CAJ | 학술논문

背景急性细菌性结膜炎是常见的眼部感染性疾病之一,局部使用抗生素可加速恢复.目前临床应用的抗生素滴眼液都需要每天数次给药治疗,而阿奇霉素不需频繁给药且治疗疗程短. 目的评价质量分数1％阿奇霉素滴眼液对细菌性结膜炎的临床疗效和安全性.方法本研究经北京同仁医院伦理委员会批准,遵循Helsinki宣言,受试者进入研究前均签署知情同意书.采用随机、双盲前瞻性临床对照试验设计.共纳入于2011年5-9月在青岛医学院附属医院及青岛市市立医院确诊的急性细菌性结膜炎患者180例,按随机双盲分组的原则分为试验组89例,对照组91例,分别单独使用1％阿奇霉素滴眼液和安慰剂点眼,两组用药方法一致,共随访9d.裂隙灯生物显微镜下检查受试者球结膜炎症情况后评分,并进行结膜囊细菌培养,记录随访期间受试者与药物相关县不相关的不良反应,临床疗效的评价以临床治愈率为主要指标,以细菌清除率为次要指标,药物的安全性评价主要观察受试者用药后的眼部刺激性、晶状体改变和眼压变化,两组受试者上述检测结果的比较采用x2检验.结果本组受试者均按要求完成随访,无病例脱落和中止或剔除病例.试验组受试者用1％阿奇霉素滴眼液点眼后细菌性结膜炎临床治愈率为76.40％ (68/89),对照组临床治愈率为43.96％ (40/91),两组间差异有统计学意义(x2=19.73,P＜0.01)；试验组受试眼细菌清除率为85.71％ (24/28),对照组细菌清除率为60.53％ (23/38),差异有统计学意义(x2=4.99,P＜0.05).试验组与对照组均有良好的耐受性,无明显不良反应发生.结论 1％阿奇霉素滴眼液可以有效治疗细菌性结膜炎,药物安全性好,无明显不良反应.
배경 급성세균성결막염시상견적안부감염성질병지일,국부사용항생소가가속회복.목전림상응용적항생소적안액도수요매천수차급약치료,이아기매소불수빈번급약차치료료정단. 목적 평개질량분수1％아기매소적안액대세균성결막염적림상료효화안전성.방법 본연구경북경동인의원윤리위원회비준,준순Helsinki선언,수시자진입연구전균첨서지정동의서.채용수궤、쌍맹전첨성림상대조시험설계.공납입우2011년5-9월재청도의학원부속의원급청도시시립의원학진적급성세균성결막염환자180례,안수궤쌍맹분조적원칙분위시험조89례,대조조91례,분별단독사용1％아기매소적안액화안위제점안,량조용약방법일치,공수방9d.렬극등생물현미경하검사수시자구결막염증정황후평분,병진행결막낭세균배양,기록수방기간수시자여약물상관현불상관적불량반응,림상료효적평개이림상치유솔위주요지표,이세균청제솔위차요지표,약물적안전성평개주요관찰수시자용약후적안부자격성、정상체개변화안압변화,량조수시자상술검측결과적비교채용x2검험.결과 본조수시자균안요구완성수방,무병례탈락화중지혹척제병례.시험조수시자용1％아기매소적안액점안후세균성결막염림상치유솔위76.40％ (68/89),대조조림상치유솔위43.96％ (40/91),량조간차이유통계학의의(x2=19.73,P＜0.01)；시험조수시안세균청제솔위85.71％ (24/28),대조조세균청제솔위60.53％ (23/38),차이유통계학의의(x2=4.99,P＜0.05).시험조여대조조균유량호적내수성,무명현불량반응발생.결론 1％아기매소적안액가이유효치료세균성결막염,약물안전성호,무명현불량반응.
Background Acute bacterial conjunctivitis is a common ocular infectious disease.It can be cured by topical administration of antibiotics,but these antibiotic eye drops often was used several times per day at present.Azithromycin is thought to offer less using times and shorten the duration of treatment.Objective The purpose of this clinical trail was to evaluate the clinical efficacy and safety of topical administration of 1％azithromycin eye drops for the treatment of acute bacterial conjunctivitis.Methods This study was approved by Ethic Committee of Beijing Tongren Hospital and followed the Declaration of Helsinki.Written informed consent was obtained prior to entering into this trial.A randomized,double-blind and placebo-controlled study was designed.One hundred and eighty patients with acute bacterial conjunctivitis were enrolled in Affiliated Hospital of Qingdao Medical College and Qingdao Municipal Hospital from may,2011 to September,2011.Azithromycin eye drops at the concentration of 1％ was topically administered on 89 eyes of 89 patients twice per day initial and once per day later for 9 days in the trial group,and placebo eye drops was used on 91 eyes of 91 patients in the same way in the control group.The inflammation response of all eyes was examined and scored under the slit lamp microscope,and germiculture was carried out.All adverse responses were assessed during the follow-up.Clinical efficacy was evaluated with the clinical cure rate as the primary indicator and bacterial clearance rate as the secondary indicator.The safety of drug was determined,including the ocular irritation sign,lens transparency and intraocular pressure.The differences of the examining results mentioned-above were compared with Chi Square test.Results One hundred and eighty patients completed the clinical trials according to the program without lost and exclusion cases.The clinical cure rate in 89 subjects in the trial group and 91 control individuals was 76.40％ (68/89) and 43.96％ (40/91),respectively,with significant difference between them (x2=19.73,P＜0.01).The bacterial eradication rate was 85.71％ (24/28) in the trial group and 60.53％ (23/38) in the control group,showing a significant difference (x2 =4.99,P＜0.05).Both 1％ azithromycin eye drops and placebo were well-tolerated with a low incidence of adverse events.Conclusions One percent azithromycin eye drops is effective and safe for the treatment of acute bacterial conjunctivitis with less adverse reaction.