【摘要】 目的:研究替硝唑口腔贴片治疗牙周炎的疗效及安全性.方法:采用随机双盲双模拟平行对照多中心临床试验方法,将160例牙周炎受试者平均分为试验组和对照组.试验组受试者使用替硝唑口腔贴片(5mg/片),每牙位1片,2次/d,于早餐和晚餐后并漱口后将药片贴敷于2个观察牙位(磨牙或前磨牙)颊侧正中牙龈表面;口服替硝唑口服片剂赋型剂,2次/d,每次1片,分别在早餐和晚餐后服用.对照组受试者使用替硝唑口腔贴片赋型剂,用法用量与试验组相同;口服替硝唑口服片剂(500mg/片),1片,2次/d,分别在早餐后和晚餐后服用.用药5d.用药前后分别检查龈沟出血指数(SBI),菌斑指数(PLI),牙周袋深度(PD),牙松动度(TM),测定龈下菌斑菌群,进行血常规、尿常规、肝功、肾功检验.结果:试验组和对照组完成试验的病例数分别为75和70,两组受试者年龄、性别、民族、职业、临床指数基线检查计分、用药前细菌检测阳性率差异均无统计学意义(P>0.05).治疗后试验组和对照组临床检查总计分减少率(%)分别为20.72±8.27和18.83±9.88(P>0.05);龈下菌斑细菌清除率(%)分别为54.7和60.0(P>0.05);总有效率(%)分别是61.33和54.29(P>0.05).两组SBI,PLI,PD,TM计分以及龈下菌斑菌群cuf/mL总数明显下降(P<0.01),两组之间下降率差异无统计学意义(P>0.05).试验组和对照组不良事件的发生率均为7.5%,与研究药物有关的不良事件发生率在两组均为5%,无严重不良事件.两组受试者治疗前后血常规、尿常规、便常规、血生化指标都在正常值范围内.结论:替硝唑口腔贴片用于治疗牙周炎是安全有效的.更多还原

【Abstract】 AIM: To evaluate the efficacy and safety of tinidazole adhesive tablet in the treatment of periodontitis. METHODS: In the randomized, double blind, parallel-group, controlled and multicenter study, 160 adult cases of periodontitis were divided evenly into experimental group and control group. The former was treated with tinidazole adhesive tablet (TAT, 5 mg/piece) and the latter with oral tinidazole tablet (OTT, 500 mg/piece). TAT was adhered onto the buccal gingival surface facing to the cheek between every 2 adjacent premolars and molars following mouth washing after breakfast and after dinner (1 piece per tooth, 2/d). OTT was given at 2 pieces per day respectively after breakfast and after dinner. TAT placebo was administered in control group and OTT placebo in experimental group in the same manner (2 pieces per day, respectively after breakfast and after dinner). The treatment was lasted for 5 d. Before and after treatment sulcus bleeding index (SBI), pocket depth (PD), tooth mobility (TM) and plaque index (PLI) were measured, subgigival bacteria flora (SBF) was examined, blood routine tests, liver function tests and renal function tests were conducted. RESULTS: Treatment was completed in 75 and 70 cases in the experimental and control groups respectively. The distribution of age, sex, nationality and occupation in the 2 groups were not significantly different (P>0.05). Before treatment, no statistic difference was found in SBI, PD, TM,PLI, SBF positive rates and SBF (CFU/mL) between the 2 groups (P>0.05). After treatment, in the experimental and control groups the total score of clinical examination decreased by 20.72±8.27 and 18.83± 9.88 (P>0.05), the bacteria clearance rates were 54.7% and 60.0%(P>0.05),the effective rates 61.33% and 54.29% (P>0.05), respectively. SBI, PD, TM, PLI and SBF were decreased in both groups(P>0.05 between 2 groups, P<0.01 between pre- and post-treatment). The incidence of adverse events in both groups was 7.5%, the drug-related adverse event 5%. No severe adverse events occurred. All data of blood routine tests, liver function tests and renal function tests were in normal range before and after treatment. CONCLUSION:TAT is effective and safe in the treatment of periodontitis.更多还原