2025 Volume 27 Issue 4 Published: 28 April 2025
  

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  • Analysis on the occurrence and influencing factors of adverse drug reactions during long-term therapy with vedolizumab in patients with inflammatory bowel diseases
    Xie Dong, Cao Xiaocang, Yuan Hengjie, Li Zhengxiang
    2025, 27(4): 193-199. https://doi.org/10.3760/cma.j.cn114015-20240711-00558
    Abstract ( ) PDF ( )
    Objective To analyze the occurrence and influencing factors of adverse reactions in patients with inflammatory bowel disease (IBD) during the long-term treatment with vedolizumab （VDZ）.　Methods The study was a retrospective observational design. The study subjects were selected from patients who long-termly used VDZ to treat moderate-to-severe active IBD in Tianjin Medical University General Hospital from February 1, 2021 to December 31, 2023. Clinical data of patients were collected through the hospital system of clinical pharmacy management, including general information, IBD condition, VDZ maintenance treatment plan, combination of drugs, laboratory test results, etc. The adverse reactions of VDZ were screened and their clinical manifestations, severity, intervention and outcomes were analyzed descriptively. The patients were divided into 2 groups according to whether VDZ adverse reactions occurred, and the differences in clinical data between them were compared; the influencing factors of adverse reactions were analyzed by multivariate logistic regression method.　Results A total of 142 patients were included in the study, including 81 males and 61 females, aged (37.6±6.4) years with a range from 18 to 57 years. There were 103 patients (72.5%) developed VDZ adverse reactions, which mainly involved skin (52 patients, account for 50.5%), digestive system (33 patients, account for 32.0%) and respiratory system (18 patients, account for 17.5%). All 103 patients did not stop VDZ treatment, and the adverse reaction symptoms disappeared or were relieved after symptomatic treatments. Compared with patients without VDZ adverse reactions, the age of patients with VDZ adverse reactions were higher [(39.5±5.4) years vs. (32.4±6.7) years], and the proportions of patients with chronic relapsing clinical type [65.0%(67/103） vs. 41.0%(16/39)], severe disease activity [60.2%(62/103） vs. 33.3%(13/39)], combined drug use [67.0%(69/103） vs. 46.2%(18/39)], and injecting VDZ once every 4 weeks during maintenance treatment [27.2%(28/103） vs. 10.3%(4/39)] in the group were larger, with statistical significance (all P<0.05). Multivariate logistic regression analysis showed that the chronic relapsing clinical type ［odds ratio (OR)=1.012, 95% confidence interval (CI): 1.001-1.028, P=0.002］, severe disease activity (OR=1.096, 95%CI: 1.010-1.158, P=0.040), combination drugs (OR=1.035, 95%CI: 1.003-1.122, P=0.041), VDZ maintenance therapy injection interval of 4 weeks (OR=1.014, 95%CI: 1.002-1.113, P=0.005) were the risk factors for VDZ adverse reactions.　Conclusions Among IBD patients receiving long-term treatment of VDZ, the incidence of adverse reactions of VDZ was 72.5%, mainly involving skin, digestive system and respiratory system. Symptomatic treatments could be given, and the prognosis was good. Patients with chronic relapsing clinical type, severe disease activity, com- bination therapy, and shorter VDZ maintenance injection interval were at higher risk of adverse reactions.
