1.Predictive Value of Multiple Indicators such as Pregnancy-Associated Plasma Protein A in Early Pregnancy for Gestational Diabetes Mellitus
Min OU ; Zhiling WU ; Xue WANG ; Ning LI ; Fei YANG
Journal of Practical Obstetrics and Gynecology 2024;40(1):69-72
Objective:To investigate the predictive value of pregnancy-associated plasma protein A(PAPP-A),fasting blood glucose(FPG),body mass index(BMI)and age in gestational diabetes mellitus(GDM)during the first trimester.Methods:A retrospective analysis was performed on 792 pregnant women who underwent pre-natal examination and delivered in Sichuan Provincial Maternal and Child Health Care Hospital from December 2021 to June 2022.They were divided into GDM group(232 cases)and control group(560 cases)according to whether they had GDM.The clinical data,serum PAPP-A median multiple(PAPP-A MoM)in early pregnancy and FPG levels were compared between the two groups.The indicators with statistical significance in univariate analy-sis were included in multivariate Logistic regression analysis to analyze the related factors affecting the occurrence of GDM.The receiver operating curve(ROC)and area under the curve(AUC)of different indexes were plotted to compare the efficacy of GDM prediction.Results:①The age,pre pregnancy BMI,early pregnancy FPG and the proportion of assisted reproductive technology in GDM group were higher than those in control group,and the differences were statistically significant(P<0.05).The early pregnancy PAPP-A MoM level in GDM group was lower than that in control group,and the difference was statistically significant(P<0.05).②Multivariate Logistic regression analysis showed that older age,lager pre-pregnancy BMI and lager FPG in the first trimester were in-dependent risk factors for GDM occurrence(OR>1,P<0.05),while an increase of PAPP-A MoM in the first tri-mester was a protective factor(OR<1,P<0.05).③ROC showed that the combination of PAPP-A MoM in early pregnancy,FPG in early pregnancy,BMI in pre-pregnancy and age had the highest AUC(0.752)when predicting GDM,with a sensitivity of 55.6%and a specificity of 84.3%.Conclusions:The combined screening of serologi-cal(PAPP-A +FPG)and clinical data(pre-pregnancy BMI +age)in early pregnancy has a high clinical application prospect and can be popularized.
2.Evaluation of the relationship between neck and shoulder pain and scalene muscles based on shear wave elastography
Zhiling CHEN ; Xuecheng HUANG ; Min PAN ; Ying HUANG ; Yuntian WU
Chinese Journal of Tissue Engineering Research 2024;28(8):1265-1270
BACKGROUND:In clinical work,the stiffness of neck soft tissue in patients with neck and shoulder pain is mainly detected through palpation,which is highly subjective and lacks an objective basis.Real-time shear wave elastography is a quantitative elastic ultrasound technique that can objectively assess muscle elasticity and muscle status. OBJECTIVE:To apply real-time shear wave elastography to assess the stiffness of scalene muscles in patients with neck and shoulder pain and to observe the characteristics of muscle stiffness changes in the bilateral anterior,middle and posterior scalene muscles in patients with neck and shoulder pain. METHODS:From December 2021 to June 2022,36 healthy subjects(control group)and 36 patients with neck and shoulder pain(test group)were recruited at the Shenzhen Hospital of Guangzhou University of Chinese Medicine.Real-time shear wave elastography was applied to measure the mean values of elastic modulus and cross-sectional area of the anterior and middle and posterior scalene muscles bilaterally in the neutral and lateral flexion positions of the neck in both groups. RESULTS AND CONCLUSION:In the same position,there were no significant differences between the mean Values of elastic modulus of the left and right anterior scalene muscles as well as between the mean Values of elastic modulus of the left and right middle scalene muscles in each group(P>0.05);there were no significant differences between the cross-sectional area of the left and right anterior scalene muscles as well as the cross-sectional area of the left and right posteromedial scalene muscles in each group(P>0.05);and the elastic modulus and cross-sectional area of the posteromedial scalene muscles were significantly higher than those of the anterior scalene muscles in both groups(P<0.01,P<0.001).The mean Values of elastic modulus of the anterior and posteromedial scalene muscles were higher in the test group than in the control group in the neutral and lateral neck flexion positions(P<0.001),while the cross-sectional areas of the anterior and posteromedial scalene muscles were lower than those in the control group(P<0.01,P<0.001).To conclude,real-time shear wave elastography can be used to visually evaluate the differences in the mean Values of elastic modulus of the anterior and posteromedial scalene muscles in different states of the neck muscles in patients with neck and shoulder pain,whose bilateral scalene muscles are in a state of strain and stiffness.
