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OBJECTIVE To evaluate the bioequivalence of a single oral administration of two palbociclib preparations in healthy subjects under fasting and fed conditions. METHODS Twenty-four healthy subjects (fasting test) and twenty healthy subjects (fed test) were enrolled and divided into two groups. A single-center, open-label, single-dose, two-formulation, two- period, two-sequence and crossover trial was designed. The subjects in the two groups were given the test preparation (domestic Palbociclib capsules) or the reference preparation (original Palbociclib capsules) orally under fasting or fed conditions respectively followed by a 14-day washout period. The blood samples were collected at different time points before and after treatment. After pretreatment, the mass concentration of palbociclib in vivo was determined by high-performance liquid chromatography-tandem mass spectrometry with palbociclib-d8 as the internal standard. SAS V9.4 software was used to calculate the pharmacokinetic parameters and evaluate the bioequivalence. RESULTS Under fasting condition, the cmax of the test preparation and the reference preparation were (71.4±18.1) and (73.8±19.0) ng/mL; AUC0-t were (1 754±412) and (1 793±448) h·ng/mL; AUC0-∞ were (1 851±456) and (1 887±478) h·ng/mL, respectively. Under fed condition, the cmax of the test preparation and the reference preparation were (78.4±18.3) and (81.9±21.7) ng/mL; AUC0-t were (1 905±375) and (1 932±318) h·ng/mL; AUC0-∞ were (2 027±411) and (2 050±342) h·ng/mL, respectively. The 90%CI of the geometric mean ratio of the above parameters was within the acceptable range (80.00%-125.00%). Under fasting and fed conditions, there were 20 and 16 adverse events in 9 and 8 subjects, respectively, but no serious adverse event was observed. CONCLUSIONS Under the fasting and fed conditions, the test preparation and the reference preparation of Pibociclib capsules are bioequivalent and have comparable safety.
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Objective:To analyze the value of serum related cytokines in predicting intestinal mucosal injury in patients with severe acute pancreatitis (SAP) and its correlation with intestinal mucosal injury.Methods:A total of 92 patients with SAP admitted to the First Hospital of Qinhuangdao from January 2020 to December 2021 were included in the study. According to the presence or absence of intestinal mucosal barrier dysfunction, the patients were divided into intestinal mucosal barrier dysfunction group (33 cases) and non-intestinal mucosal barrier dysfunction group (59 cases). Another 100 healthy subjects were selected as the control group. Clinical data of the subjects were collected. Serum levels of procalcitonin (PCT), D-lactic acid (D-L), endotoxin, diamine oxidase (DAO), citrulline and intestinal fatty acid binding protein (I-FABP) of the three groups were compared, and the correlation between the above indexes was analyzed by Pearson correlation analysis. Receiver operating characteristic (ROC) curve was used to analyze the value of each indicator in predicting intestinal mucosal barrier dysfunction in SAP patients.Results:The levels of serum PCT, D-L, endotoxin, DAO and I-FABP in intestinal mucosal barrier dysfunction group, non-intestinal mucosal barrier dysfunction group and control group showed a downward trend, while the level of serum citrulline showed an upward trend, with statistically significant difference (all P<0.05). Pearson correlation analysis showed that serum citrulline was negatively correlated with serum PCT, D-L, and endotoxin levels ( r=-0.740, -0.629, -0.310, all P<0.05); There was a positive correlation between serum DAO and serum PCT, D-L and endotoxin levels ( r=0.482, 0.779, 0.338, all P<0.05); There was a positive correlation between serum I-FABP and serum PCT, D-L and endotoxin levels ( r=0.613, 0.421, 0.341, all P<0.05). The ROC curve results showed that the area under the curve (AUC) of serum PCT, D-L, endotoxin, DAO, citrulline, and I-FABP predicting intestinal mucosal injury in SAP patients were 0.816, 0.789, 0.732, 0.801, 0.812, and 0.857, respectively. The AUC of the combination of the above indicators predicting intestinal mucosal barrier dysfunction in SAP patients was 0.909, significantly higher than that predicted by each index alone (all P<0.05). Conclusions:The occurrence of intestinal mucosal barrier dysfunction in SAP patients may be related to the increase of serum PCT, D-L, endotoxin, DAO, I-FABP levels and the decrease of citrulline levels. It may be considered to predict the risk of intestinal mucosal injury by detecting the levels of various indicators in patients′ serum.
