1.Revision and Application of the General Rule for Particle Size Analysis by Light Scattering in the 2025 Edition of the Pharmacopoeia of the People's Republic of China
Hui WU ; Baoxi ZHANG ; Ping ZHENG ; Yongjian YANG ; Qiaoru XUE ; Yihong LU ; Xuefan CHEN ; Langui XIE ; Xia ZHAO
Herald of Medicine 2025;44(11):1773-1778
This article focused on the revision and application of General Rule 0982 Determination of Particle Size and Size Distribution by Light Scattering Method in the Chinese Pharmacopoeia(2025 edition).By referencing domestic and international technical requirements and considering practical applications,the structure and content of this general rule were analyzed,and specific revisions were proposed.Key recommendations included adding sections on method validation and results reporting to the current general rule,incorporating the appendix content into the main text,and revising/supplementing the method name,introduction,instrument requirements,and determination procedures.The revised light scattering method would strengthen China's capacity for pharmaceutical quality control.
2.Revision and Application of the General Rule for Particle Size Analysis by Light Scattering in the 2025 Edition of the Pharmacopoeia of the People's Republic of China
Hui WU ; Baoxi ZHANG ; Ping ZHENG ; Yongjian YANG ; Qiaoru XUE ; Yihong LU ; Xuefan CHEN ; Langui XIE ; Xia ZHAO
Herald of Medicine 2025;44(11):1773-1778
This article focused on the revision and application of General Rule 0982 Determination of Particle Size and Size Distribution by Light Scattering Method in the Chinese Pharmacopoeia(2025 edition).By referencing domestic and international technical requirements and considering practical applications,the structure and content of this general rule were analyzed,and specific revisions were proposed.Key recommendations included adding sections on method validation and results reporting to the current general rule,incorporating the appendix content into the main text,and revising/supplementing the method name,introduction,instrument requirements,and determination procedures.The revised light scattering method would strengthen China's capacity for pharmaceutical quality control.
3.Impact of early and timely treatment and initial antiviral treatment regimen on antiviral treatment mortality and attrition among HIV-infected patients in Liuzhou, Guangxi
QIN Litai ; HUANG Jinghua ; CHEN Huanhuan ; LAN Guanghua ; FENG Yi ; XING Hui ; ZHU Jinhui ; CAI Wenlong ; RUAN Yuhua ; ZHU Qiuying ; XIE Yihong
China Tropical Medicine 2024;24(2):126-
Objective To understand the impact of early and timely treatment and initial antiviral treatment regimen on mortality and attrition of antiretroviral therapy. Methods A retrospective cohort study was conducted using download data on antiretroviral therapy for HIV-infected patients in Liuzhou City, Guangxi Province, from the database of the Basic Information System for AIDS Control and Prevention (BISAC) from 2010 to 2020. The Cox proportional risk regression model was used to analyze the influencing factors of mortality and attrition. Results A total of 15 713 infected patients were included, including 53.4% aged 18-<50 years, 69.4% male, 61.0% farmer, 75.1% CD4 count <350 cells /μL before initial antiviral treatment, the overall mortality rate was 4.30/100 person-years, and the overall attrition was 2.42/100 person-years. The results of Cox regression analysis showed that the influencing factors of mortality were pretreatment CD4 counts of 350-<500 cells/μL(AHR=0.72, 95%CI: 0.63-0.81) and ≥500 cells/μL (AHR= 0.64, 95%CI: 0.55-0.76); duration from diagnosis to initial antiviral treatment 91-180 days (AHR=1.25, 95%CI: 1.08-1.45), 181-365 days (AHR=1.26, 95%CI: 1.08-1.47), and ≥365 days (AHR=1.26, 95%CI: 1.11-1.44); initial antiviral treatment regimens of D4T+3TC+EFV/NVP (AHR=1.47, 95%CI: 1.32-1.63) and AZT/D4T/TDF+3TC+LPV/r (AHR=1.73, 95%CI: 1.50-1.99). Factors affecting attrition were pretreatment CD4 counts of 350-499 cells/μL (AHR=1.32, 95%CI: 1.16-1.50) and ≥500 cells/μL (AHR=1.28, 95%CI: 1.10-1.50); interval from HIV positivity confirmation to initial dosing ≥365 days (AHR=1.21, 95%CI: 1.04-1.40), initial antiviral treatment regimens of TDF+3TC+NVP (AHR=1.32, 95%CI: 1.13-1.55), AZT+3TC+EFV/NVP (AHR=1.43, 95%CI: 1.26-1.62) and AZT/D4T/TDF+3TC+LPV/r (AHR=1.33, 95CI%: 1.06-1.67). Conclusions Early and timely treatment and the initial antiviral treatment regimen of TDF+3TC+EFV have good efficacy, but attention should be paid to the high risk of attrition of HIV-infected people with high CD4 count before treatment.
