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嵌体式蝶形软骨鼓膜成形术的评估:一项随机临床试验。

Evaluation of inlay butterfly cartilage tympanoplasty: a randomized clinical trial.

作者信息

Mauri M, Lubianca Neto J F, Fuchs S C

机构信息

Department of Otorhinolaryngology, Fundação Faculdade Federal de Ciências Médicas de Porto Alegre, R. Cel Corte Real 122/603, Porto Alegre, RS, Brazil, CEP-90630-080.

出版信息

Laryngoscope. 2001 Aug;111(8):1479-85. doi: 10.1097/00005537-200108000-00027.

DOI:10.1097/00005537-200108000-00027
PMID:11568587
Abstract

OBJECTIVES/HYPOTHESIS: In 1998 Eavey described a new inlay technique for tympanoplasty in the pediatric age group using a cartilage graft through a transcanal approach. This technique was found to be effective and comfortable (no external canal incisions or ear packing). This study evaluated the efficacy of modified-inlay cartilage tympanoplasty compared with the conventional underlay tympanoplasty.

STUDY DESIGN

Randomized clinical trial.

METHODS

Patients were enrolled from December 1998 to March 2000. Seventy tympanoplasties were done in adults with medium-sized tympanic membrane (TM) perforations: 34 inlay tympanoplasties and 36 underlay tympanoplasties (control group). The main outcome measures were the "take rate" on the 30th postoperative day and the audiometric result at the second postoperative month. Secondary outcome measures include subjective postoperative hearing, postoperative pain, duration of surgery, and cost of the procedures.

RESULTS

The "take rate" did not differ between groups on the 30th postoperative day (88.2% in the inlay tympanoplasty group vs 86.1% in the underlay tympanoplasty group; P =.8). After a mean follow-up of 7.5 +/- 3.8 months (range, 3-16 mo), the "take rate" was 85.3% in the inlay tympanoplasty group and 83.3% in the underlay tympanoplasty group (P =.8). In the inlay tympanoplasty group there was closure of the air-bone gap (ABG) to within 10 dB in 64.7% and to within 20 dB in 94.1%. The corresponding numbers to underlay tympanoplasty were 75% and 97.2%. In only 2 cases (5.9%) in the inlay tympanoplasty group and in 1 case (2.8%) in the underlay tympanoplasty group the ABG was greater than 20 dB. No audiometric difference was observed between groups (P =.6). Most patients in the inlay tympanoplasty group reported immediate improvement in their hearing (P <.0001). Pain was reported by 10 patients in the inlay tympanoplasty group and by 30 patients in the underlay tympanoplasty group on the first postoperative day (P <.0001). The duration of the surgery (mean +/- standard deviation) was 33.6 +/- 7.8 minutes for the inlay tympanoplasty group and 62.9 +/- 12.7 minutes for the underlay tympanoplasty group (P <.0001). The estimated charge for inlay tympanoplasty at our institution was 65% less expensive than underlay tympanoplasty.

CONCLUSION

The "take rate" and audiometric results following inlay cartilage tympanoplasty or underlay tympanoplasty were similar. Inlay butterfly cartilage tympanoplasty did not require general anesthesia, was less expensive, and more comfortable to the patient.

摘要

目的/假设:1998年,伊维描述了一种用于小儿鼓膜成形术的新型嵌体技术,该技术通过经耳道入路使用软骨移植。该技术被发现有效且舒适(无需外耳道切口或耳部填塞)。本研究评估了改良嵌体软骨鼓膜成形术与传统夹层鼓膜成形术相比的疗效。

研究设计

随机临床试验。

方法

1998年12月至2000年3月招募患者。对70例患有中等大小鼓膜穿孔的成人进行了鼓膜成形术:34例嵌体鼓膜成形术和36例夹层鼓膜成形术(对照组)。主要结局指标为术后第30天的“成功率”和术后第二个月的听力测定结果。次要结局指标包括术后主观听力、术后疼痛、手术持续时间和手术费用。

结果

术后第30天两组的“成功率”无差异(嵌体鼓膜成形术组为88.2%,夹层鼓膜成形术组为86.1%;P = 0.8)。平均随访7.5±3.8个月(范围3 - 16个月)后,嵌体鼓膜成形术组的“成功率”为85.3%,夹层鼓膜成形术组为83.3%(P = 0.8)。在嵌体鼓膜成形术组中,64.7%的气骨导间距(ABG)缩小至10 dB以内,94.1%缩小至20 dB以内。夹层鼓膜成形术组的相应数字分别为75%和97.2%。嵌体鼓膜成形术组仅2例(5.9%)和气骨导间距夹层鼓膜成形术组仅1例(2.8%)的气骨导间距大于20 dB。两组之间未观察到听力测定差异(P = 0.6)。嵌体鼓膜成形术组的大多数患者报告听力立即改善(P < 0.0001)。术后第一天,嵌体鼓膜成形术组有10例患者报告疼痛,夹层鼓膜成形术组有30例患者报告疼痛(P < 0.0001)。嵌体鼓膜成形术组的手术持续时间(平均±标准差)为33.6±7.8分钟,夹层鼓膜成形术组为62.9±12.7分钟(P < 0.0001)。在我们机构,嵌体鼓膜成形术的估计费用比夹层鼓膜成形术便宜65%。

结论

嵌体软骨鼓膜成形术或夹层鼓膜成形术后的“成功率”和听力测定结果相似。嵌体蝶形软骨鼓膜成形术无需全身麻醉,费用较低,对患者更舒适。

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