缓释亚抗菌剂量强力霉素可增强牙周病患者的龈下刮治和根面平整效果。

Modified-release subantimicrobial dose doxycycline enhances scaling and root planing in subjects with periodontal disease.

作者信息

Preshaw Philip M, Novak M John, Mellonig James, Magnusson Ingvar, Polson Alan, Giannobile William V, Rowland Randal W, Thomas John, Walker Clay, Dawson Dolphus R, Sharkey Dennis, Bradshaw Mark H

机构信息

Department of Periodontology, School of Dental Sciences, Newcastle University, Framlington Place, Newcastle upon Tyne, U.K.

出版信息

J Periodontol. 2008 Mar;79(3):440-52. doi: 10.1902/jop.2008.070375.

DOI:10.1902/jop.2008.070375

PMID:18315426

Abstract

BACKGROUND

Previous studies showed that adjunctive subantimicrobial dose doxycycline (SDD; 20 mg, twice daily) provides significant clinical benefits to scaling and root planing (SRP). A modified-release SDD formulation containing 40 mg doxycycline (SDD-40) to be taken once daily has been developed. The aim of this study was to investigate the efficacy of SDD-40 when used as an adjunct to SRP for the treatment of periodontitis.

METHODS

A 9-month, double-masked, randomized, placebo-controlled, multicenter study was conducted to test the efficacy of adjunctive SDD-40 in 266 subjects with periodontitis. Subjects were treated by SRP and randomized to receive SDD-40 or placebo for 9 months with evaluations at 3, 6, and 9 months.

RESULTS

Adjunctive SDD-40 provided significantly greater clinical benefits than placebo at all time points. At month 9, at sites with baseline probing depths (PD) > or =6 mm, 72% to 76% of sites in the SDD-40 group demonstrated clinically significant PD reductions and clinical attachment level (CAL) gains > or =2 mm compared to 56% to 58% of sites in the placebo group (P <0.0001); 48% to 52% of sites in the SDD-40 group demonstrated PD reductions and CAL gains > or =3 mm compared to 32% of sites in the placebo group (P <0.0001). In moderate sites (baseline PD 4 to 6 mm), adjunctive SDD-40 provided significant clinical benefits compared to placebo for mean CAL (all time points: P <0.05), PD (3 months: P = 0.002; 6 and 9 months: P = 0.001), and bleeding on probing (BOP) (3 months: P <0.01; 6 months: P <0.02; 9 months: P <0.05). In deep sites (baseline PD > or =7 mm), SDD-40 provided significant benefits over control for mean CAL (3 months: P <0.05; 6 and 9 months: P <0.01), PD (all time points: P <0.001), and BOP (3 months: P <0.05; 6 months: not statistically significant; 9 months: P <0.05). Compliance with study medication was high (>92%) with no significant differences in adverse events between groups and no evidence of microbiologically significant changes or development of antibiotic resistance in the subgingival flora in either group.

CONCLUSION

SDD-40 used as an adjunct to SRP resulted in significantly greater clinical benefits than SRP alone in the treatment of periodontitis.

摘要

背景

既往研究表明，辅助使用亚抗菌剂量强力霉素（SDD；20毫克，每日两次）对龈下刮治和根面平整术（SRP）具有显著的临床益处。已研发出一种含40毫克强力霉素的缓释SDD制剂（SDD - 40），每日服用一次。本研究的目的是调查SDD - 40作为SRP辅助治疗牙周炎的疗效。

方法

进行了一项为期9个月的双盲、随机、安慰剂对照、多中心研究，以测试辅助使用SDD - 40对266例牙周炎患者的疗效。患者接受SRP治疗，并随机分为接受SDD - 40或安慰剂治疗9个月，在3、6和9个月时进行评估。

结果

在所有时间点，辅助使用SDD - 40比安慰剂具有显著更大的临床益处。在第9个月时，基线探诊深度（PD）≥6毫米的部位，SDD - 40组中72%至76%的部位显示出临床上显著的PD降低，临床附着水平（CAL）增加≥2毫米，而安慰剂组为56%至58%的部位（P<0.0001）；SDD - 40组中48%至52%的部位显示出PD降低且CAL增加≥3毫米，而安慰剂组为32%的部位（P<0.0001）。在中度部位（基线PD 4至6毫米），与安慰剂相比，辅助使用SDD - 40在平均CAL（所有时间点：P<0.05）、PD（3个月：P = 0.002；6和9个月：P = 0.001）以及探诊出血（BOP）方面（3个月：P<0.01；6个月：P<0.02；9个月：P<0.05）提供了显著的临床益处。在深度部位（基线PD≥7毫米），SDD - 40在平均CAL（3个月：P<0.05；6和9个月：P<0.01）、PD（所有时间点：P<0.001）以及BOP方面（3个月：P<0.05；6个月：无统计学意义；9个月：P<0.05）比对照组具有显著益处。研究药物的依从性很高（>92%），两组之间不良事件无显著差异，且两组龈下菌群均无微生物学显著变化或抗生素耐药性发展迹象。