AIM To compare the one-week clinical effects of single doses of dexlansoprazole and esomeprazole on grades A and B erosive esophagitis.METHODS We enrolled 175 adult patients with gastroesophageal reflux disease(GERD)....AIM To compare the one-week clinical effects of single doses of dexlansoprazole and esomeprazole on grades A and B erosive esophagitis.METHODS We enrolled 175 adult patients with gastroesophageal reflux disease(GERD). The patients were randomized in a 1:1 ratio into two sequence groups to define the order in which they received single doses of dexlansoprazole(n = 88) and esomeprazole(n = 87) for an intention-to-treat analysis. The primary endpoints were the complete symptom resolution(CSR) rates at days 1, 3, and 7 after drug administration.RESULTS Thirteen patients were lost to follow-up, resulting in 81 patients in each group for the per-protocol analysis. The CSRs for both groups were similar at days 1, 3 and 7. In the subgroup analysis, the female patients achieved higher CSRs in the dexlansoprazole group than in the esomeprazole group at day 3(38.3% vs 18.4%, P = 0.046). An increasing trend toward a higher CSR was observed in the dexlansoprazole group at day 7(55.3% vs 36.8%, P = 0.09). In the esomeprazole group, female sex was a negative predictive factor for CSR on post-administration day 1 [OR =-1.249 ± 0.543; 95%CI: 0.287(0.099-0.832), P = 0.022] and day 3 [OR =-1.254 ± 0.519; 95%CI: 0.285(0.103-0.789), P = 0.016]. Patients with spicy food eating habits achieved lower CSRs on day 1 [37.3% vs 21.4%, OR =-0.969 ± 0.438; 95%CI: 0.380(0.161-0.896), P = 0.027]. CONCLUSION The overall CSR for GERD patients was similar at days 1-7 for both the dexlansoprazole and esomeprazole groups, although a higher incidence of CSR was observed on day 3 in female patients who received a single dose of dexlansoprazole.展开更多
Background The relationship between symptom elimination and normalization of esophageal acid level of gastroesophageal reflux disease （GERD） on proton-pump inhibitor （PPI） therapy has been questioned. This study a...Background The relationship between symptom elimination and normalization of esophageal acid level of gastroesophageal reflux disease （GERD） on proton-pump inhibitor （PPI） therapy has been questioned. This study aimed to evaluate the relationship between symptom response and gastro-esophageal acidity control in Chinese patients with GERD on esomeprazole therapy, and to assess the role of 24-hour esophageal pH-metry after therapy in GERD patients.Methods GERD patients with typical reflux symptoms were enrolled and received esomeprazole 40 mg once daily for 4 weeks. Patients with positive baseline 24-hour esophageal pH-metry were divided into two groups depending on an additional dual-channel 24-hour pH-metry after treatment. The pH- group achieved normalization of esophageal pH level whereas the pH＋ group did not.Results Of the 80 patients studied, 76 had abnormal baseline esophageal pH levels. Of these, 90% （52/58） of symptom-free patients and 67% （12/18） of symptom-persistent patients achieved esophageal pH normalization after therapy （P=0.030）. The mean post-therapy gastric nocturnal percent time of pH 〈4.0 was significantly higher in pH＋group than that in pH- group （P 〈0.001） after therapy. The multivariate regression analysis identified hiatus hernia （P〈0.001） and persistent reflux symptom （P=0.004） were two independent factors predicting the low post-therapy esophageal pH level.Conclusions Symptom elimination is not always accompanied by esophageal pH normalization, and vice verse.Esophageal pH-metry is recommended for GERD patients with hiatus hernia or with persistent reflux symptoms after PPI therapy.展开更多
