Study on bioequivalence evaluation of dexamethasone acetate tablets in Chinese healthy volunteers / 中国临床药理学与治疗学

AIM: To assess the bioequivalence of oral dexamethasone acetate tablets between the test and reference formulations in healthy adult Chinese subjects on an empty stomach and after meals. METHODS: A randomized, open, single-dose, two-cycle double crossover bioequivalence study was followed. Twenty-four healthy subjects were included in the fasting group, and 32 healthy subjects were included in the postprandial group, taking 2 tablets (0.75 mg/tablet) of the test formulation (T) or 3 tablets (0.50 mg/tablet) of the reference formulation (R) per cycle for two cycles. The concentrations of dexamethasone acetate in human plasma were determined using liquid chromatography-mass spectrometry, and the pharmacokinetic parameters were calculated according to the non-atrial model using WinNonlin 8.0 software.The bioequivalence of both the test formulation and the reference formulation was evaluated. RESULTS: The pharmacokinetic parameters after oral administration of dexamethasone acetate tablets in a fasted state in subjects with the reference formulation are as follows: Tmax 1.13 (0.50, 4.00) and 1.00 (0.50, 5.00) h, AUC0-t (72.25±21.55) and (69.23±17.76) ng · mL

Efficacy，safety and cost-effectiveness of polyisobutylene-type Gutong plaster in the treatment of osteoarthritis in Chinese adults / 中国药房

OBJECTIVE To evaluate the efficacy， safety and cost-effectiveness of polyisobutylene （PIB）-type Gutong plaster （called “PIB Gutong plaster” for short） versus non-steroidal anti-inflammatory drugs （NSAIDs） in the treatment of osteoarthritis in Chinese adults. METHODS Based on a real-world study， after propensity score matching， the decrease in pain visual simulation score， utility increase， time to pain resolution， time to return to normal range of motion and total adverse events of PIB Gutong plaster versus three NSAIDs （celecoxib， diclofenac sodium， and ibuprofen） were evaluated. Cost-utility analysis was used to calculate the incremental cost-effectiveness ratio （ICER） of patients using PIB Gutong plaster versus the three NSAIDs from the perspective of the whole society， and sensitivity analysis was carried out. RESULTS In terms of effectiveness， the recovery time of joint activity in PIB Gutong plaster group was significantly longer than that in celecoxib group， the decrease in VAS score of PIB Gutong plaster was significantly higher than that of ibuprofen but significantly lower than that of diclofenac sodium； the time of pain disappearance was longer than that in diclofenac sodium group and ibuprofen group， and the increase in health utility was significantly lower than that in diclofenac sodium group （P＜0.05）. In terms of safety， there were no significant differences in the incidence and severity of adverse events of PIB Gutong plaster， compared with the three NSAIDs， without statistical significance （P＜0.05）. In terms of cost-effectiveness， compared with celecoxib and diclofenac sodium， PIB Gutong plaster was dominant. Compared with ibuprofen， the ICER value of PIB Gutong plaster was 178 611.58 yuan/QALY， indicating that at the current price， PIB Gutong plaster was cost-effective if the threshold was 3 times GDP per capita. The results of sensitivity analysis were consistent with those of basic analysis. CONCLUSIONS The efficacy of PIB Gutong plaster was better than that of ibuprofen， similar to that of celecoxib， but worse than that of diclofenac sodium， the safety was consistent with the three NSAIDs， and the cost-effectiveness of PIB Gutong plaster needs to be improved.

