不同作用机制药物对功能性消化不良疗效特点的对照研究

背景:米曲菌胰酶片是含米曲菌霉提取物和胰酶的双层包衣复合消化酶制剂,临床上广泛用于治疗功能性消化不良(FD),但目前尚缺乏其与其他FD治疗药物如促动力药、质子泵抑制剂(PPI)临床疗效的随机对照研究。目的:比较米曲菌胰酶片、多潘立酮片、埃索美拉唑镁肠溶片三种不同作用机制药物对中国人群FD的疗效和安全性。方法:浙江中医药大学附属第一医院2015年11月—2016年6月门诊FD患者82例纳入研究,入选者符合罗马Ⅲ标准且幽门螺杆菌感染阴性。患者随机分为3组,分别接受米曲菌胰酶片(A组)、多潘立酮片(B组)和埃索美拉唑镁肠溶片(C组)治疗,疗程4周,观察消化不良症状改善和不良反应发生情况。结果:经4周治疗后,A、B、C组FD症状改善的总有效率分别为93.1%、88.9%和69.2%,3组间总体差异有统计学意义(P0.05)。多潘立酮片改善餐后饱胀和早饱感症状最有效;埃索美拉唑镁肠溶片对上腹痛、上腹灼烧感和嗳气反酸症状敏感性高;米曲菌胰酶片对各项症状的改善作用均介于多潘立酮片与埃索美拉唑镁肠溶片之间。治疗过程中无患者出现不良反应。结论:消化酶、促动力药和PPI对于FD的治疗各有其敏感症状和最佳适应证,消化酶制剂米曲菌胰酶片总体疗效最佳。     

埃索美拉唑联合莫沙必利治疗重度反流性食管炎的疗效观察

目的探讨埃索美拉唑联合莫沙必利治疗重度反流性食管炎的临床疗效。方法将90例经内镜证实为Ⅱ、Ⅲ级反流性食管炎患者随机分为埃索美拉唑联合莫沙必利组（A组）、奥美拉唑联合莫沙必利组（B组）和埃索美拉唑组（C组）,三组分别口服埃索美拉唑20 mg,2次/d,莫沙必利5 mg,3次/d;口服奥美拉唑20 mg,2次/d,莫沙必利5 mg,3次/d;以及口服埃索美拉唑20 mg,2次/d治疗,疗程8周,停药后复查胃镜,观察治愈率,并记录症状改善情况及不良反应。结果治疗8周后A、B、C三组症状改善总有效率分别为96.88%、75.00%、70.00%;胃镜下有效率分别为93.75%、71.43%、66.67%,A组与其他两组比较均有显著性差异（P〈0.05）。结论埃索美拉唑联合莫沙必利治疗重度反流性食管炎有较高的治愈率和症状改善率,临床疗效明显优于奥美拉唑联合莫沙必利及单独应用埃索美拉唑治疗。     

埃索美拉唑联合莫沙必利、铝碳酸镁治疗难治性胃食管反流病的临床观察

目的观察埃索美拉唑、铝碳酸镁、莫沙必利治疗难治性胃食管反流病(rGERD)的临床疗效。方法 120例rGERD患者随机分为3组:A组(n=40)、B组(n=40)和C组(n=40)。分别采用埃索美拉唑+莫沙必利+铝碳酸镁、埃索美拉唑+莫沙必利及铝碳酸镁+莫沙必利治疗,4周及8周评价临床症状及有效率。结果治疗8周后A组在症状评分和内镜分级均较B、C组显著改善(P<0.05)。A组4周、8周后临床症状评分有效率分别为80.0%和92.5%,3组比较差异显著(P<0.05)。结论埃索美拉唑联合莫沙必利、铝碳酸镁是治疗rGERD的有效方法。     

