AIM： Itopride is a newly developed prokinetic agent, which enhances gastric motility through both antidopaminergic and anti-acetylcholinesterasic actions. The importance of esophageal motor dysfunction in the pathoge...AIM： Itopride is a newly developed prokinetic agent, which enhances gastric motility through both antidopaminergic and anti-acetylcholinesterasic actions. The importance of esophageal motor dysfunction in the pathogenesis of gastro-esophageal reflux disease （GERD） makes it interesting to examine the effect of itopride on esophageal acid exposure.METHODS： The effect of itopride on esophageal acid reflux variables for 24 h was studied in 26 patients with GERD symptoms, pre-entry total acid exposure time （pH〈4） of more than 5% and mild esophagitis （SavaryMiller grades I, II） proven by endoscopy. Ambulatory 24hpH-metry and symptom assessment were performed after treatments with 150 or 300 mg itopride thrice a day （t.i.d.） for 30 d in random order, using an open label method.For evaluating the safety of itopride, blood biochemical laboratory test was performed and the serum prolactin level was also examined before and after treatment.RESULTS： Total symptom score was significantly decreased after treatment in 150- or 300-mg group. Itopride 300 mg was significantly effective than 150 mg on decreasing the total per cent time with pH〈4, total time with pH〈4 and DeMeester score. No serious adverse effects were observed with administration of itopride in both groups.CONCLUSION： Itopride 100 mg t.i.d, is effective on decreasing pathologic reflux in patient with GERD and therefore it has the potential to be effective in the treatment of this disease.展开更多
AIMTo study the effect of itopride on gastric accommodation, gastric emptying and drinking capacity in functional dyspepsia (FD). METHODSRandomized controlled trial was conducted to check the effect of itopride on gas...AIMTo study the effect of itopride on gastric accommodation, gastric emptying and drinking capacity in functional dyspepsia (FD). METHODSRandomized controlled trial was conducted to check the effect of itopride on gastric accommodation, gastric emptying, capacity of tolerating nutrient liquid and symptoms of FD. We recruited a total of 31 patients having FD on the basis of ROME III criteria. After randomization, itopride was received by 15 patients while 16 patients received placebo. Gastric accommodation was determined using Gastric Scintigraphy. <sup>13</sup>C labeled octanoic breadth test was performed to assess gastric emptying. Capacity of tolerating nutrient liquid drink was checked using satiety drinking capacity test. The intervention group comprised of 150 mg itopride. Patients in both arms were followed for 4 wk. RESULTSMean age of the recruited participant 33 years (SD = 7.6) and most of the recruited individuals, i.e., 21 (67.7%) were males. We found that there was no effect of itopride on gastric accommodation as measured at different in volumes in the itopride and control group with the empty stomach (P = 0.14), at 20 min (P = 0.38), 30 min (P = 0.30), 40 min (P = 0.43), 50 min (P = 0.50), 60 min (P = 0.81), 90 min (P = 0.25) and 120 min (P = 0.67). Gastric emptying done on a sub sample (n = 11) showed no significant difference (P = 0.58) between itopride and placebo group. There was no significant improvement in the capacity to tolerate liquid in the itopride group as compared to placebo (P = 0.51). Similarly there was no significant improvement of symptoms as assessed through a composite symptom score (P = 0.74). The change in QT interval in itopride group was not significantly different from placebo (0.10). CONCLUSIONOur study found no effect of itopride on gastric accommodation, gastric emptying and maximum tolerated volume in patients with FD.展开更多
AIM:To evaluate the therapeutic effects of itopride vs other drugs(placebo,domperidone,mosapride) for functional dyspepsia(FD).METHODS:Randomized controlled trials(RCTs) of itopride for FD were retrieved from database...AIM:To evaluate the therapeutic effects of itopride vs other drugs(placebo,domperidone,mosapride) for functional dyspepsia(FD).METHODS:Randomized controlled trials(RCTs) of itopride for FD were retrieved from databases.Relevant information was extracted and analyzed,using the relative risk(RR) and weighted mean deviation,as appropriate.A random or fixed effect model was used,based on the heterogeneity of the included articles,and visual inspection of funnel plots was used to evaluate publication bias.RESULTS:Nine RCTs enrolling 2620 FD cases were included;1372 cases received itopride treatment and 1248 cases received placebo or other drugs(control groups).Compared with control groups,itopride had superior RR values of 1.11 [95%CI:(1.03,1.19),P = 0.006],1.21 [95%CI:(1.03,1.44),P = 0.02],and1.24 [95%CI:(1.01,1.53),P = 0.04] for global patient assessment,postprandial fullness,and early satiety,respectively.For the Leeds Dyspepsia Questionnaire score,the weighted mean deviation was-1.38 [95%CI:(-1.75,-1.01),P < 0.01].The incidence of adverse effects was similar in the itopride and control groups.The funnel plots for all indicators showed no evidence of publication bias.CONCLUSION:Itopride has good efficacy in terms of global patients assessment,postprandial fullness,and early satiety in the treatment of patients with FD and shows a low rate of adverse reactions.Itopride can greatly improve FD syndromes-score.展开更多
