1.Comparative analysis on elderly-friendly management of drug instructions in China,the United States and Japan
Siyi WANG ; Xiaoyong YU ; Jiayuan JIANG ; Kan TIAN
China Pharmacy 2025;36(9):1030-1034
OBJECTIVE To compare the measures taken by China, the U.S. and Japan to adapt drug instructions to aging, and provide reference for the reform of elderly-friendly drug instructions in China. METHODS The relevant documents published by the official websites of National Medical Products Administration of China, the U.S. FDA, and Pharmaceuticals and Medical Devices Agency of Japan, were consulted. Additionally, relevant literature from comprehensive databases such as CNKI, Wanfang data, and Web of Science, as well as search engines, was reviewed to understand the measures taken by the above countries in elderly-friendly management process of drug instructions. The comparative analysis was conducted for elderly-friendly adaptations of drug instructions in China, the U.S. and Japan, and the suggestions were put forward for the reform of elderly-friendly drug instructions in China. RESULTS & CONCLUSIONS The measures taken by China, the U. S., and Japan in the process of elderly- friendly management of drug labels had different emphases: China adopted large fonts and simplified drug instructions to alleviate the problem of the elderly being unable to read and understand drug instructions; the U.S. had set up a special section for the elderly in the drug instructions for special populations and issued the principles for writing information on medications for the elderly. The U. S. and Japan had established a classification management system for patient instructions and professional instructions, promoted structured electronic instructions, and built a unified electronic instructions platform. It is recommended that China incorporate elderly-specific medication information into the writing requirements of drug instructions, improve specific measures to encourage the reform of drug instructions suitable for the elderly, improve the accessibility and readability of electronic drug instructions, and build a drug instruction information disclosure platform to better ensure the safety of medication for the elderly.
2.Characteristics analysis of pediatric medicines with priority review and approval for marketing in China
Haoyu YANG ; Kan TIAN ; Xue YOU ; Hongwei DAN ; Qian WANG ; Xiaoyong YU
China Pharmacy 2025;36(5):519-523
OBJECTIVE To analyze the characteristics of pediatric medicines with priority review and approval for marketing in China, providing a reference for promoting enterprise R&D and production, as well as improving the supply guarantee mechanism for pediatric medicines. METHODS Based on publicly available data sources such as List of Approved Information for Pediatric Medications Subject to Priority Review and Approval, Pharnexcloud biomedical database, and National Medical Insurance Drug Directory, this study conducted a comprehensive analysis of the main characteristics of pediatric medicines with priority review and approval for marketing. RESULTS As of June 30, 2024, a total of 68 pediatric medicines had been approved through the priority review and approval process, covering 12 therapeutic areas, with oral dosage forms accounting for 64.71%. The median time from application to inclusion in priority review was 35.50 days, with an average of 41.69 days. The median time from inclusion in priority review to market approval was 1.24 years, with an average of 1.42 years. This included 12 domestic new medicines, 21 domestic generic medicines, 35 imported medicines, as well as 29 pediatric-specific medicines and 21 orphan medicines. Additionally, 31 of these medicines had been included in the medical insurance catalog, representing a proportion of 45.59%. CONCLUSIONS Currently, a trend of differentiated competition is emerging between domestic and imported pediatric medicines. The therapeutic areas for pediatric medicines are continuously expanding, and the dosage forms are becoming more tailored to children’s needs. However, there are still issues such as slow progress in new medicine development, insufficient stability in the medicine review and approval process, and a need to increase the proportion of medicines included in medical insurance.
