AIM:To compare efficacy,patient compliance,acceptability,satisfaction,safety,and adenoma detection rate of sodium phosphate tablets(NaP,CLICOLONTM)to a standard 4 L polyethylene glycol(PEG)solution for bowel cleansing...AIM:To compare efficacy,patient compliance,acceptability,satisfaction,safety,and adenoma detection rate of sodium phosphate tablets(NaP,CLICOLONTM)to a standard 4 L polyethylene glycol(PEG)solution for bowel cleansing for adults undergoing colonoscopy.METHODS:In this multicenter,randomized,prospective,investigator-blind study,the relatively young(19-60years)healthy outpatients without comorbidity were randomly assigned to one of two arms.All colonoscopy were scheduled in the morning.The NaP group was asked to take 4 tablets,5 times the evening before and4 tablets,3 times early on the morning of the colonoscopy.The PEG group was asked to ingest 2 L of solution the evening before and 2 L early in the morning of the procedure.Adequacy of bowel preparation was scored using the Boston bowel preparation scale.RESULTS:No significant differences were observed between the NaP group(n=158)and PEG group(n=162)in bowel cleansing quality(adequate preparation93.0%vs 92.6%,P=0.877),patient compliance(P=0.228),overall adverse events(63.3%vs 69.1%,P=0.269),or adenoma detection rate(34.8%vs 35.2%,P=0.944).Patient acceptability,satisfaction,and patient rating of taste were higher in the NaP group than in the PEG group(P<0.001).CONCLUSION:NaP tablets,compared with PEG solution,produced equivalent colon cleansing,did not cause more side effects,and had better patient acceptability and satisfaction in the relatively young(age<60years)healthy individuals without comorbidity.An oral tablet formulation could make bowel preparation less burdensome,resulting in greater patient participation in screening programs.展开更多
The objective of this study is to investigate the feasibility of using chitosanesodium alginate(CSeSA)based matrix tablets for extended-release of highly water-soluble drugs by changing formulation variables.Using tri...The objective of this study is to investigate the feasibility of using chitosanesodium alginate(CSeSA)based matrix tablets for extended-release of highly water-soluble drugs by changing formulation variables.Using trimetazidine hydrochloride(TH)as a water-soluble model drug,influence of dissolution medium,the amount of CSeSA,the CS:SA ratio,the type of SA,the type and amount of diluents,on in vitro drug release from CSeSA based matrix tablets were studied.Drug release kinetics and release mechanisms were elucidated.In vitro release experiments were conducted in simulated gastric fluid(SGF)followed by simulated intestinal fluid(SIF).Drug release rate decreased with the increase of CSeSA amount.CS:SA ratio had only slight effect on drug release and no influence of SA type on drug release was found.On the other hand,a large amount of water-soluble diluents could modify drug release profiles.It was found that drug release kinetics showed the best fit to Higuchi equation with Fickian diffusion as the main release mechanism.In conclusion,this study demonstrated that it is possible to design extended-release tablets of watersoluble drugs using CSeSA as the matrix by optimizing formulation components,and provide better understanding about drug release from CSeSA matrix tablets.展开更多
AIM: To compare the efficacy and acceptance of senna tablet and sodium phosphate solution for bowel preparation before colonoscopy.METHODS: One hundred and thirty four patients, who needed elective colonoscopy, were r...AIM: To compare the efficacy and acceptance of senna tablet and sodium phosphate solution for bowel preparation before colonoscopy.METHODS: One hundred and thirty four patients, who needed elective colonoscopy, were randomly allocated to take 180 mg senna tablet or 95 mL sodium phosphate solution on the day before colonoscopy. The effi cacies of both laxatives were compared using the mean difference of colon-cleanliness score of the rectum, sigmoid segments, descending colon, transverse colon and cecum. The scores were rated by two observers who were blinded to the laxatives administered. The higher score means that the colon is cleaner. The efficacy of both laxatives were equivalent if the 95% confidence interval of the mean difference of the score of colon lie within -1 to +1. RESULTS: On intention-to-treat analysis, the mean cleanliness scores in the four segments of colon except the cecum were higher in the sodium phosphate group than those in senna group (7.9 ± 1.7 vs 8.3 ± 1.5, 8.0 ± 1.8 vs 8.5 ± 1.4, 7.9 ± 2.0 vs 8.5 ± 1.3, 7.9 ± 2.0 vs 8.2 ± 1.4 and 7.2 ± 1.7 vs 6.9 ± 1.4, respectively). The 95% conf idence intervals (95% CI) of mean difference in each segment of colon were not found to lie within 1 point which indicated that their effi cacies were not equivalent. The taste of senna was better than sodium phosphate solution. Also, senna had fewer side effects. CONCLUSION: The effi cacy of senna is not equivalentto sodium phosphate solution in bowel preparation for colonoscopy, but senna may be considered an alternative laxative.展开更多
