目的:从随机对照试验(RCT)中评估氧氟沙星滴耳液与不干预治疗外伤性鼓膜(TM)穿孔的有效性。数据来源:Medline/PubMed,中部,临床试验。政府,谷歌学者。研究选择:纳入标准:(1)英语;(2)RCT研究;(3)报告了氧氟沙星应用的结果和自发愈合的结果。排除标准:(1)没有对照组的研究;(2)患有严重耳科疾病的患者,如慢性化脓性中耳炎或听骨破裂或颅脑损伤的患者;(3)没有治疗前价值的研究或单臂临床研究。数据提取:国家/地区,出版年份,每个手臂的参与者数量,患者特征,如年龄,性别,干预细节,偏侧性,TM穿孔的原因,穿孔位置,随访时间,听力增益,TM闭合率,和关闭时间。结果:共分析6项RCTs研究。共有502名参与者被纳入;氧氟沙星治疗的闭合率的相对风险为1.18[95%置信区间(CI),1.08至1.28,P<.001],愈合时间的平均差异(MD)为-18.4(95%CI,-19.96至-16.82,P<.001),表明氧氟沙星对TM穿孔的闭合有显着影响。然而,氧氟沙星组的听力无临床显著影响(SMD:0.21,95%CI,0.02~0.40,P=.03).此外,氧氟沙星组患者与观察组患者相比感染风险降低13%,但这一估计没有统计学意义。结论:氧氟沙星用于外伤性TM穿孔患者可有效缩短愈合时间,提高TM穿孔闭合率。当向患有创伤性TM穿孔的患者开具氧氟沙星时,没有证据表明听力损失或感染率增加。
Objectives: To evaluate the effectiveness of ofloxacin ear drops versus no intervention in the repair of traumatic tympanic membrane (TM) perforations from randomized controlled trials (RCTs). Data Sources: Medline/PubMed, CENTRAL, Clinical Trials.Gov, and Google Scholar. Study Selection: Inclusion criteria: (1) English language; (2) RCT studies; (3) reported the outcomes on the application of ofloxacin and outcomes of spontaneous healing. Exclusion criteria: (1) studies without a control group; (2) patient with severe otologic disease such as chronic suppurative otitis media or ossicular disruption or patients with craniocerebral injury; (3) studies with no pretreatment values or single-arm clinical studies. Data Extraction: Country, year of publication, number of participants in each arm, patient characteristics such as age, sex, intervention details, laterality, cause of TM perforation, position of perforation, follow-up time, hearing gain, rate of TM closure, and closure time. Results: A total of 6 RCTs studies were analyzed. A total of 502 participants were included; the relative risk for closure rate of ofloxacin treatment was 1.18 [95% confidence interval (CI), 1.08 to 1.28, P < .001] and the mean difference (MD) for healing time was -18.4 (95% CI, -19.96 to -16.82, P < .001), suggesting ofloxacin has a significant effect on closure of TM perforations. However, no clinically significant effect in hearing (SMD: 0.21, 95% CI, 0.02 to 0.40, P = .03) was seen in ofloxacin group. Also, patients in the ofloxacin group were associated with a 13% reduction in the risk of infections compared to their observation-assigned counterparts, but this estimate was not statistically significant. Conclusion: Ofloxacin use in patients with traumatic TM perforation is effective in reducing healing time and increasing rate of TM perforation closure. No evidence of increased risk of hearing loss or infection rates are encountered when ofloxacin is prescribed to patients with traumatic TM perforation.