1.Visual feature extraction combining dissolution testing for the study of drug release behavior of gliclazide modified release tablets
Si-yu CHEN ; Ze-ya LI ; Ping LI ; Xin-qing ZHAO ; Tao GONG ; Li DENG ; Zhi-rong ZHANG
Acta Pharmaceutica Sinica 2025;60(1):225-231
Oral solid dosage forms require processes such as disintegration and dissolution to release the drug before it can be absorbed and utilized by the body. In this manuscript, imaging technology was used to continuously visualize and characterize the
2.Bioequivalence study of etoricoxib tablets in healthy Chinese subjects
Zhen-Zhen JIAO ; Li XU ; Man LIU ; Tian-Ze HU ; Dan SONG ; Xiao-Juan WANG ; Zhi-Jing ZHAO ; Hui-Chen LIU
The Chinese Journal of Clinical Pharmacology 2024;40(5):718-722
Objective To study the pharmacokinetic characteristics of etoricoxib tablets in healthy Chinese subjects and to evaluate the bioequivalence and safety of the test and reference formulations.Methods In a randomised,single-dose,two-period,two-sequence crossover trial,28 healthy subjects were enrolled under the fasting and fed conditions,respectively,who received a single oral dose of 60 mg of etoricoxib tablets in the test or reference formulation.The concentration of etoricoxib in plasma was detected by LC-MS/MS,and the main pharmacokinetic parameters were calculated to evaluate bioequivalence and using WinNonlin 8.2 software.Results The main pharmacokinetic parameters of the test and reference preparations were as follows:The fasting condition Cmax of etoricoxib were(1 176.96±287.95)and(1 164.93±189.65)ng·mL-1;AUC0-t were(18 651.95±6 100.27)and(19 241.39±6 107.48)ng·h·mL-1;and AUC0-∞ were(19 939.15±7 553.27)and(20 536.31±7 223.40)ng·h·mL-1.The fed condition Cmax of etoricoxib were(913.50±184.72)and(878.59±164.35)ng·mL-1;and AUC0-t were(19 085.22±5 155.01)and(18 669.54±4 508.21)ng·h·mL-1;AUC0-∞ were(20 103.77±5 567.02)and(19 528.05±4 989.74)ng·h·mL-1.The 90%confidence intervals for the geometric mean ratios of the main pharmacokinetic parameters in the fasting and fed conditions fell between 80.00%and 125.00%.The incidence of adverse events in the fasting and fed conditions were 28.57%and 21.43%,respectively.Conclusion Two kinds of etoricoxib tablets are bioequivalent,and have similar safety in healthy Chinese subjects.
3.Suggestions for revision of the epilepsy items in the military disability appraisal norms
Shu-Yi QU ; Ze CHEN ; Yuan-Hang PAN ; Ze-Zhi WANG ; Xin-Bo ZHANG ; Yong-Hong LIU
Medical Journal of Chinese People's Liberation Army 2024;49(1):6-9
Epilepsy is a common neurological disease,has the characteristics of recurrent attacks and long-term treatment,thus bringing great pressure to patients and their families.Therefore,it is particularly important to do a good job of disability assessment.In recent years,with the development of the discipline,academic organizations such as the International League Against Epilepsy(ILAE)and China Association Against Epilepsy(CAAE)have successively updated the definition and diagnostic criteria of epilepsy and seizures.However,some items of epilepsy in the current Criteria for Disability Rating of Military Personnel(Trial)issued by People's Liberation Army(PLA)in 2011 can no longer meet the latest guidelines at home and abroad.Therefore,we suggest that the items related to epilepsy in the Criteria for Disability Rating of Military Personnel(Trial)should be revised to ensure that the disability evaluation being completed fairly and successfully.