AIM To compare the tolerability and quality of bowel cleansing between 2 L polyethylene glycol(PEG)and reduced-dose sodium phosphate(Na P)tablets as a preparation for colonoscopy.METHODS Two hundred patients were rand...AIM To compare the tolerability and quality of bowel cleansing between 2 L polyethylene glycol(PEG)and reduced-dose sodium phosphate(Na P)tablets as a preparation for colonoscopy.METHODS Two hundred patients were randomly assigned to the PEG or Na P groups at the same ratio.The Na P group patients took 30 tablets with 2 L of clear liquid,while the PEG group patients took 2L of PEG.Tolerability was assessed by a questionnaire about taste,volume,and the overall impression.The bowel cleansing quality was evaluated by colonoscopists.RESULTS Although Na P showed better tolerability in terms of taste,volume and overall impression(P<0.01,P<0.01 and P=0.02,respectively),the overall cleansing quality was better in the PEG group(P<0.01).A subgroup analysis,stratified by sex and age,indicated that Na P was associated with better tolerability and equivalent bowel cleansing quality in females of<50years of age.CONCLUSION Despite the better tolerability,the use of 30 Na P tablets with 2 L of clear liquid should be limited due to its lower cleansing quality;however,in certain cases the regimen may deserve consideration,particularly in cases involving young women.展开更多
BACKGROUND Yougui pills have long been used to treat hypothyroidism,usually in combination with levothyroxine sodium in clinical treatment,while their clinical efficacy and safety are still controversial when compared...BACKGROUND Yougui pills have long been used to treat hypothyroidism,usually in combination with levothyroxine sodium in clinical treatment,while their clinical efficacy and safety are still controversial when compared to levothyroxine treatment alone.AIM To explore the clinical efficacy and safety of Yougui pills combined with levothyroxine sodium in the treatment of hypothyroidism.METHODS This meta-analysis was performed in accordance with the PRISMA guidelines.Randomized controlled trials on Yougui pills in the treatment of hypothyroidism published from 2008 to May 2021 were searched in a total of 8 databases(4 databases in Chinese and 4 databases in English).The quality of the included studies was evaluated according to the Cochrane risk assessment tool.Weighted mean difference(WMD)was used for continuous variables,and relative risk(RR)was used for binary variables.Data were extracted,and the meta-analysis was conducted with the statistical software of Stata15.0 and RevMan5.0.RESULTS A total of 140 articles were retrieved,and 9 of them were finally included,with a total sample size of 936 cases.The main meta-analysis results are as follows:(1)The group of Yougui pills combined with levothyroxine sodium had a significantly higher overall response rate than the group of levothyroxine sodium(RR=1.20,95%CI 1.12,1.28,P<0.00001);(2)Yougui pills combined with levothyroxine sodium achieved significantly better efficacy than levothyroxine sodium alone in alleviating adverse symptoms[standard mean difference(SMD)=-1.10,95%CI:-1.37,-0.84,P<0.00001];(3)The level of thyrotropin stimulating hormone in the group of Yougui pills combined with levothyroxine sodium was significantly lower than in the control group of levothyroxine sodium(WMD=-1.38,95%CI:-2.10,-0.67,P=0.00001);(4)The level of free triiodothyronine in the group of Yougui pills combined with levothyroxine sodium was higher than that in the control group of levothyroxine sodium(WMD=0.41,95%CI:0.03,0.79,P=0.03);(5)The level of free thyroxine in the group of Yougui pills combined with levothyroxine sodium was significantly higher than that in the control group of levothyroxine sodium(SMD=0.83,95%CI:0.44,1.22,P≤0.0001);and(6)The adverse reactions in the group of Yougui pills combined with levothyroxine sodium were significantly less than those in the control group of levothyroxine sodium(RR=0.33,95%CI:0.20,-0.53,P<0.00001).CONCLUSION In the treatment of hypothyroidism,the combination of Yougui pills with levothyroxine sodium may be better than levothyroxine sodium treatment alone.展开更多
