2025 Volume 27 Issue 6 Published: 28 June 2025
  

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  • Hotspot issues and future directions in the research of anti-bacterial agent-associated acute kidney injury in children
    Zhang Jianjiang, Dou Wenjie
    2025, 27(6): 321-324. https://doi.org/10.3760/cma.j.cn114015-20250424-00225
    Abstract ( ) PDF ( )
    Due to physiological and metabolic characteristics and disease characteristics being different from adults, such as the high incidence of infectious diseases, children are at a high-risk of acute kidney injury (AKI) related to anti-bacterial agents, and there were many challenges in prevention and treatment. The hot issues in the research of anti-bacterial agent-related AKI in children, including the study of nephrotoxicity mechanism of anti-bacterial agents, the exploration of early biomarkers， and the optimization of treatment strategies, are expounded in this article. In the future, it is recommended to strengthen researches on child specificity, deepen basic researches, optimize monitoring plans for pediatric treatment drugs, and establish a pediatric drug monitoring system,  so as to provide references for rational clinical drug use of the anti-bacterial agents and further researches on AKI.
  • Analysis of the efficacy and safety of adrenocorticotropic hormone therapy in children with steroid dependent or frequently relapsed nephrotic syndrome
    Niu Yunhe, Bao Ying, Huang Huimei, Li Zhijuan, Zhang Min, Wang Ying, Liang Nan, Wang Yanping, Yang Nan
    2025, 27(6): 325-331. https://doi.org/10.3760/cma.j.cn114015-20241018-00099
    Abstract ( ) PDF ( )
    Objective To observe the efficacy and safety of adrenocorticotropic hormone (ACTH) therapy in children with steroid dependent nephrotic syndrome (SDNS)/frequently relapsed nephrotic syndrome (FRNS).　Methods The clinical data of children with SDNS/FRNS who received treatment with prednisone acetate tablets were retrospectively collected from June 2019 to June 2023 in the Nephrology Department of Xi′an Children′s Hospital. The children were divided into glucocorticoid+ACTH group and glucocorticoid group, according to whether ACTH was used or not. The differences in cortisol, total cholesterol and 24 hour urinary protein quantity between 2 groups of children at baseline and follow-up endpoints were compared, and the effectiveness (the proportion of no recurrence and discontinuation of glucocorticoid) and occurrence of adverse reactions were evaluated.　Results A total of 39 patients with SDNS/FRNS were included in this study, with 21 cases in the glucocorticoid+ACTH group and 18 cases in the glucocorticoid group. Among the 39 children, there were 33 cases of SDNS and 6 cases of FRNS, respectively. The proportion of baseline low cortisol levels was 76.9% (30/39). The proportion of cortisol levels returning to normal after ACTH treatment in the glucocorticoid+ACTH group was 76.2% (16/21). The baseline and follow-up endpoint for cortisol levels in the glucocorticoid+ACTH group were 28.0(19.8, 51.5) μg/L and 79.9(58.9, 113.0) μg/L, respectively. The baseline and follow-up endpoint for cortisol levels in the glucocorticoid group were 21.0(15.8, 37.4) μg/L and 25.3(18.2, 51.4) μg/L, respectively. In the 2 groups of cortisol levels, there was statistically significant difference in the interaction effect between time and group (Wald χ2=11.595, P=0.001), there was a statistically significant difference at the follow-up endpoint between the 2 groups (Wald χ2=19.462, P<0.001), and the difference was statistically significant in the time effect of the glucocorticoid+ACTH group (Wald χ2=21.100, P<0.001). The baseline and follow-up endpoint for total cholesterol in the glucocorticoid+ACTH group were 4.95(4.23, 5.26) mmol/L and 4.38(4.04, 5.24) mmol/L, respectively. The baseline and follow-up endpoint for total cholesterol in the glucocorticoid group were 4.80 (4.17, 5.28) mmol/L and 5.74 (5.04, 6.88) mmol/L, respectively. In the 2 groups of total cholesterol, there was statistically significant difference in the interaction effect between time and group (Wald χ2=9.842, P=0.002), there was statistically significant difference at the follow-up endpoint between the 2 groups（Wald χ2=12.187，P<0.001）, the difference