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.Effect of age on endolymphatic hydrops in Meniere’s disease patients based on three-dimensional inversion-recovery with real reconstruction sequence imaging
Wei CHEN ; Yan SHA ; Weiling CHENG
Chinese Journal of Clinical Medicine 2025;32(2):195-199
Objective To analyze correlation of endolymphatic hydrops (EH) in the inner ear with age in Meniere’s disease (MD) patients. Methods A retrospective analysis were underwent in 101 definite unilateral MD patients. They were divided into young-age (<18 years old) group, middle-age (18-45 years old) group and elder-age (>45 years old) group. All patients underwent inner ear three-dimensional inversion-recovery with real reconstruction (3D-real IR) imaging 4 hours after intravenous gadolinium injection. EH rates among different groups were compared. Results The positive rates of EH in the young-age group, middle-age group and elder-age group were 68.2% (15/22), 54.5% (18/33) and 56.5% (26/46), respectively (P=0.567). There was no difference in the positive rates of EH in vestibule and cochlea among three groups. There was no difference in the rates of mild and significant EH in vestibule and cochlea among three groups. Conclusions Age might not be related to the occurrence of EH in the inner ear in MD patients.
3.Investigation and analysis of pharmaceutical management in compact medical consortium of Guangdong province
Xiaodan ZHU ; Xiao CHEN ; Weiling CAO ; Yuan ZENG ; Zuojing LU ; Xuejun LI ; Wenying CHEN
China Pharmacy 2024;35(4):390-394
OBJECTIVE To investigate the current situation of pharmaceutical management in compact medical consortium of Guangdong province, and to provide decision-making basis for promoting the high-quality construction and sustainable development of the provincial medical consortium. METHODS A self-designed questionnaire was used to select 50 compact medical consortiums in Guangdong province. The survey was answered by the heads of the pharmacy department of the general hospitals. The survey covered the basic scale of the consortium, the appointment of chief pharmacists, the implementation of pharmaceutical management and pharmaceutical care homogenization within the consortium, the difficulties in promoting the homogenization, and the expected provincial support. Descriptive statistical analysis was performed on the survey results. RESULTS A total of 50 questionnaires were collected, and the effective recovery rate was 100%. There were 16 chief pharmacists (32.00%) in charge of the pharmacy department of the general hospital in the medical consortium. Thirty-seven medical consortiums (74.00%) had established a drug supply support system within the consortium, 35 medical consortiums (70.00%) had carried out pharmaceutical management and coordination work within the medical consortium, 23 medical consortiums (46.00%) had established a clinical medication guidance system, 25 medical consortiums chenwenying2016@163.com (50.00%) had established a bidirectional communication mechanism, and only 8 medical consortiums (16.00%) had developed new models of pharmaceutical care. At present, the difficulties in promoting the homogenization of pharmaceutical management and pharmaceutical care within the medical consortium were mainly found in three aspects: the wide gap in management level of each member unit, the lack and uneven level of pharmaceutical personnel, and insufficient policy support and implementation. Most medical consortiums hoped that relevant departments could promote the homogenization of pharmaceutical work by holding special training courses or special supervision. CONCLUSIONS At present, the compact medical consortium in Guangdong province has achieved initial results in the implementation of the chief pharmacist system, the homogenization of pharmaceutical management and pharmaceutical care. However, it is still necessary to improve the coverage of chief pharmacist appointments in the medical consortium, implement the homogenization of pharmaceutical management, and accelerate the homogenization process of pharmaceutical care.
