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.

Low-Dose Erythromycin Treatment on Intractable Allergic Rhinitis Associated with Bronchus Asthma / 实用儿科临床杂志

Objective To explore the therapeutic effect and medication safety of low-dose erythromycin treatment on intractable allergic rhinitis(AR) associated with bronchus asthma.Methods Totally 173 cases of children received outpatient treatment because of AR associated with asthma,their ages ranging from 3 to 14 years.Among them,78 cases developed intractable AR with symptoms of asthma having been controlled or satisfactorily controlled after 2 courses of conventional treatment.Seventy-six children with intractable AR received full follow-up and were randomly divided into observation group and control group.The control group was given different second-generation antihistamines,when necessary,supplemented by nasal glucocorticoids.In the observation group,the same treatment as it was done in control group was continued,plus oral treatment with erythromycin enteric-coated capsules(10 mg?kg-1?d-1,which were taken 3 times a day for 1 month) to the observation group.Both observation group and control group were in accordance with the norms of the treatment of asthma.Results The improvement rate,inefficiency and the total efficiency were different between observation group and control group,and the diffe-rence was statistically significant(?2=12.629,8.412,8.412,Pa0.05).Their liver function was also monitored and was found normal before treatment and after the replacement of drugs for 1 month,including alanine ami-notransferase,aspartate aminotransferase,albumin,globulin,and were found normal.Conclusions On the basis of conventional treatment,low-dose erythromycin treatment of intractable AR is effective and safe.However,the treatment must be limited to the refractory cases,and the appropriate indications must be strictly observed.