  • Literature case analysis of nivolumab-induced Stevens-Johnson syndrome/toxic epidermal necrolysis
    Wang Li, Ren Xiuli, Zhang Mei, Lin Zehui, Zhang Xusheng, Lu Cuicui
    2025, 27(4): 200-206. https://doi.org/10.3760/cma.j.cn114015-20240611-00436
    Abstract ( ) PDF ( )
    Objective To explore the clinical features of nivolumab-induced Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN).　Methods Relevant databases at home and abroad (as of December 31, 2023) were searched to collect case reports of nivolumab-induced SJS/TEN, and the demographic characteristics, nivolumab application, combination drugs, clinical manifestations, intervention measures, and outcomes were extracted and analyzed descriptively and statistically.　Results A total of 27 case reports were included and 29 patients were enrolled in the study, including 18 males and 11 females. The age ranged from 45 to 86 years, with an average age of 67 years. The primary diseases were mainly melanoma, stomach cancer, and lung cancer. Twelve patients had records of nivolumab administration, and the dosage was within the recommended range in the labels; 13 patients had records of combination drugs, mainly other antineoplastic drugs, hypoglycemic drugs, antihypertensive drugs, lipid-regulating drugs, etc. The time from using nivolumab to the diagnosis of SJS/TEN was 7 d to 3 years, and 20 patients were <8 weeks. The clinical manifestations were mainly diffuse erythema, flaky skin peeling and erosion, mucosal involvement, etc. Sixteen patients had skin biopsy records, all of which met the histopathological characteristics of SJS/TEN. After the diagnosis of SJS/TEN, 17 patients discontinued nivolumab and received symptomatic treatments, of which 15 patients had improved skin symptoms, one patient had worsened skin symptoms, and one patient had no record of skin outcome; 12 patients had no record of whether or not discontinuing nivolumab, of which 8 patients had improved skin symptoms, 2 patients had worsened skin symptoms, one patient had no record of skin outcome, and one had no record of prognosis. One patient rechallenged nivolumab, severe SJS/TEN recurred. Thirteen of 29 patients died. Of them, 1 died due to cardiac arrest, 4 due to worsened skin rash, and 8 due to primary disease progression.　Conclusions SJS/TEN caused by nivolumab mostly occurs within 8 weeks of treatment, and the clinical manifestations were similar to those caused by other drugs. The mortality rate of nivolumab-induced SJS/TEN is high, and skin rash could be improved after withdrawal of nivolumab and symptomatic treatments.
  • Adverse events in mavacamten treatment for hypertrophic cardiomyopathy: a study based on the US FDA Adverse Event Reporting System database
    Yan Yilong, Zhang Yi'nan, Zhao Zhigang
    2025, 27(4): 207-211. https://doi.org/10.3760/cma.j.cn114015-20240620-00473
    Abstract ( ) PDF ( )
    Objective To mine the risk signals of adverse events (AEs) in mavacamten treatment for hypertrophic cardiomyopathy, and provide reference for safe use of the drug in clinic.　Methods AE reports on mavacamten from June 2022 to June 2024 were collected by searching US Food and Drug Adminis- tration Adverse Event Reporting System (FAERS) database. AEs were classified and standardized according to the system organ class (SOC) and preferred term (PT) of Medical Dictionary for Regulatory Activities version 26.1. Reporting odds ratio (ROR) method and comprehensive standard method of the UK Medicines and Healthcare Products Regulatory Agency (MHRA) were used to mine the AE risk signals. An AE that simultaneously met the criteria of ≥3 reports, lower limit of the 95% confidence interval (CI) of ROR >1, PRR ≥2, and χ2 ≥4 was defined as a risk signal. Descriptive statistical analysis on signals was performed.　Results A total of 1 041 AE reports were collected, involving 47 PTs and 12 SOCs. The top 10 risk signals based on the number of AE reports were dyspnea, dizziness, fatigue, atrial fibrillation, cardiac failure, palpitation, nasopharyngitis, chest pain, COVID-19, and weight increased. Except dizziness and heart failure, above AEs were not recorded in the label. The top 10 risks in signal intensity were acquired left ventricle outflow tract obstruction, transvalvular pressure gradient increased, cardiovascular symptom, echocardiogram abnormal, hypervolaemia, left ventricular failure, ejection fraction decreased, coronavirus infection, brain fog, and atrial fibrillation. Except cardiovascular symptom, left ventricular failure, and ejection fraction decreased, above AEs were not recorded in the label.　Conclusions The AE risk signals of mavacamten in the treatment for hypertrophic cardiomyopathy recorded in the label are mainly heart failure and ejection fraction decreased. Clinicians and pharmacists should also be vigilant against risk signals not recorded in the lakel, such as atrial fibrillation, fatigue, nasopharyngitis, coronavirus infection, and brain fog, etc.
