BACKGROUND & AIMS: BACKGROUND AND OBJECTIVES:Secondary hyperparathyroidism is a common consequence of chronic kidney disease. Cinacalcet (Sensipar(®)) is often prescribed in combination to reduce elevated levels of parathyroid hormone, calcium and phosphorus. The objective of this study was to assess the effects of concomitantly administered therapies of calcium carbonate (CaCO(3); TUMS(®)), sevelamer hydrochloride (HCl; Renagel(®)) and pantoprazole sodium (Protonix(®)) on the pharmacokinetics and safety of cinacalcet in healthy subjects. METHODS:Three randomized, open-label, two-way crossover pharmacokinetic studies were conducted in healthy subjects. Participants received single doses of cinacalcet alone or in combination with either CaCO(3), sevelamer HCl or pantoprazole. The pharmacokinetic profile of cinacalcet was characterized. Safety assessments including adverse event reporting, changes in vital signs and clinical laboratory measurements were conducted throughout the studies. RESULTS:The 90 % confidence intervals for the area under the concentration-time curve from time zero to the last quantifiable concentration (AUC(last)), area under the concentration-time curve from time zero to infinity (AUC(0-∞)) and maximum plasma concentration (C(max)) of cinacalcet were within the accepted range of 80-125 % for both CaCO(3) and sevelamer HCl co-administration with cinacalcet. No severe or serious adverse events or clinically relevant changes in physical or laboratory findings occurred during the studies. CONCLUSION:The pharmacokinetic parameters of cinacalcet were not affected by co-administration of CaCO(3), sevelamer HCl or pantoprazole. Co-administration of these agents with cinacalcet does not require an adjustment of the dose of cinacalcet.

背景与目标：

BACKGROUND & AIMS: Pantoprazole is a specific inhibitor of the H+/K(+)-ATPase of the gastric parietal cell. The dose-dependency of a range of pantoprazole pharmacokinetic characteristics was studied. Twelve healthy male subjects were given 10, 20, 40 and 80 mg pantoprazole intravenously according to a randomized, single blind, 4-period change-over scheme. The area under the concentration vs time curve (AUC) and the maximum serum concentration (Cmax) showed a linear increase in line with the dose. Apparent volume of distribution (Vd area), clearance (Cl) and terminal half-life (t1/2) were independent of the dose. The dose-independent elimination of pantoprazole was attributed to the lack of interaction of the drug with cytochrome P450. In clinical practice, a good predictable response, as well as a low potential for interaction with other drugs might be expected.

背景与目标： 泮托拉唑是胃壁细胞H/K ()-ATPase的特异性抑制剂。研究了一系列泮托拉唑药代动力学特征的剂量依赖性。根据随机，单盲，4期转换方案，对12名健康男性受试者进行了10、20、40和80 mg泮托拉唑的静脉注射。浓度与时间曲线下的面积 (AUC) 和最大血清浓度 (Cmax) 随剂量呈线性增加。表观分布体积 (Vd面积)，清除率 (Cl) 和末端半衰期 (t1/2) 与剂量无关。pantoprazole的剂量依赖性消除归因于药物与细胞色素p450缺乏相互作用。在临床实践中，可以预期良好的可预测反应以及与其他药物相互作用的潜力较低。

