1.Pharmacokinetics and Bioequivalence of Rosuvastatin Calcium Capsules and Tablets in Healthy Volunteers
Yaxin SUN ; Feng QIU ; Mingming ZHAO ; Limei ZHAO ; Guofei LI
China Pharmacist 2015;(2):190-193
Objective:To develop an HPLC-MS/MS method for the determination of rosuvastatin in plasma and study the relative bioavailability and bioequivalence of the capsules and tablets in Chinese healthy volunteers. Methods: A single oral dose (20 mg of the test or reference preparation) was given to 24 male healthy volunteers in a randomized crossover study. The plasma concentration of rosuvastatin was determined by HPLC-MS/MS. The pharmacokinetic parameters were calculated and the bioavailability and bioequiva-lence of the two preparations were evaluated by DAS 3. 0 software. Results:After a single dose, the pharmacokinetic parameters of ro-suvastatin capsules and tablets were as follows:Tmax was (3. 56 ± 1. 68) h and (3. 63 ± 1. 56) h, Cmax was (21. 17 ± 13. 74) ng· ml-1 and (26.33 ±23.22) ng·ml-1, t1/2 was (10.68 ±5.50) h and (9.04 ±6.00) h, AUC0-t was (219.31 ±146.09) ng·h· ml-1 and (252. 43 ± 194. 96) ng·h·ml-1 , AUC0-∞ was (225. 32 ± 146. 76) ng·h·ml-1 and (257. 24 ± 194. 61) ng·h·ml-1 , respectively. The 90% confidential interval of AUC0-t, AUC0-∞ and Cmax was 81. 1%-106% , 81. 8%-105. 4% and 77. 9%-104. 5%, respectively. The mean relative bioavailability of the test preparation(the capsules) to the reference preparation(the tablets) was (100. 7 ± 54. 1)%. Conclusion:The test and reference preparations are bioequivalent.
2.A clinical research of short-cycle repeat transurethral resection combined pirarubicin treatment of T2 invasive bladder cancer
Fei LI ; Guofei ZHANG ; Wei DENG ; Junjie MA ; Zhen YAN ; Yue WU
Journal of Chinese Physician 2015;(3):351-353
Objective To investigate the short-cycle repeated transurethral resection ( Re-TURBT) combined pirarubicin treatment of T2 muscle invasive bladder tumor efficacy and safety.Methods From October 2010 to December 2013, 56 clinically diagnosed cases of bladder cancer were divided into two groups;the experimental group was taken a short-cycle repeat transurethral resection surgery, and the con-trol group taken along open surgery to remove the tumor and its surrounding 2cm bladder tissue, postopera-tive patients were given pirarubicin infusion therapy.Results Each patient completed the trial.For the ex-perimental group, blood loss and operative time was significantly lower than the control group ( P <0.05). For experimental group after 3 months, 6 months, and 12 months, maximum bladder capacity ( MBC) and patient perception of bladder condition ( PPBC) were significantly higher than control group ( P <0.05 ) . For experimental group after 3 months and 6 months, maximum urinary flow rate ( Qmax) was significantly higher than control group ( P <0.05) , but no significant difference between two groups at 12 months.The incidence of adverse events, vascular endothelial growth factor ( VEGF) , and a total recurrence rate showed no significant difference ( P >0.05).For experimental group, bladder perforation in 1 case, 1 case was forced to open surgery, the incidence rate was about 6.7%.Conclusions The short-cycle repeated trans-urethral resection combined pirarubicin treatment of T2 invasive bladder tumor was simple, effective and se-curity.