  • Study on risk factors of hypocalcemia in middle and advanced stages of chronic kidney disease patients with hyperkalemia and non-dialysis after potassium lowering therapy
    Wang Daoyan, Gao Yanli, Sun Zuoyan, Chen Zhongguang
    2025, 27(4): 212-217. https://doi.org/10.3760/cma.j.cn114015-20250103-00007
    Abstract ( ) PDF ( )
    Objective To analyze the risk factors of hypocalcemia in 3-5 stages of chronic kidney disease (CKD) patients with hyperkalemia and non-dialysis after potassium lowering therapy.　Methods Clinical data of 3-5 stages of CKD patients with hyperkalemia and non-dialysis treated in Linyi Central Hospital from January 2019 to November 2024 were collected through the electronic medical record system. According to whether the corrected calcium level after potassium lowering treatments was lower than 2.12 mmol/L, the patients were divided into hypocalcemia group and non-hypocalcemia group. The gender, age, body mass index, primary disease, disease duration, comorbidity, use of potassium lowering drugs, concomitant medication, and blood potassium, corrected calcium, carbon dioxide binding capacity, blood magnesium, blood phosphorus, estimated glomerular filtration rate, and total parathyroid hormone before potassium lowering treatments between the 2 groups were compared. Multiple logistic regression analysis was used to identify the risk factors for hypocalcemia in 3-5 stages of CKD patients with hyperkalemia and non-dialysis after potassium lowering therapy.　Results A total of 260 patients were entered, including 58 with blood calcium lower than 2.12 mmol/L, and incidence of hypocalcemia was 22.3%. The differences in the baseline corrected calcium, blood phosphorus, carbon dioxide binding capacity, estimated glomerular filtration rate, and total parathyroid hormone between the hypocalcemia group and the non-hypocalcemia group were statistically significant (P<0.05). The factors with P<0.1, including primary disease, baseline corrected calcium, blood phosphorus, carbon dioxide binding capacity, estimated glomerular filtration rate, and total parathyroid hormone, were included in the multivariate logistic regression analysis. The results showed that the probability of hypocalcemia at baseline corrected calcium levels of 2.12-2.21, 2.22-2.31, and 2.32-2.41 mmol/L was 49.306 times, 13.651 times, and 13.342 times that of at ≥2.42 mmol/L, respectively. Low carbon dioxide binding capacity (odds ratio=0.909, 95% confidence interval: 0.836-0.987) was also a risk factor of hypocalcemia in 3-5 stages CKD patients with hyperkalemia and non-dialysis after potassium lowering therapy.　Conclusions Three to five stages of CKD patients with hyperkalemia and non- dialysis are prone to hypocalcemia after potassium lowering therapy. The low levels of baseline corrected calcium and carbon dioxide binding may be closely related to the occurrence of hypocalcemia in 3-5 stages of CKD patients with hyperkalemia and non-dialysis after potassium lowering therapy.