was statistically significant between the 2 groups in the time effect at baseline and the follow-up endpoint (glucocorticoid+ACTH group: Wald χ2=6.488, glucocorticoid group: Wald χ2=7.112; all P<0.05). The baseline and follow-up endpoint for 24 hour urinary protein quantity in the glucocorticoid+ACTH group were 115（105，128） mg/d and 121（113，128） mg/d, respectively. The baseline and follow-up endpoint for 24 hour urinary protein quantity in the glucocorticoid group were 118（113，125） mg/d and 138（119，2 100） mg/d, respectively. In the 2 groups of 24 hour urinary protein quantity, there was statistically significant difference in the interaction effect between time and group (Wald χ2=7.743, P=0.005), there was statistically significant difference at the follow-up endpoint between the 2 groups (Wald χ2=7.779, P=0.005), and the difference was statistically significant in the time effect of the glucocorticoid group (Wald χ2=13.331, P<0.001). The proportion of no recurrence (17/21) and discontinuation of oral glucocorticoid (16/21) in the glucocorticoid+ACTH group were higher than those in the glucocorticoid group (the proportion were both 6/18), and the differences between the 2 groups were statistically significant (the chi square values were 9.084 and 7.240, respectively; all P<0.01). No adverse reactions occurred in the glucocorticoid group. The incidence of adverse reactions in the glucocorticoid+ACTH group was 14.3% (3/21), of which 2 cases developed generalized urticaria and 1 case developed hypertension.　Conclusions ACTH has a good efficacy and safety in children with SDNS/FRNS. The results of this study need to be further validated by increasing the sample size and conducting multicenter studies.
  • Risk factors of acute kidney injury induced by vancomycin in pediatric patients: a meta-analysis
    Tuo Mingfu, Di Xiaoyuan, Yang Kun, Tang Caie, Du Yan, He Hongying
    2025, 27(6): 332-338. https://doi.org/10.3760/cma.j.cn114015-20241210-00196
    Abstract ( ) PDF ( )
    Objective To systematically evaluate the incidence and risk factors of acute kidney injury (AKI) induced by vancomycin in pediatric patients.　Methods Databases of PubMed, Embase, The Cochrane Library, Web of Science, CNKI, Wanfang, VIP, Chinese Biomedical Database (CBM) were searched and articles about the risk factors of AKI induced by vancomycin in pediatric patients from inception to June 2024 were collected. Quality assessment was performed using the Newcastle-Ottawa Scale (NOS) for the included studies. Meta-analysis of the data for relevant exposure factors extracted from the included literature was conducted using Rev Man 5.4. The strength of association between the exposure factors and AKI was expressed using the odds ratio (OR) and its 95% confidence interval (CI).　Results A total of 13  studies were entered, involving 11 073 patients. Of them, 1 388 patients were in AKI group and 9 685 patients in non-AKI group. The incidence of AKI was 12.53%, ranging from 4.62% to 27.07%. The quality evaluation results showed that the 13 documents were all of high-quality (NOS score ≥7 points). Meta-analysis showed that admission to intensive care unit (ICU) （OR=2.39, 95%CI: 1.59-3.59, P<0.001）, vancomycin using time ≥7 d (OR=2.19, 95%CI: 1.44-3.34，P=0.003), vancomycin steady-state trough concentration ≥15 mg/L (OR=2.98, 95%CI: 2.22-4.01, P<0.001), combined with nephrotoxic drugs ≥2 kinds (OR=2.92, 95%CI=1.84-4.64, P<0.001), combined with piperacillin sodium and tazobactam sodium (OR=2.71, 95%CI: 1.72- 4.27, P<0.001), combined with carbapenem (OR=2.36, 95%CI: 1.36-4.10, P=0.002), combined with aminoglycosides (OR=1.78, 95%CI: 1.35-2.35, P<0.001), combined with loop diuretics (OR=3.16, 95%CI: 2.36- 4.23, P<0.001), combined with amphotericin B (OR=2.26, 95%CI: 1.35-3.79, P=0.002), combined with contrast medium (OR=2.34, 95%CI: 1.04-5.25, P=0.040), and combined with aciclovir (OR=1.74, 95%CI: 1.04-2.84, P=0.030) were all risk factors of AKI induced by vancomycin in pediatric patients.　Conclusions The incidence of vancomycin-related AKI in pediatric patients was 12.53%. Admission to ICU, vancomycin trough concentration ≥15 mg/L, medication time ≥7 d, and concomitant use of ≥2 nephrotoxic drugs and etc.were risk factors of vancomycin-related AKI.
