Objective To study the pharmacokinetic profile of zidovudine and lamivudine tablets(ZL)in Chinese healthy subjects and to evaluate its bioequivalence and safety.Methods A randomized,open,single-dose,two-sequence,four-cycle and fully replicated crossover bioequivalence trial was conducted in 32 healthy subjects both fasting and postprandial,and two preparations of ZL tablets were administered orally in each cycle,with a washout period of 5 days.The concentrations of zidovudine and lamivudine in plasma were determined using high performance liquid chromatography-tandem mass spectrometry.The pharmacokinetic evaluation index parameters were statistically analyzed using Phoenix WinNonlin version 8.1 data statistical software to evaluate bioequivalence.Results The Cmax of zidovudine under fasting and postprandial conditions between ZL and the reference drugs after a single dose were(3 782.499±1 921.649)vs.(3 543.164±1 946.076)ng·mL-1 and(1 585.827±914.246)vs.(1 667.595±862.945)ng·mL-1,respectively.And the AUC0-t for fasting and postprandial conditions of zidovudine was(3 177.091±819.538)vs.(3 071.375±972.145)h·ng·mL-1 and(2 437.999±478.147)vs.(2 402.725±477.792)h·ng·mL-1,respectively;while the AUC0-∞ were(3 225.674±825.131)vs.(3 093.448±972.340)h·ng·mL-1and(2 464.310±480.790)vs.(2 427.693±477.933)h·ng·mL-1,respectively.The Cmax of a single dose of lamivudine under fasting and postprandial conditions between ZL and the reference drugs were(1 923.329±490.572)vs.(1 830.570±476.947)ng·mL-1 and(1 922.711±589.130)vs.(1 881.857±527.577)ng·mL-1,respectively.The AUC0-t for preprandial and postprandial lamivudine was(7 598.265±1 376.774)vs.(7 283.422±1 356.146)h·ng·mL-1 and(7 554.169±958.379)vs.(7 329.376±924.075)h·ng·mL-1,respectively,whereas the AUC0-∞ were(7 734.038±1 326.907)vs.(7 405.088±1 340.036)h·ng·mL-1 and(7 660.916±958.694)vs.(7 435.102±930.448)h·ng·mL-1,in fasting and fed tests,the 90％confidence intervals(CI)of the geometric mean ratios of the main pharmacokinetic parameters between test and reference preparations were all within the range of 80％-125％,respectively.A total of 37 adverse events occurred during the trial period,including 21 in the fasting group and 16 in the postprandial group,and no serious adverse events occurred.Conclusion The test formulations of zidovudine and lamivudine tablets were bioequivalent and well tolerated in healthy Chinese subjects under fasting and fed conditions compared to the reference tablets.

Objective To explore the expression of pepsinogen Ⅰ/Ⅱ(PG Ⅰ/PG Ⅱ),nucleosome assembly protein 1 like protein 1(NAP1L1),and SERPINB5 in the serum of gastric cancer patients and their correlation with prognosis.Methods From February 2019 to February 2022,200 gastric cancer patients admitted to Zhuozhou Hospital were served as the gastric cancer group and another 100 patients with benign gastric lesions who received the treatment at Zhuozhou Hospital during the same period were served as the benign group,with 200 healthy adults as the control group.Chemiluminescence and ELISA methods were used to detect the serum PG Ⅰ/PG Ⅱ,NAP1L1,and SERPINB5.ROC curve was used to explore the diagnostic value.Kaplan-Meier method was used to explore the survival curve.Moreover,multivariate Cox method was used to analyze the factors that affected the prognosis.Results Compared with the control group,the benign group and gastric cancer group had the lower serum PGⅠ/PG Ⅱ and higher serum NAP1L1 and SERPINB5,and the difference was statistically significant(P<0.05).Compared with the benign group,the gastric cancer group had the lower serum PG Ⅰ/PG Ⅱ and higher serum NAP1L1 and SERPINB5,and the difference was statistically significant(P<0.05).PG Ⅰ/PG Ⅱ,NAP1L1,and SERPINB5 were all influential factors in gastric carcinogenesis(P<0.05).The AUC values of serum PG Ⅰ/PG Ⅱ,NAP1L1,and SERPINB5 alone in the diagnosis of gastric cancer were 0.821,0.808,and 0.833,respectively.The AUC of the combination