3.The clinical study about levetiracetam on cognitive function and emotional influence in the patients with partial epilepsy
Jianlei ZHANG ; Guofei LI ; Na CHANG ; Zhaohui WANG ; Dajian LIU ; Weiya HE
Chinese Journal of Postgraduates of Medicine 2014;37(28):55-57
Objective To investigate the clinical influence about levetiracetam on cognitive function and emotional influence in the patients with partial epilepsy.Methods A total of 62 patients with partial epilepsy were divided into carbamazepine group (30 cases) and levetiracetam group (32 cases) by random digits table method,carbamazepine group was treated by carbamazepine while levetiracetam group was treated by levetiracetam.The patients were assessed before treatment and 4,8,12,16 weeks after treatment by the Montreal cognitive assessment scale (MoCA),self rating anxiety scale (SAS) and self rating depression scale (SDS).Results There was no significant difference in MoCA score between two groups before treatment and 4 weeks after treatment (P > 0.05).MoCA score at 8,12,16 weeks after treatment in levetiracetam group was better than that in carbamazepine group [(22.6 ± 2.1) scores vs.(20.8 ± 2.6) scores,(23.5±2.7) scoresvs.(21.3± 2.8) scores,(24.6±4.7) scoresvs.(21.2±3.0) scores],the difference was statistically significant (P < 0.05).There was no significant difference between SAS score,SDS score between two groups before and after treatment (P > 0.05).Conclusion In the process of treating the patients with partial epilepsy by drug,levetiracetam is superior to carbamazepine on the improvement of cognitive function,but the mood improvement is not obvious.
4.The expression and clinical pathological significance of PDCD in laryngocarcinoma.
Guofei FENG ; Peihua LI ; Huihua YOU ; Wen LIU ; Xu ZHANG ; Xuegu XU ; Guangming SUN ; Fengchao LI
Journal of Clinical Otorhinolaryngology Head and Neck Surgery 2011;25(1):16-19
OBJECTIVE:
To investigate the expression and clinical pathological significance of PDCD4 in laryngocarcinoma tissue and its potential significance to clinic.
METHOD:
Western-blotting and immunohistochemistry ana lyse to measure the protein expression of PDCD4 in 54 cases of laryngocarcinoma tissues (studying group) and their paraneoplastic normal tissues (control group). The correlations of PDCD4 with clinical pathological parameters were analyzed.
RESULT:
PDCD4 protein was positively expressed in paraneoplastic normal tissue while which was lost or decreased in laryngocarcinoma tissue by Western blot and immunohistochemistry. Immunohistochemistry assay showed the location of PDCD4 protein in cells was different between the studying group and the control group. The expression level of PDCD4 was related to the pathological grades of the laryngocarcinoma. It's higher in the well-differentiated tumor group than that in the poorly differentiated ones. But the expressions of PDCD4 were no differences among other clinical parameters including sex, age, clinical classification, clinical stage and the cervical lymphonodus who had been metastases or not.
CONCLUSION
PDCD4 gene is anti-oncogene. It may play an important role in the pathogenesis and development of laryngeal carcinoma and it may be a new target of therapy for laryngo carcinoma.
Adult
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Aged
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Aged, 80 and over
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Apoptosis Regulatory Proteins
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metabolism
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Female
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Genes, Tumor Suppressor
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Humans
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Immunohistochemistry
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Laryngeal Neoplasms
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metabolism
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pathology
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Male
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Middle Aged
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RNA-Binding Proteins
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metabolism
5.Pathogenic bacteria distribution and drug resistance of postoperative infection in elderly patients with gastric cancer complicated with diabetes mellitus