3.Therapeutic effect of resveratrol on osteoarthritis of temporomandibular joint and its mechanism
Gao SUN ; Jing HE ; Qi ZHAO ; Jianhong SHI ; Zhiling LIAO ; Yuanye TIAN ; Guomin WU
Journal of Jilin University(Medicine Edition) 2024;50(6):1547-1556
Objective:To discuss the therapeutic effect of resveratrol on the temporomandibular joint osteoarthritis(TMJOA),and to clarify the related mechanism.Methods:Forty-five SD rats were randomly divided into control group,model group,and resveratrol group,and there were 15 rats in each group.The rats in model group and resveratrol group were intra-articularly injected with 50 μL of 20 g·L-1 monosodium iodoacetate(MIA)to set TMJOA rat models,while the rats in control group were injected with an equal volume of normal saline.Three weeks after modeling,the rats in resveratrol group received an injection of 80 μL resveratrol solution,once a week for three weeks,while the rats in control and model groups were injected with an equal volume of normal saline.Micro-computed tomography(Micro-CT)system was used to detect the condyle structure and the bone volume fraction(BV/TV),trabecular thickness(Tb.Th),trabecular spacing(Tb.Sp),and trabecular number(Tb.N)of the rats in various groups were calculated;HE staining and toluidine blue staining were used to observe the pathomorphology of temporomandibular joint(TMJ)tissue of the rats in various groups;immunohistochemistry was used to detect the expression levels of SRY-related HMG box(SOX)-9,matrix metalloproteinase(MMP)-13,silent information regulator(Sirt)1,phosphatidylinositol 3-kinase(PI3K),phosphorylated protein kinase B(p-Akt),and phosphorylated mammalian target of rapamycin(p-mTOR)in TMJ tissue of the rats in various groups;real-time quantitative PCR(RT-qPCR)method was used to detect the expression levels of SOX-9,MMP-13,Sirt1,PI3K,mTOR,and Akt mRNA in TMJ tissue of the rats in various groups.Results:Three weeks after modeling,condylar bone was destructed,the surface was roughness,and continuity interruption were observed,indicating TMJOA model of the rats was established successfully.The Micro-CT system results showed that the condylar surface of the rats in control group was smooth and regularly shaped,with continuous bone texture;the rats in model group had significant condylar destruction,disrupted continuity,surface roughness,and varying degrees of bone defects;the rats in resveratrol group showed alleviated condylar lesions and improved appearance.Compared with control group,the BV/TV and Tb.Th of the rats in model group were significantly decreased(P<0.05),and Tb.Sp was significantly increased(P<0.05);compared with model group,the BV/TV and Tb.Th of the rats in resveratrol group were significantly increased(P<0.05),and the Tb.Sp was significantly decreased(P<0.05).The HE staining results showed clear layers and orderly chondrocyte arrangement in condyle of the rats in control group;the rats in model group showed rough uneven surface,obvious defects,and typical TMJOA features;the rats in resveratrol group showed slightly rough surface with generally clear layers and orderly arranged cells.The toluidine blue staining results showed distinct blue-purple staining of chondrocytes in hypertrophic layer of the rats in control group;pale staining or even loss of staining in some areas of the rats in model group;and distinct and relatively uniform staining in hypertrophic layer of the rats in resveratrol group.The immunohistochemistry results showed that compared with control group,the expression levels of MMP-13,PI3K,p-Akt,and p-mTOR proteins in TMJ tissue of the rats in model group were significantly increased(P<0.05),while the expression levels of SOX-9 and Sirt1 proteins in TMJ tissue of the rats were significantly decreased(P<0.05);compared with model group,the expression levels of SOX-9 and Sirt1 proteins in TMJ tissue of the rats in resveratrol group were significantly increased(P<0.05),whereas the expression levels of MMP-13,PI3K,p-Akt,and p-mTOR proteins were significantly decreased(P<0.05).The RT-qPCR results showed that compared with control group,the expression levels of MMP-13,PI3K,Akt,and mTOR mRNA in TMJ tissue of the rats in model group were significantly increased(P<0.05),while the expression levels of SOX-9 and Sirt1 mRNA were significantly decreased(P<0.05);compared with model group,the expression levels of SOX-9 and Sirt1 mRNA in TMJ tissue of the rats in resveratrol group were significantly increased(P<0.05),whereas the expression levels of MMP-13,PI3K,Akt,and mTOR mRNA were significantly decreased(P<0.05).Conclusion:Resveratrol has therapeutic effect on TMJOA,and its mechanism may be related to the activation of Sirt1 and inhibition of the PI3K-Akt-mTOR signaling pathway.