  • Analysis of differences on contraindication information for children in domestic and foreign drug instructions
    Zhou Pengxiang, Xu Xinwen, Wang Xiaoling, Zhao Ruiling, Zhao Zhigang
    2025, 27(6): 339-347. https://doi.org/10.3760/cma.j.cn114015-20240828-00017
    Abstract ( ) PDF ( )
    Objective To explore the differences on contraindication information for children in domestic and foreign drug instructions, and provide reference for improving the relevant information in Chinese drug insert sheets.　Methods Chinese drug insert sheets of chemicals and biological products contained in the China Pharmacopoeia 2020 and those of the western medicines in the 2023 China′s Basic Medical Insurance, Work-related Injury Insurance and Childbirth Insurance Drug Catalog were collected; drugs that were marked as contraindication for children were selected and relevant contraindication information in the Chinese drug insert sheets was collected. Instructions of the above-mentioned drugs approved by the U.S. Food and Drug Administration (English labels) were also collected, and the information on pediatric medication was reviewed and compared with the Chinese drug insert sheets.　Results A total of 222 drugs were labeled as contraindication for children in the Chinese drug insert sheets, of which 149 were available for their English labels; 123 drugs (17.5%) were not labeled as contraindication for children in English labels, and 26 (82.5%) were labeled. The 123 drugs that were not labeled as contraindication for children in the English labels included the following conditions: 58 were labeled as contraindication for children of some age in the Chinese drug insert sheets but not in the English labels, and relevant medication information was provided; 40 were labeled as contraindication for children of some age group in the Chinese drug insert sheets but was described as the effectiveness and safety of the use for children have not yet been determined for this age group in the English labels; 13 were labeled as contraindication for children in the Chinese drug insert sheets, but the medication information on children in the English labels was not clear or missing; 12 were labeled as contraindicated for children in Chinese drug insert sheets but not in the English labels, only expressed as not yet determined or not recommended for use, etc., with inconsistent age group. Among the 26 drugs labeled as contraindication for children in both Chinese and English instructions, the contraindication age group were the same in above 2 instructions for 20 drugs, and were inconsistent for the other 6 drugs; reasons for contraindication were described in both the 2 instructions for 17 drugs (13 were consistent, 4 were inconsistent), only in English labels for 8 drugs, and only in Chinese drug insert sheets for 1 drug.　Conclusions Many drugs are labeled as contraindication for children in Chinese drug insert sheets, but reasons for contraindication are rarely explained. Differences in children′s age in contraindications exist for some drugs between the Chinese drug insert sheets and English labels. The information on contraindications for children in Chinese drug insert sheets still needs to be further improved.
  • Investigation on medical staff′s awareness of pharmacovigilance and the construction of pharmacovigilance system in medical institutions
    Zhang Yi′nan, Li Xinchen, Shi Weizhong, Zhang Li, Li Guoqing, Zhao Zhigang
    2025, 27(6): 348-355. https://doi.org/10.3760/cma.j.cn114015-20240715-00580
    Abstract ( ) PDF ( )
    Objective To investigate the awareness of medical staff on pharmacovigilance and the current situation of the construction of pharmacovigilance system in medical institutions.　Methods A self-designed questionnaire was sent to medical institutions in China through Professional Committee on Pharmacovigilance Research, China Society for Drug Regulation in the form of Wechat, and medical staff participated voluntarily. The contents of the questionnaire included 23 questions in 4 dimensions, including the basic information of the respondents, their understanding of the concept and regulations of pharmacovigilance, the management of pharmacovigilance, and the reporting and feedback of adverse drug reactions(ADRs)/events in their medical institutions. The survey time was from August 18, 2023 to October 18, 2023. The data from the questionnaire were analyzed descriptively.　