1.Status of tuberculosis prevention and control knowledge with perceived stress among college and middle school students with pulmonary tuberculosis in Yantai
Chinese Journal of School Health 2025;46(12):1706-1710
Objective:
To understand the current status of tuberculosis prevention and control knowledge and perceived stress among college and middle school students with pulmonary tuberculosis (PTB) in Yantai City, and to analyze the related factors, so as to provide a basis for the school to carry out health education and psychological counseling.
Methods:
A matched case control study was conducted, with 100 PTB student patients in junior high school and above who were diagnosed at designated medical institutions from October 2020 to October 2024. Four healthy control students of the same gender, same dormitory, or same class were selected for each case. Therefore, 100 cases and 400 controls were investigated by questionnaire. The following information was collected: personal basic information; tuberculosis prevention and control awareness; and scores of the Chinese Perceived Stress Scale (CPSS). Conditional Logistic regression model and mixed linear models were used to compare the PTB prevention and control awareness rate, as well as the perceived stress between the case and control groups. Multiple linear regression analysis was used to analyze the factors that may affect the perceived stress of students with PTB.
Results:
The awareness rates of four tuberculosis knowledge items (symptoms of PTB, main causes of onset after infection, consequences of PTB patients not receiving standardized and complete treatment, the most important method to prevent PTB) were higher in the case group (40.00%, 72.00% , 38.00%, 49.00%) than the control group (21.50%, 57.50%, 22.25%, 31.25%) and the differences were statistically significant ( Wald χ 2=18.44, 8.78, 13.20, 16.89, all P <0.01). The tension score (10.49±4.20), loss of control score ( 11.21± 4.58), and total score (21.70±6.88) in the case group were higher than the control group (9.35±4.73, 9.75±5.60, 19.09±8.36) and the differences were statistically significant ( t =2.21, 2.42, 2.88, all P <0.05). The results of multiple linear regression analysis showed that age ≥ 18 years and family history of tuberculosis were the related factors affecting the overall perceived stress and tension of college and middle school students with PTB ( B total scores =4.50, 5.91; B tension score =2.39, 3.23, all P <0.05).
Conclusions
The tuberculosis prevention and control awareness rate, and the perceived stress of college and middle school students with PTB in Yantai are both higher than students without tuberculosis. Moreover, the perceived stress of students with PTB who are aged ≥18 years or have a family history of tuberculosis is even higher.
2.Correlation analysis between preoperative C 2 slope and effectiveness at 2 years after short-segment anterior cervical discectomy and fusion.
Zhaojun CHENG ; Yan GONG ; Yanchi GAN ; Jiahui HE ; De LIANG ; Hui REN ; Xiaobing JIANG
Chinese Journal of Reparative and Reconstructive Surgery 2025;39(3):341-345
OBJECTIVE:
To investigate correlation between preoperative C 2 slope (C2S) and effectiveness at 2 years after short-segment anterior cervical discectomy and fusion (ACDF), with the aim of providing reliable indicators for predicting effectiveness.
METHODS:
One hundred and eighteen patients with cervical spondylotic myelopathy, who received short-segment ACDF between January 2018 and December 2022 and met the selection criteria, were enrolled in the study. There were 46 males and 72 females, aged from 26 to 80 years, with a mean age of 53.6 years. The operative duration was (127.6±33.46) minutes and the intraoperative blood loss was (34.75±30.40) mL. All patients were followed up 2 years. The pre- and post-operative Neck Disability Index (NDI), Japanese Orthopaedic Association (JOA) score, and visual analogue scale (VAS) score for pain were recorded. Based on the anteroposterior and lateral cervical X-ray films, the sagittal parameters of the cervical spine were measured [C 2-C 7 Cobb angle, C 0-C 2 Cobb angle, T 1 slope, C2S, sagittal segmental angle (SSA) of the surgical segment, and average surgical disc height (ASDH) of the surgical segment]. Statistical analyses were performed to assess the differences in these indicators between pre- and post-operation, as well as the correlations between the preoperative C2S and the JOA score, NDI, and VAS score at 2 years after operation. The patients were allocated into group A (C2S >11.73°) and group B (C2S≤ 11.73°) according to the median value of the preoperative C2S (11.73°). The JOA score, NDI, and VAS score before operation and at 2 years after operation, as well as the differences between pre- and post-operative values (change values), were compared between the two groups.