BACKGROUND The pharmacokinetics and bioequivalence of esomeprazole in healthy Chinese subjects and the effects of food on the pharmacokinetics have not been well studied.AIM To evaluate the pharmacokinetic characteris...BACKGROUND The pharmacokinetics and bioequivalence of esomeprazole in healthy Chinese subjects and the effects of food on the pharmacokinetics have not been well studied.AIM To evaluate the pharmacokinetic characteristics of esomeprazole magnesium(Eso)enteric-coated capsule in the healthy subjects in China and the bioequivalence of the two formulations.METHODS This study was conducted in the Phase I Clinical Trial Unit of the Affiliated Hospital of Changchun University of Chinese Medicine.A total of 64 healthy subjects were enrolled in the study.Thirty-two subjects fasted or fed,took the test or reference formulation Eso enteric-coated capsule by a four-cycle,two-sequence crossover of fasting/fed,self-controlled method.The liquid chromatographymass spectrometry was performed to determine the drug plasma concentration at 16 different time points within 12 h after drug administration.The pharmacokinetic parameters Cmax,area under the curve(AUC)0-t,and AUC0-inf were calculated to evaluate the bioequivalence.RESULTS Pharmacokinetic parameters were evaluated after subjects took the test formulation and control formulation under fasting status.The ratio of geometric means of Cmax was 104.15%,with a confidence interval(CI)of 98.20-110.46%.The ratio of geometric means of AUC0-t was 105.26%,with a CI of 99.80-111.01%.The ratio of geometric means of AUC0-inf was 105.37%,with a CI of 99.97-111.06%.The pharmacokinetic parameters were also evaluated after subjects took the reference formulation of Eso enteric-coated capsule after eating.The upper limit of 95%CI of the geometric mean ratio of pharmacokinetic parameters of Eso enteric-coated capsules in the postprandial state Cmax was-0.1689,and the point estimate was 0.9509(0.80-1.25).The upper limit of 95%CI of the geometric mean ratio of pharmacokinetic parameters of Eso enteric-coated capsules in the postprandial state AUC0-t was-0.1015(≤0),and the point estimate was 0.9003(0.80-1.25).The upper limit of 95%CI of the geometric mean ratio of pharmacokinetic parameters of Eso enteric-coated capsules in the postprandial state AUC0-inf was-0.0593(≤0),and the point estimate was 0.8453(0.80-1.25).The results indicated that the two formulations were bioequivalent under both fasting and fed states.CONCLUSION The two types of esomeprazole tablets were bioequivalent under both fasting and fed states,and both were generally well tolerated.展开更多
目的观察和胃降逆止嗽方治疗胃食管反流性咳嗽(胃气上逆证)临床效果。方法96例胃食管反流性咳嗽(胃气上逆证)患者按照随机数字表法分为对照组和观察组各48例。对照组采用调整生活方式联合常规西药治疗,观察组采用调整生活方式联合和胃...目的观察和胃降逆止嗽方治疗胃食管反流性咳嗽(胃气上逆证)临床效果。方法96例胃食管反流性咳嗽(胃气上逆证)患者按照随机数字表法分为对照组和观察组各48例。对照组采用调整生活方式联合常规西药治疗,观察组采用调整生活方式联合和胃降逆止嗽方治疗。治疗12周后,评价两组中医证候积分(阵发性咳嗽、咳嗽时泛酸水、嘈杂、上腹不适)、莱塞斯特咳嗽生命质量问卷(lesser cough quality of life questionnaire,LCQ)评分、反流性疾病问卷(reflux disease questionnaire,RDQ)评分、食管运动功能(食管收缩波幅、食管蠕动波传导速度、平均收缩持续时间)、临床治疗效果、疾病复发概率以及治疗安全性。结果比较发现观察组治疗有效率明显高于对照组,对比有统计学差异;对比两组患者治疗后出现阵发性咳嗽等临床症状的概率,发现患者RDQ评分均有下降,但是观察组评分下降较为明显(P<0.05)。两组治疗后LCQ评分均升高(P<0.05),且观察组LCQ评分高于对照组(P<0.05)。治疗后,发现两组患者食管收缩波幅、食管蠕动波传导速度都出现了升高的情况(P<0.05),持续收缩时间明显缩短(P<0.05),且观察组食管运动功能指标改善情况都高于对照组,两组患者对比有统计学差异P<0.05,观察组3个月复发率和治疗后6个月复发率都较低,分别低于对照组3个月复发率(16.67%)和治疗后6个月的复发率(39.58%)(P<0.05)。治疗期间两组患者不良反应发生率相比无统计学意义。结论和胃降逆止嗽方可以有效缓解患者临床症状,同时,还能够促进患者食管运动,减少临床复发,改善生活质量,且治疗安全性高。展开更多