4.Electrospun nanofiber scaffolds for soft and hard tissue regeneration
Xinyi WANG ; Xianrui XIE ; Yujie CHEN ; Xiaoyu WANG ; Xiaoqing XU ; Yihong SHEN ; Xiumei MO
Chinese Journal of Tissue Engineering Research 2024;28(3):426-432
BACKGROUND:Currently,electrospun nanofibers,which are biomimetic materials of natural extracellular matrix and contain a three-dimensional network of interconnected pores,have been successfully used as scaffolds for various tissue regeneration,but are still faced with the challenge of extending the biomaterials into three-dimensional structures to reproduce the physiological,chemical as well as mechanical properties of the tissue microenvironment. OBJECTIVE:To summarize the process and principles of electrostatic spinning and to explore the applications of the resulting electrospun nanofibers in tissue regeneration of skin,blood vessels,nerves,bone,cartilage and tendons/ligaments. METHODS:With"electrospinning,electrospun nanofibers,electrospun nanofiber scaffolds,tissue regeneration"as the Chinese and English search terms,Google Academic Database,PubMed,and CNKI were searched,and finally 88 articles were included for review. RESULTS AND CONCLUSION:(1)The electrospun nanofibers are a natural fibrous extracellular matrix mimetic material and contain a three-dimensional network of interconnected pores that have been successfully used as scaffolds for a variety of tissue regeneration applications.(2)Several papers have described the great potential of electrospun nanofiber scaffolds applied to the regeneration of skin,blood vessels,nerves,bones,cartilage and tendons/ligaments,providing a solid theoretical basis for its final application in clinical disease treatment,or for its transformation into practical products to enter the market.(3)However,the current research results are mostly based on cell experimental research results in vitro,and whether it can be finally applied to human body still needs clinical verification.(4)At present,many kinds of electrospun products for various clinical needs have been commercialized in and outside China,indicating that the research field of electrospun nanofiber scaffolds for soft and hard tissue regeneration has great research value and application potential.
5.Case report: cerebral and pulmonary fat embolism after facial autologous fat injection
Jun ZUO ; Shaolin MA ; Yihong QU ; Weiting FANG ; Yong YOU ; Hongju XIE
Chinese Journal of Plastic Surgery 2023;39(2):176-181
Cerebral fat embolism (CFE) combined with pulmonary fat embolism (PFE) is an extremely rare and serious complication after fat injection. In order to improve the understanding of the mechanism of this complication, this article reported the diagnosis, treatment and pathological results of a patient with CFE and PFE after facial autologous fat injection. A 34-year-old female underwent an injection of autologous fat in her right cheek at another institution in March 2021 and developed into a coma. 1.5 hours later, she was taken to the Emergency Department of the Second Affiliated Hospital of Hainan Medical University. CT revealed a massive infarction in the right cerebral hemisphere and bilateral acute pneumonia. The patient was treated with dehydration, anti-infection, anticoagulation and microcirculation improvement in the intensive care unit. But the patient died due to the critical condition. Postmortem autopsy and histopathological examination, revealed ischemic stroke with hemorrhagic transformation, and pulmonary embolism with acute pneumonia. It was speculated that the fat embolus passed through the damaged main trunk or branch of the right facial artery, and then retrograde to the right external carotid artery, common carotid artery and internal carotid artery to cause middle cerebral artery occlusion. At the same time, the embolus returned to the right atrium along with the accompanying vein of the above artery, and reached the pulmonary vascular bed through the pulmonary circulation, resulting in pulmonary embolism. Plastic surgeons should have extensive knowledge with the anatomical structure of facial blood vessels, master the injection techniques, and improve the awareness of fat embolism when performing facial fat transplantation.
