Rahmaty Benyamin, Naraghi Mohsen, Mesbahi Alireza, Mohebbi Alireza, Sadeghi Bahman, Zadeh Amir Reza, Almasi Amir
Head and Neck Surgery Department, Arak University of Medical Sciences, Arak, Iran.
Otolaryngology Research Center, Amir Alam Hospital, Tehran University of Medical Sciences, Northern Saadi Ave, District 12, Tehran, Iran.
Aesthetic Plast Surg. 2025 Feb 4. doi: 10.1007/s00266-024-04646-2.
To evaluate the effectiveness of bromelain on periorbital oedema, subconjunctival haemorrhage, and ecchymosis after preservation rhinoplasty.
Randomised, double-blind, placebo-controlled trial SETTING: Tertiary referral centre METHODS: In this double-blind clinical trial, participants aged 18-45 who were scheduled for open preservation rhinoplasty using the push-down technique and lateral osteotomy were recruited. Twenty-three cases were assigned to the placebo group and twenty-three to the experimental group Bromelain.
Regarding gender, 17.39% (8 cases) were male, and 82.61% (38 cases) were female. Comparing the severity of left and right eye ecchymosis between groups at different times showed that bromelain was significantly effective on both sides on the 7th day (p = 0.012). Like ecchymosis, the results demonstrated that bromelain was also considerably effective on subconjunctival haemorrhage on the seventh day post-operatively (p = 0.015). However, the intensity of oedema between groups at different times did not significantly differ.
Bromelain increases serum fibrinolytic activity and decreases plasma fibrinogen levels. It is significantly more effective on subconjunctival haemorrhage and ecchymosis compared with the placebo on the seventh day in both eyes after rhinoplasty. Hence, this study indicates that bromelain is remarkably more effective than a placebo in reducing subconjunctival haemorrhage and ecchymosis.
Iranian Registry of Clinical Trials ID: IRCT20180519039720N2 LEVEL OF EVIDENCE I: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .
评估菠萝蛋白酶对保留性隆鼻术后眶周水肿、结膜下出血和瘀斑的疗效。
随机、双盲、安慰剂对照试验
三级转诊中心
在这项双盲临床试验中,招募了计划采用下压技术和外侧截骨术进行开放式保留性隆鼻的18至45岁参与者。23例被分配到安慰剂组,23例被分配到菠萝蛋白酶实验组。
性别方面,男性占17.39%(8例),女性占82.61%(38例)。比较不同时间组间左右眼瘀斑严重程度,结果显示菠萝蛋白酶在第7天对双侧均有显著效果(p = 0.012)。与瘀斑情况类似,结果表明菠萝蛋白酶在术后第7天对结膜下出血也有显著效果(p = 0.015)。然而,不同时间组间水肿程度无显著差异。
菠萝蛋白酶可提高血清纤溶活性并降低血浆纤维蛋白原水平。隆鼻术后第7天,与安慰剂相比,其对双眼结膜下出血和瘀斑的效果显著更优。因此,本研究表明菠萝蛋白酶在减轻结膜下出血和瘀斑方面比安慰剂效果显著更好。
伊朗临床试验注册中心编号:IRCT20180519039720N2
证据水平I:本期刊要求作者为每篇文章指定证据水平。有关这些循证医学评级的完整描述,请参阅目录或作者在线指南www.springer.com/00266 。