Macfadyen C A, Acuin J M, Gamble C
Liverpool School of Tropical Medicine, International Health Research Group, Pembroke Place, Liverpool, UK L3 5QA.
Cochrane Database Syst Rev. 2005 Oct 19;2005(4):CD004618. doi: 10.1002/14651858.CD004618.pub2.
Chronic suppurative otitis media (CSOM) causes ear discharge and impairs hearing.
Assess topical antibiotics (excluding steroids) for treating chronically discharging ears with underlying eardrum perforations (CSOM).
The Cochrane Ear, Nose and Throat Disorders Group Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library Issue 1, 2005), MEDLINE (January 1951 to March 2005), EMBASE (January 1974 to March 2005), LILACS (January 1982 to March 2005), AMED (1985 to March 2005), CINAHL (January 1982 to March 2005), OLDMEDLINE (January 1958 to December 1965), PREMEDLINE, metaRegister of Controlled Trials (mRCT), and article references.
Randomised controlled trials; any topical antibiotic without steroids, versus no drug treatment, aural toilet, topical antiseptics, or other topical antibiotics excluding steroids; participants with CSOM.
One author assessed eligibility and quality, extracted data, entered data onto RevMan; two authors inputted where there was ambiguity. We contacted investigators for clarifications.
Fourteen trials (1,724 analysed participants or ears). CSOM definitions and severity varied; some included otitis externa, mastoid cavity infections and other diagnoses. Methodological quality varied; generally poorly reported, follow-up usually short, handling of bilateral disease inconsistent. Topical quinolone antibiotics were better than no drug treatment at clearing discharge at one week: relative risk (RR) was 0.45 (95% confidence interval (CI) 0.34 to 0.59) (two trials, N = 197). No statistically significant difference was found between quinolone and non-quinolone antibiotics (without steroids) at weeks one or three: pooled RR were 0.89 (95% CI 0.59 to 1.32) (three trials, N = 402), and 0.97 (0.54 to 1.72) (two trials, N = 77), respectively. A positive trend in favour of quinolones seen at two weeks was largely due to one trial and not significant after accounting for heterogeneity: pooled RR 0.65 (0.46 to 0.92) (four trials, N = 276) using the fixed-effect model, and 0.64 (95% CI 0.35 to 1.17) accounting for heterogeneity with the random-effects model. Topical quinolones were significantly better at curing CSOM than antiseptics: RR 0.52 (95% CI 0.41 to 0.67) at one week (three trials, N = 263), and 0.58 (0.47 to 0.72) at two to four weeks (four trials, N = 519). Meanwhile, non-quinolone antibiotics (without steroids) compared to antiseptics were more mixed, changing over time (four trials, N = 254). Evidence regarding safety was generally weak.
AUTHORS' CONCLUSIONS: Topical quinolone antibiotics can clear aural discharge better than no drug treatment or topical antiseptics; non-quinolone antibiotic effects (without steroids) versus no drug or antiseptics are less clear. Studies were also inconclusive regarding any differences between quinolone and non-quinolone antibiotics, although indirect comparisons suggest a benefit of topical quinolones cannot be ruled out. Further trials should clarify non-quinolone antibiotic effects, assess longer-term outcomes (for resolution, healing, hearing, or complications) and include further safety assessments, particularly to clarify the risks of ototoxicity and whether quinolones may result in fewer adverse events than other topical treatments.
慢性化脓性中耳炎(CSOM)会导致耳内流脓并损害听力。
评估局部用抗生素(不包括类固醇)治疗伴有鼓膜穿孔的慢性耳内流脓(CSOM)的效果。
Cochrane耳鼻喉疾病组试验注册库、Cochrane对照试验中央注册库(CENTRAL,Cochrane图书馆2005年第1期)、MEDLINE(1951年1月至2005年3月)、EMBASE(1974年1月至2005年3月)、LILACS(1982年1月至2005年3月)、AMED(1985年至2005年3月)、CINAHL(1982年1月至2005年3月)、OLDMEDLINE(1958年1月至1965年12月)、PREMEDLINE、对照试验元注册库(mRCT)以及文章参考文献。
随机对照试验;任何不含类固醇的局部用抗生素,与不进行药物治疗、耳道冲洗、局部用防腐剂或其他不含类固醇的局部用抗生素进行对比;CSOM患者。
由一位作者评估纳入标准和质量,提取数据,并将数据录入RevMan;如有歧义,由两位作者录入。我们联系研究者进行澄清。
14项试验(1724名分析参与者或耳)。CSOM的定义和严重程度各不相同;一些试验纳入了外耳道炎、乳突腔感染及其他诊断。方法学质量参差不齐;总体报告不佳,随访通常较短,对双侧疾病的处理不一致。局部用喹诺酮类抗生素在一周时清除耳内流脓方面优于不进行药物治疗:相对危险度(RR)为0.45(95%置信区间(CI)0.34至0.59)(两项试验,N = 197)。在第一周或第三周时,喹诺酮类抗生素与非喹诺酮类抗生素(不含类固醇)之间未发现统计学上的显著差异:合并RR分别为0.89(95%CI 0.59至1.32)(三项试验,N = 402)和0.97(0.54至1.72)(两项试验,N = 77)。在两周时观察到的有利于喹诺酮类抗生素的积极趋势很大程度上归因于一项试验,在考虑异质性后并不显著:采用固定效应模型时合并RR为0.65(0.46至0.92)(四项试验,N = 276),采用随机效应模型考虑异质性时为0.64(95%CI 0.35至1.17)。局部用喹诺酮类抗生素在治愈CSOM方面明显优于防腐剂:一周时RR为0.52(95%CI 0.41至0.67)(三项试验,N = 263),两至四周时为0.58(0.47至0.72)(四项试验,N = 519)。同时,与防腐剂相比,非喹诺酮类抗生素(不含类固醇)的情况更为复杂,随时间变化(四项试验,N = 254)。关于安全性的证据总体较弱。
局部用喹诺酮类抗生素在清除耳内流脓方面比不进行药物治疗或局部用防腐剂效果更好;非喹诺酮类抗生素(不含类固醇)与不进行药物治疗或防腐剂相比的效果不太明确。关于喹诺酮类抗生素与非喹诺酮类抗生素之间的任何差异,研究也尚无定论,尽管间接比较表明不能排除局部用喹诺酮类抗生素的益处。进一步的试验应阐明非喹诺酮类抗生素的效果,评估长期结局(如痊愈、愈合、听力或并发症),并进行进一步的安全性评估,特别是要明确耳毒性风险以及喹诺酮类抗生素是否可能比其他局部治疗导致更少的不良事件。