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全身用阿莫西林/甲硝唑的临床获益可能取决于牙周炎的阶段和等级:ABPARO 试验的探索性亚分析。

Clinical benefits of systemic amoxicillin/metronidazole may depend on periodontitis stage and grade: An exploratory sub-analysis of the ABPARO trial.

机构信息

Department of Periodontology, Johann Wolfgang Goethe-University Frankfurt am Main, Frankfurt am Main, Deutschland.

Institute of Biostatistics and Clinical Research, University of Münster, Münster, Germany.

出版信息

J Clin Periodontol. 2023 Sep;50(9):1239-1252. doi: 10.1111/jcpe.13838. Epub 2023 Jun 9.

Abstract

AIM

Assessment of treatment response after systemic amoxicillin/metronidazole adjunctive to subgingival instrumentation (SI) according to stages and grades of the 2018 classification of periodontal diseases.

MATERIALS AND METHODS

We carried out exploratory re-analysis of the placebo-controlled, multi-centre ABPARO trial (52; 45/60 years of age; 205 males, 114 active smokers). Patients were randomized to SI with systemic amoxicillin 500 mg/metronidazole 400 mg (three times a day for 7 days, n = 205; ANTI) or placebo (n = 200; PLAC) and maintenance therapy every 3 months. Patients were reclassified according to the 2018 classification (stage/extent/grade). Treatment effect was the percentage of sites per patient with new attachment loss ≥1.3 mm (PSAL ≥ 1.3 mm) at 27.5 months post-baseline/randomization.

RESULTS

All patients were assigned according to the stage (n = 49 localized stage III, n = 206 generalized stage III, n = 150 stage IV). Because of missing radiographs, only 222 patients were assigned to grades (n = 73 B, n = 149 C). Treatment (PLAC/ANTI) resulted in PSAL ≥ 1.3 mm (median; lower/upper quartile) in localized stage III (PLAC: 5.7; 3.3/8.4% vs. ANTI: 4.9; 3.0/8.3%; p = .749), generalized stage III (8.0; 4.5/14.3% vs. 4.7; 2.4/9.0%; p < .001), stage IV (8.5; 5.1/14.4% vs. 5.7; 3.3/10.6%; p = .008), grade B (4.4; 2.4/6.7% vs. 3.6; 1.9/4.7%; p = .151) and grade C (9.4; 5.3/14.3% vs. 4.8; 2.5/9.4%; p < .001).

CONCLUSIONS

In generalized periodontitis stage III/grade C, a clinically relevant lower percentage of disease progression after adjunctive systemic amoxicillin/metronidazole was observed compared to placebo (PLAC: 9.7; 5.8/14.3% vs. ANTI: 4.7; 2.4/9.0%; p < .001).

摘要

目的

根据 2018 年牙周病分类的阶段和等级,评估全身阿莫西林/甲硝唑辅助龈下刮治和根面平整(SRP)治疗后的治疗反应。

材料和方法

我们对多中心、安慰剂对照的 ABPARO 试验(52 例;45/60 岁;205 名男性,114 名主动吸烟者)进行了探索性再分析。患者被随机分为全身阿莫西林 500mg/甲硝唑 400mg(每天 3 次,共 7 天,n=205;ANTI)或安慰剂(n=200;PLAC)组,并每 3 个月进行维持治疗。根据 2018 年分类(阶段/程度/等级)对患者进行重新分类。治疗效果是每位患者新附着丧失≥1.3mm(PSAL≥1.3mm)的位点百分比,在基线/随机分组后 27.5 个月。

结果

所有患者均按阶段(n=49 例局限性牙周炎 III 期,n=206 例广泛性牙周炎 III 期,n=150 例牙周炎 IV 期)进行分配。由于缺少 X 光片,只有 222 名患者被分配到等级(n=73 B,n=149 C)。治疗(PLAC/ANTI)导致局限性牙周炎 III 期(PLAC:5.7;3.3/8.4% vs. ANTI:4.9;3.0/8.3%;p=.749)、广泛性牙周炎 III 期(8.0;4.5/14.3% vs. 4.7;2.4/9.0%;p<.001)、牙周炎 IV 期(8.5;5.1/14.4% vs. 5.7;3.3/10.6%;p=.008)、等级 B(4.4;2.4/6.7% vs. 3.6;1.9/4.7%;p=.151)和等级 C(9.4;5.3/14.3% vs. 4.8;2.5/9.4%;p<.001)的 PSAL≥1.3mm (中位数;下四分位数/上四分位数)比例较低。

结论

与安慰剂(PLAC:9.7;5.8/14.3% vs. ANTI:4.7;2.4/9.0%;p<.001)相比,全身性阿莫西林/甲硝唑辅助治疗后,广泛性牙周炎 III 期/等级 C 患者的疾病进展比例较低,具有临床相关性。

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