4.Construction and validation of a predictive model for early occurrence of lower extremity deep venous thrombosis in ICU patients with sepsis
Zhiling QI ; Detao DING ; Cuihuan WU ; Xiuxia HAN ; Zongqiang LI ; Yan ZHANG ; Qinghe HU ; Cuiping HAO ; Fuguo YANG
Chinese Critical Care Medicine 2024;36(5):471-477
Objective:To investigate the risk factors of lower extremity deep venous thrombosis (LEDVT) in patients with sepsis during hospitalization in intensive care unit (ICU), and to construct a nomogram prediction model of LEDVT in sepsis patients in the ICU based on the critical care scores combined with inflammatory markers, and to validate its effectiveness in early prediction.Methods:726 sepsis patients admitted to the ICU of the Affiliated Hospital of Jining Medical University from January 2015 to December 2021 were retrospectively included as the training set to construct the prediction model. In addition, 213 sepsis patients admitted to the ICU of the Affiliated Hospital of Jining Medical University from January 2022 to June 2023 were retrospectively included as the validation set to verify the performance of the prediction model. Clinical data of patients were collected, such as demographic information, vital signs at the time of admission to the ICU, underlying diseases, past history, various types of scores within 24 hours of admission to the ICU, the first laboratory indexes of admission to the ICU, lower extremity venous ultrasound results, treatment, and prognostic indexes. Lasso regression analysis was used to screen the influencing factors for the occurrence of LEDVT in sepsis patients, and the results of Logistic regression analysis were synthesized to construct a nomogram model. The nomogram model was evaluated by receiver operator characteristic curve (ROC curve), calibration curve, clinical impact curve (CIC) and decision curve analysis (DCA).Results:The incidence of LEDVT after ICU admission was 21.5% (156/726) in the training set of sepsis patients and 21.6% (46/213) in the validation set of sepsis patients. The baseline data of patients in both training and validation sets were comparable. Lasso regression analysis showed that seven independent variables were screened from 67 parameters to be associated with the occurrence of LEDVT in patients with sepsis. Logistic regression analysis showed that the age [odds ratio ( OR) = 1.03, 95% confidence interval (95% CI) was 1.01 to 1.04, P < 0.001], body mass index (BMI: OR = 1.05, 95% CI was 1.01 to 1.09, P = 0.009), venous thromboembolism (VTE) score ( OR = 1.20, 95% CI was 1.11 to 1.29, P < 0.001), activated partial thromboplastin time (APTT: OR = 0.98, 95% CI was 0.97 to 0.99, P = 0.009), D-dimer ( OR = 1.03, 95% CI was 1.01 to 1.04, P < 0.001), skin or soft-tissue infection ( OR = 2.53, 95% CI was 1.29 to 4.98, P = 0.007), and femoral venous cannulation ( OR = 3.72, 95% CI was 2.50 to 5.54, P < 0.001) were the independent influences on the occurrence of LEDVT in patients with sepsis. The nomogram model was constructed by combining the above variables, and the ROC curve analysis showed that the area under the curve (AUC) of the nomogram model for predicting the occurrence of LEDVT in patients with sepsis was 0.793 (95% CI was 0.746 to 0.841), and the AUC in the validation set was 0.844 (95% CI was 0.786 to 0.901). The calibration curve showed that its predicted probability was in good agreement with the actual probabilities were in good agreement, and both CIC and DCA curves suggested a favorable net clinical benefit. Conclusion:The nomogram model based on the critical illness scores combined with inflammatory markers can be used for early prediction of LEDVT in ICU sepsis patients, which helps clinicians to identify the risk factors for LEDVT in sepsis patients earlier, so as to achieve early treatment.
