1.Clinical efficacy of azithromycin for treatment of Mycoplasma pneumoniae pneumonia with gene mutations at site A2063G of 23S rRNA in children
Wen LI ; Tongyong LUO ; Fei WANG ; Bo ZHANG ; Yongxian JIANG ; Siqi HU
Journal of Chongqing Medical University 2025;50(11):1569-1572
Objective:To observe the clinical efficacy of azithromycin for the treatment of Mycoplasma pneumoniae pneumonia(MPP)with gene mutations at site A2063G of 23S rRNA in children.Methods:Data were retrospectively collected for 242 children diagnosed with MPP at Sichuan Provincial Maternity and Child Health Care Hospital from January to December 2023,in whom MPP was detected using targeted next-generation sequencing(tNGS).According to the presence or absence of mutations,the children were classified into mutation group(88 cases)and non-mutation group(154 cases).Results:Gene mutations at site A2063G of 23S rRNA were detected in 88 patients.The chest X-rays of both groups showed more lesions in the right lung than in the left lung.Both groups were treated with azithromycin and compared for differences in age,sex,duration of fever,C-reactive protein level,time to improvement of chest X-rays,days of medication,and response rate,with no significant differences found in the above indicators(P>0.05).However,the duration of respiratory symptoms was significantly longer in the mutation group than in the non-mutation group[(11.51±3.31)d vs.(10.06±3.63)d,P<0.05].Conclusion:Azithromycin is effective in treating MPP with gene mutations at site A2063G of 23S rRNA.
2.Effects of Zamerovimab/Mazorelvimab on the rabies virus neutralizing antibody level in the grade Ⅲ rabies post exposure subjects
Xiuqing WANG ; Yongxian ZHA ; Zhengxiong WANG ; Ya JIANG ; Xiangyu ZHANG ; Jiangshu GUO ; Jingyu LI ; Xiaoqiang LIU
Chinese Journal of Experimental and Clinical Virology 2024;38(4):388-394
Objective:This study aimed to evaluate the immunoprotective effect of anti-rabies virus cocktail monoclonal antibody Zamerovimab/Mazorelvimab after rabies exposure.Methods:The dynamic data of rabies virus neutralizing antibody (RVNA) were analyzed in the Zamerovimab/Mazorelvimab Chinese phase Ⅲ study (clinical trial registration number: CTR20201819).Results:The full analysis set showed that RVNA geometric mean titers (GMT) on the 4 th, 8 th, 15 th, 43 rd, and 99 th day in the Zamerovimab/Mazorelvimab group were 4.413 IU/ml, 5.178 IU/ml, 17.062 IU/ml, 14.672 IU/ml, and 2.836 IU/ml, respectively, while those in the human rabies immunoglobulin (HRIG) group were 0.299 IU/ml, 0.451 IU/ml, 11.374 IU/ml, 18.063 IU/ml, and 6.769 IU/ml, respectively. The positive rates of RVNA on the 4 th, 8 th, 15 th, 43 rd, and 99 th day in the Zamerovimab/Mazorelvimab group were 99.9%, 99.6%, 100%, 100%, and 97.4%, respectively, while those in the HRIG group were 23.3%, 34.1%, 97.6%, 99.6%, and 98.4%, respectively. Conclusions:Compared with HRIG, Zamerovimab/Mazorelvimab cocktail monoclonal antibody reached the required protection level of RVNA very soon, thus effectively provided an immediate neutralizing effect of passive immunization therapies against rabies virus.
3.Analysis of anaphylaxis caused by gonadorelin in children in gonadotropin-releasing hormone stimulation test
Yongxian JIANG ; Xi YE ; Aiyan LI ; Bo QIN ; Wenwen CHEN ; Bingchen LANG ; Gen LI
Adverse Drug Reactions Journal 2023;25(9):538-542
Objective:To explore the clinical characteristics of anaphylaxis caused by gonadorelin in children in gonadotropin-releasing hormone (GnRH) stimulation test.Methods:The research subjects were children aged ≤14 years who experienced anaphylaxis using gonadorelin in the Chengdu Adverse Reaction Center database from January 1, 2015 to December 31, 2021. The purpose of medication was GnRH stimulation test. Through the hospital information system, the children′s basic information, usage of gonadorelin, occurrence of severe allergic reactions, and treatments and outcomes of anaphylaxis were collected and retrospectively analyzed.Results:A total of 14 cases of anaphylaxis in children caused by gonadorelin in the GnRH stimulation test were collected, including 3 males and 14 females, with an age of (9±2) years. All 14 cases were evaluated with a score of ≥5 using the Naranjo evaluation method. The dose of gonadorelin in the 14 children was (2.55±0.09) μg/kg and the drug was all given by intravenously injection; anaphylaxis occurred in 4 children during the first GnRH stimulation test and in 10 children during the second GnRH stimulation test. The time from medication to anaphylaxis occurence was (6.0±3.5) minutes. The symptoms of anaphylaxis in 14 children were systemic allergic reactions, involving various systems throughout the body. All children had 3 or more types of systemic damage. After anaphylaxis occurrence, gonadorelin was discontinued in all 14 patients; 5 received intramuscular injection of adrenaline, 5 received intravenous injection of adrenaline, 1 received intravenous injection of isoprenaline and intramuscular injection of adrenaline, and 3 received intravenous injection of dexamethasone only. After treatments, all children were improved.Conclusions:Anaphylaxis caused by gonadorelin in children is a rare but severe adverse reaction, and the drug may have a possibility of cross allergy with GnRH analogues. Therefore, when diagnosing and treating precocious puberty in children, medication should be given under monitoring conditions.
