1.Pharmaceutical Care for An Elderly Patient with mGluR5 Antibody Encephalitis Treated with Ofatumumab
Lingna GAO ; Xiaoli ZHU ; Xueting DU ; Jingzhe HAN
Herald of Medicine 2025;44(1):116-120
Objective To analyze the involvement of pharmacists in the pharmaceutical care of olfacatumumab in the treatment of elderly patients with refractory anti-metabotropic glutamate receptor 5(mGluR5)encephalitis and to provide a reference for the treatment and pharmaceutical care of patients with refractory autoimmune encephalitis(AE).Methods An 81-year-old patient with anti-mGluR5 encephalitis who had poor first-line immunotherapy effect.The key points of pharmaceutical care were determined according to the patient's condition and the characteristics of therapeutic drugs.The drug selection,administration mode,drug interaction,adverse reactions,and precautions of ofatumumab were put forward.At the same time,the patients and their families were given medication guidance and discharge education,and regular follow-up was carried out.Results With the cooperation of doctors,the patient was provided with whole-process pharmaceutical care,and the patient's condition was improved,and the patient's condition was good so far.Conclusion Clinical pharmacists pay attention to the effectiveness and safety of the treatment with ofatumumab by carrying out individualized pharmaceutical care for this patient,which fully reflects the value of clinical pharmacists and provides a reference for the treatment and pharmaceutical care of refractory AE patients.
2.Risk signal mining and analysis of adverse events in agalsidase beta therapy for Fabry disease
Zongyun LI ; Jiaxun JIAO ; Lingna GAO ; Xiaoli ZHU
Adverse Drug Reactions Journal 2025;27(11):686-693
Objective:To mine risk signals of adverse events (AE) in agalsidase beta therapy for Fabry disease and provide reference for the safe use in clinical practice.Methods:The AE reports with agalsidase beta as the primary suspect drug in the US Food and Drug Administration Adverse Event Reporting System (FAERS) database from the first quarter of 2004 to the third quarter of 2024 were collected and the clinical information of patients involved was analyzed descriptively. AEs were standardized and categorized using the preferred term (PT) and system organ class (SOC) in Medical Dictionary for Regulatory Activities version 26.0. Signal mining was performed using the reporting odds ratio (ROR) method and Bayesian confidence propagation neural network (BCPNN) method. A PT was defined as the risk signal if the number of reports was ≥3, the lower limit of the 95% confidence interval ( CI) of ROR was >1, and the information component minus two times standard deviation ( IC025) was >0. Descriptive statistical analysis were then conducted on the risk signals. The relative risk of target adverse events in gender subgroups was evaluated using the ROR method. Results:A total of 24 163 AE reports with agalsidase beta as the primary suspect drug were collected, involving 7 763 patients and 2 382 PTs. Severe adverse events accounted for 34.9% (2 712/7 763). A total of 121 risk signals (namely PTs) across 15 SOCs were obtained. The top 5 PTs ranked by number of reports were pyrexia (483 cases), chills (449 cases), infusion related reaction (282 cases), chest pain (221 cases), and cerebrovascular accident (218 cases). The top 5 PTs ranked by signal intensity were cornea verticillata ( ROR=56.44, IC025=4.59), drug specific antibody present ( ROR=54.13, IC025=5.46), cerebral calcification ( ROR=24.82, IC025=3.16), myocardial necrosis marker increased ( ROR=24.14, IC025=3.83), and infusion site rash ( ROR=20.41, IC025=3.46). Among the top 30 PTs ranked by number of reports and signal intensity, there were 4 and 13 PTs not documented in the drug label, respectively. The former included atrial fibrillation, cellulitis, neuralgia, and pallor, while the latter included cornea verticillate, cerebral calcification, auricular swelling, vein discoloration, aortic dilatation, bundle branch block, myocardial fibrosis, cardiac infection, vein rupture, sudden hearing loss, meningitis viral, deafness transitory, and corneal opacity. Subgroup analysis by sex showed that males had higher risks in developing chills, tremor, drug specific antibody detection, renal failure, and renal impairment, while females had higher risks in weight increase and dizziness. Conclusions:The main risk signals of adverse events of agalsidase beta include pyrexia, chills, and infusion related reactions, which are consistent with those documented in package inserts. In addition, potential new risk signals such as atrial fibrillation, cellulitis, neuralgia, cornea verticillate, auricular swelling, and sudden hearing loss were also detected. The relative risks of some target adverse events vary between genders, and it is recommended to strengthen targeted drug monitoring and individualized management in clinical practice.
