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Progress in the application of real-world data in post-market surveillance of medical devices TENG Yingying, LI Chaiquan, XU Yang, TANG Xun, GAO Pei 2022, 19(3): 233-238.  DOI: 10.19803/j.1672-8629.2022.03.01 Abstract ( 404 )   PDF (3171KB) ( 294 )   Objective To summarize the progress of applying real-world data in medical device post-market surveillance, so as to provide supervision basis for medical device supervision and management department. Methods Relevant regulation and guidance documents were searched on the NMPA, FDA and EU official website, and relevant literatures were also searched. Results Regulatory agencies from different countries successively issued and updated the guidelines for the application of real-world data. The development of the technologies, such as unique device identification, common data models, and distributed health data networks, helped link multiple data sources to form a larger database. Natural language processing technology also promoted the application of electronic medical records/health data in post-market surveillance. More and more registry data, as well as the data recorded by digital health and wearable devices, provided post-market surveillance extra data source that was different from traditional databases for collecting adverse events. The algorithms to detect safety signal automatically improved the efficiency and immediacy of the medical device post-market surveillance. Conclusion The increasing availability of real-world data sources and the development of automatic detection technologies have promoted the application of real-world data in post-market monitoring of medical devices. References | Related Articles | Metrics

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Bias and control in the monitoring and evaluation of post-marketing drug using the medical big data WANG Li, WANG Xiaomo, YANG Chenlu 2022, 19(3): 239-243.  DOI: 10.19803/j.1672-8629.2022.03.02 Abstract ( 300 )   PDF (1202KB) ( 452 )   Objective To introduce the current situation, existing bias and possible control methods of post-marketing drug monitoring and evaluation research based on medical big databases at home and abroad, suggesting references for drug risk monitoring and management in China. Methods The specific practices of post-marketing drug monitoring and evaluation based on medical big data in the developed countries were systematically summarized, and the gaps in China were analyzed. The bias and control in research design, data collection, and statistical analysis were evaluated. In addition, the opportunities and challenges facing our country at present were assessed. Results and Conclusion The developed countries have established efficient and sustainable post-marketing monitoring and vigilance systems based on medical big data. Full consideration and control of potential bias in study design, implementation, and statistical analysis are necessary to determine the causal relationship between drugs and adverse reactions. We should learn from European and American advanced experience, improve and integrate existing medical big data, and carry out research on pharmacoepidemiology. References | Related Articles | Metrics

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Threshold setting of biochemical indexes related to diagnosis of drug-induced liver injury NIE Xiaolu, PENG Yaguang, SUN Zimo, PENG Xiaoxia 2022, 19(3): 244-247.  DOI: 10.19803/j.1672-8629.2022.03.03 Abstract ( 262 )   PDF (1192KB) ( 301 )   Objective To investigate the currently-used biochemical thresholds related to the diagnosis of drug-induced liver injury (DILI) in order to provide reference for monitoring of adverse drug reactions. Methods Based on the newly released guidelines for clinical diagnosis and treatment, expert consensus and health industry standards of DILI at home and abroad, the latest classification of pathogenesis of DILI and the establishment of thresholds of biochemical indicators related to diagnosis were summarized. Results The current international biochemical diagnostic criteria for DILI were determined as follows: ①ALT≥5×ULN; ②ALT≥3×ULN, TBL > 2×ULN, without ALP elevation; ③ALP≥2×ULN, especially with 5'- nucleotide enzyme elevation, but without any bone disease (ALP elevation is caused by the liver). The reference intervals of biochemical test indexes related to the diagnosis of DILI were age-dependent in children. Conclusion In DILI-related studies, especially those for children, the thresholds of DILI-related biochemical indicators should be determined by the reference interval corresponding to each age group in order to make outcome judgment more accurate. References | Related Articles | Metrics

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Gender differences in adverse reactions in high-dose glucocorticoids in mice WEI Kezhao, WU Huan, ZHANG Zixu, FENG Jiahua, GAO Jianping 2022, 19(3): 248-251.  DOI: 10.19803/j.1672-8629.2022.03.04 Abstract ( 175 )   PDF (1399KB) ( 214 )   Objective To study the effects of high-dose glucocorticoid on the general condition, immune organs and endocrine system in mice of different sexes. Methods Male and female mice were randomly divided into control group and cortisol group (50 mg·kg-1 each time, 2 times/d), and were intramuscularly injected with saline or cortisol for 14 days, respectively. The body weight was measured once every 3 days throughout the experiment, and the body temperature, voluntary activity times and swimming time after 7 days off the medication were measured. After 9 days off the medication, blood samples were taken, immune organs and sexual organs were separated and weighed and then their indexes were calculated, MDA content was measured by TBA method, and SOD activity was measured by hydroxylamine method, estradiol level in female mice and testosterone level in male mice were measured by ELISA methods in serum. Results Compared with the control group, the weight of mice was significantly lower from the fourth day of intramuscular cortisol (P<0.05 or P<0.01), the male mice lost more weight than the female mice, and the weight of the male group did not recover after drug withdrawal of the cortisol group. The time of swimming and times of voluntary movement were significantly decreased (P<0.05), the spleen mass and its index, testis index of male mice were significantly increased (P<0.05 or P<0.01), the thymus mass and its index, epididymis and prostate mass and index were significantly decreased (P<0.05 or P<0.01), the adrenal gland and seminal vesicle were not significantly changed of male mice in the cortisol group. The ovary mass and its index were significantly decreased (P<0.05), the mass and index of spleen, thymus, adrenal gland and uterus were not significantly changed of female mice in the cortisol group. The level of serum testosterone in male mice and estradiol in female mice were slightly decreased by cortisol, but there was no significant difference between them. Conclusion After long-term high dose administration in mice, cortisol can affect the general condition of mice, cause abnormal immune and endocrine organs, and have a tendency to reduce the secretion of sex hormones, especially in male mice. References | Related Articles | Metrics