4.Construction of nursing quality standard in bone oncology department
Weiling ZHANG ; Xiaomin HUANG ; Qian WANG ; Sushuang CHEN ; Xiaolin CAI ; Tianwen HUANG ; Yuan GAO
Chinese Journal of Practical Nursing 2024;40(9):701-709
Objective:To establish the standard of nursing quality in bone oncology department, and provide the basis for scientific evaluation of nursing quality in bone oncology department.Methods:On the theoretical basis of Donabedian′s three-dimensional quality model of "structure-process-outcome", and through literature review and semi-structured interview method, the "evaluation index of nursing quality in bone oncology department" was preliminatively formulated from November 2022 to June 2023. The Delphi method was used to select 31 experts from 31 third-level A hospitals and nursing colleges in 27 provinces or municipalities across the country for two rounds of correspondence consultation. The criteria were screened and modified to determine the evaluation criteria of nursing quality in bone tumor specialty.Results:The questionnaire recovery rate of 2 rounds of expert consultation was 100.00%, the authority coefficient of 2 rounds of expert consultation was 0.93, and the coefficient of variation of 1, 2 and 3-grade standards were all less than or equal to 0.25. The Kendall′s coefficient of concordance of the primary standards of the two rounds of expert consultation were both 0.088, in the secondary standards were 0.103 and 0.140, in the tertiary standards were 0.119 and 0.110. Through 2 rounds of expert letter consultation, the evaluation criteria for the quality of care in bone tumor specialties were divided into three levels, including 3 primary standards (structural quality criteria, process quality criteria and outcome quality criteria), 21 secondary standards and 80 tertiary standards.Conclusions:The construction process of nursing quality standard in bone oncology department is scientific and reliable, reflecting specialty characteristics, and can provide scientific basis for the evaluation of nursing quality in bone oncology department and standardize nursing behavior.
5.Population genetics analysis of Oncomelania hupensis in Jiaxing, Zhejiang Province, 2022
Weiling GU ; Hanqi PENG ; Hanxiang ZHANG ; Zelin XIANG ; Zhongwen CHEN ; Xiaofei FU ; Yunpeng QI ; Liang XIE ; Jie HU ; Dabing LYU
Shanghai Journal of Preventive Medicine 2024;36(6):559-562
ObjectiveTo genotype Oncomelania hupensis, based on microsatellites, in different snail-bearing environments in Jiaxing City, Zhejiang Province, for population genetics analysis in order to explore the reasons and influencing factors for the existence or proliferation of snails and to provide scientific basis for effective monitoring and control of snails. MethodsA total of 90 snail samples from three populations were collected in Yaobang Village (YB) and Sanxing Village (SX) in Pinghu City, and Yunhe Farm (YH) in Xiuzhou District, all were selected for snail checking in key snail habitats of Jiaxing City in 2022. DNA of the snails was genotyped and analyzed for population genetics using nine microsatellite loci. ResultsA total of 84 alleles were observed, and the mean number of alleles (Na) was 7.889, 5.667, and 3.778 for YB, SX, and YH respectively; the number of effective alleles (NeA) was 4.807, 3.329, and 2.294, respectively; and the coefficients of inbreeding (FIS) were 0.400, 0.377, and 0.493, respectively. Under the Infinite Allele Model (IAM), the SX and YH might have a recent bottleneck. The NEstimator and LDNe software calculated effective population sizes (Ne) were above 31.9. AMOVA analysis showed that the variation of snails in the three populations mainly existed among individuals, accounting for 41.4% of the total variation. The value of the index of genetic differentiation between populations (FST) was 0.286, indicating a high degree of genetic differentiation. The results of the principal component analysis and phylogenetic tree were consistent, and the three populations were divided into two lineages, YB and SX were one lineage, and YH belonged to another independent lineage. Population history and dynamics analysis showed that the gene flow of the three populations was insufficient, population divergence history indicated that YH might have diverged from SX first, and YB was produced by the contact fusion of SX and YH. ConclusionThe genetic diversity of snail populations in Jiaxing City is generally low, and the snail populations are unstable, with a great degree of genetic differentiation and insufficient gene flow among populations. This study can provide a basis for evaluating the effectiveness of the control of the snail as well as monitoring the trend of the spread of the snail.
