Triple Tablets In The Treatment Of Recurrent Aphthous Ulcer (heart And Product Heat Syndrome) Clinical Studies

OBJECTIVEThe purpose of this study is to evaluate the therapeutic effect and adverse reaction of Sanlian Tablet in treatment of minor recurrent oral ulcer. At the same time, to appraise the clinical curative effect and measure the security of this medicine by comparing with the known effective medicine (Qinlian Tablet). All the conclusion is to be offered scientific basis for clinical application. METHODSIt was a random, double blind, group controled study comparing with the known effective medicine. 80 patients with minor recurrent oral ulcer were divided into two groups at random;60 in therapy group and the other 20 in control group. The therapy group was treated with Sanlian Tablet 2g, per os, 3 times a day for 5 days. The control group was treated with Qinlian Tablet 2g, per os, 3 times a day for 5 days. Security indexes including renal function, hepatic function, electrocardiogram, blood-rt, urine-rt and stool-rt were tested before and after 5-days treatment. Then the results of indexes were compared between 2 groups, the main clinical symptoms and physical signs were observed and recorded after the treatment as well. RESULTS1. The main symptoms and physical signs of the patients ameliorate and part of the patients recovered from the disease. There were statistically significant differences after treatment in each group(P < 0.01); there were not statistically significant differences between two groups(P > 0. 05). The two kinds of medicine were effective on these symptoms and physical signs.2. The moderate and the serious cases were decreased after treatment.5 patients recovered in therapy group and 2 in control one. There were statistically significant differences after treatment in each group(P<0. 01).3. There were not statistically significant differences between 2 groups in the total effective rate of the Traditional Chinese Medicine grade (P>0.05).4. There were not statistically significant differences between 2 groups in the total effective rate of the Traditional Chinese Medicine main symptoms and physical signs(P>0. 05).5. The total effective rate on ulcer of the Sanlian Tablet group and Qinlian Tablet group was 95. 0% and 90. 0%. There were not statistically significant differences (P>0.05).6. The total effective rate of pain recorded by patients on the third day was 76. 7% and 50. 0%. The result of the therapy group was better than the other one. There was statistically significant difference (P<0. 05). Sanlian Tablet is more efficient on improving pain than Qinlian Tablet.7. The pain indexes recorded by patients reduced in each group. But there was not statistically significant difference between two groups(P>0. 05).8. Both kinds of medicine had no obvious effect to the heart function, hepatic function, renal function, blood-rt, urine-rt and stool-rt of all patients. Only one adverse reaction happened in therapy group ,but there was no serious effection. The reaction did not appear again when the patient took medicine after a meal everyday. The differences of incidence rate of adverse reaction between 2 groups were not statistically significant (P>0. 05).CONCLUSIONSanlian Tablet can improve the clinical symptoms, physical signs of patients with minor oral ulcer. The therapeutic effect on ulcer pain of Sanlian Tablet is better than that of Qinlian Tablet. The incidence rate of adverse reaction of Sanlian Tablet is not higher than that of Qinlian Tablet. The facts suggest that Sanlian Tablet is a kind of safe medicine. It is worth generalizing to clinical use.