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OBJECTIVE@#To observe the clinical characteristics of mild and common COVID-19 patients infected with the Omicron variant, and to analyze related factors affecting the time to negative conversion of viral nucleic acid detection.@*METHODS@#Clinical data of 1781 patients with coronavirus disease 2019 (COVID-19) admitted to a cabin hospital in Shanghai from April 12 to May 26, 2022, were retrospectively analyzed, including age, gender, height, weight, clinical symptoms, comorbid diseases, COVID-19 vaccination, treatment, and nucleic acid negative conversion time. Univariate and multivariate logistic regression analyses were used to analyze the influencing factors of nucleic acid negative conversion time.@*RESULTS@#Among the 1781 patients, 995 were male and 786 were female, with a median age of 39 (30, 52) years. There were 727 patients (40.8%) with overweight and obesity [body mass index (BMI) > 24 kg/cm 2) and 413 patients (23.2%) had comorbid diseases. 205 cases (11.5%) were not vaccinated while 1576 cases were vaccinated. There were 1233 cases (69.2%) with one or more symptoms. The main clinical symptoms were cough (60.3%), expectoration (50.4%) and fever (36.9%). 1444 cases (81.0%) were treated with Chinese medicine, 78 cases (4.4%) were treated with western medicine, 14 cases (0.8%) were treated with integrated Chinese and western medicine, and 245 cases (13.8%) did not receive any medical treatment. All patients improved and were discharged. The median nucleic acid negative conversion time was 10.3 (7.4, 12.4) d. Univariate and multivariate analysis showed that, age ≥ 60 years ( OR=1.537, 95% CI: 1.116 - 2.115, P<0.01), BMI > 24 kg/cm 2 ( OR=1.344, 95% CI: 1.106 - 1.634, P<0.01 ) and hypertension ( OR=1.518, 95% CI: 1.094 - 2.106, P<0.05) were independent risk factors for prolonged nucleic acid negative conversion. COVID-19 vaccination ( OR=0.548, 95% CI: 0.398 - 0.755, P<0.01) was a protective factor, that is, vaccination shortened the time for the nucleic acid test to become negative.@*CONCLUSIONS@#The symptoms of the Omicron variant infection were relatively mild and occult. Age ≥ 60 years old, comorbid hypertension, no vaccination and BMI > 24 kg/cm 2 are independent influencing factors for prolonged nucleic acid negative conversion.
