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可吸收缝线与丝线用于治疗埃塞俄比亚沙眼性倒睫的随机对照试验。

Absorbable versus silk sutures for surgical treatment of trachomatous trichiasis in Ethiopia: a randomised controlled trial.

机构信息

The London School of Hygiene and Tropical Medicine, London, United Kingdom.

出版信息

PLoS Med. 2011 Dec;8(12):e1001137. doi: 10.1371/journal.pmed.1001137. Epub 2011 Dec 13.

DOI:10.1371/journal.pmed.1001137
PMID:22180732
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3236737/
Abstract

BACKGROUND

Trachoma causes blindness through an anatomical abnormality called trichiasis (lashes touching the eye). Trichiasis can recur after corrective surgery. We tested the hypothesis that using absorbable sutures instead of silk sutures might reduce the risk of recurrent disease among patients with major trichiasis in a randomised trial.

METHODS AND FINDINGS

1,300 individuals with major trichiasis from rural villages in the Amhara Region of Ethiopia were recruited and assigned (1:1) by computer-generated randomisation sequence to receive trichiasis surgery using either an absorbable suture (polyglactin-910) or silk sutures (removed at 7-10 days) in an otherwise identical surgical technique. Participants were examined every 6 months for 2 years by clinicians masked to allocation. The primary outcome measure was recurrent trichiasis (≥one lash touching the eye) at 1 year. There was no difference in prevalence of recurrent trichiasis at 1 year (114 [18.2%] in the absorbable suture group versus 120 [19.7%] in the silk suture group; odds ratio = 0.90, 95% CI 0.68-1.20). The two groups also did not differ in terms of corneal opacification, visual acuity, conjunctival inflammation, and surgical complications.

CONCLUSIONS

There was no evidence that use of absorbable polyglactin-910 sutures was associated with a lower prevalence of trichiasis recurrence at 1 year postsurgery than silk sutures. However, from a programmatic perspective, polyglactin-910 offers the major advantage that patients do not have to be seen soon after surgery for suture removal. The postoperative review after surgery using absorbable polyglactin-910 sutures can be delayed for 3-6 months, which might allow us to better determine whether a patient needs additional surgery.

TRIAL REGISTRATION

ClinicalTrials.gov NCT00522860.

摘要

背景

沙眼通过一种称为倒睫(睫毛触及眼睛)的解剖异常导致失明。矫正手术后,倒睫可能会复发。我们通过一项随机试验检验了这样一个假设,即在主要倒睫患者中,使用可吸收缝线而非丝线缝线可能会降低疾病复发的风险。

方法和发现

1300 名来自埃塞俄比亚阿姆哈拉地区农村村庄的主要倒睫患者,通过计算机生成的随机序列分组,采用可吸收缝线(聚乳酸-910)或丝线缝线(7-10 天拆除)进行相同手术技术的倒睫手术。在 2 年的时间里,临床医生每 6 个月对参与者进行一次检查,对分配情况进行盲法评估。主要结局指标为 1 年内复发的倒睫(≥1 根睫毛触及眼睛)。1 年内复发的倒睫发生率在两组之间无差异(可吸收缝线组 114 例[18.2%],丝线缝线组 120 例[19.7%];比值比=0.90,95%置信区间 0.68-1.20)。两组在角膜混浊、视力、结膜炎症和手术并发症方面也没有差异。

结论

没有证据表明在手术后 1 年内,使用可吸收聚乳酸-910缝线与丝线缝线相比,倒睫复发的发生率更低。然而,从规划的角度来看,聚乳酸-910的主要优势在于患者不必在手术后立即进行缝线拆除。使用可吸收聚乳酸-910缝线进行手术后的复查可以延迟 3-6 个月,这可能使我们能够更好地确定患者是否需要额外的手术。

试验注册

ClinicalTrials.gov NCT00522860。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/52af/3236737/166e5d6a3a57/pmed.1001137.g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/52af/3236737/0cc9885f2998/pmed.1001137.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/52af/3236737/166e5d6a3a57/pmed.1001137.g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/52af/3236737/0cc9885f2998/pmed.1001137.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/52af/3236737/166e5d6a3a57/pmed.1001137.g002.jpg

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