A specific, precise and stability indicating high-performance thin-layer chromatographic method for simultaneous estimation of pantoprazole sodium and itopride hydrochloride in pharmaceutical formulations was develope...A specific, precise and stability indicating high-performance thin-layer chromatographic method for simultaneous estimation of pantoprazole sodium and itopride hydrochloride in pharmaceutical formulations was developed and validated. The method employed TLC aluminium plates precoated with silica gel 60F254 as the stationary phase. The solvent system consisted of methanol：water：ammonium acetate; 4.0：1.0：0.5 （v/v/v）. This system was found to give compact and dense spots for both itopride hydrochloride （Rf value of 0.55__＋0.02） and pantoprazole sodium （Rf value of 0.85＋0.04）. Densitometric analysis of both drugs was carried out in the reflectance- absorbance mode at 289 nm. The linear regression analysis data for the calibration plots showed a good linear relationship with R2=0.9988___0.0012 in the concentration range of 100--400 ng for pantoprazole sodium. Also, the linear regression analysis data for the calibration plots showed a good linear relationship with R2=0.9990_＋0.0008 in the concentration range of 200-1200 ng for itopride hydrochloride. The method was validated for specificity, precision, robustness and recovery. Statistical analysis proves that the method is repeatable and selective for the estimation of both the said drugs. As the method could effectively separate the drug from its degradation products, it can be employed as a stability indicating method.展开更多
Background: The efficacy of lubiprostone for chronic constipation has been established through phase III clinical trials. Nevertheless, the continuation of lubiprostone therapy is reportedly difficult due to the devel...Background: The efficacy of lubiprostone for chronic constipation has been established through phase III clinical trials. Nevertheless, the continuation of lubiprostone therapy is reportedly difficult due to the development of nausea. The objective of this study is to determine whether the administration of itopride hydrochloride can reduce lubiprostone-related nausea. Methods: Two hundred and thirty-five patients who were receiving lubiprostone (24 μg capsule twice daily) were enrolled. Seventy-one patients took a prophylactic dose of itopride (50 mg tablet twice daily) together with lubiprostone to prevent nausea. Thus, the patients were divided into 2 groups: lubiprostone alone (164;control group) and combination therapy with lubiprostone and itopride (71;itopride group). Efficacy measures included changes in constipation scoring system scores, the incidence of treatment-related adverse events including nausea, and the percentage of patients who discontinued treatment within two weeks after administration. Results: Of the 235 patients who were enrolled, 196 were available for analysis. Both treatment groups experienced statistically significant improvements in constipation scoring system scores. The percentage of patients who reported ≥1 adverse event was significantly higher in the control group (40.9%) than in the itopride group (21.9%). The percentage of patients experiencing nausea was statistically and significantly lower in the itopride group than in the control group (9.4% versus 22.7%). The itopride regimen was also statistically superior compared to the control regimen in terms of treatment discontinuation. Conclusion: The prophylactic administration of itopride can decrease the risk of nausea in patients receiving lubiprostone and consequently reduce the risk of treatment discontinuation.展开更多
AIM:To evaluate the effect of prokinetic drugs on electrogastrography(EGG) parameters according to symptomatic changes in patients with functional dyspepsia(FD).METHODS:Seventy-four patients with FD were prospectively...AIM:To evaluate the effect of prokinetic drugs on electrogastrography(EGG) parameters according to symptomatic changes in patients with functional dyspepsia(FD).METHODS:Seventy-four patients with FD were prospectively enrolled in this study between December 2006 and December 2010.We surveyed the patients using a questionnaire on dyspeptic symptoms before and after an 8-wk course of prokinetic drug treatment.We also measured cutaneous pre-prandial and postprandial EGG recordings including percentage of gastric waves(normogastria,bradygastria,tachygastria),dominant frequency(DF),dominant power(DP),dominant frequency instability coefficient(DFIC),dominant power instability coefficient(DPIC),and the ratio of post-prandial to fasting in DP before and after the 8-wk course of prokinetic drug treatment.RESULTS:Fifty-two patients(70%) achieved symptomatic improvement after prokinetic drug treatment.Patients who had normal gastric slow waves showed symptom improvement group after treatment.Postprandial DF showed a downward trend in the symptom improvement group,especially in the itopride group.Post-prandial DP was increased regardless of symptom improvement,especially in the itopride group and mosapride group.Post-prandial DFIC and DPIC in the symptom improvement group were significantly increased after the treatment.The EGG power ratio was increased after treatment in the symptom improvement group(0.50 ± 0.70 vs 0.93 ± 1.77,P = 0.002),especially in the itopride and levosulpiride groups.CONCLUSION:Prokinetics could improve the symptoms of FD by regulating gastric myoelectrical activity,and EGG could be a useful tool in evaluating the effects of various prokinetics.展开更多