  • Quality evaluation of adverse drug reaction reports based on weighted TOPSIS-RSR model
    Wu Liang, Chen Jingbao, Chen Xiaoxiao, Jiang Shanyue, Shen Yun
    2025, 27(4): 218-224. https://doi.org/10.3760/cma.j.cn114015-20240719-00606
    Abstract ( ) PDF ( )
    Objective To understand the quality of adverse drug reaction (ADR) reports in Lu′an Hospital of Traditional Chinese Medicine (our hospital) and its change trend in recent years, and explore the methods of objectively evaluating the quality of ADR reports.　Methods According to the 20 evaluation indicators of the ADR report quality evaluation scoring table in the Appendixes 5 of Provisions for Adverse Drug Reaction Reporting and monitoring, the ADR reports submitted to the National Center for ADR Monito- ring from 2013 to 2022 by our hospital were evaluated. The weighted technique for order preference by similarity to ideal solution (TOPSIS) combined with rank-sum ratio (RSR) model was used to rank the quality of ADR reports into the following 5 grades: excellent, good, medium, qualified and unqualified, according to the weight of each evaluation index. The quality grading results were tested to determine the rationality of grading.　Results A total of 3 947 ADR reports were included in the analysis, including 1 361 new/serious ADR reports (34.5%), and the average score of quality evaluation index was 87.9. After 2016, the number of ADR reports and the proportion of reports with scores ≥ 80 increased-significantly. Among the 20 evaluation indicators, 10-had a high pass rate, 7 had a medium or upper pass rate, and 3 had a low pass rate. The TOPSIS-RSR model was used to classify the quality of ADR reports. The overall proportions of excellent, good, moderate, qualified, and unqualified reports were 4.7% (186/3 947), 23.0% (908/3 947), 45.3% (1 787/3 947), 23.4% (925/3 947), and 3.6% (141/3 947), respectively. The homogeneity of variance test showed that each grade met the homogeneity of variance, and the analysis of variance results showed that the differences between every 2 grades were statistically significant (P<0.001), indicating that the quality grading was reasonable.　Conclusions After 2016, the quantity and quality of ADR reports in our hospital have significant improvement, but there are still some evaluation indicators with low pass rate. Using the weighted TOPSIS-RSR model to grade the quality of ADR reports can more objectively reflect the quality of ADR reports.
  • Safety analysis of different types of influenza vaccines in Fujian Province from 2019 to 2023
    Lin Zhiqiang, Xiao Jianxiong, Wu Ruihong, Pan Weiyi, Chen Zhifei, Wang Qin
    2025, 27(4): 225-231. https://doi.org/10.3760/cma.j.cn114015-20240620-00476
    Abstract ( ) PDF ( )
    Objective To analyze and compare the reporting data of adverse events following immunization (AEFI) of influenza vaccines in Fujian Province from 2019 to 2023.　Methods Using the National Immunization Program Information Management System, the AEFI reports and vaccination data of influenza vaccines in Fujian Province from 2019 to 2023 were collected, and the reporting rates and clinical characteristics of AEFI of 6 types of influenza vaccines were compared. The 6 types of vaccines in the analysis were as follows: trivalent inactivated influenza vaccines (IIV3) for 6-35 months old people, IIV3 for ≥3 years old people, trivalent live attenuated nasal spray vaccine (LAIV3) for 3-17 years old people, quadrivalent inactivated influenza vaccines (IIV4) for 6-35 months old people, IIV4 for ≥6 months old people, and IIV4 for ≥3 years old people.　Results From 2019 to 2023, a total of 87 687.21 million doses of influenza vaccine were vaccinated in Fujian Province, and 510 cases of AEFI were reported, with a reporting rates of 5.82 per 100 000 doses. Among the 510 cases, 443 (86.86%) were general reactions, 56 (10.98%) were abnormal reactions, 1 (0.20%) was psychogenic reactions, and 10 (1.96%) were coincidence. There were no reports of vaccination accidents and vaccine quality accidents. The reporting rates of AEFI were relatively higher in 2019 and 2020 (18.38 and 18.00 per 100 000 doses, respectively), and lower in 2021, 2022 and 2023 (8.91, 10.68 and 2.30 per 100 000 doses, respectively); the differences were statistically significant (all P<0.05). The differences of reporting rates of AEFI between  IIV3 for 6 35 months old people and IIV4 for 6-35 months old people, the injectable vaccines and nasal spray vaccines were not statistically significant. However, the reporting rates of overall AEFI, general reactions and abnormal reactions of IIV3 for ≥3 years old people were all higher than those