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首页> 外文期刊>JAMA facial plastic surgery >Safety and Efficacy of Cosmetic Augmentation of the Nasal Tip and Nasal Dorsum With Expanded PolytetrafluoroethyleneA Randomized Clinical Trial
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Safety and Efficacy of Cosmetic Augmentation of the Nasal Tip and Nasal Dorsum With Expanded PolytetrafluoroethyleneA Randomized Clinical Trial

机译：鼻尖和鼻背部的化妆品增强与膨胀聚四氟乙酯随机临床试验的安全性和疗效

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摘要

Importance Expanded polytetrafluoroethylene (ePTFE) is a widely used alloplast, but studies of augmentation of the nasal tip and nasal dorsum with ePTFE are lacking.Objective To investigate whether attaching the conchal cartilage as shield grafts at the distal end of the graft can prevent extrusion and whether the use of ePTFE in the nasal tip can achieve a stable aesthetic outcome.Design, Setting, and Participants A randomized clinical trial was performed from April 1, 2006, to October 31, 2008. Follow-up was completed in 2012 and 2017. The study was conducted at the Department of Plastic and Reconstructive Surgery, Shanghai Ninth People’s Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China. One hundred fifty patients seeking rhinoplasty were recruited, and 129 were eligible for inclusion in the study. All the recruited patients were intent-to-treat populations who were randomized into 2 groups: an ePTFE-only group and an ePTFE with conchal cartilage group.Interventions Expanded PTFE was used for augmentation of the nasal tip and nasal dorsum in both groups. Conchal cartilage was placed above the distal end in the ePTFE with conchal cartilage group.Main Outcomes and Measures Preoperative and postoperative standard photographs were obtained. Postoperative satisfaction and complications were evaluated.Results Of the 129 patients (mean age [range], 28 years [21-45 years]; 6 male and 123 female) eligible for inclusion in this study, 76 (mean age [range], 31 years [22-45 years]; 4 male and 72 female) were available for follow-up (mean [range], 106.9 months [100-131 months]) through 2017, including 39 in the ePTFE-only group and 37 in the ePTFE with conchal cartilage group. Infection occurred in 2 patients (5%) in the ePTFE-only group vs 1 patient (3%) in the ePTFE with conchal cartilage group (infection rate [OR, 1.946; 95% CI, 0.169-22.413; P > .99]). Soft-tissue reaction occurred in 0 patients in the ePTFE-only group vs 1 patient (3%) in the ePTFE with conchal cartilage group (soft-tissue reaction rate [OR, 0.000; 95% CI, 0.000-8.538; P = .49]). Irregularity occurred in 0 patients in the ePTFE-only group vs 3 patients (8%) in the ePTFE with conchal cartilage group (irregularity rate [OR, 0.000; 95% CI, 0.000-1.066; P = .11]). Extrusion occurred in neither of the 2 groups.Conclusions and Relevance A new technique using ePTFE alone for augmentation of the nasal tip and nasal dorsum achieved safe, attractive, and acceptable outcomes in nasal contouring and patient satisfaction. The use of conchal cartilage as a shield in the nasal tip is not necessary.Level of Evidence 1.Trial Registration Chinese Clinical Trial Registry identifier: ChiCTR-INR-17011101.
机译：重要性扩增的聚四氟乙烯（EPTFE）是一种广泛使用的所有蛋白，但缺乏研究鼻尖和鼻背部的鼻尖和鼻背部的研究缺乏。目的是研究是否将Charchal软骨附着在移植物远端处的屏蔽移植物中可以防止挤出和无论是鼻尖的ePTFE是否可以实现稳定的审美结果。设计，设定和参与者在2008年4月1日至2008年10月31日开始进行随机临床试验。随访于2012年和2017年完成。该研究在中国上海焦通大学医学院上海九人民医院，中国上海市上海市九人民医院进行了研究。招募了一百五十名寻求鼻成形术的患者，129名有资格纳入该研究。所有募集的患者都是意图治疗，群体被随机分为2组：仅ePTFE群体和具有Charchal软骨组的EPTFE。Interventions扩增的PTFE用于两组中的鼻尖和鼻背部的增强。将Conchal软骨置于EPTFE中的远端上方，通过Charchal软骨组。获得结果和措施术前和术后标准照片。评估术后满意度和并发症。129名患者的结果（平均年龄[范围]，28岁[21-45岁]; 6男性和123名女性）符合本研究的资格，76（平均年龄[范围]，31年份[22-45岁]; 4男性和72名女性可用于随访（平均值]，106.9个月[100-131个月]）到2017年，其中包括仅39个ePTFE集团和37 eptfe与conchal软骨组。在EPTFE组对ePTFE中的2名患者（5％）中发生感染（5％），在EPTFE中，与Cherchal软骨组（感染率[或1.946; 95％CI，0.169-22.413; p> .99] ）。软组织反应发生在EPTFE患者中，在EPTFE中的ePTFE组VS 1患者（3％）中发生eTCHAL软骨组（软组织反应速率[或0.000; 95％CI，0.000-8.538; P =。 49]）。在EPTFE群中的0名患者中发生不规则性，ePTFE中的3例患者（8％），在EPTFE中，与Conchal软骨组（不规则率[或0.000; 95％CI，0.000-1.066; p = .11]）。挤出发生在2组中。结论和相关性使用EPTFE的新技术仅用于增强鼻尖和鼻背部，在鼻腔轮廓和患者满意度方面取得了安全，有吸引力和可接受的结果。在鼻尖中的屏蔽中使用Conchal软骨是不必要的。1.证据1.Trial注册中国临床试验登记处标识符：CHICTR-INR-17011101。

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  • 来源
    《JAMA facial plastic surgery》 |2018年第4期|共7页
  • 作者

    Yifei?Gu; Wenxin?Yu; Yunbo?Jin; Hui?Chen; Gang?Ma; Shih-jen?Chang; Xiaoxi?Lin;

  • 作者单位

    Department of Plastic and Reconstructive Surgery Shanghai Ninth People’s Hospital Shanghai Jiao;

    Department of Plastic and Reconstructive Surgery Shanghai Ninth People’s Hospital Shanghai Jiao;

    Department of Plastic and Reconstructive Surgery Shanghai Ninth People’s Hospital Shanghai Jiao;

    Department of Plastic and Reconstructive Surgery Shanghai Ninth People’s Hospital Shanghai Jiao;

    Department of Plastic and Reconstructive Surgery Shanghai Ninth People’s Hospital Shanghai Jiao;

    Department of Plastic and Reconstructive Surgery Shanghai Ninth People’s Hospital Shanghai Jiao;

    Department of Plastic and Reconstructive Surgery Shanghai Ninth People’s Hospital Shanghai Jiao;

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  • 正文语种 eng
  • 中图分类 整形外科学（修复外科学）;
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