目的:探讨埃索美拉唑联合黛力新治疗老年伴抑郁非糜烂性胃食管反流病(non-erosive reflux disease,NERD)的疗效及对生活质量的影响.方法:将青海大学附属医院老年科门诊2012-01/2013-12收治的82例伴抑郁老年NERD患者随机分为对照组(n=41...目的:探讨埃索美拉唑联合黛力新治疗老年伴抑郁非糜烂性胃食管反流病(non-erosive reflux disease,NERD)的疗效及对生活质量的影响.方法:将青海大学附属医院老年科门诊2012-01/2013-12收治的82例伴抑郁老年NERD患者随机分为对照组(n=41)和观察组(n=41),两组均于早餐前给予20 mg埃索美拉唑口服治疗,仅观察组于早餐后口服20 mg黛力新,两组均持续用药8 wk.采用GERD问卷分析两组治疗前后的总体及不同症状得分来评价疗效,分别以治疗前后的汉密尔顿抑郁量表(Hamilton depression scale,HAMD)、Zung抑郁自评量表(self-rating depression scale,SDS)及中文版SF-36生活质量量表评价抑郁及生活质量改善情况,同时分析两组用药期间的不良反应.结果:观察组的总有效率高于对照组(92.7%vs 75.6%,P<0.05);两组治疗前的症状、抑郁及生活质量评分的差异均无统计学意义,但治疗后的以上各指标均优于治疗前(P<0.05);与对照组相比,观察组治疗后的GERD问卷总分及不同症状得分和HAMD、SDS评分均降低,生活质量总分及躯体相关、心理相关生活质量得分均升高(P<0.05).两组治疗期间不良反应较轻,发生率较低且差异无统计学意义(P>0.05).结论:埃索美拉唑联合黛力新治疗老年伴抑郁NERD的效果较好,不仅可改善相关症状,同时可缓解抑郁并提高生活质量,患者可耐目的:探讨埃索美拉唑联合黛力新治疗老年伴抑郁非糜烂性胃食管反流病(non-erosive reflux disease,NERD)的疗效及对生活质量的影响.方法:将青海大学附属医院老年科门诊2012-01/2013-12收治的82例伴抑郁老年N E R D患者随机分为对照组(n=41)和观察组(n=41),两组均于早餐前给予20 mg埃索美拉唑口服治疗,仅观察组于早餐后口服20 m g黛力新,两组均持续用药8 w k.采用GERD问卷分析两组治疗前后的总体及不同症状得分来评价疗效,分别以治疗前后的汉密尔顿抑郁量表(Hamilton depression scale,H A M D)、Z u n g抑郁自评量表(s e l f-r a t i n g depression scale,SDS)及中文版SF-36生活质量量表评价抑郁及生活质量改善情况,同时分析两组用药期间的不良反应.结果:观察组的总有效率高于对照组(92.7%vs 75.6%,P<0.05);两组治疗前的症状、抑郁及生活质量评分的差异均无统计学意义,但治疗后的以上各指标均优于治疗前(P<0.05);与对照组相比,观察组治疗后的GERD问卷总分及不同症状得分和HAMD、S D S评分均降低,生活质量总分及躯体相关、心理相关生活质量得分均升高(P<0.05).两组治疗期间不良反应较轻,发生率较低且差异无统计学意义(P>0.05).结论:埃索美拉唑联合黛力新治疗老年伴抑郁NERD的效果较好,不仅可改善相关症状,同时可缓解抑郁并提高生活质量,患者可耐受,安全有效,可在老年伴抑郁NERD治疗中推广.展开更多
基金Supported by Research Foundation of Chang Gung Memorial Hospital,No.CMRPG8D1441
文摘AIM To compare the one-week clinical effects of single doses of dexlansoprazole and esomeprazole on grades A and B erosive esophagitis.METHODS We enrolled 175 adult patients with gastroesophageal reflux disease(GERD). The patients were randomized in a 1:1 ratio into two sequence groups to define the order in which they received single doses of dexlansoprazole(n = 88) and esomeprazole(n = 87) for an intention-to-treat analysis. The primary endpoints were the complete symptom resolution(CSR) rates at days 1, 3, and 7 after drug administration.RESULTS Thirteen patients were lost to follow-up, resulting in 81 patients in each group for the per-protocol analysis. The CSRs for both groups were similar at days 1, 3 and 7. In the subgroup analysis, the female patients achieved higher CSRs in the dexlansoprazole group than in the esomeprazole group at day 3(38.3% vs 18.4%, P = 0.046). An increasing trend toward a higher CSR was observed in the dexlansoprazole group at day 7(55.3% vs 36.8%, P = 0.09). In the esomeprazole group, female sex was a negative predictive factor for CSR on post-administration day 1 [OR =-1.249 ± 0.543; 95%CI: 0.287(0.099-0.832), P = 0.022] and day 3 [OR =-1.254 ± 0.519; 95%CI: 0.285(0.103-0.789), P = 0.016]. Patients with spicy food eating habits achieved lower CSRs on day 1 [37.3% vs 21.4%, OR =-0.969 ± 0.438; 95%CI: 0.380(0.161-0.896), P = 0.027]. CONCLUSION The overall CSR for GERD patients was similar at days 1-7 for both the dexlansoprazole and esomeprazole groups, although a higher incidence of CSR was observed on day 3 in female patients who received a single dose of dexlansoprazole.