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Network pharmacology of dendrobium alkaloids against cerebral ischemia-reperfusion injury LIU Xiaoli, LIU Shengwei, LIAO Yuan, ZENG Fanping, LIU Jie 2022, 19(3): 252-258.  DOI: 10.19803/j.1672-8629.2022.03.05 Abstract ( 137 )   PDF (3256KB) ( 77 )   Objective To study the mechanism by which dendrobium alkaloids combats cerebral ischemia-reperfusion injury based on network pharmacology. Methods The databases Pharmamapper and BATMAN-TCM were used to predict dendrobium alkaloids targets, and disease targets associated with cerebral ischemia-reperfusion injury (CIRI) were acquired via the GeneCards database. VENNY2.1.0 was used to map the potential targets of dendrobium alkaloids acting on CIRI before the potential targets were imported to Cytoscape3.8.2 software so as to construct a PPI network. Finally, the R package clusterProfiler was used for GO enrichment analysis and KEGG pathway analysis. Results A total of 214 dendrobine-related targets and 513 cerebral ischemia-reperfusion injury-related targets were found, 58 of which were intersection targets. After PPI analysis, the top ten core target genes were ALB, MAPK1, MAPK8, CASP3, IGF1, SRC, NOS3, MMP2, HSP90AA1 and ESR1. Based on the analysis of KEGG enrichment pathways, 14 significant pathways were obtained, including the Rap1 signaling pathway, MAPK signaling pathway and chemokine signaling pathway. Conclusion Dendrobium alkaloids can treat CIRI through multiple targets and multiple pathways, and may play a role in resisting cerebral ischemia-reperfusion injury mainly by means of inflammation and apoptosis. References | Related Articles | Metrics

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Influence of miR-205-5p targeting eIF4E on proliferation, invasion and epithelial-mesenchymal transition of MCF-7 cells ZHANG Naxian, LIU Liu, LI Gang, LIU Linrui, LI Yuanying 2022, 19(3): 259-264.  DOI: 10.19803/j.1672-8629.2022.03.06 Abstract ( 54 )   PDF (2476KB) ( 57 )   Objective To investigate the influence of micro ribonucleic acid-205-5p (miR-205-5p) targeting eukaryotic initiation factor 4E (eIF4E) on the proliferation, invasion and epithelial-mesenchymal transition of human breast cancer MCF-7 cells so as to provide reference for the development of new targeted therapeutic drugs against mammary cancer (MC). Methods MCF-7 cells were cultured, and miR-205-5p was transfected into mimic-NC and miR-205-5p mimic to verify the targeting relationship between miR-205-5p and eIF4E. Meanwhile, the cultured MCF-7 cells were divided into the control group (normally cultured MCF-7 cells), mimic-NC group, pcDNA group, miR-205-5p mimic group, miR-205-5p group, eIF4E-pcDNA group, and miR-205-5p+eIF4E-pcDNA group. The effect of miR-205-5p targeting eIF4E on the proliferation, migration and epithelial-mesenchymal transition of MCF-7 cells was analyzed. Results The relative expression level of miR-205-5p was significantly higher in the miR-205-5p mimic group than in the control group and mimic-NC group, while the mRNA expression level of eIF4E was significantly lower (P<0.05). The luciferase activity (R/F ratio) of eIF4E wild-type and mimic positive group was lower. The relative expressions of eIF4E protein and mRNA were significantly higher in the eIF4E-pcDNA group than in the control group and pcDNA group (P<0.05). The positive rate of MCF-7 cells, colony distribution rate, Ki67 and PCNA protein expression levels in the miR-205-5p group were significantly lower than those in the control group, eIF4E-pcDNA group, and miR-205-5p+eIF4E-pcDNA group (P<0.05). The positive rate and number of aggressive cells in the miR-205-5p group were significantly lower or smaller than those in the control group, miR-205-5p+eIF4E-pcDNA group, and eIF4E-pcDNA group (P<0.05), but the number of aggressive cells was the largest in eIF4E-pcDNA group. The positive expression rates and protein expression levels of the epithelial mesenchymal markers E-Cadherin, N-Cadherin, and Vimentin of MCF-7 cells were significantly lower in the miR-205-5p group than in the control group, miR-205-5p+eIF4E-pcDNA group, and eIF4E-pcDNA group (P<0.05), but significantly higher in the eIF4E-pcDNA group than in the other groups (P<0.05). Conclusion miR-205-5p can effectively inhibit the proliferation, invasion and epithelial-mesenchymal transition of human breast cancer MCF-7 cells by negatively targeting eIF4E, which is expected to provide reference for the development of new gene-targeted therapeutic drugs against MC. References | Related Articles | Metrics

