Periodontal tissue regeneration using fibroblast growth factor-2: randomized controlled phase II clinical trial.
Periodontal tissue regeneration using fibroblast growth factor-2: randomized controlled phase II clinical trial.
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牙周组织再生使用成纤维细胞生长因子-2：随机对照II期临床试验。
DOI：
10.1371/journal.pone.0002611
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发表时间：
2008-07-02
期刊：
影响因子：
3.7
通讯作者：
Murakami, Shinya
中科院分区：
文献类型：
--
作者：
Kitamura, Masahiro;Nakashima, Keisuke;Kowashi, Yusuke;Fujii, Takeo;Shimauchi, Hidetoshi;Sasano, Takashi;Furuuchi, Toshi;Fukuda, Mitsuo;Noguchi, Toshihide;Shibutani, Toshiaki;Iwayama, Yukio;Takashiba, Shogo;Kurihara, Hidemi;Ninomiya, Masami;Kido, Jun-ichi;Nagata, Toshihiko;Hamachi, Takafumi;Maeda, Katsumasa;Hara, Yoshitaka;Izumi, Yuichi;Hirofuji, Takao;Imai, Enyu;Omae, Masatoshi;Watanuki, Mitsuru;Murakami, Shinya
目前，信号分子作为组织再生刺激剂的医疗用途的选择有限。临床前证据表明成纤维细胞生长因子（FGF）-2可以促进牙周再生。本研究旨在阐明 FGF-2 在刺激牙周炎损失的牙周组织再生中的活性，并评估这种刺激的安全性。我们使用含有 3% 羟丙基纤维素 (HPC) 的重组人 FGF-2 作为载体，并进行了一项涉及 13 家机构的随机双盲对照试验。受试者包括 74 名患者，显示 2 壁或 3 壁垂直骨缺损，测量距离骨嵴顶端≥3 毫米。患者被随机分为 4 组：P 组，给予不含 FGF-2 的 HPC； L组，给予含有0.03% FGF-2的HPC； M组，给予含有0.1% FGF-2的HPC； H 组，给予含有 0.3% FGF-2 的 HPC。每位患者均接受皮瓣手术，在此期间我们向骨缺损处施用 200 µL 适当的研究药物。在给药前和给药后 36 周内，患者接受了牙周组织检查和所研究区域的标准化放射线摄影。结果，36周时P组（23.92%）和H组（58.62%）的牙槽骨高度增加率存在显着差异（p = 0.021）。 P组和H组36周时牙槽骨高度的线性增加分别为0.95毫米和1.85毫米（p = 0.132）。没有发现与研究药物有关的严重不良事件。尽管与 P 组相比，FGF-2 组的临床附着水平和牙槽骨增加没有统计学上的显着差异，但 36 周时 P 组和 H 组之间牙槽骨高度增加率的显着差异 (p = 0.021) 表明，FGF-2 在刺激牙周炎患者牙周组织再生方面可预期具有一定功效。 ClinicalTrials.gov NCT00514657
The options for medical use of signaling molecules as stimulators of tissue regeneration are currently limited. Preclinical evidence suggests that fibroblast growth factor (FGF)-2 can promote periodontal regeneration. This study aimed to clarify the activity of FGF-2 in stimulating regeneration of periodontal tissue lost by periodontitis and to evaluate the safety of such stimulation. We used recombinant human FGF-2 with 3% hydroxypropylcellulose (HPC) as vehicle and conducted a randomized double-blinded controlled trial involving 13 facilities. Subjects comprised 74 patients displaying a 2- or 3-walled vertical bone defect as measured ≥3 mm apical to the bone crest. Patients were randomly assigned to 4 groups: Group P, given HPC with no FGF-2; Group L, given HPC containing 0.03% FGF-2; Group M, given HPC containing 0.1% FGF-2; and Group H, given HPC containing 0.3% FGF-2. Each patient underwent flap operation during which we administered 200 µL of the appropriate investigational drug to the bone defect. Before and for 36 weeks following administration, patients underwent periodontal tissue inspections and standardized radiography of the region under investigation. As a result, a significant difference (p = 0.021) in rate of increase in alveolar bone height was identified between Group P (23.92%) and Group H (58.62%) at 36 weeks. The linear increase in alveolar bone height at 36 weeks in Group P and H was 0.95 mm and 1.85 mm, respectively (p = 0.132). No serious adverse events attributable to the investigational drug were identified. Although no statistically significant differences were noted for gains in clinical attachment level and alveolar bone gain for FGF-2 groups versus Group P, the significant difference in rate of increase in alveolar bone height (p = 0.021) between Groups P and H at 36 weeks suggests that some efficacy could be expected from FGF-2 in stimulating regeneration of periodontal tissue in patients with periodontitis. ClinicalTrials.gov NCT00514657
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