Objective To evaluate the efficacy and safety of mesalazine modified-release tablets in the treatment of mild and moderate active ulcerative colitis (UC).Methods This study was a multicenter,single-blinded and randomized controlled study.A total of 251 active UC patients in 18 hospitals were enrolled into this study from November 2010 to January 2012.The subjects were divided into the mesalazine modified-release tablets group (n=123) and the mesalazine enteric-coated tablets group (n=128),three times daily,each of which took mesalazine modified-release tablets or mesalazine enteric coated tablets 800 mg,respectively,and the course of treatment was eight weeks.The difference of UC disease activity index (UC-DAI),UC-DAI at the beginning minus UC-DAI at the final evaluation,was calculated at final evaluation.And this was the primary efficacy parameter.Complete remission rate and effective rate were considered as the secondary efficacy parameter.Adverse drug reactions rates of two groups were calculated and taken as safety evalution.If the lower limit of the 95 ％ confidence interval was more than-0.1 in the difference of the decrease in UC-DAI between the two groups,the non-inferiority of mesalazine modified release tablets to mesalazine enteric-coated tablets was demonstrated.The analysis of covariance model was used for the primary efficacy parameter and the sub-group analysis.And chisquare test was used for the comparison between the two groups in the secondary efficacy parameter and in the adverse drug reactions.Results At the final evaluation,the decrease in UC-DAI of mesalazine modified-release tablets group was 2.84 and that of mesalazine enteric-coated tablets group was 2.56.The reduction degree was 0.27.The lower limit of the 95 ％ confidence interval in the difference of the decrease in UC DAI between the two groups was-0.34,which demonstrated the non-inferiority of mesalazine modified release tablets to mesalazine enteric-coated tablets.The complete remission rates of mesalazine modified release tablets group and mesalazine enteric-coated tablets group were 48.33％ (58/120) and 55.65％ (69/124) and the effective rates were 63.33％ (76/120) and 66.94％ (83/124),and there was no statistically significant difference between the two groups (all P＞ 0.05).At final evaluation,the decrease in UC DAI of mild patients (UC DAI 3 to 5 at enrollment) of mesalazine modified-release tablets group and mesalazine enteric-coated tablets group were 2.16 and 2.05,respectively; the difference of mesalazine modified release tablets group and mesalazine enteric coated tablets group of reduction degree of UC-DAI was 0.11,that of moderate patients (UC-DAI 6 to 8 at enrollment) were 3.49 and 3.03,respectively,the difference of mesalazine modified-release tablets group and mesalazine enteric-coated tablets group of reduction degree of UC DAI was 0.46,and there was no statistically significant difference between the groups (all P＞0.05).The adverse drug reactions rates of mesalazine modified-release tablets group and mesalazine enteric coated tablets group were 6.61％ (8/121) and 10.24％ (13/127),and there was no statistically significant difference between the two groups (P＞ 0.05).No serious adverse drug reactions were found in two groups.Conclusion Mesalazine modified release tablets has good efficacy and high safety in the treatment of mild to moderate active UC.

Objective To evaluate the efficacy and safety of mesalazine modified-release tablets in the maintenance treatment of patients with ulcerative colitis (UC) in remission phase.Methods This study was a multi-center,single-blinded and randomized controlled study.From November 2010 to August 2012,251 patients with UC from 18 hospitals were enrolled.According to the randomization table,all patients were divided into the mesalazine modified-release tablets group (n 126) and the mesalazine enteric-coated tablets group (n=125).The course of treatment were both 48 weeks.The primary efficacy parameter of the two groups including the rate of non-recurrence of bloody stool,and the secondary efficacy parameter including period of non-recurrence of bloody stool,period of non-recurrence of UC,incidence of adverse events and adverse drug reactions were observed.The GENMOD model was applied to calculate 95％ confidence interval (CI) of the rate of non-recurrence of bloody stool of the two groups.If the lower limits was over-10％ of the setting,it indicated that the former was not inferior to the latter.Results In 48 weeks of maintenance treatment,the rate of non-recurrence of bloody stool of themesalazinemodified-release tablets group was 82.99％(95％CI 73.53％ to 92.45％) and 73.30％ (95％ CI 64.04％ to 82.56％) in the mesalazine enteric-coated tablets group,respectively,and the difference between the two groups was 9.69％(95％CI-1.15％ to 20.53％ (＞-10％)) which indicated the mesalazine modified-release tablets group was not inferior to the mesalazine enteric-coated tablets group.There was no significant difference in the period of non recurrence of bloody stool and period of non recurrence of UC between the two groups (both P＞0.05).The incidence of adverse events was 48.78％ (60/123) in the mesalazine modified-release tablets group and 48.00％ (60/125) in the mesalazine enteric-coated tablets group,and the difference was not statistically significant (P=0.902).The incidence of adverse reactions was 16.26 ％ (20/123) in the mesalazine modified release tablets group and 13.60 ％ (17/125) in the mesalazine enteric-coated tablets group.There was no statistically significant difference (P =0.556).Conclusion Mesalazine modified release tablets can help maintain long-term remission in patients with UC,and can be used as a safe and effective alternative medicine in the treatments of UC in remission phase.