BACKGROUND & AIMS: Pantoprazole is a new substituted benzimidazole, which is a potent inhibitor of gastric acid secretion by its inhibition of H+,K(+)-ATPase. Pantoprazole, 40 mg, was compared with the H2-receptor antagonist ranitidine, 300 mg, in the healing of acute duodenal ulcer. Two hundred seventy-six patients with endoscopically diagnosed duodenal ulcer were studied in this multicenter double-blind study. Patients were reendoscopied after two weeks of treatment, and those patients whose ulcers remained unhealed were also endoscoped after an additional two weeks of treatment. The primary end point was the complete healing of the ulcer. Demographic characteristics were comparable in both treatment groups. After two weeks of treatment, 90/124 (73%) patients in the pantoprazole group had healed ulcers compared with 57/126 (45%) patients in the ranitidine group (P < 0.001, per-protocol analysis). After four weeks, the cumulative healing rates were 92% and 84% in the pantoprazole and ranitidine groups, respectively (P = 0.073). Symptoms were also improved at week 2, with 84% and 72% of patients in the pantoprazole and ranitidine groups, respectively, reporting no ulcer pain (P < 0.05, per-protocol analysis). Both treatments were well tolerated. This study has confirmed the superiority of pantoprazole compared with ranitidine in the healing of duodenal ulcers and pain relief after two weeks of treatment and has shown pantoprazole to be well tolerated in this indication.

背景与目标： 泮托拉唑是一种新的取代苯并咪唑，它通过抑制H，K ()-atp酶而成为胃酸分泌的有效抑制剂。将40 mg的泮托拉唑与H2-receptor拮抗剂雷尼替丁300 mg在急性十二指肠溃疡的愈合中进行了比较。在这项多中心双盲研究中，对76例经内镜诊断为十二指肠溃疡的患者进行了研究。治疗两周后，患者进行了内窥镜检查，而那些溃疡仍未愈合的患者在另外两周的治疗后也进行了内窥镜检查。主要终点是溃疡完全愈合。两个治疗组的人口统计学特征具有可比性。治疗2周后，泮托拉唑组90/124例 (73% 例) 溃疡愈合，雷尼替丁组57/126例 (45% 例) 溃疡愈合 (P <0.001，符合方案分析)。4周后，泮托拉唑组和雷尼替丁组的累积治愈率分别为92% 和84% (P = 0.073)。在第2周时症状也得到改善，泮托拉唑组和雷尼替丁组分别有84% 和72% 患者，报告无溃疡疼痛 (P <0.05，符合方案分析)。两种治疗都具有良好的耐受性。这项研究证实了泮托拉唑与雷尼替丁相比，在治疗两周后的十二指肠溃疡愈合和缓解疼痛方面具有优势，并表明泮托拉唑在这种适应症中具有良好的耐受性。

BACKGROUND & AIMS: :Proton pump inhibitors (PPI) are being considered for antineoplastic therapeutic regimens due to their ability to reverse H(+) homeostasis in tumor microenvironment and induce tumor cell death. In order to explore additional mechanism(s) underlying antitumor action of PPI, the present investigation was undertaken to investigate the effect of a PPI pantoprazole (PPZ) on the activation of tumor-associated macrophages (TAM) to tumoricidal state in a murine model of a transplantable T cell lymphoma of spontaneous origin growing in ascitic form. In vivo administration of PPZ to tumor-bearing mice resulted in an enhanced TAM recruitment in tumor microenvironment with M1 macrophage phenotype and augmented activation of TAM to tumoricidal state along with expression of tumor cytotoxic molecules. The study also demonstrates that TAM activating action of PPZ is of indirect nature mediated via its antitumor activity, reversal of tumor-induced immunosuppression and a consequent shift of cytokine balance in the tumor microenvironment favoring polarization of macrophages to M1 type. The study further shows that adoptive transfer of TAM harvested from PPZ-administered tumor-bearing hosts causes an efficient retardation of tumor growth. Possible mechanisms and significance of these observations with respect to the designing of antitumor therapy using PPI are discussed.

