2025 Volume 27 Issue 3 Published: 28 March 2025
  

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  • Expert consensus of clinical application and pharmaceutical care for intravenous iron agents (2024)
    Chinese Pharmacological Society Professional Committee of Drug-induced Diseases, Guangdong Pharmaceutical Association
    2025, 27(3): 129-141. https://doi.org/10.3760/cma.j.cn114015-20240929-00070
    Abstract ( ) PDF ( )
    Iron deficiency is the most common cause of anemia. Intravenous iron is a common therapeutic drug for iron deficiency and iron deficiency anemia, which is commonly used in the treatment of anemia patients with chronic kidney disease, heart failure, inflammatory bowel disease, and cancer, as well as anemia patients in perioperative period and during pregnancy and lactation. In order to strengthen the rational use of intravenous iron and improve the pharmaceutical care level, the Chinese Pharmacological Society Professional Committee of Drug-induced Diseases and the Guangdong Pharmaceutical Association organized experts majoring in medicine, pharmacy, nursing, hospital mana- gement and other specialties to develop this consensus through discussing, retrieving domestic and foreign literature, and collecting evidence-based medical evidence. The differences among intravenous iron agents, clinical situations of applica- tion, and the safety issues are considered in the consensus, in order to provide the basis for the rational application and pharmaceutical care in clinic.
  • Pay attention to the prevention and supervision of kidney injury related to sodium-glucose transporter 2 inhibitors
    Ji Liwei
    2025, 27(3): 142-146. https://doi.org/10.3760/cma.j.cn114015-20240528-00368
    Abstract ( ) PDF ( )
    Sodium-glucose transporter 2 inhibitors (SGLT2i) are currently widely used as a class of hypoglycemic drugs. Due to their unique hypoglycemic mechanism and significant cardio-renal protective effect, SGLT2i have become one of the core drugs in the treatment of type 2 diabetes mellitus. However, in recent years, it has been found that SGLT2i can lead to increased serum creatinine and urea nitrogen in some patients, and the risk of kidney injury has gradually attracted clinical attention. How to effectively prevent and supervise the potential renal injury risk while giving full play to its therapeutic advantages has become an important topic in current clinical practice and drug safety management. Multi-dimensional prevention and supervision strategies should be adopted in clinical practice such as identifying high-risk populations based on the latest evidence, strictly screening patients, dynamically monitoring renal function, optimizing combination medication regimens, and achieving risk warning using biomarkers and artificial intelligence tools.
  • Literature case analysis of Fournier gangrene caused by sodium-glucose cotransporter 2 inhibitors
    Cang Daixiao, Sun Ru'nan, Quan Xianghua, Yang Xue, Xing Xiaomin, Zhao Jun
    2025, 27(3): 147-152. https://doi.org/10.3760/cma.j.cn114015-20240528-00376
    Abstract ( ) PDF ( )
    Objective To analyze the characteristics of Fournier gangrene (FG) induced by sodium-glucose cotransporter 2 inhibitors (SGLT2i), and provide reference for clinical safe drug use.　Methods CNKI, Wanfang Med Online, VIP, PubMed, Web of Science and other databases (up to January 2024) were retrieved and clinical data on patients with FG associated with the 5 kinds of SGLT2i currently used in clinical practice in China were collected and descriptively analyzed, including gender, age, comorbidities, concomitant medications, onset time and clinical manifestations of SGLT2i-related FG, laboratory and imaging examination results, treatment and outcomes, etc.　Results A total of 15 documents were included in the analysis, involving 15 patients, with 12 males and 3 females. The age of these patients ranged from 34 to 72 years, with 11 cases being over 50 years. Dapagliflozin was used in 7 cases, empagliflozin in 6 cases, canagliflozin in 2 cases, and no related reports on ertugliflozin and henagliflozin were collected. The main clinical manifestations of the 15 patients were redness, swelling, pain, abscess or purulent discharge in perineum, scrotum and perianal, etc. The time from application of SGLT2i to onset of FG ranged from 1 month to 6 years. Wound secretion bacterial culture was performed in 10 patients, and the results were all positive, including 9 cases of bacterial infection and 1 case of mixed infection of bacteria and fungi. All 13 patients who underwent imaging examinations had imaging manifestations related to FG. SGLT2i were discontinued in all patients. After treatments with broad-spectrum antibiotics and surgery, 14 cases were improved and 1 case was cured.　Conclusions SGLT2i has the risk of causing FG, which is more common in males. The clinical use of SGLT2i should be monitored closely. Secretion culture and imaging examination are helpful for the diagnosis of FG. The patient′s prognosis is good after discontinuation of medication, symptomatic treatment, and surgery.