不同疗程伴同疗法与含铋剂四联疗法根除幽门螺杆菌的疗效

目的:观察不同疗程的伴同疗法与含铋剂四联疗法根除幽门螺杆菌(Helicobacter pylori,H.pylori)的疗效和安全性.方法:随机选取2014-07-01/2015-07-01郑州大学第一附属医院消化内科门诊就诊,行胃镜检查明确胃部疾病(慢性糜烂性胃炎或消化性溃疡)并行13C呼气试验检测阳性的282例患者,按照就诊顺序,分别采用4组治疗方案:A组:埃索美拉唑镁肠溶片20 mg bid+克拉霉素片500 mg bid+阿莫西林胶囊1000 mg bid+甲硝唑片400 mg bid,7 d;B组:埃索美拉唑镁肠溶片20 mg bid+克拉霉素片500 mg bid+阿莫西林胶囊1000 mg bid+枸橼酸铋钾胶囊220 mg bid,7 d;C组:埃索美拉唑镁肠溶片20 mg bid+克拉霉素片500 mg bid+阿莫西林胶囊1000 mg bid+甲硝唑片400 mg bid,14 d;D组:埃索美拉唑镁肠溶片20 mg bid+克拉霉素片500 mg bid+阿莫西林胶囊1000mg bid+枸橼酸铋钾胶囊220 mg bid,14 d.根除治疗结束后4 wk复查13C呼气试验.结果:本研究共纳入患者282例,按符合方案(per-protocol,PP)分析A组H.pylori根除率为84.06%,B组为83.33%,C组为94.12%,D组为97.91%;按意向性(intention to treat,ITT)分析A组为80.56%,B组为78.57%,C组为92.96%,D组为91.55%,其中A组与B组、C组与D组的H.pylori根除率,经PP分析及ITT分析差异均无统计学意义;A组与C组、B组与D组的H.pylori根除率,经PP分析及ITT分析差异均有统计学意义(P0.05);各组不良反应发生率及症状缓解率差异均无统计学意义.结论:伴同疗法和含铋剂四联疗法2 wk方案H.pylori根除率高、安全性良好且症状缓解率高,可推荐为临床根除H.pylori的一线治疗方案.     

联合应用埃索美拉唑、铝碳酸镁和莫沙比利治疗难治性胃食管反流病

目的:探讨联合应用埃索美拉唑、铝碳酸镁和莫沙比利治疗难治性胃食管反流病(r-GERD)的临床疗效.方法:101例rGERD患者随机为A(n=36),B(n=34)和C组(n=31),分别采用埃索美拉唑 铝碳酸镁 莫沙比利、埃索美拉唑 莫沙比利及铝碳酸镁 莫沙比利治疗.4及8 wk后评价临床症状,8 wk后评价内镜下有效率.结果:治疗4 wk后,A,B和C组临床症状总改善率分别为88.9%,79.4%和61.3%,A组与B,C两组相比差异显著(χ2=7.3531,P＜0.05).治疗8 wk后,A,B和C组临床症状总改善率分别为97.2%,88.2%和71.0%,内镜下有效率分别为94.4%,85.3%和67.7%,A组临床症状总改善率和内镜下有效率与B,C组相比存在显著性差异(χ2=9.6079,P＜0.01;χ2=8.6496,P＜0.05).结论:埃索美拉唑联合铝碳酸镁和莫沙比利治疗rGERD有很高的临床疗效.     

老年NERD患者应用埃索美拉唑联合伊托必利的疗效

目的探讨埃索美拉唑联合伊托必利治疗老年非糜烂性胃食管反流病(NERD)的疗效观察。方法采用随机对照的方法将117例老年NERD患者分为两组,观察组58例,对照组59例。两组年龄、性别均无明显差异(P0.05)。治疗组予埃索美拉唑联合伊托必利口服,对照组予埃索美拉唑加多潘立酮口服,8w为1个疗程,观察用药前后疗效及治疗中的副作用。结果治疗后两组患者症状都有所缓解,而观察组在治疗后的恶心、反流症状积分明显低于对照组,但在显效率、总有效率上明显高于对照组,两组比较有显著差异(P0.05)。伊托必利无明显不良反应。结论埃索美拉唑联合伊托必利是治疗老年NERD的理想药物,方法简便,可靠安全。明显优于埃索美拉唑和多潘立酮组合。     