of IIV4 for ≥3 years old people (7.77 per 100 000 doses vs. 3.88 per 100 000 doses, 6.18 per 100 000 doses vs. 3.59 per 100 000 doses, 1.41 per 100 000 doses vs. 0.19 per 100 000 doses). The reporting rates of overall AEFI and general reaction of IIV3 for 6-35 months old people were both higher than those of IIV3 for ≥3 years old (16.47 per 100 000 doses vs. 7.77 per 100 000 doses, 13.05 per 100 000 doses vs. 6.18 per 100 000 doses), and the differences were statistially significant (all P<0.05). The reporting rates of general abnormal reactions of IIV4 for 6-35 months old and ≥ 6 months old people were both higher than those of IIV4 for ≥3 years old people (14.73 per 100 000 doses and 9.52 per 100 000 doses vs. 3.88 per 100 000 doses); the reporting rates of general reactions and abnormal reactions of IIV4 for ≥6 months old people were both higher than those of IIV4 for ≥3 years old people (12.94 per 100 000 doses vs. 3.59 per 100 000 doses, 1.34 per 100 000 doses vs. 0.19 per 100 000 doses), the dif- ferences were statistcially significant (all P<0.05). In terms of clinical features, the reporting rates of fever (37.6-38.5 ℃ and ≥ 38.5 ℃), local redness and swelling (diameter 2.6-5.0 cm), and local induration (diameter  ≤2.5 cm and 2.6-5.0 cm) after vaccination of IIV3 for ≥3 years old people were higher than those of IIV4  for ≥ 3 years old people (1.41 per 100 000 doses vs. 0.64 per 100 000 doses, 3.00 per 100 000 doses vs. 1.16 per 100 000 doses); the reporting rates of allergic rash and angioedema of IIV3 for ≥ 3 years old people were higher than those of IIV4 for ≥3 years old people (0.53 per 100 000 doses vs. 0.12 per 100 000 doses, 0.35 per 100 000 doses vs. 0); the differences were statistically significant (all P<0.016 7).　Conclusions The reporting rates of AEFI for influenza vaccines in Fujian Province from 2019 to 2023 was showing a downward trend. The AEFI was mainly general reactions. The reporting rates of AEFI were different among dif- ferent influenza vaccines, but the overall safety was good.
  • Research progress of biomarkers in immune-related adverse events caused by immune checkpoint inhibitors
    Tang Yiheng, Cai Dachuan
    2025, 27(4): 232-237. https://doi.org/10.3760/cma.j.cn114015-20240729-00656
    Abstract ( ) PDF ( )
    Immune checkpoint inhibitors (ICIs) are widely used in the treatment of various malignant tumors. While achieving therapeutic benefits, immune-related adverse events (irAEs) caused by ICIs have also drawn clinical attention. irAEs can affect almost all organs in the body, and the diversity of clinical manifestations increases the difficulty for clinicians and pharmacists to diagnose and intervene. Therefore, finding reliable biomarkers that can accurately predict and diagnose irAEs has significant clinical value. This article reviews the research progress of biomarkers of ICIs-related adverse events, providing a reference for the safe application of these drugs in clinical treatment.
  • Research progress on anti-inflammatory mechanism and safety of traditional Chinese medicine in the treatment of epilepsy
    Hu Ya'nan, Yue Wei, Ling Ling, Zhang Jinwei
    2025, 27(4): 238-244. https://doi.org/10.3760/cma.j.cn114015-20241109-00140
    Abstract ( ) PDF ( )
    Neuroinflammatory response runs through the pathological process of epilepsy, and the regulation of proinflammatory factors such as (tumor necrosis factor-α, TNF-α), (interleukin, IL)-1β, IL-6 and Toll-like receptors 4/nuclear factor-kappa B signaling pathways may help improve epilepsy symptoms. Traditional Chinese medicines with anti-epileptic effects can be mainly divided into the following 6 categories: Pinggan Xifeng drugs (平肝息风药, liver-calming and wind-extinguishing herbs), Qingre drugs (清热药, heat-clearing drugs), Huatan drugs (化痰药, phlegm-relieving drugs), Huoxue Huayu drugs (活血化瘀药, circulation-promoting and stasis-removing drugs), Buxu drugs (补虚药, tonifying drugs), and Kaijiao drugs (开窍药, consciousness-restoring drugs). The active ingredients contained in these traditional Chinese medicines can play a therapeutic role in epilepsy treatment by regulating the release of key proinflammatory factors and inflammatory signaling pathways. Adverse reactions caused by Chinese patent medicines involve a variety of factors, which can be summarized into the process of medicinal materials preparation, the principle of traditional Chinese medicine compatibility, the accuracy of dialectical treatment, individual differences, etc. When using anti-epileptic Chinese medicine in clinical practice, it should be flexibly applied according to specific conditions to achieve the goal of precise treatment.