文摘AIM:To compare efficacy,patient compliance,acceptability,satisfaction,safety,and adenoma detection rate of sodium phosphate tablets(NaP,CLICOLONTM)to a standard 4 L polyethylene glycol(PEG)solution for bowel cleansing for adults undergoing colonoscopy.METHODS:In this multicenter,randomized,prospective,investigator-blind study,the relatively young(19-60years)healthy outpatients without comorbidity were randomly assigned to one of two arms.All colonoscopy were scheduled in the morning.The NaP group was asked to take 4 tablets,5 times the evening before and4 tablets,3 times early on the morning of the colonoscopy.The PEG group was asked to ingest 2 L of solution the evening before and 2 L early in the morning of the procedure.Adequacy of bowel preparation was scored using the Boston bowel preparation scale.RESULTS:No significant differences were observed between the NaP group(n=158)and PEG group(n=162)in bowel cleansing quality(adequate preparation93.0%vs 92.6%,P=0.877),patient compliance(P=0.228),overall adverse events(63.3%vs 69.1%,P=0.269),or adenoma detection rate(34.8%vs 35.2%,P=0.944).Patient acceptability,satisfaction,and patient rating of taste were higher in the NaP group than in the PEG group(P<0.001).CONCLUSION:NaP tablets,compared with PEG solution,produced equivalent colon cleansing,did not cause more side effects,and had better patient acceptability and satisfaction in the relatively young(age<60years)healthy individuals without comorbidity.An oral tablet formulation could make bowel preparation less burdensome,resulting in greater patient participation in screening programs.
基金supported by Liaoning Institutions excellent talents support plan(No.LR2013047).
文摘The objective of this study is to investigate the feasibility of using chitosanesodium alginate(CSeSA)based matrix tablets for extended-release of highly water-soluble drugs by changing formulation variables.Using trimetazidine hydrochloride(TH)as a water-soluble model drug,influence of dissolution medium,the amount of CSeSA,the CS:SA ratio,the type of SA,the type and amount of diluents,on in vitro drug release from CSeSA based matrix tablets were studied.Drug release kinetics and release mechanisms were elucidated.In vitro release experiments were conducted in simulated gastric fluid(SGF)followed by simulated intestinal fluid(SIF).Drug release rate decreased with the increase of CSeSA amount.CS:SA ratio had only slight effect on drug release and no influence of SA type on drug release was found.On the other hand,a large amount of water-soluble diluents could modify drug release profiles.It was found that drug release kinetics showed the best fit to Higuchi equation with Fickian diffusion as the main release mechanism.In conclusion,this study demonstrated that it is possible to design extended-release tablets of watersoluble drugs using CSeSA as the matrix by optimizing formulation components,and provide better understanding about drug release from CSeSA matrix tablets.
文摘AIM: To compare the efficacy and acceptance of senna tablet and sodium phosphate solution for bowel preparation before colonoscopy.METHODS: One hundred and thirty four patients, who needed elective colonoscopy, were randomly allocated to take 180 mg senna tablet or 95 mL sodium phosphate solution on the day before colonoscopy. The effi cacies of both laxatives were compared using the mean difference of colon-cleanliness score of the rectum, sigmoid segments, descending colon, transverse colon and cecum. The scores were rated by two observers who were blinded to the laxatives administered. The higher score means that the colon is cleaner. The efficacy of both laxatives were equivalent if the 95% confidence interval of the mean difference of the score of colon lie within -1 to +1. RESULTS: On intention-to-treat analysis, the mean cleanliness scores in the four segments of colon except the cecum were higher in the sodium phosphate group than those in senna group (7.9 ± 1.7 vs 8.3 ± 1.5, 8.0 ± 1.8 vs 8.5 ± 1.4, 7.9 ± 2.0 vs 8.5 ± 1.3, 7.9 ± 2.0 vs 8.2 ± 1.4 and 7.2 ± 1.7 vs 6.9 ± 1.4, respectively). The 95% conf idence intervals (95% CI) of mean difference in each segment of colon were not found to lie within 1 point which indicated that their effi cacies were not equivalent. The taste of senna was better than sodium phosphate solution. Also, senna had fewer side effects. CONCLUSION: The effi cacy of senna is not equivalentto sodium phosphate solution in bowel preparation for colonoscopy, but senna may be considered an alternative laxative.
