Discussion on quality control in clinical trials of interventional valvular medical devices / 中国胸心血管外科临床杂志

@#With the rapid development of the field of interventional therapy of cardiac valve, the innovative researches of interventional therapy of cardiac valve products have become the focus of global research. At present, there is a serious shortage of interventional valvular medical devices on the market in China, and large-scale interventional valve products are undergoing early human trials or confirmatory clinical trials. The effective quality control of clinical trials is of great significance to ensure that clinical trial data can be used to support the marketing of device products. By analyzing the problems in clinical trials quality control of interventional valvular medical devices in our hospital, and combining the characteristics of device products and diseases, we explore the key points of quality control and provide reference for the implementation and completion of high-quality clinical trials.

Clinical Study of Bencycloquidium Bromide Nasal Spray in the Treatment of Rhinitis after Cold / 中国药房

OBJECTIVE:To evaluate the effects and safety of Bencycloquidium bromide nasal spray in the treatment of acute rhinitis after a cold. METHODS:A multicenter,dose parallel controlled,randomized,double-blind,placebo-controlled clinical tri-al was conducted. Two hundred and thirty-eight patients with acute rhinitis after a cold were selected and divided into group A(24 cases),B(24 cases),C(24 cases),D(24 cases),E(23 cases),F(24 cases),G(23 cases),H(24 cases),I(24 cases),J (24 cases). Group A-C were given Bencycloquidium bromide nasal spray 22.5μg,45μg,90μg,respectively,bid,spraying it once for each nostril. Group D-F were given Bencycloquidium bromide nasal spray 22.5 μg,45 μg,90 μg,respectively,tid,spraying it once for each nostril. Group G-I were given Bencycloquidium bromide nasal spray 22.5 μg,45 μg,90 μg,respectively,qid,spray-ing it once for each nostril. Group J was given placebo. All groups were treated for(4±1)d. Rhinorrhea score and continuous rhi-norrhea duration were compared among 10 groups,and the safety was evaluated. RESULTS:The rhinorrhea score and continuous rhinorrhea duration of 10 groups were improved significantly,with statistical significance (P0.05). There was no statistical significance in the incidence of ADR among 10 groups(P>0.05). CONCLUSIONS:Bencycloquidium bromide nasal spray with 90 μg,qid times significantly improves rhinorrhea score and continuous rhinorrhea duration with good safety.