of the three was 0.916,indicating that their combined diagnostic value was superior(Z=3.142,3.896,3.114,P<0.05).During the 3-year follow-up period of gastric cancer patients,57 cases died,accounting for 28.50%(57/200),and 143 cases survived.Patients with the high expression of PG Ⅰ/PG Ⅱ had a higher 3-year overall survival rate after the surgery compared to those with low expression,and the difference was statistically significant(χ2=7.830,P<0.05);and patients with the low expression of NAP1L1 and SERPINB5 had a higher 3-year overall survival rate after the surgery compared to those with high expression,and the difference was statistically significant(χ2=8.612,13.321,P<0.05).The serum PG Ⅰ/PG Ⅱ levels in the death group were lower than those in the survival group,and the serum NAP1L1,SERPINB5 levels were higher in patients with preoperative lymph node metastasis and TNM stage Ⅲ-Ⅳ than those in the survival group,and the difference was statistically significant(P<0.05).Elevated level of PG Ⅰ/PG Ⅱ was a protective factor for the prognosis of gastric cancer patients,while preoperative lymph node metastasis,elevated levels of NAP1L1 and SERPINB5 were risk factors affecting the prognosis of gastric cancer patients(P<0.05).Conclusion Serum PG Ⅰ/PG Ⅱ levels are decreased and NAP1L1 and SERPINB5 levels are increased in gastric cancer patients,and NAP1L1 and SERPINB5 are risk factors affecting the prognosis of gastric cancer patients,while PG Ⅰ/PG Ⅱ is a protective factor.

Objective To study the pharmacokinetic profile of zidovudine and lamivudine tablets(ZL)in Chinese healthy subjects and to evaluate its bioequivalence and safety.Methods A randomized,open,single-dose,two-sequence,four-cycle and fully replicated crossover bioequivalence trial was conducted in 32 healthy subjects both fasting and postprandial,and two preparations of ZL tablets were administered orally in each cycle,with a washout period of 5 days.The concentrations of zidovudine and lamivudine in plasma were determined using high performance liquid chromatography-tandem mass spectrometry.The pharmacokinetic evaluation index parameters were statistically analyzed using Phoenix WinNonlin version 8.1 data statistical software to evaluate bioequivalence.Results The Cmax of zidovudine under fasting and postprandial conditions between ZL and the reference drugs after a single dose were(3 782.499±1 921.649)vs.(3 543.164±1 946.076)ng·mL-1 and(1 585.827±914.246)vs.(1 667.595±862.945)ng·mL-1,respectively.And the AUC0-t for fasting and postprandial conditions of zidovudine was(3 177.091±819.538)vs.(3 071.375±972.145)h·ng·mL-1 and(2 437.999±478.147)vs.(2 402.725±477.792)h·ng·mL-1,respectively;while the AUC0-∞ were(3 225.674±825.131)vs.(3 093.448±972.340)h·ng·mL-1and(2 464.310±480.790)vs.(2 427.693±477.933)h·ng·mL-1,respectively.The Cmax of a single dose of lamivudine under fasting and postprandial conditions between ZL and the reference drugs were(1 923.329±490.572)vs.(1 830.570±476.947)ng·mL-1 and(1 922.711±589.130)vs.(1 881.857±527.577)ng·mL-1,respectively.The AUC0-t for preprandial and postprandial lamivudine was(7 598.265±1 376.774)vs.(7 283.422±1 356.146)h·ng·mL-1 and(7 554.169±958.379)vs.(7 329.376±924.075)h·ng·mL-1,respectively,whereas the AUC0-∞ were(7 734.038±1 326.907)vs.(7 405.088±1 340.036)h·ng·mL-1 and(7 660.916±958.694)vs.(7 435.102±930.448)h·ng·mL-1,in fasting and fed tests,the 90％confidence intervals(CI)of the geometric mean ratios of the main pharmacokinetic parameters between test and reference preparations were all within the range of 80％-125％,respectively.A total of 37 adverse events occurred during the trial period,including 21 in the fasting group and 16 in the postprandial group,and no serious adverse events occurred.Conclusion The test formulations of zidovudine and lamivudine tablets were bioequivalent and well tolerated in healthy Chinese subjects under fasting and fed conditions compared to the reference tablets.