RESULTS:
The T 1 slope, C 2-C 7 Cobb angle, C 0-C 2 Cobb angle, SSA, and ASDH at immediate after operation and JOA score, NDI, and VAS score at 2 years after operation significantly improved in 118 patients when compared with preoperative ones ( P<0.05). Pearson correlation analysis showed that preoperative C2S was not correlated with JOA score and NDI at 2 years after operation ( P>0.05), but negatively correlated with VAS score ( P<0.05). There were 59 patients with preoperative C2S>11.73° (group A) and 59 with C2S≤11.73° (group B). There was no significant difference in preoperative JOA score, NDI, and VAS score between the two groups ( P>0.05). There were significant differences in VAS score at 2 year after operation and the change value between the two groups ( P<0.05); there was no significant difference in the JOA score and NDI ( P>0.05).
CONCLUSION
Patients with cervical spondylotic myelopathy and a higher preoperative C2S exhibited superior long-term pain relief and effectiveness following short-segment ACDF.
Humans
;
Male
;
Spinal Fusion/methods*
;
Female
;
Middle Aged
;
Cervical Vertebrae/diagnostic imaging*
;
Diskectomy/methods*
;
Aged
;
Adult
;
Treatment Outcome
;
Aged, 80 and over
;
Spondylosis/diagnostic imaging*
;
Pain Measurement
;
Preoperative Period
;
Follow-Up Studies
3.Wip1 Phosphatase Regulates Hematopoietic Function in Mouse Spleen.
Xiao-Ping REN ; Zhi-Lin CHANG ; Yi WANG ; Hui-Min ZHU ; Wen-Yan HE
Journal of Experimental Hematology 2025;33(5):1491-1498
OBJECTIVE:
To investigate the regulatory effect of Wip1 phosphatase on hematopoietic function in the mouse spleen.
METHODS:
Wip1 knockout mice were bred, and the effect of Wip1 deletion on the proportion and number of hematopoietic stem/progenitor cells, as well as their mature subsets in mouse spleen was detected by flow cytometry. The Proteome ProfilerTM antibody array was used to analyze the role of Wip1 deletion on the expression of inflammatory cytokines in CD45highCD11b+ myeloid cells sorted from mouse spleen.
RESULTS:
Wip1 deletion resulted in smaller size and significant reduction of cell number in the mouse spleen. The absolute numbers of hematopoietic stem/progenitor cells were decreased. Meanwhile, the absolute number of T and B lymphocytes also significantly declined. However, the proportion of erythroid progenitors and erythroid cells at various stage significantly increased, but the number of mature erythroid cells decreased. Furthermore, the myeloid cells and their subsets neutrophils, monocytes, CD45highCD11b+ and CD45lowCD11b+ were all reduced. CD45highCD11b+ myeloid cells displayed proinflammatory phenotype in the spleen.
CONCLUSION
Wip1 gene deletion impairs normal hematopoietic function in the mouse spleen, leading to a significant reduction of mature hematopoietic cells of various lineages, and proinflammatory phenotype in CD45highCD11b+ myeloid cells.
Animals
;
Mice
;
Spleen/cytology*
;
Mice, Knockout
;
Hematopoietic Stem Cells/cytology*
;
Myeloid Cells/cytology*
;
Protein Phosphatase 2C
;
Hematopoiesis
;
Flow Cytometry
4.Brucea javanica Seed Oil Emulsion and Shengmai Injections Improve Peripheral Microcirculation in Treatment of Gastric Cancer.