5.Study of factors associated with the false-positive rate of second-trimester serological screening in 632, 825 cases in Sichuan based on propensity score matching
Zhiling WU ; Min OU ; Mengling YE ; Guangming DENG ; Yi DENG ; Xueyan WANG
Chinese Journal of Medical Genetics 2024;41(12):1432-1440
Objective:To retrospectively analyze the results of second-trimester serological prenatal screening and explore the factors which may influence the false-positive rate (FPR).Methods:From January 2013 to December 2022, false-positive samples with follow-up outcomes from 632, 825 second-trimester serological prenatal screening samples tested at Sichuan Provincial Maternity and Child Health Care Hospital were selected as the study group, while true-negative samples were 1 : 1 matched as the control group by propensity-score matching (PSM). Univariate and Multivariate Logistic Regression Models were used to analyze the influencing factors. The study has approved by the Medical Ethics Committee of the Sichuan Provincial Maternity and Child Health Care Hospital (Ethic No.20240607-270).Results:The study and control groups were each matched with 305, 998 cases. Univariate analysis showed that sampling season, the difference between ultrasound and gestational weeks calculated by last menstrual period (LMP), monthly median multiple of the median (mMoM) of alpha-fetoprotein (AFP), and monthly mMoM of free β-human chorionic gonadotropin (free β-hCG) were significantly different between the two groups ( P<0.05). Multivariate Logistic Regression analysis showed that winter ( OR=0.938; 95% CI: 0.893~0.985), monthly AFP mMoM ≥ 1.11 ( OR=0.846; 95% CI: 0.761~0.941), monthly free β-hCG mMoM ≤ 0.89 ( OR=0.827; 95% CI: 0.737~0.929) are protective factors for FPR increase, whilst spring ( OR=1.124; 95% CI: 1.072~1.179), summer ( OR=1.121; 95% CI: 1.062~1.183), the difference between ultrasound and gestational weeks calculated by LMP of 8~14 days ( OR=1.319; 95% CI: 1.241~1.402), > 14 days ( OR=1.689; 95% CI: 1.542~1.850), monthly AFP mMoM of 0.90~0.94 ( OR=1.088; 95% CI: 1.046~1.131), and monthly free β-hCG mMoM of 1.05~1.10 ( OR=1.046; 95% CI: 1.000~1.094), ≥ 1.11 ( OR=1.062; 95% CI: 1.002~1.126) are risk factors for FPR increase. Conclusion:Sampling season, difference between ultrasound and gestational weeks by LMP, monthly AFP mMoM, and monthly free β-hCG mMoM are risk factors for FPR during serological prenatal screening. Screening laboratories should look for the cause of abnormal FPR through such factors and adjust them accordingly.