埃索美拉唑镁治疗幽门螺杆菌阳性胃十二指肠炎的临床疗效及安全性

目的探讨埃索美拉唑镁治疗幽门螺杆菌(HP)阳性胃十二指肠炎的临床疗效及安全性。方法 54例HP阳性胃十二指肠炎患者随机分为对照组及试验组各27例;对照组给予克拉霉素缓释片0.5 g+阿莫西林克拉维酸钾片562.5 mg+奥美拉唑肠溶片20 mg,2次/d,口服;试验组给予克拉霉素缓释片0.5 g+阿莫西林克拉维酸钾片562.5 mg+埃索美拉唑镁肠溶片20 mg,2次/d,口服。比较两组患者治疗前后血清胃蛋白酶原(PG)Ⅰ、PGⅡ、PGⅠ/PGⅡ水平、治疗有效率及安全性。结果治疗后,与对照组比较,试验组患者血清PGⅠ、PGⅡ水平较低,PGⅠ/PGⅡ水平较高,差异显著(P<0.05)。试验组的治疗有效率显著高于对照组(P<0.05)。两组患者不良反应发生率无明显差异(P>0.05)。结论埃索美拉唑镁能显著降低HP阳性胃十二指肠炎患者血清胃PGⅠ、PGⅡ水平,提高PGⅠ/PGⅡ水平,有效根除HP。     

瑞巴派特和埃索美拉唑防治非甾体抗炎药胃病的疗效对比

[目的]观察对比瑞巴派特和埃索美拉唑防治长期服用非甾体抗炎药（NSAIDs）所致胃肠黏膜损伤的临床疗效.[方法]对160例服用NSAIDs患者,随机分为A、B、C组.A组60例单用NSAIDs,B组50例加服瑞巴派特,C组50例加服埃索美拉唑,8～12周后进行症状随访及胃镜检查.[结果]3组间在临床症状、胃黏膜急性糜烂、消化性溃疡及病情程度等方面比较差异均有统计学意义（P＜0.05）.在具有溃疡危险因素的患者中,C组防治效果优于B组,B组又优于A组,3组间差异有统计学意义（P＜0.05）.[结论]瑞巴派特和埃索美拉唑能有效防治NSAIDs胃病发生,具有溃疡危险因素的患者应同时服用埃索美拉唑,普通患者服用瑞巴派特即可达到防治目的.     

指针疗法联合埃索美拉唑、莫沙比利治疗胃食管反流病食管外症状疗效观察

[目的]研究分析指针疗法联合埃索美拉唑、莫沙比利治疗胃食管反流病(GERD)食管外症状的临床疗效。[方法]将以食管外症状为主要表现并确诊为GERD患者140例随机分为2组。A组70例,采用指针疗法联合埃索美拉唑、莫沙比利治疗;B组70例,采用埃索美拉唑、莫沙比利治疗,疗程均为8周。观察2组患者临床症状缓解情况,食管黏膜的恢复程度及不良反应。[结果]治疗后,A组有效63例,无效7例,总有效率为90.00%;B组有效57例,无效13例,总有效率为81.43%。A组的有效率和食管黏膜恢复程度均高于B组(P<0.05),且不良反应少。A组以食管外症状为主要表现的GERD患者中以气郁痰阻证及肝胃郁热证最为多见,且治疗后临床疗效优于其他3种证型,差异有统计学意义(P<0.05)。[结论]指针疗法联合埃索美拉唑、莫沙比利治疗GERD食管外症状效果明显,值得临床推广。     

