1.Signal mining and analysis of adverse drug events of tirzepatide
Zeyu XIE ; Zhuoru LIANG ; Guimei ZHENG ; Weiling CAO ; Jisheng CHEN
China Pharmacy 2025;36(8):956-960
OBJECTIVE To identify and analyze adverse drug event (ADE) signals associated with tirzepatide based on the FDA Adverse Event Reporting System (FAERS) database, providing a reference for clinical medication safety. METHODS ADE reports from January 1, 2022, to June 30, 2024, with tirzepatide as the primary suspected drug, were extracted from the FAERS database. Medical Dictionary for Regulatory Activities was used to systematically categorize the selected system organ class (SOC) and preferred term of ADE. Signal mining and analysis were performed using the reporting odds ratio method and the proportional reporting ratio method. RESULTS A total of 39 229 ADE reports related to tirzepatide were obtained, including 3 934 severe ADE reports (10.03%). The majority of severe ADE reports were related to hospitalization or prolonged hospitalization (3.82%), involving 131 positive ADE signals. Among the reports with documented patient gender and age, 26 195 were female (66.77%), 7 869 were male (20.06%), and the majority of patients were aged 18-64 years (54.26%). The top three most frequently reported ADE were injection site pain, nausea, and injection site hemorrhage. Strong ADE signals not mentioned in the tirzepatide instruction included injection site coldness, starvation ketoacidosis, injection site hemorrhage, hunger, elevated adrenaline, injection site skin cracking, binge eating, skin laxity, intestinal sepsis, lack of satiety, and dysesthesia. Subgroup analysis for patient’s gender and age showed differences in the proportion of ADE reports across different SOC. Male patients or those aged≥65 years had a higher risk of gastrointestinal system disorders compared to female patients or those aged <65 years. CONCLUSIONS In clinical use of tirzepatide, in addition to monitoring ADE listed in the instruction, attention should also be paid to ADE not mentioned in the instruction, such as injection site coldness, starvation ketoacidosis, injection site hemorrhage, elevated adrenaline, and intestinal sepsis, to ensure patient safety.
2.Rapid health technology assessment of tirzepatide for diabetes mellitus type 2 and long-term weight management
Zeyu XIE ; Yinuo LIU ; Zhuoru LIANG ; Yaohua CAO ; Guimei ZHENG ; Weiling CAO
China Pharmacy 2025;36(9):1141-1146
OBJECTIVE To evaluate the efficacy, safety and cost-effectiveness of tirzepatide for diabetes mellitus type 2 (T2DM) and long-term weight management, and provide evidence-based basis for clinical drug treatment and health insurance policy formulation. METHODS Computer searches were conducted in Embase, PubMed, the Cochrane Library, CNKI and health technology assessment (HTA) official website from their inception to October 1st 2024 to collect HTA report, systematic review/ meta-analysis and pharmacoeconomic study on tirzepatide for the treatment of T2DM or for weight management. After data extraction and quality evaluation, descriptive analysis was performed on the research results. RESULTS Totally 18 papers were included, including 14 systematic reviews/meta-analyses and 4 pharmacoeconomics studies, and no HTA report was retrieved. In terms of efficacy, most results showed that the tirzepatide 10 mg and 15 mg were significantly better than other glucagon-like peptide-1 (GLP-1) receptor agonists in reducing glycosylated hemoglobin, body weight, and waist circumference (P<0.05). In terms of safety, compared with other GLP-1 receptor agonists, tirzepatide did not increase the incidence of gastrointestinal-related adverse events (AE), the incidence of AE of grade ≥3, or the incidence of severe hypoglycemia (P>0.05). However, tirzepatide 15 mg may significantly increased the incidence of hypoglycemia and the rate of discontinuation due to adverse reactions (P< 0.05). In terms of cost-effectiveness, based on the background of foreign pharmacoeconomic studies, tirzepatide was more cost- effective compared to semaglutide and liraglutide in the treatment of T2DM or for weight management. CONCLUSIONS Tirzepatide at doses of 10 mg and 15 mg has good efficacy and safety for the treatment of T2DM and for long-term weight management. However, when using the 15 mg dose of tirzepatide, close monitoring is required due to the risk of hypoglycemia and discontinuation due to adverse reactions it may pose. Based on pharmacoeconomic studies conducted abroad results, tirzepatide exhibits economic advantages.