Literature Study on Pharmacoeconomic Evaluation of Aspirin for Cardiovascular Disease Prevention / 中国药房

OBJECTIVE：To review the method and results of pharmacoeconomic evaluation of aspirin for cardiovascular disease prevention ，and to provide reference for economic evaluation of aspirin and clinical medication decision. METHODS ： Using“cardiovascular disease ”“cost-effectiveness”“cost-utility”“cost-benefit”“cost effectiveness ”“cost utility ”as the Chinese search terms ，using“cost-effectiveness”“cost-utility”“cost-benefit”“economic analysis ”“pharmacoeconomics”as English search terms，relevant literatures about pharmacoeconomic evaluation of aspirin for cardiovascular disease prevention published during January 1，2000 to January 17，2021 were retrieved from CNKI ，Wanfang database ，VIP，PubMed，Web of Science ，the Cochrane Library. After screening literatures according to inclusion and exclusion criteria ，extracting relevant data ，the quality of included literatures was evaluated with CHEERS scale. The method and results of pharmacoeconomic evaluation of aspirin in the prevention of cardiovascular diseases were analyzed statistically in terms of basic information ，literature quality ，model structure and elements ，health status and utility value ，cost items and sources ，health output ，economic evaluation and sensitivity analysis. RESULTS & CONCLUSIONS ：Nine literatures were included ，and the total coincidence rates of the literatures were all above 80.00％. The pharmacoeconomic evaluation of aspirin in the prevention of cardiovascular disease mainly adopted Markov model ， and the model structure was relatively mature. The cost mainly considered the direct cost ，and the data mainly came from the medical insurance database ；utility was calculated according to the utility value of health state ，which mostly came from the existing literatures. The sensitivity analysis adopted deterministic sensitivity analysis and probabilistic sensitivity analysis ，and the main influential factor was cost. It was economical to use aspirin for cardiovascular disease prevention in most cases ，and aspirin was more economical for primary prevention of cardiovascular disease. It is suggested that domestic scholars can refer to China ’s pharmacoeconomic guidelines to carry out relvant pharmacoeconomic evaluation research more standardized.

Formulation and analysis of comprehensive quality competency evaluation scale for medical graduates / 中华医学教育探索杂志

Objective:To meet the demand of medical system for talents, the training of medical students' competency has become a new direction of medical education. This study aims to evaluate the effectiveness of training quality in medical graduates through the competency scale.Methods:Taking "attitude", "skill" and "knowledge" as the evaluation dimensions, the competency development was divided into four levels of "state", "explain", "apply" and "transfer", and we proposed the competence concept of "A.S.K.-SEAT" and formulated an evaluation scale. Questionnaires and behavior event interviews (BEI) were conducted in medical graduates of Shantou University in 2018. Reliability and validity of the questionnaire were evaluated and current situation of different competency items were analyzed.Results:A total of 155 questionnaires were collected with good reliability and validity, and 15 graduates participated in BEI. A total of 21 A.S.K. competency items (including five basic competency items and two discriminating competency items) and SEAT textual descriptions were finally established.Conclusion:A.S.K.-SEAT scale can provide valid references for the competency evaluation of medical graduates.

The effects of enteral immunonutrition on cell immune level and clinical efficacy in patients with severe tuberculous / 中国中西医结合急救杂志

