中华眼科杂志
中華眼科雜誌
중화안과잡지
Chinese Journal of Ophthalmology
2010年
6期
525-531
,共7页
喹诺酮类%氧氟沙星%结膜炎,细菌性%多中心研究
喹諾酮類%氧氟沙星%結膜炎,細菌性%多中心研究
규낙동류%양불사성%결막염,세균성%다중심연구
Quinolones%Ofloxacin%Conjunctivitis,bacterial%Multicenter study
目的 探讨氟喹诺酮类抗生素加替沙星和左氧氟沙星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、对照试验.2006年8月至2007年10月,在复旦大学附属眼耳鼻喉科医院、河南省眼科研究所、温州医学院附属视光医院、南京医科大学第一附属医院、第四军医大学西京医院、西安交通大学医学院第二附属医院6所医院进行研究.以盐酸左氧氟沙星滴眼液为有效对照,将诊断为细菌性结膜炎的235例(235只眼)患者按随机区组法分入两组:试验组118只眼,对照组117只眼,试验组滴用加替沙星,对照组滴用左氧氟沙星,每组给药方法均为每次2滴,第1-2天,每2小时滴1次,8次/d;以后每4小时滴1次,4次/d,滴入结膜囊内,疗程为7 d.所有人组患者均在试验开始前及试验结束后行结膜囊细菌培养及药物敏感试验,并在用药前和用药后第3-5天、第6-8天分别对症状、体征观察进行综合评分以及评价其安全性.采用协方差分析方法、CMH X2方法、Pearson X2检验、Fisher检验对实验数据进行统计学分析.结果 加替沙星组和左氧氟沙星组的有效率分别为94.0%(110/117只眼)和93.8%(106/113只眼),差异无统计学意义(X2=0.052,P=0.8201).加替沙星组和左氧氟沙星组的细菌清除率分别为94.1%(80/85只眼)和92.5%(74/80只眼),两组比较差异无统计学意义(P=0.3470).用药后第3～5天症状体征综合评分下降幅度加替沙星组为(4.436±2.310)分,左氧氟沙星组为(3.814±1.962)分,差异有统计学意义(F=7.280,P=0.0075).用药后第6～8天症状体征综合评分下降幅度加替沙星组为(7.487 ±2.821)分,左氧氟沙星组为(6.912±2.911)分,差异有统计学意义(F=4.060,P=0.0452).视力及局部用药后耐受性评分在两组之间无显著差异(视力F=1.04,P=0.3080;局部用药后耐受性X2=0.1372,P=0.7111).根据全部患者细菌培养结果,细菌性结膜炎致病菌以革兰阳性菌为主(共检测出革兰阳性菌20种,革兰阴性菌8种),加替沙星对革兰阳性菌的最低抑菌浓度低于左氧氟沙星(表皮葡萄球菌、金黄色葡萄球菌、凝固酶阴性葡萄球菌、甲型溶血性链球菌等).结论 加替沙星滴眼液对细菌性结膜炎有良好的治疗作用,能够有效清除致病菌,起效快,作用强,且体外抗菌活性高,不易产生耐药性,具备良好的安全性和眼部耐受性.