  • Adverse event signal mining of semaglutide and liraglutide for weight management: a study based on the FDA Adverse Event Reporting System database
    Li Baojian, Hu Xiaoling, Yue Zichen
    2025, 27(3): 153-161. https://doi.org/10.3760/cma.j.cn114015-20240614-00446
    Abstract ( ) PDF ( )
    Objective To mine the adverse event (AE) risk signals of semaglutide and liraglutide in weight management populations, and provide references for the safe use of these drugs in relevant patients.　Methods The reporting odds ratio (ROR) method, proportional reporting ratio (PRR) method, Bayesian confidence propagation neural network (BCPNN) method, and empirical Bayesian geometric mean (EBGM) method were used to mine the AE risk signals of semaglutide and liraglutide in weight management populations from the US Food and Drug Administration Adverse Event Reporting System (FAERS) database from the 1st quarter of 2010 to the 4th quarter of 2023. Adverse events that met the criteria of all 4 mining methods were considered as risk signals. The adverse events were classified and statistically analyzed using the system organ class (SOC) and preferred term (PT) of the 26.1 version of the Medical Dictionary for Regulatory Activities 26.1 version, and the identified risk signals were analyzed.　Results During the set period, 2 292 AE reports for semaglutide for weight management (excluding diabetes) and 2 973 for liraglutide were retrieved. The semaglutide-related AE reports involved 83 PTs, among which 57 were already recorded in the instructions and 26 were not. Among the 26 PTs not recorded in the labels, the top 5 PTs in terms of AE report numbers were increased appetite, hunger, panic attack, binge eating, and feeling cold; the top 5 PTs in terms of ROR values were lack of satiety, hunger-induced ketoacidosis, myoglobinuria, binge eating, and bulimia. The liraglutide-related AE reports involved 74 PTs, among which 60 were already recorded in the instructions and 14 were not. Among the 14 PTs not recorded in the labels, the top 5 PTs in terms of AE report numbers were weight gain, increased appetite, binge eating, weight fluctuation, and pancreatic cyst; the top 5 PTs in terms of ROR values were lack of satiety, binge eating, hepatic adenoma, increased appetite, and pancreatic cyst. Three PTs of severe AEs that were not recorded in the labels for semaglutide were identified, namely, olfactory abnormality, ketoacidosis, and panic attack. One PT of severe AE that was not recorded in the labels for liraglutide was identified, namely, metastatic pancreatic cancer.　Conclusion The AE risk signals of semaglutide and liraglutide in weight management include AEs not recorded in the labels, and some are even serious AEs, which need to be identified and prevented in clinical practice.