Objective To evaluate the effects of enteral immunonutrition on cell immunity level and clinical efficacy in patients with severe tuberculosis. Methods Sixty patients with severe tuberculosis were admitted to the department of tuberculosis intensive care unit of Hangzhou Red Cross Hospital from June 2015 to June 2017, and they were randomly divided into a conventional enteral nutrition group (EN group) and a enteral immunonutrition group (EIN group), each group 30 cases. Based on the patients' gastrointestinal tolerance condition, the EN group was treated with therapies of normal nutrition support, anti-tuberculosis, anti-infection, etc.; the EIN group was treated with enteral immunonutrition (TPF-T), and simultaneously with anti-tuberculosis, anti-infection, etc. therapies according to the disease situation. The target energy maintained at 104.6 kJ·d-1·kg-1and the therapeutic course was 14 days in the two groups. The levels of interleukins (IL-6, IL-10) and interferon-γ (IFN-γ), white blood cell count (WBC), C-reactive protein (CRP), procalcitonin (PCT), cell immune indexes (T cell subgroup CD4+, CD8+) were observed before treatment and on day 14 after treatment in the patients of two groups; the changes of acute physiology and chronic health evaluation Ⅱ (APACHE Ⅱ) score before treatment and after treatment and 28-day mortality rate were recorded in the two groups. Results After treatment, the levels of WBC, CRP, PCT were obviously lower than those before treatment, while the levels of IL-6, IFN-γ, CD4+in the two groups were significantly higher than those before treatment, and the changes of the EIN group were more significant than those in the EN group [WBC (×109/L): 8.0±3.1 vs. 10.0±2.4, CRP (mg/L): 30.3±9.1 vs. 45.8±6.6, PCT (μg/L): 2.2±1.8 vs. 4.3±2.2, IL-6 (mg/L): 182.53±8.52 vs. 168.42±7.62, IFN-γ (mg/L): 32.52±3.5 vs. 25.41±2.6, CD4+: 0.56±0.06 vs. 0.45±0.08, all P < 0.05]. The level of CD8+after treatment in the two groups was higher than that before treatment (the EN group: 0.28±0.06 vs. 0.27±0.07, the EIN group: 0.27±0.08 vs. 0.26±0.09), the APACHE Ⅱ scores in the two groups were lower than those before treatment (the EN group: 11±6 vs. 18±4, the EIN group: 10±3 vs. 17±6), the 28-day mortality in the EIN group was lower than that in the EN group [13.3% (4/30) vs. 16.7% (5/30)], no statistical significant difference in CD8+, APACHE Ⅱscore, 28-day mortality between the two groups being found (all P > 0.05). Conclusion Enteral immunonutrition can improve the level of cell immunity and decrease the degree of inflammatory response, and increase the clinical curative effect in patients with severe tuberculosis.

Effect of electroacupuncture on denervated skeletal muscle atrophy and expression of IGF-1/PI3K/AKT in rats / 中国针灸

OBJECTIVE@#To observe the effects of electroacupuncture (EA) on denervated skeletal muscle atrophy and expression of IGF-1/PI3K/AKT signaling pathway in rats, and to explore the possible mechanisms of it.@*METHODS@#Thirty-six male SD rats were randomly divided into a control group, a model group and an EA group. Denervated muscle atrophy model was made by cutting off the left hindlimb sciatic nerve in the model group and the EA group. In the EA group, EA, dense-disperse wave, 2 Hz/33 Hz and 1.5-2 mA, was connected at "Zusanli" (ST 36) and "Shangjuxu" (ST 37). The treatment was given for 30 min every time, once a day and a total of 20 times were needed, there was 2 days interval every 5 times. The rats in the control group and model group were fixed in the same cage every day but not applied EA. Sciatic nerve function index (SFI) and ratio of muscle wet weight (RWW) were measured after treatment. HE staining was used to determine the ratio of cross-sectional area (RCA) and the ratio of fiber diameter (RFD). TUNEL and double immunofluorescence staining were used to evaluate the myocyte apoptosis, proliferation and differentiation. The mRNA expressions of IGF-1 and AKT were detected by real-time PCR. The total protein of AKT, p-AKT (Ser473) and p-AKT (Thr308) were detected by western blot.@*RESULTS@#Compared with the control group, SFI, RWW, RCA and RFD of the model group were significantly decreased and apoptotic index of myocytes were significantly increased (all <0.01). Compared with the model group, the above indexes of the EA group were improved (all <0.05), and the expressions of PAX3 and PAX7 related to proliferation and differentiation of muscle satellite cells were significantly increased (both <0.01), p-AKT (Ser473) protein level was increased (<0.05).@*CONCLUSION@#EA can improve the atrophy of denervated muscles, reduce myocyte apoptosis, and promote the proliferation and differentiation of muscle satellite cells. The mechanism may be related to the increase of p-AKT (Ser473) level and activation of AKT signaling pathway.