文摘AIM To compare the tolerability and quality of bowel cleansing between 2 L polyethylene glycol(PEG)and reduced-dose sodium phosphate(Na P)tablets as a preparation for colonoscopy.METHODS Two hundred patients were randomly assigned to the PEG or Na P groups at the same ratio.The Na P group patients took 30 tablets with 2 L of clear liquid,while the PEG group patients took 2L of PEG.Tolerability was assessed by a questionnaire about taste,volume,and the overall impression.The bowel cleansing quality was evaluated by colonoscopists.RESULTS Although Na P showed better tolerability in terms of taste,volume and overall impression(P<0.01,P<0.01 and P=0.02,respectively),the overall cleansing quality was better in the PEG group(P<0.01).A subgroup analysis,stratified by sex and age,indicated that Na P was associated with better tolerability and equivalent bowel cleansing quality in females of<50years of age.CONCLUSION Despite the better tolerability,the use of 30 Na P tablets with 2 L of clear liquid should be limited due to its lower cleansing quality;however,in certain cases the regimen may deserve consideration,particularly in cases involving young women.
基金Supported by the National Natural Science Foundation of China,No.81973754Shaanxi University of Traditional Chinese Medicine Innovation Team Project,No.2019-QN06.
文摘BACKGROUND Yougui pills have long been used to treat hypothyroidism,usually in combination with levothyroxine sodium in clinical treatment,while their clinical efficacy and safety are still controversial when compared to levothyroxine treatment alone.AIM To explore the clinical efficacy and safety of Yougui pills combined with levothyroxine sodium in the treatment of hypothyroidism.METHODS This meta-analysis was performed in accordance with the PRISMA guidelines.Randomized controlled trials on Yougui pills in the treatment of hypothyroidism published from 2008 to May 2021 were searched in a total of 8 databases(4 databases in Chinese and 4 databases in English).The quality of the included studies was evaluated according to the Cochrane risk assessment tool.Weighted mean difference(WMD)was used for continuous variables,and relative risk(RR)was used for binary variables.Data were extracted,and the meta-analysis was conducted with the statistical software of Stata15.0 and RevMan5.0.RESULTS A total of 140 articles were retrieved,and 9 of them were finally included,with a total sample size of 936 cases.The main meta-analysis results are as follows:(1)The group of Yougui pills combined with levothyroxine sodium had a significantly higher overall response rate than the group of levothyroxine sodium(RR=1.20,95%CI 1.12,1.28,P<0.00001);(2)Yougui pills combined with levothyroxine sodium achieved significantly better efficacy than levothyroxine sodium alone in alleviating adverse symptoms[standard mean difference(SMD)=-1.10,95%CI:-1.37,-0.84,P<0.00001];(3)The level of thyrotropin stimulating hormone in the group of Yougui pills combined with levothyroxine sodium was significantly lower than in the control group of levothyroxine sodium(WMD=-1.38,95%CI:-2.10,-0.67,P=0.00001);(4)The level of free triiodothyronine in the group of Yougui pills combined with levothyroxine sodium was higher than that in the control group of levothyroxine sodium(WMD=0.41,95%CI:0.03,0.79,P=0.03);(5)The level of free thyroxine in the group of Yougui pills combined with levothyroxine sodium was significantly higher than that in the control group of levothyroxine sodium(SMD=0.83,95%CI:0.44,1.22,P≤0.0001);and(6)The adverse reactions in the group of Yougui pills combined with levothyroxine sodium were significantly less than those in the control group of levothyroxine sodium(RR=0.33,95%CI:0.20,-0.53,P<0.00001).CONCLUSION In the treatment of hypothyroidism,the combination of Yougui pills with levothyroxine sodium may be better than levothyroxine sodium treatment alone.
