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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.
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0.05). However,Simo Decoction can ameliorate the symptoms,such as epigastric pain,early satiety,etc.,better than Domperidone tablets(P
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Objective:To investigate the clinical effects and main pharmacological actions of Pingantongluo Granules (Radix Paeoniae Alba, Rhizoma Gastrodiae, Radix Salviae Miltiorrhizae, Rhizoma Chuanxiong, Concha Haliotidis, etc.) for migraine with liver wind and blood stasis symptom. Methods: Randomized controlled trail, double blind and double dummy method were applied. Yuntongding Tablets was used as a control drug in clinical investigation and Routunding Tablets as a control drug in pharmacological experiment study. Results: The total effective rates of the treatment group and the control group were 95.0% and 83.3% for migraine and 80.0% and 61.6% for the liver wind and blood stasis symptom, respectively. Pinggantongluo Granules began to act on migraine in ( 11.75 ? 6.70 )h, and the control drug did in ( 18.30 ? 8.22 )h. There were a significant difference between two groups ( P