Impact of natural selection on the polymorphism of HLA-G 3'UTR among five ethnic Chinese populations / 中华医学遗传学杂志

<p><b>OBJECTIVE</b>To assess the impact of natural selection and genetic background on the polymorphisms of HLA-G 3-untranslated regions (UTR) among five ethnic Chinese populations.</p><p><b>METHODS</b>PCR and DNA sequencing were used to determine the polymorphisms among 432 individuals from the five ethnic populations. Their genetic background was determined by genotyping of 10 short tandem repeats (STRs).</p><p><b>RESULTS</b>Eight variations were identified among Gelao, Mongolian and Kirgiz populations, while only 7 were found in Shui and Dai people. For all 3 southern populations (Gelao, Shui, and Dai), the observed heterozygosites (Ho) was higher than expected heterozygosities (He). But this was reversed for the 2 northern populations (Mongolian and Kirgiz). The Ho and He of the 10 neutral STRs were in random distribution. Ewens-Watterson testing based on haplotypes of the HLA-G 3'UTR has suggested that a natural selection had occurred in the region where Dai and Shui had inhabited, but not in the northern region where Mongolian and Kirgiz population inhabited. Polygenetic trees based on the HLA and STRs were also different.</p><p><b>CONCLUSION</b>The HLA-G 3'UTR of Dai and Shui people who lived in southern China may have subjected to a selection pressure. Based on current knowledge, this pressure may have been driven by a pathogenic selection.</p>

Effect of IL-21 on Treg cells in peripheral blood mononuclear cells in pathogenesis of Graves disease / 中国免疫学杂志

Objective:To explore the role of IL-21 in regulating the expression of peripheral blood Treg cells in the pathogenesis of Graves disease ( GD ) . Methods: Electrochemical luminescence detection was used to determine levels of thyroid function indexes and autoantibodies. Peripheral blood mononuclear cells (PBMCs) were extracted,then,cultured in the presence or absence of IL-21 in vitro. The level of IL-10 protein was measured by enzyme-linked immunosorbent assay ( ELISA) ,and expressions of Foxp3 and IL-10 mRNA were examined by Real-time PCR. Results: Compared to eGD and control group, there were significant differences in the levels of thyroid function indexes in GD group (P0. 05). Before IL-21 stimulation,compared to eGD and control groups,expressions of Foxp3 and IL-10 mRNA and level of IL-10 protein were significantly higher in GD group ( P0. 05). After IL-21 stimulation,expressions of Foxp3,IL-10 mRNA and IL-10 protein levels were decreased markedly in all three groups,among which GD group showed the greatest change(P<0. 05). Conclusion:IL-21 may inhibit the differentiation of Treg cells and the production of IL-10,therefore decreasing the number of Treg cells and the ability of suppressing effector T cells ,thus should be involved in the pathogenesis of GD.

Study of Wide Pulse Wave Electroacupuncture at Zusanli (ST36) for Preventing and Treating Lower Limb Muscle Atrophy / 上海针灸杂志

Objective To sift and optimize pulse width for electroacupuncture prevention and treatment of muscular atrophy. Method A model of lower limb muscle atrophy was made in 40 rats. They were randomized into groupsⅠ (no electroacupuncture),Ⅱ (a pulse width of 0.5 ms and a frequency of 2 Hz), Ⅲ (a pulse width of 100 ms and a frequency of 2 Hz) and Ⅳ (a pulse width of 200 ms and a frequency of 2 Hz). Points Zusanli (ST36) and Chengshan(BL57) were given electroacupuncture. Sciatic function index (SFI), gastrocnemius muscle wet weight ratio (GW), the cross-sectional area of gastrocnemius muscle fibers (GC), gastrocnemius muscle cell diameter (GD) and gastrocnemius muscle cell apoptosis index (AI) were used as indicators of therapeutic effect. Result Compared with group Ⅰ, SFI and GW increased significantly in groups Ⅲ and Ⅳ (P<0.05). Compared with groupsⅠ and Ⅱ, AI on the affected side decreased significantly in groups Ⅲ and Ⅳ (P<0.05). Conclusion The therapeutic effect of electroacupuncture is related to its pulse width. The pulse widths of 100 ms and 200 ms are significantly more effective than a pulse width of 0.5 ms from a conventional electroacupuncture device in preventing and treating muscular atrophy.

