目的 采用高效液相色谱法测定受试者口服埃索美拉唑肠溶胶囊与埃索美拉唑镁肠溶片后血药浓度,评价埃索美拉唑肠溶胶囊的生物等效性。 方法 2009年9月-10月,36例健康男性受试者单次交叉口服埃索美拉唑肠溶胶囊(试验制剂)和埃索美拉唑镁肠溶片(参比制剂),测定给药后不同时间点血浆中埃索美拉唑经时血药浓度,采用DAS 2.0软件进行药物代谢动力学参数计算和生物等效性评价。 结果 受试者单次口服试验制剂与参比制剂后,达峰时间分别为(2.19 ± 0.96)、(2.43 ± 0.92) h,峰浓度分别为(1 748.86 ± 615.81)、(1 442.92 ± 476.41) μg/L,药时曲线下面积(AUC)0-t分别为(3 927.14 ± 1 839.10)、(3 878.79 ± 1 734.84) μg/L·h,AUC0-∞分别为(3 998.36 ± 1 866.22)、(3 918.31 ± 1 773.44) μg/L·h。试验制剂与参比制剂的生物等效性为94.0%,其90%CI为(82.3%,107.2%)。 结论 埃索美拉唑肠溶胶囊与埃索美拉唑镁肠溶片生物等效。
目的:探讨内镜下氩离子凝固术(APC)联合抑酸治疗对Barrett食管的临床疗效。方法:选择经内镜及病理确诊的Barrett食管患者40例,随机分为两组,治疗组21例,对照组19例,治疗组经内镜下APC治疗后联合埃索美拉唑20mg 2次/日连续3月,对照组单用埃索美拉唑20mg 2次/日连续3月,分别于3月、6月、12月对两组进行临床症状积分和内镜及病理随访。结果:两组治疗后3、6、12月临床症状积分缓解无明显差异性(Plt;0.05),但从内镜、病理随访的有效率来看,治疗组与对照组相比有显著差异性(Plt;0.05)。结论:BE内镜下APC联合抑酸治疗能有效逆转Barrett上皮,是一种安全、有效的治疗方法。
ObjectiveTo explore and analyze the clinical diagnosis and treatment of gastroesophageal reflux disease (GERD) which is manifested mainly as stubborn pharyngitis. MethodsFrom February 2010 to December 2012, 79 cases were diagnosed as stubborn pharyngitis and otolaryngology standard treatment was invalid. GERD questionnaire ratings and conventional endoscopy were performed for patients with obvious manifestations of stubborn pharyngitis shown on the laryngoscopy. They were randomly divided into treatment group (n=40) and control group (n=39). Patients in the treatment group accepted esomeprazole 40 mg, qd, for 12 weeks; and patients in the control group had sucralfate suspension 15 mL bid for 12 weeks. At the three observation points which are 4, 8, and 12 weeks after treatment began, clinical symptom score and pharyngeal inflammatory changes were recorded, and at the end of the treatment, all patients underwent endoscopy, and esophageal mucosal healing was observed. ResultsThere was no significant difference between the two groups of patients in terms of general data. After the treatment, the symptom scores were significantly decreased in the treatment group at the three observation points (P<0.05). The same situation happened also in the control group, but the difference was not significant (P>0.05). The symptom scores between the two groups after treatment were significantly different (P<0.5). And the effective rate for local pharyngeal infection was 83.9% and 41.4% in the treatment group and the control group respectively (P<0.05). ConclusionSome atypical GERDs feature by the symptoms of stubborn pharyngitis. Clinically, patients with long-term stubborn pharyngitis should be screened to exclude the possibility of GERD. esomeprazole therapy can significantly improve the pharyngitis symptoms and relieve local inflammation.
ObjectivesTo systematically review the efficacy and safety of esomeprazole versus omeprazole in the treatment of acute non-variceal upper gastrointestinal bleeding (ANVUGIB).MethodsPubMed, EMbase, The Cochrane Library, CNKI, WanFang Data and VIP databases were electronically searched to collect the randomized controlled trials (RCTs) about the efficacy and safety of esomeprazole versus omeprazole in the treatment of ANVUGIB from inception to January, 2019. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies, then, meta-analysis was performed by using RevMan 5.3 software.ResultsA total of 17 RCTs involving 2 086 patients were included. The results of meta-analysis showed that, the total effective rate of esomeprazole group was higher than omeprazole group (RR=1.09, 95%CI 1.04 to 1.14, P=0.000 6), the incidence of adverse reactions was lower than omeprazole group (OR=0.27, 95%CI 0.18 to 0.40, P<0.000 01), the average hemostasis time was shorter than omeprazole group (MD=−0.64, 95%CI −0.94 to −0.34, P<0.0001), and the difference were statistically significant.ConclusionsCurrent evidence shows that in the treatment of ANVUGIB, esomeprazole has rapid hemostasis, significant effect and fewer adverse reactions, which is worthy of wide application and promotion. Due to limited quality and quantity of the included studies, more high-quality studies are required to verify the above conclusions.