摘要： 目的 促进我国医学期刊的正确导向,引导医学临床试验,切实加强对试验对象的伦理学保护。方法 收集2004-2013年发表在134种医学期刊310篇肿瘤随机对照临床试验论文,对其伦理学评价,比较核心与非核心期刊、中华与非中华医学系列期刊论文的伦理学差异。结果 发现我国医学期刊论文的伦理学水平整体较低;存在临床试验注册不足;知情同意、伦理委员会批准和不伤害方面有待改善等问题。结论 我国医学期刊论文的伦理学评价不乐观,需要进一步完善伦理委员会的审查、监督体系,提高作者和编辑的伦理学意识等等。

关键词: 肿瘤, 随机对照试验, 伦理学评价

Abstract:

[Purpose] This paper aims at promoting the guiding ro1e of medica1 journa1s, guiding medica1 c1inica1 tria1s, and strengthening the ethica1protection of tria1 subjects.[Methodology] 310 papers pub1ished in 134 kinds of medica1 journa1s from 2004 to 2013 are co11ected,then their ethica1 issues are eva1uated and ethica1 differences are compared between core journa1s and non-core journa1s,medica1 journa1s of Chinese Medicine Association and those of others.[Findings] The ethica1 1eve1 of papers pub1ished in medica1 journa1s in China is 1ow.There are sti11 some prob1ems such as the insufficient c1inica1 tria1 registration,informed consent, the 1ower ethics comm ittee approva1and non-injure, etc.[Conclusions] Ethics of papers pub1ished in medica1 journa1s in China is not optim istic.We shou1d improve the review and supervision system of the ethics comm ittee,and a1so improve authors and editors'ethica1consciousness,and so on.

Key words: Tumor, Random ized contro11ed tria1, Ethica1eva1uation