  • Renal insufficiency induced by anaplastic lymphoma kinase inhibitors
    Wu Haiting, Wang Hanping, Ye Wei, Li Xuemei, Zheng Ke
    2025, 27(4): 245-247. https://doi.org/10.3760/cma.j.cn 114015-20240711-00533
    Abstract ( ) PDF ( )
    A 66-year-old female patient with lung adenocarcinoma was treated with crizotinib  ［the first-generation anaplastic lymphoma kinase (ALK) inhibitors］ 250 mg twice daily. Prior to treatment, the patient's liver and kidney functions were normal. One month after treatment, her serum creatinine (Scr) was 85 μmol/L, and alanine aminotransferase (ALT) was 115 U/L. After discontinuing crizotinib for 10 days, both Scr and ALT returned to normal. One month later, the patient underwent a right lower lobectomy. Crizotinib was restarted postoperatively, and she developed symptoms of lower limb edema and poor appetite. After more than 3 months of treatment, her Scr increased to 129 μmol/L, ALT was 96 U/L, and aspartate aminotransferase (AST) was 83 U/L. Crizotinib was then switched to alectinib (the second- generation ALK inhibitors) 600 mg orally twice daily, and the patient′s gastrointestinal symptoms and liver function were rapidly improved. However, her Scr continued to increase gradually (140 -150 μmol/L). Renal biopsy pathology indicated IgA nephropathy and acute tubular injury. After 4 months of alectinib treatment, Scr was 174 μmol/L, and the drug was promptly discontinued. One month after discontinuation, Scr decreased to 125 μmol/L. Due to tumor progression, the patient restarted alectinib at a reduced dose (300 mg twice daily). Three months later, Scr increased to 177 μmol/L. Subsequently, alectinib was replaced with lorlatinib (the third-generation ALK inhibitors) 100 mg once daily due to tumor progression. After 6 months of treatment, the tumor condition was controlled, and Scr decreased to 124 μmol/L.
  • Venetoclax-induced tumor lysis syndrome
    Guo Ningning, Zhang Yanli
    2025, 27(4): 248-251. https://doi.org/10.3760/cma.j.cn114015-20240918-00050
    Abstract ( ) PDF ( )
    A 70-year-old male patient was treated with venetoclax 100 mg orally once daily for acute myeloid leukemia. Before treatment, laboratory tests showed serum potassium 3.61 mmol/L, serum calcium 1.88 mmol/L, inorganic phosphate 1.33 mmol/L, serum uric acid 276.3 μmol/L, aspartate amino- transferase (AST) 23 U/L, gamma-glutamyl transferase (GGT) 179 U/L, and lactate dehydrogenase (LDH) 797 U/L. Six hours later of medication, the patient experienced chest tightness, wheezing, fever with chills, and the highest body temperature was 38.3 ℃. Laboratory tests showed serum potassium 5.54 mmol/L, serum calcium 1.76 mmol/L, inorganic phosphate 3.41 mmol/L, serum uric acid 827.2 μmol/L, AST 205 U/L, GGT 157 U/L, LDH 4 789 U/L, and D-dimer 51.19 mg/L, respectively. It was considered that there was a high possibility of tumor lysis induced by venetoclax, and the drug was immediately stopped. Symptomatic treatments were given, including oxygen inhalation, electrocardiogram monitoring, fluid infusion, alkalinization of urine, and uric acid reduction. The fever of the patient was alleviated on the day of drug withdrawal, the symptoms of chest distress and asthma were improved the next day, and 3 days later, laboratory tests showed serum potassium 4.24 mmol/L, serum calcium 2.02 mmol/L, inorganic phosphate 1.76 mmol/L, serum uric acid 275.0 μmol/L, AST 37 U/L, GGT 80U/L, LDH 1 146 U/L, and D-dimer 7.97 mg/L； venetoclax treatment was resumed and the tumor lysis syndrome-related symptoms did not recur.
