塞克硝唑片用于口腔冠周炎疗效的临床试验

A clinical traial of secnidazole in the treatment pericoronitis

目的观察塞克硝唑片治疗口腔冠周炎的临床疗效及安全性。方法,采用多中心、随机、双盲、阳性药平行对照的临床方法,将127例患者随机分为塞克硝唑片组(A组)和替硝唑片组(B组),分别在用药前、用药第5天观察并记录患者的临床症状、体征变化、不良事件。结果①一般资料受试组和对照组参加人数、性别、年龄、病情、感染类型,总用药量,疗程均无明显差异(P>0.05)。②有效性A组有效率93.75%,细菌转阴率为70.69%,B组有效率为92.06%,细菌转阴率为76.27%,组间比较无统计学差异(P>0.05)。③安全性2组血尿常规、肝肾功能及心电图均无明显影响,A组和B组不良事件发生率分别为7.09%和9.52%,无统计学差异(P=0.5042)。结论塞克硝唑片是治疗口腔冠周炎的一种安全有效药物,值得临床推广应用。

Objective：To study the effects and side effects of secnidazole in the treatment of pericoronitis. Methods： A randomized, double-blinded, controlled, multicenter clinical study was conducted. Pericoronal washing was performed in all patients at the first visit ,0.5 g of secnidazole was administered to the experimantal cases （64）, 1/d. 0.5 g of tinidazole to the controls（63）, 1/d. The treatment was continued for 5 days and the effects were evaluated by clinical and laboratary examination before and after treatment. Results：There were no obvious differences in case number, sex, age and infection type between the 2 groups. The clinical effective rates（ % ） in experimental and control groups were 93.75 and 92.06 （ P 〉 0.05 ）, the bactiria elimination rates （ % ） 70.69 and 76.27 （ P 〉 0.05 ） respectively. Adverse events（ all slight） were observed in 7.09% of the cases in experimental group and 9.52% in the control（ P 〉 0.05 ）. Conclusion ： Secnidazole is effective and safe in the treatment of pericoronitis.