Bioequivalence and safety evaluation of domestic Nadroparin calcium injection in Chinese healthy volunteers / 中国药房

OBJECTIVE To evaluate the bioequivalence and safety of two k inds of Nadroparin calcium injection in healthy Chinese volunteers by subcutaneous injection. METHODS According to the block randomization method ，24 Chinese healthy adult volunteers were included and divided into TR （test preparation-reference preparation ）group and RT （reference preparation-test preparation）group at a ratio of 1∶1. A randomized ，open-labelled，single-dose and two-cycle crossover study was designed ，the fasting subjects of two groups were given test or reference preparation 6 150 AⅩaIU subcutaneously on the first day of each cycle and exchanged in the second cycle ，and the wash-out period was 7 days. The blood samples were collected at different time points before and after administration. The activity of anti-coagulant factor Ⅹa（Anti-Ⅹa）and Anti- Ⅱa in human plasma were determined by chromogenic substrate method ，and the pharmacodynamic parameters were calculated according to the non-atrioventricular model and the bioequivalence was evaluated. The occurrence of adverse events （AEs）was recorded. RESULTS After administration ，the main pharmacodynamic parameters for Anti- Ⅹa activity of test preparation and reference preparation were as follows ：t1/2 were（4.87±1.06） and（4.03±1.00）h，tmax were 4.50（2.00，8.00）and 5.50（2.50，8.00）h，Anti-Ⅹamax were（0.66±0.12）and（0.56±0.11）IU/mL；main pharmacodynamic parameters of Anti- Ⅱa activity of two preparations were as follows ：t1/2 were（3.64±1.60）and（5.74±7.23）h，tmax were 4.00（2.50，8.00）and 4.00（2.00，8.00）h，Anti-Ⅱamax were both （0.10±0.03）IU/mL. The values of 90％confidence interval of geometric mean ratio of Anti- Ⅹamax，AUEC0－t and AUEC 0－∞ were 110.98％-123.50％，112.11％-121.24％and 111.57％-120.00％， respectively. During experiment ，14 subjects reported 19 cases of mild AEs ，among which hematoma ，purpura and maculopapular rash may be related to drugs ；no serious AEs were observed. CONCLUSIONS The domestic Nadroparin calcium injection is bioequivalent to the reference preparation ，and both of them show good safety.

Effectiveness analysis and inspirations of rational administration of carbapenem / 中华医院管理杂志

The hospital introduced a multi-department synergy in management of the rational use of carbapenems. Specifically,the medical affairs department conducts training and appraisal of doctors along with a monthly checkup of medical records. The pharmaceutical affairs division conducts prior prescriptions checkup and follow-up comment. The clinical microbiology laboratory and the hospital-acquired infection management department monitors and releases such infection and bacterial resistance information of the whole hospital in real time. The results showed increased prescriptions of imipenem and cilastatin sodium, and decreased prescriptions of biapenem for injection. Drug resistance analysis showed that carbapenem resistant strains increased by 28%,but the total number of patients reduced by 10% and total number of patients with multidrug resistance remained unchanged. It is proposed to further antimicrobial stewardship in the hospital to achieve rational drug use and curb bacterial resistance.

Progress of research on gabapentin for refractory chronic cough / 中国生化药物杂志

Objective To review advance of gabapentin in treatment of refractory chronic cough, and to provide evidence for its clinical usage and further study.The original articles referring to gabapentin’ s effect on sensory neuropathy such as refractory chronic cough, which were retrieved from CNKI, Wanfang Medical Network, as well as PubMed over the last 15 years, were reviewed.The safety, efficacy and its mechanism of gabapentin were sorted, generalized and analyzed.Gabapentin appears to be effective and safe in the treatment of sensory neuropathic disorder such as refractory chronic cough, and its effective treatment results may come ture through improving central sensitization, which indicates the drug has new clinical application value.Relevant clinical trials investigating its efficacy and safety profile in the treatment of cough are limited and further research are needed.