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Humanos , Femenino , Masculino , Persona de Mediana Edad , SARS-CoV-2 , COVID-19/epidemiología , Vacunas contra la COVID-19 , Estudios Retrospectivos , China , Hipertensión/epidemiología , Ácidos NucleicosRESUMEN
Objective:To determine the risk factors of extubation failure and its effect on the prognosis of patients who had successfully passed a spontaneous breathing trial (SBT).Methods:The clinical data of patients with mechanical ventilation more than 24 hours who passed SBT admitted to department of intensive care unit (ICU) of First Hospital of Qinhuangdao from November 2018 to November 2019 were retrospectively analyzed. According to the outcome of weaning within 48 hours after weaning, patients were divided into weaning success group and weaning failure group. The baseline data, the presence of basic cardiopulmonary diseases, B-type natriuretic peptide (BNP), fluid balance, albumin and hemoglobin within 24 hours before weaning, the time of mechanical ventilation before weaning, rapid shallow breathing index (RSBI) during SBT, oxygenation index, cough peak flow at the end of SBT, and prognostic indicators were collected. The outcome of weaning was taken as the dependent variable, and the observation factors were taken as the independent variable for univariate analysis. The factors with statistical significance in univariate analysis were analyzed by binary Logistic regression to determine the influencing factors of weaning failure.Results:Of the 204 patients, 167 (81.9%) were successfully weaned, and 37 (18.1%) failed. Compared with the weaning success group, the total duration of mechanical ventilation and the length of ICU stay in the weaning failure group were significantly longer [days: 13.0 (7.5, 23.5) vs. 5.0 (3.0, 8.0), 17.0 (12.5, 31.0) vs. 10.0 (6.0, 15.0), both P < 0.01], and the tracheotomy rate and mortality were significantly higher (32.4% vs. 0%, 51.4% vs. 0%, both P < 0.01). Univariate analysis showed that there were significant differences in age, proportion of patients with cardiopulmonary diseases, BNP and cough peak flow between weaning failure group and weaning success group [age (years old): 70.65±15.78 vs. 62.69±15.82, cardiopulmonary diseases: 62.2% vs. 24.6%, BNP (ng/L): 416.87 (32.70, 1 225.80) vs. 45.36 (10.00, 273.60), cough peak flow (L/min): 59.89±9.06 vs. 83.84±16.52, all P < 0.01]. However, there were no significant differences in gender, acute physiology and chronic health evaluationⅡ (APACHEⅡ) at admission, mechanical ventilation time before weaning, albumin, hemoglobin, oxygenation index, RSBI and fluid balance 24 hours before weaning between weaning failure group and weaning success group [male: 51.4% vs. 68.3%, APACHEⅡ: 16.70±6.65 vs. 15.67±6.28, mechanical ventilation time before weaning (days): 6.0 (2.5, 11.0) vs. 5.0 (3.0, 8.0), albumin (g/L): 27.78±4.15 vs. 27.76±4.46, hemoglobin (g/L): 102.43±15.80 vs. 100.61±17.19, oxygenation index (mmHg, 1 mmHg = 0.133 kPa): 359.33±79.83 vs. 365.75±78.23, RSBI (times·L -1·min -1): 50.73±24.97 vs. 46.76±15.53, positive fluid balance: 70.3% vs. 69.5%, all P > 0.05]. The results of binary Logistic regression analysis showed that age ≥ 75 years old [odds ratio ( OR) = 3.099, 95% confidence interval (95% CI) was 1.003-9.574, P = 0.049], presence of cardiopulmonary diseases ( OR = 3.599, 95% CI was 1.126-11.498, P = 0.031), BNP within 24 hours before weaning ( OR = 1.002, 95% CI was 1.000-1.003, P = 0.005) were the risk factors of extubation failure, while cough peak flow at the end of SBT was the protective factor ( OR = 0.869, 95% CI was 0.823-0.917, P = 0.000). Conclusions:For patients who had successfully passed SBT, age ≥ 75 years old, the presence of cardiopulmonary diseases and an increased level of BNP within 24 hours were the risk factors of extubation failure. In addition, the higher the cough peak flow at the end of SBT, the lower the risk of weaning failure will be.
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Objective@#To explore the effect of working memory intervention training on working memory and literacy of children with developmental dyslexia,so as to provide a preference for practice of the trianing of working memory among children with dyslexia.@*Methods@#A total of 32 children with dyslexia of grade 3-5 in a primary school in Guiyang were randomly divided into two groups: the study group (n=16) and the control group (n=16),and the software of training exercises of working memory was applied to conduct interventional trainings of different durations to 2 gruops of children.@*Results@#Through the intervention training of working memory, the scores of literacy and working memory tasks in the study group (2 217.88±252.32, 105.13±7.68) were significantly higher than those in the control group (1 907.69 ± 545.15, 96.50 ± 11.04) (t=2.06, 2.56, P<0.05).@*Conclusion@#The working memory ability of children with dyslexia can be improved by working memory intervention training for a certain period of time. The intervention effect is not only significant in the trained working memory task, but also can be extended to other untrained contents such as literacy.