3.Astragali Radix Polysaccharide Inhibits Proliferation and Migration of Gastric Cancer Cells by Targeting ID1 and Akt
Peizheng SHI ; Shanshan XIAO ; Xinjiang ZHANG ; Yixiang NIE ; Xianchao WANG ; Jing HUANG ; Jie MEI ; Huaquan LAN ; Tuanyun JI ; Tianyi ZHANG ; Xiaoyong WEI ; Qiaohong YANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(15):96-105
ObjectiveTo explore the regulatory effects and mechanisms of Astragali Radix polysaccharide (APS) on inhibitor of differentiation1 (ID1) and protein kinase B (Akt) in gastric cancer. MethodsImmunohistochemical staining was used to detect the expression of ID1 and Akt in 61 gastric cancer tissue samples and 20 adjacent normal gastric tissue samples. Immunofluorescence was used to detect the localization of ID1 and Akt. The effects of APS at the concentrations of 0.625, 1.25, 2.5, 5, 10, 20 mg·L-1 on the proliferation of gastric cancer MGC-803 cells were examined by the cell counting kit-8(CCK-8) method and the colony formation assay. The target information of APS was retrieved from the Traditional Chinese Medicine Systems Pharmacology and Analysis Platform and Swiss Target Prediction. Keywords such as gastric cancer, gastric tumor, and stomach cancer were searched against GeneCards, UniProt, DisGeNET, and Online Mendelian Inheritance in Man (OMIM) for the screening of gastric cancer-related targets. The online tool jvenn was used to create the Venn diagram to identify the common targets, and STRING and Cytoscape were used to construct the protein-protein interaction network. Gene Ontology (GO) and Kyoto Encyclopedia of Genes and Genomes (KEGG) pathway enrichment analyses were conducted via R 4.2.2 to predict the potential roles of APS in the development of gastric cancer. The cell scratch assay was employed to assess the effect of APS on the migration of MGC-803 cells. The protein and mRNA levels of ID1 and Akt in the cells treated with APS were determined by Western blot and Real-time PCR, respectively. ResultsCompared with the adjacent normal gastric tissue, the gastric adenocarcinoma tissue showed increased positive expression of ID1 (χ2 =81.00, P<0.01). Immunofluorescence detection showed that ID1 and Akt were mainly located in the cytoplasm of gastric adenocarcinoma cells. Bioinformatics analysis identified 14 common genes shared between APS and gastric cancer. The average degree of protein-protein interaction network nodes was 14.29. GO and KEGG pathway enrichment results showed that ID1 and Akt were significantly enriched in the Rap1 and phosphatidylinositol-3-kinase (PI3K) /Akt signaling pathways. Cell experiments demonstrated that 5-fluorouracil (0.1 mg·L-1) and APS (10, 20 mg·L-1) groups showed decreased cell proliferation, migration, and colony formation. Compared with the control group, 10, 20 mg·L-1 APS inhibited the proliferation of MGC-803 cells (P<0.01), with 10 mg·L-1 APS demonstrating stronger inhibitory effect. In addition, APS at 10, 20 mg·L-1 inhibited the migration (P<0.01) and colony formation (P<0.05, P<0.01) of MGC-803 cells. Compared with the control group, APS at 10, 20 mg·L-1 down-regulated the protein levels of ID1 (P<0.01) and Akt (P<0.05) and the mRNA levels of ID1 (P<0.05, P<0.01) and Akt (P<0.05, P<0.01) in MGC-803 cells. ConclusionID1 and Akt are highly expressed in the gastric adenocarcinoma tissue, which may be related to the development of gastric cancer. APS can down-regulate the protein and mRNA levels of ID1 and Akt to exert anti-tumor effects, which is expected to provide new therapeutic targets for gastric cancer treatment.
4.Characteristics of injury cases among the elderly in Ningbo City from 2014 to 2023
SUN Qiang ; HUANG Ying ; LI Xiaoyong ; YANG Chenying ; WANG Sijia
Journal of Preventive Medicine 2025;37(8):822-826,831
Objective:
To analyze the characteristics of injury surveillance cases among the elderly in Ningbo City, Zhejiang Province from 2014 to 2023, so as to provide the basis for formulating targeted injury intervention measures.
Methods:
Injury surveillance cases aged ≥60 years were collected from seven injury sentinel hospitals in Ningbo City through the Zhejiang Provincial Chronic Disease Surveillance Information Management System from 2014 to 2023. Population distribution, temporal distribution, injury circumstances, and clinical characteristics were described.
