首页> 中文期刊> 《实用口腔医学杂志》 >一清胶囊治疗边缘性牙龈炎随机、双盲、多中心临床试验

一清胶囊治疗边缘性牙龈炎随机、双盲、多中心临床试验

         

摘要

Objective:To evaluate the effects and safety of Yiqing capsule in the treatment of marginal gingivitis.Methods:192 cases of marginal gingivitis were randomly divided into 3 groups:group A (Yiqing capsule,n =96),group B (placebo,n =48) and group C (bovine bezoar detoxification capsule,n =48).All the cases were given supragingivial scaling when they were enrolled into this trial.Then after oral use of the drugs for 7 days,the effects and safety of the drugs were evaluated.Results:The distribution of age,sex,race and body weight was not significantly different among the 3 groups(P >0.05).Before treatment,no statistic difference was found in gingiva pain,score of traditional chinese medicine symptoms,GI and SBI (P > 0.05),but there was statistic difference in gingiva swelling(P =0.036 4).Mter treatment,gingiva pain score in group A was lower than in group B or C (P < 0.05).Swelling of gingiva,score of Traditional Chinese Medicine symptoms,GI and SBI was lower,the effectiveness was higher in group A than those in group B (P < 0.05),there was no statistic difference between group A and group C (P > 0.05).There was no statistic difference in the incidence of adverse event among 3 groups (P =0.068 4).Conclusion:Yiqing capsule is effective and safe in the treatment of marginal gingiv1tis.%目的:评价一清胶囊辅助治疗边缘性牙龈炎的有效性和安全性.方法:192例边缘性牙龈炎患者,随机分成A组(一清胶囊组)96例,B组(安慰剂组)48例,C组(牛黄解毒胶囊组)48例.所有病例纳入时均进行全口龈上洁治术,3组分别服药7d后,观察其治疗的有效性和安全性.结果:A、B、C3组年龄、性别、民族、体重分布以及治疗前各项基线检查(除牙龈肿胀外)均无组间差异,3组具有可比性.治疗后,对于牙龈疼痛,A组与B组、A组与C组的组间比较均有统计学差异;对于中医肿胀、中医症状积分和、GI以及SBI,A组疗效显著高于B组,但是A组与C组疗效无统计学差异.3组不良事件发生率差别无统计学意义.结论:临床上使用一清胶囊辅助龈上洁治术治疗边缘性牙龈炎安全有效.

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