甲磺酸帕珠沙星滴眼液治疗细菌性结膜炎的疗效及安全性评价:多中心随机双盲平行对照临床试验  

Efficacy and safety of pazufloxacin mesylate eye drops for bacterial conjunctivitis:a multicenter randomized,double-masked,parallel controlled clinical trial

作　　者：张月琴[1] 贺翔鸽 阴正勤 王林农[4] 李龙标[5] 张虹[6] 王勤美 吴建伟 王丽娅[1] 赵东卿[1] 贺燚[1] 祝磊[1] 李家臣[1] 张俊杰[1] Zhang Yueqin;He Xiangge;Yin Zhengqin;Wang Linnong;Li Longbiao;Zhang Hong;Wang Qinmei;Wu Jianwei;Wang Liya;Zhao Dongqing;He Yi;Zhu Lei;Li Jiachen;Zhang Junjie(Henan Eye Hospital,Henan Eye Institute,Zhangzhou 450003,China;Department of Ophthalmology,Daping Hospital of Army Specialty Medical Center,Chongqing 400042,China;Department of Ophthalmology,Army Medical University,Southwest Hospital,Chongqing 400042,China;Department of Ophthalmology,Nanjing First Hospital,Nanjing 210006,China;Department of Ophthalmology,The First Affiliated Hospital of Soochow University,Suzhou 215006,China;Department of Ophthalmology,The Second Affiliated Hospital of Tianjin Medical University,Tianjin 300211,China;Eye Hospital,Wenzhou Medical University,Wenzhou 325027,China;Shapuaisi Pharmaceutics Co.,Pinghu 314200,China)

机构地区：[1]河南省眼科研究所河南省立眼科医院,郑州450003 [2]陆军特色医学中心大坪医院眼科,重庆400042 [3]陆军军医大学西南医院眼科,重庆480038 [4]南京市第一医院眼科,210006 [5]苏州大学附属第一医院眼科,215006 [6]天津医科大学附属第二医院眼科,300211 [7]温州医科大学附属眼视光医院325027 [8]浙江莎普爱思制药有限公司,浙江平湖314200

出　　处：《中华实验眼科杂志》2019年第7期546-552,共7页Chinese Journal Of Experimental Ophthalmology

摘　　要：目的评估氟喹诺酮类抗生素甲磺酸帕珠沙星滴眼液治疗细菌性结膜炎的临床疗效和安全性。方法采用多中心、随机、双盲临床试验,于2008年3-10月在中国7家医院纳入细菌性角膜炎患者共520例520眼,采用3∶1的比例将患眼随机分为试验组和对照组,试验组390眼,采用甲磺酸帕珠沙星滴眼液点眼;对照组130眼,采用盐酸左氧氟沙星滴眼液点眼作为阳性对照。2个组均每日点眼4次,每次1~2滴,疗程均为7~14d。分别于试验开始前及结束后收集各组患眼结膜囊内分泌物行细菌培养及药物敏感性试验;于用药前和用药后0、7和14d对患眼症状和体征进行观察和评分,评价甲磺酸帕珠沙星滴眼液点眼后的并发症和不良反应,评估药物的安全性。结果意向性分析(ITT)证实试验组和对照组治疗后痊愈率分别为59.38%和60.47%,总有效率分别为88.80%和86.05%,校正中心效应后组间总有效率比较差异无统计学意义(χ^2=0.12,P=0.72)。临床可评价(CE)分析表明试验组和对照组治疗后痊愈率分别为63.48%和63.87%,总有效率分别为92.46%和88.24%,校正中心效应后组间比较差异无统计学意义(P>0.05)。校正后意向性分析(MITT)显示,试验组和对照组治疗后痊愈率分别为60.57%和62.07%,总有效率分别为90.32%和88.51%,校正中心效应后2个组差异无统计学意义(P>0.05)。微生物可评价分析(ME)结果显示,试验组和对照组痊愈率分别为63.71%和63.41%,总有效率分别为93.44%和90.24%,校正中心效应后组间比较差异无统计学意义(P>0.05)。ITT显示试验组和对照组细菌清除率分别为89.42%和90.80%,CE分析分别为90.11%和92.77%,校正中心效应后组间细菌清除率比较差异无统计学意义(χ^2=0.15,P=0.70;χ^2=0.82,P=0.36)。用药后3、7和14d,2个组患眼眼部不良反应(包括耐受性、烧灼感、刺痛感和眼痒)发生率比较差异无统计学意义(P=0.34)。结论甲磺酸帕珠沙星滴眼液点眼治�Objective To compare the clinical efficacy and safety following the topical application of pazufloxacin mesylate eye drops with levofloxacin eye drops (LOFX) for bacterial conjunctivitis. Methods A multicenter,randomized,investigator-masked,parallel-controlled clinical trial was performed.Five hundred and twenty eyes of 520 patients with bacterial conjunctivitis were enrolled from March to October 2008 in seven ophthalmic centers in China.The patients were randomized into trial group and control group in 3 ∶ 1 ratio with the 390 eyes in the trial group and 130 eyes in the control group.Pazufloxacin mesylate eye drops was topically used 4 times per day for consecutively 7-14 days in the trial group,and levofloxacin eye drops was used in the same way in the control group.Microbiological cultures for conjunctiva sac secretions and drug sensitive test were carried out before and at the end of the administration of eye drops.The signs and symptoms were observed and scored before treatment and 0,3,7 and 14 days after treatment.The adverse events following the administration of the eye drops were evaluated and compared. Results The intention to treat analysis (ITT) showed that the cure rate was 59.38% in the trial group and 60.47% in the control group,with the effective rate 88.80% and 86.05%,respectively,with an insignificant difference between the two groups (χ^2 =0.12 ,P =0.72).The clinically evaluable analysis (CE) exhibited that the cure rates were 63.48% in the trial group and 63.87% in the control group,with the effective rate 92.46% and 88.24%,which was not significantly different between them (χ^ 2 =0.54 ,P =0.46).The modified-ITT analysis (mITT) showed that the cure rates were 60.57% in the trial group and 62.07% in the control group,with the effective rate 90.32% and 88.51%,without significant difference between the two groups ( P >0.05).Based on microbiologically evaluable analysis (ME),the clinical cure rates were 63.71% and 63.41% in the trial group and control group,and the effective rates were 93.44%

关 键 词：甲磺酸帕珠沙星滴眼液 结膜炎 细菌性 多中心随机双盲临床试验 治疗结局 安全性 

分 类 号：R777.31[医药卫生—眼科]