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Single dose toxicity of Ficus microcarpa in mice GAO Zhanwang, ZHANG Xin, MO Zunhui, WANG Lingli, YI Zhibiao 2022, 19(3): 265-269.  DOI: 10.19803/j.1672-8629.2022.03.07 Abstract ( 173 )   PDF (1952KB) ( 70 )   Objective To study the changes of indexes of pathology, hematology and biochemistry under single-dose toxicity in mice treated with a median lethal dose (LD50) or maximum tolerance dose (MTD) of Ficus microcarpa so as to evaluate the safety of Ficus microcarpa. Methods In LD50 tests, the mice were randomly divided into 6 groups and given by gavage different doses of Ficus microcarpa. The general condition of mice and the morphological changes of viscera were observed after 7 days. In MTD experiments, the mice were randomly divided into 3 groups and given three times by gavage different drugs at different doses. The changes in toxic reactions and in hematological and biochemical indexes were observed and recorded within 14 days. Results There was no death of mice in LD50 tests, suggesting that LD50 could not be calculated. The MTD was calculated as 70.4 g·kg-1 by the crude dose. In addition, histopathological observations revealed that the organs of mice in each group did not exhibit pathological reactions. And compared with the blank control group and the equivalent dose group, there was no statistical difference in hematological or biochemical index in the maximum tolerance dose group (P>0.05), and no obvious acute toxic reactions or death caused by Ficus microcarpa were observed. Conclusion Ficus microcarpa is quite safe. References | Related Articles | Metrics

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VigiRank prediction model of Uppsala monitoring center CHEN Chao, ZHAO Yunfei, WANG Changzhi, GONG Lixiong, LIU Wei 2022, 19(3): 270-274.  DOI: 10.19803/j.1672-8629.2022.03.08 Abstract ( 272 )   PDF (1246KB) ( 201 )   Objective To outline the principles, processes and applications of the vigiRank signal detection method in Uppsala Monitoring Centre (UMC) so as to provide reference for the establishment and improvement of pharmacovigilance signal detection statistics in China. Methods Scopus, Web of Science, PubMed and other databases were searched for the purpose of literature research, and the UMC official website was consulted to analyze the workflow and application of the vigiRank prediction model. Results VigiRank,a signal detection method developed by UMC, combined multiple strength-of-evidence aspects of adverse drug reaction (ADR) reports, including Informative reports (INF), Narrative (NAR), Dechallenge (DCH), Rechallenge (RCH), Causality assessment (CAU and CAU+), Time-to-onset (TTO), Sole reporting (SOL), Multiple reporting elements (MUL), Resultsreporting (REC), Disproportional reporting (DIS), Geographic spread (GEO), and Time trend (TRE). According to the lasso-logistic model, five predictive variables were included in the vigiRank score system and the vigiRank score of a drug-ADR pair was calculated. An expert team conducted a preliminary evaluation in the descending order of scores, and chose drug-ADR pairs that needed to be further analyzed before they conducted an in-depth evaluation and finally screened out risk signals. Conclusion VigiRank has taken into account the number and quality of ADR reports, and is able to identify early signs of harm from drugs, which is of great referential value for improving the detection methods of ADR signals in China. References | Related Articles | Metrics

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Characteristics of dear health care provider letters in Europe and America LIANG Jiaqi, SHAO Rong, LIU Pengcheng, LI Ming, RENG Jingtian, TANG Ren, WANG Yue 2022, 19(3): 275-278.  DOI: 10.19803/j.1672-8629.2022.03.09 Abstract ( 381 )   PDF (1251KB) ( 448 )   Objective To give advice on risk communication methods related to Dear Health Care Provider Letters in China. Methods The difference in the initiation, implementation process, and effectiveness evaluation of Dear Health Care Provider Letters was analyzed by reviewing the related guidelines and regulations for the implementation of Dear Health Care Provider Letters in Europe and the United States. Results There was difference in specific classification, initiation, and details of Dear Health Care Provider Letters in Europe and the United States, which could serve as reference for China. Conclusion It is recommended that China start Dear Health Care Provider Letters, issue relevant guidelines and specify the details. References | Related Articles | Metrics