文摘Background The relationship between symptom elimination and normalization of esophageal acid level of gastroesophageal reflux disease （GERD） on proton-pump inhibitor （PPI） therapy has been questioned. This study aimed to evaluate the relationship between symptom response and gastro-esophageal acidity control in Chinese patients with GERD on esomeprazole therapy, and to assess the role of 24-hour esophageal pH-metry after therapy in GERD patients.Methods GERD patients with typical reflux symptoms were enrolled and received esomeprazole 40 mg once daily for 4 weeks. Patients with positive baseline 24-hour esophageal pH-metry were divided into two groups depending on an additional dual-channel 24-hour pH-metry after treatment. The pH- group achieved normalization of esophageal pH level whereas the pH＋ group did not.Results Of the 80 patients studied, 76 had abnormal baseline esophageal pH levels. Of these, 90% （52/58） of symptom-free patients and 67% （12/18） of symptom-persistent patients achieved esophageal pH normalization after therapy （P=0.030）. The mean post-therapy gastric nocturnal percent time of pH 〈4.0 was significantly higher in pH＋group than that in pH- group （P 〈0.001） after therapy. The multivariate regression analysis identified hiatus hernia （P〈0.001） and persistent reflux symptom （P=0.004） were two independent factors predicting the low post-therapy esophageal pH level.Conclusions Symptom elimination is not always accompanied by esophageal pH normalization, and vice verse.Esophageal pH-metry is recommended for GERD patients with hiatus hernia or with persistent reflux symptoms after PPI therapy.
文摘BACKGROUND The pharmacokinetics and bioequivalence of esomeprazole in healthy Chinese subjects and the effects of food on the pharmacokinetics have not been well studied.AIM To evaluate the pharmacokinetic characteristics of esomeprazole magnesium(Eso)enteric-coated capsule in the healthy subjects in China and the bioequivalence of the two formulations.METHODS This study was conducted in the Phase I Clinical Trial Unit of the Affiliated Hospital of Changchun University of Chinese Medicine.A total of 64 healthy subjects were enrolled in the study.Thirty-two subjects fasted or fed,took the test or reference formulation Eso enteric-coated capsule by a four-cycle,two-sequence crossover of fasting/fed,self-controlled method.The liquid chromatographymass spectrometry was performed to determine the drug plasma concentration at 16 different time points within 12 h after drug administration.The pharmacokinetic parameters Cmax,area under the curve(AUC)0-t,and AUC0-inf were calculated to evaluate the bioequivalence.RESULTS Pharmacokinetic parameters were evaluated after subjects took the test formulation and control formulation under fasting status.The ratio of geometric means of Cmax was 104.15%,with a confidence interval(CI)of 98.20-110.46%.The ratio of geometric means of AUC0-t was 105.26%,with a CI of 99.80-111.01%.The ratio of geometric means of AUC0-inf was 105.37%,with a CI of 99.97-111.06%.The pharmacokinetic parameters were also evaluated after subjects took the reference formulation of Eso enteric-coated capsule after eating.The upper limit of 95%CI of the geometric mean ratio of pharmacokinetic parameters of Eso enteric-coated capsules in the postprandial state Cmax was-0.1689,and the point estimate was 0.9509(0.80-1.25).The upper limit of 95%CI of the geometric mean ratio of pharmacokinetic parameters of Eso enteric-coated capsules in the postprandial state AUC0-t was-0.1015(≤0),and the point estimate was 0.9003(0.80-1.25).The upper limit of 95%CI of the geometric mean ratio of pharmacokinetic parameters of Eso enteric-coated capsules in the postprandial state AUC0-inf was-0.0593(≤0),and the point estimate was 0.8453(0.80-1.25).The results indicated that the two formulations were bioequivalent under both fasting and fed states.CONCLUSION The two types of esomeprazole tablets were bioequivalent under both fasting and fed states,and both were generally well tolerated.