6.Study of factors associated with the false-positive rate of second-trimester serological screening in 632, 825 cases in Sichuan based on propensity score matching
Zhiling WU ; Min OU ; Mengling YE ; Guangming DENG ; Yi DENG ; Xueyan WANG
Chinese Journal of Medical Genetics 2024;41(12):1432-1440
Objective:To retrospectively analyze the results of second-trimester serological prenatal screening and explore the factors which may influence the false-positive rate (FPR).Methods:From January 2013 to December 2022, false-positive samples with follow-up outcomes from 632, 825 second-trimester serological prenatal screening samples tested at Sichuan Provincial Maternity and Child Health Care Hospital were selected as the study group, while true-negative samples were 1 : 1 matched as the control group by propensity-score matching (PSM). Univariate and Multivariate Logistic Regression Models were used to analyze the influencing factors. The study has approved by the Medical Ethics Committee of the Sichuan Provincial Maternity and Child Health Care Hospital (Ethic No.20240607-270).Results:The study and control groups were each matched with 305, 998 cases. Univariate analysis showed that sampling season, the difference between ultrasound and gestational weeks calculated by last menstrual period (LMP), monthly median multiple of the median (mMoM) of alpha-fetoprotein (AFP), and monthly mMoM of free β-human chorionic gonadotropin (free β-hCG) were significantly different between the two groups ( P<0.05). Multivariate Logistic Regression analysis showed that winter ( OR=0.938; 95% CI: 0.893~0.985), monthly AFP mMoM ≥ 1.11 ( OR=0.846; 95% CI: 0.761~0.941), monthly free β-hCG mMoM ≤ 0.89 ( OR=0.827; 95% CI: 0.737~0.929) are protective factors for FPR increase, whilst spring ( OR=1.124; 95% CI: 1.072~1.179), summer ( OR=1.121; 95% CI: 1.062~1.183), the difference between ultrasound and gestational weeks calculated by LMP of 8~14 days ( OR=1.319; 95% CI: 1.241~1.402), > 14 days ( OR=1.689; 95% CI: 1.542~1.850), monthly AFP mMoM of 0.90~0.94 ( OR=1.088; 95% CI: 1.046~1.131), and monthly free β-hCG mMoM of 1.05~1.10 ( OR=1.046; 95% CI: 1.000~1.094), ≥ 1.11 ( OR=1.062; 95% CI: 1.002~1.126) are risk factors for FPR increase. Conclusion:Sampling season, difference between ultrasound and gestational weeks by LMP, monthly AFP mMoM, and monthly free β-hCG mMoM are risk factors for FPR during serological prenatal screening. Screening laboratories should look for the cause of abnormal FPR through such factors and adjust them accordingly.
7.Study of factors associated with the false-positive rate of second-trimester serological screening in 632,825 cases in Sichuan based on propensity score matching.
Zhiling WU ; Min OU ; Mengling YE ; Guangming DENG ; Yi DENG ; Xueyan WANG
Chinese Journal of Medical Genetics 2024;41(12):1432-1440
OBJECTIVE:
To retrospectively analyze the results of second-trimester serological prenatal screening and explore the factors which may influence the false-positive rate (FPR).
METHODS:
From January 2013 to December 2022, false-positive samples with follow-up outcomes from 632,825 second-trimester serological prenatal screening samples tested at Sichuan Provincial Maternity and Child Health Care Hospital were selected as the study group, while true-negative samples were 1 : 1 matched as the control group by propensity-score matching (PSM). Univariate and binary logistic regression models were used to analyze the influencing factors. This study was approved by the Medical Ethic Committee of Sichuan Provincial Maternity and Child Health Care Hospital (Ethic No. 20240607-270).
RESULTS:
The study and control groups were each matched with 305,998 cases. Univariate analysis showed that sampling season, the difference between ultrasound and gestational weeks calculated by last menstrual period (LMP), monthly median multiple of the median (mMoM) of alpha-fetoprotein (AFP), and monthly mMoM of free β -human chorionic gonadotropin (free β -hCG) were significantly different between the two groups (P < 0.05). Binary logistic regression analysis showed that Winter (OR = 0.938; 95%CI: 0.893 ~ 0.985), monthly AFP mMoM ≥ 1.11 (OR = 0.846; 95%CI: 0.761 ~ 0.941), monthly free β -hCG mMoM ≥ 0.89 (OR = 0.827; 95%CI: 0.737 ~ 0.929) are protective factors for FPR increase, whilst Spring (OR = 1.124; 95%CI: 1.072 ~ 1.179), Summer (OR = 1.121; 95%CI: 1.062 ~ 1.183), the difference between ultrasound and gestational weeks calculated by LMP of 8 ~ 14 days (OR = 1.319; 95%CI: 1.241 ~ 1.402), < 14 days (OR = 1.689; 95%CI: 1.542 ~ 1.850), monthly AFP mMoM of 0.90 ~ 0.94 (OR = 1.088; 95%CI: 1.046 ~ 1.131), and monthly free β -hCG mMoM of 1.05 ~ 1.10 (OR = 1.046; 95%CI: 1.000 ~ 1.094), ≥ 1.11 (OR = 1.062; 95%CI: 1.002 ~ 1.126) are risk factors for FPR increase.