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Current applications of pharmacovigilance in medications during pregnancy LU Yanan, BAI Ruixue, YANG Yuehui 2022, 19(3): 279-282.  DOI: 10.19803/j.1672-8629.2022.03.10 Abstract ( 336 )   PDF (1196KB) ( 400 )   Objective To explore the current applications of pharmacovigilance in drug therapies during pregnancy. Methods The developments of pharmacovigilance in different countries and regions were summarized. The characteristics of common medications in pregnant populations were analyzed. According to the characteristics of safe medications during pregnancy, the related adverse reactions were investigated, the patterns of safe medications were explored, and the applications of pharmacovigilance during pregnancy were discussed. Finally, suggestions for improving pharmacovigilance during pregnancy were offered. Results In recent years, pharmacovigilance at home and abroad developed rapidly in order to better evaluate drug safety and guide clinical use. Different countries and regions established corresponding pharmacovigilance systems. The pregnant were a special medication group. Due to various needs, medications were common during pregnancy. Changes in the physiological and psychological status of pregnant women during could directly affect the efficacy of medications. The incidence of adverse drug reactions after medication during pregnancy was high. Conclusion Attention should be paid to the safety of medications during pregnancy and more effective pharmacovigilance systems during pregnancy should be established. References | Related Articles | Metrics

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Relationships between family and class and toxicity of traditional Chinese herbal medicines ZHANG Hongqi, LIU Ying, ZHOU Chaofan 2022, 19(3): 283-286.  DOI: 10.19803/j.1672-8629.2022.03.11 Abstract ( 159 )   PDF (1165KB) ( 173 )   Objective To explore the common toxic components, adverse reactions and toxicity related factors of traditional Chinese herbal medicines (TCHMs) from the perspective of the family and class so as to provide data for research on the common properties between the family and class, the individual mechanism for detoxification and on safe, proper and accurate medications in clinic. Methods The Chinese Pharmacopoeia 2020 was consulted. Based on studies on the safety and effectiveness of TCHMs, the correlations between the family and class of TCHMs and their toxicity were revealed. Results The mechanisms of toxicity and detoxification of TCHMs in the same family and class had something in common. The research on the mechanism of detoxification was supposed to start with the shared toxicity that was related to the processing, usage, dosage, compatibility and the balance of yin and yang of the human body. Conclusion Under the guidance of TCM theories, modern methods for quality control can be used to study the toxic parts, toxic components and the relationships between “dose-effect-toxicity” of toxic TCHMs so as to establish safety criteria. By analyzing the common components of toxic TCHMs from the same family and class and by studying the regularities of detoxification, we can advance our understanding of the toxicity and adverse reactions of TCHMs in order to ensure safe and rational drug use. References | Related Articles | Metrics

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162 reports of adverse drug reactions induced by omeprazole sodium for injection ZHANG Xi, LI Pengfei, ZHAO Jie, LIU Lihong 2022, 19(3): 287-291.  DOI: 10.19803/j.1672-8629.2022.03.12 Abstract ( 407 )   PDF (1278KB) ( 411 )   Objective To study the features of adverse drug reactions (ADR) induced by omeprazole sodium injection, and provide a basis rational usage of drugs in clinic. Methods 162 cases of ADR reports caused by omeprazole sodium injection were collected from January 1, 2015 to March 31, 2020 from Beijing ADR monitoring system. The field in each case report was standardized, and the ADR symptoms were extracted and standardized by WHO adverse reaction terminology. In addition, genders, ages, and ADR involved organs/systems, adverse reaction time, drug dispensing, administration route, dosage of administration, drug combination, severity and outcome of adverse reactions in ADR were retrospectively analyzed. Results 82 patients over 60 years old were reported to have ADR, accounting for 50.62% of all cases reported. Adverse reactions/events related to omeprazole sodium injection were mainly rashes, elevated transaminases, pruritus, chills, etc. to the percentage of skin damage (32.18%) and systemic damage (14.37%) were relatively high. Most of these adverse reactions occurred in the initial stage of drug administration. Hepatobiliary system damage accounted for 13.79%. Such adverse reactions usually occurred after a few days of drug administration. There were many cases of unreasonable drug usage and off-label drug usage. Conclusion Clinical management of omeprazole sodium injection should be strengthened, and the process of drug administration should be closely observed to reduce the occurrence of ADR. Production enterprises should promptly revise and improve the safety information of drug instructions to ensure the safety of drug usage for patients. References | Related Articles | Metrics