6.Case report: cerebral and pulmonary fat embolism after facial autologous fat injection
Jun ZUO ; Shaolin MA ; Yihong QU ; Weiting FANG ; Yong YOU ; Hongju XIE
Chinese Journal of Plastic Surgery 2023;39(2):176-181
Cerebral fat embolism (CFE) combined with pulmonary fat embolism (PFE) is an extremely rare and serious complication after fat injection. In order to improve the understanding of the mechanism of this complication, this article reported the diagnosis, treatment and pathological results of a patient with CFE and PFE after facial autologous fat injection. A 34-year-old female underwent an injection of autologous fat in her right cheek at another institution in March 2021 and developed into a coma. 1.5 hours later, she was taken to the Emergency Department of the Second Affiliated Hospital of Hainan Medical University. CT revealed a massive infarction in the right cerebral hemisphere and bilateral acute pneumonia. The patient was treated with dehydration, anti-infection, anticoagulation and microcirculation improvement in the intensive care unit. But the patient died due to the critical condition. Postmortem autopsy and histopathological examination, revealed ischemic stroke with hemorrhagic transformation, and pulmonary embolism with acute pneumonia. It was speculated that the fat embolus passed through the damaged main trunk or branch of the right facial artery, and then retrograde to the right external carotid artery, common carotid artery and internal carotid artery to cause middle cerebral artery occlusion. At the same time, the embolus returned to the right atrium along with the accompanying vein of the above artery, and reached the pulmonary vascular bed through the pulmonary circulation, resulting in pulmonary embolism. Plastic surgeons should have extensive knowledge with the anatomical structure of facial blood vessels, master the injection techniques, and improve the awareness of fat embolism when performing facial fat transplantation.
7.Influences of age-adjusted Charlson comorbidity index on prognosis of patients undergoing laparoscopic radical gastrectomy: a multicenter retrospective study
Zukai WANG ; Jianxian LIN ; Yanchang XU ; Gang ZHAO ; Lisheng CAI ; Guoxin LI ; Zekuan XU ; Su YAN ; Zuguang WU ; Fangqin XUE ; Yihong SUN ; Dongbo XU ; Wenbin ZHANG ; Peiwu YU ; Jin WAN ; Jiankun HU ; Xiangqian SU ; Jiafu JI ; Ziyu LI ; Jun YOU ; Yong LI ; Lin FAN ; Jianwei XIE ; Ping LI ; Chaohui ZHENG ; Changming HUANG
Chinese Journal of Digestive Surgery 2022;21(5):616-627
Objective:To investigate the influences of age-adjusted Charlson comorbidity index (ACCI) on prognosis of patients undergoing laparoscopic radical gastrectomy.Methods:The retrospective cohort study was conducted. The clinicopathological data of 242 gastric cancer patients who underwent laparoscopic radical gastrectomy in 19 hospitals of the Chinese Laparoscopic Gastrointestinal Surgery Study Group-04 study, including 54 patients in Fujian Medical University Union Hospital, 32 patients in the First Hospital of Putian City, 32 patients in Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine, 31 patients in Zhangzhou Affiliated Hospital of Fujian Medical University, 17 patients in Nanfang Hospital of Southern Medical University, 11 patients in the First Affiliated Hospital with Nanjing Medical University, 8 patients in Qinghai University Affiliated Hospital, 8 patients in Meizhou People′s Hospital, 7 patients in Fujian Provincial Hospital, 6 patients in Zhongshan Hospital of Fudan University, 6 patients in Longyan First Hospital, 5 patients in the First Affiliated Hospital of Xinjiang Medical University, 5 patients in the First Hospital Affiliated to Army Medical University, 4 patients in the Second Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine, 4 patients in West China Hospital of Sichuan University, 4 patients in Beijing University Cancer Hospital, 