文摘目的观察和胃降逆止嗽方治疗胃食管反流性咳嗽(胃气上逆证)临床效果。方法96例胃食管反流性咳嗽(胃气上逆证)患者按照随机数字表法分为对照组和观察组各48例。对照组采用调整生活方式联合常规西药治疗,观察组采用调整生活方式联合和胃降逆止嗽方治疗。治疗12周后,评价两组中医证候积分(阵发性咳嗽、咳嗽时泛酸水、嘈杂、上腹不适)、莱塞斯特咳嗽生命质量问卷(lesser cough quality of life questionnaire,LCQ)评分、反流性疾病问卷(reflux disease questionnaire,RDQ)评分、食管运动功能(食管收缩波幅、食管蠕动波传导速度、平均收缩持续时间)、临床治疗效果、疾病复发概率以及治疗安全性。结果比较发现观察组治疗有效率明显高于对照组,对比有统计学差异;对比两组患者治疗后出现阵发性咳嗽等临床症状的概率,发现患者RDQ评分均有下降,但是观察组评分下降较为明显(P<0.05)。两组治疗后LCQ评分均升高(P<0.05),且观察组LCQ评分高于对照组(P<0.05)。治疗后,发现两组患者食管收缩波幅、食管蠕动波传导速度都出现了升高的情况(P<0.05),持续收缩时间明显缩短(P<0.05),且观察组食管运动功能指标改善情况都高于对照组,两组患者对比有统计学差异P<0.05,观察组3个月复发率和治疗后6个月复发率都较低,分别低于对照组3个月复发率(16.67%)和治疗后6个月的复发率(39.58%)(P<0.05)。治疗期间两组患者不良反应发生率相比无统计学意义。结论和胃降逆止嗽方可以有效缓解患者临床症状,同时,还能够促进患者食管运动,减少临床复发,改善生活质量,且治疗安全性高。
文摘目的:探讨埃索美拉唑联合黛力新治疗老年伴抑郁非糜烂性胃食管反流病(non-erosive reflux disease,NERD)的疗效及对生活质量的影响.方法:将青海大学附属医院老年科门诊2012-01/2013-12收治的82例伴抑郁老年NERD患者随机分为对照组(n=41)和观察组(n=41),两组均于早餐前给予20 mg埃索美拉唑口服治疗,仅观察组于早餐后口服20 mg黛力新,两组均持续用药8 wk.采用GERD问卷分析两组治疗前后的总体及不同症状得分来评价疗效,分别以治疗前后的汉密尔顿抑郁量表(Hamilton depression scale,HAMD)、Zung抑郁自评量表(self-rating depression scale,SDS)及中文版SF-36生活质量量表评价抑郁及生活质量改善情况,同时分析两组用药期间的不良反应.结果:观察组的总有效率高于对照组(92.7%vs 75.6%,P<0.05);两组治疗前的症状、抑郁及生活质量评分的差异均无统计学意义,但治疗后的以上各指标均优于治疗前(P<0.05);与对照组相比,观察组治疗后的GERD问卷总分及不同症状得分和HAMD、SDS评分均降低,生活质量总分及躯体相关、心理相关生活质量得分均升高(P<0.05).两组治疗期间不良反应较轻,发生率较低且差异无统计学意义(P>0.05).结论:埃索美拉唑联合黛力新治疗老年伴抑郁NERD的效果较好,不仅可改善相关症状,同时可缓解抑郁并提高生活质量,患者可耐目的:探讨埃索美拉唑联合黛力新治疗老年伴抑郁非糜烂性胃食管反流病(non-erosive reflux disease,NERD)的疗效及对生活质量的影响.方法:将青海大学附属医院老年科门诊2012-01/2013-12收治的82例伴抑郁老年N E R D患者随机分为对照组(n=41)和观察组(n=41),两组均于早餐前给予20 mg埃索美拉唑口服治疗,仅观察组于早餐后口服20 m g黛力新,两组均持续用药8 w k.采用GERD问卷分析两组治疗前后的总体及不同症状得分来评价疗效,分别以治疗前后的汉密尔顿抑郁量表(Hamilton depression scale,H A M D)、Z u n g抑郁自评量表(s e l f-r a t i n g depression scale,SDS)及中文版SF-36生活质量量表评价抑郁及生活质量改善情况,同时分析两组用药期间的不良反应.结果:观察组的总有效率高于对照组(92.7%vs 75.6%,P<0.05);两组治疗前的症状、抑郁及生活质量评分的差异均无统计学意义,但治疗后的以上各指标均优于治疗前(P<0.05);与对照组相比,观察组治疗后的GERD问卷总分及不同症状得分和HAMD、S D S评分均降低,生活质量总分及躯体相关、心理相关生活质量得分均升高(P<0.05).两组治疗期间不良反应较轻,发生率较低且差异无统计学意义(P>0.05).结论:埃索美拉唑联合黛力新治疗老年伴抑郁NERD的效果较好,不仅可改善相关症状,同时可缓解抑郁并提高生活质量,患者可耐受,安全有效,可在老年伴抑郁NERD治疗中推广.