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A analysis of safety of 73 users of carrelizumab HUANG Can, QI Lamei, LI Duohui, CHEN Zhaolin, JU Jing 2022, 19(3): 292-295.  DOI: 10.19803/j.1672-8629.2022.03.13 Abstract ( 194 )   PDF (1273KB) ( 145 )   Objective To retrospectively analyze the safety of carrelizumab in clinical use among cancer patients and to provide reference for rational use of this drug. Methods The clinical data on inpatients who had received carrilizumab in the Affiliated Anqing Hospital of Anhui Medical University between January 1 and December 31, 2020 was collected. The basic information on these patients, medications and the incidence of immune-related adverse events (irAEs) were recorded and analyzed to evaluate the safety of clinical medication. The relationships between irAEs and gender, age, preexisting diseases and cancer types were explored. Results Carrelizumab was used by seventy-three tumor patients for 264 times, and forty-one of these patients experienced off-label drug use. irAEs occurred in thirty-nine of these patients, six of whom had adverse reactions involving three or more systems. Among the cases of adverse reactions, twenty-nine were of grade 1~2 toxicity, nine of grade 3 toxicity, and one of grade 4 toxicity, including endocrine toxicity, skin and mucosal toxicity and liver toxicity. The incidence of irAEs varied according to types of tumors, being the highest with liver cancer and the lowest with lung cancer, and the difference was statistically significant. Conclusion The off-label drug use of carrelizumab is common. The incidence of irAEs is high, but symptoms are not severe. Early detection and interventions are of great importance. References | Related Articles | Metrics

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Research progress in effects of lopinavir / ritonavir used by lactating females on sucklings ZHOU Boya, YUAN Sisi, FENG Xin 2022, 19(3): 296-301.  DOI: 10.19803/j.1672-8629.2022.03.14 Abstract ( 113 )   PDF (1141KB) ( 101 )   Lopinavir / ritonavir has been approved for the treatment of human immunodeficiency virus (HIV) infection in China. It is also listed as an effective antiviral drug amid the COVID-19 pandemic in China. Lactating women infected with COVID-19 will have to face the problem of which antiviral drugs should be selected during lactation. This paper was intended to summarize the pharmacokinetics of lopinavir / ritonavir, the concentrations of lopinavir / ritonavir in breast milk and in sucklings in the real world, the effect on sucklings, and the evidence related to the use of lopinavir / ritonavir in some infants. Lopinavir / ritonavir is a quite safe antiviral drug for lactating women, and its effect on sucklings is very small. If lopinavir / ritonavir has to be used in lactating women infected with the COVID-19 virus, suckling can be continued as long as the virus will not be transmitted vertically through suckling. The levels of serum sodium, serum potassium, cholesterol, triglyceride, blood glucose, alanine transaminase and insulin in sucklings should be monitored. References | Related Articles | Metrics

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Current medications and influencing factors for senile patients with NVAF CHAI Xiaoli, ZHANG Chen, FENG Qingchun, LIU Huan 2022, 19(3): 302-305.  DOI: 10.19803/j.1672-8629.2022.03.15 Abstract ( 75 )   PDF (1282KB) ( 73 )   Objective To investigate current medications for elderly patients with non-valvular atrial fibrillation (NVAF) and the effect on anticoagulant therapies. Methods A total of 482 elderly patients with NVAF hospitalized in cardiovascular departments of five big hospitals in Changsha between March 2015 and March 2019 were selected as the subjects. A self-designed questionnaire was used to investigate the demographic data that was compared between the two groups. The usage of antithrombotic therapies and multiple drugs (≥5 drugs) was evaluated, and the influencing factors of multiple drugs were analyzed by logistic regression analysis. Results Among the 482 patients, 250 (51.87%) were properly treated, 58 (12.05%) were over-treated, 37 (7.68%) were undertreated, and 137 (28.42%) were left untreated. Logistic regression analysis showed that levels of education, type of medical insurance, hypertension, diabetes, coronary heart disease and heart failure were independent risk factors for multiple drug use (P<0.05). Conclusion Multiple medication is common in elderly NVAF patients, and the proportion of anticoagulant therapies needs to be improved. References | Related Articles | Metrics

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Clinical characteristics and risk factors of thrombocytopenia induced by fluoroquinolones CHEN Congcong, TAN Ruijuan, WANG Lidan, ZHANG Yuanyuan, HU Xiaoyan, CHEN Yuanyuan 2022, 19(3): 306-309.  DOI: 10.19803/j.1672-8629.2022.03.16 Abstract ( 207 )   PDF (1278KB) ( 164 )   Objective To investigate the prevalence of and risk factors for thrombocytopenia caused by fluoroquinolones in order to provide reference for rational use of fluoroquinolones. Methods A retrospective study was made of 596 cases of adverse drug reactions (ADR) in two hospitals between Jan 1, 2015 and Dec 31, 2019. According to the diagnostic criteria for thrombocytopenia, these patients were divided into the thrombocytopenia group (44 patients) and non- thrombocytopenia group (552 patients). Univariate and multiple logistic regression analysis was used to identify risk factors related to thrombocytopenia. Results Thrombocytopenia caused by fluoroquinolones accounted for 7.38% of the total ADR. There were 26 cases (59.09%) with platelet counts below 75% of the normal level, 12 cases (27.27%) below 50%~75% of the normal level, and 6 cases (13.64%) below 50% of the normal level. After discontinuation of medication, those symptoms gradually returned to normal. Univariate and multivariate logistic analysis showed that APACHE-II score ≥20 points (OR = 2.09, 95%CI=1.10 to 3.99, P=0.022), creatinine clearance rate≤30 mL·min-1 (OR=2.01, 95%CI= 1.08 to 3.75, P=0.031), overdose medication (OR= 2.02, 95%CI=1.08 to3.72, P=0.028) and duration of medication ≥14 days (OR=1.95, 95%CI=1.04 to 3.64, P=0.043 ) were independent risk factors for thrombocytopenia caused by fluoroquinolones. Conclusion When patients are using fluoroquinolones, clinicians should be alert to the occurrence of thrombocytopenia, especially among severe cases (APACHE-II score≥20) or cases with renal insufficiency (creatinine clearance ≤30 mL·min-1), overdose medication and long-term medication (≥14 days). References | Related Articles | Metrics

