石辛牙痛口含片治疗胃火牙痛(智齿冠周炎)Ⅱ期临床试验

Phase Ⅱ clinical trial of Shixinyatong buccal tablets in the treatment of gastropyretic toothache(pericoronitis)

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法。纳入符合胃火牙痛(智齿冠周炎)试验组(石辛)、对照组(牛黄)各120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0.6 g×2,4/d,口服牛黄解毒片的赋形剂0.3 g×3,3/d;牛黄组患者口服牛黄解毒片0.3 g×3,3/d,含化石辛牙痛口含片的赋形剂,0.6 g×2,4/d。主症按0、2、4、6分级计分;次症按0、1、2、3分级计分。疗程5 d,用SAS 6.12软件统计分析。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。结果:石辛组脱落(失访)3例,牛黄组脱落2例。受试者脱落率、人口学特征、病情基线组间差别均无统计学意义(P>0.05)。第3天和第5天时主症、次症积分以及病情总积分均明显下降(P=0.000),其减少值石辛组大于牛黄组(P<0.001);石辛组显效率大于牛黄组(P=0.000)。第5天时主症各项指标石辛组积分下降值大于牛黄组(P<0.05)。生命体征治疗前后均在正常范围,组间差异无统计学意义(P>0.05),实验室检查全部患者治疗前未出现明显异常变化。3例发生与研究药物有关不良事件,石辛组1例,为"中度",停药后好转,退出试验。牛黄组2例,为轻度,未影响试验。结论:石辛牙痛口含片治疗胃火牙痛(智齿冠周炎)疗效优于牛黄解毒片,安全性与牛黄解毒片相似。

Objective ： To study the effects and safety of Shixinyatong buccal tablets in the treatment of gastropyretic toothache （ pericoronitis）. Methods： Randemized, double-blinded, double-imitated, parallel-controlled and multi-center clinical study was employed. 120 cases of gastropyretic toothache （pericoronitis） was enrolled in the experimental group（SBT group） and another 120 in control group（ CBD group）. Perieoronal pocket rinsing was performed for each case at the first visit, then the patients in SBT group were treated by Shixin buccal tablets（SBT） , 0.6 g × 2, 4/d and oral adiministration of the vehicle of cow- bezoare detnxicating tablets,0.3 g× 3, 3/ d. The patients in CBD group were treated by oral adiministration of cow-bezoare detoxicating tablets（SBD） , 0.3 g ×3, 3/d and the vehicle of SBT, 0.6 g× 2, 4/d respectively. Pain, gingiva contagious tumefaction, pyorrhea of periocoronal pocket and limitation of mouth opening were scored by 0, 2, 4 and 6 as the major physical signs and symptoms（MAS） ; periocoronal flap and pocket, facial swelling, hot and foul breath, costipation, lymphadenectasis, thirsty and desire of cold drinks, fever by 0, 1, 2 and 3 as the minor （ MIS）. Treatment was continued for 5 days and data were statistically analysed with SAS6.12 software. Significant effectiveness was identified by the decrease of total score of all the physical signs and symptoms（TS）≥70% ,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： 3 cases divorced from SBT group and 2 from CBD group. The demographic data and all the scores before treatment were not statistically different between groups（P 〉0.05）. 3 and 5 days after treatment the TS, TSMA and TSMI were decreased（ P = 0. 000） in both groups, in SBT group decreased more than in CBD（ P 〈 0. 001 ）. Significant effectiveness ratio of SBT group was higher than that of CBD （ P = 0. 000）. 5 days after treatment TS of MASs and the scores of each MAS in SBT group decreased more than in CBD（ P 〈0.05 ）. Vital signs were in normal range and not statisticaly different between groups（ P 〉 0.05 ）. The clinical lab examinations showed no abnormal changes. Drug-related AE were observed in 3 cases, 1 with moderate AE in SBT group recovered after drug withdrawal, 2 with mild AE in CBD group recovered without aditional treatment. Conclusion： Shixinyatong buccal tablet is more effective in the treatment of gastropyretic toothache （pericoronitis） than cow-bezoare detoxicating tablets and with similar safety.