Study On The Safety Of Clinical Trial With Antiulcer Capsule

Dundenal ulcer(DU),which is mainly related to the digestion of stomach acid and pepsin,is one of multiple diseases that causes bleeding,perforation,pyloric obstruction,and other discomforts of the digestive system.The typical clinical manifestations of DU include rhythmic and periodic bellyache.The DU can be relieved by taking appropriate medication or diet.At present,duodenal ulcer is a heterogeneous disease groups that caused by various etiologies.For example,the infection of Helicobacter pylori(Hp)and the application of NSAIDs can lead to the autodigestion of gastric acid and pepsin,eventually causing the duodenal ulcer.At present,the treatment of duodenal ulcer mainly aims to achieve the therapeutic goal by eradicating Hp.However,the long-term use of western medicine will increase the resistance of patients and cause certain side effects.Duodenal ulcer belongs to"epigastric pain" category in the theory of Chinese medicine.During the active stage,it is charactered by the sthenia syndrome,heat syndrome and blood stasis syndrome(syndrome of blood stasis and heat accumulation).Inflammatory manifestations,such as hyperemia and edema,can be observed around the ulcers under the gastroscope.Sometimes the ulcers will even bleed.The theory of Chinese medicine believes that "blood can carry Qi and it is the protector of Qi.The tired blood stop and accumulate.It inevitably results in the depression and stagnation of Qi,which is refer to "blood ill inevitably accompanied by the stagnation of Qi".Besides,it will be accompanied by the abdominal fullness,and heating anorexia.Therefore,it is the mechanism of the duodenal ulcer.Chinese medicine has good curative effect and little side effects,so the development of Chinese medicine has great prospects for the treatment of duodenal ulcer.Antiulcer capsule is a new drug mainly consists of Panax notoginseng saponins,cambootan alkaloids,celandine alkaloids and other components.The curative effects include heat-clearing and damp-drying,elimination of blood stasis,mscle growth,gastric pain relieving and others effects.It is mianly applied for the DU with symptoms of epigastric pain and acid regurgitation(syndrome of blood stasis and heat accumulation).In the preclinical study of antiulcer capsule,pharmacological and toxicological experiments were carried out.Pharmacological experiments showed that antiulcer capsule has a significant effect on the treatment of duodenal ulcer.The toxicological effect showed that antiulcer capsule had no obvious toxic and side effects on major organs.The tolerance tests of the clinical stage I and clinical stage ? has determined the test dose of antiulcer capsule.In order to further explore the safety of antiulcer capsule,based on its previous clinical trial results,we studied out the test scheme of the safety test of phase ?c clinical trials of the antiulcer capsule.The randomized,open-label,parallel-design,multicenter clinical test method is adopted.It includes 40 patients which are randomly allocated with the the radio of combination therapy group:positive control group=1:1.The combination group is treated with antiulcer capsule and triple therapy,while positive control group is treated with the quadruple therapy.The safety of traditional antiulcer capsule was evaluated from three aspects,including the safety of vital signs,the laboratory safety indicators and adverse reactions,in order to further determine the safety of antiulcer capsule.The safety results showed that,under the certain sample size,the incidence of adverse reaction in the combination group was 20.00%and the incidence of adverse reaction in the positive control group was 15.00%.There are no serious adverse events,and all the adverse reaction were cured or improved.There was no significant difference between the incidence of adverse reaction in the combination group and the positive control group.There were no significant differences in vital signs too.In the laboratory examination,there were 2 cases(5%)who have the normal baseline and the 4-week anomaly with clinical significance.2 cases belonged to the pos-itive control group.There were 4 cases(10%)who have baseline anomaly without clinical significance.3 cases belonged to the combination group and 1case belonged to the positive control group.All cases were re-classified as good.It shows that the antiulcer capsule has high security.Generally,the clinical trial of antiulcer capsule has low incidence on adverse events during the treatment of duodenal ulcer,low impact on the safety laboratory index on the subjects,no impact on the vital signs of subjects under the certain sample size,so it has high security.The experiment has further confirmed the safety of antiulcer capsule and provides a powerful basis for the effective implementation of the III stage experiments and the effective treatment of duodenal ulcer.Meanwhile,it also provides experimental basis for the listing of antiulcer capsule.