Results The collected questionnaires were from medical institutions in 31 provinces, autonomous regions, and municipalities directly under the central government, with a total of over 100 questionnaires collected in each region. A total of 10 991 medical staff participated in the survey, including 5 504 pharmacists, 2 120 doctors, and 3 367 nurses. Among them, 10 131 (92.18%) respondents had heard of pharmacovigilance, 4 511 (41.04%) had participated in pharmacovigilance-related works, 9 368 respondents (86.41%) answered that the ADRs monitoring and management system had been established in medical institutions where they worked, 8 186 respondents (75.51%) answered that leading group for pharmacovigilance (including ADRs monitoring) had been set up in the medical institutions where they worked, 8 605 respondents (79.37%) answered that the pharmacovigilance works was managed by special personnel in the institutions where they worked, 7 859 (72.49%) answered that there were liaison officers in the clinical departments where they worked, 6 043 (55.74%) answered that the individuals would be rewarded for reporting ADRs, 4 809 （44.36%） answered that pharmacovigilance had been included in the daily works and assessment indicators of the departments, and 5 351 （49.36%） answered that reports of ADRs were reviewed by special personnel. Active reporting by medical staff was the main collection channel of ADRs, 3 391 (31.28%) answered they had actively captured ADRs from the hospital information system, and 7 728 (71.28%) answered they had reported ADRs through the hospital information system, 10 061 (92.81%) answered that the monitoring results of ADRs would be regularly fed back in the hospitals where they worked, and 6 239 (57.55%) answered that regular training on pharmacovigilance for all medical staff would be provided in the institutions where they worked.　Conclusions Medical staff have generally heard of pharmacovigilance and are aware of the national pharmacovigilance system, but they still have insufficient understanding of the concept and regulations of pharmacovigilance. The degree of participating in pharmacovigilance works of medical staff in different regions are different. The monitoring and management of ADRs could be paid attention to in the most medical institutions, but the degree of improvement of pharmacovigilance system in different levels of medical institutions is different.
  • Research progress on the application and safety of CD20 monoclonal antibody in children with refractory nephrotic syndrome
    Wen Jing, Qin Jianwei, Jiang Weihao, Xu Shitian
    2025, 27(6): 356-361. https://doi.org/10.3760/cma.j.cn114015-20241108-00138
    Abstract ( ) PDF ( )
    The use of CD20 monoclonal antibody in the treatment of children with refractory nephrotic syndrome (RNS) is a novel drug therapy in recent years. Some CD20 monoclonal antibodies have positive efficacy and few adverse reactions, which can reduce the use of hormone drugs and immunosuppressants to a certain extent. However, the treatment of nephrotic syndrome is off-label, and the application time in clinic is not long, especially for children′s RNS, and more high-quality clinical studies are still needed for long-term efficacy and safety. The application and safety research progress of CD20 monoclonal antibody (including rituximab, ofatumumab, obinutuzumab, etc.) in the treatment of children with RNS from the aspects of mechanism of action, clinical application, pharmacokinetic characteristics, adverse reactions monitoring, and prevention are reviewed in this article, so as to provide reference for rational and safe clinical use.
  • Overview of the application of prescription sequence symmetry analysis in pharmacovigilance
    Dou Wei, Liu Xin, Zuo Wei, Yu Jiaxin, Wu Jiayu, Zhang Bo
    2025, 27(6): 362-368. https://doi.org/10.3760/cma.j.cn114015-20240802-00670
    Abstract ( ) PDF ( )
    Prescription sequence symmetry analysis (PSSA) is one of the important methods for post-marketing pharmacovigilance based on the real-world medical prescription databases. It can be used to detect prescription cascades and mine adverse drug reaction (ADR) signals, which has been verified by many studies. PSSA shows high specificity and medium sensitivity in identifying ADR. It can quantify the correlation or risks of ADR. It is easy to use and simple in algorithm, and it has good robustness to some non time-dependent confounding factors. However, the results may be affected by some human confounding factors and data quality. This paper reviews the principle, calculation method, application scope, and precaution of PSSA by reviewing related literature on PSSA domestically and abroad, in order to provide reference for pharmacovigilance in China.