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Objective@#To evaluate the impact of pre-transplant course on transplant outcomes in patients with acute myeloid leukemia (AML) .@*Methods@#A retrospective analysis was conducted in 107 patients with AML who received allogeneic hematopoietic stem cells transplantation (allo-HSCT) in the first complete remission stage (CR1) from January 2012 to June 2014.@*Results@#①46 cases received allo-HSCT within 6 months upon diagnosis, including 25 males and 21 females, with a median age of 26 (12-60) y. 61 cases received allo-HSCT after 6 months upon diagnosis, including 34 males and 27 females, with a median age of 31 (14-58) years. There is no statistical significance in patients’ age, gender, NCCN risk stratification, courses for induction, minimal residual disease (MRD) status, transplantation type and infection rates prior to transplantation. Total courses of chemotherapy before allo-HSCT were 4 (3-5) and 5 (4-10) for the two groups, respectively. ②Incidences of Grade Ⅱ-Ⅳ aGVHD were 26.09% (12/46) for the <6-month group and 24.59% (15/61) for the ≥6 months group (P=0.860) . Incidences of Grade Ⅲ/Ⅳ aGVHD were 2.17% (1/46) for the <6-month group and 14.75% (9/61) for the ≥6 months group (P=0.027) . ③ Probabilities of 2-year overall survival (OS) were (90.3±4.6) % for the <6 months group and (75.7±5.7) % for the ≥6 months group (P=0.042) . Probabilities of 2-year disease-free survival (DFS) were (90.7±4.4) % for the <6 months group and (76.3±5.5) % for the ≥6 months group (P=0.038) . ④ During the median follow-up of 863 (26-2 026) days, cumulative incidences of non-relapse mortality were (4.4±3.1) % for the <6 months group and (18.2±5.0) % for the ≥6 months group (P=0.047) . ⑤ Univariate analysis showed that age, NCCN risk stratification, MRD status before transplantation and rates of infection was not related to transplantation outcomes. Chemotherapy courses before allo-HSCT (≤4 or >4) was related to OS and DFS (P=0.044, P=0.039) , but not to NRM (P=0.079) .@*Conclusion@#AML patients who obtained CR1 could achieve better long-term survival by receiving allo-HSCT within 6 months after diagnosis.
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Objective To summarize clinical phenotypes and pathological characteristics in myopathies with tubular aggregates (TAs).Methods We reviewed 5 697 patients who performed muscle biopsies in our department between January 2001 and July 2015.We collected the cases with TAs and made classification based on their clinical diagnoses and pathological changes.Results Fifty-seven patients (1.00%) showed TAs in muscle specimens,including 50 (87.72%) males and 7 (12.28%) females.According to clinical,neurophysiological,pathological and genetic analysis,the diagnoses included 23 (40.35%) cases of periodic paralysis,7 (12.28%) cases of chronic alcohol intoxication,6 (10.53%) cases of congenital myasthenic syndrome,5 (8.77%) cases of exercise-induced cramps,3 (5.26%) cases of necrotizing myopathy,1 (1.75%) case of stromal interaction molecule 1-associated myopathy,limbgirdle muscular dystrophy 2E,myotonic dystrophy,myotonia congenita,paramyotonia congenitia,hypothyroid myopathy respectively.Other cases of unknown cause included unclassified distal myopathy,external ophthalmoplegia,white matter lesions,mental retardation,stroke,early onset weakness,pulmonary arterial hypertension.Besides TAs,pathological changes also included necrosis of muscle fibers (3 cases,5.26%),neurogenic changes (3 cases,5.26%) and muscular dystrophic changes (1 case,1.75%).Conclusions Our results indicated that TAs are usually found in males and could present in many types of hereditary or acquired neuromuscular disease as independent or accompanying changes.Periodic paralysis,chronic alcohol intoxication and congenital myasthenic syndrome are 3 major diseases causing myopathies with TAs.