埃索美拉唑镁、铝碳酸镁和伊托比利治疗胃食管反流病42例疗效观察

目的探讨联合应用埃索美拉唑镁、铝碳酸镁和伊托比利治疗胃食管反流病（gastroesophageal reflux disease,GERD）的临床疗效。方法将83例GERD病人随机分为A组和B组,分别采用埃索美拉唑镁、铝碳酸镁及伊托比利和奥美拉唑、铝碳酸镁及伊托比利治疗。3周后评价临床疗效,6周后评价胃镜下有效率。结果治疗3周后A组和B组病人临床症状总改善率分别是92.9%和73.2%,差异有统计学意义（P〈0.05）。治疗6周后A组和B组病人胃镜下有效率分别是97.6%和80.5%,差异有统计学意义（P〈0.05）。结论埃索美拉唑镁、铝碳酸镁和伊托比利治疗GERD优于奥美拉唑、铝碳酸镁及伊托比利。     

Efficacy of pantoprazole 20 mg daily compared with esomeprazole 20 mg daily in the maintenance of healed gastroesophageal reflux disease: a randomized, double-blind comparative trial - the EMANCIPATE study

OBJECTIVES: To compare the efficacy and tolerability of pantoprazole 20 mg once daily with that of esomeprazole 20 mg once daily for 6 months as maintenance therapy in patients with previously healed gastroesophageal reflux disease. METHODS: In an initial open-label acute phase, outpatients with endoscopically confirmed gastroesophageal reflux disease (Los Angeles grades A-D) received pantoprazole 40 mg once daily for 4 or 8 weeks. Those healed (defined as the absence of esophagitis, and 'no' or 'mild' heartburn and acid regurgitation) were randomized in the double-blind manner for maintenance therapy with pantoprazole 20 mg once daily or esomeprazole 20 mg once daily for 6 months. RESULTS: In the acute healing phase, 1452 patients were recruited to receive pantoprazole 40 mg once daily. Healing success was 91% (intent-to-treat analysis). A total of 1303 patients entered the maintenance phase of the study. Pantoprazole 20 mg once daily and esomeprazole 20 mg once daily were equally effective at maintaining patients in remission; 84 and 85% of pantoprazole and esomeprazole recipients remained in combined endoscopic and symptomatic remission at 6 months (intent-to-treat analysis). The confidence interval of the difference was (-5.7; +infinity), showing that pantoprazole is as effective as esomeprazole with a noninferiority margin of 5.8%. Combined endoscopic and symptomatic remission was independent of Helicobacter pylori status. Both treatments were well tolerated and safe. CONCLUSION: Treatment with pantoprazole 20 mg once daily or esomeprazole 20 mg once daily provides similarly effective and well-tolerated maintenance of previously healed gastroesophageal reflux disease irrespective of baseline H. pylori status.     

40 mg pantoprazole and 40 mg esomeprazole are equivalent in the healing of esophageal lesions and relief from gastroesophageal reflux disease-related symptoms

BACKGROUND: Proton pump inhibitors are regarded as the most effective class of acid suppressive medication for gastroesophageal reflux disease treatment. There is considerable interest regarding the dose equivalence between various proton pump inhibitors. GOALS: To compare the efficacy of pantoprazole and esomeprazole with regard to healing and relief from gastroesophageal reflux disease-related symptoms. STUDY: Multicenter, randomized, double-blind study. Patients with gastroesophageal reflux disease grades B/C (Los Angeles classification) received 40 mg pantoprazole daily (n = 113) or 40 mg esomeprazole daily (n = 114). Healing (endoscopy) and relief from gastroesophageal reflux disease-related symptoms (direct questioning) were assessed at first and final visit (after 4, 6, 8, or 10 weeks of treatment). RESULTS: Overall healing in both treatment groups was 88% of patients (intention-to-treat population), 95% (pantoprazole), and 90% (esomeprazole) (per-protocol population); statistically, this indicates "at least equivalence" between treatments. Overall relief from gastroesophageal reflux disease-related symptoms was similar for pantoprazole (55%) and esomeprazole (51%, per-protoco). No correlation between healing and symptom relief was seen. The majority of reported adverse events were assessed as "not related" to the study drug. Pantoprazole and esomeprazole have comparably good safety and tolerability. CONCLUSION: In patients with gastroesophageal reflux disease, 40 mg pantoprazole daily and 40 mg esomeprazole daily are equally effective for healing of esophageal lesions and relieving gastroesophageal reflux disease-related symptoms.     