3.Analysis of the changes and characteristics of TPO -Ab and TG -Ab in patients with type 2 diabetes
Weiling JU ; Shujun ZHENG ; Juan ZHANG ; Runlin CAO
Chinese Journal of Primary Medicine and Pharmacy 2018;25(15):1994-1997
Objective To study the changes and characteristics of TPO -Ab and TG-Ab in type 2 diaetic patients and provide new ideas for the diagnosis of diabetes.Methods From January 2014 to January 2017,160 samples in General Hospital of Taiyuan Iron&Steel (Group) Co.Ltd were selected,80 healthy people and 80 patients with type 2 diabetes,fasting venous 5 mL blood was obtained in the morning ,then electrochemical luminescence method was used to test TPO-Ab and TG-Ab contents.The diabetic patients were divided into four groups :TPO-Ab normal group,TPO-Ab elevation group,TG-Ab normal group,TG-Ab elevation group.The blood glucose,age and gender of the four groups were compared.Results Compared with the control group ,the proportions of increased TPO -Ab and TG-Ab in diabetic patients were 11.25%and 2.5%respectively,the difference was statistically significant (χ2=4.86,P<0.05).In type 2 diabetic patients,the blood glucose value of the normal TPO -Ab group was (6.67 ± 1.53)mmol/L,which in the TPO -Ab elevation group was (7.87 ±1.24) mmol/L,the difference was statistically significant (t=2.94,P<0.05).The blood glucose of the normal TG -Ab group was (6.75 ±1.34)mmol/L,which in the TG-Ab elevation group was (7.04 ±1.25)mmol/L,the difference was statistically significant (t=2.82,P<0.05).TPO-Ab and TG-Ab elevation had no obvious relation with age ,gender.The age of the normal TPO -Ab group was (62.1 ±6.3)years,which in the TPO-Ab elevation group was (63.0 ±4.9)years,there was no statisti- cally significant difference (t=1.37,P>0.05).The age of the normal TG -Ab group was (62.8 ±7.1)years,which in the TG-Ab elevation group was (61.6 ±2.7)years,the difference was not statistically significant (t=1.27,P>0.05).In male patients,TPO-Ab normal accounted for 84.09%,TPO-Ab rise accounted for 15.91%.In female patients,TPO-Ab normal accounted for 86.11%,TPO-Ab rise accounted for 13.89%,there was no statistically significant difference (χ2=1.20,P>0.05).In male patients,TG-Ab normal accounted for 97.73%,TG-Ab rise accounted for 2.27%, in female patients, TG -Ab normal accounted for 97.22%, TG -Ab rise accounted for 2.78%,there was no statistically significant difference (χ2=0.97,P>0.05).Conclusion TPO-Ab and TG-Ab in type 2 diabetes patients are higher than healthy people.The increase of TPO -Ab and TG -Ab is positively correlated with blood glucose level.The increase of TPO-Ab and TG-Ab is not correlated with age and gender.