4.A Case Report of Multidisciplinary Diagnosis and Treatment of a Patient with Tuberous Sclerosis Complex and Multi-Organ Involvement
Hua ZHENG ; Yunfei ZHI ; Lujing YING ; Lan ZHU ; Mingliang JI ; Ze LIANG ; Jiangshan WANG ; Haifeng SHI ; Weihong ZHANG ; Mengsu XIAO ; Yushi ZHANG ; Kaifeng XU ; Zhaohui LU ; Yaping LIU ; Ruiyi XU ; Huijuan ZHU ; Li WEN ; Yan ZHANG ; Gang CHEN ; Limeng CHEN
JOURNAL OF RARE DISEASES 2024;3(1):79-86
Tuberous sclerosis complex(TSC)is a rare genetic disease that can lead to benign dysplasia in multiple organs such as the skin, brain, eyes, oral cavity, heart, lungs, kidneys, liver, and bones. Its main symptoms include epilepsy, intellectual disabilities, skin depigmentation, and facial angiofibromas, whilst incidence is approximately 1 in 10 000 to 1 in 6000 newborns. This case presents a middle-aged woman who initially manifested with epilepsy and nodular depigmentation. Later, she developed a lower abdominal mass, elevated creatinine, and severe anemia. Based on clinical features and whole exome sequencing, the primary diagnosis was confirmed as TSC. Laboratory and imaging examinations revealed that the lower abdominal mass originated from the uterus. CT-guided biopsy pathology and surgical pathology suggested a combination of leiomyoma and abscess. With the involvement of multiple organs and various complications beyond the main diagnosis, the diagnostic and therapeutic process for this patient highlights the importance of rigorous clinical thinking and multidisciplinary collaboration in the diagnosis and treatment of rare and challenging diseases.
5.Application of China-made Toumai? Robot in laparoscopic radical prostatectomy
Zhi-Feng WEI ; Yu-Hao CHEN ; Ze-Peng ZHU ; Qi JIANG ; Yu XIONG ; Feng-Feng LU ; Zhen-Qian SONG ; Bin JIANG ; Xiao-Feng ZHU ; Tian-Hao FENG ; Xiao-Feng XU ; Gang YANG ; Wu WEI ; Ai-Bing YAO ; Jing-Ping GE
National Journal of Andrology 2024;30(8):696-700
Objective:To evaluate the safety and efficiency of China-made Toumai Robot-assisted laparoscopic radical prosta-tectomy(LRP).Methods:This study included 40 cases of PCa treated from January 2023 to May 2023 by robot-assisted LRP with preservation of the bladder neck and maximal functional urethral length,15 cases with the assistance of Toumai Robot(the TMR group)and the other 25 with the assistance of da Vinci Robot as controls(the DVR group).We recorded the docking time,laparo-scopic surgery time,vesico-urethral anastomosis time,intraoperative blood loss and postoperative urinary continence,and compared them between the two groups.Results:Operations were successfully completed in all the cases.No statistically significant differ-ences were observed between the TMR and DVR groups in the docking time(6 min vs 5 min,P>0.05)or intraoperative blood loss(200 ml vs 150 ml,P>0.05).The TMR group,compared with the DVR group,showed a significantly longer median laparoscopic surgery time(146 min vs 130 min,P<0.05)and median vesico-urethral anastomosis time(19 min vs 16 min,P<0.05).There were no statistically significant differences between the TMR and DVR groups in the rates of urinary continence recovery immediately af-ter surgery(60.0%[9/15]vs 64.0%[16/25],P>0.05)or at 1 month(80.0%[12/15])vs(76.0%[19/25],P>0.05),3 months(93.3%[14/15])vs(92.0%[23/25],P>0.05)and 6 months postoperatively(100%[15/15])vs(96%[24/25],P>0.05).Conclusion:China-made Toumai? Robot surgical system is safe and reliable for laparoscopic radical prosta-tectomy,with satisfactory postoperative recovery of urinary continence.
6.Strategies for prevention and treatment of spinal degenerative diseases from perspective of traditional Chinese medicine for bone health.
