本文關(guān)鍵詞： 隨機(jī)對(duì)照臨床試驗(yàn) 隨機(jī)分配 分配遮蔽 信封法 兩聯(lián)單　出處：《醫(yī)學(xué)研究生學(xué)報(bào)》2017年01期 　論文類型：期刊論文

【摘要】：目的隨機(jī)分配遮蔽對(duì)保證高質(zhì)量的隨機(jī)對(duì)照臨床試驗(yàn)(RCT)具有重要意義。文中通過(guò)對(duì)信封法隨機(jī)分配遮蔽技術(shù)的改進(jìn),以期設(shè)計(jì)一種更為便捷、有效的兩聯(lián)單隨機(jī)分配遮蔽方法。方法根據(jù)產(chǎn)生的隨機(jī)分配序列,為每一受試者制作一份隨機(jī)分配兩聯(lián)單,并按順序裝訂成冊(cè),制作成帶有封面和使用說(shuō)明的隨機(jī)分配簿。兩聯(lián)單的第一聯(lián)為說(shuō)明聯(lián),第二聯(lián)為分配聯(lián),兩聯(lián)序號(hào)相同、四周密封膠聯(lián),并在兩聯(lián)的相同區(qū)域處留空用于簽署受試者信息。第一聯(lián)書寫的內(nèi)容可完全復(fù)寫至第二聯(lián)上;第二聯(lián)分配信息的背面涂黑印刷,避免透光識(shí)別而導(dǎo)致分配信息的提前破解。當(dāng)研究者確定受試者合格后,依先后順序選擇受試者對(duì)應(yīng)的兩聯(lián)單。在第一聯(lián)簽署受試者信息后沿周邊撕開暴露第二聯(lián)分配信息,并將該受試者分配至第二聯(lián)上所指定的組別。隨機(jī)分配薄可委托專業(yè)印刷機(jī)構(gòu)。按照隨機(jī)分配序列表,并在嚴(yán)格的質(zhì)量控制下印刷制作,對(duì)于多中心臨床試驗(yàn)可分中心獨(dú)立印制。結(jié)果該方法已在18項(xiàng)臨床試驗(yàn)中得到應(yīng)用,其中5項(xiàng)為多中心試驗(yàn),3項(xiàng)為產(chǎn)品注冊(cè)試驗(yàn)。結(jié)論兩聯(lián)單隨機(jī)分配簿方法制作容易、操作簡(jiǎn)單、監(jiān)查方便,可有效實(shí)現(xiàn)臨床試驗(yàn)隨機(jī)分配遮蔽,對(duì)確保隨機(jī)化質(zhì)量具有較強(qiáng)的實(shí)用價(jià)值。
[Abstract]:Objective to improve the random distribution masking technique of envelope method in order to design a more convenient way to ensure the high quality of RCTs in randomized controlled clinical trials. Method according to the generated random distribution sequence, we make a random allocation list for each subject, and bind it into a book in order. A random distribution book with cover and usage instructions is made. The first of the two binders is the explanatory one and the second is the distribution joint, with the same serial number and four sealants. The contents of the first copy can be completely duplicated to the second one. The second distribution information is blackened on the back to avoid light transmission recognition resulting in early interpretation of the distribution information when the researcher determines that the subjects are qualified. The subjects were selected in sequence for the two combinations. The second distribution information was exposed along the periphery after the first copy signed the subject information. The subjects were assigned to the group designated on the second set. The random distribution book could be entrusted to the professional printing organization. According to the random distribution sequence list, the subject could be printed under strict quality control. Results the method has been used in 18 clinical trials, 5 of which are multicenter trials. Conclusion the double single random distribution book method is easy to make, easy to operate and easy to monitor, and can effectively realize random distribution masking in clinical trials. It has strong practical value to ensure the quality of randomization.
【作者單位】： 南方醫(yī)科大學(xué)金陵醫(yī)院(南京軍區(qū)南京總醫(yī)院)醫(yī)務(wù)部;南京軍區(qū)南京總醫(yī)院國(guó)家腎臟疾病臨床醫(yī)學(xué)研究中心全軍腎臟病研究所;
【基金】：國(guó)家自然科學(xué)基金(81473066)
【分類號(hào)】：R969.4
【正文快照】： 0引言在隨機(jī)對(duì)照臨床試驗(yàn)中,無(wú)論是臨床研究者還是受試對(duì)象,一旦事先知曉了被分配的組別,都可能會(huì)因?yàn)閭�(gè)人的主觀因素潛在地或有意識(shí)地破壞隨機(jī)分配,進(jìn)而影響整個(gè)臨床試驗(yàn)的質(zhì)量[1-2]。2016年國(guó)家食品藥品監(jiān)督管理總局發(fā)布的《藥物臨床試驗(yàn)的生物統(tǒng)計(jì)學(xué)指導(dǎo)原則》中指出,隨機(jī)

【相似文獻(xiàn)】

相關(guān)期刊論文 前3條

1 劉莫天;;病患者玩電子游戲可減少痛苦[J];科普天地(資訊版);2011年11期

2 梁偉雄,溫澤淮,呂曉慶,王奇,賴世隆;中央隨機(jī)分配交互式語(yǔ)音操作系統(tǒng)在新藥臨床試驗(yàn)中的應(yīng)用[J];中藥新藥與臨床藥理;2004年02期

3 ;[J];;年期

，

本文編號(hào)：1451691