注射用盐酸米诺环素治疗呼吸和泌尿系感染的多中心随机对照临床研究.DOCVIP

临床医学论文-注射用盐酸米诺环素治疗呼吸和泌尿系感染的多中心随机对照临床研究 ??????? ??????????? 作者：张建初 辛建保 向菲 刘建设 熊盛道 刘谨 ????????????????? 蓝儒竹　韩雪芳 程永毅 江南 廖常志 熊瑛 陈明 尹平 【摘要】? 目的 评价国产盐酸米诺环素粉针治疗急性细菌性感染的有效性和安全性。方法 采用多中心、单盲、随机对照研究方法，试验组114例，给予盐酸米诺环素100mg静脉滴注，bid；对照组122例，给予盐酸左氧氟沙星注射液200mg静脉滴注，bid。两药疗程均为7～14d。结果 试验组总痊愈率和有效率分别为49.12%和86.84%；对照组分别为51.64%和84.43%。试验组和对照组细菌清除率分别为94.92%和93.85%，两组比较差异均无显著意义(P0.05)。试验组不良反应发生率为21.95%，对照组为9.60%，两组比较差异有显著意义(χ2=7.1076，P=0.0077)。结论 盐酸米诺环素治疗急性细菌性感染临床疗效确切，不良反应能够耐受。 【关键词】? 细菌感染； 随机对照试验； 米诺环素； 左氧氟沙星 ??? ABSTRACT? Objective? To evaluate the clinical efficacy and safety of domestic injectable minocycline hydrochloride on the treatment of acute bacterial infections.? Methods? A singleblind multicenter randomized comparison clinical study was conducted. One hundred fourteen patients in experiment group were treated with minocycline hydrochloride intravenously at the dose of 100mg bid for 7～14 days and 122 patients in control group were administrated with levofloxacin intravenously 200mg bid for 7～14 days.? Results? The cure rates and effective rates were 49.12% and 86.84% in the experiment group, and 51.64% and 84.43% in the control group, respectively. The bacterial eradication rates were 94.92% and 93.85%, respectively. There was nostatistically significant difference of the parameters between the two treatment groups (P0.05). Adverse reactions were observed in 21.95% and 9.60% of patients in the treatment and control groups, There was statistically significant difference between the two treatment groups (χ2=7.1076, P=0.0077).?Conclusions Domestic injectable minocycline hydrochloride was effective and safe for the treatment of acute bacterial infections. The adverse reactions could be tolerated. 牋?KEY WORDS?Bacterial infections;?Randomized comparison study;?Minocycline hydrochloride;?Levofloxaxin ??? 盐酸米诺环素(minocycline hydrochloride)是长效半合成四环素类广谱抗菌药物，抗菌谱与四环素相近，对各种敏感细菌所致感染均有效，对支原体、衣原体、立克次体感染也具有很好的效果。根据国家药品监督管理局《药物临床批件》2003L04078号文，本研究采用多中心随机原则，以国产盐酸左氧氟沙星注射液为对照，观察了盐酸米诺环素对