  • Analysis of influencing factors and construction of risk prediction model for cardio-cerebrovascular complications in patients with type 2 diabetes mellitus
    Rui Min, Wang Jianjie, Ling Zhigang
    2025, 27(3): 162-168. https://doi.org/10.3760/cma.j.cn114015-20240613-00439
    Abstract ( ) PDF ( )
    Objective To understand the influencing factors for cardio-cerebrovascular complications in patients with T2DM and construct a nomogram risk prediction.　Methods The study design was a prospective observational study, and the subjects were selected from hospitalized patients with T2DM admitted to Huangshan City People′s Hospital from May 2022 to April 2023. Data on patients' gender, age, body mass index, alcohol consumption, smoking status, family history of cardio-cerebrovascular diseases, insulin use, duration of diabetes, blood pressure, and routine laboratory test results were collected using the hospital electronic medical record system. At discharge, patients were assessed using the T2DM-Specific Medication Belief Scale (total score range: 10-50), Medication Literacy Assessment Scale (total score range: 0-7), and Morisky Medication Adherence Scale (total score range: 0-8). Patients were followed up by telephone for 6 months after discharge and divided into 2 groups based on the occurrence of cardio-cerebrovascular complications. Logistic regression analysis was performed using SPSS 26.0 software to identify influencing factors for cardio-cerebrovascular complications in T2DM patients. A nomogram prediction model was constructed using R 4.1.0 software, and internal validation of the model was conducted using the Bootstrap method.　Results A total of 294 T2DM patients were included in the analysis. The medication belief score was (32.6±5.6) score, the medication literacy score was (4.2±0.5) score, and the medication adherence score was (6.1±0.8) score. During the 6 month follow-up, a total of 43 patients (14.6%) experienced cardio- cerebrovascular complications, including of coronary heart disease (23 cases), heart failure (12 cases), and stroke (8 cases). Compared to patients without cardio-cerebrovascular complications, patients with complications had higher body mass index, glycosylated hemoglobin A1c (HbA1c), D-dimer, and uric acid levels, as well as lower medi- cation belief scores, medication literacy scores, and medication adherence scores (all P<0.05). Binary logistic regression analysis showed that HbA1c, D-dimer, uric acid, medication belief, medication literacy, and medication adherence were influencing factors for cardio-cerebrovascular complications in T2DM patients. Accordingly, a nomogram prediction model was established. Internal validation results of the model showed that the concordance index was 0.958, the area under the receiver operating characteristic curve was 0.824, and the calibration curve was close to the ideal curve.　Conclusions The current status of medication belief, medication literacy, and medication adherence in T2DM patients was not ideal. High levels of HbA1c, D-dimer, and uric acid, as well as poor medication belief, medication literacy, and medication adherence were risk factors for cardio-cerebrovascular complications in T2DM patients. The nomogram model, which integrated multiple influencing factors, had high value in predicting the risks.
  • Investigation of the current preparation status and analysis of the application on first-aid drugs of rescue vehicles in children′s medical institutions in China
    Xue Zhimin, Fan Huixia, Gao Ming′e, Lu Taotao
    2025, 27(3): 169-175. https://doi.org/10.3760/cma.j.cn114015-20240428-00283
    Abstract ( ) PDF ( )
    Objective To analyze the current preparation and usage situation of first-aid drugs in the rescue vehicles in children′s medical institutions, and provide references for optimizing the list of emergency drugs.　Methods First-aid drug lists in the rescue vehicles of 12 children′s medical institutions from 11 provinces and municipalities in China were collected through questionnaire surveys, and the drugs as well as their quantities were compared. The existing problems in the use of first-aid drugs in the 12 medical institutions were investigated by on-site interviews. The usage information of first-aid drugs in the rescue vehicles of the General Surgery and Cardiology Department of Shanxi Children′s Hospital from May 2022 to April 2023 was collected through the hospital information center, and usage frequency and dosage per patient of the drugs were calculated. Descriptive statistical analysis was conducted on the collected data.　