Li QUAN ; Wen-Hao NIU ; Fu-Peng YANG ; Yan-da ZHANG ; Ru DING ; Zhi-Qing HE ; Zhan-Hui WANG ; Chang-Zhen REN ; Chun LIANG
Chinese journal of integrative medicine 2025;31(4):299-310
OBJECTIVE:
To explore and verify the effect and potential mechanism of Brucea javanica Seed Oil Emulsion Injection (YDZI) and Shengmai Injection (SMI) on peripheral microcirculation dysfunction in treatment of gastric cancer (GC).
METHODS:
The potential mechanisms of YDZI and SMI were explored through network pharmacology and verified by cellular and clinical experiments. Human microvascular endothelial cells (HMECs) were cultured for quantitative real-time polymerase chain reaction, Western blot analysis, and human umbilical vein endothelial cells (HUVECs) were cultured for tube formation assay. Twenty healthy volunteers and 97 patients with GC were enrolled. Patients were divided into surgical resection, surgical resection with chemotherapy, and surgical resection with chemotherapy combining YDZI and SMI groups. Forearm skin blood perfusion was measured and recorded by laser speckle contrast imaging coupled with post-occlusive reactive hyperemia. Cutaneous vascular conductance and microvascular reactivity parameters were calculated and compared across the groups.
RESULTS:
After network pharmacology analysis, 4 ingredients, 82 active compounds, and 92 related genes in YDZI and SMI were screened out. β-Sitosterol, an active ingredient and intersection compound of YDZI and SMI, upregulated the expression of vascular endothelial growth factor A (VEGFA) and prostaglandin-endoperoxide synthase 2 (PTGS2, P<0.01), downregulated the expression of caspase 9 (CASP9) and estrogen receptor 1 (ESR1, P<0.01) in HMECs under oxaliplatin stimulation, and promoted tube formation through VEGFA. Chemotherapy significantly impaired the microvascular reactivity in GC patients, whereas YDZI and SMI ameliorated this injury (P<0.05 or P<0.01).
CONCLUSIONS
YDZI and SMI ameliorated peripheral microvascular reactivity in GC patients. β-Sitosterol may improve peripheral microcirculation by regulating VEGFA, PTGS2, ESR1, and CASP9.
Humans
;
Microcirculation/drug effects*
;
Drugs, Chinese Herbal/administration & dosage*
;
Stomach Neoplasms/physiopathology*
;
Emulsions
;
Male
;
Plant Oils/administration & dosage*
;
Brucea/chemistry*
;
Middle Aged
;
Female
;
Drug Combinations
;
Human Umbilical Vein Endothelial Cells/metabolism*
;
Seeds/chemistry*
;
Injections
;
Vascular Endothelial Growth Factor A/metabolism*
;
Aged
;
Network Pharmacology
5.Expert consensus on early orthodontic treatment of class III malocclusion.
Xin ZHOU ; Si CHEN ; Chenchen ZHOU ; Zuolin JIN ; Hong HE ; Yuxing BAI ; Weiran LI ; Jun WANG ; Min HU ; Yang CAO ; Yuehua LIU ; Bin YAN ; Jiejun SHI ; Jie GUO ; Zhihua LI ; Wensheng MA ; Yi LIU ; Huang LI ; Yanqin LU ; Liling REN ; Rui ZOU ; Linyu XU ; Jiangtian HU ; Xiuping WU ; Shuxia CUI ; Lulu XU ; Xudong WANG ; Songsong ZHU ; Li HU ; Qingming TANG ; Jinlin SONG ; Bing FANG ; Lili CHEN
International Journal of Oral Science 2025;17(1):20-20
The prevalence of Class III malocclusion varies among different countries and regions. The populations from Southeast Asian countries (Chinese and Malaysian) showed the highest prevalence rate of 15.8%, which can seriously affect oral function, facial appearance, and mental health. As anterior crossbite tends to worsen with growth, early orthodontic treatment can harness growth potential to normalize maxillofacial development or reduce skeletal malformation severity, thereby reducing the difficulty and shortening the treatment cycle of later-stage treatment. This is beneficial for the physical and mental growth of children. Therefore, early orthodontic treatment for Class III malocclusion is particularly important. Determining the optimal timing for early orthodontic treatment requires a comprehensive assessment of clinical manifestations, dental age, and skeletal age, and can lead to better results with less effort. Currently, standardized treatment guidelines for early orthodontic treatment of Class III malocclusion are lacking. This review provides a comprehensive summary of the etiology, clinical manifestations, classification, and early orthodontic techniques for Class III malocclusion, along with systematic discussions on selecting early treatment plans. The purpose of this expert consensus is to standardize clinical practices and improve the treatment outcomes of Class III malocclusion through early orthodontic treatment.