Objective To develop an inpatient assessment form for geriatric syndromes,aiming to quickly and accurately determine whether elderly inpatients are at risk of geriatric syndromes.Methods From May 2021 to December 2023,an initial item pool for the scale was proposed through literature review.Sixteen experts from four fields of geriatric nursing,nursing management,nursing education,and geriatric medicine were selected from seven institutions in six provinces and cities across the country.Two rounds of Delphi expert consultation were conducted to inquire about the assessment form.Results The enthusiasm coefficient of the two rounds of expert consultation was 100.00%,and the expert authority coefficient was 0.88.In the first round of expert consultation,the importance ratings of the three-level indicators ranged from 4.06 to 4.75,with a coefficient of variation of 0.09 to 0.25,a full score rate of 43.75%to 81.25%,and a Kendall coordination coefficient W of 0.210.In the second round of expert consultation,the importance ratings of the three-level indicators ranged from 4.63 to 4.94,with a coefficient of variation of 0.05 to 0.13,a full score rate of 62.50%to 93.75%,and a Kendall coordination coefficient W of 0.419.After two rounds of expert consultation,the inpatient assessment form for geriatric syndromes was finally determined,including 5 first-level indicators(past history,physical function,common geriatric symptoms,mental and psychological status,socioeconomic status),26 second-level indicators,and 41 third-level indicators.Conclusion The inpatient assessment form for geriatric syndromes developed in this study is scientifically and practically feasible and can be used to quickly identify the risk of geriatric syndromes in elderly inpatients.

Objective To introduce a traceability closed-loop management system for the entire process of drug dispensing in the inpatient department.Methods In line with the requirements for intelligent healthcare construction and six-level electronic medical records development,a paperless drug dispensing process for the inpatient department was designed.A traceability closed-loop management system was established by improving both hardware equipment and software function.The system's practical effectiveness was evaluated from multiple perspectives.Results With process transformation,the workflow efficiency of doctors,nurses,pharmacists and clinical support staff has been significantly improved.Costs in terms of human resources and materials have been reduced,and the safe and rational use of medication has been promoted.Conclusions The improved process,which is based on the construction of intelligent devices and information technology,achieves a closed-loop and traceable management system for the entire drug dispensing process in the inpatient department.This system offers the benefits of safety,standardization,efficiency,and closed-loop traceability.It reduces the risk of dispensing mistakes,improves the safety of medication and has strong scalability.

Objective To evaluate the effectiveness of stabilization splint combined with routine home treatment in the treatment of masticatory myofascial pain.Methods A total of 32 patients with masticatory myofascial pain were selected from the Department of Prosthodontics,Guangxi Medical University Affiliated Stomatoiogical Hospital from June 2019 to June 2021,who received stabilization splint combined with routine home treatment.The clinical effective rate was analyzed after 3 months treatment.Visual analogue scale(VAS)and T-Scan Ⅲ digital occlusal evaluation system were performed before and after 3 months treatment to evaluate pain degree and occlusal function of patients respectively.The indexes of occlusal function were asymmetry index of occlusal force(AOF),center of force(COF),number of occlusal contacts(NOC),and occlusal time(OT).Results ①The clinical effective rate was 93.75%after treatment;②VAS,AOF,COF,and OT were significantly lower compared with prior treatment(P<0.05).There was no significant difference in the NOC before and after treatment(P>0.05).Conclusion Stabilization splint combined with routine home treatment for masticatory myofascial pain are effective in relieving pain and improving occlusal function.

