复方双黄补漱口水减轻慢性龈炎的随机对照研究  

A randomized controlled study on the alleviation of gingivitis by compound Shuanghuangbu mouthwash

作　　者：陈治龙 向勇 任晓琳 杜若岚 程然[1] 蔡和 程立[1] 胡涛[1] CHEN Zhi-long;XIANG Yong;REN Xiao-lin;DU Ruo-lan;CHENG Ran;CAI He;CHENG Li;HU Tao(National Center for Stomatology&National Clinical Research Center for Oral Diseases&Frontier Innovation Center for Dental Medicine Plus,West China Hospital of Stomatology,Sichuan University,Sichuan Chengdu 610041,China)

机构地区：[1]国家口腔医学中心,国家口腔疾病临床医学研究中心,前沿医学中心口腔医学+,四川大学华西口腔医院,四川成都610041

出　　处：《临床口腔医学杂志》2024年第5期277-280,共4页Journal of Clinical Stomatology

基　　金：四川大学华西口腔医院探索与研发临床研究项目(LCYJ2020-DL-4);四川省自然科学基金项目(24NSFSC0636)。

摘　　要：目的:评价复方双黄补漱口水减轻牙龈炎症的有效性及安全性。方法:采用随机、单盲、平行对照设计,纳入80名符合纳排标准的研究参与者,随机分为实验组(使用复方双黄补漱口水)和对照组(使用蒸馏水)。在基线和第4、8周时记录牙龈炎症相关指标,并检查口腔软硬组织。结果:实验组和对照组的基线特征差异无统计学意义(P>0.05)。各疗效指标两组间比较,治疗后8周MGI、BI、BOP%差异有统计学意义(P<0.05);各疗效指标变化率组间比较,基线-8周时实验组MGI、BI、BOP%下降较对照组更明显,4周-8周时实验组MGI、BOP%下降较对照组更明显,差异均有统计学意义(P<0.05)。两组不良事件发生率差异无统计学意义(P>0.05)。结论:复方双黄补漱口水使用8周可有效减轻牙龈炎症,减少牙龈出血,临床应用安全。Objective:To evaluate the efficacy and safety of compound Shuanghuangbu mouthwash in reducing gingi-val inflammation.Methods:A randomized,single-blind,parallel-controlled design was used to enroll 80 study participants who met the criteria and were randomly divided into a test group(using compound Shuanghuangbu mouthwash)and a control group(using distilled water).Indicators related to gingival inflammation were recorded at baseline and at the fourth and eighth weeks,and the hard and soft tissues of the oral cavity were examined.Results:The difference in baseline characteris-tics between the test and control groups was not statistically significant(P>0.05).Comparison between the two groups for each efficacy index,the difference in MGI,BI,and BOP%at 8 weeks after treatment was statistically significant(P<0.05).Comparison between the groups for the rate of change of each efficacy index,the decline in MGI,BI,and BOP%was more pronounced in the experimental group than the control group at the baseline-8 weeks,and in the experimental group at the 4-week-8-week period,the decrease in MGI,and BOP%was more pronounced in the experimental group than the control group,and the differences were all statistically significant(P<0.05).The difference in the incidence of adverse events be-tween the two groups was not statistically significant(P>0.05).Conclusion:Compound Shuanghuangbu mouthwash can ef-fectively reduce gingival inflammation and gingival bleeding when used for 8 weeks,and it is safe for clinical application.

关 键 词：漱口水 慢性龈炎 牙菌斑 随机对照试验 

分 类 号：R781.41[医药卫生—口腔医学]