Humans
;
Malocclusion, Angle Class III/classification*
;
Orthodontics, Corrective/methods*
;
Consensus
;
Child
6.Sex development disorder with discordant chromosome karyotype and gene detection:a case report and literature review
Yan-Lin REN ; Ya-Li LI ; Kun LI ; Fan ZHANG ; Li-Min RONG ; Xiao-Ping YU ; Jun GU ; Yan-Hua KANG ; Ying HE
Medical Journal of Chinese People's Liberation Army 2025;50(1):50-56
Objective To report the diagnosis,treatment,and verification process of a patient with sex development disorder whose chromosomal karyotype and genetic test results are inconsistent,and conduct a literature review to improve the understanding of the mosaic status of sexual development disorders.Methods A 14-year-old patient presented with primary amenorrhea on April 3,2020,at the First Affiliated Hospital of Hebei North University,exhibiting female sexual characteristics.The patient underwent ultrasonic/magnetic resonance imaging of gonads,assessment of gonadal axis function,chromosomal karyotype,and molecular genetic testing,as well as pelvic exploration,malignant gonads resection,and hormone replacement therapy,resulting in drug-induced menstruation.During the diagnosis and treatment,it was found that the patient's chromosomal karyotype analysis was inconsistent with the molecular genetic test results.Subsequently,samples from the three germ layer cells were taken,and fluorescence in situ hybridization(FISH)was used to detect the sex chromosomes in each germ layer cell.XY probes were used to label the gonadal pathological sections to explore the distribution differences of the Y chromosome in the gonads,and changes in anti-Müllerian hormone(AMH)levels before and after surgery were compared.Databases such as Wanfang and PubMed were searched to summarize relevant cohort study literature and understand the current status of research on this disease.Results The patient's body exhibited a significant differences between the 45,X and 46,XY cell lines in different germ layers and within the same layer tissues.The proportion of 45,X in buccal mucosal cells derived from the ectoderm was 30%(6/20),in peripheral blood lymphocytes derived from the mesoderm was 9.7%(11/114),and in bladder shed cells derived from endoderm was 20.4%(22/108).The gonadal pathological sections labeled with XY probes indicated a mosaic state with a reduced Y-chromosome;where the epididymal structure area had a 45,X cell line mosaic of 50.0%,and the malignant area had a normal"Y"content.After gonadal resection,AMH levels significantly dropped from 7.28 pmol/L to<0.07 pmol/L.Literature review revealed that patients with 45,X/46,XY have a complex phenotype spectrum,most with features of Turner syndrome,and female phenotypes are at risk of gonadal tumors.Conclusions In the diagnosis of difficult cases of sex development disorders,when performing peripheral blood karyotype testing,the number of counted cells and analyzed cells should be increased as much as possible,and multi-germ layer cell sampling should be performed.Gonads with a high"Y"mosaic rate are more prone to malignancy in the abdominal cavity.Detecting AMH levels can distinguish cryptorchidism and anorchidism in sexual development disorders with Y chromosomes.