背景与目标： : 质子泵抑制剂 (PPI) 因其逆转肿瘤微环境中H () 稳态并诱导肿瘤细胞死亡的能力而被考虑用于抗肿瘤治疗方案。为了探索PPI抗肿瘤作用的其他机制，进行本研究是为了研究PPI泮托拉唑 (PPZ) 对以腹水形式生长的自发起源的可移植T细胞淋巴瘤的鼠模型中肿瘤相关巨噬细胞 (TAM) 活化为杀瘤状态的影响。向荷瘤小鼠体内施用PPZ导致具有M1巨噬细胞表型的肿瘤微环境中TAM募集增强，TAM激活增强至杀瘤状态以及肿瘤细胞毒性分子的表达。研究还表明，PPZ的TAM激活作用是通过其抗肿瘤活性，逆转肿瘤诱导的免疫抑制以及随之而来的肿瘤微环境中细胞因子平衡的转移而间接介导的，从而有利于巨噬细胞向M1型极化。研究进一步表明，从PPZ施用的荷瘤宿主中收获的TAM的过继转移会导致肿瘤生长的有效延迟。讨论了这些观察结果在使用PPI设计抗肿瘤治疗方面的可能机制和意义。

BACKGROUND & AIMS: BACKGROUND:Mechanical ventilation increases risk for bleeding in the upper part of the gastrointestinal tract. Proton pump inhibitors, although they are more potent and longer acting inhibitors of gastric acid production than are histamine(2) antagonists, also are generally more expensive. Data comparing the 2 types of agents for preventing gastrointestinal bleeding in critically ill patients are limited. OBJECTIVES:To compare the effectiveness of famotidine (a histamine(2) antagonist) and pantoprazole (a proton pump inhibitor) in preventing stress ulcers in critically ill patients receiving mechanical ventilation. METHODS:Data were collected from the Project Impact database. All patients who received mechanical ventilation for more than 48 hours from November 2002 to June 2006 and were treated with either drug were included. Patients receiving other drugs or with known bleeding in the upper part of the gastrointestinal tract, thrombocytopenia, or coagulopathy were excluded. RESULTS:A total of 522 patients who received famotidine and 95 who received pantoprazole were included. Bleeding in the upper part of the gastrointestinal tract was more common in patients receiving pantoprazole than in patients receiving famotidine (0.38% vs 3.2%, P= .03). Although scores on the Acute Physiology and Chronic Health Evaluation II were higher in patients who received pantoprazole (P= .01), other outcome measures did not differ significantly between groups. Bleeding in the upper part of the gastrointestinal tract was more frequent among dialysis patients receiving pantoprazole than among those receiving famotidine. CONCLUSIONS:Famotidine and pantoprazole are similarly effective for preventing bleeding in the upper part of the gastrointestinal tract in patients receiving mechanical ventilation.

背景与目标：

BACKGROUND & AIMS: :BACKGROUND AND OBJECTIVE: An increasing trend in prescribing proton pump inhibitors (PPIs) inevitably increases the risk of unwanted drug-drug interactions (DDIs). The aim of this study was to uncover pharmacokinetic interactions between two PPIs-omeprazole and pantoprazole-and venlafaxine. METHODS:A therapeutic drug monitoring database contained plasma concentrations of venlafaxine and its active metabolite O-desmethylvenlafaxine. We considered three groups: a group of patients who received venlafaxine without confounding medications (non-PPI group, n = 906); a group of patients who were comedicated with omeprazole (n = 40); and a group of patients comedicated with pantoprazole (n = 40). Plasma concentrations of venlafaxine, O-desmethylvenlafaxine and active moiety (venlafaxine + O-desmethylvenlafaxine), as well as dose-adjusted plasma concentrations, were compared using non-parametrical tests. RESULTS:Daily doses of venlafaxine did not differ between groups (p = 0.949). The Mann-Whitney U test showed significantly higher plasma concentrations of active moiety, as well as venlafaxine and O-desmethylvenlafaxine, in both PPI groups [p = 0.023, p = 0.011, p = 0.026, +29% active moiety, +27% venlafaxine, +36% O-desmethylvenlafaxine (pantoprazole); p = 0.003, p = 0.039 and p < 0.001, +36% active moiety, +27% venlafaxine, +55% O-desmethylvenlafaxine (omeprazole)]. Significantly higher concentration-by-dose (C/D) values for venlafaxine and active moiety were detected in the pantoprazole group (p = 0.013, p = 0.006, respectively), while in the omeprazole group, C/D ratios for all three parameters-venlafaxine, O-desmethylvenlafaxine and active moiety-were significantly higher (p = 0.021, p < 0.001 and p < 0.001, respectively). CONCLUSIONS:Significantly higher plasma concentrations for all parameters (venlafaxine, O-desmethylvenlafaxine, active moiety) suggest clinically relevant inhibitory effects of both PPIs, most likely on the cytochrome P450 (CYP) 2C19-mediated metabolism of venlafaxine. The findings might be the result of different degrees of CYP2C19 involvement, therefore the inhibition of CYP2C19 by both PPIs may lead to an increased metabolism via CYP2D6 to O-desmethylvenlafaxine.