Objective:To investigate the distribution and drug resistance of common pathogens causing urinary tract infection (UTI) in children in Beijing, so as to provide reference for clinical rational use of antibiotics.Methods:It was a retrospective cohort study. The results of clinical data, urine culture and drug sensitivity in children with urinary infection treated in the Department of Nephrology, Children's Hospital Affiliated to Capital Institute of Pediatrics from June 2018 to June 2018 were retrospectively analyzed. According to the diagnostic criteria of "Chinese expert consensus on the diagnosis and treatment of UTI (2015 edition) - Complicated urinary tract infection", the children were divided into complex group and simple group according to whether they had complicated factors, and the pathogenic factors of the complex group were analyzed. The χ 2 test was used to compare the distribution of pathogenic bacteria in urine culture and the resistance rate of Escherichia coli to common antibiotics between the two groups. Results:A total of 187 children with UTI were enrolled in this study. The age ranged from 1 month after birth to 17 years old, and the median age was 8 months. There were 88 males (47.1%) and 99 females (52.9%), and the male/female ratio was 1:1.125. Male infants accounted for 79.5% (70/88) of male infants and female infants accounted for 48.5% (48/99) of female infants. There were 45 cases (24.1%) in the simple UTI group and 142 cases (75.9%) in the complicated UTI group. A total of 216 strains of pathogens were isolated, mainly Gram-negative bacteria (151/216, 69.9%), of which Escherichia coli was the most common (86/216, 39.8%). The second was gram-positive bacteria (57/216, 26.4%), among which Enterococcus faecium (37/216, 17.1%) was the most common. The positive rate of Escherichia coli infection in the simple UTI group was significantly higher than that in the complicated UTI group [71.1% (32/45) vs. 31.6% (54/171), χ2=23.234, P<0.001], and the positive rate of Klebsiella pneumoniae, Pseudomonas aeruginosa, Enterococcus faecium and fungal infection in the simple UTI group was significantly lower than those in the complicated UTI group. However, the differences were not statistically significant (all P>0.05). The resistance rate of Escherichia coli to ampicillin was the highest in children with UTI [91.9% (79/86)], and it was sensitive to amikacin, meropenem, imipenem, piperacillin/tazobactam, cefepime, piperacillin, cefazolin, cefoperazone/sulbactam. The drug resistance rates were 5.8% (5/86), 5.8% (5/86), 9.3% (8/86), 10.5% (9/86), 14.0% (12/86), 15.1% (13/86), 18.6% (16/86) and 18.6% (16/86), respectively. The resistance rate of Escherichia coli infection to ceftriaxone in the complicated UTI group was significantly higher than that in the simple UTI group [59.3% (32/54) vs. 24.4% (11/32), χ2=4.977, P=0.026]. Eight fungi (3.7%) were susceptible to fluconazole, voriconazole, itraconazole and amphotericin B. Conclusions:The main pathogens of UTI in children are Gram-negative bacteria, among which Escherichia coli is the most common pathogen, but the proportion of infection has a downward trend in recent years. The resistance rate of ceftazidime and ceftriaxone is relatively low, which can be used as empirical drugs for children with UTI in this region.

