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. 2006 Jan 25(1):CD005608. doi: 10.1002/14651858.CD005608.
Chronic suppurative otitis media (CSOM) causes ear discharge and impairs hearing.
To compare systemic antibiotics and topical antiseptics or antibiotics (excluding steroids) for treating chronically discharging ears with an underlying eardrum perforation (CSOM).
The Cochrane ENT Disorders Group Specialised Register, 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, Metadatabase of registers of ongoing trials (mRCT), and article references.
Randomised controlled trials; any systemic versus topical treatment (excluding steroids); participants with CSOM.
One author assessed eligibility and quality, extracted data, entered data into RevMan; two authors provided a second assessment of titles and abstracts, and inputted where there was ambiguity. We contacted investigators for clarifications.
Nine trials (833 randomised participants; 842 analysed participants or ears). CSOM definitions and severity varied; some included mastoid cavity infections, other diagnoses, or complications. Methodological quality varied; generally poorly reported, follow-up short, handling of bilateral disease inconsistent. Topical quinolone antibiotics were better than systemic antibiotics at clearing discharge at 1-2 weeks: relative risks (RR) were, 3.21 (95% confidence interval (CI) 1.88 to 5.49) using systemic non-quinolone antibiotics (2 trials, N = 116), and 3.18 (1.87 to 5.43) using systemic quinolone (3 trials, N = 175); or 2.75 (1.38 to 5.46) in favour of systemic plus topical quinolone over systemic quinolone alone (2 trials, N = 90). No statistically significant benefit was seen at 2-4 weeks for topical non-quinolone antibiotic (without steroids) or topical antiseptic over systemic antibiotics (mostly non-quinolones), but numbers were small: one trial tested topical non-quinolones (N = 31); two tested antiseptics (N = 152). No benefit of adding systemic to topical treatment at 1-2 weeks was detected either, although evidence was limited (three trials, N = 204). Evidence regarding safety was generally weak. Adverse events reported were generally mild, although hearing worsened by ototoxicity (damaging auditory hair cells) was seen with chloramphenicol drops (non-quinolone antibiotic).
AUTHORS' CONCLUSIONS: Topical quinolone antibiotics can clear aural discharge better than systemic antibiotics; topical non-quinolone antibiotic (without steroids) or antiseptic results are less clear. Evidence regarding safety was weak. Further studies should clarify topical non-quinolones and antiseptic effectiveness, assess longer-term outcomes (for resolution, healing, hearing, or complications), and include further safety assessments, particularly to clarify the risks of ototoxicity and whether there may be fewer adverse events with topical quinolones than other topical or systemic treatments.
慢性化脓性中耳炎(CSOM)会导致耳内流脓并损害听力。
比较全身用抗生素与局部用防腐剂或抗生素(不包括类固醇)治疗伴有鼓膜穿孔的慢性耳流脓(CSOM)的效果。
Cochrane耳鼻喉疾病专业组专门注册库、Cochrane对照试验中心注册库(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、正在进行的试验注册库元数据库(mRCT)以及文章参考文献。
随机对照试验;任何全身治疗与局部治疗(不包括类固醇)的比较;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;两位作者对标题和摘要进行二次评估,并在存在歧义时进行录入。我们联系研究者进行澄清。
9项试验(833名随机参与者;842名分析参与者或耳朵)。CSOM的定义和严重程度各不相同;一些试验包括乳突腔感染、其他诊断或并发症。方法学质量参差不齐;总体报告不佳,随访时间短,对双侧疾病的处理不一致。局部用喹诺酮类抗生素在1 - 2周时比全身用抗生素更能有效清除耳内流脓:使用全身非喹诺酮类抗生素时相对危险度(RR)为3.21(95%置信区间(CI)1.88至5.49)(2项试验,N = 116),使用全身喹诺酮类抗生素时为3.18(1.87至5.43)(3项试验,N = 175);或者全身加局部用喹诺酮类抗生素比单独全身用喹诺酮类抗生素更有效,RR为2.75(1.38至5.46)(2项试验,N = 90)。在2 - 4周时,局部用非喹诺酮类抗生素(无类固醇)或局部用防腐剂与全身用抗生素(大多为非喹诺酮类)相比,未观察到统计学上的显著益处,但样本量较小:一项试验测试了局部用非喹诺酮类抗生素(N = 31);两项试验测试了防腐剂(N = 152)。在1 - 2周时,也未检测到局部治疗加全身治疗的益处,尽管证据有限(3项试验,N = 204)。关于安全性的证据总体较弱。报告的不良事件一般较轻,不过氯霉素滴耳液(非喹诺酮类抗生素)可导致因耳毒性(损害听觉毛细胞)而使听力恶化。
局部用喹诺酮类抗生素比全身用抗生素能更好地清除耳内流脓;局部用非喹诺酮类抗生素(无类固醇)或防腐剂的效果尚不清楚。关于安全性的证据较弱。进一步的研究应阐明局部用非喹诺酮类抗生素和防腐剂的有效性,评估长期结局(如耳流脓消退、愈合、听力或并发症情况),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局部用喹诺酮类抗生素是否比其他局部或全身治疗的不良事件更少。