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

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 gastropyretic toothache type.