Objective:To investigate the distribution and drug resistance of common pathogens causing urinary tract infection (UTI) in children in Beijing, so as to provide reference for clinical rational use of antibiotics.Methods:It was a retrospective cohort study. The results of clinical data, urine culture and drug sensitivity in children with urinary infection treated in the Department of Nephrology, Children's Hospital Affiliated to Capital Institute of Pediatrics from June 2018 to June 2018 were retrospectively analyzed. According to the diagnostic criteria of "Chinese expert consensus on the diagnosis and treatment of UTI (2015 edition) - Complicated urinary tract infection", the children were divided into complex group and simple group according to whether they had complicated factors, and the pathogenic factors of the complex group were analyzed. The χ 2 test was used to compare the distribution of pathogenic bacteria in urine culture and the resistance rate of Escherichia coli to common antibiotics between the two groups. Results:A total of 187 children with UTI were enrolled in this study. The age ranged from 1 month after birth to 17 years old, and the median age was 8 months. There were 88 males (47.1%) and 99 females (52.9%), and the male/female ratio was 1:1.125. Male infants accounted for 79.5% (70/88) of male infants and female infants accounted for 48.5% (48/99) of female infants. There were 45 cases (24.1%) in the simple UTI group and 142 cases (75.9%) in the complicated UTI group. A total of 216 strains of pathogens were isolated, mainly Gram-negative bacteria (151/216, 69.9%), of which Escherichia coli was the most common (86/216, 39.8%). The second was gram-positive bacteria (57/216, 26.4%), among which Enterococcus faecium (37/216, 17.1%) was the most common. The positive rate of Escherichia coli infection in the simple UTI group was significantly higher than that in the complicated UTI group [71.1% (32/45) vs. 31.6% (54/171), χ2=23.234, P<0.001], and the positive rate of Klebsiella pneumoniae, Pseudomonas aeruginosa, Enterococcus faecium and fungal infection in the simple UTI group was significantly lower than those in the complicated UTI group. However, the differences were not statistically significant (all P>0.05). The resistance rate of Escherichia coli to ampicillin was the highest in children with UTI [91.9% (79/86)], and it was sensitive to amikacin, meropenem, imipenem, piperacillin/tazobactam, cefepime, piperacillin, cefazolin, cefoperazone/sulbactam. The drug resistance rates were 5.8% (5/86), 5.8% (5/86), 9.3% (8/86), 10.5% (9/86), 14.0% (12/86), 15.1% (13/86), 18.6% (16/86) and 18.6% (16/86), respectively. The resistance rate of Escherichia coli infection to ceftriaxone in the complicated UTI group was significantly higher than that in the simple UTI group [59.3% (32/54) vs. 24.4% (11/32), χ2=4.977, P=0.026]. Eight fungi (3.7%) were susceptible to fluconazole, voriconazole, itraconazole and amphotericin B. Conclusions:The main pathogens of UTI in children are Gram-negative bacteria, among which Escherichia coli is the most common pathogen, but the proportion of infection has a downward trend in recent years. The resistance rate of ceftazidime and ceftriaxone is relatively low, which can be used as empirical drugs for children with UTI in this region.

ObjectiveTo investigate effect of astragaloside Ⅳ on the proliferation， migration， and invasion of colorectal cancer HCT116 cells and the underlying molecular mechanism. MethodColorectal cancer HCT116 cells were classified into blank group （DMSO） and low-dose （15.7 mg·L^-1）， medium-dose （31.4 mg·L^-1）， and high-dose （62.8 mg·L^-1） astragaloside Ⅳ groups. After drug treatment， the morphological changes of HCT116 cells were observed under an inverted microscope. Cell viability was detected by cell counting kit-8 （CCK-8） assay， and the migration and invasion of cells were detected based on scratch assay and Transwell assay. The expression of cyclin-dependent kinase inhibitor （p21）， CyclinD₁， B-cell lymphoma-2 （Bcl-2）， and Bcl-2-associated X protein （Bax） in the cells was examined by Western blot. ResultCompared with the blank group， cells in the three astragaloside Ⅳ groups demonstrated slow growth， low density， inconsistent morphology， nuclear shrinkage， degradation of cytoplasm， and high death rate. Moreover， cell viability decreased in a concentration-dependent manner in the astragaloside Ⅳ groups. Cell migration and invasion were inhibited （P<0.05， P<0.01）， and the inhibition rate was in positive correlation with the concentration of the astragaloside Ⅳ. The expression of pro-apoptotic protein Bax in low-dose， medium-dose and high-dose astragaloside Ⅳ groups increased gradually in a concentration-dependent manner， while the expression of p21， CyclinD₁ and anti-apoptotic protein Bcl-2 decreased gradually in a concentration-dependent manner compared with those in the blank group （P<0.05， P<0.01）. ConclusionAstragaloside Ⅳ can suppress the proliferation， migration， and invasion of colorectal cancer HCT116 cells and promote the apoptosis， thus inhibiting the occurrence and development of colorectal cancer.