3.Risk signal mining and analysis of adverse events in agalsidase beta therapy for Fabry disease
Zongyun LI ; Jiaxun JIAO ; Lingna GAO ; Xiaoli ZHU
Adverse Drug Reactions Journal 2025;27(11):686-693
Objective:To mine risk signals of adverse events (AE) in agalsidase beta therapy for Fabry disease and provide reference for the safe use in clinical practice.Methods:The AE reports with agalsidase beta as the primary suspect drug in the US Food and Drug Administration Adverse Event Reporting System (FAERS) database from the first quarter of 2004 to the third quarter of 2024 were collected and the clinical information of patients involved was analyzed descriptively. AEs were standardized and categorized using the preferred term (PT) and system organ class (SOC) in Medical Dictionary for Regulatory Activities version 26.0. Signal mining was performed using the reporting odds ratio (ROR) method and Bayesian confidence propagation neural network (BCPNN) method. A PT was defined as the risk signal if the number of reports was ≥3, the lower limit of the 95% confidence interval ( CI) of ROR was >1, and the information component minus two times standard deviation ( IC025) was >0. Descriptive statistical analysis were then conducted on the risk signals. The relative risk of target adverse events in gender subgroups was evaluated using the ROR method. Results:A total of 24 163 AE reports with agalsidase beta as the primary suspect drug were collected, involving 7 763 patients and 2 382 PTs. Severe adverse events accounted for 34.9% (2 712/7 763). A total of 121 risk signals (namely PTs) across 15 SOCs were obtained. The top 5 PTs ranked by number of reports were pyrexia (483 cases), chills (449 cases), infusion related reaction (282 cases), chest pain (221 cases), and cerebrovascular accident (218 cases). The top 5 PTs ranked by signal intensity were cornea verticillata ( ROR=56.44, IC025=4.59), drug specific antibody present ( ROR=54.13, IC025=5.46), cerebral calcification ( ROR=24.82, IC025=3.16), myocardial necrosis marker increased ( ROR=24.14, IC025=3.83), and infusion site rash ( ROR=20.41, IC025=3.46). Among the top 30 PTs ranked by number of reports and signal intensity, there were 4 and 13 PTs not documented in the drug label, respectively. The former included atrial fibrillation, cellulitis, neuralgia, and pallor, while the latter included cornea verticillate, cerebral calcification, auricular swelling, vein discoloration, aortic dilatation, bundle branch block, myocardial fibrosis, cardiac infection, vein rupture, sudden hearing loss, meningitis viral, deafness transitory, and corneal opacity. Subgroup analysis by sex showed that males had higher risks in developing chills, tremor, drug specific antibody detection, renal failure, and renal impairment, while females had higher risks in weight increase and dizziness. Conclusions:The main risk signals of adverse events of agalsidase beta include pyrexia, chills, and infusion related reactions, which are consistent with those documented in package inserts. In addition, potential new risk signals such as atrial fibrillation, cellulitis, neuralgia, cornea verticillate, auricular swelling, and sudden hearing loss were also detected. The relative risks of some target adverse events vary between genders, and it is recommended to strengthen targeted drug monitoring and individualized management in clinical practice.
4.Pharmaceutical Care for An Elderly Patient with mGluR5 Antibody Encephalitis Treated with Ofatumumab
Lingna GAO ; Xiaoli ZHU ; Xueting DU ; Jingzhe HAN
Herald of Medicine 2025;44(1):116-120
Objective To analyze the involvement of pharmacists in the pharmaceutical care of olfacatumumab in the treatment of elderly patients with refractory anti-metabotropic glutamate receptor 5(mGluR5)encephalitis and to provide a reference for the treatment and pharmaceutical care of patients with refractory autoimmune encephalitis(AE).Methods An 81-year-old patient with anti-mGluR5 encephalitis who had poor first-line immunotherapy effect.The key points of pharmaceutical care were determined according to the patient's condition and the characteristics of therapeutic drugs.The drug selection,administration mode,drug interaction,adverse reactions,and precautions of ofatumumab were put forward.At the same time,the patients and their families were given medication guidance and discharge education,and regular follow-up was carried out.Results With the cooperation of doctors,the patient was provided with whole-process pharmaceutical care,and the patient's condition was improved,and the patient's condition was good so far.Conclusion Clinical pharmacists pay attention to the effectiveness and safety of the treatment with ofatumumab by carrying out individualized pharmaceutical care for this patient,which fully reflects the value of clinical pharmacists and provides a reference for the treatment and pharmaceutical care of refractory AE patients.
