Bardhan K D
Rotherham General Hospitals NHS Trust, Rotherham, UK.
Drugs Today (Barc). 1999 Oct;35(10):773-808. doi: 10.1358/dot.1999.35.10.561696.
Pantoprazole, the third proton pump inhibitor (PPI) to become available, has been extensively investigated. Pantoprazole inhibits acid more powerfully than histamine H(2) receptor antagonists (H(2)RAs) and omperazole 20 mg and raises median 24-h gastric pH from about 1.5 to 3-4 in healthy volunteers and in duodenal ulcer patients to above 5. Results from studies have confirmed that pantoprazole is superior to H(2)RAs in speed of healing and symptom relief in patients with peptic ulcer. In patients with duodenal ulcer pantoprazole was as effective as omperazole 20 mg and in patients with gastric ulcer pantoprazole was statistically superior to omeprazole 20 mg after 4 weeks. In triple combination therapy of peptic ulcer disease, the mean eradication rate of Helicobacter pylori in data pooled from 32 pantoprazole-based studies was 86% and compliance with treatment was about 90%. Results pooled from 5 large clinical trials of gastroesophageal reflux disease showed healing rates significantly superior to those achieved with H(2)RAs and similar to those of other PPIs at 4 and 8 weeks. Symptom relief was more rapid with pantoprazole and maintenance treatment kept the majority of patients in remission; relapse rates at 1 year were 25-28% on 20 mg daily and 6-22% on 40 mg daily. Maintenance treatment with pantoprazole 40 mg has been shown to keep most patients with aggressive or refractory ulcer and reflux disease in remission for up to 3 years. Pantoprazole was also effective in the management of patients with Zollinger-Ellison syndrome. In volunteers given aspirin, pantoprazole 40 mg proved significantly superior to ranitidine and placebo in preventing the development of mucosal damage and was significantly better than placebo in preventing gastric ulcer and duodenal ulcer in arthritic patients on nonsteroidal antiinflammatory drugs. Clinical trials, postmarketing surveillance and long-term studies have confirmed that pantoprazole is effective and safe for the short- and long-term management of peptic ulcer and reflux disease, with side effects similar in incidence and type to those of H(2)RAs.
泮托拉唑是第三种上市的质子泵抑制剂(PPI),已得到广泛研究。泮托拉唑抑制胃酸的作用比组胺H₂受体拮抗剂(H₂RAs)和20毫克奥美拉唑更强,可使健康志愿者和十二指肠溃疡患者的24小时胃pH值中位数从约1.5提高到3至4,在十二指肠溃疡患者中pH值可升至5以上。研究结果证实,在消化性溃疡患者的愈合速度和症状缓解方面,泮托拉唑优于H₂RAs。在十二指肠溃疡患者中,泮托拉唑与20毫克奥美拉唑疗效相当;在胃溃疡患者中,4周后泮托拉唑在统计学上优于20毫克奥美拉唑。在消化性溃疡疾病的三联联合治疗中,从32项以泮托拉唑为基础的研究汇总数据来看,幽门螺杆菌的平均根除率为86%,治疗依从性约为90%。从5项胃食管反流病大型临床试验汇总的结果显示,在4周和8周时,愈合率显著高于H₂RAs,与其他PPI相似。泮托拉唑缓解症状更快,维持治疗可使大多数患者病情缓解;每日服用20毫克时,1年复发率为25%至28%,每日服用40毫克时为6%至22%。已证明,每日服用40毫克泮托拉唑进行维持治疗,可使大多数患有侵袭性或难治性溃疡及反流病的患者病情缓解长达3年。泮托拉唑在卓-艾综合征患者的治疗中也有效。在服用阿司匹林的志愿者中,40毫克泮托拉唑在预防黏膜损伤方面明显优于雷尼替丁和安慰剂,在预防服用非甾体抗炎药的关节炎患者发生胃溃疡和十二指肠溃疡方面明显优于安慰剂。临床试验、上市后监测和长期研究证实,泮托拉唑在消化性溃疡和反流病的短期及长期治疗中有效且安全,其副作用的发生率和类型与H₂RAs相似。