7.Diagnostic value of novel inflammatory markers related to routine blood tests in elderly patients with chronic cardiovascular disease complicated with frailty
Xing-Man FAN ; Yan-Yan LI ; Qiong-Yi HE ; Wei-Na LUO ; Xiao-Hua LAN ; Kai-Jie ZHANG ; Meng WANG ; Xiang-Ren KONG ; Hai-Tao ZHANG
Medical Journal of Chinese People's Liberation Army 2025;50(3):301-308
Objective To investigate the diagnostic value of 4 novel inflammatory markers related to routine blood tests,namely neutrophil-to-lymphocyte ratio(NLR),red blood cell distribution width(RDW),hemoglobin-to-RDW ratio(HRR)and systemic immune-inflammation index(SII),in elderly patients with chronic cardiovascular disease(CVD)complicated with frailty.Methods Retrospectively analyze 110 patients with chronic stable CVD who were hospitalized in the cadre ward of cardiovascular medicine at the Air Force Characteristic Medical Center from January 2022 to June 2023.According to the assessment results of the Fried scale,they were divided into three groups:non-frailty group(Fried score=0,n=30),the pre-frailty group(Fried score 1 or 2,n=40)and frailty group(Fried score≥3,n=40).The differences in general information,the impairment rate of daily living activities,miniature nutritional assessment-short form(MNA-SF)scores,mini-mental state examination(MMSE)scores,and the indicators such as NLR,RDW,HRR,and SII among the three groups were compared.Spearman rank correlation was used to analyze the correlation between NLR,RDW,HRR,SII and frailty scores as well as each frailty indicator.Multivariate logistic regression analysis was performed to identify the independent risk factors for frailty in elderly patients with chronic CVD,and the receiver operating characteristic(ROC)curve was used to assess the clinical diagnostic value of NLR and HRR in elderly patients with chronic CVD complicated with frailty.Results Compared with non-frailty group and pre-frailty group,patients in frailty group were older,with higher impaired rates of daily living activities,NLR,RDW,and SII,and lower MNA-SF scores,MMSE scores,and HRR,and differences were statistically significant(P<0.05).Spearman rank correlation analysis showed that the frailty score was positively correlated with NLR(rs=0.354,P<0.001),and RDW(rs=0.448,P<0.001),negatively correlated with HRR(rs=-0.232,P=0.024),and had no significant correlation with SII(rs=0.144,P=0.167).Further analysis of the correlation between the above novel inflammatory markers and the 5 components of frailty showed that NLR was positively correlated with fatigue(rs=0.228,P=0.017),slowed walking speed(rs=0.299,P<0.001),and low physical function(rs=0.319,P<0.001);RDW was positively correlated with decreased grip strength(rs=0.321,P<0.001),slowed walking speed(rs=0.422,P<0.001),and low physical function(rs=0.246,P=0.001);and HRR was negatively correlated with slowed walking speed(rs=-0.230,P=0.025),and low physical function(rs=-0.299,P=0.003).Multivariate logistic regression analysis showed that MNA-SF score(OR=0.577,95%CI 0.342-0.973)was an independent protective factor for pre-frailty in elderly patients with chronic CVD(P<0.05);NLR(OR=7.866,95%CI 1.101-56.185)was an independent risk factor for frailty,while HRR(OR=0.344,95%CI 0.120-0.983)and MNA-SF score(OR=0.292,95%CI 0.146-0.580)were independent protective factors for frailty in elderly CVD patients(P<0.05).The area under the ROC curve of NLR and HRR for diagnosing frailty in elderly patients with chronic CVD were 0.778 and 0.749,respectively.Conclusion NLR and HRR have high clinical diagnostic value for frailty in elderly patients with chronic CVD,and are expected to become effective inflammatory markers for screening elderly patients with chronic CVD complicated with frailty.
