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1.2%瑞舒伐他汀与1.2%阿托伐他汀凝胶局部给药及再给药治疗慢性牙周炎骨内缺损的随机安慰剂对照临床试验

1.2% Rosuvastatin Versus 1.2% Atorvastatin Gel Local Drug Delivery and Redelivery in Treatment of Intrabony Defects in Chronic Periodontitis: A Randomized Placebo-Controlled Clinical Trial.

作者信息

Pradeep A R, Garg Vibhuti, Kanoriya Dharmendra, Singhal Sandeep

机构信息

Department of Periodontology, Government Dental College and Research Institute, Bengaluru, Karnataka, India.

出版信息

J Periodontol. 2016 Jul;87(7):756-62. doi: 10.1902/jop.2016.150706. Epub 2016 Feb 15.

DOI:10.1902/jop.2016.150706
PMID:26878748
Abstract

BACKGROUND

Statins (3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors) are an important group of hypolipidemic drugs that are able to modulate inflammation and alveolar bone loss. Rosuvastatin (RSV) and atorvastatin (ATV) are known to inhibit osteoclastic bone resorption and have been proposed to have osteostimulative properties. The aim of this study is to evaluate and compare the efficacy of 1.2% RSV and 1.2% ATV gel local drug delivery (LDD) and redelivery systems, in addition to scaling and root planing (SRP), for the treatment of intrabony defects (IBDs) in patients with chronic periodontitis (CP).

METHODS

A total of 90 individuals with 90 IBDs was randomly allocated to treatment with SRP followed by LDD of 1.2% RSV, 1.2% ATV, or placebo gel. Clinical and radiographic parameters, including plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD), clinical attachment level (CAL), and IBD depth, were recorded at baseline and 6 and 9 months.

RESULTS

All three groups showed significant reduction in PI and mSBI at all intervals. Mean mSBI and PD reductions, CAL gain, and IBD depth reduction with statin drugs were significantly greater than with placebo gel LDD. Improvements in these parameters were significantly greater with RSV LDD than ATV or placebo gels at 6 and 9 months.

CONCLUSION

LDD of 1.2% RSV results in significantly greater clinico-radiographic improvement than 1.2% ATV or placebo gels as adjunct to mechanical periodontal therapy.

摘要

背景

他汀类药物(3-羟基-3-甲基戊二酰辅酶A还原酶抑制剂)是一类重要的降血脂药物,能够调节炎症和牙槽骨丧失。已知瑞舒伐他汀(RSV)和阿托伐他汀(ATV)可抑制破骨细胞的骨吸收,并被认为具有骨刺激特性。本研究的目的是评估和比较1.2% RSV和1.2% ATV凝胶局部给药(LDD)及再给药系统联合龈下刮治和根面平整(SRP)治疗慢性牙周炎(CP)患者骨内缺损(IBD)的疗效。

方法

将90例患有90处IBD的个体随机分配接受SRP治疗,随后分别给予1.2% RSV、1.2% ATV或安慰剂凝胶进行LDD。在基线、6个月和9个月时记录临床和影像学参数,包括菌斑指数(PI)、改良龈沟出血指数(mSBI)、探诊深度(PD)、临床附着水平(CAL)和IBD深度。

结果

所有三组在各个时间点PI和mSBI均显著降低。使用他汀类药物时,平均mSBI和PD降低、CAL增加以及IBD深度降低均显著大于使用安慰剂凝胶LDD。在6个月和9个月时,RSV LDD组这些参数的改善显著大于ATV或安慰剂凝胶组。

结论

作为机械性牙周治疗的辅助手段,1.2% RSV的LDD在临床和影像学改善方面显著优于1.2% ATV或安慰剂凝胶。

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