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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。
A randomized controlled clinical trial was designed. The therapeutic drugs were clarithromycin (CRM) tablets. The control drug was domestic erythromycin ethyl succinate tablets. A total of 175 cases of acute bacterial infections were treated, including 134 randomized controlled trials (treatment group and control group Group of 67 cases), open treatment group of 41 cases. The results showed that the CRM of 108 patients with a total clinical cure rate of 64.8%, the clinical efficiency of 96.3%, bacterial negative conversion rate of 96.9%, bacterial clearance rate of 96.3%, the incidence of adverse reactions 7.4 %. The results of randomized controlled trials showed that there was no significant difference (P> 0.05) in the curative effect of therapeutic drug on Gram-positive aerobic bacteria in lower respiratory tract and oral anaerobic bacteria infection. This verification of bacterial culture was positive in 153 cases, the positive rate of 87.4%, drug sensitivity test showed a good CRM in vitro antibacterial effect. At the end of the course of treatment, 8 of 9 resistant bacteria in the treatment group were cleared, reflecting the more pronounced efficacy of CRM in vivo.