5.Quantitative analysis of macular structure and microvascular changes in patients with diabetic macular ischemia
Changying LIU ; Lingna LI ; Meizi GAO ; Xuzheng ZHAO
Chinese Journal of Ocular Fundus Diseases 2024;40(2):116-121
Objective:To observe the changes of macular structure and microvessels in eyes with diabetes macular ischemia (DMI).Methods:A retrospective case study. From January 2023 to July 2023, 23 patients of 31 eyes diagnosed with DMI at Tangshan Ophthalmological Hospital were included in this study. Among them, there were 14 males with 23 eyes; Female cases with 8 eyes. Age were (59.5±4.6) years old. According to the DMI grading standard formulated by the research group for early treatment of diabetes retinopathy, the patients were divided into mild DMI group, moderate DMI group, and severe DMI group, with 8, 12, and 11 eyes respectively. The blood flow density (VD), perfusion area (FA), small vessel VD (SVD), inner retinal capillary plexus VD, FA, and outer retinal, choroidal, and ganglion cell complex (GCC) thickness within 1 mm of the macular fovea in retinal superficial vascular plexus (SVP)were measured using a scanning frequency light source optical coherence tomography instrument. The changes in macular structure and microvasculature in the affected eyes of different degrees of DMI groups were compared and observed. Inter group comparisons were conducted using one-way ANOVA or Kruskal Wallis H-test. Spearman correlation analysis was used to analyze the correlation between DMI severity and GCC, outer retina, choroid thickness, VD, FA and SVP VD, SVD and FA in inner retina. Results:The GCC ( F=70.670), outer retinal thickness ( H=12.393), VD ( F=105.506), SVD ( H=25.300), FA ( F=107.655), and VD ( H=24.098) and FA ( H=25.300) of the retinal SVP in the mild, moderate, and severe DMI groups were compared, and the differences were statistically significant ( P<0.05). There was no statistically significant difference in choroidal thickness ( H=2.441, P>0.05). Pairwise comparison between groups: VD, SVD, FA of GCC thickness and SVP, and VD of inner retina were statistically significant between severe DMI group and moderate DMI group, and between moderate DMI group and mild DMI group ( P<0.05). The thickness of outer retina was statistically significant between severe DMI group and moderate DMI group ( P<0.05). Inner retinal FA: there were statistically significant differences between severe DMI group, moderate DMI group and mild DMI group ( P<0.05). The correlation analysis results showed that GCC ( r s=-0.918), outer retinal thickness ( r s=-0.448), and inner retinal VD ( r s=-0.894) and FA ( r s=-0.918), as well as VD ( r s=-0.919), SVD ( r s=-0.924), and FA ( r s=-0.939) of retinal SVP, were all negatively correlated with the degree of DMI ( P<0.05). There was no correlation between choroidal thickness and degree of DMI ( r s=-0.081, P>0.05). Conclusion:The thickness of GCC, outer retina and choroid, the VD, SVD, and FA of the retinal SVP, the VD and FA of inner retina are all reduced in eyes with different degrees of DMI, while all of them are negatively correlated with the degree of DMI, except for choroid thickness.
6.Diagnosis and therapy for a case of Crohn′s disease complicated with deep vein thrombosis and Guillain-Barre syndrome by the cooperation of multidisciplinary team
Chenfei TAN ; Yating YANG ; Lingna YE ; Min GAO ; Qian CAO
Chinese Journal of Inflammatory Bowel Diseases 2023;07(4):371-374
This article reports a rare Crohn′s disease (CD) case complicated with deep vein thrombosis and Guillain-Barre syndrome (GBS). Through the diagnosis and treatment of the multidisciplinary team, the condition of patient is relieved with no recurrence. Prevention of venous thromboembolism, rare extraintestinal manifestations and rare side adverse of anti-tumor necrosis factor-α monoclonal antibodies and their mechanisms in CD patients were discussed for reference.
7.Diagnosis and therapy for a case of Crohn′s disease complicated with deep vein thrombosis and Guillain-Barre syndrome by the cooperation of multidisciplinary team
Chenfei TAN ; Yating YANG ; Lingna YE ; Min GAO ; Qian CAO
Chinese Journal of Inflammatory Bowel Diseases 2023;07(4):371-374
This article reports a rare Crohn′s disease (CD) case complicated with deep vein thrombosis and Guillain-Barre syndrome (GBS). Through the diagnosis and treatment of the multidisciplinary team, the condition of patient is relieved with no recurrence. Prevention of venous thromboembolism, rare extraintestinal manifestations and rare side adverse of anti-tumor necrosis factor-α monoclonal antibodies and their mechanisms in CD patients were discussed for reference.
