Analysis of Quality Management of in Vitro Diagnostic Reagent Clinical Trials / 中国医疗器械杂志

Clinical trial is an important step of in vitro diagnostic reagents research and development. Based on the Guiding Principles and the key points of inspect on the spot, combined with the actual work experience, the article focuses on the prominent problems in the whole process of in vitro diagnostic reagent clinical trials. It is helpful to improve the level of hospital drug clinical trial centre and the quality of in vitro diagnostic reagent clinical trials by analyzing the issues.

Rationality Evaluation of Cefoxitin Use in Our Hospital by AHM Weighted TOPSIS Method / 中国药房

OBJECTIVE:To evaluate the rationality of cefoxitin use in our hospital. METHODS:Evaluation index and evalua-tion criteria were established on the basis of DUE. The relative weight of evaluation index were calculated by using attribute-based AHM weight method,and the gas between medical orders and complete rational ones were evaluated by using TOPSIS processing method. The proportion of rational medical orders were calculated to evaluate the rationality of drug use. RESULTS:Among 116 medical records,there were 19%reasonable medical orders(including 4.3%complete reasonable medical orders,5 cases),50%ba-sically reasonable medical orders(58 cases)and 31% unreasonable medical orders(36 cases). CONCLUSIONS:It is reasonable and feasible to use AHM weighted TOPSIS method to evaluate the rationality of cefoxitin. The utilization of cefoxitin in our hospital is basically reasonable,but there are still many problems.

Effects of DUE Criteria on the Evaluation of Glucocorticoids Use in Oncology Department / 中国药房

OBJECTIVE:To explore the establishment of DUE criteria for the evaluation of glucocorticoids(GCs)use in oncol-ogy department of our hospital,and to evaluate the rationality of glucocorticoid use. METHODS:DUE criteria for GCs in our hos-pital was established preliminary,and used to evaluate medication indication,medication course,medication results,etc. Medical records of 300 patients receiving GCs were collected from oncology department of our hospital during Apr. to Dec. in 2013(before intervention)and Jun. 2014 to Mar. 2015(after intervention)via hospital information system. The application of GCs was evaluat-ed. RESULTS:Pexamethasone sodium phosphate injection was used most frequently in our hospital(82.34%),followed by Dexa-methasone acetate tablet(15.33%)and prednisone asetate tablets(2.33%). The mest common purpose of GCs use in oncology de-partment of our hospital is radiotherapy and chemotherapy induced vomiting prevention and treatment(55.55% of total case),fol-lowed by anti-inflammatory therapy(14.19%)and chemotheraphy drug pretreatment(12.76%). After intervention,rational use of GCs for tumor had been improved greatly,and the rate of unqualified drug dosage and medication course decreased from 6.87% to 3.95%,and that of decreased from 3.58% to 2.74%. CONCLUSIONS:The establishment of DUE criteria and continuous criteria improvement during clinical rational drug use guidance can promote rational use of GCs in oncology department.