1.Interpretation of key quality indicators of phospholipid pharmaceutical excipients and analysis of their impact on drug formulations
Yaowei LI ; Wenqi LIU ; Lin YANG ; Fengjiao JIANG ; Lei CHEN ; Xinxin ZHANG ; Yong GAN
Drug Standards of China 2025;26(5):473-481
Phospholipid pharmaceutical excipients are primarily composed of a glycerol backbone,fatty acid chains,and phosphate groups.Due to their amphiphilic structure and unique physicochemical properties,they are commonly used as emulsifiers and carrier materials in pharmaceutical formulations.The pharmacopoeias of various countries have included phospholipid based pharmaceutical excipients and specified the testing methods and limits for their critical quality attributes.This article focuses on the current inclusion status,characteristic indicators,component content determination indicators,and functionality-related indicators determination methods and limits of phospholipid pharmaceutical excipients of various countries,in order to provide references and a basis for the rational applicatione of phospholipid pharmaceutical excipients.
2.Interpretation of key quality indicators of phospholipid pharmaceutical excipients and analysis of their impact on drug formulations
Yaowei LI ; Wenqi LIU ; Lin YANG ; Fengjiao JIANG ; Lei CHEN ; Xinxin ZHANG ; Yong GAN
Drug Standards of China 2025;26(5):473-481
Phospholipid pharmaceutical excipients are primarily composed of a glycerol backbone,fatty acid chains,and phosphate groups.Due to their amphiphilic structure and unique physicochemical properties,they are commonly used as emulsifiers and carrier materials in pharmaceutical formulations.The pharmacopoeias of various countries have included phospholipid based pharmaceutical excipients and specified the testing methods and limits for their critical quality attributes.This article focuses on the current inclusion status,characteristic indicators,component content determination indicators,and functionality-related indicators determination methods and limits of phospholipid pharmaceutical excipients of various countries,in order to provide references and a basis for the rational applicatione of phospholipid pharmaceutical excipients.
3.Study on risk factors for coma in patients with hypoglycemia
Quanhong LIN ; Yaowei XU ; Yuzhuo LI ; Lebai LIU ; Shifan TANG ; Xiaowan LIN ; Zhaohua XIN
Chinese Journal of Emergency Medicine 2024;33(9):1273-1280
Objective:To investigate the incidence and risk factors of coma in patients with hypoglycemia (≤3.9 mmol/L).Methods:A retrospective study was conducted. Patients aged 20 years and older with blood glucose levels ≤3.9 mmol/L, and measured by emergency physicians from January 2020 to December 2022 were collected. Baseline patient data, clinical values collected on-site, and treatment outcomes were analyzed. The Glasgow Coma Scale (GCS) was used to determine if patients were comatose, with GCS ≤8 classified as the coma group and GCS >8 as the non-coma group. Further analysis was conducted on the resuscitated coma group to identify factors affecting patient recovery. Patients were divided into eight age groups, seven time periods within 24 h, and six blood glucose level groups to calculate the incidence of coma. A multivariate logistic regression model was constructed to analyze independent risk factors for coma in hypoglycemic patients.Results:A total of 754 patients with blood glucose levels ≤3.9 mmol/L were collected, with 425 cases of coma and 329 non-coma cases, resulting in a coma probability of 56.37% (95% CI: 52.82%-59.91%). Patients in the coma group were older ( P<0.001) and had a higher prevalence of diabetes compared to the non-coma group (82.12% vs. 67.78%, P<0.001). The age of all patients was (73.05±15.20) years, with the 61-90 years age groups being the most prone to hypoglycemia and coma. In terms of time distribution, the high-incidence periods for hypoglycemia and coma were 0-6 o’clock, 6-9 o’clock, and 14-18 o’clock. The primary causes of hypoglycemia included reduced energy intake after insulin injection (12.07%), improper use of insulin (6.37%), and reduced energy intake (6.23%), with 71.09% of cases having unknown causes. Additionally, 18.44% of patients used insulin before the onset of hypoglycemia, with a higher proportion in the coma group compared to the non-coma group (22.12% vs. 13.68%, P=0.003). The initial blood glucose level of all patients was (2.13±0.85) mmol/L, with lower levels observed in the coma group compared to the non-coma group ( P<0.001). The probabilities of coma occurrence corresponding to blood glucose levels were: 1.1-1.5 mmol/L (72.97%), 1.6-2.0 mmol/L (68.90%), 2.1-2.5 mmol/L (54.10%), 2.6-3.0 mmol/L (38.20%), 3.1-3.5 mmol/L (37.50%), and 3.6-3.9 mmol/L (19.40%). Multivariate logistic regression analysis indicated that age ( OR=1.021, 95% CI: 1.010-1.033, P<0.001), insulin use before onset ( OR=1.948, 95% CI: 1.142-3.323, P=0.014), and blood glucose concentration ( OR=0.426, 95% CI: 0.347-0.522, P<0.001) were independent predictors of coma in hypoglycemic patients. The investigation revealed that after intravenous injection of 50% glucose solution, 215 of 425 coma patients regained consciousness (50.58%), and the recovery time was (18.43±9.09) min. Patients in the recovery group were younger and had lower initial blood glucose levels compared to the non-recovery group (both P<0.05), while recovery group re-measured blood glucose levels were higher than those in the non-recovery group ( P=0.002). Conclusions:The probability of coma in hypoglycemic patients was high, with insulin use being a common trigger. Proper use of insulin is essential to prevent hypoglycemia and coma.