Ling-Hui LI ; Xu WEI ; Li-Guo ZHU ; Yi-Li ZHANG ; Shang-Quan WANG ; Kai SUN ; Bao-Yu QI ; Xiao-Kuan QIN ; Xiao-Yang WANG ; Ming CHEN ; Zhi-Ze LIU
China Journal of Chinese Materia Medica 2024;49(21):5681-5685
The population aging and the coming of the information era are accompanied with the growing incidence of spinal degenerative diseases, which result in heavy social and economic burdens. Under the guidance of the tendon-bone theory, rich experience has been accumulated in the prevention and diagnosis of spinal degenerative diseases with traditional Chinese medicine(TCM), which demonstrates unique advantages. China's government has placed people's health in the strategic position of development, providing a favorable environment for the realization of healthy aging. The Healthy China 2030 advocates special actions for healthy bones. As China is facing an important period of demographic transition, the Traditional Chinese Medicine for Bone Health Program has emerged, combining the needs of the national health strategy and the advantages of TCM. This paper discusses the background and significance of the program. According to the theory of five body constituents and the characteristics of musculoskeletal system diseases, this paper constructs a theoretical system of "tendon-meridian-muscle-bone-marrow" to explain the structure and function of the musculoskeletal system. From the holistic view of TCM, this system shows not only the structure and function of the musculoskeletal system but also the patterns of disease development and the mechanism of TCM treatment. The system facilitates the research on not only the comorbidities related to bone health but also the occurrence, development, and outcome of diseases. In the management of chronic degenerative diseases, attention should be paid to the establishment and improvement of the disease prevention and control system in addition to the disease treatment alone. Finally, this paper introduces the characteristic advantages of TCM in the whole process of prevention, diagnosis, treatment, rehabilitation, and health maintenance of spinal degenerative diseases, aiming to enrich the connotation of the tendon-bone theory, provide ideas and implementation strategies for TCM clinical practice, and ultimately achieve the effective management of the diagnosis and treatment of spinal degenerative diseases.
Humans
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Medicine, Chinese Traditional
;
Spinal Diseases/prevention & control*
;
Drugs, Chinese Herbal/therapeutic use*
;
China
;
Bone and Bones/drug effects*
7.Efficacy of Wuda Granule on Recovery of Gastrointestinal Function after Laparoscopic Bowel Resection: A Randomized Double-Blind Controlled Trial.
Hai-Ping ZENG ; Li-Xing CAO ; De-Chang DIAO ; Ze-Huai WEN ; Wen-Wei OUYANG ; Ai-Hua OU ; Jin WAN ; Zhi-Jun PENG ; Wei WANG ; Zhi-Qiang CHEN
Chinese journal of integrative medicine 2024;30(12):1059-1067
OBJECTIVE:
To evaluate the efficacy and safety of Wuda Granule (WDG) on recovery of gastrointestinal function after laparoscopic bowel resection in the setting of enhanced recovery after surgery (ERAS)-based perioperative care.
METHODS:
A total of 108 patients aged 18 years or older undergoing laparoscopic bowel resection with a surgical duration of 2 to 4.5 h were randomly assigned (1:1) to receive either WDG or placebo (10 g/bag) twice a day from postoperative days 1-3, combining with ERAS-based perioperative care. The primary outcome was time to first defecation. Secondary outcomes were time to first flatus, time to first tolerance of liquid or semi-liquid food, gastrointestinal-related symptoms and length of stay. Subgroup analysis of the primary outcome according to sex, age, tumor site, surgical time, histories of underlying disease or history of abdominal surgery was undertaken. Adverse events were observed and recorded.
RESULTS:
A total of 107 patients [53 in the WDG group and 54 in the placebo group; 61.7 ± 12.1 years; 50 males (46.7%)] were included in the intention-to-treat analysis. The patients in the WDG group had a significantly shorter time to first defecation and flatus [between-group difference -11.01 h (95% CI -20.75 to -1.28 h), P=0.012 for defecation; -5.41 h (-11.10 to 0.27 h), P=0.040 for flatus] than the placebo group. Moreover, the extent of improvement in postoperative gastrointestinal-related symptoms in the WDG group was significantly better than that in the placebo group (P<0.05). Subgroup analyses revealed that the benefits of WDG were significantly superior in patients who were male, or under 60 years old, or surgical time less than 3 h, or having no history of basic disease or no history of abdominal surgery. There were no serious adverse events.
CONCLUSION
The addition of WDG to an ERAS postoperative care may be a viable strategy to enhance gastrointestinal function recovery after laparoscopic bowel resection surgery. (Registry No. ChiCTR2100046242).