4.Echocardiographic assessment of coronary artery Z scores in children with Kawasaki disease after 7-14 years
Jingjing ZHENG ; Bei XIA ; Weiling CHEN ; Hongkui YU ; Zhou LIN
Chinese Journal of Medical Imaging Technology 2018;34(4):538-542
Objective To assess long-term outcomes of coronary artery (CA) Z scores in children with Kawasaki disease (KD) with echocardiography.Methods Echocardiographic data of 100 KD children during 7-14 years interval follow-up were analyzed retrospectively.The children were divided into dilatation group (n =54,CA dilated) and non-dilatation group (n=46,CA not dilated) at the acute phase.Fifty one children were selected simultaneously as the controls (control group).Diameters and Z scores of left main coronary artery (LMCA),left anterior descending (LAD) and proximal right coronary artery (pRCA) were compared,and factors affecting CA diameter during the recovery phase were analyzed.Results CA diameters in dilatation group were larger than those in non-dilatation group and control group (all P<0.05),whereas no statistical difference of CA diameter was found between non-dilatation group and control group (all P>0.05).In dilatation group,Z score of LMCA,LAD and pRCA was 0.569 5 ± 1.061 6,0.420 (-0.029,1.078) and 0.640(0.283,1.250),while in non dilatation group,Z score of LMCA,LAD and pRCA was-0.0313±0.8467,-0.0662±0.6612 and 0.1887±0.5935,respectively.In control group,Z score of LMCA,LAD and pRCA was-0.1246±1.0167,-0.2558±1.0848 and 0.1943±0.6101,respectively.Z scores in dilatation group were larger than those in non-dilatation group and control group (all P<0.05),while no statistical differences of Z scores was found between nondilatation group and control group (all P>0.05).Dilation degree of CA at the acute phase was the factor affecting longterm CA dilation (odds ratio=39.146,P<0.001).Conclusion During 7-14 years of follow-up,CA diameters and Z scores kept to increase in KD children with CA dilatation at the acute phase.The dilation degree of CA at the acute phase in KD children affects the long-term CA dilation.
5.Performance verification and evaluation of 4 domestic chemiluminescence systems on 8 tumor mark-ers
Yan SHI ; Yancai WEI ; Weiling ZHENG ; Jialing WEI ; Miaoli SONG ; Gengchao ZHU ; Xun LU ; Chen YANG
Chinese Journal of Nuclear Medicine and Molecular Imaging 2018;38(12):801-804
Objective To validate the performance of 4 domestic chemiluminescence immunoassay (CLIA) systems on 8 tumor markers quantitative assay kits. Methods Four domestic CLIA systems were randomly marked as A, B, C, D and 8 tumor markers, including carbohydrate antigen (CA)125, CA15-3, CA19-9, ferritin (Fer), alpha-fetoprotein (AFP), carcinoembryonic antigen (CEA), prostate-specific an-tigen (PSA) and free PSA (fPSA) were determined. According to the standard of Clinical and Laboratory Standards Institute (CLSI), the precision, methodological comparison and analytical measure range of 4 systems were validated. Clinical serum samples were obtained from patients in Suzhou Hospital. According to the CLSI EP9-A3 protocol, imported equipment was used as the reference system. The biases of medical de-cision points were assumed, and Pearson correlation analysis and Spearman correlation analysis were used to analyze the data. Results The precision verification of CA125 and PSA on A, CA125 and AFP on B, CA125, CEA, AFP and PSA on C, and all 8 tumor markers on D could meet the laboratory quality control requirements. The correlations of the test results between A-D and the imported equipment were significant (all P<0.05) with the correlation coefficients 0.79-0.99, 0.47-0.99, 0.90-0.98 and 0.78-1.00, respec-tively, and the number of acceptable tests at the level of medical decision was 5, 2, 5, 4. All tests were certified to meet the analytical measure range validation. Conclusions The detection performance of 4 do-mestic CLIA systems for all 8 tumor markers are different. The performance of domestic CLIA systems should be tested when choosing one that can meet laboratory quality control requirements.
6.Development and application of CK-MB specific monoclonal antibodies.