8.Analysis of influential factors of cardiotoxicity induced by trastuzumab combined with chemotherapy
Xiaoli ZHU ; Chen LYU ; Xueting DU ; Jiaxun JIAO ; Lingna GAO ; Xia SUN ; Hongfang MA
China Pharmacy 2022;33(8):992-995
OBJECTIVE To analyze the influential factors of cardioto xicity in patients with positive breast cancer of human epidermal growth factor receptor 2(HER-2)treated by trastuzumab combined with chemotherapy. METHODS From April 2017 to January 2021,200 HER-2 positive breast cancer patients receiving pirarubicin + cyclophosphamide combined with sequential paclitaxel+trastuzumab were collected from our hospital. According to the presence or absence of cardiotoxicity ,the patients were divided into cardiotoxicity group and non-cardiotoxicity group. The clinical data and echocardiographic results of the patients were collected,and the influential factors of cardiotoxicity were analyzed. RESULTS Among 200 patients,43 patients suffered from cardiotoxicity with the incidence of 21.5%. The proportion of patients with cardiotoxicity during pirarubicin+cyclophosphamide therapy accounted for 5.5%(11/200),and the proportion of patients with cardiotoxicity during sequential paclitaxel+trastuzumab therapy accounted for 20.5%(41/200);the latter was significantly higher than the former (P<0.01). At the same time ,the decrease of left ventricular ejection fraction during sequential therapy of paclitaxel and trastuzumab was significantly higher than that during pirarubicin+cyclophosphamide therapy [ 14%(12%,17%)vs. 7%(3%,10%),P<0.001]. Compared with patients without cardiotoxicity ,the proportion of patients with cardiotoxicity with a history of hyperlipidemia was significantly higher (P< 0.01),while the proportion of patients receiving dexrazoxane was significantly lower (P<0.01). Results of binary Logistic regression analysis showed that the history of hyperlipidemia [OR =3.672,95% CI(1.499,8.992),P=0.004] and the use of dextrazoxane [OR =0.154,95% CI(0.072,0.330), P<0.001] were associated with the occurrence of cardiotoxicity. CONCLUSIONS Hyperlipidemia is an independent risk factor for cardiotoxicity induced by pirarubicin + cyclophosphamide combined with sequential paclitaxel+trastuzumab in HER 2 positive breast cancer patients ,while the use of dextrazoxane is a protective factor.
9.Insulin autoimmune syndrome induced by captopril
Xueting DU ; Xiaoli ZHU ; Lingna GAO ; Hongshuang SUN ; Hongfang MA
Adverse Drug Reactions Journal 2022;24(3):162-164
A 66-year-old female patient regularly received nifedipine sustained release tablets 20 mg twice daily and captopril 25 mg once daily by mouth for 2 years due to hypertension. Low blood glucose (3.0 mmol/L) appeared in recent 1 year, frequent hypoglycemic coma occurred in recent 4 months. Laboratory tests showed minimum fasting glucose 1.6 mmol/L, insulin 12 mU/L, C-peptide 1.78 nmol/L, and positive anti-insulin antibody. Insulin autoimmune syndrome was considered, which might be associated with captopril. Then captopril was stopped, nifedipine sustained-release tablets was continued, irbesartan hydrochlorothiazide was added, and prednisone 30 mg orally once daily was given at the same time. In addition, the patient was asked to adjust diet, including low carbohydrate and eating less and often. After stopping captopril for 3 days, her blood glucose was between 4.3 to 11.2 mmol/L, and hypoglycemia did not recur.
10.Insulin autoimmune syndrome induced by captopril
Xueting DU ; Xiaoli ZHU ; Lingna GAO ; Hongshuang SUN ; Hongfang MA
Adverse Drug Reactions Journal 2022;24(3):162-164
A 66-year-old female patient regularly received nifedipine sustained release tablets 20 mg twice daily and captopril 25 mg once daily by mouth for 2 years due to hypertension. Low blood glucose (3.0 mmol/L) appeared in recent 1 year, frequent hypoglycemic coma occurred in recent 4 months. Laboratory tests showed minimum fasting glucose 1.6 mmol/L, insulin 12 mU/L, C-peptide 1.78 nmol/L, and positive anti-insulin antibody. Insulin autoimmune syndrome was considered, which might be associated with captopril. Then captopril was stopped, nifedipine sustained-release tablets was continued, irbesartan hydrochlorothiazide was added, and prednisone 30 mg orally once daily was given at the same time. In addition, the patient was asked to adjust diet, including low carbohydrate and eating less and often. After stopping captopril for 3 days, her blood glucose was between 4.3 to 11.2 mmol/L, and hypoglycemia did not recur.

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