目的 探討氟喹諾酮類抗生素加替沙星和左氧氟沙星治療細菌性結膜炎的臨床療效和安全性.方法 採用多中心、隨機、雙盲、對照試驗.2006年8月至2007年10月,在複旦大學附屬眼耳鼻喉科醫院、河南省眼科研究所、溫州醫學院附屬視光醫院、南京醫科大學第一附屬醫院、第四軍醫大學西京醫院、西安交通大學醫學院第二附屬醫院6所醫院進行研究.以鹽痠左氧氟沙星滴眼液為有效對照,將診斷為細菌性結膜炎的235例(235隻眼)患者按隨機區組法分入兩組:試驗組118隻眼,對照組117隻眼,試驗組滴用加替沙星,對照組滴用左氧氟沙星,每組給藥方法均為每次2滴,第1-2天,每2小時滴1次,8次/d;以後每4小時滴1次,4次/d,滴入結膜囊內,療程為7 d.所有人組患者均在試驗開始前及試驗結束後行結膜囊細菌培養及藥物敏感試驗,併在用藥前和用藥後第3-5天、第6-8天分彆對癥狀、體徵觀察進行綜閤評分以及評價其安全性.採用協方差分析方法、CMH X2方法、Pearson X2檢驗、Fisher檢驗對實驗數據進行統計學分析.結果 加替沙星組和左氧氟沙星組的有效率分彆為94.0%(110/117隻眼)和93.8%(106/113隻眼),差異無統計學意義(X2=0.052,P=0.8201).加替沙星組和左氧氟沙星組的細菌清除率分彆為94.1%(80/85隻眼)和92.5%(74/80隻眼),兩組比較差異無統計學意義(P=0.3470).用藥後第3～5天癥狀體徵綜閤評分下降幅度加替沙星組為(4.436±2.310)分,左氧氟沙星組為(3.814±1.962)分,差異有統計學意義(F=7.280,P=0.0075).用藥後第6～8天癥狀體徵綜閤評分下降幅度加替沙星組為(7.487 ±2.821)分,左氧氟沙星組為(6.912±2.911)分,差異有統計學意義(F=4.060,P=0.0452).視力及跼部用藥後耐受性評分在兩組之間無顯著差異(視力F=1.04,P=0.3080;跼部用藥後耐受性X2=0.1372,P=0.7111).根據全部患者細菌培養結果,細菌性結膜炎緻病菌以革蘭暘性菌為主(共檢測齣革蘭暘性菌20種,革蘭陰性菌8種),加替沙星對革蘭暘性菌的最低抑菌濃度低于左氧氟沙星(錶皮葡萄毬菌、金黃色葡萄毬菌、凝固酶陰性葡萄毬菌、甲型溶血性鏈毬菌等).結論 加替沙星滴眼液對細菌性結膜炎有良好的治療作用,能夠有效清除緻病菌,起效快,作用彊,且體外抗菌活性高,不易產生耐藥性,具備良好的安全性和眼部耐受性.
목적 탐토불규낙동류항생소가체사성화좌양불사성치료세균성결막염적림상료효화안전성.방법 채용다중심、수궤、쌍맹、대조시험.2006년8월지2007년10월,재복단대학부속안이비후과의원、하남성안과연구소、온주의학원부속시광의원、남경의과대학제일부속의원、제사군의대학서경의원、서안교통대학의학원제이부속의원6소의원진행연구.이염산좌양불사성적안액위유효대조,장진단위세균성결막염적235례(235지안)환자안수궤구조법분입량조:시험조118지안,대조조117지안,시험조적용가체사성,대조조적용좌양불사성,매조급약방법균위매차2적,제1-2천,매2소시적1차,8차/d;이후매4소시적1차,4차/d,적입결막낭내,료정위7 d.소유인조환자균재시험개시전급시험결속후행결막낭세균배양급약물민감시험,병재용약전화용약후제3-5천、제6-8천분별대증상、체정관찰진행종합평분이급평개기안전성.채용협방차분석방법、CMH X2방법、Pearson X2검험、Fisher검험대실험수거진행통계학분석.결과 가체사성조화좌양불사성조적유효솔분별위94.0%(110/117지안)화93.8%(106/113지안),차이무통계학의의(X2=0.052,P=0.8201).가체사성조화좌양불사성조적세균청제솔분별위94.1%(80/85지안)화92.5%(74/80지안),량조비교차이무통계학의의(P=0.3470).용약후제3～5천증상체정종합평분하강폭도가체사성조위(4.436±2.310)분,좌양불사성조위(3.814±1.962)분,차이유통계학의의(F=7.280,P=0.0075).용약후제6～8천증상체정종합평분하강폭도가체사성조위(7.487 ±2.821)분,좌양불사성조위(6.912±2.911)분,차이유통계학의의(F=4.060,P=0.0452).시력급국부용약후내수성평분재량조지간무현저차이(시력F=1.04,P=0.3080;국부용약후내수성X2=0.1372,P=0.7111).근거전부환자세균배양결과,세균성결막염치병균이혁란양성균위주(공검측출혁란양성균20충,혁란음성균8충),가체사성대혁란양성균적최저억균농도저우좌양불사성(표피포도구균、금황색포도구균、응고매음성포도구균、갑형용혈성련구균등).결론 가체사성적안액대세균성결막염유량호적치료작용,능구유효청제치병균,기효쾌,작용강,차체외항균활성고,불역산생내약성,구비량호적안전성화안부내수성.