8.Knowledge, attitudes and practices towards scrub typhus control and associated influencing factors among residents in Longling County, Yunnan Province in 2023
Yu ZHOU ; Shujuan YANG ; Yuan YANG ; Yan HE ; Shulian YUAN ; Zhaowen CHEN ; Tianguang REN
Chinese Journal of Schistosomiasis Control 2024;36(5):507-513
Objective To investigate the knowledge, attitudes and practices (KAP) towards scrub typhus control and analyse the influencing factors among residents in Longling County, Yunnan Province in 2023, so as to provide insights into management of scrub typhus in the county. Methods Two townships were randomly sampled from Longling County, Baoshan City, Yunnan Province in July 2023, and 2 to 3 administrative villages were randomly selected from each township. Then, 20 to 40 households were randomly selected from each village, and 1 to 2 villagers were surveyed in each household. Residents’ KAP towards scrub typhus control was investigated, and factor affecting residents’ KAP towards scrub typhus control were identified with independent samples t test or analysis of variance (ANOVA) and multiple linear regression analysis. Results A total of 417 questionnaires were allocated, and 410 valid questionnaires were recovered, with an effective recovery rate of 98.32%. Of all respondents, 65.85% (270/410) heard of scrub typhus but were not familiar with it, and 12.68% (52/410) and 1.95% (8/410) were familiar and very familiar with it, respectively. Residents mainly acquired scrub typhus control knowledge via their relatives and friends. The knowledge, attitude, and behavior scores of the respondents with regard to scrub typhus were (34.14 ± 13.07), (55.04 ± 6.69), and (21.40 ± 5.61), respectively, and the total score for knowledge, belief, and behavior in relation to scrub typhus prevention and control was (110.57 ± 18.80). Univariate analysis revealed that age (F = 3.12, P < 0.05), education (F = 10.77, P < 0.05), occupation (F = 4.89, P < 0.05), frequency of outdoor activities (F = 3.61, P < 0.05), and type of place of residence (t = 1.33, P < 0.05) were the factors that influenced the participants’ scores for knowledge of the prevention and control of scrub typhus. Multiple linear regression analysis revealed that literacy level (β = 10.20 to 16.71, P < 0.05) and category of residence (β = −7.23, P < 0.05) were the factors that influenced residents’ current knowledge and trust behavior in relation to scrub typhus. Conclusions Place of residence and educational level are critical factors affecting scrub typhus control among residents in Longling County, Yunnan Province. Intensified health education pertaining to scrub typhus control and appropriate behavioral interventions are required among residents living in urban areas, with a low educational level and frequent outdoor activities.
9.Quality Standard and Acute Toxicity Study of Triadica Cochinchinensis
Fang LYU ; Xiao XU ; Xiaopeng WU ; Yan YOU ; Dongjie SHAN ; Xueyang REN ; Xianxian LI ; Qingyue DENG ; Yingyu HE ; Gaimei SHE
Chinese Journal of Modern Applied Pharmacy 2024;41(4):512-519
OBJECTIVE
To establish the quality standard of Triadica cochinchinensis and to perform the acute toxicity study.
METHODS
Appearance properties, powder microscopic identification, and thin-layer chromatography(TLC) identification were researched. The specific chromatogram was established by HPLC. The content of cadmium(Cd), lead(Pb), arsenic(As), copper(Cu), and mercury(Hg) was determined by inductively coupled plasma-mass spectrometry(ICP-MS). Acute toxicity was studied by maximum dose.
RESULTS
The outer skin of herbs was dark brown, and the inner surface was light yellow brown and fibrous. Besides, crystal sheath fiber was common, and calcium oxalate clusters arranges in rows. In the TLC diagram of the test product, the fluorescent spots of the same color were displayed at the corresponding position of the control product(scopoletin, isofraxidin). Five common peaks were calibrated in the characteristic map and the three characteristic peaks(scopoletin, isofraxidin, dimethylfraxetin) were recognized. The content of the measured heavy metal elements was lower than the national limit standard. The linear correlation coefficient was R2 > 0.999. The precision, stability, repetitive RSD were < 10%. The average recovery rate of the added sample was 80%−120%, and the RSD was < 10%. The maximum dose of the acute toxicity test was 184.09 g·kg−1. The 14 d internal body mass, food intake, organ-body ratios, the serum glutamic pyruvic transaminase, glutamic oxaloacetic transaminase, blood urea nitrogen, and creatinine were not significantly different by comparing with the normal controls. Therefore, no significant toxicity was observed.