  • Acute kidney injury induced by anti-novel coronavirus drug simnotrelvir/ritonavir
    Yu Fuwen, Liu Yubo, Tian Shuxia
    2025, 27(4): 251-253. https://doi.org/10.3760/cma.j.cn114015-20240724-00624
    Abstract ( ) PDF ( )
     A 71-year-old female patient underwent laparoscopic right hemicolectomy due to intestinal obstruction caused by malignant colon tumor. The patient had a fever 7 hours after surgery. Because of suspected abdominal infection, intravenous infusion of 2 g mezlocillin was given once every 8 hours on the day of operation. Three days later, the patient was given simnotrelvir (0.75 g)/ritonavir (0.1 g) once every 12 hours because of the positive nucleic acid test of novel coronavirus. Two days later after medication, the patient′s serum creatinine (Scr) increased from 40.2 μmol/L before treatment to 165.1 μmol/L, and the estimated glomerular filtration rate (eGFR) decreased from 100.6 ml/(min·1.73 m2) before treatment to 26.7 ml/(min·1.73 m2), without significant oliguria. Drug-induced acute kidney failure (AKI) was suspec- ted, and mezlocillin and simnotrelvir/ritonavir were discontinued. After 3 days of drug withdrawal, the patient′s renal function was improved, with Scr 78.1 μmo1/L; after 15 days, the Scr was 49.7 μmo1/L and eGFR was 93.8 ml/(min·1.73 m2). It was considered that the patient′s AKI was likely to be related to simnotrelvir/ritonavir. However, the possibility of nephrotoxicity enhancement due to the combination of simnotrelvir/ritonavir and mezlocillin could not be excluded. 
  • IgA vasculitis induced by tislelizumab
    Wang Kexin, Sun Bao, Luo Zhiying, Que Suyun, Zhang Bikui, Liu Wenhui
    2025, 27(4): 253-256. https://doi.org/10.3760/cma.j.cn114015-20240731-00660
    Abstract ( ) PDF ( )
    A 55-year-old male patient received immunotherapy combined with chemotherapy regimen（intravenous infusions of tislelizumab 200 mg on day 1, paclitaxel protein-bound 470 mg, and carboplatin 500 mg on day 1) after surgery for left upper lung squamous cell carcinoma, with 21 days as a treatment cycle. After more than half a month of medication in the 1st cycle, the patient developed multiple symmetrical purple red bruises on both lower limbs, which did not fade when pressed. The purple red bruising disappeared the next day after treatment with anti-allergic drugs. After 3 days of medication in the 3rd cycle, the patient developed a large number of scattered red papules on both lower limbs, protruding from the surface of the skin and accompanied by itching, a small number of red papules were scattered on both upper limbs and the face; after 15 days, the patient felt poor appetite; after 16 days, the patient experienced abdominal pain accompanied by vomiting and loose yellow stool. Laboratory tests showed a blood creatinine level of 204 μmol/L and occult blood in urine (+++). Pathological examination of skin tissue at the lesion site of the patient suggested IgA vasculitis (IgAV). After excluding other factors such as primary disease and infection, it was considered that the IgAV was probably related to tislelizumab. Tislelizumab was discontinued, anti-allergic and anti-inflammatory drugs, and glucocorticoid were given. After 2 weeks of treatments, the skin purpura gradually disappeared, and the abdominal pain and renal function indicators were improved. After fully aware of the risks, the patient was restarted tislelizumab immunotherapy combined with chemotherapy, and anti-allergic drugs were add at the same time. IgVA did not recur.
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