1.Research on safety risk signals of five drugs for Gaucher disease
Cheng YI ; Qiwei HAN ; Jing XU ; Nianfeng GUO ; Mengru BAI
China Pharmacy 2026;37(12):1607-1613
OBJECTIVE To evaluate the characteristics of adverse drug event (ADE) associated with five therapeutic agents for Gaucher disease(imiglucerase, velaglucerase alfa, taliglucerase alfa, eliglustat,and miglustat). METHODS ADE reports related to the above five drugs were retrieved from the FDA Adverse Event Reporting System (FAERS) database from January 2004 to September 2025. The reporting odds ratio (ROR) and proportional reporting ratio (PRR) methods were applied for data mining. system organ class (SOC) and preferred term (PT) from the Medical Dictionary for Regulatory Activities (MedDRA, version 26.0) drug ADE terminology were used for classification and statistical analysis of ADE. RESULTS A total of 4 329, 1 740, 500, 1 329 and 998 ADE reports were retrieved for the aforementioned five drugs, respectively, generating 4 612, 2 605, 776, 1 157 and 2 185 ADE signals. These signals involved 26 SOC, affecting 25, 26, 16, 19, and 19 SOC, respectively. The predominant SOCs were various injuries, poisoning and procedural complications, as well as infections and infestations. The top one PTs of each drug were as follows: bone infarction, zinc deficiency, failure to perform drug monitoring steps, ichthyosis, abnormal nerve conduction examination. New suspected PTs included weight gain and spontaneous abortion for imiglucerase and velaglucerase alfa, weight gain for taliglucerase alfa and eliglustat, and neuropsychiatric manifestations such as dementia and apathy for miglustat. In terms of severe ADEs, other serious medical events were predominant for imiglucerase and taliglucerase alfa; prolonged hospital stays were the main severe ADE for velaglucerase alfa and eliglustat; and death was the leading severe ADE for miglustat. CONCLUSIONS In clinical medication, apart from common ADE,for imiglucerase, clinicians should be alert to bone infarction, weight gain and spontaneous abortion, and strengthen monitoring related to bones, metabolism and pregnancy. For velaglucerase alfa, attention should be paid to zinc deficiency, bone infarction, weight gain and spontaneous abortion, with focused monitoring of nutritional status and pregnancy risks. For taliglucerase alfa, failure to perform drug monitoring steps and weight gain require vigilance, and medication procedures should be standardized along with regular weight monitoring. For eliglustat, clinicians need to watch out for ichthyosis and weight gain and pay close attention to skin conditions. For miglustat, bone infarction, abnormal nerve conduction examination and dementia should be closely monitored, with enhanced surveillance on nervous system function, infections and prognosis of critically ill patients,to ensure patient medication safety.
2.The reliability and accuracy of the summation method in calculating the area of subcap aponeurotic hematoma
Nianfeng XIE ; Lei WANG ; Yinlong XU ; Jun LIU ; Lihong ZHOU
Chinese Journal of Forensic Medicine 2025;40(3):365-368
Objective To verify the accuracy of the"manual tracing+summation method"for calculating the area of subcap aponeurotic hematoma using CT images in the practice of judicial expertise.Methods Subcap aponeurotic hematoma at different locations were simulated using"skull+colored clay plastic"model.The simulated hematoma areas were calculated via RadiAnt DICOM Viewer(64-bit)after CT scanning and compared with manual measurements.Results(1)For completely scaned simulated hematoma,the area of manual calculation is smaller than that measured by the expert assistance system for human injury identification,yet demonstrated relatively high accuracy;(2)Scanning planes parallel to the three scan baselines has the greatest impact on the imaging of top hematoma,often leading to incomplete scanning of both the top of the skull and hematoma.Conclusion When the scan of hematoma is complete,the subcap aponeurotic hematoma calculated by manual tracing is close to true values.However,incomplete scans may lead to disputable results and time-consuming and laborious manual calculations.In view of the current situation,pixel level semantic segmentation technology in the field of computer vision can be combined with the application of level set,gray reconstruction and other segmentation algorithms to obtain the three-dimensional outline of the hematoma area,so as to calculate the hematoma area and provide the most direct data analysis for judicial identification.