Guofei HUANG ; Jun LI ; Junwen HE ; Yong YANG ; Xiaowei ZHANG ; Liang AN
International Journal of Laboratory Medicine 2018;39(8):922-924,928
Objective To investigate the distribution and drug resistance of pathogens in elderly patients with gastric cancer complicated with diabetes mellitus.Methods 367 elderly patients with gastric cancer and diabetes mellitus were selected from the hospital from March 2010 to March 2017.The samples were isolated and cultured.The Gram positive bacteria were tested by GN201,the Gram negative bacteria susceptibility test was carried out by GP,and the drug susceptibility test was carried out by disk diffusion method.Results There were 68 cases of postoperative infection in gastric cancer patients with diabetes mellitus,and 79 strains were isolated and cultured.Among the gram negative bacteria,Escherichia coli,Klebsiella pneumoniae and Pseudomonas aeruginosa were the main pathogens.Among the Gram positive bacteria,Staphylococcus aureus and Staphylococcus epidermidis were the main pathogens.The main Gram negative bacteria,Escherichia coli to ceftazidime with levofloxacin resistance rates were 93.33% and 80.00%;Klebsiella pneumoniae had a higher drug resistance rate for cefoperazone and ciprofloxacin,76.92% and 69.23% respectively;a relatively high rate of Pseudomonas aeruginosa resistant to levofloxacin was 80.00%.Among the gram positive bacteria,the re-sistance rates of Staphylococcus aureus to penicillin and erythromycin were relatively high,respectively 91. 67% and 83.33%.Staphylococcus epidermidis had relatively high resistance rates to penicillin and erythromy-cin,100.00% and 77.78% respectively.Conclusion Gastric cancer complicated by diabetes mellitus elderly patients with postoperative infection of pathogenic bacteria distribution is given priority to with Gram-negative bacteria was the most common in,Pseudomonas aeruginosa,the main pathogenic bacteria of Escherichia coli to ceftazidime with levofloxacin resistant rate of Klebsiella pneumoniae was higher on cefoperazone and ciproflox-acin resistant Pseudomonas aeruginosa,the resistance rate of Pseudomonas aeruginosa to levofloxacin is high, and it is important to apply antibiotics rationally according to drug sensitivity test.
6.Secular trend of BMI and its consistency with selfrated BMI status among Chinese children and adolescents
LI Minchao, YANG Zhiqin, ZHAO Tianwang, LU Guofei,LEI Chaoqiu
Chinese Journal of School Health 2020;41(10):1491-1494
Objective:
To describe the secular trend of BMI and its consistency with self-rated BMI status in Chinese children and adolescents, and to further investigate the related factors affecting self-rated BMI,so as to provide a scientific reference for interventional measures.
Methods:
A total of 6 238 children and adolescents aged 6-18 years were selected according to date from Chinese Health and Nutrition Svrvey during 2000-2015 and the criteria from National Health Commission of China.The Lambda-Mu-Sigma method(LMS) and Kappa consistency test were, respectively, applied to describe the percentiles for BMI and its agreement with self-rated BMI status. Multinomial Logistic model was used to assess the related factors influencing self-rated BMI status.
Results:
P50 and P85 percentiles showed an increasing trend, especially the increase of high percentile of BMI. Regardless of age and sex, the measured and self-rated BMI showed low agreement. More than 50% of over-weighted or underweighted children perceived themselves as normal-weight, and about 1/4 of normal weight students misclassified themselves as abnormal in weight. Urban boys were more likely to evaluate themselves as underweight [OR(95%CI) =1.43(1.18-1.73)]. Boys who favored popular showed[OR(95%CI)=1.80(1.23-2.55) and cartoon [OR (95%CI) =1.39(1.00-1.96)] were more likely to consider themselves as overweight. Girls in the older age group [OR (95%CI)=2.74(2.08-3.61)] and urban [1.53(1.21-1.94)] who favored popular programs [OR(95%CI) =1.74(1.27-2.38)] were more likely to perceived themselves as overweight. But girls who like anime/cartoons were more likely to think they were underweight [OR(95%CI)=1.78(1.33-2.40)].
Conclusion
The trend of BMI has shown an increasing trend in the past decade and it demonstrated a large bias with perceived BMI. Age, area and type of video were significant factors that influenced the self-rated BMI status.
