using cone-beam CT (CBCT). The correlation between OSI n and CBCT was analyzed, and then the diagnostic efficacy of OSI was assessed using the receiver operating characteristic (ROC) curves. The setup errors of six patients with 3D printed silicone bolus detected using OSI (OSI bolus, OSI b) were obtained through off-line image registration, and then the detection precision of OSI n and OSI b in the translational directions was compared. Results:The setup errors in the case of OSI n were highly correlated with CBCT in the translational direction ( r ≥ 0.80), but were weakly correlated in the rotation direction ( r < 0.40). In the ROC analysis, the area under the curve (AUC) in the y direction was the lowest and was in the order of AUC 5 mm ≥AUC 3 mm > 0.75 for any translational direction. The difference in the detection precision between OSI n and OSI b was not statistically significant in the x and z directions ( P > 0.05), but was statistically significant in the y direction ( Z = -2.56, P = 0.01). In the y direction, the systematic error of detection precision in the case of OSI b was 3.11 mm higher than that in the case of OSI n, and the random error of detection precision in the case of OSI b was 1.9 mm higher than that in the case of OSI n. Conclusions:OSI cannot yet substitute CBCT in the postmastectomy radiotherapy setup, but its detection error is still within the clinically acceptable range. The performance of OSI-assisted setup is expected to be further improved by mitigating the interference of factors such as bolus in the imaging path through operational training.
8.Bibliometrics analysis of sarcopenic obesity based on Web of Science
Xiangyu SUN ; Jiamin LI ; Xiaoming ZHANG ; Chen ZHU ; Yunfeng BAI ; Hongpeng LIU ; Xinjuan WU
Chinese Journal of Modern Nursing 2022;28(26):3545-3552
Objective:To explore the research status and trends of sarcopenic obesity at home and abroad, so as to provide a reference for the nursing staff to carry out related clinical work or research.Methods:The articles on sarcopenic obesity included from January 1, 2000 to December 31, 2021 were retrieved in the Web of Science core database. Bibliometric analysis was performed using CiteSpace software.Results:From 2000 to 2021, there were 1 252 articles related to sarcopenic obesity, and the number of articles published showed an upward trend year by year. Totals of 83 countries or regions participated in the research, and the country with the largest number of publications was the United States (286) . The most published journal was Clinical Nutrition (44) . The author with the most papers was Wolfgang Kemmler (14) , and the institution with the most papers was Korea University (57) . Research hotspots mainly focused on immune resistance, disease risk and nutritional intervention.Conclusions:Bibliometric analysis reveals research patterns and trends in sarcopenic obesity. Foreign countries started early in this research field, and my country is still in its infancy. There is also an urgent need to cultivate research leaders in the field of sarcopenic obesity, form an inter-institutional cooperation mechanism, and carry out multidisciplinary teamwork to promote the health of the elderly.
9.Bibliometrics analysis of sarcopenic obesity based on Web of Science
Xiangyu SUN ; Jiamin LI ; Xiaoming ZHANG ; Chen ZHU ; Yunfeng BAI ; Hongpeng LIU ; Xinjuan WU
Chinese Journal of Modern Nursing 2022;28(26):3545-3552
Objective:To explore the research status and trends of sarcopenic obesity at home and abroad, so as to provide a reference for the nursing staff to carry out related clinical work or research.Methods:The articles on sarcopenic obesity included from January 1, 2000 to December 31, 2021 were retrieved in the Web of Science core database. Bibliometric analysis was performed using CiteSpace software.Results:From 2000 to 2021, there were 1 252 articles related to sarcopenic obesity, and the number of articles published showed an upward trend year by year. Totals of 83 countries or regions participated in the research, and the country with the largest number of publications was the United States (286) . The most published journal was Clinical Nutrition (44) . The author with the most papers was Wolfgang Kemmler (14) , and the institution with the most papers was Korea University (57) . Research hotspots mainly focused on immune resistance, disease risk and nutritional intervention.Conclusions:Bibliometric analysis reveals research patterns and trends in sarcopenic obesity. Foreign countries started early in this research field, and my country is still in its infancy. There is also an urgent need to cultivate research leaders in the field of sarcopenic obesity, form an inter-institutional cooperation mechanism, and carry out multidisciplinary teamwork to promote the health of the elderly.
10.Feasibility evaluation of estimating the 24-hour urinary sodium excretion in Chinese population with three spot urine methods
Xiaofu DU ; Xiangyu CHEN ; Jie ZHANG ; Le FANG ; Jianwei XU ; Yamin BAI ; Jieming ZHONG
Chinese Journal of Preventive Medicine 2020;54(4):420-424
Objective:To evaluate the feasibility of three spot urine methods (Kawasaki, INTERSALT and Tanaka) for estimating the 24 h urinary sodium excretion in the Chinese population.Methods:In 2017, 1 499 participants aged 18 to 69 years old were selected from Yiwu City, Haining City, Taishun County, Yinzhou District of Ningbo City and Liandu District of Lishui City of Zhejiang Province by using the multistage random sampling method. Sociodemographic information of the subjects was collected with questionnaires and physical measurements were performed. 24 h urine was collected and urinary volume was recorded. The concentrations of urinary sodium, potassium and creatinine were also measured. Kawasaki, INTERSALT and Tanaka spot urine methods were applied to estimate the 24 h urinary sodium excretion and compared with actual values among 1 426 participants who passed urine integrity test.Results:The age of participants was (46.71±14.04) years old, including 700 males, accounting for 49.1%. The actual value of 24 h urinary sodium excretion was (167.10±74.70) mmol, but Kawasaki method overestimated it as (184.61±57.10) mmol, and INTERSALT and Tanaka methods underestimated it as(134.62±39.21) and (143.20±35.66) mmol. Estimated difference (95 %CI) (mmol) from small to large was Kawasaki method [17.51 (13.54, 21.47)], Tanaka method [-23.90 (-27.60, -20.20)] and INTERSALT method [-32.48 (-36.29, -28.67)]. With the increase of 24 h sodium intake, all estimation methods changed from the overestimation to underestimation. In those with 24 h sodium intake <9.0 g, the estimated difference (95 %CI) of the INTERSALT method was the smallest as 43.15 (37.73, 48.57) and 1.26 (-2.10, 4.63) mmol for <6.0 and 6.0-8.9 g groups, respectively. In those with 24 h sodium intake≥9.0 g, the Kawasaki method had the smallest estimated difference (95 %CI) as -12.50 (-18.14, -6.86) and -53.73 (-61.25, -46.22) for 9.0-11.9 g and ≥ 12.0 g group, respectively. The consistency analysis of the Bland-Altman method showed that the Kawasaki method had the best consistency with actual measured value and it had the least number of points outside the range (69 points accounting for 4.84%). Conclusion:Among the three spot urine methods, the Kawasaki method has better applicability in predicting the excretion of 24 h urine sodium in the Chinese population.

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