3.The reliability and accuracy of the summation method in calculating the area of subcap aponeurotic hematoma
Nianfeng XIE ; Lei WANG ; Yinlong XU ; Jun LIU ; Lihong ZHOU
Chinese Journal of Forensic Medicine 2025;40(3):365-368
Objective To verify the accuracy of the"manual tracing+summation method"for calculating the area of subcap aponeurotic hematoma using CT images in the practice of judicial expertise.Methods Subcap aponeurotic hematoma at different locations were simulated using"skull+colored clay plastic"model.The simulated hematoma areas were calculated via RadiAnt DICOM Viewer(64-bit)after CT scanning and compared with manual measurements.Results(1)For completely scaned simulated hematoma,the area of manual calculation is smaller than that measured by the expert assistance system for human injury identification,yet demonstrated relatively high accuracy;(2)Scanning planes parallel to the three scan baselines has the greatest impact on the imaging of top hematoma,often leading to incomplete scanning of both the top of the skull and hematoma.Conclusion When the scan of hematoma is complete,the subcap aponeurotic hematoma calculated by manual tracing is close to true values.However,incomplete scans may lead to disputable results and time-consuming and laborious manual calculations.In view of the current situation,pixel level semantic segmentation technology in the field of computer vision can be combined with the application of level set,gray reconstruction and other segmentation algorithms to obtain the three-dimensional outline of the hematoma area,so as to calculate the hematoma area and provide the most direct data analysis for judicial identification.
4.Effects of ursodeoxycholic acid on intrahepatic cholestasis in rats.
Lanjuan LI ; Xiaowei XU ; Fangfang LU ; Nianfeng ZHAO
Chinese Medical Journal 2003;116(7):1099-1103
OBJECTIVETo investigate the effects of treatment with ursodeoxycholic acid (UDCA) on intrahepatic cholestasis in rats, and to explore its mechanism.
METHODRats suffering from intrahepatic cholestasis were treated with UDCA. Their serum alanine transaminase (ALT), alkaline phosphatase (ALP), total bilirubin (TBIL), direct bilirubin (DBIL), gamma-glutamyl transpeptidase (gamma-GT), total cholesterol (TCH), bile flow, total bile acid excretion, total Na(+) and TCH of bile were measured before and after treatment. In addition, the changes of liver tissue under microscrope were observed and recorded.
RESULTSCompared with the control group, serum ALT, ALP, TBIL, DBIL, gamma-GT and TCH of rats in the treatment group decreased, while bile flow, total bile acid excretion, total Na(+) and TCH decreased significantly. Degeneration of hepatocytes, infiltration of inflamed cells and proliferation of small bile ducts in the treatment group were improved under microscope.
CONCLUSIONUDCA may have therapeutic effects on cholestatic hepatitis. The mechanism may involve in its hydrophilicity, choleretic effect and immune modulation.
Animals ; Cholestasis, Intrahepatic ; drug therapy ; Male ; Rats ; Rats, Sprague-Dawley ; Ursodeoxycholic Acid ; therapeutic use
5.DEVELOPMENT OF A NOVEL SUSPENSION CONCENTRATE OF NICLOSAMIDE AND ITS MOLLUSCICIDAL EFFECT AGAINST ONCOMELANIA SNAILS
Jianrong DAI ; Nianfeng XU ; Yousheng LIANG ; Yao ZHANG ; Yinchan ZHU
Chinese Journal of Schistosomiasis Control 1989;0(01):-
Objective To develop a novel suspension concentrate of niclosamide (SCN) and evaluate its characteristics and molluscicidal effect against Oncomelania snails. Methods Niclosamide was milled by a sand granule mill and mixed with different amounts of wetting agent, dispersant agent, thickener, and water etc., to develop suspension concentrates, and its dispersion, suspensibility and stability were evaluated. According to the results of evaluation the best recipe and quality indexes for producing SCN were selected. The molluscicidal effects against Oncomelania snails were tested under lab condition and in field. Results The novel SCN contained 25% niclosamide (w/w), 1.5%-2.0% wetting agent (RS 3), 4% dispersant (FS 2), 0.10% thickener, a litte of other agent and water. The quality indexes which the SCN reached were as following: the content of niclosamide was more than 25%(w/w); the suspensibal rate was more than 90%; the pH was from 4 to 7; the size of more than 98% granules of niclosamide was smaller than 44?m; the thickener was smaller than 600 mpa.s. The SCN was very stable when it was stored in high or in low temperature. Under lab condition the LC 50 concentrations of SCN by the immersion method for 24, 48 and 72 hours were 0.0474 mg/L, 0.0412 mg/L and 0.0412 mg/L respectively while the LC 50 concentrations of 50% wettable powder of niclosamide (WPN) were 0.0947 mg/L, 0.0583 mg/L and 0.0442 mg/L. In the field death rates of the snails sprayed with 2.0 g/(L?m 2 ) of 25% SCN after 3, 7 and 15 days were 95.77%, 99.07%, 97.09% while the death rates of the snails sprayed with 2.0 g/(L?m 2 )of 50% WPN were 97.37%, 95.17% and 97.41%. Conclusion SCN had stable quality and high molluscicidal effect against Oncomelania snails, and it was suitable to be used in the field. The molluscicidal effect using 2.0 g/(L? m 2 ) of 25% SCN was similar with that using 2.0 g/(L?m 2) of 50% WPN.

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