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Adverse reactions of skin drugs and concomitant liver and kidney dysfunction in inpatients JIN Haobin, ZHENG Lei, YANG Jing, GUAN Yuyao, ZHANG Xiaoli 2022, 19(3): 310-312.  DOI: 10.19803/j.1672-8629.2022.03.17 Abstract ( 153 )   PDF (1158KB) ( 151 )   Objective To study and analyze the correlations between clinical drug use and adverse drug reactions (ADR) related to skin drugs in order to promote rational drug use in clinic. Methods Eight hundred and fifty-eight cases of drug-induced skin ADR treated in our hospital between July 1, 2007 and December 31, 2018 were collected and statistically analyzed. Results There were 266 types of drugs involved in 858 cases of skin ADR, including antibiotic injection, blood-regulating formula and nutritional support drugs. The main routes of administration were intravenous administration (63.16%) and oral administration (25.19%). There were 747 cases of mild ADR, 71 serious ADR and 38 new ADR. 100 of these cases of skin ADR were accompanied by abnormal levels of glutamic pyruvic transaminase, glutamic oxaloacetic transaminase and serum creatinine. Conclusions kin ADR induced by drugs are mainly skin rash and pruritus, which are often accompanied by liver and kidney injury. Clinicians should assess the risk of ADR according to the patients' preexisting diseases, history of allergy and properties of various drugs, develop individualized drug delivery plans, and reduce the occurrence of ADR. References | Related Articles | Metrics

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Medication safety and combined medication in patients with type 2 diabetes mellitus XIANG Yufang, SUN Hui, CHEN Yue, WANG Ningsheng, LUO Shishu, ZHANG Zhi, FENG Bianling 2022, 19(3): 313-316.  DOI: 10.19803/j.1672-8629.2022.03.18 Abstract ( 223 )   PDF (1194KB) ( 253 )   Objective To investigate the current incidence of adverse drug reactions (ADR) and combined drug regimens for patients with type 2 diabetes mellitus (T2DM). Methods All the ADR reports of T2DM patients in Shaanxi Province collected between 2015 and 2019 were selected to analyze the basic data, clinical manifestations and influencing factors of ADR, and the combined use of drugs. Results A total of 2 050 cases of ADR related to T2DM patients in Shaanxi Province were collected, including damage to the gastrointestinal system, metabolic and nutritional disorders and damage to the skin and its accessories. Femininity, old age and combined drug use were the common causes of ADR, and combined drug use with metformin accounted for the highest proportion of all cases of combined drug use. Conclusion Clinicians should focus their attention on high-risk groups of ADR, including women, elderly patients and users of multiple drug combinations, and select the proper combination of drugs. References | Related Articles | Metrics

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930 cases of adverse drug reactions induced by antibacterial drugs in children XU Zhe, JU Ping, LUO Qi, YANG Huan, WANG Yang 2022, 19(3): 317-321.  DOI: 10.19803/j.1672-8629.2022.03.19 Abstract ( 210 )   PDF (1359KB) ( 197 )   Objective To analyze the characteristics of adverse drug reactions induced by antibacterial drugs in children so as to provide reference for safe clinical drug use. Methods A total of 930 reports of ADR induced by antibacterial drugs in children submitted by our hospital to the National ADR Monitoring Center between 2017 to 2019 were analyzed retrospectively. Results Among the 930 cases of ADR reported, 565 (60.75%) were males and 365 (39.25%) were females. The incidence of ADR in patients aged 0 to 6 was the highest (88.07%). Most of the cases of ADR were induced by intravenous injection, accounting for 99.03%. 637 of these cases (68.49%) were induced by macrolides. The injury to the gastrointestinal system was the most common ADR, which accounted for 93.33% of the total. Most of these ADR were cured or improved after corresponding treatment. Conclusion The influencing factors of ADR induced by antibacterial drugs are complicated. The monitoring of ADR in children should be upgraded so as to promote rational use of drugs and ensure safe and effective drug use in clinic. References | Related Articles | Metrics