Results The first-aid drug lists in 12 hospitals were various, including 7 to 22 kinds of drugs and invol- ving a total of 23 drugs. These mainly included vasoactive drugs, cardiotonic drugs, antiarrhythmic drugs, antiangina and anti-ischemic drugs for the heart, antispasmodic drugs, diuretics, dehydrating drugs, sedative-hypnotic drugs, and glucocorticoids, all of which were injections. The drugs that were included in all the lists of 12 hospitals were epinephrine, dopamine, dexamethasone, furosemide, and atropine. The drug lists of different rescue vehicles throughout the hospital were the same in 4 hospitals, while the lists varied among departments based on their specific clinical needs in the other 8 hospitals. None of the 12?hospitals had a first?aid drug usage manual. The on?site interview results showed that, the existing problems about drug prepa- ration and use in rescue vehicles mainly involved the following 6 aspects: drug types, quantities, labels, storage, procurement, and usage. In Shanxi Children′s Hospital, the types and quantities of first?aid drugs in rescue vehicles of General Surgery Department and Cardiology Department were the same. There were 6 and 9 kinds of drugs were used in the 2 departments during rescue operations, respectively. The drugs that were never used in either department included promethazine, lidocaine, diazepam, phenobarbital, raceanisodamine, sodium bicarbonate, atropine, glucose, and calcium gluconate.　Conclusions The phenomenon of unreasonable kinds and quantities of first?aid drugs in the rescue vehicles existed in the children′s medical institutions, and the drugs provided did not fully match the actual clinical needs. There was an urgent need for preparation guidelines and usage manuals of first?aid drugs that were suitable for children′s medical institutions to enhance the scientificity of drug supply and the correctness of usage.
  • Investigation and analysis on safety of empirical or experimental medication for adult-onset Still disease before diagnosis
    Cong Shan, Liu Yiming, Wei Xianping, Hou Jiqiu, Chen Junjun, Wang Dongxue
    2025, 27(3): 176-181. https://doi.org/10.3760/cma.j.cn114015-20240603-00410
    Abstract ( ) PDF ( )
    Objective To investigate and analyze the safety of empirical or experimental medication (EEM) for adult-onset Still disease (AOSD) before diagnosis.　Methods The AOSD inpatients admitted to the Second Hospital of Jilin University from January 1, 2019 to December 31, 2023 were collected through hospital information system, and those who were misdiagnosed on admission were screened out. The main clinical characteristics, laboratory tests, misdiagnosis situation, the use of EEM and their adverse drug reactions (ADR), and the potential drug-drug interactions in the misdiagnosed patients were analyzed by descriptive statistics.　Results During the set time period, a total of 49 patients with AOSD were admitted to the hospital, of which 16 (32.7%) were misdiagnosed with other diseases on admission. Among the 16 patients, 10 were male and 6 were female, with a median age of 53 years. The main clinical manifestations were fever (in 15 patients), arthralgia/arthritis (in 10 patients), lymphadenopathy (in 10 patients), rash (in 9 patients), pleural or pericardial effusion (in 6 patients), pneumonia (in 5 patients), splenomegaly (in 4 patients) and sore throat (in 4 patients). Abnormalities in laboratory tests included white blood cell count elevation (in 13 patients), platelets count elevation (in 8 patients), serum ferritin elevation (>500 μg/L, in 12 patients), and abnormal liver function (in 9 patients). The median time of treatment before admission was 5.5 months (11 days to 27.0 months), and the median time from admission to diagnosis of AOSD was 12 days. Before the diagnosis of AOSD, all patients received a long time of EEM, including antibiotics, traditional Chinese medicine preparations, liver-protection drugs, anti- allergic drugs and antiviral drugs in 15, 12, 11, 3 and 2 patients, respectively. Four patients experienced ADRs related to EEM, all of which were caused by antibiotics. There were potential interactions in the therapeutic drugs in 4 patients.　Conclusion The misdiagnosis rate of AOSD was high. Patients might had accepted multiple EEMs before the definite diagnosis, which posed risks of ADRs and drug interactions.