4.Analysis of anaphylaxis caused by gonadorelin in children in gonadotropin-releasing hormone stimulation test
Yongxian JIANG ; Xi YE ; Aiyan LI ; Bo QIN ; Wenwen CHEN ; Bingchen LANG ; Gen LI
Adverse Drug Reactions Journal 2023;25(9):538-542
Objective:To explore the clinical characteristics of anaphylaxis caused by gonadorelin in children in gonadotropin-releasing hormone (GnRH) stimulation test.Methods:The research subjects were children aged ≤14 years who experienced anaphylaxis using gonadorelin in the Chengdu Adverse Reaction Center database from January 1, 2015 to December 31, 2021. The purpose of medication was GnRH stimulation test. Through the hospital information system, the children′s basic information, usage of gonadorelin, occurrence of severe allergic reactions, and treatments and outcomes of anaphylaxis were collected and retrospectively analyzed.Results:A total of 14 cases of anaphylaxis in children caused by gonadorelin in the GnRH stimulation test were collected, including 3 males and 14 females, with an age of (9±2) years. All 14 cases were evaluated with a score of ≥5 using the Naranjo evaluation method. The dose of gonadorelin in the 14 children was (2.55±0.09) μg/kg and the drug was all given by intravenously injection; anaphylaxis occurred in 4 children during the first GnRH stimulation test and in 10 children during the second GnRH stimulation test. The time from medication to anaphylaxis occurence was (6.0±3.5) minutes. The symptoms of anaphylaxis in 14 children were systemic allergic reactions, involving various systems throughout the body. All children had 3 or more types of systemic damage. After anaphylaxis occurrence, gonadorelin was discontinued in all 14 patients; 5 received intramuscular injection of adrenaline, 5 received intravenous injection of adrenaline, 1 received intravenous injection of isoprenaline and intramuscular injection of adrenaline, and 3 received intravenous injection of dexamethasone only. After treatments, all children were improved.Conclusions:Anaphylaxis caused by gonadorelin in children is a rare but severe adverse reaction, and the drug may have a possibility of cross allergy with GnRH analogues. Therefore, when diagnosing and treating precocious puberty in children, medication should be given under monitoring conditions.
5.Pharmaceutical care of a child with congenital hyperinsulinemia and establishment of self-supplied drugs safety management mode
Jia YANG ; Yongxian JIANG ; Wenwen CHEN ; Wanjun TAO ; Gen LI
Adverse Drug Reactions Journal 2021;23(4):202-204
An one-month-old boy was treated with diazoxide capsules purchased by his parents from abroad for congenital hyperinsulinemia. In order to correct his hypoglycemia, the treatment plan was designed as follows: diazoxide capsules with an initial dose of 8.72 mg orally thrice daily [5 mg/(kg·d)] and intravenously high concentration glucose were given at the same time, then the supplement of intravenous glucose was gradually reduced and the dose of diazoxide was gradually increased under close monitoring of blood glucose levels, and finally the intravenous glucose was stopped with the stable blood glucose level (≥3.9 mmol/L). During the first 7 days of treatment, the dose of intravenous glucose and diazoxide were adjusted as planned, the child′s blood glucose was 3.1-5.3 mmol/L, and no hypoglycemia occurred. On the 8th day, the pharmacist found that the child was not awake and the blood glucose was 2.2 mmol/L during patient rounds. After questioning his parents, it was found that the dose of diazoxide was reduced to the initial dose by the parents themselves, leading to an episode of hypoglycemia, which was a medication error caused by the lack of self-supplied drugs management. The pharmacist immediately intervened on his parents′ treatment adherence. The dose of diazoxide was re-adjusted and the child′s blood glucose returned to normal. With the increase of the diazoxide dose, the child developed an adverse reaction of water and sodium retention. The addition of hydrochlorothiazide was recommended by the pharmacists after reviewing previous literatures and the adverse reaction of the child disappeared. Through this case, the clinical management standard of self-supplied drugs for special diseases and the database of safe drug use were established and a multi-disciplinary team for joint services consisting physicians and pharmacists was formed in the hospital under the efforts of clinical pharmacists. The safety management of medication in treatment of hospitalized and discharged children was strengthened and good results have been achieved.
