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口服法莫替丁减少食管癌和贲门癌患者放疗血液学并发症的效果:一项随机对照试验。

Effectiveness of oral famotidine in reducing the hematologic complications of radiotherapy in patients with esophageal and cardia cancers: a randomized controlled trial.

机构信息

Social Determinants of Health Research Center, Zanjan University of Medical Sciences, Zanjan, Iran.

Department of Radiation Oncology, School of Medicine, Vali-e-Asr Hospital, Zanjan University of Medical Sciences, Zanjan, Iran.

出版信息

Radiat Oncol. 2023 May 20;18(1):83. doi: 10.1186/s13014-023-02281-w.

Abstract

BACKGROUND

Chemoradiotherapy complications has always been of great concern to both clinicians and patients during the course of treatment. The purpose of the present study was to examine the effectiveness of oral famotidine on the reduction of hematologic complications of patients with esophageal and gastric cardia cancers undergoing radiotherapy.

METHODS

A single-blind controlled trial was conducted on 60 patients with esophageal and cardia cancers, who were undergoing chemoradiotherapy. Patients were randomly assigned to 2 groups with 30 patients to receive either 40 mg of oral famotidine (daily and 4 h before each session) or placebo. Complete blood count with differential, platelet counts, and hemoglobin levels were obtained weekly during treatment. The main outcome variables were lymphocytopenia, granulocytopenia, thrombocytopenia, and anemia.

RESULTS

The findings indicated a significant effect of famotidine on reduction of thrombocytopenia among intervention group compared to control group (P < 0.0001). Even so, the effect of intervention was not significant for other outcome variables (All, P ≥ 0.05). The lymphocyte (P = 0.007) and platelet (P = 0.004) counts were also significantly greater in famotidine group in comparison with placebo group at the end of the study.

CONCLUSION

As evidenced by the findings of the current study, famotidine might be recommended as an effective radioprotective agent among patients with esophageal and gastric cardia cancers to prevent Leukocyte and platelet reduction to some extent. Trial registration This study was prospectively registered at irct.ir (Iranian Registry of Clinical Trials) with the code IRCT20170728035349N1, 2020-08-19.

摘要

背景

放化疗并发症一直是临床医生和患者在治疗过程中非常关注的问题。本研究旨在观察口服法莫替丁对接受放化疗的食管和贲门癌患者血液学并发症的降低作用。

方法

对 60 例接受放化疗的食管和贲门癌患者进行了一项单盲对照试验。患者被随机分为两组,每组 30 例,分别接受 40mg 口服法莫替丁(每日一次,每次治疗前 4 小时)或安慰剂。在治疗过程中每周进行全血细胞计数、血小板计数和血红蛋白水平检测。主要观察变量为淋巴细胞减少症、粒细胞减少症、血小板减少症和贫血症。

结果

结果表明,与对照组相比,法莫替丁组在降低血小板减少症方面有显著效果(P<0.0001)。然而,干预组对其他观察变量的影响不显著(均 P≥0.05)。与安慰剂组相比,法莫替丁组在研究结束时的淋巴细胞(P=0.007)和血小板(P=0.004)计数也显著更高。

结论

根据本研究的结果,法莫替丁可作为食管和贲门癌患者的有效放射防护剂,在一定程度上预防白细胞和血小板减少。

试验注册

本研究前瞻性地在 irct.ir(伊朗临床试验注册中心)注册,注册号为 IRCT20170728035349N1,2020-08-19。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/81c4/10199581/bc9817ea7f3e/13014_2023_2281_Fig1_HTML.jpg

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