埃索美拉唑在内蒙古地区不同民族间胃食管反流病治疗中的应用

目的 观察埃索美拉唑治疗内蒙占地区不同民族胃食管反流病(GERD)患者的疗效.方法 随机抽取2006年3月至2008年3月行胃镜检查及胃食管反流诊断问卷(RDQ)调查的120例汉族及120例蒙古族GERD患者,均给予埃索美拉唑20 mg每日1次口服,共6周.治疗2、4、6周时,以RDQ进行评分,RE患者治疗6周复查胃镜,观察胃镜下食管炎症愈合情况.结果 两组口服埃索美拉唑2周后临床有效率均大于50%,但第4、6周时,蒙古族组有效率明显低于汉族组.6周后蒙古族RE患者愈合率明显低于汉族组.结论 因民族差异、饮食习惯的不同,导致埃索美拉唑治疗效果的不同,可通过延长用药时间、调整饮食习惯来取得更好的疗效.     

质子泵抑制剂治疗持续不卧床腹膜透析患者胃食管反流症状的疗效观察

目的 评估慢性肾功能衰竭持续不卧床腹膜透析(CAPD)患者的胃食管反流症状及质子泵抑制剂治疗的疗效.方法 选取2008年1月至7月一般情况良好、透析充分的CAPD患者58例,采用胃食管反流病诊断问卷(RDQ)评估其胃食管反流症状.RDQ累积评分≥6分且<12分者给予埃索美拉唑镁肠溶片20 mg每日 1次,对于RDQ累积评分≥12分者给予上述药物每日2次,每次20 mg.4周后再次评估RDQ评分,判断疗效.结果 各种消化道症状的出现频率中反流症状出现频率最高(64.7%),其次为反酸(52.9%)、非心源性胸痛(47.1.%)和烧心(17.6%).PPI治疗4周后RDQ分值较治疗前降低(P<0.05);治疗前RDQ评分总分≥12分者和<12分者疗效比较差异无统计学意义(P=0.059).结论 PPI能缓解CAPD患者的胃食管反流症状,但其疗程以及疗效评估尚需进一步研究证实.     

复方比黑马尔江胶囊治疗胃食管反流病的疗效与安全性研究

ObjectiveTo compare the clinical efficacy and safety of compound Bihmarjan capsule and esomeprazole magnesium enteric-coated tablets on gastroesophageal reflux disease. MethodsThis study was an open, randomized and positive controlled trial. 120 patients with gastroesophageal reflux disease were participated in this study. According to the random number table, the patient is randomly divided into three groups, namely, group A is the lower dose group of compound Bihmarjan capsules, group B is the high dose group of Bihmarjan capsules, and group C is the Esomeprazole Magnesium Enteric-coated Tablets group. Group A were given 2 g (5 capsules) of compound Bihmarjan capsules 3 times daily; group B were given 4 g (10 capsules) of compound Bihmarjan capsules 3 times daily; group C were given 40 mg of Esomeprazole Magnesium Enteric-coated Tablets once daily. They were on medication for 4 weeks. Follow up was done in second and fourth weeks of the study. The clinical efficacy and incidence of adverse events were analyzed. ResultsIn three groups,77.5%, 87.5% and 90% of patients reported significant improvement of clinical symptom on Gerd-Q score respectively. The total clinical efficacy of group A and group B was 84.75%, and the total incidence of adverse event was 2.5%. there was no significant difference between group B and C in the clinical efficacy (P＞0.05), when the clinical efficacy of group A was worse than other two group (P＜0.05). The incidence of adverse events in group A and B were lower than group C (P＜0.05). ConclusionThe clinical efficacy of high dose Bihmarjan capsules is similar to Esomeprazole and the incidences of adverse event is lower than control group. Bihmarjan capsules have therapeutic potentials in the treatment of gastroesophageal reflux disease.     