7.Progress in individualized use of linezolid in adult critically ill patients
Ming ZHANG ; Guofei LI ; Hao SUN
China Pharmacy 2022;33(12):1520-1524
Linezolid is a n anti-infective drug commonly used in clinic. Considering the large difference of individual condition , severe basic disease ,poor organ function and large variety and quantity of drugs ,standard dose of linezolid may not be suitable for all critically ill patients. This paper reviews the relevant researches on the application of linezolid in adult critically ill patients in recent years ,analyzes the pharmacokinetic characteristics of critically ill patients ,and summarizes the influence of common physiological and pathological changes in critically ill patients on drugs. When using linezolid ,the clinical comprehensive evaluation of this special group should be strengthened. In addition to appropriately reducing the drug dosage of patients with liver/ kidney function injury ,it is also necessary to consider appropriately increasing the drug dosage in other cases. After medication ,in order to avoid excessive or insufficient drug exposure ,clinical medication monitoring should be strengthened ,especially the important mean as therapeutic drug monitoring should be used well.
8.Efficacy and safety comparison of lacosamide and carbamazepine in the treatment of adult patients with newly diagnosed epilepsy
Xiaqing GUO ; Guofei LI ; Yuhua SUN ; Donglin ZHENG
China Pharmacy 2024;35(4):464-467
OBJECTIVE To compare the efficacy and safety of lacosamide (LCM) and carbamazepine (CAR) as monotherapy in the treatment of adult patients with newly diagnosed epilepsy. METHODS By methods of retrospective analysis, 84 adult patients with newly diagnosed epilepsy, were admitted to the Department of Neurology, Huaihe Hospital of Henan University during Sept. 2020-Jun. 2022, were divided into the control group (40 cases, receiving CAR treatment) and the observation group (44 cases, receiving LCM treatment) according to different medication regimens. Total response rate, epilepsy seizure frequency, blood lipid levels, and the occurrence of adverse events (AEs) of patients were compared between the 2 groups. RESULTS In the first month after treatment, there was no statistically significant difference in the total response rate between the observation group (63.64%) and the control group (55.00%, P>0.05); the frequency of epilepsy seizure in both groups was significantly reduced compared to before treatment (P<0.05), but there was no statistically significant difference between 2 groups (P>0.05). In the third month after treatment, the total response rate of the observation group (90.91%) was significantly higher than control group (67.50%, P<0.05); the frequencies of epilepsy seizure in both groups were significantly reduced compared to before treatment, and the observation group was significantly lower than the control group (P<0.05). In the third month after treatment, the levels of total cholesterol (TC), triglyceride (TG) and low-density lipoprotein cholestrol (LDL-C) in the control group and the level of LDL-C in the observation group were significantly higher than before treatment, and the levels of TC, TG and LDL-C in the observation group were significantly lower than those in the control group (P<0.05). There was no statistically significant difference in the incidence of AEs between the observation group (15.91%) and the control group (17.50%, P>0.05). CONCLUSIONS Both LCM and CAR have certain effects in the treatment of newly diagnosed epilepsy in adults, which can reduce the frequency of epilepsy seizure in patients and have comparable safety. Meanwhile, LCM has better long-term efficacy than CAR in treating newly diagnosed epilepsy in adults, and its impact on the patient’s blood lipid is smaller than CAR.