3 patients in the First Affiliated Hospital of Xiamen University, 3 patients in Guangdong Provincial People′s Hospital, 2 patients in the First Affiliated Hospital of Xi′an Jiaotong University, from September 2016 to October 2017 were collected. There were 193 males and 49 females, aged 62(range, 23?74)years. Observation indicators: (1) age distribution, comorbidities and ACCI status of patients; (2) the grouping of ACCI and comparison of clinicopathological characteristics of patients in each group; (3) incidence of postoperative early complications and analysis of factors affecting postoperative early complications; (4) follow-up; (5) analysis of factors affecting the 3-year recurrence-free survival rate of patients. Follow-up was conducted using outpatient examination or telephone interview to detect postoperative survival of patients up to December 2020. Measurement data with normal distribution were represented as Mean± SD, and comparison between groups was conducted using the t test. Measurement data with skewed distribution were represented as M( Q1, Q3) or M(range), and comparison between groups was conducted using the Mann-Whitney U test. Count data were described as absolute numbers or percentages, and comparison between groups was conducted using the chi-square test or Fisher exact probability. Comparison of ordinal data was conducted using the nonparametric rank sum test. The X-Tile software (version 3.6.1) was used to analyze the best ACCI grouping threshold. The Kaplan-Meier method was used to calculate survival rates and draw survival curves. The Log-Rank test was used for survival analysis. The Logistic regression model was used to analyze the factors affecting postoperative early complications. The COX proportional hazard model was used for univariate and multivariate analyses of factors affecting the 3-year recurrence-free survival rate of patients. Multivariate analysis used stepwise regression to include variables with P<0.05 in univariate analysis and variables clinically closely related to prognosis. Results:(1) Age distribution, comor-bidities and ACCI status of patients. Of the 242 patients, there were 28 cases with age <50 years, 68 cases with age of 50 to 59 years, 113 cases with age of 60 to 69 years, 33 cases with age of 70 to 79 years. There was 1 patient combined with mild liver disease, 1 patient combined with diabetes of end-organ damage, 2 patients combined with peripheral vascular diseases, 2 patients combined with peptic ulcer, 6 patients combined with congestive heart failure, 8 patients combined with chronic pulmonary diseases, 9 patients with diabetes without end-organ damage. The ACCI of 242 patients was 2 (range, 0-4). (2) The grouping of ACCI and comparison of clinicopathological characteristics of patients in each group. Results of X-Tile software analysis showed that ACCI=3 was the best grouping threshold. Of the 242 patients, 194 cases with ACCI <3 were set as the low ACCI group and 48 cases with ACCI ≥3 were set as the high ACCI group, respectively. Age, body mass index, cases with preoperative comorbidities, cases of American Society of Anesthesiologists classification as stage Ⅰ, stage Ⅱ, stage Ⅲ, tumor diameter, cases with tumor histological type as signet ring cell or poorly differentiated adenocarcinoma and cases with tumor type as moderately or well differentiated adenocarcinoma, cases with tumor pathological T staging as stage T1, stage T2, stage T3, stage T4, chemotherapy cycles were (58±9)years, (22.6±2.9)kg/m 2, 31, 106, 85, 3, (4.0±1.9)cm, 104, 90, 16, 29, 72, 77, 6(4,6) in the low ACCI group, versus (70±4) years, (21.7±2.7)kg/m 2, 23, 14, 33, 1, (5.4±3.1)cm, 36, 12, 3, 4, 13, 28, 4(2,5) in the high ACCI group, showing significant differences in the above indicators between the two groups ( t=-14.37, 1.98, χ2=22.64, Z=-3.11, t=-2.91, χ2=7.22, Z=-2.21, -3.61, P<0.05). (3) Incidence of