4.Cuproptosis in relation to MIRI and heart failure
Xiaoxiao LIU ; Hongyu LI ; Yaowei ZHAO ; Xiyuan MA ; Chunyang DONG ; Qiang TANG
Chinese Journal of Arteriosclerosis 2024;32(12):1082-1088
Timely restoration of blood supply after myocardial infarction is crucial for saving the infarcted myocardi-um.So far,the most effective method is to restore myocardial oxygenation and coronary blood flow through coronary inter-ventional therapy.However,reperfusion may also lead to greater heart damage due to the reintroduction of molecular oxy-gen.New treatments are needed to protect the heart from myocardial ischemia-reperfusion injury(MIRI)to improve clini-cal outcomes in patients with acute myocardial infarction and heart failure(HF).A deeper understanding of the mecha-nisms of MIRI and the search for new treatments could provide key evidence to mitigate myocardial damage and improve pa-tient survival.At present,it has been found that copper,as a trace element in human body,can have a significant pro-tective effect on MIRI.Copper can reduce apoptosis in cardiomyocytes,that is,control the self-destruction process of cell,so as to reduce the degree of myocardial injury.However,the potential relationship between abnormal copper ion metabolism as well as cuproptosis and MIRI as well as HF has not been explored.In this review,we focus on potential therapeutic strategies for MIRI and understand the metabolic pathways of copper in the human body,so as to provide more options and hope for the treatment of cardiovascular diseases.
5.Cuproptosis in relation to MIRI and heart failure
Xiaoxiao LIU ; Hongyu LI ; Yaowei ZHAO ; Xiyuan MA ; Chunyang DONG ; Qiang TANG
Chinese Journal of Arteriosclerosis 2024;32(12):1082-1088
Timely restoration of blood supply after myocardial infarction is crucial for saving the infarcted myocardi-um.So far,the most effective method is to restore myocardial oxygenation and coronary blood flow through coronary inter-ventional therapy.However,reperfusion may also lead to greater heart damage due to the reintroduction of molecular oxy-gen.New treatments are needed to protect the heart from myocardial ischemia-reperfusion injury(MIRI)to improve clini-cal outcomes in patients with acute myocardial infarction and heart failure(HF).A deeper understanding of the mecha-nisms of MIRI and the search for new treatments could provide key evidence to mitigate myocardial damage and improve pa-tient survival.At present,it has been found that copper,as a trace element in human body,can have a significant pro-tective effect on MIRI.Copper can reduce apoptosis in cardiomyocytes,that is,control the self-destruction process of cell,so as to reduce the degree of myocardial injury.However,the potential relationship between abnormal copper ion metabolism as well as cuproptosis and MIRI as well as HF has not been explored.In this review,we focus on potential therapeutic strategies for MIRI and understand the metabolic pathways of copper in the human body,so as to provide more options and hope for the treatment of cardiovascular diseases.