背景与目标：

BACKGROUND & AIMS: BACKGROUND:The effects of PPIs on human sperm fertilizing capacity were poorly investigated although these drugs are widely over-used. Two publications retrospectively studied relationships between any PPI intake and sperm parameters from patients consulting at infertility clinics, but the conclusions of these reports were contradictory. Only two reports investigated the effects of lansoprazole and omeprazole on sperm motility and found lansoprazole to be deleterious and omeprazole to be neutral for sperm motility. The inconsistency of the PPI effect in the previous reports emphasizes the need for more basic research on human spermatozoa, taking into account the hypothesis that the different PPI drugs may have different effects on sperm physiology. OBJECTIVES:Do PPIs, which are among the most widely sold drug in the word, impact negatively human sperm capacitation and sperm motility? MATERIALS AND METHODS:The effects of PPIs on human sperm maturation and motility were analyzed by CASA, flow cytometry, and Western blot. RESULTS:We tested the impact of 6 different PPIs on human sperm motility and capacitation. We showed that pantoprazole, but not the other PPIs, decreased sperm progressive motility and capacitation-induced sperm hyperactivation. We therefore investigated further the effects of pantoprazole on sperm capacitation, and we observed that it had a significant deleterious effect on the capacitation-induced hyperpolarization of the membrane potential and capacitation-associated protein phosphorylation. DISCUSSION AND CONCLUSION:Our results indicate that exposure to pantoprazole has an adverse effect on the physiological competence of human spermatozoa. As the capacitation process takes place within the female tract, our results suggest that PPIs intake by the female partner may impair in vivo sperm maturation and possibly fertilization. Moreover, the absence of adverse effect by PPIs on mouse sperm emphasizes the need to develop reprotox assays using human material to better assess the effects of medication intake on sperm physiology.

背景与目标：

BACKGROUND & AIMS: OBJECTIVE:To determine the efficacy of pantoprazole therapy for daytime somnolence, psychomotor vigilance, and quality of life in patients with mild-moderate obstructive sleep disordered breathing (OSDB) and gastroesophageal reflux disease (GERD). STUDY DESIGN:Randomized, double-blind, placebo-controlled crossover trial. METHODS:Sixty patients with daytime sleepiness, mild-moderate OSDB and GERD were randomly assigned a 2-week treatment with pantoprazole 40 mg or placebo followed by a 2-week washout period and crossover respectively to 2-week treatment with placebo or pantoprazole. Outcomes included Epworth Sleepiness Score (ESS), sleep-related quality-of-life (FOSQ), and reaction time. RESULTS:With pantoprazole, patients reported statistically significantly greater improvement of overall reflux symptoms (P = 0.0003) and in ESS (P = 0.04). A significant improvement was noted in FOSQ for both treatments with a trend toward greater improvement with pantoprazole (P = 0.058). No improvement in reaction times was observed. CONCLUSION:Patients with coexistent GERD and OSDB noted significant improvement in daytime sleepiness after treatment with pantoprazole over placebo likely related to a reduction in nocturnal reflux-related arousals.