postoperative early complications and analysis of factors affecting postoperative early complications. Of the 242 patients, 33 cases had postoperative early complications, including 20 cases with local complications and 16 cases with systemic complica-tions. Some patients had multiple complications at the same time. Of the 20 patients with local complications, 12 cases had abdominal infection, 7 cases had anastomotic leakage, 2 cases had incision infection, 2 cases had abdominal hemorrhage, 2 cases had anastomotic hemorrhage and 1 case had lymphatic leakage. Of the 16 patients with systemic complications, 11 cases had pulmonary infection, 2 cases had arrhythmias, 2 cases had sepsis, 1 case had liver failure, 1 case had renal failure, 1 case had pulmonary embolism, 1 case had deep vein thrombosis, 1 case had urinary infection and 1 case had urine retention. Of the 33 cases with postoperative early complications, there were 3 cases with grade Ⅰ complications, 22 cases with grade Ⅱ complications, 5 cases with grade Ⅲa complications, 2 cases with grade Ⅲb complications and 1 case with grade Ⅳ complica-tions of Clavien-Dindo classification. Cases with postoperative early complications, cases with local complications, cases with systemic complications were 22, 13, 9 in the low ACCI group, versus 11, 7, 7 in the high ACCI group, respectively. There were significant differences in cases with postoperative early complications and cases with systemic complications between the two groups ( χ2=4.38, 4.66, P<0.05), and there was no significant difference in cases with local complications between the two groups ( χ2=2.20, P>0.05). Results of Logistic regression analysis showed that ACCI was a related factor for postoperative early complications of gastric cancer patients undergoing laparoscopic radical gastrectomy [ odds ratio=2.32, 95% confidence interval ( CI) as 1.04-5.21, P<0.05]. (4) Follow-up. All the 242 patients were followed up for 36(range,1?46)months. During the follow-up, 53 patients died and 13 patients survived with tumor. The 3-year recurrence-free survival rate of the 242 patients was 73.5%. The follow-up time, cases died and cases survived with tumor during follow-up, the 3-year recurrence-free survival rate were 36(range, 2-46)months, 29, 10, 80.0% for the low ACCI group, versus 35(range, 1-42)months, 24, 3, 47.4% for the high ACCI group. There was a significant difference in the 3-year recurrence-free survival rate between the two groups ( χ2=30.49, P<0.05). (5) Analysis of factors affecting the 3-year recurrence-free survival rate of patients. Results of univariate analysis showed that preoperative comorbidities, ACCI, tumor diameter, histological type, vascular invasion, lymphatic invasion, neural invasion, tumor pathological TNM staging, postoperative early complications were related factors for postoperative 3-year recurrence-free survival rate of gastric cancer patients undergoing laparoscopic radical gastrectomy [ hazard ratio ( HR)=2.52, 3.64, 2.62, 0.47, 2.87, 1.90, 1.86, 21.77, 1.97, 95% CI as 1.52-4.17, 2.22-5.95, 1.54-4.46, 0.27-0.80, 1.76-4.70, 1.15-3.12, 1.10-3.14, 3.01-157.52, 1.11-3.50, P<0.05]. Results of multivariate analysis showed that ACCI, tumor pathological TNM staging, adjuvant chemotherapy were indepen-dent influencing factors for postoperative 3-year recurrence-free survival rate of gastric cancer patients undergoing laparoscopic radical gastrectomy ( HR=3.65, 11.00, 40.66, 0.39, 95% CI as 2.21-6.02, 1.40-86.73, 5.41-305.69, 0.22-0.68, P<0.05). Conclusions:ACCI is a related factor for post-operative early complications of gastric cancer patients undergoing laparos-copic radical gastrectomy. ACCI, tumor pathological TNM staging, adjuvant chemotherapy are indepen-dent influencing factors for postoperative 3-year recurrence-free survival rate of gastric cancer patients undergoing laparoscopic radical gastrectomy.