6.Effect of underdilated stent on the occurrence of hepatic encephalopathy after transjugular intrahepatic portosystemic shunt creation
Chaoyang WANG ; Bin XIONG ; Jiacheng LIU ; Chongtu YANG ; Shuguang JU ; Yaowei BAI ; Wei YAO ; Yingliang WANG
Chinese Journal of Internal Medicine 2022;61(5):537-542
Objective:To evaluate whether underdilated stent could reduce the occurrence of hepatic encephalopathy (HE) after transjugular intrahepatic portosystemic shunt (TIPS) creation.Methods:A total of 197 patients with decompensated liver cirrhosis, who had underwent TIPS creation at Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, were analyzed retrospectively, including 110 males and 87 females with age 25-79 (54±11) years old. Uncovered and covered stents with 8 mm diameter were implanted in all subjects, and then dilated by balloon catheters with 6 mm or 8 mm diameter. The patients were divided into two groups, including underdilated group (6 mm, n=105) and control group (8 mm, n=92).Kaplan-Meier curves were used to illustrate cumulative rate of HE, and the differences were assessed with the log-rank test. Multivariate analyses with a Cox regression model were conducted to explore the risk factors for HE. Results:During a median follow-up period of 29 (12-54) months, 16 (15.2%) patients developed HE in the underdilated group and 27 (29.3%) patients in the control group. There was a significant difference in the cumulative rate of HE ( P=0.014), but no statistical differences were found in terms of variceal rebleeding, shunt dysfunction and survival between the two groups ( P=0.608, P=0.659, P=0.968). In multivariated analysis, group assignment (underdilated vs. control, HR=0.291, 95% CI 0.125-0.674, P=0.004) was identified as an independent risk factor for HE after TIPS creation. Conclusion:Underdilated TIPS could reduced the risk of HE compared with completely dilated TIPS, with comparable risk of variceal rebleeding, shunt dysfunction and mortality. And it is worthy of applying this technique to a large sample of patients in clinical practice.
7.Reliability and validity of the Chinese version of self-assessment of fall risk questionnaire for hospitalized patients
Hualu YANG ; Beirong MO ; Ping LIU ; Huiying MAI ; Yaowei LIU
Chinese Journal of Modern Nursing 2017;23(32):4111-4114
Objective To translate the self-assessment of fall risk questionnaire for hospitalized patients (SAFR) into Chinese and test the reliability and validity of the instrument.Methods After obtaining permission from the original author, we translated the SAFR to Chinese and to do back-translation as well as cultural adjustment. And then, the Chinese version of SAFR was confirmed and its content validity was tested. Besides, the retest reliability, internal consistency reliability and construct validity of the Chinese version of SAFR were tested in nursing unit of our hospital.Results The Chinese version of SAFR was with high reliability and validity with 0.80 for the retest reliability ICC (P<0.05) and 0.688 for the Cronbach's α reliability coefficient. The content validity index (CVI) was 0.97 with the method of Delphi expert consultation. The construct validity of the instrument was measured by factor analysis. There were two common factors (eigenvalue >1) extracted by exploratory factor analysis with 57.588% for the cumulative variance contribution rate.Conclusions The Chinese version of SAFR has high reliability and validity with convenient and fast operation. The instrument can be considered a primary screening instrument of self-assessment of fall risk for hospitalized patients.
8.Diagnostic value of intraductal ultrasonography for biliary stricture
Yunhong LI ; Xiaoping ZOU ; Yuling WU ; Yuling YAO ; Mingdong LIU ; Yaowei AI ; Zhaomin XU
Chinese Journal of Digestive Endoscopy 2012;23(1):11-14
Objective To investigate the diagnostic value of intraductal ultrasonography for the quality of biliary stricture.Methods Data of the patients who had received operation because of biliary stricture after IDUS examination from 2006 to 2010 were collected.IDUS results were compared with those of operation.Results There were 43 cases of malignant strictures and 6 benign strictures in total.The sensitivity,specificity,positive predictive value,negative predictive value and diagnostic accuracy of intraductal uhrasonography for the quality of biliary stricture were 97.7% ( 42/43 ),83.3% ( 5/6 ),97.7% ( 42/43 ),83.3% (5/6) and 95.9% (47/49),respectively,which were significantly higher than conventional imaging like ultrasound B,CT and MRCP.Twenty one cases in 32 were diagnosed as malignant biliary stricture with cytological brushing,with the diagnostic accuracy of 65.6%.All cases had been diagnosed by IDUS.Conclusion Intraductal ultrasonography is of high diagnostic value for biliary stricture.However,cytological brushing based on IDUS is of limited diagnostic value for malignant biliary stricture.

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