CAJ | 학술논문

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.
목적:연구석신아통구함편치료위화아통(지치관주염)적료효급안전성.방법:수궤쌍맹쌍모의평행대조다중심법.납입부합위화아통(지치관주염)시험조(석신)、대조조(우황)각120 례.취진당천행상규관주대충세.석신조환자함화석신아통구함편0.6 g×2, 4/d,구복우황해독편적부형제0.3 g×3, 3/d;우황조환자구복우황해독편0.3 g×3, 3/d,함화석신아통구함편적부형제,0.6 g×2, 4/d.주증안0、2、4、6 분급계분;차증안0、1、2、3 분급계분.료정5 d,용SAS 6.12연건통계분석.용약전후진행혈、뇨、분상규급간공、신공、심전도검사,기록불량사건.결과:석신조탈락(실방)3 례,우황조탈락2 례.수시자탈락솔、인구학특정、병정기선조간차별균무통계학의의(P>0.05).제3 천화제5 천시주증、차증적분이급병정총적분균명현하강(P=0.000),기감소치석신조대우우황조(P<0.001);석신조현효솔대우우황조(P=0.000).제5 천시주증각항지표석신조적분하강치대우우황조 (P<0.05).생명체정치료전후균재정상범위,조간차이무통계학의의(P>0.05),실험실검사전부환자치료전미출현명현이상변화.3 례발생여연구약물유관불량사건,석신조1 례,위"중도",정약후호전,퇴출시험.우황조2 례,위경도,미영향시험.결론:석신아통구함편치료위화아통(지치관주염)료효우우우황해독편,안전성여우황해독편상사.
Objective: To study the effects and safety of Shixinyatong buccal tablets in the treatment of gastropyretic toothache (perico-ronitis). 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). Pericoronal 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 detoxicating 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 i-dentified 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 theTS, 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.