Analysis of Essential Thrombocythemia Combining Myocardial Infarction in 10 Patients / 中国循环杂志

Objective: To analyze the characteristics, treatment and prognosis in patients with essential thrombocythemia (ET) combining myocardial infarction (MI). Methods: A total of 10 patients with ET combining MI treated in our hospital from 2003-01 to 2015-07 were retrospectively studied. The basic clinical information with major admission complaints, previous history and peripheral platelet counts were recorded;echocardiograph, coronary angiography (CAG), application of anti-platelet drugs and platelet reductive therapy with the prognosis were recorded in all patients. Results: There were 6 male and 4 female with a mean age of (55.3 ± 9.7) years, 7 patients with AMI and 3 with old MI. The platelet counts at admission were (500-599) × 109/L in 3 patients, (600-699) × 109/L in 1 patient, (700-799) × 109/L in 3 patients, (800-899) × 109/L in 1 patients, (900-999) × 109/L in 1 patient and more than 1000 × 109/L in 1 patient. Echocardiograph indicated that 5 patient had LVEF≤50%and 5 had LVEF>50%. CAG revealed that there were 9 cases with left anterior descending involved, 2 with circumlfex involved and 5 with right coronary involved. All patients received dual anti-platelet drugs before operation, 4 had hydroxyurea for (20-30) days before operation and no post-operative cardiovascular events occurred;6 patients without hydroxyurea medication and 1 of them was re-hospitalized for angina pectoris and 2 had progressed coronary lesions. Conclusion: Application of platelet reductive therapy at before and after interventional treatment may improve the prognosis in patients with ET combining MI.

Analysis of Allergic Adverse Reaction Caused by Non-ionic Iodinated Contrast Media in 52 Patients With Coronary Angiography / 中国循环杂志

Objective: To analyze the current status of allergic adverse reactions caused by non-ionic iodinated contrast media in patients with coronary angiography (CAG). Methods: A total of 1 225 patients who received non-ionic iodinated contrast media for CAG in our hospital from 2011-02 to 2013-09 were retrospectively studied. There were 52 patients suffered from allergic adverse reactions including 47 (90.38%) male and 5 (9.62%) female. The allergic reaction to iodixanol, iohexol, iopamidol and iopromide were in 34, 3, 3 and 12 patients respectively. The clinical symptoms and outcomes of allergic reaction in 4 iodinated contrast media were analyzed. Results: There were 40/52 (76.92%) patients with mild allergic reaction, 11(21.15%) with moderate and 1 (1.92%) with severe reaction. 13 patients had the reaction within 1 hour of contrast media injection and 39 had the reaction between 1 hour to 3 days of contrast media injection. There 34 patients were cured by symptomatic and anti-allergic treatment, 1 patient was rescued from allergic shock and no death occurred. Conclusion: Application of non-ionic iodinated contrast media in CAG is safe, while closely observe the allergic adverse reaction with the in time and symptomatic treatment is very important in clinical practice.