Humans
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Laparoscopy/adverse effects*
;
Male
;
Female
;
Middle Aged
;
Double-Blind Method
;
Recovery of Function
;
Drugs, Chinese Herbal/adverse effects*
;
Treatment Outcome
;
Gastrointestinal Tract/physiopathology*
;
Defecation
;
Aged
;
Intestines/physiopathology*
8.Study on the mechanism of metformin promoting brain protection via AMPK autophagy signal pathway
Zhi-Fang QIN ; Yan-Ze WANG ; Bi-Hua CHEN ; Man-Hong ZHOU
The Chinese Journal of Clinical Pharmacology 2023;39(23):3424-3428
Objective To explore whether metformin preconditioning can protect brain injury after cardiac arrest/cardiopulmonary resuscitation(CA/CPR)and its possible mechanisms and signaling pathways.Methods Constructed a CA model by using electrical stimulation.Rats were randomly divided into the sham group(0.9%NaCl gavage daily for 14 days,without inducing CA),model group(CA model was induced after 0.9%NaCl gavage daily for 14 days),experimental group(CA model was induced after 200 mg·kg-1 Met+0.9%NaCl gavage daily for 14 days),Cc group[200 mg·kg-1 Met+0.9%NaCl gavage daily for 14 days,adenosine 5'-monophosphate kinase-activated protein(AMPK)inhibitor Compoud C(Cc)was injected intraperitoneally at 1 hour before modeling],chloroquine(CQ)group(daily 200 mg·kg-1 Met+0.9%NaCl gavage for 14 days,intraperitoneal injection of autophagy inhibitor CQ at 1 hour before modeling)and AICAR group(continuous daily 200 mg·kg-1 Met+0.9%NaCl gavage for 14 days,intraperitoneal injection of AMPK agonist AICAR at 1 hour before modeling).The 7-day survival rate after CA/CPR via using survival curves was recorded;the neurological function 7-days after CA/CPR was scored by using the neurological disability scale;the protein malondialdehyde(MDA)level were measured using the Coomassie Brilliant Blue method;detection of reactive oxygen species(ROS)levels in brain tissue by using ROS fluorescent probe DHE;Western blotting was used to determine the expression levels of related proteins such as AMPK,p-AMPK,microtubule associated protein 1 light chain 3 Ⅰ(LC3 Ⅰ),LC3 Ⅱ,and p62 in brain tissue.Results The 7-day survival rates of sham,model,experimental,Cc,CQ and AICAR groups rats were 100%,40%,70%,40%,40%and 65%,respectively;the 7-day neurological function scores were 78.35±1.65,46.50±4.41,67.93±4.64,49.50±3.53,52.00±2.83 and 68.33±1.53,respectively;the ROS levels were(417.60±8.37),(748.60±36.05),(575.80±10.73),(713.80±18.85),(668.20±9.58)and(566.00±24.48)U·mg-1,respectively;the MDA levels were(4.38±0.33),(8.06±0.76),(5.50±0.48),(7.18±0.29),(6.82±0.31)and(5.20±0.34)nmol·mg-1,respectively;the brain tissue p-AMPK/AMPK were 0.74±0.04,0.87±0.01,1.61±0.01,0.55±0.05,1.09±0.09 and 1.27±0.07,respectively;the p62 values were 0.42±0.02,0.86±0.05,0.61±0.04,0.98±0.04 and 0.78±0.03,respectively;the LC3 Ⅱ/LC3 1 were 0.29±0.32,0.37±0.26,0.96±0.78,0.58±0.26,0.43±0.03 and 1.40±0.10,respectively.Compared with the model group,the differences of above indexes in the experimental group,AICAR group were statistically significant(all P<0.05);compared with the experimental group,the differences of above indexes in the Cc group,CQ group were statistically significant(all P<0.05).Conclusion Metformin preconditioning can play a protective role in brain injury after cardiac arrest/cardiopulmonary resuscitationin in rats by activating the AMPK signaling pathway,regulating mitochondrial energy metabolism and promoting autophagy.
9.Etiology composition and prognosis of pediatric chronic critical illness in a pediatric intensive care unit.
Zi-Feng TAN ; En-Si LI ; Wei-Bin ZHONG ; Dong-Ru YANG ; Ke-Ze MA ; Zhi-Jun LAI ; Su-Jun CHEN ; Man ZHENG
Chinese Journal of Contemporary Pediatrics 2023;25(8):843-848
OBJECTIVES:
To explore the etiology composition and outcomes of pediatric chronic critical illness (PCCI) in the pediatric intensive care unit (PICU).
METHODS:
The children who were hospitalized in the PICU of Dongguan Children's Hospital Affiliated to Guangdong Medical University and met the diagnostic criteria for PCCI from January 2017 to December 2022 were included in the study. The etiology of the children was classified based on their medical records and discharge diagnoses. Relevant clinical data during hospitalization were collected and analyzed.