背景与目标：

BACKGROUND & AIMS: :A 42 year old male patient without previous psychiatric history developed 48 hours after he was placed on a helicobacter pylori eradication treatment with amoxicillin, clarithromycin and pantoprazole a brief psychosis accompanied by delusional beliefs, personality changes and disorientation. After discontinuation of the tripletherapie and administration of risperidone he recovered within 72 hours. The follow up of the patient two, twelve and seventy-two weeks after discharge showed that he remained euthymic and free of psychotic symptoms.

背景与目标： : 一名42岁的男性患者在接受阿莫西林，克拉霉素和泮托拉唑根除幽门螺杆菌治疗后48小时出现了精神病，伴有妄想信念，人格改变和迷失方向。停用三联疗法并服用利培酮后，他在72小时内康复。出院后第二，十二和七十二周对患者的随访表明，他仍然保持正常状态，没有精神病症状。

BACKGROUND & AIMS: OBJECTIVE AND DESIGN:The effect of increasing doses of pantoprazole, a newly developed proton pump inhibitor, given at once daily doses of 40, 80 and 120 mg, on intragastric pH and serum gastrin profiles was studied in 15 healthy subjects in a randomized, double-blind, crossover study and compared to recordings without therapy. Measurements of intragastric pH and serum gastrin were performed on the 7th day of treatment by continuous pH recording and radioimmunoassay in blood samples obtained in 1-h intervals, respectively. RESULTS:Pantoprazole significantly increased gastric pH above basal at all pantoprazole doses studied: median 24-h pH rose from 1.2 without therapy to 3.4, 3.3 and 3.6 at 40, 80 and 120 mg daily, respectively. The corresponding integrated 24-h gastrin output was 1632, 2338 and 2248 pg/ml x 24 h compared to 575 pg/ml x 24 h without pantoprazole. There was no interindividual correlation between values of 24-h median pH and 24-h gastrin output at any pantoprazole dose studied. However, fasting gastrin levels closely correlated with 24-h gastrin output (r = 0.789; P < 0.0001). The acid inhibitory effect was significantly (P < 0.01) augmented in Helicobacter pylori positive subjects. CONCLUSION:It is concluded that pantoprazole is an effective inhibitor of gastric acid secretion. Increasing a single pantoprazole dose above 40 mg does not lead to increased median pH elevation. The individual extent of acid inhibition does not predict the magnitude of gastrin elevation. Acid inhibition appears more efficient in Helicobacter pylori positive subjects.

背景与目标：

BACKGROUND & AIMS: Twenty-three healthy, male volunteers completed this doubleblind, randomized, placebo controlled, 2-period crossover study to assess the influence of multiple doses of pantoprazole on single-dose phenytoin pharmacokinetics. During each treatment period, the volunteers received either one 40 mg pantoprazole tablet or placebo for 7 days. In addition, a single-dose of 300 mg (3 x 100 mg capsules) phenytoin sodium was administered on day 4 of each treatment period. A 14-day wash-out period was allowed between phenytoin administrations. The results indicate that pantoprazole neither affects the rate nor the extent of absorption, nor the elimination of phenytoin.

背景与目标： 23名健康的男性志愿者完成了这项双盲，随机，安慰剂对照，2期交叉研究，以评估多剂量泮托拉唑对单剂量苯妥英药代动力学的影响。在每个治疗期间，志愿者接受40 mg泮托拉唑片剂或安慰剂治疗7天。此外，在每个治疗期的第4天给予单剂量的300 mg (3 × 100 mg胶囊) 苯妥英钠。苯妥英钠给药之间允许14天的冲洗期。结果表明，泮托拉唑既不影响吸收速率，也不影响吸收程度，也不影响苯妥英的消除。

BACKGROUND & AIMS: OBJECTIVE:Renal-transplant patients who are immunosuppressed with cyclosporin A (CyA) are often treated with proton-pump inhibitors to prevent ulcer disease. No data are available on the effect of the novel proton-pump inhibitor pantoprazole on CyA levels.

