石辛牙痛口含片治疗胃火牙痛智齿冠周炎Ⅲ期临床试验  

Phase Ⅲ clinical trial of Shixinyatong buccal tablets in the treatment of pericoronitis of gastropyretic toothache type

作　　者：吴军正[1] 李元聪[2] 胡开进[1] 卜献春[3] 向楠[4] 温德升[1] 关素敏[1] 

机构地区：[1]第四军医大学口腔医学院,西安710032 [2]湖南中医学院第一附属医院 [3]湖南省中医药研究院附属医院 [4]湖北中医学院附属医院

出　　处：《实用口腔医学杂志》2012年第1期79-84,共6页Journal of Practical Stomatology

基　　金：国家中小企业创新基金(编号:05C26214201065)

摘　　要：目的:研究石辛牙痛口含片治疗胃火牙痛智齿冠周炎的疗效及安全性。方法:随机双盲双模拟平行对照多中心临床试验。纳入符合胃火牙痛智齿冠周炎患者432例。就诊当天行常规冠周袋冲洗。石辛组患者含化石辛牙痛口含片,口服牛黄解毒片赋形剂;牛黄组患者口服牛黄解毒片,含化石辛牙痛口含片赋形剂,疗程5 d。主症中疼痛按VAS法记分,其余主症、次症及舌象、舌苔、脉象均按等级计分。症状体征总积分减轻率≥90%判断为痊愈,70%～89%显效,30%～69%有效,≤29%无效。用药前后进行血、尿、粪常规及肝功、肾功、心电图检查,记录不良事件。用SAS 6.12软件统计分析。结果:符合方案数据集(PPS)石辛组309例、牛黄组101例。人口学特征、病情基线组间差别均无统计学意义(P>0.05)。治疗3 d和5d时2组症状体征总积分、主症积分、次症积分均下降(P=0.000),石辛组积分的下降值高于牛黄组(P<0.000 1)。第5天治愈率和显效率石辛组为45.6%和42.4%;牛黄组为8.9%和33.7%(P<0.000 1)。实验室检查未发现具有临床意义的异常结果。与研究药物有关的不良事件石辛组9例15次,牛黄组7例7次(P=0.084 8);各组均未发生导致病例脱落的不良事件和严重不良事件。结论:石辛牙痛口含片治疗胃火牙痛智齿冠周炎是安全、有效的。Objective： To study the effects and safety of shixinyatong buccal tablets（SBT） in the treatment of pericoronitis of gastropyretic toothache type.Methods： 432 cases of pericoronitis of gastropyretic toothache type were enrolled in a randemized,double-blinded,double-imitated,parallel-controlled and multi-center clinical trial.Pericoronal pocket rinsing was performed for each case at the first visit,then the patients in the experimental（SBT） group were treated by SBT and oral administration of the vehicle of cow-bezoar detoxicating tablet（CBDT）.Those in the control（CBDT） group were treated by oral adiministration of CBDT and the vehicle of SBT respectively.Pain was scored by VAS.The other major symptoms（MAS）,minor symptoms（MIS）,tongue manifestation,tongue coating and pulse manifestation were scored by grade.Treatment was continued for 5 days and data were statistically analysed with SAS 6.12 soft ware.Cure was identified by the ≥90% decrease of total score of all the symptoms（TS）,significant effectiveness 70%~89%,effectiveness 30%~69% and ineffectiveness ≤29%.Routine examinations of blood,urine and stool,function of liver and kidney and electrocardiogram were conducted before and after treatment.Adverse events（AE） were observed.Results： Per protocol set（PPS） included 309 in SBT group and 101 in CBDT.The demographic data and all the scores before treatment were not statistically different between groups（P0.05）.3 and 5 days after treatment the TS,MAS and MIS scores were decreased（P=0.000） in both groups,in SBT group decreased more than in CBDT（P0.000 1）.The ratios（%） of cure and significant effectiveness in SBT group were 45.6 and 42.4,in CBDT group 8.9 and 33.7,respectively（P0.000 1）.The lab examinations showed no abnormal findings with clinical significance.drug-related AE were observed in 9 cases in SBT group and 7 in CBDT group（P=0.084 8）.Conclusion： Shixinyatong buccal tablet is effective and safe in the treatment of pericoronitis of gastropy

关 键 词：石辛牙痛口含片 牛黄解毒片 胃火牙痛 智齿冠周炎 

分 类 号：R782.31[医药卫生—口腔医学]