Results:
A total of 67 259 injury surveillance cases among the elderly were reported in Ningbo City from 2014 to 2023, including 32 159 males (47.81%) and 35 100 females (52.19%). The median age was 68.00 (interquartile range, 14.00) years. The three months with a higher number of cases were December (6 271 cases, 9.32%), August (6 226 cases, 9.26%) and October (6 221 cases, 9.25%). The primary causes of injury were falls (25 276 cases, 37.58%), stabs (12 250 cases, 18.21%), and sprains (11 815 cases, 17.57%). The injury occurred mainly in homes (44 975 cases, 66.87%) and streets/urban areas (16 174 cases, 24.05%). The predominant activities at the time of injury were leisure activities (28 801 cases, 42.82%) and household chores (23 647 cases, 35.16%). The proportions of falls as the cause of injury and injuries occurring at home among females and people aged 80 years and above were relatively high. The predominant sites of injury were upper limbs (23 354 cases, 34.72%) and lower limbs (20 343 cases, 30.25%). The predominant nature of injury were soft tissue injuries (43 345 cases, 64.44%) and bone and joint injuries (22 042 cases, 32.77%). Injuries were primarily mild and moderate in severity, with 46 391 cases (68.97%) and 20 205 cases (30.04%), respectively. The proportion of bone and joint injuries, moderate in injuries among females and people aged 80 years and above was relatively high.
Conclusions
The main causes of injury surveillance cases among the elderly in Ningbo City from 2014 to 2023 were falls and stabs, and the injuries occurred mainly in homes and streets/urban areas. Female and elderly people have a higher risk of injury.
5.Establishment of ultra-performance liquid chromatography-tandem mass spectrometry method for assay of tobramycin in human serum and its use in a pharmacokinetic study of tobramycin inhalation in bronchiectasis patients
Yu WANG ; Xiaoyong XU ; Xiaolan HUANG ; Xiaofen LIU ; Yaxin FAN ; Jiali HU ; Hailan WU ; Jing ZHANG ; Beining GUO
Chinese Journal of Infection and Chemotherapy 2024;24(5):545-552
Objective To establish an ultra-performance liquid chromatography-tandem mass spectrometry(UPLC-MS/MS)method for determination of tobramycin in human serum,and examine the utility of the method in a clinical pharmacokinetic study of tobramycin inhalation.Methods Serum samples were pretreated by solid phase extraction with tobramycin-D12 as internal standard.Chromatographic separation was performed on a TitankHilic(2.1 mm × 100 mm,3 μm)column.The mobile phase consisted of0.1%formic acid-acetonitrile and 0.1%formic acid aqueous solution at a flow rate of 0.4 mL/min.Electrospray ionization source and multiple reaction monitoring(MRM)scanning were used for monitoring the quantitative ion pairs with m/z 468.3→m/z 163.3(tobramycin)and m/z 480.6→m/z 166.2(tobramycin-D12).The established method was investigated in terms of selectivity,interaction,concomitant medication,standard curve and lower limit of quantitation,precision and accuracy,recovery,matrix effect,and stability of tobramycinin.Results The linear range of tobramycin was 0.050 0-10.0 mg/L(R2=0.999 5).The intra-and inter-batch precision was satisfactory(coefficient of variation[CV]≤3.6%).The accuracy ranged from-0.4%to 6.0%.The matrix effect factor(MF)in human serum samples(including hemolysis and lipemia)ranged from 92.2%to 94.9%(CV≤2.7%).The recovery of tobramycinin was 79.5%-81.9%in serum samples,while the recovery of internal standard was 78.9%.The analyte was stable in serum samples for 72 h at room temperature and for 274 days at-20℃/-70℃.The pharmacokinetic study of tobramycin inhalation in bronchiectasis patients showed that after continuous administration of tobramycin 300 mg twice a day to 3 patients,the mean Cmax of tobramycin was(0.72±0.61)mg/L on Day 1 and(0.76±0.73)mg/L on Day 28,respectively.The corresponding Tmax was(1.83±0.61)h and(1.50±0.50)h,respectively.Conclusions The UPLC-MS/MS method established in this study is sensitive,accurate and rapid.It is successfully applied to the clinical pharmacokinetic study of tobramycin inhalation.The method may be suitable for therapeutic drug monitoring of tobramycin in clinical practice.