Efficacy of Rabeprazole in the Treatment of Symptomatic Gastroesophageal Reflux Disease

The purpose of this study was to assess the rapidity of symptom relief and 4-week efficacy of rabeprazole 20 mg in patients with moderately severe nonerosive gastroesophageal reflux disease. Data were analyzed from 2 similarly designed, double-blind, placebo-controlled, multicenter, U.S. trials. After a 2-week placebo run-in period, patients (N = 261) were randomized to 4 weeks of rabeprazole 20 mg once daily or placebo. Patients kept symptom diaries and scored symptom severity. Median time to first 24-hour heartburn-free interval was 3.5 days for the rabeprazole group compared with 19.5 days for the placebo group (P ≤ .0002). Complete heartburn relief at week 4 was 32% with rabeprazole and 3.8% with placebo (P ≤ .001). Rabeprazole also significantly improved other GERD-associated symptoms (e.g., regurgitation, belching, early satiety) by week 4 compared with placebo (P ≤ .05). Rabeprazole provides fast and potent relief from heartburn and other symptoms of nonerosive gastroesophageal reflux disease. Supported by Eisai Inc., Teaneck, New Jersey, and Janssen Pharmaceutica Inc., Titusville, New Jersey.     

Ranitidine therapy for gastroesophageal reflux disease. Results of a large double-blind trial

In a multicenter, double-blind trial, 284 patients with gastroesophageal reflux disease were evaluated before, during, and after six weeks of treatment with either placebo or ranitidine (150 mg twice daily). Randomization resulted in two comparable patient groups. Ranitidine treatment was significantly more effective than placebo treatment in decreasing the frequency and the severity of heartburn during both daytime and nighttime assessment periods. There was a significant correlation between improvement in heartburn symptoms and decrease in antacid consumption; hence, patients receiving ranitidine consumed significantly fewer antacid tablets. Among patients with endoscopic esophagitis at baseline, the overall change in endoscopic classification after six weeks of therapy was significantly better for the ranitidine-treated patients. The ranitidine-treated group had less evidence of erosions and ulcerations as well as greater healing. There were no differences between the groups with respect to changes in esophageal mucosal sensitivity to acid perfusion or changes in histologic grading of esophageal mucosal biopsy specimens. The ranitidine safety profile was similar to that of previous studies. We conclude that, in patients with gastroesophageal reflux disease, ranitidine therapy, 150 mg twice daily, markedly reduced the heartburn symptoms of reflux disease and significantly improved the endoscopic appearance of the esophageal mucosa.     

Efficacy of adding sodium alginate to omeprazole in patients with nonerosive reflux disease: a randomized clinical trial