9.Analysis of foodborne diseases pathogen infection characteristics in Haining City, Zhejiang Province from 2014 to 2023
Minchao LI ; Lijun SONG ; Guofei LU ; Yunheng ZHANG ; Tianwang ZHAO
Shanghai Journal of Preventive Medicine 2024;36(7):638-643
ObjectiveTo analyze the epidemiological characteristics of pathogens in foodborne disease cases in Haining City, Zhejiang Province, and to provide a basis for the prevention and investigation of foodborne diseases and outbreak events. MethodsInformation on foodborne disease patients from 2014 to 2023 was collected, and stool or anal swab samples were tested for relevant pathogens. The χ2 test was used to compare the differences in pathogen detection rates among different groups, and multivariate logistic regression analysis was used to analyze the risk factors for pathogen detection. ResultsA total of 5 814 samples were tested, with a positive detection rate of 15.36%. The detection rates were 4.95% for norovirus, 4.49% for Escherichia coli, 3.59% for Salmonella, 2.22% for Vibrio parahaemolyticus, and 0.11% for Shigella. The positive detection rates showed seasonal characteristics, with a minor peak in March-April dominated by norovirus and a major peak in July-September dominated by bacteria. The three groups with the highest detection rates were workers, white-collar workers and other groups. Multivariate logistic regression analysis showed that age, season, and antibiotic use before consultation were significant influencing factors for pathogen detection (P<0.05). Total pathogen detection risk was lower in the group that took antibiotics before visiting the clinic compared to those who did not (OR=0.29, 95%CI: 0.15‒0.49). The detection risk for norovirus was lower in the preschool age group (OR=0.19, 95%CI: 0.04‒1.00), in summer and autumn (OR range 0.23‒0.41), and in the group taking antibiotics (OR=0.42, 95%CI: 0.15‒0.92), but higher in the adolescent group (OR=1.40, 95%CI: 1.05‒1.88). The detection risk for enteropathogenic Escherichia coli was higher in summer (OR=1.82, 95%CI: 1.30‒2.60). The detection risk for Salmonella increased in the elderly group and in summer (OR range 1.44‒2.21), but decreased in the adolescent group, in winter, and in the group taking antibiotics (OR range 0.22‒0.65). The detection risk for Vibrio parahaemolyticus increased in summer and autumn (OR range 1.80‒1.90), but decreased in the primary and secondary school student group and in winter (OR range 0.10‒0.32). ConclusionThe prevalence of foodborne disease pathogens in Haining City is relatively high. Age, season, and antibiotic use before consultation are independent influencing factors for pathogen detection. These findings suggest that specific hypotheses regarding pathogenic factors can be proposed based on the time of occurrence and the age distribution of cases during field investigations of foodborne outbreaks.
10.Evaluation on the efficacy of prevention programs and relevant factors targeting mother-to-infant transmission on hepatitis B virus in Yunnan province.
Zhengrong DING ; Wenyu KANG ; Lin LU ; Liping SHEN ; Zhixian ZHAO ; Guofei HUANG ; Qing XIONG ; Kai LI ; Yi KONG
Chinese Journal of Epidemiology 2014;35(2):114-116
OBJECTIVETo explore the efficacy of prevention programs and relevant factors targeting mother-to-infant transmission of HBV in Yunnan province.
METHODSIn Yunnan province, we selected HBsAg positive pregnant women that delivered in hospital from January 1st through June 30th, 2011. Newborns of these pregnant women were under PMTCT (prevention of mother to child treatment) program and followed. Every infant was drawn 2 ml venous blood and questionnaire survey was carried out when the baby was 7-12 month-old and completed the vaccination processes. Serum samples of them were then collected and detected on the 5 serological indicators of HBV.
RESULTSwere analyzed statistically.
RESULTSThere were 2 765 infants in the study program. The success rate of PMTCT was 95.88% . Rates of coverage on both timely-birth dose and 3 doses of HepB were 97.03% and 92.30% respectively. The overall vaccinated rate and timely-birth vaccinated rate on hepatitis B immunoglobulin (HBIG) were 68.97% and 94.49% respectively. The success rate of PMTCT was 97.16% after administration of passive-active immune-prophylaxis (HepB and HBIG), compared to the rate as 93.01% when vaccinated with HepB only. Significant differences were seen in the successful rates of PMTCT between combined and non-combined immunization. Either the combined or non-combined immunization, there were significant differences seen in the success rates of PMTCT regardless the positivity status of HBsAg or HBeAg, among the infected mothers.
CONCLUSIONThe efficacy of passive-active immune-prophylaxis program seemed to be better than the one without combined immunization. It was vitally important for the infants whose mothers' HBsAg and HBeAg status were positive, to receive regular and timely combined immunization. In order to promote the PMTCT in Yunnan province, vaccinated rate on HBIG should be further improved.
China ; epidemiology ; Female ; Hepatitis B ; epidemiology ; prevention & control ; Hepatitis B virus ; Humans ; Immunization ; Infant, Newborn ; Infectious Disease Transmission, Vertical ; prevention & control ; Mothers ; Pregnancy ; Pregnancy Complications, Infectious ; prevention & control