CONCLUSION
Sampling season, difference between ultrasound and gestational weeks by LMP, monthly AFP mMoM, and monthly free β -hCG mMoM are risk factors for FPR during serological prenatal screening. Screening laboratories should look for the cause of abnormal FPR through such factors and adjust them accordingly.
Humans
;
Female
;
Pregnancy
;
Propensity Score
;
Pregnancy Trimester, Second/blood*
;
Retrospective Studies
;
China
;
False Positive Reactions
;
Adult
;
Prenatal Diagnosis/methods*
;
alpha-Fetoproteins/analysis*
;
Logistic Models
;
Chorionic Gonadotropin, beta Subunit, Human/blood*
8.Prognostic factors of spontaneous rupture hemorrhage in primary liver cancer
Yuanyuan TONG ; Zhiling GAO ; Longyun WU ; Chaoyun ZHAO ; Rong LU ; Hao YANG ; Changhao SUN ; Yong CHEN
Chinese Journal of Hepatobiliary Surgery 2023;29(5):343-348
Objective:To explore the independent influencing factors of patients with spontaneous rupture hemorrhage of primary liver cancer (PLC).Methods:A retrospective cohort study was conducted. The clinical data of 128 patients with PLC spontaneous rupture hemorrhage in Ningxia Medical University General Hospital from January 2017 to March 2022 were analyzed, including 108 males and 20 females, aged (53.4±10.6) years. According to different treatment, 128 patients were divided into liver resection group (LR, n=28), interventional group [ n=39, transcatheter arterial chemoembolization (TACE) and transcatheter arterial embolization (TAE)], and conservative group ( n=61). Univariate and multivariate Cox regression was performed to analyze prognostic factors. The LR and TACE groups were subdivided into LR (aLR, n=15), TACE/TAE (aTACE, n=33) and LR+ TACE ( n=19) groups. Kaplan-Meier analysis was performed, and the survival rate was compared by log-rank test. Results:The median survival time of LR group and TACE group was 23 months and 21 months, respectively, with no statistical significance ( P>0.05). The median survival time (38 months) in LR+ TACE group was significantly longer than that in aLR group (10 months) and aTACE group (9 months), and the difference was statistically significant ( P<0.05). Univariate analysis showed that Barcelona Clinical Liver Cancer (BCLC)staging, tumor length ≥10.0 cm, vascular invasion, α-fetoprotein ≥400 μg/L, total bilirubin, prothrombin time and treatment affected overall survival of PLC spontaneous rupture hemorrhage patients (all P<0.05). Multivariate analysis showed that BCLC staging, tumor length ≥10.0 cm, Child-Pugh grade and treatment were independent influencing factors for overall survival of PLC spontaneous rupture hemorrhage patients (all P<0.05). Conclusion:BCLC stage, tumor length ≥10.0 cm, Child-Pugh grade and treatment method are independent predictors of overall survival in patients with spontaneous rupture of PLC. LR combined with TACE therapy can improve the survival and prognosis of patients with spontaneous rupture of primary liver cancer.
