ABSTRACT
Objective To analyze the effect of Compound Azintamide Enteric-coated Tablets combined with laparoscopic cholecystectomy on patients with gallstone and cholecystitis. Methods 72 cases of cholelithiasis and cholecystitis were randomly divided into experimental group and control group, each had 36 cases. Two groups of patients were treated with Compound Azintamide Enteric-coated Tablets, and on this basis, the experimental group received laparoscopic treatment, while the control group was treated with traditional laparotomy. After treatment, the differences between the two groups in general situation, the efficacy and the quality of life were compared. Results The bleeding volume, operation time and treatment in experimental group patients after hospitalization were lower than patients in the control group (P<0.05), the curative effect and quality of life in experimental group were better than patients of control group, the difference were statistically significant (P<0.05). Conclusion Compound Azintamide Enteric-coated Tablets combined laparoscopic surgery on gallstone and cholecystitis has better efficacy and better quality of life.
ABSTRACT
Objective To analyze the effect of Compound Azintamide Enteric-coated Tablets combined with laparoscopic cholecystectomy on patients with gallstone and cholecystitis. Methods 72 cases of cholelithiasis and cholecystitis were randomly divided into experimental group and control group, each had 36 cases. Two groups of patients were treated with Compound Azintamide Enteric-coated Tablets, and on this basis, the experimental group received laparoscopic treatment, while the control group was treated with traditional laparotomy. After treatment, the differences between the two groups in general situation, the efficacy and the quality of life were compared. Results The bleeding volume, operation time and treatment in experimental group patients after hospitalization were lower than patients in the control group (P<0.05), the curative effect and quality of life in experimental group were better than patients of control group, the difference were statistically significant (P<0.05). Conclusion Compound Azintamide Enteric-coated Tablets combined laparoscopic surgery on gallstone and cholecystitis has better efficacy and better quality of life.
ABSTRACT
Objective To explore the efficacy and safety of compound azintamide enteric‐coated tablets in the treatment of patients with dyspepsia after gastrointestinal surgery .Methods Multicenter , randomized ,double blind ,placebo‐controlled ,parallel controlled method w as applied .From January 2011 to January 2013 , of 240 patients with dyspepsia after gastrointestinal surgery from 12 hospitals in Shanghai were enrolled and divided into medicine treatment group (n= 120) and placebo control group (n= 120 ) ,received compound azintamide enteric‐coated tablets or placebo , respectively . Compound azintamide enteric‐coated tablet (100 mg) or placebo was oral taken each time ,three times per day for four weeks .Total and respective score of dyspeptic symptoms (abdominal distension ,loss of appetite ,early satiety ,belching ,nausea ,abdominal pain or abdominal discomfort) were evaluated prior to study and on the 1st , 2nd , 3rd and 4th week after treatment . On the 4th week after treatment ,the efficacy of the improvement of dyspeptic symptoms was compared between the two groups ,and the safety was also evaluated .The score of the quality‐of‐life was compared between the two groups prior to study and on the 4thweek after treatment .The t‐test was performed for comparison between measurement data ,Chi‐square test was used for count data ,and rank sum test was used for rank data .Results At one week after treatment ,the scores of abdominal distension (4 .61 ± 0 .98 ) ,early satiety (2 .87 ± 0 .64 ) ,belching (3 .03 ± 0 .58) ,abdominal pain or abdominal discomfort (3 .13 ± 0 .79) and total score (18 .32 ± 3 .44) of patients in medicine treatment group were significantly lower than those of placebo control group (8 .83 ± 1 .28、4 .28 ± 0 .61、4 .87 ± 1 .07、5 .46 ± 0 .87、29 .63 ± 5 .50) ,and the differences were statistically significant (t=28 .524、17 .400、16 .453、21 .619 and 18 .983 ,all P 0 .05) .At 2nd ,3rd and 4th week after treatment ,respective score of dyspeptic symptoms and total score of medicine treatment group (2nd week:2.57±1.28,1.87±1.17,1.55±1.27,1.55±1.08,1.09±0.82,1.98±1.02,10.53±4.54,3rdweek:1 .42 ± 0 .60 ,1 .11 ± 0 .45 ,0 .94 ± 0 .37 ,0 .94 ± 0 .41 ,0 .79 ± 0 .31 ,1 .42 ± 0 .55 ,6 .52 ± 2 .41 ,4th w eek:1.13±0.51,0.46±0.12,0.58±0.13,0.38±0.16,0.30±0.07,0.81±0.33,3.65±1.06)wereall significantly lower than those of placebo control group (2nd week:8 .50 ± 2 .61 ,3 .78 ± 2 .01 ,4 .08 ± 2 .14 , 4.73±2.64,2.27±2.13,4.91±2.24,28.25±8.86,3rdweek:7.92±2.51,3.68±1.76,4.08±1.86, 4.71±1.77,2.14±0.83,5.01±1.31,27.54±8.09,4th week:7.63±2.37,3.67±1.63,3.92±2.08, 4 .66 ± 2 .95 ,2 .14 ± 1 .65 ,4 .67 ± 2 .34 ,and 26 .68 ± 7 .45) ,and the differences were statistically significant (all t=0 .000 ,all P<0 .01) .At 4th week after treatment ,the total efficacy of total score improvement of dyspepsia symptoms in medicine treatment group was 86 .21% (100/116) ,which was significantly better than that of placebo control group (39 .16% (47/120)) ,and the difference was statistically significant (Z=9 .464 ,P<0 .01) .The total score of quality of life in medicine treatment group was significantly lower than that of placebo control group (12 .24 ± 4 .30 and 22 .13 ± 6 .18) ,and the difference was statistically significant (t=14 .225 , P< 0 .01 ) .No adverse events was observed in both groups during treatment period . Conclusion Compound azintamide enteric‐coated tablets may effectively improve dyspeptic symptoms and quality of life in patients with dyspepsia after gastrointestinal surgery ,and with good safety .
ABSTRACT
Objective To evaluate the efficacy and safety of compound azintamide enteric-coated tablet in the treatment of patients with post-cholecystectomy dyspepsia.Methods A multicentre,randomized,double-blinded,placebo-controlled trail was conducted.A total of 120 patients with post-cholecystectomy dyspepsia were divided into azintamide group (n=60) and placebo group (n＝60),taking compound azintamide enteric-coated tablet or placebo 100 mg each time,three times per day for 28 days.The score of each dyspeptic symptom (abdominal distension,loss of appetite,early satiety,belching,nausea,abdominal pain or abdominal discomfort) and total score of dyspepsia were evaluated prior to study and on the 7th,14th,21st and 28th day after treatment.The efficacy of the improvement of dyspeptic symptoms was compared between the two groups on the 28th day after treatment and the safety was evaluated.The score of the quality-of-life was compared between the two groups prior to study and on the 28th day after treatment.The t-test or chi-square test was performed for statistical analysis.Results The scores of abdominal distension,belching,nausea,abdominal pain or abdominal discomfort and the total score of azintamide group on the 7th day after treatment (5.7±3.1,3.5±2.1,0.3±0.1,3.3±1.7 and 17.9±9.6) were significantly lower than those prior to study (8.9±5.3,5.3±2.5,0.9±0.4,4.5±3.7,24.3±14.5;t=3.758,3.976,10.494,2.125 and 2.654,allP＜0.05).On the14th,21st and28thday after treatment in azintamide group,the score of each dyspeptic symptom and the total score were lower than those prior to study.The symptom of abdominal distension significantly improved on the 7th,14th,21st and 28th day after treatment in placebo group,and the score of early satiety and total score of dyspepsia were significantly lower on the 28th day after treatment compared with those before treatment.In azintamide group,the total efficacy rate was 66.7％ (40/60),which was higher than that of placebo group (38.3％,23/60) and the difference was statistically significant (x2 =9.653,P ＜ 0.01).On the 28th day after treatment,SF-NDI of azintamide group was 4.4±3.4,which was significantly lower than that of placebo group (9.6±6.0) and the difference was statistically significant (t=5.450,P＜0.01).In azintamide group there was one patient with rash on the 7th day after treatment,and in placebo group there was one patient with headache on the 14th day after treatment.The symptoms disappeared seven days after medicine withdrawal.Conclusion Compound azintamide enteric-coated tablet effectively improves dyspeptic symptoms and quality of life in patients with post-cholecysteetomy dyspepsia and has good safety.