Nonerosive reflux disease (NERD) is the most common form of gastroesophageal reflux disease. Patients with NERD have a lower response rate to proton pump inhibitors (PPIs) than patients with erosive esophagitis when gauged from relief of heartburn. Sodium alginate decreases the acidity of refluxate and protects the esophageal mucosa. However, whether the addition of sodium alginate to PPI therapy can improve NERD symptoms remains unknown. Accordingly, the aim of this study was to evaluate the efficacy of adding sodium alginate to basal PPI therapy for NERD. Patients who had experienced heartburn on at least 2 days per week during the 1-month period before entering the study and had no endoscopic mucosal breaks (grade M or N according to Hoshihara's modification of the Los Angeles classification) were randomized to one of two treatments for 4 weeks: omeprazole (20 mg once daily) plus sodium alginate (30 mL four times a day) (group A) or omeprazole (20 mg once daily) alone (group B). Eighty-seven patients were enrolled, and 76 patients were randomly assigned to group A (n = 36) or group B (n = 40). Complete resolution of heartburn for at least 7 consecutive days by the end of treatment was significantly more common in group A (56.7%) than in group B (25.7%). One patient from group A had mild drug-related diarrhea that was not clinically serious. In conclusion, omeprazole combined with sodium alginate was better than omeprazole alone in Japanese patients with NERD.     

Efficacy of S-Pantoprazole 20?mg Compared with Pantoprazole 40?mg in the Treatment of Reflux Esophagitis: A Randomized, Double-Blind Comparative Trial

Background

S-isomer (S) pantoprazole is known to be more effective and less dependent on cytochrome 2C19 than R-isomer (R)-pantoprazole.

Aim

The purpose of this study was to compare the efficacy and safety of S-pantoprazole 20?mg versus pantoprazole 40?mg for treatment of reflux esophagitis.

Methods

This multi-center, double-blind, randomized trial enrolled patients with endoscopically documented reflux esophagitis. Patients were assigned to receive either 20?mg S-pantoprazole or 40?mg pantoprazole once daily for 4?weeks. Endoscopy and symptoms were assessed after 4?weeks of treatment. In patients whose reflux esophagitis was not resolved at 4?weeks, treatment was extended to 8?weeks and symptoms were reassessed. Heartburn, chest pain, acid regurgitation, globus, and overall symptoms were rated. The primary efficacy endpoint was healing of esophagitis, and secondary endpoints were symptomatic and endoscopic improvement.

Results

Sixty-seven patients in the S-pantoprazole group (52 male, mean age 51?years) and 62 in the pantoprazole group (61 male, mean age 50?years) were analyzed per protocol. The healing rate of reflux esophagitis was 85?% at 4?weeks and 94?% at 8?weeks in the S-pantoprazole group, which did not differ from those in the pantoprazole group (84 and 97?%, respectively). After treatment, individual and overall gastroesophageal reflux disease (GERD) symptoms and esophagitis improved compared with baseline inflammation in both groups. Intergroup differences in symptoms and endoscopic healing were not significant.

Conclusion

The efficacy and safety of 20?mg S-pantoprazole were comparable to those of 40?mg pantoprazole for treatment of reflux esophagitis and symptomatic improvement of GERD.     

胃食管反流病埃索美拉唑治疗长期随访研究

目的 研究埃索美拉唑长期维持或间歇治疗胃食管反流病(GERD)的疗效及安全性.方法 28例GERD患者先以每日2次每次20 mg埃索美拉唑为基础进行综合治疗2周,之后按治疗方式分为长期维持治疗组和间歇治疗组.维持治疗组患者为服用缓解症状所需最小剂量半年以上者.间歇治疗组患者每日1次口服埃索美拉唑20 mg维持至症状完全消失后停药,若症状复发则再以相同方案进行治疗.统计分析两组患者的用药剂量、复发情况及长期服用埃索美拉唑的不良反应.结果 13例患者需长期维持治疗(维持时间7～44个月),15例患者可通过间歇治疗达到症状缓解,均未见与埃索美拉唑相关的不良反应.13例长期维持治疗者中,缓解症状所需埃索美拉唑剂量7例为每日1次每次20 mg,5例为每日2次每次20 mg,1例为隔日1次每次20 mg.随访间歇治疗组患者10～57个月,发现服药时间越长,患者缓解时间越长,Pearson相关系数为0.447,差异有统计学意义(P=0.008).结论 GERD患者可通过埃索美拉唑长期维持治疗和间歇治疗两种方式缓解症状,且安全性较好.