Objective To evaluate the efficacy and safety of rabeprazole sodium injection in the treatment of non-esophageal variceal upper gastrointestinal bleeding in comparison with the positive control,omeprazole.Methods From January 2010 to January 2011,231 patients with non-esophageal variceal upper gastrointestinal bleeding from 20 hospitals were divided into rabeprazole group and omeprazole group in this multicenter,randomized,blind,parallel-group,positive drug controlled clinical trial.Hemostasis rate in 72 hours was the primary endpoint.Hemostasis rate in 120 hours,time to hemostasis,blood transfusion volume and the rate of switching treatments were the secondary endpoint.And safety was also analyzed.Chi square test and Wilcoxon rank sum test were performed for statistical analysis.Results At 72 hours after treatment,the hemostasis rates of rabeprazole group and omeprazole group were 98.20％(109/111)and 98.25％(112/114), respectively, and the difference was not statistically significant (P＞0.05).The 95％ confidence interval (CI) of the rate difference between the two group was-3.50 ％ to 3.40 ％.The result of non-inferiority test indicated that the lower limit of the 95％CI of the rate difference between the two groups was-2.95％ (U=5.652,P＜0.01),and rabeprazole group was not inferior to omeprazole group.At 12 hours after treatment,the hemostatic rates of rabeprazole group and omeprazole group were 63.06％(70/111) and 53.51％(61/114),respectively,and there was no statistically significant difference (P＞0.05).At 120 hours after treatment,the hemostasis rates of rabeprazole group and omeprazole group were 99.10 ％ (110/111) and 98.25 ％ (112 /114),and there was no statistically significant difference (P＞0.05).The median time of hemostasis of two groups was 24 hours.During the treatment,there were two cases and seven cases of rabeprazole group and omeprazole group received blood transfusions,respectively;there were 0.90％ (1/111) and 2.63 ％ (3/114) patients switched to other treatment,and no statistically significant difference was found (P＞0.05).The rates of adverse event of rabeprazole group and omeprazole group were 11.61％ (13/112) and 5.26％ (6/114),respectively.The rates of adverse reaction were 6.25％ (7/112) and 4.39％ (5/114),respectively.The differences in the rates of adverse event and adverse reaction between two groups were not statistically significant(both P＞0.05).Conclusion Rabeprazole sodium injection is an effective and safe drug in the treatment of non-esophageal variceal upper gastrointestinal bleeding.

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.

Combined Modality Therapy ; Congresses as Topic ; Head and Neck Neoplasms ; therapy ; Humans

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 .01 ) . However there was no significant difference in the scores of loss of appetite and nausea (both 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 .

Objective To analyze the epidemic characteristics of mushroom poisoning incident in order to find the regularity of outbreak and provide the fundamental guidelines of prophylaxis,control,diagnosis and treatment.Methods According to the reported information from the Management Information System of Public Health Emergency in China mainland,the area-time distribution of mushroom poisoning incidents from 2004 to 2014 was analyzed,and the descriptive analysis of mushrooms poisoning incidents including causes,places,occupation of victims and incidents identification were made from 2010 to 2014.Results In China (excluding Hong Kong,Macao and Taiwan),the top five provinces of mushroom poisoning incidents were Yunnan,Guizhou,Sichuan,Guangxi and Hunan.The epidemic peak was reached in summer-autumn season.The major and significant incidents accounted for 76.56％ of overall mushroom poisoning incidents,and the fatality rate of 3 701 patients accounted for 21.24％ (786 deaths).The causes were mistaking poisonous mushrooms as edible mushrooms or purchasing poisonous mushrooms in the market by accident.About 87.50％ incidents happened at home.Farmers,workers,children and students were easily subjected to mushroom poisoning because of their large range of activities,strong curiosity and lacking related ability for distinguishing edible mushroom from poisonous mushrooms.No identification was done in 200 mushroom poisoning incidents from 2010 to 2014,which accounted for 92.59％ of mushroom poisoning incidents in the corresponding period.Standard species identification was carried out only in two poisonous mushroom incidents.Conclusions Mushroom poisoning incident was one of the most important causes of death in per-oral poisoning incidents.It should to cope with surveillance and meticulous management during high prevalence season and in high-risk provinces.At the same time,it should be strengthened to train doctors and health professionals with the knowledge of identification of mushroom poisoning in key areas as well as to develop the health promotion of mushrooms poisoning prevention.

Objective To investigate the accuracy of predicting middle cerebral artery infaction with contin -ue electroencephalograph .Methods 40 cases with middle cerebral artery infaction were divided into malignant groups(14) and binigan groups(26).They were all with continued beside electroencephalograph within 24 hours after admission.Results Abnormal CEEG rate in malignant groups [85.71%(12/14)]was significantly higher than that in binigan groups[65.38%(17/26)](χ2 =10.405,P=0.001).In malignant groups,severe abnormal CEEG was seen in 4 cases developed coma at the second day of admission ,moderate abnormal CEEG was found in 6 cases,slight abnormal CEEG was detected in 2 cases,normal CEEG was detected in 2 cases.Conclusion Early CEEG has a cer-tain value for predicting middle cerebral artery infaction .

Biopsy ; Guideline Adherence ; Humans ; Immunohistochemistry ; Lymphoma ; classification ; diagnosis ; pathology ; Practice Guidelines as Topic ; World Health Organization

Adult ; Aged ; Female ; Humans ; Laryngeal Neoplasms ; diagnosis ; surgery ; Male ; Middle Aged ; Neoplasms, Muscle Tissue ; diagnosis ; surgery