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Objective To explore the mediator effect of coping styles in relationship between hope level and subjective well-being of empty-nesters in urban community.Methods 208 empty-nesters were tested with Herth Hope Scale,Coping Style Questionnaire and Subjective Well-Being to investigate the influence and the pathways of hope and coping styles on subjective well-being with structural equation modeling.Results Influence of hope level on subjective well-being of empty-nesters in urban community accorded with completely-mediated model (x2/df =1.971,GFI =0.955,AGFI =0.911,RMSEA =0.068),and influence of hope level mediated by positive coping styles accounted for 41.76%(Z=3.692,P<0.01).Conclusion The influence of hope level on subjective well-being is mediated mainly by positive coping styles for empty-nesters in urban community.
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Objective To explore the multiple departments to carry out QCC in increasing the qualified rate of the crit-ical value of account registration. Methods Setting up QCC, by establishing the theme of improving the qualification rate of critical value ledger registration, taking recycle management(PDCA),taking action program, conducting survey, factor analysis, and taking relative measures and evaluation. In order to compare the qualified rate of critical value ac-count registration and to sharpen the awareness rate of reporting systems and processes around QCC. Results After the implementation of QCC, the qualified rate of critical value account registration of clinical departments increased from 26.93% to 86.63%, and that of the medical departments increased from 68.34% to 93.73%. Meanwhile, the false nega-tive rate of Medical departments decreased from 7.20%to 2.47%, and the awareness rate of reporting systems and process-es around QCC increased from 35.44% to 89.02%.The differences were statistically significant (P<0.05). Conclusion Joint multiple departments' implementation on QCC can optimize work flow, enhance the work system, improve the qualified rate of critical value account registration, ensure the safety of patients, and increase the quality of medical treatment. Hence, it is worth promoting in clinical practice.
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Objective To investigate the pulmonary microvascular responsiveness of diabetic animals to sepsis and the potential mechanism of NO system.Methods Sixty-four Wistar rats of clean grade were randomly (random number) divided into 4 groups,namely normal control group (group A,n =16),diabetes group (group B,n =16),sepsis group (group C,n =16),diabetes and sepsis group (group D,n =16).Diabetic mellitus model was made in rats with injection of streptozotocin,STZ (65 mg/kg).Successful model was defined as the blood glucose value≥ 16.67 mmol/L 48 hours after injection of STZ.All animals were fed 4 weeks before initiation of next experiment.The sepsis model was established by intravenous injection of LPS (10 mg/kg) in rats.RT-PCR was used to determine the mRNA expression of Tie-2 in rats'blood.The ratio of dry/wet of lung tissue and the extravasation of Evans blue dye into the lung were detected.Quantitation of NO in lung tissue and serum was measured by using Griess method.RT-PCR was also used for determination of iNOS,eNOS,DDAH2 mRNA expressions in lung tissue.Data were analyzed with ANONA and LSD method for comparison between groups,and P < 0.05 was considered statistically significant.Results Compared with septic group.,the diabetic rats with sepsis group demonstrated higher expression of Tie-2 mRNA in blood (19.72 ± 0.70) vs.(3.99 ± 0.92),P =0.00,lower ratio of dry/wet in lung tissue (0.19 ±0.01) vs.(0.22 ±0.01),P =0.000,higher permeability of Evans blue dye into lung tissue (3.76 ± 0.77) vs.(1.74 ± 0.24),P =0.000.Serum NO level was lower in group D than that in group C (123.13 ±4.24) vs.(188.30 ±5.18),P =0.000,however,NO levels in lung tissue of both group D and group C were higher than that in control group (53.62 ± 6.70),(23.63± 3.92) vs.(10.37 ± 1.29),P =0.00,and NO level in group D was higher in 2 times than that in group C (P =0.00).However,there were no differences in eNOS expression among groups A,B and C,but the difference in eNOS expression was present between group D with lower expression and group A,that lower in group D (0.07 ±0.02) vs.(0.38 ±0.05),P=0.017.Compared with group C,the expression of iNOS was higher in group D (80.23 ±2.49),(32.48±5.37) vs.(1.74±0.23),P=0.00),and the expression of DDAH2 was lower in group D (0.49 ±0.13),(7.26 ±0.50) vs.(11.96 ±0.55).Conclusions Diabetic rats with sepsis enhanced endothelial cell damages.Diabetes deteriorates the regulatory activity of NO system,suggesting the potential mechanism of the worsened damages of EC in diabetic sepsis host.
