【摘要】 目的对替硝唑含片治疗牙周炎和冠周炎的疗效及安全性进行评价。方法试验采用多中心、随机、双盲、平行对照临床试验设计方案。来自上海、杭州和成都的三个单位分别完成试验样本的1/3。试验药替硝唑含片(商品名津和()由申办单位深圳市中联制药有限公司提供。阳性对照药为国家食品药品监督管理局已批准上市的替硝唑含片,均为每次含服5 m g,每日4次,疗程6天。疗效评定指标包括牙周炎、冠周炎病人的主观症状和客观体征,牙周炎病人还要评定牙龈指数、出血指数、菌斑指数和牙周袋深度。从牙周炎病人的病变牙菌斑、冠周炎病人的冠周分泌物取样做需氧和厌氧培养,比较牙周和冠周可疑致病菌培养分离的结果。观察和记录不良事件,进行适当处理和随访。结果共157例符合纳入标准,失访14例(8.9%)。遵循设计方案,受试者纳入牙周炎109例(试验组57、对照组52例),冠周炎34例(试验组、对照组各17例)。基线分析显示两组具有可比性。治疗结束时复查,牙周炎试验组与对照组牙龈出血85%以上明显改善,牙龈疼痛、咬合疼痛均有减轻,两组间差异无统计学意义(P>0.05);牙周袋深度、出血指数、牙龈指数、菌斑指数均有减少,其差值的两组间差异无统计学意义(P>0.05)。冠周炎病例60%以上获得症状改善,75%以上冠周脓液消失,60%以上淋巴结肿大消退,张口度均有增加,两组间差异无统计学意义(P>0.05)。以显著改善及痊愈计算有效率,两组均达到88.2%。治疗前在牙周、冠周均可查到不同类型的可疑致病菌,而治疗后复查发现大部分致病菌株消失或数量减少,两组间差异无统计学意义(P>0.05)。治疗前后在试验组、对照组均未检出白色念珠菌。在治疗期间共有9例发生不良事件,其中试验组与对照组分别为5例(6.8%)、4例(5.8%),两组间比较无显著差异,均为轻度一过性,不影响继续用药。结论深圳市中联制药有限公司研制的替硝唑含片(商品名津和()能有效抑制牙周炎、冠周炎常见病原菌,但不引起菌群失调;可减少牙周、冠周炎的症的严重程度,促进其好转或康复。不良反应少而轻微。其疗效与国家食品药品监督管理局已批准上市的替硝唑含片相当。更多还原

【Abstract】 Objective To assess the effectiveness and safety of tinidazole buccal tablets produced by China Associate Pharmaceutical Co.,Ltd.on periodontitis and pericoronitis.Methods A multicenter randomized controlled double-blind trial was designed.Three units from Shanghai,Hangzhou and Chengdu joined the study.The trial tablet of tinidazole was supplied by the mentioned Pharmaceuticals company.A marketed tinidazole produced by Zhejiang Hacon Marine Bio-Pharmaceutical Co.Ltd.,was used as positive control.Both drugs were administered at a dose of 5 mg four times daily for 6 days.Outcomes measurement included symptoms,clinical signs of the patients with periodontitis or pericoronitis,and gingival index(GI),bleeding index(BI),plaque index(PI) and periodontal depth(PD) were measured for the patients with periodontitis.Subgingival bacterial samples taken from subgingival plaque of diseased teeth of the cases with periodontitisor from exudates of diseased wisdom teeth of the cases with pericoronitis were cultivated aerobically and anaerobically.Putative microorganisms were isolated and colony forming unit(CFU) were counted before and after treatments.All adverse drug reactions(ADR) were observed,recorded,properly treated and followed.Results Altogether,157 cases met the inclusion criteria and entered the study.Lost to follow-up happened in 14 cases with drop-out rate of 8.9%.In per-protocal cases there were 109 with periodontitis(57 in trial group and 52 in control group) and 34 with pericoronitis(17 in trial group and 17 in control group).Baseline analysis demonstrated that the two groups were comparable.At the final examination,it was found that 85% of the cases in the periodontitis group showed significant improvement gingival bleeding,both gingival pain and biting pain subsided,PD,BI,GI and PI reduced with no significant difference between trial and control groups(P>0.05).The symptoms of sixty percent of cases with pericoronitis were improved.More than 75% of the cases with pericoronal pus,the pus were eliminated.Over 60% of the cases with lymphadenitis,the node swelling was subsided.Mouth opening increased in all cases with pericoronitis.All improvements in the cases with pericoronitis showed no significant difference between trial and control groups(P>0.05).The effective rate only including cured and markedly improved cases reached 88.2% in both groups of pericoronitis.Various species of putative microorganisms were detected in patients with periodontitis or pericoronitis before treatment.A great proportion of the putative microorganisms eliminated or the quantity reduced after treatment,with no significant difference between trial and control groups(P>0.05).Candida albicans was not detected before and after treatment.Nine patients developed ADRs,5(6.8%)in trial group and 4(5.8%)in control group.All the ADRs were mild and transient,not interfering with drug administration.Conclusions This study showed the tinidozole buccal tablet with commercial name "Jinhe" supplied by China Associate Pharmaceutical Co.,Ltd.do inhibit the common putative microorganisms of periodontitis and pericoronitits,and do not influence balance of the local commensal microganisms.It reduces severity of the infectious inflammation and benefits improvement and/or rehabilitation of periodontitis and pericoronitis,with only mild and transient ADRs.The trial and control tablets have similar efficacy and safety for patients with periodontits or pericoronitis.更多还原