| Background and ObjectiveFunctional dyspepisa(FD) is a common clinical gastrointestinal functional disease. About 20% to 40% patients of the gastrointestinal outpatients will be diagnosed as FD. Recently, the RomeⅢcriteria which served as an important diagnosing basis was proposed. The pathogeny and pathogenesis of FD is not clear till now, while it's considered that gastrointestinal dyskinesis, abnormal acid secretion of stomach, HP infection, change of gastrointestinal correlative hormone or psychological factors induced FD. More and more evidence showed that gastrointestinal dyskinesis play an important role. Trimebutine Maleate is a bidirectional regulator to gastrointestinal movement which acts directly on the K+,Na+ channels in the smooth muscle of digestive tract and the opium receptors in the neuroplexus of gastrointestinal tract. It adjusts the gastrointestinal movement according to the different state of the smooth muscle. Both trimebutine maleate tablet and trimebutine maleate retard tablets are regulators to gastrointestinal movement. The mechanism of action and the medication of them are the same, while the latter has many advantages such as a longer period of active time and less administer frequency.This study was designed to assess the short term effect and safety of trimebutine maleate retard tablets in the treatment of FD by a randomized, double-blind test compared to trimebutine maleate tablet.Materials and methods1. Case selection Patients of the gastrointestinal outpatients who met the Rome III criteria for FD were selected. They all volunteered to take part in the study and signed the agreement. Then these patients were randomized equally to two groups.2. Methods A randomized, double-blind, parallel-controlled study was conducted, and it consisted of a 1-week baseline period, a 2-week treatment period and a 1-week withdraw period.3. Medication The observed group was treated with trimebutine maleate retard tablets (take one tablet twice a day) and trimebutine maleate tablet placebo(take two tablets three times a day), and the control group was treated with trimebutine maleate tablet (take two tablets three times a day) and trimebutine maleate retard tablets placebo (take one tablet twice a day).4. Observe items The symptom of FD (epigastric pain, epigastric burn, the sensation of fullness and early repletion) was assessed according to the standard before treatment and the first and second week after treatment. Body temperature, pulse rate, respiratory rate and blood pressure of patients were recorded at pre-treatment and post-treatment. blood routine, urine routine, stool routine and occult blood tests, liver function (ALT,AST,TBIL), renal function (BUN,Cr) and ECG were measured. all the adverse reactions were recorded.5. The criteria of symptom and therapeutic effect (1) Criteria of symptom score Recording the score acorrding to the severity of symptom,0 point:no symptom,1 point:the mild symptom need special attention to be felt,2 point:the symptom is obvious, but it did not affect the normal life and work.3 point:the symptom is obvious, and affected the normal life and work. Recording the score acorrding to the frequency of the symptom,0 point:no attack,1 point:the disease attacked 1 to 2 days per week,2 point:the disease attacked 3 to 5 days per week,3 point:the disease attacked almost everyday or the symptom was persistent. The symptom score was the sum of severity score and frequency score, the total score of the patient was the sum of the four symptom score. (2) Criteria of therapeutic effect Healed:the symptoms disappeared; remarkably effective:more than 80% symptoms were imporved; effective:more than 50% symptoms were imporved; ineffective:less than 50% symptoms were imporved; depravation:no symptom was imporved. The improvement rate=[(total score before treatment-total score after treatment)/total score before treatment]×100%. The total effective rate= [(healed cases+fully recovered cases+effectice cases)/total cases]×100%.6. Statistical method all the parameters were analyzed by SAS software. The measurement data was descriped by mean±SD, the data was analyzed by pairing t-test and ANOVA. The data can't met above criteria was analyzed by nonparameter test. Enumeration data was descriped by frequnce, and was analyzed by chi-square test (or CMH test) or nonparameter test. The significant standard was P<0.05. Result136 patients were selected in this experiment,6 cases (4.41%) escaped,64 cases in observed group and 66 cases in control group were eligible.1. There was good comparability of the population statistic characteristics, physical examanation and disease characteristics between the two groups(P>0.05).2. The assessment of symptom score:The symptom of Patients were improved obviously in the two groups, every symptom score of the two groups decreased. there was no significant difference between the two groups in each symptom scores post-treatment 1 week and 2 weeks (P>0.05). The total symptom score of observed group was 12.5±3.97, while it became 4.35±3.07 after 2 weeks treatment, there were significant differences in the total symptom scores between pre-treatment and post-treatment (P<0.001). The total symptom score of control group was 12.41±3.62, while it became 4.53±3.88 after 2 weeks treatment, there were significant differences in the total symptom scores between pre-treatment and post-treatment (P<0.001). No significant difference were observed between the two groups in the total symptom scores post-treatment 1 week and 2 weeks (P>0.05).3. The therapeutic effect results:In the observed group,8 cases (12.5%) were healed,13 cases (20.3%) were remarkably effective,32 cases (50.0%) were effective, 11 cases (17.2%) were ineffective, the total effective rate is 82.8%. In the control group,10 cases (15.2%) were healed,16 cases(24.2%) were remarkably effective,26 cases (39.4%) were effective,14 cases (21.2%) were ineffective, the total effective rate is 78.8%. There was no significant difference in the therapeutic effect results between the two groups(P>0.05).4. The safety analysis Body temperature, pulse rate, respiratory rate and blood pressure of patients did not change obviously after treatment in the two groups; the ALT of one case in the control group increased mildly (58U/L), and it was considered induced by the drug. The blood routine, urine routine, stool routine and occult blood tests, liver function, renal function and ECG of the other cases were normal before and after treatment. There was no adverse reaction in the observed group, there was one case of adverse reaction in the control group(1.52%). There was no significant difference between the two groups(P>0.05).ConclusionsTrimebutine maleate retard tablets is an effective medicine for fundamental symptom of FD. The short term effect is stable, and it is well tolerated with a good safety profile. |
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