  • Successful treatment of a case of lethal dose of felodipine poisoning with V-A ECMO
    Zhu Xiangyu, Sun Mingyue, Liu Yuan, Zhao Zhikun, Jiang Ping, Pan Weiwei, Wang Ziyu, Zhang Yajuan, Fu Jing, Yang Haichen, Du Yeping, Zhang Jinsong, Shi Yan
    2025, 27(6): 369-371. https://doi.org/10.3760/cma.j.cn114015-20240701-00506
    Abstract ( ) PDF ( )
    A 36-year-old male developed unconsciousness and no response to voice stimuli after taking approximately 2 050 mg felodipine (the specific time was unknown). Two hours later, he was sent to the department of emergency by his family and admitted to the hospital. His vital signs showed body temperature 35.1 ℃, pulse 148 times/min, respiration 32 times/min, and blood pressure 65/34 mmHg. Acute drug poisoning, acute toxic cardiomyopathy, acute toxic shock, acute type Ⅱ respiratory failure, acute toxic encephalopathy, and acute renal failure were diagnosed based on the patient′s clinical manifestations combined with laboratory tests results, cardiac ultrasound, chest and abdominal CT scans. Endotracheal intubation connected to a ventilator for invasive assisted ventilation, pressure boosting, and fluid resuscitation were given. At the same time, repeated gastric lavage and enema were performed to remove toxins. Blood perfusion was intermittently and repeatedly administered, and continuous renal replacement therapy was used. The blood concentration of felodipine was 1 298 μg/L at 2 hours after admission, and cardiac arrest occurred at 4 hours. Venous-arterial extracorporeal membrane oxygenation (V-A ECMO) treatment was administered immediately. After 48 hours of ECMO operation, sedatives were discontinued and the patient′s consciousness was improved after 4 hours. On the 5th day of ECMO treatment, his heart rate was 72 beats per minute, and blood pressure was 127/65 mmHg. The blood concentration of felodipine decreased to 2 μg/L. The patient′s vital signs were significantly improved and ECMO supportive treatment was withdrawn. After 26 days of hospitalization, the patient recovered and was discharged.
  • Adrenal crisis caused by combination chemotherapy with vincristine, etoposide, and carboplatin in a child
    Guo Qing, Wu Yue
    2025, 27(6): 372-374. https://doi.org/10.3760/cma.j.cn114015-20240914-00047
    Abstract ( ) PDF ( )
    A 5-year-old male patient with congenital adrenal hyperplasia and 21-hydroxylase deficiency was treated with intervention, laser, left eye retinoblastoma resection, and retinal repositioning  surgery for left eye retinoblastoma at the age of 2 years and 3 months. At the age of 3 years and 4 months, the child underwent peritoneal tumor resection and partial adrenalectomy for adrenal neuroblastoma. Hydrocortisone 2.5 mg thrice daily orally and fludrocortisone 0.02 mg once daily orally were given regularly for a long time after surgery. Three years after the resection of the left eye retinoblastoma, the tumor recurred and the child underwent another resection and retinal retinal repositioning surgery for the left eye retino- blastoma. After the surgery, he received a combination chemotherapy of vincristine (1.06 mg by intravenous infusion on day 1), etoposide (105 mg by intravenous infusion on days 1-2), and carboplatin (395 mg by intravenous infusion on day 1) (VEC) for left retinoblastoma, with 28 days as one treatment cycle. After 2 days of medication, the child experienced nausea, vomiting, and abdominal discomfort. After 5 days, he developed pale complexion, nausea, vomiting, and poor mental state. Laboratory tests showed cortisol 29.6 μg/L, blood sodium 133 mmol/L, and random blood glucose 2.4 mmol/L. Adrenal crisis caused by VEC chemotherapy was considered. Oral hydrocortisone was stopped and switch to intravenous infusion of hydrocortisone 10 mg thrice daily, while symptomatic treatment such as sodium supplementation was given. After 2 days, the symptoms of the child were improved. After 7 days, the child had no nausea or vomiting, cortisol increased to 291.0 μg/L, and blood sodium and blood glucose returned to normal.