  • Research progress of increased heart rate related to glucagon- like peptide- 1 receptor agonists#br#
    Wang Li, Zhang Xusheng, Ren Xiuli, Shen Chengwu, Lu Cuicui
    2025, 27(3): 182-187. https://doi.org/10.3760/cma.j.cn114015- 20240508- 00315
    Abstract ( ) PDF ( )
    Glucagon- like peptide- 1 receptor agonists (GLP- 1RA) have been widely used in the treatment of type 2 diabetes mellitus (T2DM). However, the acceleration of heart rate caused by GLP- 1RA should not be ignored. In the general population and patients with diabetes, increased heart rate has an independent correlation with the incidence and mortality of cardiovascular diseases. In general, the long- acting GLP- 1RA seem to exert a greater effect in increasing heart rate, and the effect is dose- dependent and negatively correlated with baseline heart rate. The increase in heart rate caused by GLP- 1RA may be related to enhanced sympathetic nervous activity, reflex tachycardia as a response to vasodilation, etc. It is advisable to closely monitor the increased heart rate induced by GLP- 1RA in clinical practice, especially in patients with high- risk factors for cardiovascular disease. In case of elevated heart rate, the management begins with immediate discontinuation of the GLP- 1RA and symptomatic intervention should be given if necessary.
  • Adalimumab-induced cervical lymph node tuberculosis
    Wu Guiying, Mu Guilan, Wuriliga, Li Hongbin, Wang Yong, Bai Lijie
    2025, 27(3): 188-189. https://doi.org/10.3760/cma.j.cn114015- 20240103- 00002
    Abstract ( ) PDF ( )
    A 38- year- old male patient with ankylosing spondylitis received subcutaneous injection of adalimumab 40 mg once every 2 weeks. After 21 months of medication, the patient developed fever, fatigue, swelling, and pain in the right neck lymph node and throat. Laboratory tests showed that the tuberculin test was strong positive, mycobacterium tuberculosis γ- interferon release test was 1  911.98  ng/L, and erythrocyte sedimentation rate was 27  mm/1 h. The biopsy of right neck lymph node showed granulomatous inflammation of the lymph node. The patient was diagnosed with cervical lymph node tuberculosis, which was considered to be related to adalimumab. The drug was stopped and anti-tuberculosis treatments were given. The next day, the patient′s temperature returned to normal. After 5 days, the swelling and pain of cervical lymph nodes and throat, and the fatigue were relieved gradually. After 45 days, the above symptoms in the patient disappeared.
  • Thrombotic thrombocytopenic purpura induced by penpulimab and sintilimab
    Zhang Li‘na, Wang Quan, Gao Jian, Fang Wei, Gao Na, Li Jinfeng
    2025, 27(3): 190-192. https://doi.org/10.3760/cma.j.cn114015-20240510-00331
    Abstract ( ) PDF ( )
    A 52-year-old male patient with recurrent Hodgkin′s lymphoma was treated with a combination therapy of gemcitabine, oxaliplatin, and sintilimab for 6 cycles, and sintilimab monotherapy for 15 cycles. Because of disease progression, the therapy was switched to decitabine (10 mg intravenous infusion on day 1-5) and penpulimab (200 mg intravenous infusion on day 8), with 21 days as one cycle. On the 5th day after the last administration of the 10th cycle, the patient experienced discomfort such as headache and poor appetite; on the 7th day, he suddenly developed unconscious and faint. The patient had a body temperature of 38.1 ℃ and mild yellowish skin and mucous membranes throughout the body. Laboratory tests showed platelet count 9×109/L, red blood cell count 4.1×1012/L, hemoglobin 113 g/L, pro- thrombin time 15.6 s, blood creatinine 101.6 μmol/L, total bilirubin 61.1 μmol/L, and creatine kinase isoenzyme 43 U/L. Based on laboratory and imaging examinations, immune checkpoint inhibitors causing acquired thrombotic thrombocytopenic purpura was considered. The patient underwent 3 times of plasma exchanges, and received intravenous infusion of methylprednisolone 80 mg once daily and other symptomatic treatments for 5 days. The patient′s yellowish skin and mucous membranes throughout the body disappeared. The glucocorticoid was decreased gradually. Two months later, the patient′s laboratory test indicators such as platelet count and total bilirubin returned to normal.
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