6.Research progress on sugar alcohol sweeteners and their effects on human body
Meng WANG ; Xiaoyong LI ; Li QIN
Chinese Journal of Clinical Nutrition 2024;32(3):186-192
Sugar alcohol sweeteners are now widely used in the food additives industry as sugar substitutes. According to the World Health Organization, long-term intake of artificial sweeteners may have negative effects on health, but the only exception is sugar alcohols. As a result, researches on sugar alcohol sweeteners have gained increasing study interests in recent years. As the study progresses, it has been found that sugar alcohol sweeteners are closely related with gut microbes, lipid metabolism, cardiovascular disease and tumors. In addition, recent studies have also shown that some sugar alcohols are endogenous metabolites which can predict the risk of a variety of diseases. This review systematically details the effects of sugar alcohol sweeteners on human body and the underlying mechanisms, in order to provide a reference for the scientific research in this field.
7.Comparison of robot-assisted Y-V plasty and laparoscopic Y-V plasty in the treatment of refractory bladder neck contracture after BPH surgery
Jianwen HUANG ; Xiaoyong HU ; Ying WANG ; Xinru ZHANG ; Lujie SONG ; Qiang FU
Chinese Journal of Urology 2024;45(4):320-324
Objective:To evaluate the efficacy of robot-assisted Y-V plasty (RAYV) and laparoscopic Y-V plasty (LYV) in the treatment of refractory bladder neck contracture (BNC) after BPH surgery.Methods:A retrospective analysis was performed for the clinical data of 42 patients with refractory BNC after BPH surgery from January 2020 to July 2023, including 18 RAYV and 24 LYV. There were no significant differences between both groups( P>0.05) in term of median age [68(62, 81) years vs. 70(61, 76) years], median body mass index [20.7(17.6, 26.1) kg/m 2 vs. 19.8(16.3, 25.3) kg/m 2], median Q max [9.4(5.6, 13.2) ml/s vs. 8.9(6.2, 12.2)ml/s], median IPSS [20.5(15, 23) vs. 21.1(17, 23)], median QOL score [4.6 (4, 6) points vs. 4.8 (4, 6) points] and median postvoid residual volume [84.7(58, 125)ml vs. 78.3(50, 120)ml]. Preoperative examination of one patient in the RAYV group showed no contractile function of the external urethral sphincter.The surgical procedure was basically the same for both groups: entering into the retropubic space, and incision of the anterior wall of bladder and prostate urethra was performed in an inverted Y-shaped. After excising the scar around the anterior wall of bladder neck, the apex of inverted V-shaped bladder wall flap is brought to the base of the Y-shaped incision using two 3-0 running suture. The catheter was removed 2 weeks after surgery. Perioperative and follow-up data were compared between the two groups. Results:All surgeries were successfully completed without complications. The difference between RAYV and the LYV group in operation time [71.8(50, 98)min vs. 105.9(71, 143)min] and postoperative drainage removal time [2.7(2, 4)d vs. 4.5(3, 7)d] was statistically significant ( P<0.05). There was no significant difference between both groups in term of intraoperative blood loss [50.4(20, 100) ml vs. 60.8(40, 150) ml] and postoperative hospital stay [4.1(3, 5)d vs. 4.6(3, 7)d]( P>0.05). All patients were followed up with a median follow-up of 16.5(2, 41) months. There was no significant difference between RAYV and LYV in term of postoperative Q max [27.9(11.7, 37.6) ml/s vs. 22.4(12.3, 31.5)ml/s], IPSS[5.1(4, 9) points vs. 4.8(4, 10) points], QOL[1.6(1, 3) points vs. 1.5(1, 3) points] and postvoid residual volume [5.6(0, 15) ml vs. 7.2(5, 20) ml] ( P>0.05). The postoperative bladder neck patency rates in the RAYV group and the LYV group were 94.4%(17/18) and 95.8%(23/24), respectively, with no significant difference( P>0.05). In terms of urinary continence, 1 patient in the RAYV group had no contractile function of the external urethral sphincter before surgery, and none of the 41 patients with good preoperative continence had urinary incontinence after surgery. Conclusions:The effect of RAYV in the treatment of refractory BNC after BPH surgery is comparable to that of LYV, but RAYV can shorten the operation time and postoperative drainage time.