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Adverse drug reactions caused by antipsychotic drugs in 631 cases CAO Lisha, WANG Jisheng, ZHANG Fang, CHEN Jing, GUO Haoning 2022, 19(3): 322-324.  DOI: 10.19803/j.1672-8629.2022.03.20 Abstract ( 160 )   PDF (1232KB) ( 149 )   Objective To analyze the characteristics, regularity and influencing factors of adverse drug reactions (ADR) caused by antipsychotics in our hospital over the past five years. Methods Six hundred and thirty-one reports of antipsychotics-related ADR submitted by our hospital to the national ADR monitoring network between 2015 and 2019 were statistically analyzed. Results Among the 631 cases, the percentage of females was 52.93% (334 cases), compared with (47.07%) (297 cases) for males (P < 0.01). The majority of the patients (475) were aged 20~60, accounting for 75.28%. ADR mostly occurred within 15 days of medication, accounting for 62.44%. 631 patients developed 679 ADR, and risperidone, olanzapine and clozapine were the top three drugs responsible for these ADR. Extrapyramidal reactions were the most common (218 cases), followed by constipation (101 cases). Conclusion Atypical antipsychotics have gradually become the main antipsychotic drugs. When they are combined with other psychiatric drugs, the incidence of extrapyramidal reactions is greatly increased, which deserves more attention. References | Related Articles | Metrics

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385 cases of adverse drug reactions/adverse drug events caused by Yinzhihuang preparations FENG Chengyang, ZHAO Li, LIU Dong 2022, 19(3): 325-327.  DOI: 10.19803/j.1672-8629.2022.03.21 Abstract ( 124 )   PDF (1219KB) ( 113 )   Objective To analyze adverse drug reactions (ADR) caused by Yinzhihuang preparations in order to grasp the characteristics of ADR of Yinzhihuang preparations and provide reference for rational clinical use. Methods A total of 385 reports of ADR/adverse drug events (ADE) of Yinzhihuang preparations were collected by Hubei Center for ADR Monitoring between January 1, 2012 and December 31, 2018. Dosage forms that patients used, patients' age and gender, preexisting diseases, dosages, times of occurrence, system-organs involved, and clinical manifestations were recorded and analyzed. Results Among these cases, the ratio of males to females was 1.60∶1.00, and the incidence was higher in patients aged 40 to 59 (42.86%). There were 301 reports that documented the time ADR occurred (mainly within 30min). The affected systems-organs were mostly the skin and its accessories while the main clinical manifestations were pruritus and rash. Conclusion Yinzhihuang preparations can cause ADR/ADE of varying degrees, but patients can generally improve after drug withdrawal or symptomatic treatment. Enough attention should be paid to the condition of patients after medication. References | Related Articles | Metrics

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Analysis of 283 cases of drug fever LIU Juan, ZHANG Jing, YANG Yanling, WANG Yinhui 2022, 19(3): 328-332.  DOI: 10.19803/j.1672-8629.2022.03.22 Abstract ( 165 )   PDF (1329KB) ( 170 )   Objective To explore the characteristics of drug fever and provide reference for related diagnosis and treatment. Methods Cases of drug fever reported by health institutions in Enshi Prefecture from January 1, 2015 to December 31, 2019 to the national adverse drug reaction detection system were retrospectively collected. A total of 283 cases were screened and analyzed. Results Seventy-nine of these cases (27.92%) were caused by traditional Chinese medicine, and 64 (22.61%) by antibiotics. The main route of administration was intravenous injection(249 cases, 87.99%). Most of these cases were accompanied by other symptoms, 199 of which were chills (46.28%) and 40 were skin damage (9.30%). Drug fever in most (85.87%) of the cases occurred within 7 days of administration, but it could occur as late as 28 days after administration. 268 of these cases (94.70%) had temperature remission soon after drug withdrawal. Conclusion Traditional Chinese medicine and antibiotics are the drugs mainly responsible for drug fever in Enshi prefecture. Patients with drug fever often have chills, and only a few have such allergic symptoms as skin lesions. References | Related Articles | Metrics

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Adverse reactions induced by teriparatide CUI Can, WEI Hongtao, CHENG Sheng, SHEN Su 2022, 19(3): 333-335.  DOI: 10.19803/j.1672-8629.2022.03.23 Abstract ( 350 )   PDF (1208KB) ( 125 )   Objective To analyze the patterns and characteristics of adverse reactions induced by teriparatide and to provide guidance for its rational use in clinic. Methods Domestic and foreign journals published between January 1, 2002 and March 31, 2020 were retrieved to collect data on cases of adverse reaction induced by teriparatide before statistical analysis. Results A total of 20 adverse reactions reported by 17 articles were collected, involving musculo-skeletal system disorders, metabolic and nutritional disorders and skin damage. Most of the adverse reactions were cured soon after discontinuation of medication, but musculo-skeletal system disorders might take months to cure or persist throughout one’s life. Conclusion Before prescribing teriparatide, doctors should find out about the basic biochemical indicators, such as blood calcium, phosphorus, alkaline phosphatase and creatinine and make sure that patients with bone malignant tumors, bone metastases, and at high risk of osteosarcoma are excluded from use. References | Related Articles | Metrics

