国产clarithromycin片治疗急性细菌性感染临床研究

Clinical study of domestic clarithromycin in the treatment of acute bacterial infections

采用非盲随机对照临床验证设计，治疗药物为国产ｃｌａｒｉｔｈｒｏｍｙｃｉｎ（ＣＲＭ）片，对照药物为国产琥珀酸乙酰红霉素片，共治疗急性细菌性感染１７５例，其中随机对照１３４例（治疗组与对照组各６７例），开放治疗组４１例。结果显示ＣＲＭ片对１０８例患者总的临床痊愈率６４．８％，临床有效率９６．３％，细菌阴转率９６．９％，细菌清除率９６．３％，不良反应发生率７．４％。随机对照研究显示，治疗药对下呼吸道革兰氏阳性需氧菌感染以及口腔间隙厌氧菌感染的疗效与对照药比较均无显著性差异（Ｐ＞０．０５）。本验证细菌培养阳性１５３例，阳性率８７．４％，药敏试验显示了ＣＲＭ良好的体外抗菌作用。疗程结束时，治疗组中的９株耐药菌有８株被清除，反映ＣＲＭ的体内疗效更为显著。

One hundred seventy five cases of acute bacterial infections (134 cases in a randomized trial; 41 cases in an open trial) were treated with domestic clarithromycin controlled with erythromycin ethylsuccinatis. In the 108 cases of infections treated with clarithromycin, the overall rates of clinical cure, clinical efficacy, bacteriological efficacy and bacterial clearance were 64.8%, 96.3%, 96.9% and 96.3% respectively. Slight adverse effects occured in 7.4% of patients. In the randomized trial, there were no statistical significant difference in the efficacy and safety between clarithromycin and erythromycin ethylsuccinate for treating 74 cases of lower respiratory tract Grampositive aerobic infections and 60 cases of oral cavity anaerobic infections. In vitro activity of clarithromycin against 175 clinical isolates manifested that the compound had good antibacterial activities against many Grampositive aerobes and anaerobes.