Objective To evaluate the different efficacy and safety to the treatment of baeterial conjunctivitis between the fluoroquinolone antibiotics gatifloxacin and levofloxacin.Methods A multicentre,random,double-blind and control trial was performed in six centers including Eye Ear Nose and Throar Hospital of Fudan University,Henan Eye Institute,Eye Hospital Affiliated to Wenzhou Medieal College,the First Affiliated Hospital Of Nanjing Medical University,Xijing Hospital Affiliated to the Fourth Military Medical University,the Second Affiliated Hospital of Xi'an Jiaotong University between August 2006 and October 2007. The levofloxacin was set as the efficient control. Two hundred and thirty-five patients (235 eyes ) that diagnosed as bacterial conjunctivitis were randomly divided into two groups by the method of randomized blocks, the test group (gatifloxacin) had 118 eyes and the control (levofloxacin) group had 117eyes. The drug delivery into conjunctival sac was performed at a 7-day period ( two drops per time, eight times per day at the first two days and two drops per time, four times per day at the following 5 days). All participants were given the conjunetival sac germ culture and drug sensitive test before and after the study.The combination score of signs and symptoms and evaluation of safety were conducted at the pre-dilivery day,the (4 ± 1 ) and (7 ± 1 ) dilivery day. The statistic analysis was conducted by CMH X2 test, Pearson X2 test and Fisher's exact probabilities test. Results The efficacy of the two groups was 94. 0% ( 110/117 eyes)in gatifloxacin group and 93.8% ( 106/113 eyes) in levofloxacin group with no significant difference( X2 =0.052,P = 0.8201 ). There was also no difference in the bacteria clearance between the two groups [ gatifloxacin versus levofloxacin, 94.1% (80/85 eyes) versus 92. 5% (74/80 eyes) ,P =0. 3470]. The decrease of combination score of signs and symptoms at the (4 ± 1 ) delivery day was 4. 436 +2. 310 in the gatifloxacin group and 3. 814 ± 1. 962 in the levofloxacin group, the difference of which was significant ( F =7.280,P = 0. 0075 ) . This trend was also proved at the ( 7 ± 1 ) delivery day ( gatifloxacin versus levofloxacin, 7. 487 ± 2. 821 versus 6. 912 ± 2. 911, F = 4. 060, P = 0. 0452 ). The visual acuity and the tolerance after local application of the eye drops between the two groups had no diffenrence ( the visual acuity F = 1.04, P = 0. 3080; the tolarence after local admission X2 = 0. 1372, P = 0. 7111 ). According to the result of the germ culture, the major pathogenic bacteria were Gram-positive bacteria ( totally 20 kinds of Grampositive bacteria and 8 kinds of Gram-negetive bacteria). The MIC and drug resistence of gatifloxacin to the Gram-positive bacteria was lower than that of the levofloxaxin ( Staphylococcus Epidermidis, Staphylococcus Aureus, coagulase negative Staphylococcus, α-hemolytic Streptococcus). Conclusions The gatifloxacin eye drop has a good therapeutic effect to the bacterial conjunctivitis, It can effectively clear the pathogen with fast and strong effect. Moreover, it has a low MIC in vitro, advance a prospect in drug resistance, safety and ocular tolerance.