Zimin CHEN ; Guoliang ZHOU ; Weiling XU ; Xiaohong ZHENG ; Xunzhang TONG ; Qishen KE ; Liuwei SONG ; Shengxiang GE
Chinese Journal of Biotechnology 2017;33(1):141-150
The aim of this study is to develop creatine kinase isoenzyme MB (CK-MB) specific monoclonal antibodies (mAb), and characterize the monoclonal antibody and further development of quantitative detection assay for CK-MB. The BALB/c mice were immunized with purchased CK-MB antigen, then monoclonal antibodies were prepared according to conventional hybridoma technique and screened by indirect and capture ELISA method. To identify the epitopes and evaluate the classification, purchased creatine kinase isoenzyme MB (CK-MM/BB/MB) antigen was used to identify the epitopes, with immunoblotting and synthetic CK-MM and CK-BB in different linear epitope. A double antibody sandwich ELISA was applied to screen the mAb pairs for CK-MB detection, and the quantitative detection assay for CK-MB was developed. We used 74 cases of clinical specimens for comparison of our assay with Roche's CK-MB assay. We successfully developed 22 strains of hybridoms against CK-MB, these mAbs can be divided into linear, partial conformational CK-MB, CK-MM or CK-BB cross monoclonal antibody and CK-MB specific reaction with partial conformational monoclonal antibody, and CK-MB quantitative detection assay was developed by using partial conformational monoclonal antibody. The correlation coefficient factor r of our reagent and Roche's was 0.930 9. This study established a screening method for CK-MB partial conformational specific monoclonal antibody, and these monoclonal antibodies were analyzed and an established quantitative detection assay was developed. The new assay had a high concordance with Roche's.
7.Detection situation of L-form bacteria in urinary calculi and drug resistance
Guoning LI ; Xiaoliang HUANG ; Weiling LIU ; Hangjia QIU ; Bin ZHENG
International Journal of Laboratory Medicine 2017;38(4):461-462
Objective To investigate the infection situation of L-form bacteria in urinary calculi from the patients with urolithia-sis in a hospital to provide a scientific basis for postoperative anti-infection and prevention of urinary stone recurrence.Methods The calculi samples in 265 cases of urinary calculi from October to December 2015 were collected and performed the culture of com-mon bacteria and L-form bacteria respectively.Culture of common bacteria and bacterial L-forms.Results Among 265 cases of uri-nary calculi ,8 cases(3% ,8/265) were L-form Bacterial combined with common bacterial infection ,only 7 cases(2.6% ,7/265) were L-form bacterial infection ,80 cases (30.0% ,80/265) were common bacterial infection.15 strains of L-form bacteria were detected and 96 strains of common bacteria were detected.The drug resistance of L-form bacteria was significantly increased compared with common bacteria.Conclusion The positive rate of L-form bacteria culture of urinary calculi is lower than other domestic reports. Adding hypertonic medium for conducting L-form bacterial isolation and culture in the patients with urinary tract infection can re-duce the false negative.
8.Nursing care of a patient with pancreatic cancer-related depression and postoperative delayed gastric emptying
Mingyan SHEN ; Qing LI ; Yanping ZHENG ; Weiling DAI
Chinese Journal of Nursing 2017;52(1):13-16
This paper summarized the experience of caring a patient with pancreatic cancer-related depression treated with pancreaticoduodenectomy and postoperative delayed gastric emptying.The nursing included several key points.On the base of collaboration of muhi-disciplinary teams,to strengthen supportive psychological intervention and safety management after admission;to use multimodal analgesia combined with cognitive behavioral therapy to reduce postoperative pain.After the patient was complicated with gastric emptying obstacles,solution-focus mode,sham feeding and nutritional support programs were implemented.Long-term follow-up with physician-nurse collaboration mode was implemented to enhance quality of life of the patient.
