Bichara J, Greenwell H, Drisko C, Wittwer J W, Vest T M, Yancey J, Goldsmith J, Rebitski G
Department of Periodontics, Endodontics and Dental Hygiene, School of Dentistry, University of Louisville, KY 40292, USA.
J Periodontol. 1999 Aug;70(8):869-77. doi: 10.1902/jop.1999.70.8.869.
Previous reports in the literature have shown that non-steroidal anti-inflammatory drugs (NSAID) may affect osseous tissues by either stimulating or inhibiting bone formation. This effect can be drug specific and different NSAIDs may produce opposite results. There are also reports showing that NSAIDs inhibit bone loss due to inflammatory disease process. The purpose of this randomized, controlled, blinded, clinical investigation was to determine the effect of a one week course of postsurgical naproxen on the osseous healing in intrabony defects.
Twenty-four vertical osseous defects in 24 patients were treated with either a bioabsorbable membrane plus twice daily postsurgical naproxen 500 mg for one week (test or GPN group) or with a polylactide bioabsorbable membrane alone (control or GA group). Twelve patients were included in each group. Treatment was performed on either 2- or 3-wall or combination defects. All measurements were taken from a stent by a calibrated, blinded examiner and open measurements were repeated at the 9-month second stage surgery. Power analysis to determine superiority of naproxen treatment showed that a 12 per group sample size would yield 87% power to detect a 2.0 mm difference and 64% power to detect a 1.5 mm difference.
Open defect measurements from baseline to 9 months showed a statistically significant (P < 0.05) mean defect fill of 1.96 +/- 1.27 mm and 2.04 +/- 1.71 for the GPN and GA groups, respectively. This corresponded to a mean defect fill of 42% and a mean defect resolution of approximately 75% for both groups. The differences between GPN and GA groups were not statistically significant (P > 0.05). Defect fill of > or = 50% was seen in 6 defects (50%) in the GPN group and in 5 defects (42%) in the GA group.
The administration of postsurgical naproxen failed to produce osseous healing that was statistically superior to that obtained with polylactide bioabsorbable membranes alone.
文献中先前的报告表明，非甾体抗炎药（NSAID）可能通过刺激或抑制骨形成来影响骨组织。这种作用可能具有药物特异性，不同的NSAID可能产生相反的结果。也有报告显示，NSAID可抑制炎症疾病过程导致的骨质流失。这项随机、对照、双盲临床研究的目的是确定术后服用萘普生一周疗程对骨内缺损骨愈合的影响。
24例患者的24个垂直骨缺损，一组采用可吸收生物膜加术后每天两次服用500 mg萘普生，共一周（试验组或GPN组），另一组仅采用聚丙交酯可吸收生物膜（对照组或GA组）。每组纳入12例患者。治疗针对2壁或3壁缺损或联合缺损进行。所有测量均由一名经过校准的、不知情的检查者通过支架进行，在9个月的二期手术时重复进行开放测量。确定萘普生治疗优势的功效分析表明，每组12例的样本量将有87%的功效检测出2.0 mm的差异，有64%的功效检测出1.5 mm的差异。
从基线到9个月的开放缺损测量显示，GPN组和GA组的平均缺损填充分别为1.96±1.27 mm和2.04±1.71 mm，具有统计学意义（P < 0.05）。这相当于两组的平均缺损填充率为42%，平均缺损分辨率约为75%。GPN组和GA组之间的差异无统计学意义（P > 0.05）。GPN组6个缺损（50%）和GA组5个缺损（42%）的缺损填充≥50%。
术后服用萘普生未能产生在统计学上优于单独使用聚丙交酯可吸收生物膜的骨愈合效果。
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