6.Magnifying endoscopy combined with narrow-band imaging,acetate-indigo rouge staining combined with multi-slice spiral CT in the diagnosis of early gastric cancer and precancerous lesions and clinical significance
Liang YANG ; Zhihua FENG ; Weiling MA ; Weifeng MA ; Shuai CHEN ; Lixia ZHANG ; Jihai WU
China Journal of Endoscopy 2024;30(2):9-16
Objective To analyze the diagnostic efficacy and clinical significance of magnifying endoscopy combined with narrow-band imaging(ME-NBI),acetate-indigo rouge staining and multi-slice spiral CT for early gastric cancer and precancerous lesions.Methods 202 patients with suspected early gastric cancer and precancerous lesions from February 2019 to March 2022 were regarded as the subjects of this study,all the patients underwent ME-NBI,acetate-indigo rouge staining,and multi-slice spiral CT examination;The diagnostic value of different examination methods for early gastric cancer and precancerous lesions was analyzed using the receiver operator characteristic curve(ROC curve),using the pathological results of gastric cancer as the gold standard,the diagnostic value of ME-NBI,acetate-indigo rouge staining combined with multi-slice spiral CT and their combination in early gastric cancer and precancerous lesions was analyzed using a four grid table.Results The image quality of ME-NBI and acetate-indigo rouge staining combined examinations was significantly higher than that of their respective independent examinations(P<0.05).There was significant difference in the degree of differentiation in the clinical features of patients with early gastric cancer and precancerous lesions(P<0.05).The area under the curve(AUC)of ME-NBI for the diagnosis of early gastric cancer and precancerous lesions was 0.853,the accuracy was 85.64%,the sensitivity was 88.37%,and the specificity was 83.62%.The AUC of acetate-indigo rouge staining for the diagnosis of early gastric cancer and precancerous lesions was 0.814,the accuracy was 81.68%,the sensitivity was 83.72%,and the specificity was 80.17%.The AUC of multi-slice spiral CT for the diagnosis of early gastric cancer and precancerous lesions was 0.804,with an accuracy of 80.69%,a sensitivity of 82.56%,and a specificity of 79.31%.And the AUC of the three methods combined to diagnose early gastric cancer and precancerous lesions was 0.893,with an accuracy of 89.60%,a sensitivity of 93.02%,and a specificity of 87.07%.Conclusion ME-NBI,acetate-indigo rouge staining combined with multi-slice spiral CT has high diagnostic efficacy in early gastric cancer and precancerous lesions,and can be used in clinical practice.
7.Construction and practice of an informatization management system for institutional ethical review
Luyuan ZHANG ; Chong LI ; Zhiyong DENG ; Hongying LI ; Xiaoxu ZHU ; Min CHEN ; Weiling LYU ; Mo ZHOU
Chinese Medical Ethics 2024;37(2):219-223
With the progress of society,the global development of scientific and technical research activities,and the increasing number of medical Institutional Review Board(IRB)review projects,the construction and management of electronic informatization have become extremely important.In the process of electronic information construction in institutional ethics review,it is necessary to take into account the new policy of ethical governance of science and technology,consider the system and standard operating procedures of IRB,and develop reasonable processes based on practical work,simplify manual operation,improve the accuracy of project management,achieve refined management,and facilitate communication among researchers,ethics committee secretaries,and members.
8.Shear wave elastography for evaluating hepatic iron overload in children with β-thalassemia major:Correlations with MR T2* value and serum ferritin
Murong CHEN ; Tingting LIU ; Weiling CHEN ; Yafang SUN ; Sixi LIU ; Bei XIA
Chinese Journal of Medical Imaging Technology 2024;40(1):73-76
Objective To observe the value of shear wave elastography(SWE)for evaluating hepatic iron overload in children with β-thalassemia major(β-TM),as well as the correlations of relative parameters with MR T2*value and serum ferritin.Methods Totally 96 children with β-TM and 100 healthy children(control group)were retrospectively enrolled.Children with β-TM were divided into hematopoietic stem cell transplantation(HSCT)group(n=41)or non-HSCT group(n=55)according to underwent HSCT or not.SWE parameters were compared among groups.Spearman correlation was performed to observe the correlations of liver shear wave velocity with MR T2*value and serum ferritin,as well as Young's modulus with MR T2*value and serum ferritin in children with β-TM.Results Liver shear wave velocity(LSWV)and Young's modulus in HSCT group and non-HSCT group were all higher than those in control group(all P<0.001).No significant difference of LSWV nor Young's modulus was found between HSCT group and non-HSCT group(both P>0.05).SWE parameters of children with β-TM were moderately and negatively correlated with MR T2*value(r=-0.501,P<0.05;r=-0.514,P<0.05),while weakly and positively correlated with serum ferritin(r=0.488,P<0.05;r=0.470,P<0.05).Conclusion SWE was helpful for evaluating hepatic iron overload in children with β-TM,with parameters being negatively correlated with MR T2*value and positively correlated with serum ferritin.