Exploration of SPL-PBL Teaching Method in Clinical Pharmacist Training / 中国药房

OBJECTIVE:To explore the new method for clinical pharmacists training,and provide reference for improving the quality of clinical pharmacists training. METHODS:Based on the full-awareness of Definition and characteristics of stage-progres-sive learning(SPL)and problem-based learning(PBL)teaching method,SPL-PBL teaching method was used in the teaching of the-oretical and clinical practice in the process of students training in clinical pharmacist training base. The teaching course of theoreti-cal knowledge was mainly SPL in first half and PBL in another half. While in the clinical practice teaching of ward rounds,check-ing doctor's advice,participation in the development of treatment programs and case discussion,PBL was mainly used interspersed by SPL;SPL was mainly in inquiry,pharmaceutical care and medication education interspersed by PBL. RESULTS:SPL-PBL teaching method had not only effectively aroused the enthusiasm of the students'learning,enhanced the sense of responsibility and improved their clinical professional knowledge and practice ability,but also strengthened the cultivation of students communication ability,document retrieval ability,writing communication ability and self-learning ability(four abilities) to make students more quickly into the role and improve their subjective initiative. CONCLUSIONS:Practice has proved that the SPL-PBL teaching meth-od not only gives consideratin to the inndividual differences among studengts,but also mobilizes the enthusiam,and not only gives consideration to the teaching about basic theoretical knowledge,but also strengthens the training for clinical thingkig andfour abili-ties,wich can be used for the clinical pharmacists training. Meanwhile,SPL has expanded the aplication surface of PBL beacuse that SPL has reduced the requirements of PBL for overall qulity. However,it needs to be improved because of the short time appli-cation.

Exploration of the Way of Clinical Pharmacists Participating in the Treatment for Lung Cancer / 中国药房

OBJECTIVE:To explore the approaches for clinical pharmacists to participate in the treatment for lung cancer. METHODS:Based on the work of oncology department,the content and method of clinical pharmacist participating in clinical drug therapy were introduced in the terms of rationality,drug interaction,pain treatment,etc. RESULTS:Clinical pharmacists could participate in the treatment for lung cancer through paying attention to rationality of antitumor drug and ancillary drug use, drug interaction and pharmaceutical care for pain treatment,conducting special lecture for medical staff,and developing clinical study. CONCLUSION:Clinical pharmacists can provide various pharmaceutical care to promote safe and rational drug use.

Relationship between skin barrier function and claudin-1 expression in patients with atopic dermatitis / 中华皮肤科杂志

Objective To evaluate skin barrier function in patients with atopic dermatitis (AD),and to assess its relationship with claudin-1 expression.Methods Totally,11 patients with AD and 11 healthy human controls were recruited in this study.A Tewameter TM210 was used to measure transepidermal water loss (TEWL) value,and high-frequency ultrasound to determine epidermal thickness and density,in lesional and non-lesional skin of the patients and normal skin of the healthy controls.A double-antibody sandwich enzyme-linked immunosorbent assay (ELISA) was performed to determine the serum level of free claudin-1 in these subjects.One-way analysis of variance and t test were carried out to compare these parameters in different groups,and Pearson's correlation analysis to estimate the relationship between different parameters.Results The TEWL value was significantly higher in lesional skin than in nonlesional skin of patients with AD and normal skin of the healthy controls ((36.9 ± 34.2) vs.(9.1 ± 6.0) and (4.4 ± 3.1) g·m-2·h-1,both P＜ 0.05).The epidermal thickness in AD lesions was (0.23 ± 0.04) mm,significantly higher than that in nonlesional skin ((0.18 ± 0.03) mm,P ＜ 0.01) and normal control skin ((0.18 ± 0.02) mm,P ＜ 0.01).Ultrasound images revealed a characteristic subepidermal low echo-genic band in the AD lesions.The patients with AD showed a significantly lower serum level of claudin-1 compared with the healthy controls ((0.80 ± 0.88) vs.(1.73 ± 1.85) μg/L,P ＜ 0.05).Moreover,the serum level of claudin-1 was negatively correlated with epidermal thickness (r =-0.61,P ＜ 0.01),but positively correlated with the inverse of TEWL (1/TEWL,r =0.44,P ＜ 0.05).Conclusions The impaired skin barrier function,which may be evaluated by TEWL,1/TEWL and epidermal thickness,is associated with the expression of claudin-1 in patients with AD.

Analysis on Plasma Concentration Monitoring Data of Ciclosporin in Renal Transplantation Patients Having Survived More than Seven Years / 中国药房

0.05), but significant difference when compared the older-age group with the young & middle-age group(P

Blood Concentration Monitoring of Valproic Acid: Clinical Evaluation / 中国药房

OBJECTIVE: To analyze the therapeutic drug monitoring results of valproic acid( anti- epileptic drug) . METH-ODS: The concentrations of valproic acid in 226 cases in our hospital were determined by fluorescence polarization immunoassay. RESULTS: The results showed that 47. 79% were within the normal referenced concentration range, with average concentration at( 66. 19? 12. 13) ? g? mL- 1, 46. 90% were below the lower limit and 5. 31% were above the upper limit. CONCLUS-ION: The monitoring results are far from satisfactory. It is advisable to adopt individualized administration so as to achieve the goal of treatment.