基金Supported by the 2004 Research Fund of Wonkwang University
文摘AIM： Itopride is a newly developed prokinetic agent, which enhances gastric motility through both antidopaminergic and anti-acetylcholinesterasic actions. The importance of esophageal motor dysfunction in the pathogenesis of gastro-esophageal reflux disease （GERD） makes it interesting to examine the effect of itopride on esophageal acid exposure.METHODS： The effect of itopride on esophageal acid reflux variables for 24 h was studied in 26 patients with GERD symptoms, pre-entry total acid exposure time （pH〈4） of more than 5% and mild esophagitis （SavaryMiller grades I, II） proven by endoscopy. Ambulatory 24hpH-metry and symptom assessment were performed after treatments with 150 or 300 mg itopride thrice a day （t.i.d.） for 30 d in random order, using an open label method.For evaluating the safety of itopride, blood biochemical laboratory test was performed and the serum prolactin level was also examined before and after treatment.RESULTS： Total symptom score was significantly decreased after treatment in 150- or 300-mg group. Itopride 300 mg was significantly effective than 150 mg on decreasing the total per cent time with pH〈4, total time with pH〈4 and DeMeester score. No serious adverse effects were observed with administration of itopride in both groups.CONCLUSION： Itopride 100 mg t.i.d, is effective on decreasing pathologic reflux in patient with GERD and therefore it has the potential to be effective in the treatment of this disease.
基金Supported by Higher Education Commission Pakistan,No20-1051/R&D/2007
文摘AIMTo study the effect of itopride on gastric accommodation, gastric emptying and drinking capacity in functional dyspepsia (FD). METHODSRandomized controlled trial was conducted to check the effect of itopride on gastric accommodation, gastric emptying, capacity of tolerating nutrient liquid and symptoms of FD. We recruited a total of 31 patients having FD on the basis of ROME III criteria. After randomization, itopride was received by 15 patients while 16 patients received placebo. Gastric accommodation was determined using Gastric Scintigraphy. <sup>13</sup>C labeled octanoic breadth test was performed to assess gastric emptying. Capacity of tolerating nutrient liquid drink was checked using satiety drinking capacity test. The intervention group comprised of 150 mg itopride. Patients in both arms were followed for 4 wk. RESULTSMean age of the recruited participant 33 years (SD = 7.6) and most of the recruited individuals, i.e., 21 (67.7%) were males. We found that there was no effect of itopride on gastric accommodation as measured at different in volumes in the itopride and control group with the empty stomach (P = 0.14), at 20 min (P = 0.38), 30 min (P = 0.30), 40 min (P = 0.43), 50 min (P = 0.50), 60 min (P = 0.81), 90 min (P = 0.25) and 120 min (P = 0.67). Gastric emptying done on a sub sample (n = 11) showed no significant difference (P = 0.58) between itopride and placebo group. There was no significant improvement in the capacity to tolerate liquid in the itopride group as compared to placebo (P = 0.51). Similarly there was no significant improvement of symptoms as assessed through a composite symptom score (P = 0.74). The change in QT interval in itopride group was not significantly different from placebo (0.10). CONCLUSIONOur study found no effect of itopride on gastric accommodation, gastric emptying and maximum tolerated volume in patients with FD.
基金Supported by The Natural Science Foundation of Zhejiang Province of China,No. LY12H29002Traditional Chinese Medicine Science Foundation of Zhejiang Province of China,No. 2011ZB032
文摘AIM:To evaluate the therapeutic effects of itopride vs other drugs(placebo,domperidone,mosapride) for functional dyspepsia(FD).METHODS:Randomized controlled trials(RCTs) of itopride for FD were retrieved from databases.Relevant information was extracted and analyzed,using the relative risk(RR) and weighted mean deviation,as appropriate.A random or fixed effect model was used,based on the heterogeneity of the included articles,and visual inspection of funnel plots was used to evaluate publication bias.RESULTS:Nine RCTs enrolling 2620 FD cases were included;1372 cases received itopride treatment and 1248 cases received placebo or other drugs(control groups).Compared with control groups,itopride had superior RR values of 1.11 [95%CI:(1.03,1.19),P = 0.006],1.21 [95%CI:(1.03,1.44),P = 0.02],and1.24 [95%CI:(1.01,1.53),P = 0.04] for global patient assessment,postprandial fullness,and early satiety,respectively.For the Leeds Dyspepsia Questionnaire score,the weighted mean deviation was-1.38 [95%CI:(-1.75,-1.01),P < 0.01].The incidence of adverse effects was similar in the itopride and control groups.The funnel plots for all indicators showed no evidence of publication bias.CONCLUSION:Itopride has good efficacy in terms of global patients assessment,postprandial fullness,and early satiety in the treatment of patients with FD and shows a low rate of adverse reactions.Itopride can greatly improve FD syndromes-score.