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The thought of "Treating kidney for teenagers, treating liver for the middle-aged and treating spleen for the old" was proposed by the ancient doctors based on women's different physiological stages in their life. Based on the physiological features in different stage of women and the relation between the liver, spleen and kidney and the Chong-meridian, the author put the thought into clinical practice. With detailed case explanation, the author elucidated the value of this thought.
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Objective To analyze spiral CT manifestations and the diagnostic value of pulmonary embolism (PE).Methods Spiral CT pulmonary angiography (SCTPA) and chest plain CT scan were performed in 25 cases with highly-suspected PE. CT findings were retrospectively analyzed.Results The direct signs of PE appeared as complete or partial filling defect within pulmonary arteriae on SCTPA.191 branches of pulmonary artery were involved in all cases,of them, 44 branches were centrally located(23.0%), 115 branches were eccentrically located (60.2%),7 branches were mural filling defect (3.7%), 25 branches were complete occlusion (13.1%).The indirect signs of PE included irregular consolidation (n=15), patchy ground glass opacities (n=6),local streak shadows(n=4),"mosaic"sign (n=5), pleural effusion(n=16) ,pericardial effusion (n=3)and simple emboli no other signs(n=3).Conclusion SCTPA is a fast ,effective, security and non-invasive diagnostic method for PE .
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Objective:To investigate functional changes of AMs to explore the mechanisms for weakened pulmonary local immune defense function in DM.Methods:Wistar rat model was established by intraperitoneal injection of streptozotocin at 60 mg/kg.The rats were performed BAL to collected AMs.Cock RBC phagotosis rate of AM was counted with HE method.AMs underwent in vitro incubation,and supernant TNF-? content was determined with ELISA method.Results:The phagotosis rate of 4 weeks DM group and 8 weeks DM group decreased significantly in statistics commpared with the control group(P
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Objective To investigate the perfusion characteristics of normal pancreas and pancreatic carcinoma on multi-slice spiral CT(MSCT).Methods Perfusion CT for pancreatic cancer was performed with sixteen-slice spiral CT in 26 patients(all of them were then confirmed by pathology).Eighteen patients without pancreatic disorders served as controls.Contrast medium-enhanced dynamic CT was performed,and the data were analyzed by using commercial software to calculate tissue blood flow(BF),blood volume(BV),mean transit time(MTT),and vascular permeability-surface(PS)area product.Perfusion parameters of normal pancreas and tumors tissues were compared.Results Technical failures were experienced in 1(3.85%)subjects of pancreatic carcinoma.The mean BF,BV,MTT and PS in pancreatic carcinoma were(68.89?73.42)mL/(100 mg? min),(10.02?3.59)mL/100 mg,(8.23?3.26)s,(28.63?9.35)mL/(100 mg?min),respectively.The mean BF,BV,MTT and PS in normal pancreas tissue were(173.53?71.33)mL/(100 mg?min),(14.43?3.15)mL/100 mg,(7.15?5.45)s,(13.98?8.53)mL/(100 mg?min),respectively.The mean BF,BV and PS between pancreatic carcinoma and normal pancreas were statistically significant(BF,PS:P0.05).Conclusion CT perfusion imaging can be used to identify patients with pancreatic carcinomas,because individual differences exist in the results of CT perfusion.