9.Relationship between exon 11 CAG triplet nucleotide repeats of myocyte enhancer binding factor-2A polymorphisms and ischemic stroke caused by large artery atherosclerosis
Feng WANG ; Zhongming YING ; Min ZHU ; Zhou ZHENG ; Xiaofei HU ; En WANG ; Changzhu WU ; Xinwei HE ; Weiling LI ; Cai LI ; Feng ZHU ; Xiaoping JIN
Chinese Journal of Neuromedicine 2017;16(12):1259-1264
Objective To investigate the relationship between exon 11 CAG triplet nucleotide repeats ([CAG]n) of myocyte enhancer binding factor-2A (MEF2A ) polymorphisms and ischemic stroke caused by large artery atherosclerosis (LAA). Methods Two hundred and five patients with first onset ischemic stroke caused by LAA, admitted to our hospital from June 2010 to December 2014, and 192 healthy controls were chosen in our study. The polymorphisms of exons 11 of MEF2A gene were genotyped by polymerase chain reaction-sequence-based typing (PCR-SBT). The relation of ischemic stroke caused by LAA with polymorphisms of (CAG)n was analyzed. Results Different (CAG)n alleles could be detected, with repeated sequences of 9-11. Frequencies for the different (CAG)n alleles in exon 11 CAG of MEF2A gene were not the same between the ischemic stroke patients and the controls (χ2=8.547, P=0.036). The distribution frequency of the (CAG)9 allele in the ischemic stroke group was significantly higher than that in the control group (χ2=6.650, P=0.010). Logistic regression analysis indicated that systolic pressure and (CAG)9 (OR=1.401, P=0.017, 95%CI: 1.063-1.847) were the independent risk factors of acute ischemic stroke caused by LAA. Conclusion The (CAG)n polymorphisms may be associated with ischemic stroke caused by LAA and the (CAG)9 allele may be one of the genetic susceptibility factors for this subtype of stroke.
10.Association of ADAMTS-1 gene polymorphisms with ischemic stroke caused by large artery atherosclerosis.
Chenling LYU ; Yawen CHEN ; Min ZHU ; Xiaoping JIN ; Peng LIU ; Zhou ZHENG ; Cai LI ; Feng ZHU ; Xiaofei HU ; Feng WANG ; Weiling LI ; Wanfeng WANG
Chinese Journal of Medical Genetics 2015;32(6):844-848
OBJECTIVETo assess the association of a disintegrin and metallo-proteinase with thrombospondin type 1 motifs (ADAMTS-1) gene polymorphism and ischemic stroke caused by large artery atherosclerosis (LAA).
METHODSIn total 767 patients and 506 controls were recruited. Single nucleotide polymorphisms (SNPs) rs416905 (T/C) and rs402007 (G/C) of the ADAMTS-1 gene were genotyped by polymerase chain reaction and DNA sequencing.
RESULTSFrequencies of the rs402007 GC+CC genotype and the C allele were significantly different between the two groups (68.84% vs. 60.67%, χ2=9.012, P=0.003, OR=1.432; 45.24% vs. 38.54%, χ2=11.208, P=0.001, OR=1.318). Binary logistic regression has confirmed that the above difference was significant (P=0.001, OR=1.521, 95%CI: 1.183-1.955). The frequencies of TC+CC and GC+CC genotypes were similar between the two groups, and so was it with the C allele. The two SNPs had been in complete linkage disequilibrium (D'=1.0, r2=1.0).
CONCLUSIONThe rs416905 and rs402007 polymorphisms of the ADAMTS-1 gene may be associated with ischemic stroke caused by LAA. The C allele of the rs402007 locus may be a susceptibility factor for this subtype of stroke.
ADAM Proteins ; genetics ; ADAMTS1 Protein ; Aged ; Alleles ; Atherosclerosis ; complications ; Base Sequence ; Blood Glucose ; metabolism ; Brain Ischemia ; complications ; Fasting ; blood ; Female ; Gene Frequency ; Genetic Predisposition to Disease ; genetics ; Genotype ; Humans ; Logistic Models ; Male ; Middle Aged ; Polymerase Chain Reaction ; Polymorphism, Single Nucleotide ; Risk Factors ; Sequence Analysis, DNA ; Smoking ; Stroke ; blood ; etiology ; genetics

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