Kirsch L S, Jackson W B, Goldstein D A, Discepola M J
Department of Ophthalmology, Shiley Eye Center, University of California at San Diego, La Jolla, USA.
Can J Ophthalmol. 1995 Feb;30(1):11-20.
To compare the efficacy of two treatment regimens, tobramycin drops-erythromycin ointment and ofloxacin drops-placebo ointment, in sterilizing the external ocular adnexa when given perioperatively. A second objective was to determine the aqueous humour concentration of ofloxacin and tobramycin.
Randomized double-blinded clinical trial.
University-affiliated hospital.
Patients aged 18 years or more scheduled to undergo planned cataract surgery who were judged likely to complete the trial.
Of 55 patients enrolled 6 were disqualified and 49 completed the trial.
Preoperative instillation of 10 drops of a 0.3% solution of ofloxacin (26 eyes) or tobramycin (23 eyes) in the operative eye, starting the evening before surgery. Tobramycin-treated eyes received erythromycin ointment after surgery; ofloxacin-treated eyes received petrolatum ointment. Lid and conjunctival swabs were obtained from both eyes on the day before surgery (visit 1), at surgery (visit 2) and on the first postoperative day (visit 3). Aqueous humour samples were obtained from the study eyes at surgery.
Threshold growth of bacteria on culture, aqueous humour concentration of ofloxacin or tobramycin.
At visit 1, 96% of all eyes had positive cultures; this result persisted at visits 2 and 3 for the control eyes. For the treated eyes the incidence of positive cultures decreased from visit to visit. By visit 3 lid cultures were positive for 7 (27%) of the ofloxacin-treated eyes and 7 (30%) of the tobramycin-treated eyes; conjunctival cultures were positive for 0 (0%) of the ofloxacin-treated eyes and 1 (4%) of the tobramycin-treated eyes. No significant differences were seen in culture positivity between the treatment groups at any visit. The mean aqueous humour concentration of ofloxacin was significantly higher than that of tobramycin (0.4084 vs. 0.0279 microgram/mL) (p < 0.001).
Both ofloxacin-placebo treatment and tobramycin-erythromycin treatment were more effective than no treatment in sterilizing the external ocular adnexa. The two treatments were equally efficacious in eliminating bacteria, more successfully in the conjunctiva than the lids. Topically administered ofloxacin demonstrated significantly greater anterior chamber penetration than topically administered tobramycin.
比较围手术期给予妥布霉素滴眼液-红霉素眼膏和氧氟沙星滴眼液-安慰剂眼膏两种治疗方案对外眼附属器消毒的效果。第二个目的是测定氧氟沙星和妥布霉素的房水浓度。
随机双盲临床试验。
大学附属医院。
计划接受白内障手术、年龄18岁及以上且被判定可能完成试验的患者。
55名入组患者中,6名被取消资格,49名完成试验。
术前在手术眼滴入10滴0.3%氧氟沙星溶液(26只眼)或妥布霉素溶液(23只眼),从手术前一晚开始。妥布霉素治疗组术后给予红霉素眼膏;氧氟沙星治疗组给予凡士林眼膏。在手术前一天(访视1)、手术时(访视2)和术后第一天(访视3)从双眼采集眼睑和结膜拭子。在手术时从研究眼采集房水样本。
培养物中细菌的阈值生长、氧氟沙星或妥布霉素的房水浓度。
在访视1时,所有眼中96%培养结果为阳性;对照眼在访视2和3时仍保持这一结果。治疗眼的培养阳性率逐次访视下降。到访视3时,氧氟沙星治疗组7只眼(27%)眼睑培养阳性,妥布霉素治疗组7只眼(30%)眼睑培养阳性;氧氟沙星治疗组0只眼(0%)结膜培养阳性,妥布霉素治疗组1只眼(4%)结膜培养阳性。在任何一次访视中,治疗组之间培养阳性率均无显著差异。氧氟沙星的平均房水浓度显著高于妥布霉素(0.4084对0.0279微克/毫升)(p<0.001)。
氧氟沙星-安慰剂治疗和妥布霉素-红霉素治疗在外眼附属器消毒方面均比不治疗更有效。两种治疗在消除细菌方面同样有效,在结膜上比在眼睑上更成功。局部应用氧氟沙星的前房穿透性显著大于局部应用妥布霉素。