阿奇霉素作为成人牙周炎非手术治疗辅助药物的双盲安慰剂对照试验：临床结果
A double-blind placebo-controlled trial of azithromycin as an adjunct to non-surgical treatment of periodontitis in adults: clinical results.
作者信息
Smith S R, Foyle D M, Daniels J, Joyston-Bechal S, Smales F C, Sefton A, Williams J
机构信息
Department of Periodontology, St Bartholomew's and the Royal London School of Medicine and Dentistry, Queen Mary and Westfield College, London, UK.
出版信息
J Clin Periodontol. 2002 Jan;29(1):54-61. doi: 10.1034/j.1600-051x.2002.290109.x.
BACKGROUND/AIMS: The aim of the study was to investigate the clinical and microbiological effects of azithromycin as an adjunct to the non-surgical treatment of periodontitis in adults. Azithromycin is an antibiotic which is taken up by phagocytes and is released over long periods in inflamed tissue but requires a total of only three doses of 500 mg to produce its therapeutic effect.
METHOD
46 patients were treated in a double-blind placebo-controlled study with assessments at weeks 0, 1, 2, 3, 6, 10 and 22. Throughout the trial measurements were made of plaque, gingival bleeding, calculus, probing pocket depths and bleeding on probing. Microbiological sampling was carried out from a selected pocket >or=6 mm at each visit. The regime employed consisted of OHI, scaling and root planing at weeks 0, 1 and 2 with reinforcement of OHI and minimal scaling at weeks 6, 10 and 22. Patients were randomly assigned to receive either azithromycin, (A), or placebo capsules, (C), 500 mg, 1x daily for 3 days at week 2. 44 patients completed the study. Mean pocket depths were analysed using analysis of covariance in 3 groups with initial pocket depth values of 1-3 mm, 4-5 mm and >or=6 mm.
RESULTS
The results of the microbiology have been reported in a separate paper. The clinical data showed that by week 22 a lower % of pockets initially >5 mm deep remained above that level in the 23 patients taking azithromycin (A), than the 21 taking the placebo (C), (A, 5.6%; C, 23.3%). Also at week 22, for pockets initially 4 mm or more, the test group had fewer pockets >3 mm deep (A, 26.1%; C, 44.3%), fewer failing to improve in probing depth (A, 6.6%; C, 21.6%) and fewer continuing to bleed on probing (A, 46.9%; C, 55.6%) when compared with the control group. Pocket depths initially 4-5 mm or 6-9 mm analysed by analysis of covariance showed lower mean pocket depths in the patients on azithromycin, at weeks 6, 10 and 22, (pockets initially 4-5 mm, p<0.001 on all occasions, pockets initially 6-9 mm, p<0.001, week 6; p< 0.003, week 10; p<0.001, week 22).
CONCLUSIONS
Azithromycin may be a useful adjunct in the treatment of adult periodontitis, particularly where deep pockets are present.
背景/目的：本研究旨在调查阿奇霉素作为成人牙周炎非手术治疗辅助药物的临床和微生物学效果。阿奇霉素是一种抗生素，可被吞噬细胞摄取，并在炎症组织中长时间释放，但其产生治疗效果总共只需服用三剂500毫克。
方法
46名患者参与了一项双盲安慰剂对照研究，在第0、1、2、3、6、10和22周进行评估。在整个试验过程中，对菌斑、牙龈出血、牙石、探诊袋深度和探诊出血进行测量。每次就诊时，从一个选定的深度≥6毫米的牙周袋进行微生物采样。采用的治疗方案包括在第0、1和2周进行口腔卫生指导（OHI）、洁治和根面平整，并在第6、10和22周强化OHI和进行最小程度的洁治。患者被随机分配接受阿奇霉素（A组）或安慰剂胶囊（C组），在第2周每天服用一次500毫克，共服用3天。44名患者完成了研究。使用协方差分析对3组患者的平均袋深度进行分析，这3组患者的初始袋深度值分别为1 - 3毫米、4 - 5毫米和≥6毫米。
结果
微生物学结果已在另一篇论文中报道。临床数据显示，到第22周时，在最初袋深>5毫米的患者中，服用阿奇霉素（A组）的23名患者中仍高于该水平的牙周袋百分比低于服用安慰剂（C组）的21名患者（A组为5.6%；C组为23.3%）。同样在第22周时，对于最初深度为4毫米或更深的牙周袋，与对照组相比，试验组深度>3毫米的牙周袋更少（A组为26.1%；C组为44.3%），探诊深度未改善的更少（A组为6.6%；C组为21.6%），探诊时仍出血的也更少（A组为46.9%；C组为55.6%）。通过协方差分析对最初深度为4 - 5毫米或6 - 9毫米的牙周袋进行分析显示，在第6、10和22周时，服用阿奇霉素的患者平均袋深度更低（最初深度为4 - 5毫米的牙周袋，在所有时间点p<0.001；最初深度为6 - 9毫米的牙周袋，第6周p<0.001，第10周p<0.003，第22周p<0.001）。
结论
阿奇霉素可能是治疗成人牙周炎的一种有用辅助药物，特别是在存在深牙周袋的情况下。
Zotero 插件