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Three cases of antibiotic encephalopathy caused by ceftriaxone sodium injection in dialysis patients ZHU Xuting, REN Jia, HANG Yongfu 2022, 19(3): 336-338.  DOI: 10.19803/j.1672-8629.2022.03.24 Abstract ( 211 )   PDF (1156KB) ( 153 )   Objective To analyze antibiotic encephalopathy caused by ceftriaxone sodium in patients under renal dialysis, and to provide reference for clinical drug use among a special population. Methods The clinical data on three dialysis patients with psychiatric symptoms caused by ceftriaxone sodium was analyzed by a clinical pharmacist according to the correlation evaluation criteria established by the National Center for Adverse Drug Reactions and the Naranjo's Adverse Drug Evaluation Scale. Results After ceftriaxone sodium was used, all the three patients experienced different degrees of psychotic symptoms. But when antibacterial drugs were discontinued and symptomatic treatment started, these mental symptoms were alleviated. Conclusion For patients with renal insufficiency, cephalosporins should be used with caution to prevent psychiatric abnormalities that are not included in the instructions, which occasionally occur and need to be taken seriously by clinicians. References | Related Articles | Metrics

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Spontaneous muscular hemorrhage induced by warfarin tablets in a child GUO Jun, REN Dan, YE Long, ZHAO Rongxiang, WANG Yu, YU Jing 2022, 19(3): 339-341.  DOI: 10.19803/j.1672-8629.2022.03.25 Abstract ( 112 )   PDF (1135KB) ( 153 )   Objective To explore ways to monitor coagulation functions of warfarin in children with chronic diseases amid COVID-19. Methods One case of Kawasaki disease with a giant coronary aneurysm was reported, who had developed non-traumatic spontaneous lower extremity muscle hemorrhage during anticoagulation with warfarin and aspirin but without regular follow-up amid COVID-19. Response measures against the use of warfarin in children with chronic diseases during the pandemic were explored. Results Because of the COVID-19 pandemic, the child failed to be followed up regularly, resulting in coagulation dysfunction and serious non-invasive spontaneous muscle hemorrhage. After blood transfusion and improvement of coagulation function, the bleeding was stopped and the lower limb activity restored. Conclusion Warfarin is a commonly-used anticoagulant against Kawasaki disease combined with a coronary artery aneurysm, but excessive or insufficient anticoagulation can cause serious complications. Therefore, the INR of patients needs to be monitored. Clinicians should use anticoagulants with caution during the epidemic and remain alert to bleeding in unusual locations. References | Related Articles | Metrics

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One case of hypokalemia caused by moxifloxacin injection and literature analysis YANG Guiling, ZHAO Mudan, GAO Yiling, WANG Bei, ZHU Minghui 2022, 19(3): 342-344.  DOI: 10.19803/j.1672-8629.2022.03.26 Abstract ( 523 )   PDF (1115KB) ( 343 )   Objective To explore the mechanism by which hypokalemia is caused by moxifloxacin injection so as to provide reference for clinical rational and safe use of moxifloxacin. Methods The diagnosis and treatment process of one case of hypokalemia after moxifloxacin injection was analyzed. Results Symptoms of hypokalemia (2.78 mmol·L-1) occurred one week after intravenous injection of moxifloxacin. After moxifloxacin injection was withdrawn and intravenous and oral potassium supplementation was started, the level of potassium returned to normal (4.41 mmol·L-1). Conclusion Intravenous injection of moxifloxacin may lead to hypokalemia, which deserves more attention in clinic. References | Related Articles | Metrics

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One case of agranulocytosis induced by methimazole tablets ZHU Yuting, LI Maoxing 2022, 19(3): 345-348.  DOI: 10.19803/j.1672-8629.2022.03.27 Abstract ( 254 )   PDF (1130KB) ( 201 )   Objective To explore the possible mechanism of methimazole-induced agranulocytosis (MIA) and treatments for elderly patients. Methods The process of treating one case of an elderly patient with MIA and infection was analyzed based on literature retrieval. Results Despite anti-infection treatments and increasing the number of white blood cells, the patient remained feverish. Then, the patient's granulocytes gradually increased after antibacterial drugs were discontinued and methylprednisolone sodium succinate was supplemented for 3 days. The blood routine of the patient returned to normal on the 17th day. Conclusion The mechanism of MIA includes immune responses, drug toxicity and genetic susceptibility. It is recommended that an individualized dosing plan be made during the diagnosis and treatment of elderly patients. References | Related Articles | Metrics