METHODS:In a controlled treatment, we investigated the effect of pantoprazole, which was administered in a pragmatic schedule for acid suppression (40 mg as single oral dose at 2200 hours) in six renal-transplant patients who received CyA (Sandimmun optoral, 50-175 mg twice daily) and prednisolone (5-7.5 mg/24 h). CyA trough levels (0730-0800 hours) were measured by immunoassay.

RESULTS:In the absence of pantoprazole, mean CyA trough levels measured on three consecutive days were between 164 ng/ml and 173 ng/ml (therapeutic range 120-200 ng/ml). Pantoprazole did not affect CyA trough levels during an observation period up to 3 months long.

CONCLUSIONS:Pantoprazole seems to be a safe drug in combination with CyA.

背景与目标： 目的 : 用环孢菌素A (CyA) 免疫抑制的肾移植患者通常接受质子泵抑制剂治疗以预防溃疡病。没有关于新型质子泵抑制剂泮托拉唑对CyA水平的影响的数据。
方法 : 在对照治疗中，我们研究了泮托拉唑的作用，在六名接受CyA (Sandimmun optoral，每天两次50-175 mg) 和泼尼松龙 (5-7.5 mg/24小时) 的肾移植患者中，以实用的方案进行酸抑制 (40 mg，单次口服，2200小时)。通过免疫测定法测量CyA谷水平 (0730-0800小时)。
结果 : 在没有泮托拉唑的情况下，连续三天测量的平均CyA谷水平在164 ng/ml和173 ng/ml之间 (治疗范围120-200 ng/ml)。在长达3个月的观察期内，泮托拉唑不会影响CyA谷水平。
结论 : 泮托拉唑似乎是与CyA联合使用的安全药物。

BACKGROUND & AIMS: OBJECTIVES:To investigate whether pantoprazole (20 mg/d) produces significantly greater symptom control than ranitidine (300 mg/d) in patients with gastro-oesophageal reflux disease (GORD). DESIGN:Multicentre, randomised, double-blind, parallel-group comparison. SETTING:76 general practices in north-west Sydney and Newcastle, New South Wales (Australia), from 19 January 1999 to 22 September 2000. PATIENTS:307 patients aged 18 years or over presenting with symptomatic GORD. INTERVENTIONS:Pantoprazole (20 mg once daily) or ranitidine (150 mg twice daily). MAIN OUTCOME MEASURES:Patient-assessed frequency and severity of heartburn using the Gastrointestinal Symptom Rating Scale (GSRS) and a patient heartburn diary. RESULTS:Pantoprazole was associated with significantly higher rates of complete control of GORD symptoms than ranitidine at four weeks (40% v 19%; P < 0.001), eight weeks (55% v 33%; P < 0.001), six months (71% v 56%; P = 0.007) and 12 months (77% v 59%; P = 0.001). CONCLUSIONS:Low-dose pantoprazole is an effective alternative to standard-dose ranitidine for initial and maintenance treatment of patients with symptomatic GORD.

背景与目标：

BACKGROUND & AIMS: BACKGROUND:Stress ulcer prophylaxis (SUP) using ranitidine, a histamine H2 receptor antagonist, has been associated with an increased risk of ventilator-associated pneumonia. The proton pump inhibitor (PPI) pantoprazole is also commonly used for SUP. PPI use has been linked to an increased risk of community-acquired pneumonia. The objective of this study was to determine whether SUP with pantoprazole increases pneumonia risk compared with ranitidine in critically ill patients. METHODS:The cardiothoracic surgery database at our institution was used to identify retrospectively all patients who had received SUP with pantoprazole or ranitidine, without crossover between agents. From January 1, 2004, to March 31, 2007, 887 patients were identified, with 53 patients excluded (pantoprazole, 30 patients; ranitidine, 23 patients). Our analysis compared the incidence of nosocomial pneumonia in 377 patients who received pantoprazole with 457 patients who received ranitidine. RESULTS:Nosocomial pneumonia developed in 35 of the 377 patients (9.3%) who received pantoprazole, compared with 7 of the 457 patients (1.5%) who received ranitidine (odds ratio [OR], 6.6; 95% confidence interval [CI], 2.9 to 14.9). Twenty-three covariates were used to estimate the probability of receiving pantoprazole as measured by propensity score (C-index, 0.77). Using this score, pantoprazole and ranitidine patients were stratified according to their probability of receiving pantoprazole. After propensity adjusted, multivariable logistic regression, pantoprazole treatment was found to be an independent risk factor for nosocomial pneumonia (OR, 2.7; 95% CI, 1.1 to 6.7; p = 0.034). CONCLUSION:The use of pantoprazole for SUP was associated with a higher risk of nosocomial pneumonia compared with ranitidine. This relationship warrants further study in a randomized controlled trial.