  • Arrhythmia and hypokalemia induced by mistaken use of overdose of procaterol in a child
    Zhi Dongli, He Wei, Zhu Cui
    2025, 27(6): 375-377. https://doi.org/10.3760/cma.j.cn114015-20241008-00080
    Abstract ( ) PDF ( )
    A 9 years and 8 months old girl was prescribed procaterol hydrochloride oral solution (procaterol) 25 μg (5 ml) twice daily for cough and asthma. The girl mistakenly took 25 ml of procaterol because her grandmother thought it was 25 μg. After 30 minutes, the girl developed restlessness, shortness of breath, trembling hands, and vomiting. Physical examination showed heart rate 148 beats/min, cardiac auscultation showed arrhythmia, electrocardiogram showed frequent ventricular premature beat, and labora- tory tests showed blood potassium 2.5 mmol/L. Procaterol poisoning was considered. Oxygen inhalation, electrocardiographic monitoring, metoprolol tartrate tablets 25 mg orally, and symptomatic and supportive treatments such as coenzyme A, adenosine triphosphate, and potassium chloride, were given immediately. Two hours alater, the child′s restlessness disappeared and shortness of breath was improved; the electro- cardiogram reexamination showed no ventricular premature beat. Ten hours later, the heart rate returns to normal. The next day, her blood potassium level returned to normal.
  • Interstitial lung disease due to savolitinib
    Qiu Rui, Luo Mingying, Zheng Gaofeng, Li Jinlan
    2025, 27(6): 377-379. https://doi.org/10.3760/cma.j.cn114015-20241010-00084
    Abstract ( ) PDF ( )
    A 77-year-old male patient with lung adenocarcinoma received targeted therapy with savolitinib 400 mg orally once daily. Eleven days later, he developed fever and chest CT scan revealed interstitial changes in both lungs, which were improved after savolitinib withdrawal and glucocorticoids treatment. The patient was given the same dose of savolitinib orally again. Three days later, the patient′s cough and shortness of breath worsened. Laboratory tests showed percentage of neutrophils 90% and procalcitonin 1.56 μg/L. Chest CT scan indicated interstitial changes in the right lung. The patient was diagnosed with interstitial pneumonia companied with infection, which was considered to be related to savolitinib. Savolitinib was discontinued and glucocorticoids and anti-infective therapy were given. After 14 days, the patient′s cough and shortness of breath were improved, laboratory tests showed percentage of  neutrophils 89% and procalcitonin 0.18 μg/L.
  • Fruquintinib-induced acute myocardial infarction complicated by heart failure
    Zhao Lijuan, Yan Baoqing, Shao Jianzhou, Liu Yupeng
    2025, 27(6): 380-382. https://doi.org/10.3760/cma.j.cn114015-20240926-00063
    Abstract ( ) PDF ( )
    A 75-year-old female patient with postoperative colon cancer received fruquintinib (5 mg once daily, 3 weeks on and 1 week off per 4 week cycle). The patient had normal blood pressure in the past, and approximately one week after medication, she developed hypertension with systolic blood pressure 180-190 mmHg and unknown diastolic pressure. The patient′s blood pressure was with adequate control after self-administration of nifedipine sustained-release tablets twice (20 mg/dose). After 3 weeks of fruquintinib treatment, bilateral lower limb edema occurred in the patient, leading to a 1 week drug discontinuation. Upon resuming the medication for 1 day, the patient suddenly developed dyspnea and loss of consciousness. Chest CT revealed signs of heart failure. Laboratory tests showed high-sensitivity cardiac troponin I (hs-cTnI) 0.27 μg/L, creatine kinase (CK)-MB 7.13 μg/L, myoglobin 132.88 μg/L, and N-terminal pro-B-type natriuretic peptide (NT-proBNP) 4 039.8 ng/L. Fruquintinib was discontinued, and the patient received myocardial nutritional support, diuretics, anticoagulants, hepatoprotective agents, and potassium supplementation, etc. On day 2, the patient regained consciousness with hs-cTnI 0.28 μg/L, CK-MB 4.63 μg/L, myoglobin 34.25 μg/L, and NT-proBNP 10 181.3 ng/L. Antiplatelet therapy, diuretics, lipid-lowering agents, and antihypertensive treatment were initiated. On day 3, color doppler echocardiography confirmed myocardial infarction complicated by heart failure. Fruquintinib-induced acute non-ST-segment elevation myocardial infarction with acute heart failure was considered. On day 6 of fruquintinib discontinuation, NT-proBNP decreased to 295.8 ng/L, and all laboratory test parameters normalized on day 9. One month later, repeated tests showed no abnormalities in the myocardial enzyme.
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