RESULTS:
Among the 3 955 hospitalized children in the PICU from January 2017 to December 2022, 321 cases (8.12%) met the diagnostic criteria for PCCI. Among the 321 cases, the most common etiology was infection (71.3%, 229 cases), followed by unintentional injury (12.8%, 41 cases), postoperation (5.9%, 19 cases), tumors/immune system diseases (5.0%, 16 cases), and genetic and chromosomal diseases (5.0%, 16 cases). Among the 321 cases, 249 cases (77.6%) were discharged after improvement, 37 cases (11.5%) were discharged at the request of the family, and 35 cases (10.9%) died in the hospital. Among the deaths, infection accounted for 74% (26/35), unintentional injury accounted for 17% (6/35), tumors/immune system diseases accounted for 6% (2/35), and genetic and chromosomal diseases accounted for 3% (1/35). From 2017 to 2022, the proportion of PCCI in PICU diseases showed an increasing trend year by year (P<0.05). Among the 321 children with PCCI, there were 148 infants and young children (46.1%), 57 preschool children (17.8%), 54 school-aged children (16.8%), and 62 adolescents (19.3%), with the highest proportion in the infant and young children group (P<0.05). The in-hospital mortality rates of the four age groups were 14.9% (22/148), 8.8% (5/57), 5.6% (3/54), and 8.1% (5/62), respectively. The infant and young children group had the highest mortality rate, but there was no statistically significant difference among the four groups (P>0.05).
CONCLUSIONS
The proportion of PCCI in PICU diseases is increasing, and the main causes are infection and unintentional injury. The most common cause of death in children with PCCI is infection. The PCCI patient population is mainly infants and young children, and the in-hospital mortality rate of infant and young children with PCCI is relatively high.
Adolescent
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Infant
;
Child, Preschool
;
Humans
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Child
;
Critical Illness
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Prognosis
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Child, Hospitalized
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Chronic Disease
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Intensive Care Units, Pediatric
10.Association Analysis between Genotype and Phenotype of α,β-Thalassaemia Carriers in Huizhou Area of Guangdong Province.
Di-Na CHEN ; Zhi-Yang GUAN ; Ze-Yan ZHONG ; Hai-Lin HE ; Guo-Xing ZHONG ; Zhi-Yong WU ; Jian-Hong CHEN
Journal of Experimental Hematology 2023;31(4):1133-1137
OBJECTIVE:
To analyze the prevalence, genotype distribution and hematological characteristics of α,β-thalassaemia carriers in Huizhou area of Guangdong Province.
METHODS:
10 809 carriers of simple β-thalassaemia and 1 757 carriers of α,β-thalassaemia were enrolled as our study cohort. The hematological parameters were detected by automated blood cell counters and automatic capillary electrophoresis. Suspension array technology, gap-polymerase chain reaction (gap-PCR) and PCR-reverse dot blot were used for the genotyping of thalassaemia carriers.
RESULTS:
The prevalence of α,β-thalassaemia in Huizhou area of Guangdong Province was 1.99%. A total of 62 genotypes were detected, and the most prevalent genotype was --SEA/ αα, βCD41-42/ βN (19.29%), the next was --SEA/ αα, βIVS-II-654/ βN (16.73%). Significant differences in mean corpuscular volume (MCV) and mean corpuscular hemoglobin (MCH) were found between different genotype groups for simple β-thalassaemia and α,β-thalassaemia. Violin plots showed that carriers with co-inheritance of β-thalassaemia and mild α-thalassaemia expressed the lightest anemia, and carriers with co-inheritance of β-thalassaemia and hemoglobin H (Hb H) disease expressed the most severe anemia.
CONCLUSION
There is a high prevalence of α,β-thalassaemia in Huizhou area of Guangdong Province. Because of the lack of specific hematological makers for diagnosis of α,β-thalassaemia, it is necessary to distinguish it from simple β-thalassaemia by genotyping of α- and β-thalassaemia in order to correctly guide genetic counseling and prenatal disgnosis.
Pregnancy
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Female
;
Humans
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beta-Thalassemia/genetics*
;
Genotype
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Heterozygote
;
Phenotype
;
alpha-Thalassemia/genetics*
;
China/epidemiology*
;
Mutation

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