Treatment Of Recurrent Aphthous (heart And Product Heat Syndrome). Aphthous I Clinical Studies

OBJECTIVEThe purpose of this study is to evaluate the therapeutic effect and adverse reaction of Kouchuang I in treatment of Recurrent oral ulcer(Syndrome Of Intense Heat In Heart And Spleen). At the same time, to appraise the clinical curative effect and measure the security of this medicine by comparing with the known effective medicine (Niuhuang Tablet). All the conclusion is to be offered scientific basis for clinical application.METHODSIt was a random, open, group controled study comparing with the known effective medicine. 100 patients with Recurrent oral ulcer were divided into 2 groups at random; the ratio of the test group and the control group is 1:1. The test group was treated with Kouchuang I 100ml, per os, 3 times a day for 5 days. The control group was treated with Niuhuang Tablet 3, per os, 3 times a day for 5 days. Security indexes including blood-rt, urine-rt, stool-rt, hepatic function, renal function and electrocardiogram were tested before and after 5-days treatment. Then the results of indexes were compared between 2 groups, the main clinical symptoms and signs were observed and recorded after the treatment as well. The long-term effect of the two drugs were compared by observing the ulcer recurrence in 3 months.RESULTS1.The main symptoms and signs indexes of the two groups comparison: The main symptoms and signs indexes of the two groups were significantly improved (P< 0. 05) after the end of treatment, the test group in improving the ulcer size , the number of ulcer, the congestion of ulcer, the pain of ulcer , dry mouth and thirst, tongue and pulse was obviously superior to the control group(P< 0. 05). 2. The syndromes classification of the two groups comparison: According to the standard syndrome classification, the moderate and severe cases in the test group and the control group were reduced, 10 cases of the test group were recovered and 5 cases of the control group healed after the treatment. Drugs of the two groups can be improved syndromes (P< 0. 05), and the test group can be considered better than the control group(P < 0. 05).3. The total effective rate of the Tradition Chinese Medicine main symptoms and signs comparison: There were 12 cases recovered,15 cases effectual,20 cases effective and 3 cases ineffective in the test group, its total effective rate was 94. 0%; there were 7 cases recovered,10cases effectual,27 cases effective and 6 cases ineffective in the test group, its total effective rate was 88. 0%. Through statistical analysis, there were statistically significant differences between 2 groups in the total effective rate of the Traditional Chinese Medicine main symptoms and signs (P< 0. 05).4. The total effective rate on ulcer of the two groups comparison: The total effective rate on ulcer of the test group and control group was 90. 0% and 86.0%. There were not statistically significant differences (P > 0.05).5. The pain indexes recorded by patients comparison: The pain indexes recorded by patients reduced in each group. After the fourth day, the pain indexes of the test group was smaller than that of the control group. There were statistically significant differences between two groups (P< 0. 05).6. The recurrence rate of the two groups comparison : The recurrence rate of the test group was 45.83%, that of the control group was 80.95 %. Through statistical analysis, there were statistically significant differences between two groups (P < 0. 05).7. Security indexes of the two groups comparison: Both kinds of medicine had no obvious effect to blood-rt, urine-rt , stool-rt, hepatic function, renal function and electrocardiogram of all patients. Only 2 adverse reaction happened in test 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).CONCLUSIONKouchuang I can significantly improve the clinical symptoms and signs of patients with oral ulcer(Syndrome Of Intense Heat In Heart And Spleen), reducing the pain of ulcer, hastening ulcer recovery, alleviating symptoms such as dry mouth and thirst etc. To a certain extent, Kouchuang I can control ulcer recurrence. After the treatment of security checks, the facts suggest that Kouchuang I is a kind of safe medicine. It is worth generalizing to clinical use.