6.Application of therapeutic drug monitoring in the establishment of pharmacovigilance system for children with digoxin poisoning
Wenwen CHEN ; Yongxian JIANG ; Wanjun TAO ; Jia YANG ; Gen LI
Adverse Drug Reactions Journal 2021;23(1):35-38
A 4-month and 19-day-old girl with a body weight of 4.4 kg was treated with 5% digoxin oral solution 0.9 ml (0.045 mg) once per 12 hours after repair of ventricular septal and atrial septal defects. Spironolactone, hydrochlorothiazide, and captopril were given at the same time. The blood concentration of digoxin was detected on the 6th day of medication, and the pharmacist found that it was more than 5.0 μg/L, and immediately went to the ward to see the child. The bedside electrocardiograph showed that the baby girl had reduced heart rate (80 beats/min), arrhythmia, third-degree atrioventricular block, complete right bundle-branch block, and ST-T changes. Digoxin poisoning was diagnosed and digoxin was immediately discontinued. Three days later, the blood concentration of digoxin decreased to 1.66 μg/L, and her heart rate and electrocardiograph returned to normal. By reviewing the medication information of the baby, a digoxin poisoning event due to overdose of digoxin and drug interactions was diagnosed. Due to the event, the use of digoxin in hospitalized children in the whole hospital from January 2017 to May 2019 was investigated. Among 323 children, 14 children (4.3%) overdosed with digoxin; 235 children (72.8%) were treated with digoxin for more than 5 days, but the detection rate of blood concentration was only 12.8% (30/235); 67.5% children (240/323) were prescribed drugs that might interact with digoxin or increase the risk in digoxin treatment. Through the analysis of risk factors, improvement measures such as optimizing medical order audit system, increasing the monitoring rate of digoxin blood concentration, and strengthening training were put forward, and an expert consensus in the hospital was reached. After implementation of the improvement measures, a total of 47 children were prescribed digoxin in the whole hospital from January to June, 2020, none of them were given overdose of digoxin, and the monitoring rate of digoxin blood concentration was increased to 40.4% (19/47).
7.Establishment of pharmacovigilance system for heamocogulase agents triggered by venous thrombosis events due to the off-label drug use
Yongxian JIANG ; Wenwen CHEN ; Jia YANG ; Wanjun TAO ; Gen LI
Adverse Drug Reactions Journal 2021;23(2):91-94
Chengdu Women and Children′s Central Hospital started the construction of a pharmacovigilance system in 2017. In August of that year, 3 venous thrombosis events related to off-label use of heamocogulase agents occurred consecutively within 1 month, which aroused the vigilance of the hospital pharmacovigilance department. And these events were designated as the risk signals of pharmacovigilance. Then the application of heamocogulase agents in the whole hospital was investigated. Intervention measures including formulation of clinical application standard of heamocogulase agents, strengthening of the prescription and medical order management, and strengthening the training of medical staff on the rational use of heamocogulase agents were formulated in connection with the medication risk links, and the pharmacovigilance system of heamocogulase agents was established. From December 2017 to February 2018 after the implementation of the intervention, the consumption of heamocogulase agents decreased by 90.8% (from 6 767 to 624) and the incidences of unreasonable medication indication, irrational course of treatment, and unjustified daily dose decreased significantly, compared with those from June to August 2017 before the intervention. As of the end of 2019, no more heamocogulase agents-related venous thrombotic events have occurred.
