Polson A M, Garrett S, Stoller N H, Bandt C L, Hanes P J, Killoy W J, Southard G L, Duke S P, Bogle G C, Drisko C H, Friesen L R
University of Pennsylvania, School of Dental Medicine, Philadelphia, USA.
J Periodontol. 1997 Feb;68(2):119-26. doi: 10.1902/jop.1997.68.2.119.
The clinical safety and effectiveness of a subgingivally delivered biodegradable drug delivery system containing either 10% doxycycline hyclate (DH), 5% sanguinarium chloride (SC) or no agent (VC) was evaluated in a 9-month multi-center trial. The study was a randomized parallel design with 180 patients who demonstrated moderate to severe periodontitis. All patients had at least two quadrants with a minimum of four qualifying pockets > or = 5 mm that bled on probing. Two of the qualifying pockets were required to be > or = 7 mm. At baseline and at 4 months all qualified sites were treated with the test article administered via syringe. Probing depth reduction (PDR), attachment level gain (ALG), bleeding on probing reduction (BOP), and plaque index were determined monthly. Analysis of efficacy data from the 173 efficacy-evaluable patients indicated that all treatments gave significant positive clinical changes from baseline at all subsequent timepoints. DH was superior to SC and VC in PDR at all timepoints (P < or = 0.01 to 0.001) with a maximum reduction of 2.0 mm at 5 months. For ALG, DH was superior to VC at months 2, 3, 4, 5, 6, 8, and 9 (P < or = 0.04 to 0.002) and superior to SC at months 5, 6, 7, 8, and 9 (P < or = 0.01 to 0.001) with a maximum ALG of 1.2 mm at 6 months. For BOP reduction, DH was superior to VC at all time points (P < or = 0.05) and to SC at months 3, 5, 6, 8, and 9 (P < or = 0.03). For DH, the maximum ALG in deep (> or = 7 mm) pockets was 1.7 mm and PDR 2.9 mm compared to 0.8 mm and 1.6 mm, respectively for moderate (5 to 6 mm) pockets. Test articles were applied without anesthesia and no serious adverse events occurred in the trial. The results of this study indicate that 10% doxycycline hyclate delivered in a biodegradable delivery system is an effective means of reducing the clinical signs of adult periodontitis and exhibits a benign safety profile.
在一项为期9个月的多中心试验中，评估了一种龈下给药的可生物降解药物递送系统的临床安全性和有效性，该系统含有10%的盐酸多西环素（DH）、5%的氯化血根碱（SC）或不含任何药物（VC）。该研究采用随机平行设计，有180名表现为中度至重度牙周炎的患者。所有患者至少有两个象限，至少有四个符合条件的牙周袋≥5 mm，探诊时出血。其中两个符合条件的牙周袋需≥7 mm。在基线和4个月时，所有符合条件的部位均用通过注射器给药的试验制剂进行治疗。每月测定探诊深度减少（PDR）、附着水平增加（ALG）、探诊出血减少（BOP）和菌斑指数。对173名可进行疗效评估的患者的疗效数据进行分析表明，所有治疗在所有后续时间点均与基线相比产生了显著的积极临床变化。在所有时间点，DH在PDR方面均优于SC和VC（P≤0.01至0.001），在5个月时最大减少量为2.0 mm。对于ALG，在第2、3、4、5、6、8和9个月时，DH优于VC（P≤0.04至0.002），在第5、6、7、8和9个月时优于SC（P≤0.01至0.001），在6个月时最大ALG为1.2 mm。对于BOP减少，DH在所有时间点均优于VC（P≤0.05），在第3、5、6、8和9个月时优于SC（P≤0.03）。对于DH，深度（≥7 mm）牙周袋中的最大ALG为1.7 mm，PDR为2.9 mm，而中度（5至6 mm）牙周袋分别为0.8 mm和1.6 mm。试验制剂在未麻醉的情况下应用，试验中未发生严重不良事件。本研究结果表明，在可生物降解递送系统中递送的10%盐酸多西环素是减少成人牙周炎临床症状的有效手段，且具有良好的安全性。