8.A case of bladder contracture and ureteral stenosis after radiotherapy for cervical cancer treated with bilateral ileal ureter substitution combined with " N-shaped" bladder augmentation and plasty
Kaile ZHANG ; Jiemin SI ; Song LI ; Wenzhuo FANG ; Ying WANG ; Ranxing YANG ; Xiaohui ZHOU ; Xiaoyong HU ; Qiang FU
Chinese Journal of Urology 2024;45(9):711-713
Ureteral stenosis and bladder contracture after radiotherapy for cervical cancer are challenging issues in urology. Ileal ureteroplasty combined with ileal bladder augmentation is a potential method to improve hydronephrosis and voiding function of patients, however, the surgical procedure is complex, with high surgical risks and numerous intraoperative and postoperative complications, which have hindered the widespread application of this surgical technique. This article introduces our hospital's experience through a typical surgical case. During the surgery, ileal substitution for bilateral ureters was performed in combination with ileal " N-shaped" augmentation. Two weeks after the surgery, the single-J stent was removed, and the urinary catheter was removed three weeks after the surgery. The patient achieved voluntary urination control with smooth voiding. Follow-up examinations at 3 months and 18 months postoperatively showed no hydronephrosis in the bilateral ureters, normal renal function, and a significantly expanded bladder capacity.
9.Micro-incision of the Cystic Duct Confluence Technique in Laparoscopic Choledochal Exploration Lithotomy:Report of 267 Cases
Nan LIU ; Qi LIU ; Xiaoyong LI ; Tingting WANG ; Dexing CHEN
Chinese Journal of Minimally Invasive Surgery 2024;24(4):245-249
Objective To summarize the experience of laparoscopic common bile duct exploration(LCBDE)by means of micro-incision of the cystic duct confluence.Methods From January 2020 to March 2023,267 cases of cholecystolithiasis complicated with choledocholithiasis were given LCBDE by means of micro-incision through the cystic duct confluence.An incision was made along the inferior wall of the cystic duct to the conjunctive part of the common bile duct,and the lateral wall of the common bile duct was cut for 3-5 mm longitudinally.The bile duct exploration and stone extraction were completed under choledochoscope.Primary suture was performed.An abdominal drainage tube was placed.Results The operations were completed in all the 267 cases and the common bile duct stones were thoroughly removed.The operation time was 45-128 min(mean,96.5±9.7 min),the postoperative drainage indwelling time was 3-13 d(mean,5.1±1.2 d),and the postoperative hospitalization time was 5-13 d(mean,6.8±1.1 d).Biliary leakage occurred in 4 cases and was cured after abdominal drainage for 9-11 d.Postoperative fever was noted in 1 1 cases and was treated with anti-inflammatory therapy for 1-3 d.Abdominal abscess developed in 2 cases and was cured by abdominal drainage.A total of 242 cases(90.6%)were followed up for 6-39 months(median,11 months),of which 66 cases were followed up for more than or equal to 36 months.Residual stones were found in 2 cases,stone recurrence was noted in 2 cases,and no choledochal stenosis was found.Conclusion Laparoscopic lithotomy with micro-incision of the cystic duct confluence has a good clinical effect in the treatment of choledocholithiasis.
10.Progress in prenatal diagnosis of fetal congenital long QT syndrome
Chinese Journal of Perinatal Medicine 2024;27(7):595-598
The congenital long QT syndrome (LQTS) is a genetic disease related to cardiac repolarization disorder and is one of the main causes of fetal and neonatal mortality. However, challenges in obtaining fetal electrocardiograms refrained the prenatal diagnosis of LQTS. In recent years, technological advancement has assisted the discovery of several strategies that potentially increase the prenatal diagnosis rate of LQTS, such as fetal magnetocardiography, non-invasive fetal electrocardiography, and echocardiography. This article reviews the research progress in prenatal diagnosis of fetal LQTS using each of these methods.


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