CONCLUSION
The established standard can provide a reference for evaluating the quality of Triadica cochinchinensis. The heavy metal content of ten batches of medicinal materials is within the safe range. Acute toxicity test show that there is no obvious significant adverse teactions after oral administration, and the safe dose range is large, which can provide a reference for the subsequent development and utilization.
10.Bioequivalence study of ezetimibe tablets in Chinese healthy subjects
Pei-Yue ZHAO ; Tian-Cai ZHANG ; Yu-Ning ZHANG ; Ya-Fei LI ; Shou-Ren ZHAO ; Jian-Chang HE ; Li-Chun DONG ; Min SUN ; Yan-Jun HU ; Jing LAN ; Wen-Zhong LIANG
The Chinese Journal of Clinical Pharmacology 2024;40(16):2378-2382
Objective To evaluate the bioequivalence and safety of ezetimibe tablets in healthy Chinese subjects.Methods The study was designed as a single-center,randomized,open-label,two-period,two-way crossover,single-dose trail.Subjects who met the enrollment criteria were randomized into fasting administration group and postprandial administration group and received a single oral dose of 10 mg of the subject presparation of ezetimibe tablets or the reference presparation per cycle.The blood concentrations of ezetimibe and ezetimibe-glucuronide conjugate were measured by high-performance liquid chromatography-tandem mass spectrometry(HPLC-MS/MS),and the bioequivalence of the 2 preparations was evaluated using the WinNonlin 7.0 software.Pharmacokinetic parameters were calculated to evaluate the bioequivalence of the 2 preparations.The occurrence of all adverse events was also recorded to evaluate the safety.Results The main pharmacokinetic parameters of total ezetimibe in the plasma of the test and the reference after a single fasted administration:Cmax were(118.79±35.30)and(180.79±51.78)nmol·mL-1;tmax were 1.40 and 1.04 h;t1/2 were(15.33±5.57)and(17.38±7.24)h;AUC0-t were(1 523.90±371.21)and(1 690.99±553.40)nmol·mL-1·h;AUC0-∞ were(1 608.70±441.28),(1 807.15±630.00)nmol·mL-1·h.The main pharmacokinetic parameters of total ezetimibe in plasma of test and reference after a single meal:Cmax were(269.18±82.94)and(273.93±87.78)nmol·mL-1;Tmax were 1.15 and 1.08 h;t1/2 were(22.53±16.33)and(16.02±5.84)h;AUC0_twere(1 463.37±366.03),(1 263.96±271.01)nmol·mL-1·h;AUC0-∞ were(1 639.01±466.53),(1 349.97±281.39)nmol·mL-1·h.The main pharmacokinetic parameters Cmax,AUC0-tand AUC0-∞ of the two preparations were analyzed by variance analysis after logarithmic transformation.In the fasting administration group,the 90%CI of the log-transformed geometric mean ratios were within the bioequivalent range for the remaining parameters in the fasting dosing group,except for the Cmax of ezetimibe and total ezetimibe,which were below the lower bioequivalent range.The Cmax of ezetimibe,ezetimibe-glucuronide,and total ezetimibe in the postprandial dosing group was within the equivalence range,and the 90%CI of the remaining parameters were not within the equivalence range for bioequivalence.Conclusion This test can not determine whether the test preparation and the reference preparation of ezetimibe tablets have bioequivalence,and further clinical trials are needed to verify it.


Result Analysis
Print
Save
E-mail