雷尼替丁用于胃癌患者的前瞻性随机对照研究。约克郡胃肠肿瘤组。

A prospective randomised controlled study of the use of ranitidine in patients with gastric cancer. Yorkshire GI Tumour Group.

作者信息

Primrose J N, Miller G V, Preston S R, Gokhale J, Ambrose N S, Ward U M, Mills J G, Ehsanullah R S, Darekar B

机构信息

St James's University Hospital, Leeds, UK.

出版信息

Gut. 1998 Jan;42(1):17-9. doi: 10.1136/gut.42.1.17.

DOI:10.1136/gut.42.1.17

PMID:9505879

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC1726955/

Abstract

BACKGROUND

Does the use of the histamine H2 receptor antagonist ranitidine improve the outcome of patients with gastric cancer?

PATIENTS

A total of 222 patients with gastric cancer who had received radical or palliative resection or who were deemed inoperable at presentation.

SETTING

Hospitals within Yorkshire, the participating clinicians being members of the Yorkshire GI Tumour Group.

METHODS

A multicentre prospective randomised double blind trial comparing ranitidine 150 mg twice daily with placebo twice daily was undertaken. The principal outcome measures were survival and survival excluding those who died within 30 days of operation.

RESULTS

The median survival (95% confidence intervals) was 331 (232 to 393) days for patients in the ranitidine group compared with 187 (143 to 269) for those in the placebo group. The difference in survival was not statistically significant (p = 0.225). When patients who died within 30 days of operation were excluded (21 in the placebo group, 15 in the ranitidine group), the difference in survival remained not significant (p = 0.358). No subgroup could be identified who significantly benefited from treatment, but for patients with stage VIa cancer the median survival was 134 days with placebo compared with 313 days with ranitidine (p = 0.073).

CONCLUSION

This study does not show significant benefit from the use of ranitidine for gastric cancer but further larger studies may be indicated.

摘要

背景

使用组胺H2受体拮抗剂雷尼替丁是否能改善胃癌患者的预后？

患者

共有222例胃癌患者，这些患者接受了根治性或姑息性切除手术，或在就诊时被认为无法进行手术。

研究地点

约克郡内的医院，参与的临床医生为约克郡胃肠肿瘤组的成员。

方法

进行了一项多中心前瞻性随机双盲试验，比较每日两次服用150毫克雷尼替丁与每日两次服用安慰剂的效果。主要结局指标为生存率以及排除术后30天内死亡患者后的生存率。

结果

雷尼替丁组患者的中位生存期（95%置信区间）为331天（232至393天），而安慰剂组为187天（143至269天）。生存差异无统计学意义（p = 0.225）。排除术后30天内死亡的患者（安慰剂组21例，雷尼替丁组15例）后，生存差异仍无统计学意义（p = 0.358）。未发现有亚组能从治疗中显著获益，但对于Ⅵa期癌症患者，安慰剂组的中位生存期为134天，雷尼替丁组为313天（p = 0.073）。