背景与目标：

BACKGROUND & AIMS: BACKGROUND:Proton pump inhibitors (PPIs) are well established as first-line agents for the treatment of moderate-to-severe gastro-oesophageal reflux disease (GORD). Although all PPIs heal oesophageal lesions and provide symptomatic relief, breakthrough symptoms may occur as acidity levels rebound. Pantoprazole magnesium (pantoprazole-Mg) has a longer elimination half-life than pantoprazole sodium (pantoprazole-Na), resulting in prolonged drug exposure. OBJECTIVE:This study compares the clinical efficacy and safety of once-daily pantoprazole-Mg 40 mg with that of once-daily pantoprazole-Na 40 mg in the management of GORD. METHODS:This was a randomized, double-blind, controlled, multicentre study of non-inferiority design in outpatients with GORD. The study was conducted in 53 centres in Germany from 12 May 2003 to 18 September 2003. Male or female outpatients (aged ≥18 years) with endoscopically confirmed GORD stage I-III (according to the Savary-Miller classification modified by Siewert) were enrolled. Using a computer-generated randomization list, patients were randomized to treatment with pantoprazole-Mg 40 mg plus placebo or pantoprazole-Na 40 mg plus placebo, both given once daily for 4 or 8 weeks depending on healing of oesophagitis. The primary objective was endoscopic healing at 8 weeks. RESULTS:The intent-to-treat (ITT) group consisted of 636 patients (322 receiving pantoprazole-Mg and 314 receiving pantoprazole-Na). Endoscopically confirmed healing of reflux oesophagitis after 8 weeks occurred in 87.3% (95% CI 83.1, 90.7) of patients receiving pantoprazole-Mg and 85.0% (95% CI 80.6, 88.8) of patients receiving pantoprazole-Na (ITT population). The lower bound of the 95% CI for the between-group treatment difference was -1.3, which was within the predefined margin of non-inferiority of -10% to 0%. Healing rates after 4 weeks were superior in the pantoprazole-Mg group (72.7% [95% CI 67.5, 77.5]) compared with the pantoprazole-Na group (66.2% [95% CI 60.7, 71.5]), and the one-sided (lower bound) of the 95% CI for the difference between healing rates for the two treatments was within the predefined non-inferiority margin of -10% to 0%. Both treatments had a similar effect on GORD healing in subgroups of patients based on baseline oesophagitis grade and Helicobacter pylori status. Pantoprazole-Mg had similar efficacy to pantoprazole-Na in relieving a broad range of GORD-related symptoms across the course of the study, although symptomatic relief at 4 weeks was numerically higher in the pantoprazole-Mg group than in the pantoprazole-Na group (statistical analyses were not performed). Both treatments were well tolerated; most adverse events were of mild or moderate severity and unrelated to the study medication, and there were no unexpected safety concerns. CONCLUSION:Pantoprazole-Mg is clinically as effective and well tolerated as pantoprazole-Na in the treatment of GORD stages I-III, demonstrating non-inferiority for oesophageal healing at 8 weeks and superior healing rates at 4 weeks associated with high levels of symptomatic relief.

背景与目标：