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酶制剂(刃天青)在阻生第三磨牙术后的疗效:一项随机对照临床试验。

Efficacy of serratiopeptidase after impacted third molar surgery: a randomized controlled clinical trial.

机构信息

Department Oral Surgery and Oral Medicine, Jordan University of Science and Technology, Irbid, Jordan.

Department Periodontology, Jordan University of Science and Technology, Irbid, Jordan.

出版信息

BMC Oral Health. 2021 Mar 2;21(1):91. doi: 10.1186/s12903-021-01451-0.

DOI:10.1186/s12903-021-01451-0
PMID:33653320
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7927242/
Abstract

BACKGROUND

Serratiopeptidase has been clinically used in controlling surgical and non-surgical inflammatory conditions. This study was conducted to assess the therapeutic effect of Serratiopeptidase in patients undergoing surgical removal of impacted mandibular third molar.

METHODS

This randomized clinical trial investigated the efficacy of Serratiopeptidase and Paracetamol after surgical removal of impacted third molar for 5 days (n = 67) as compared with an equivalent dose of placebo and Paracetamol (n = 66). Outcome measures were reported pain, trismus and swelling using Laskin method. All outcome measures were recorded on days 0, 1, 2, 4, and 5 post-surgeries.

RESULTS

In this clinical trail 133 patients (mean age 23 years, 54% female) completed the study. Baseline characteristics were comparable across treatment groups. Serratiopeptidase significantly improved trismus compared with control on the 4 day (27.30 ± 7.3 mm and 32.06 ± 7.7 mm, respectively (P < 0.001) Swelling markedly improved, The distance from the lower edge of the earlobe to the midpoint of the symphysis for cases vs control were 111.49 ± 8.1 mm and 115.39 ± 9.9 mm, respectively (P < 0.001). Reported pain, showed no statistical significance difference.

CONCLUSION

Serratiopeptidase resulted in better inflammation improvement than placebo over 5 days. Further studies are warranted to assess longer-term and clinical outcomes, as well as safety.

CLINICAL RELEVANCE

Serratiopeptidase administered postoperatively helps in improving trismus and swelling after removal of impacted lower third molars. Trial registration The study was registered in ClinicalTrial.gov under the number NCT02493179. Registered 1st of June 2015, https://clinicaltrials.gov/ct2/results?cond=serratiopeptidase .

摘要

背景

沙雷肽酶已在临床用于控制手术和非手术炎症性疾病。本研究旨在评估沙雷肽酶在接受下颌阻生第三磨牙外科切除术后患者中的治疗效果。

方法

本随机临床试验研究了沙雷肽酶和对乙酰氨基酚在接受下颌阻生第三磨牙外科切除术后 5 天(n=67)的疗效,与等效剂量的安慰剂和对乙酰氨基酚(n=66)进行比较。使用 Laskin 方法报告疼痛、牙关紧闭和肿胀等结果。所有结果均在手术后第 0、1、2、4 和 5 天进行记录。

结果

在这项临床试验中,133 名患者(平均年龄 23 岁,54%为女性)完成了研究。治疗组间的基线特征具有可比性。与对照组相比,沙雷肽酶在第 4 天显著改善了牙关紧闭症(分别为 27.30±7.3mm 和 32.06±7.7mm(P<0.001))。肿胀明显改善,从耳垂下缘到下颌联合中点的距离,病例组为 111.49±8.1mm,对照组为 115.39±9.9mm(P<0.001)。报告的疼痛没有统计学差异。

结论

沙雷肽酶在 5 天内的炎症改善效果优于安慰剂。需要进一步研究来评估更长期和临床结果以及安全性。

临床相关性

术后给予沙雷肽酶有助于改善下颌阻生第三磨牙切除术后的牙关紧闭和肿胀。

试验注册

该研究在 ClinicalTrials.gov 注册,编号为 NCT02493179。于 2015 年 6 月 1 日注册,网址为 https://clinicaltrials.gov/ct2/results?cond=serratiopeptidase 。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cc45/7927242/61c51d499cf7/12903_2021_1451_Fig6_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cc45/7927242/7ccd480c195b/12903_2021_1451_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cc45/7927242/61184d1b0591/12903_2021_1451_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cc45/7927242/1a744b1bf328/12903_2021_1451_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cc45/7927242/79407f5efb98/12903_2021_1451_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cc45/7927242/1bfe053b8673/12903_2021_1451_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cc45/7927242/61c51d499cf7/12903_2021_1451_Fig6_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cc45/7927242/7ccd480c195b/12903_2021_1451_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cc45/7927242/61184d1b0591/12903_2021_1451_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cc45/7927242/1a744b1bf328/12903_2021_1451_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cc45/7927242/79407f5efb98/12903_2021_1451_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cc45/7927242/1bfe053b8673/12903_2021_1451_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cc45/7927242/61c51d499cf7/12903_2021_1451_Fig6_HTML.jpg

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