泮托拉唑预防无法手术切除的胃癌患者肿瘤性出血随机、双盲、安慰剂临床对照研究

Effect of pantoprazole in tumor bleeding prevention in patients with unresectable gastric cancer： a randomized, double-blind, placebo-controlled clinical trial

目的探讨泮托拉唑对预防无法手术切除的胃癌患者肿瘤性出血的效果。方法采用随机、双盲、安慰剂对照临床试验，选取2014年1月至2015年6月在徐州市肿瘤医院就诊的胃癌患者肿瘤性出血患者，将无法手术切除的131例胃癌患者随机分为两组，实验组66例服用泮托拉唑40 mg、1次/d；对照组65例服用安慰剂40 mg、1次/d；疗程均为8周。观察随访期间两组的肿瘤性出血、输血需求和总生存期的差异。结果患者的随访中位数时间为6.5（3.3，13.2）个月，泮托拉唑组发生肿瘤性出血7例（10.61%），安慰剂组发生13例（20.00%），两组发生肿瘤性出血的风险累计发生率差异无统计学意义（Gray′s检验：P＝0.426）。随访前5个月泮托拉唑组肿瘤性出血的累积发生率为0，低于安慰剂组的9.23%（6/65）（ Gray′s检验：P＝0.039）。两组输血需求和总生存期差异无统计学意义。随访期间无药物相关的不良反应和肿瘤性出血相关的死亡事件发生。结论泮托拉唑不能明显减少无法手术切除的胃癌患者肿瘤性出血。

Objective To investigate the effects of pantoprazole treatment in the prevention of gastric tumor bleeding in patients with unresectable gastric cancer.Methods This study was a prospective double-blind, randomized, placebo-controlled trial.From January 2014 to July 2015, patients with gastric tumor bleeding in Xuzhou Cancer Hospital were included in this study.131 cases of unresectable gastric cancer were randomly divided into two groups.In the experimental group, 66 cases were taken pantoprazole 40 mg, 1 time /d, and 65 cases in the control group were given placebo 40 mg and 1 time/d.The course of treatment was 8 weeks.The differences in tumor bleeding, blood transfusion requirements and overall survival time between the two groups were observed during the follow-up period.Results The median follow-up time was 6.5（3.3, 13.2） months.Seven cases （10.61%） in pantoprazole group had tumor bleeding, and 13 （20%） in the placebo group.There was no significant difference in cumulative risk of tumor bleeding between the two groups （Gray′s test： P=0.426）. However, in the first 5 months of follow-up, the cumulative incidence of tumor bleeding in pantoprazole group was 0, lower than that in placebo group （9.23%） （6/65） （Gray′s test： P=0.039）. There was no significant difference in blood transfusion requirement and overall survival between the two groups.No drug-related adverse reactions and bleeding related deaths occurred during the follow-up period.Conclusion Pantoprazole can not significantly reduce tumor bleeding in patients with unresectable gastric cancer.