Inhibitory Effects of Astragalosides on Proliferation of Lung Adenocarcinoma SPCA-1 Cells / 中国药房

OBJECTIVE:To investigate the inhibitory effect of astragalosides on proliferation of lung adenocarcinoma SPCA-1 cells. METHODS:After the cells were cultured in 0 (blank control),7.8,15.6,31.2,62.5,125.0 and 250.0 μg/ml for 48 h, MTT method was used to determine cell viability and median inhibitory concentration(IC50)was calculated,and terminal deoxynu-cleotidyl transferase-mediated dUTP-biotin nick end labeling assay(TUNEL)and flow cytometry were employed to detect apopto-sis. RESULTS:Compared to the blank control,after the cells were cultured in 7.8,15.6,31.2,62.5,125.0 and 250.0 μg/ml as-tragalosides for 48 h,the cell viability was poorer(P<0.01),and IC50 was 61.75 μg/ml;after the cells were cultured in 15.6,31.2, 62.5,125.0 and 250.0 μg/ml astragalosides for 48 h,the apoptosis rate was higher. CONCLUSIONS:Astragalosides have an anti-tumor effect to some degree by a mechanism which may be related to inhibiting cancer cell proliferation and accelerating apoptosis.

Analysis for Combined Use of Low Molecular Weight Heparin and Statins Causing Transaminase Elevation in 32 Patients / 中国循环杂志

Objective: To analyze the relevant factors for combined use of low molecular weight heparin (LMWH) and statins causing transaminase elevation and to provide the reference for medication safety in clinical practice. Methods: There were 45 patients who received the combination of LMWH and statins treatment, then having ALT elevation in our ward from 2011-01 to 2012-12 were collected, by exclusion of patients with the history of high ALT at admission, interrupted treatment and incomplete record of liver function tests, a total of 32 patients were ifnally enrolled for investigation. The conditions for using LMWH and statins together, type of LMWH, timing of ALT elevation after medication and clinical outcomes were retrospectively analyzed. Results: All patients received statins including simvastatin, atorvastatin, rosuvastatin and pravastatin, and 15 patients took statins before using LMWH including enoxaparin, nadroparin and dalteparin. There were 18 patients had ALT increased below 3 times of the upper limit and 14 patients had ALT level ≥ 3 times of the upper limit, and ALT elevation occurred at the average of (3 ± 3.8) days after taking LMWH. All patients stopped using LMWH upon ALT elevation and 16 of them stopped taking statins. The ALT level gradually decreased to normal by application of hepatic-protective treatment in all patients.Conclusion: Combined using LMWH and statins could cause ALT elevation, LMWH and statins may have synergistic effect, and therefore, the enhanced monitor of liver function is necessary when using the combined medication.

Efficiency of temporary cardiac pacing in the acute poisoning patients with serious bradycardia / 中国综合临床

Objective To explore the efficiency of temporary cardiac pacing on the acute poisoning patients with serious bradycardia.Methods Thirty-eight cases of the acute poisoning patients with serious bradycardia were treated randomly with temporary cardiac pacing (pacing group, 18 cases) and drug therapy (control group,20 cases) and followed with treatment for poisoning. Results Right ventricular pacing were successfully performed in 18 cases and the temporary cardiac pacemaker were placed. With the further treatment of poisoning, in the pacing group, the efficiency of anit-bradycardia and the poisoning cure rate was 100% and 88. 9% , respectively, whereas being 60% and 65.0% in the control group, respectively. The efficiency of anit-bradycardia and the poisoning cure rate were significantly different between the two groups (P < 0.01 or P < 0.05 ). Conclusions The treatment of temporary cardiac pacing has effect on the acute poisoning patients with serious bradycardi. It can effectively improve the rate of patients' resuscitation.

Clinical Study on Amlexanox Oral Coating for Treatment of Minor Recurrent Aphthous Ulcer / 中国药房

OBJECTIVE:To study the effects and security of amlexanox oral coating for treatment of minor recurrent aphthous ulcer(MIAU). METHODS:A randomized double-blind experiment was carried on 42 patients with MIAU were randomly divided into experimental group(20 patients),and control group(22 patients),each group respectively administered with amlexanox coating and placebo,at the lesion site 4 times a day for 5 days.RESULTS:At 3 days,the effective rates of healing in the experimental and control group were 85.0% and 36.4%,respectively(P