9.Role of occupational satisfaction and occupational proactive behavior in the relationship between nurse occupational insecurity and work engagement
Mingyan YANG ; Mei YANG ; Dejian ZENG ; Mingli GUO ; Xuehua WU ; Zhiling WANG ; Mingjian ZHOU
Chinese Journal of Modern Nursing 2023;29(24):3296-3301
Objective:To explore the effect of job insecurity on work engagement, and examine the mediating role of job satisfaction and the moderating role of occupational proactive behavior.Methods:Using the convenient sampling method, nurses from Southern University of Science and Technology Hospital and Jiangyou Second People's Hospital were selected as the research objects in July 2022. General information questionnaire, Occupational Insecurity Scale, Occupational Satisfaction Scale, Work Engagement Scale and Occupational Proactive Behavior were used for questionnaire investigation. A total of 598 valid questionnaires were collected. Model 4 and Model 7 in the SPSS 22.0 Process were used to test the mediating effect and the moderated mediating effect respectively.Results:Occupational insecurity was negatively correlated with occupational satisfaction and work engagement ( r=-0.202, -0.165, P<0.01) , while occupational satisfaction was positively correlated with work engagement ( r=0.549, P<0.01) . Work satisfaction played a completely mediating role in the effect of job insecurity on work engagement (mediating effect value: -0.090 9, 95% confidence interval: -0.14 - -0.04) , accounting for 65.30% of the total effect. Occupational active behavior positively moderated the relationship between job insecurity and job satisfaction (β=0.07, P<0.01) . Conclusions:Nurses' work engagement is at a high level, but occupational insecurity will reduce nurses' job satisfaction and thus reduce their work engagement. Nurses with high occupational proactive behavior can alleviate the weakening of job insecurity on job satisfaction.
10.Comparison of efficacy and safety of generic versus original vildagliptin tablets in type 2 diabetes mellitus: a real world study
Zhiyong WEN ; Jiahao GUO ; Xueming YANG ; Xueqin LI ; Yu HE ; Bo JI ; Yinxiang SUN ; Hongyun LU ; Fangfang WEN ; Guifeng WANG ; Weipei WU ; Zhiling ZHOU
Adverse Drug Reactions Journal 2023;25(3):138-144
Objective:To compare the efficacy and safety of vildagliptin tablets (the generic drug) manufactured by Qilu Pharmaceutical Co., Ltd. and vildagliptin tablets (the original drug) manufactured by Novartis Pharmaceutical Co., Ltd. in the treatment of type 2 diabetes mellitus (T2DM) in third round of national centralized volume-based procurement.Methods:The study design was a multicenter retrospective cohort study. The study subjects were T2DM patients treated with vildagliptin tablets at the Outpatient Department of Zhuhai People′s Hospital, Zhongshan City People′s Hospital, Jiangmen Central Hospital, and General Hospital of Southern Theater Command of PLA from January 2020 to December 2021. Using the hospital electronic medical record system, medical records in outpatients who met the inclusion criteria were collected, and relevant clinical data were extracted. The patients were divided into generic drug group and original drug group. To exclude the interference of confounding factors, the propensity score matching method was used. The efficacy evaluation index was the magnitude of hemoglobin A1c (HbA1c) and fasting plasma glucose (FPG) reductions within one year after administration. Generalized linear regression model was used to analyze the influencing factors for the magnitude of HbA1c and FPG reduction. The safety evaluation index was the incidence of adverse events within one year of drug use.Results:A total of 4 511 patients with T2DM who were treated with vildagliptin tablets were collected from 4 hospitals, including 3 039 in the generic drug group and 1 472 in the original drug group. After treatment, the HbA1c and FPG in patients of the 2 groups decreased compared with those before treatment. The magnitude of HbA1c and FPG reductions in patients of the generic drug group were not significantly different from those in the original drug group [0.50 (0.05, 2.30)% vs. 0.90 (-0.10, 1.70)%, Z=0.235, P=0.814; 0.59 (-0.40, 2.20) mmol/L vs. 1.00 (-0.61, 2.32) mmol/L, Z=0.421, P=0.674]. The results of generalized linear regression model analysis showed that the therapeutic drugs did not affect the magnitude of HbA1c and FPG reductions ( P=0.627, P=0.478). Compared with the original drug group, the incidences of adverse events and hypoglycemia in the generic drug group were not statistically significant [1.6‰ (5/3 039) vs. 2.7‰ (4/1 472), P=0.721; 0.7 ‰ (2/3 039) vs. 0.7 ‰ (1/1 472), P=1.000]. Conclusion:The efficacy and safety of generic vildagliptin tablets manufactured by Qilu Pharmaceutical Co., Ltd. were generally consistent with those of the original drug in the treatment of T2DM.

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