文摘A specific, precise and stability indicating high-performance thin-layer chromatographic method for simultaneous estimation of pantoprazole sodium and itopride hydrochloride in pharmaceutical formulations was developed and validated. The method employed TLC aluminium plates precoated with silica gel 60F254 as the stationary phase. The solvent system consisted of methanol：water：ammonium acetate; 4.0：1.0：0.5 （v/v/v）. This system was found to give compact and dense spots for both itopride hydrochloride （Rf value of 0.55__＋0.02） and pantoprazole sodium （Rf value of 0.85＋0.04）. Densitometric analysis of both drugs was carried out in the reflectance- absorbance mode at 289 nm. The linear regression analysis data for the calibration plots showed a good linear relationship with R2=0.9988___0.0012 in the concentration range of 100--400 ng for pantoprazole sodium. Also, the linear regression analysis data for the calibration plots showed a good linear relationship with R2=0.9990_＋0.0008 in the concentration range of 200-1200 ng for itopride hydrochloride. The method was validated for specificity, precision, robustness and recovery. Statistical analysis proves that the method is repeatable and selective for the estimation of both the said drugs. As the method could effectively separate the drug from its degradation products, it can be employed as a stability indicating method.
文摘Background: The efficacy of lubiprostone for chronic constipation has been established through phase III clinical trials. Nevertheless, the continuation of lubiprostone therapy is reportedly difficult due to the development of nausea. The objective of this study is to determine whether the administration of itopride hydrochloride can reduce lubiprostone-related nausea. Methods: Two hundred and thirty-five patients who were receiving lubiprostone (24 μg capsule twice daily) were enrolled. Seventy-one patients took a prophylactic dose of itopride (50 mg tablet twice daily) together with lubiprostone to prevent nausea. Thus, the patients were divided into 2 groups: lubiprostone alone (164;control group) and combination therapy with lubiprostone and itopride (71;itopride group). Efficacy measures included changes in constipation scoring system scores, the incidence of treatment-related adverse events including nausea, and the percentage of patients who discontinued treatment within two weeks after administration. Results: Of the 235 patients who were enrolled, 196 were available for analysis. Both treatment groups experienced statistically significant improvements in constipation scoring system scores. The percentage of patients who reported ≥1 adverse event was significantly higher in the control group (40.9%) than in the itopride group (21.9%). The percentage of patients experiencing nausea was statistically and significantly lower in the itopride group than in the control group (9.4% versus 22.7%). The itopride regimen was also statistically superior compared to the control regimen in terms of treatment discontinuation. Conclusion: The prophylactic administration of itopride can decrease the risk of nausea in patients receiving lubiprostone and consequently reduce the risk of treatment discontinuation.
文摘AIM:To evaluate the effect of prokinetic drugs on electrogastrography(EGG) parameters according to symptomatic changes in patients with functional dyspepsia(FD).METHODS:Seventy-four patients with FD were prospectively enrolled in this study between December 2006 and December 2010.We surveyed the patients using a questionnaire on dyspeptic symptoms before and after an 8-wk course of prokinetic drug treatment.We also measured cutaneous pre-prandial and postprandial EGG recordings including percentage of gastric waves(normogastria,bradygastria,tachygastria),dominant frequency(DF),dominant power(DP),dominant frequency instability coefficient(DFIC),dominant power instability coefficient(DPIC),and the ratio of post-prandial to fasting in DP before and after the 8-wk course of prokinetic drug treatment.RESULTS:Fifty-two patients(70%) achieved symptomatic improvement after prokinetic drug treatment.Patients who had normal gastric slow waves showed symptom improvement group after treatment.Postprandial DF showed a downward trend in the symptom improvement group,especially in the itopride group.Post-prandial DP was increased regardless of symptom improvement,especially in the itopride group and mosapride group.Post-prandial DFIC and DPIC in the symptom improvement group were significantly increased after the treatment.The EGG power ratio was increased after treatment in the symptom improvement group(0.50 ± 0.70 vs 0.93 ± 1.77,P = 0.002),especially in the itopride and levosulpiride groups.CONCLUSION:Prokinetics could improve the symptoms of FD by regulating gastric myoelectrical activity,and EGG could be a useful tool in evaluating the effects of various prokinetics.