8.Sodium phosphates oral solution-induced acute attack of gout: report of 3 cases
Adverse Drug Reactions Journal 2020;22(4):264-265
Three Tibetan male patients (patient 1, 64-year-old; patient 2, 51-year-old; patient 3, 39-year-old) with previous history of gout received sodium phosphates oral solution 90 ml in intestinal preparation for endoscopic examination or treatment. The patients all developed typical gout attack on day 2 after their medications, but their blood uric acid levels were lower than those before taking the medicine (patient 1, from 526 μmol/L to 417 μmol/L; patient 2, from 566 μmol/L to 374 μmol/L; patient 3, from 465 μmol/L to 379 μmol/L), respectively. The acute attack of gout in the 3 patients was considered to be related with sodium phosphates oral solution, but whether it was related with phosphate crystallization was not determined.
9.Sodium phosphates oral solution-induced acute attack of gout: report of 3 cases
Adverse Drug Reactions Journal 2020;22(4):264-265
Three Tibetan male patients (patient 1, 64-year-old; patient 2, 51-year-old; patient 3, 39-year-old) with previous history of gout received sodium phosphates oral solution 90 ml in intestinal preparation for endoscopic examination or treatment. The patients all developed typical gout attack on day 2 after their medications, but their blood uric acid levels were lower than those before taking the medicine (patient 1, from 526 μmol/L to 417 μmol/L; patient 2, from 566 μmol/L to 374 μmol/L; patient 3, from 465 μmol/L to 379 μmol/L), respectively. The acute attack of gout in the 3 patients was considered to be related with sodium phosphates oral solution, but whether it was related with phosphate crystallization was not determined.
10.Application of day surgery management mode in patients with cardiovascular interventional treatment
Xiafei SUN ; Hongxing WANG ; Yihong SONG ; Haofen XIE ; Jiamiao HU ; Yanyan XU ; Hanqun LIN
Chinese Journal of Modern Nursing 2018;24(12):1379-1382
Objective To discuss the application of day surgery management mode in patients with cardiovascular interventional treatment, evaluate the safety of day surgery and its effects on the average in-hospital days and expenses. Methods A total of 1 578 patients who received cardiovascular interventional therapy in the Department of Cardiology in Ningbo First Hospital from January 2015 to December 2016 were included in the study. They were randomly divided into the observation group and the control group, 789 cases respectively. Patients in the control group received normal in-hospital operation mode, while patients in the observation group used day surgery mode. The safety, complications, average in-hospital days and expenses were compared between two groups. Results The average in-hospital days and expenses were 1 d and 3 083 Yuan in the observation group; in the control group, average in-hospital days and expenses were (5.34±0.73) d and (3 713.70±21.06) Yuan, which were significantly higher than those in the observation group (P<0.05). There were 5 cases of bleeding in the puncture site of the radial artery, 9 cases of forearm hematoma, and 1 case of Iodine allergic reaction with a complication incidence of 1.9% in the control group. In the observation group, there were 3 cases of bleeding in the puncture site of the radial artery, 6 cases of forearm hematoma, and 2 cases of Iodine allergic reaction with a complication incidence of 1.4%. No significant difference in the complications of patients was observed between two groups (P>0.05). Conclusions The day surgery mode of patients with cardiovascular interventional treatment, which can ensure the therapeutic effect and the safety of patients, is feasible and can reduce the average in-hospital days and expenses.

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