8.Pharmaceutical care of a child with congenital hyperinsulinemia and establishment of self-supplied drugs safety management mode
Jia YANG ; Yongxian JIANG ; Wenwen CHEN ; Wanjun TAO ; Gen LI
Adverse Drug Reactions Journal 2021;23(4):202-204
An one-month-old boy was treated with diazoxide capsules purchased by his parents from abroad for congenital hyperinsulinemia. In order to correct his hypoglycemia, the treatment plan was designed as follows: diazoxide capsules with an initial dose of 8.72 mg orally thrice daily [5 mg/(kg·d)] and intravenously high concentration glucose were given at the same time, then the supplement of intravenous glucose was gradually reduced and the dose of diazoxide was gradually increased under close monitoring of blood glucose levels, and finally the intravenous glucose was stopped with the stable blood glucose level (≥3.9 mmol/L). During the first 7 days of treatment, the dose of intravenous glucose and diazoxide were adjusted as planned, the child′s blood glucose was 3.1-5.3 mmol/L, and no hypoglycemia occurred. On the 8th day, the pharmacist found that the child was not awake and the blood glucose was 2.2 mmol/L during patient rounds. After questioning his parents, it was found that the dose of diazoxide was reduced to the initial dose by the parents themselves, leading to an episode of hypoglycemia, which was a medication error caused by the lack of self-supplied drugs management. The pharmacist immediately intervened on his parents′ treatment adherence. The dose of diazoxide was re-adjusted and the child′s blood glucose returned to normal. With the increase of the diazoxide dose, the child developed an adverse reaction of water and sodium retention. The addition of hydrochlorothiazide was recommended by the pharmacists after reviewing previous literatures and the adverse reaction of the child disappeared. Through this case, the clinical management standard of self-supplied drugs for special diseases and the database of safe drug use were established and a multi-disciplinary team for joint services consisting physicians and pharmacists was formed in the hospital under the efforts of clinical pharmacists. The safety management of medication in treatment of hospitalized and discharged children was strengthened and good results have been achieved.
9.Application of therapeutic drug monitoring in the establishment of pharmacovigilance system for children with digoxin poisoning
Wenwen CHEN ; Yongxian JIANG ; Wanjun TAO ; Jia YANG ; Gen LI
Adverse Drug Reactions Journal 2021;23(1):35-38
A 4-month and 19-day-old girl with a body weight of 4.4 kg was treated with 5% digoxin oral solution 0.9 ml (0.045 mg) once per 12 hours after repair of ventricular septal and atrial septal defects. Spironolactone, hydrochlorothiazide, and captopril were given at the same time. The blood concentration of digoxin was detected on the 6th day of medication, and the pharmacist found that it was more than 5.0 μg/L, and immediately went to the ward to see the child. The bedside electrocardiograph showed that the baby girl had reduced heart rate (80 beats/min), arrhythmia, third-degree atrioventricular block, complete right bundle-branch block, and ST-T changes. Digoxin poisoning was diagnosed and digoxin was immediately discontinued. Three days later, the blood concentration of digoxin decreased to 1.66 μg/L, and her heart rate and electrocardiograph returned to normal. By reviewing the medication information of the baby, a digoxin poisoning event due to overdose of digoxin and drug interactions was diagnosed. Due to the event, the use of digoxin in hospitalized children in the whole hospital from January 2017 to May 2019 was investigated. Among 323 children, 14 children (4.3%) overdosed with digoxin; 235 children (72.8%) were treated with digoxin for more than 5 days, but the detection rate of blood concentration was only 12.8% (30/235); 67.5% children (240/323) were prescribed drugs that might interact with digoxin or increase the risk in digoxin treatment. Through the analysis of risk factors, improvement measures such as optimizing medical order audit system, increasing the monitoring rate of digoxin blood concentration, and strengthening training were put forward, and an expert consensus in the hospital was reached. After implementation of the improvement measures, a total of 47 children were prescribed digoxin in the whole hospital from January to June, 2020, none of them were given overdose of digoxin, and the monitoring rate of digoxin blood concentration was increased to 40.4% (19/47).
10.Establishment of pharmacovigilance system for heamocogulase agents triggered by venous thrombosis events due to the off-label drug use
Yongxian JIANG ; Wenwen CHEN ; Jia YANG ; Wanjun TAO ; Gen LI
Adverse Drug Reactions Journal 2021;23(2):91-94
Chengdu Women and Children′s Central Hospital started the construction of a pharmacovigilance system in 2017. In August of that year, 3 venous thrombosis events related to off-label use of heamocogulase agents occurred consecutively within 1 month, which aroused the vigilance of the hospital pharmacovigilance department. And these events were designated as the risk signals of pharmacovigilance. Then the application of heamocogulase agents in the whole hospital was investigated. Intervention measures including formulation of clinical application standard of heamocogulase agents, strengthening of the prescription and medical order management, and strengthening the training of medical staff on the rational use of heamocogulase agents were formulated in connection with the medication risk links, and the pharmacovigilance system of heamocogulase agents was established. From December 2017 to February 2018 after the implementation of the intervention, the consumption of heamocogulase agents decreased by 90.8% (from 6 767 to 624) and the incidences of unreasonable medication indication, irrational course of treatment, and unjustified daily dose decreased significantly, compared with those from June to August 2017 before the intervention. As of the end of 2019, no more heamocogulase agents-related venous thrombotic events have occurred.

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