9.Clinical application of parasacral artery perforator flap in the treatment of Pilonidal Sinus Diseases
Junhong LAN ; Zhaohong CHEN ; Yueying FAN ; Lu HAN ; Tao WANG ; Chiyu JIA ; Weiling HE
Chinese Journal of Gastrointestinal Surgery 2024;27(9):970-973
Objective:To investigate clinical efficacy of parasacral perforator flap (PPF) on postoperative wound healing in pilonidal sinus diseases (PSDs).Methods:The surgery steps were as follows: (1) To preoperatively detect parasacral perforator arteries with the handhold Doppler probe and mark them; (2) To remove the infected and necrotic tissues of PSDs completely; (3) To design the PPF according to the wound size and the parasacral perforator arteries' localization; (4) To harvest the flap from the gluteus maximus muscle surface and transfer it to the wound without tension. Several data were documented, including surgical duration, flap length, flap width, drainage tube placement duration, hospital stay, duration from operation to stitch removal, postsurgical complications and recurrence.Results:There were six patients with PSDs whose postoperative wound healing was repaired by PPF, admitted in our department from March 2021 to March 2023. Of them, five were male and one was female. Their median age was 24 (range: 18-33) years old. Their median surgical duration was 165 (range: 134-207) minutes, median length of PPF was 8 (range: 7-11) cm, median width of PPF was 3 (range: 3-4) cm, mean duration of drainage tube placement was 8 (range: 4-17) days, mean hospital stay was 13 (range: 6-23) days, mean duration from operation to stitch removal was 14 (range: 14-17) days, median follow-up time was 6-16 months. Incisions of all six cases achieved first-intention healing without early- or late-stage complications. No recurrence occurred during follow-up. All patients involved were satisfied with their clinical efficacy.Conclusion:The utility of PPF in postoperative wound healing of PPDs was effective, safe and reliable.
10.Clinical application of parasacral artery perforator flap in the treatment of Pilonidal Sinus Diseases
Junhong LAN ; Zhaohong CHEN ; Yueying FAN ; Lu HAN ; Tao WANG ; Chiyu JIA ; Weiling HE
Chinese Journal of Gastrointestinal Surgery 2024;27(9):970-973
Objective:To investigate clinical efficacy of parasacral perforator flap (PPF) on postoperative wound healing in pilonidal sinus diseases (PSDs).Methods:The surgery steps were as follows: (1) To preoperatively detect parasacral perforator arteries with the handhold Doppler probe and mark them; (2) To remove the infected and necrotic tissues of PSDs completely; (3) To design the PPF according to the wound size and the parasacral perforator arteries' localization; (4) To harvest the flap from the gluteus maximus muscle surface and transfer it to the wound without tension. Several data were documented, including surgical duration, flap length, flap width, drainage tube placement duration, hospital stay, duration from operation to stitch removal, postsurgical complications and recurrence.Results:There were six patients with PSDs whose postoperative wound healing was repaired by PPF, admitted in our department from March 2021 to March 2023. Of them, five were male and one was female. Their median age was 24 (range: 18-33) years old. Their median surgical duration was 165 (range: 134-207) minutes, median length of PPF was 8 (range: 7-11) cm, median width of PPF was 3 (range: 3-4) cm, mean duration of drainage tube placement was 8 (range: 4-17) days, mean hospital stay was 13 (range: 6-23) days, mean duration from operation to stitch removal was 14 (range: 14-17) days, median follow-up time was 6-16 months. Incisions of all six cases achieved first-intention healing without early- or late-stage complications. No recurrence occurred during follow-up. All patients involved were satisfied with their clinical efficacy.Conclusion:The utility of PPF in postoperative wound healing of PPDs was effective, safe and reliable.

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