【摘要】：目的：回顧分析新藥I期臨床試驗(yàn)中青年健康志愿受試者的各項(xiàng)實(shí)驗(yàn)室指標(biāo)，通過(guò)統(tǒng)計(jì)分析得出他們各項(xiàng)指標(biāo)的參考值范圍（在95%可信區(qū)間內(nèi)以x±1.96s計(jì)算），計(jì)算符合現(xiàn)在本實(shí)驗(yàn)室自身實(shí)驗(yàn)條件的正常值參考范圍上下限，提供使其符合本實(shí)驗(yàn)室具體條件的各項(xiàng)臨床化驗(yàn)指正常值范圍界限的依據(jù)，提供新的臨床檢驗(yàn)操作規(guī)范。通過(guò)對(duì)藥物I期臨床試驗(yàn)篩查受試者過(guò)程及數(shù)據(jù)的研究，探討受試者群體符合本實(shí)驗(yàn)室自身具體條件的正常值范圍規(guī)律，為該領(lǐng)域閾值的修訂提供依據(jù)。 方法：收集新藥I期藥物臨床試驗(yàn)已經(jīng)被納入受試者群體的研究病例選取154例健康成年男人，，其基本情況和相關(guān)化驗(yàn)室檢查指標(biāo)進(jìn)行統(tǒng)計(jì)學(xué)分析，總結(jié)其95%可信區(qū)間內(nèi)的參考范圍，也就是實(shí)際化驗(yàn)指標(biāo)正常值參考值范圍。具體包括：性別、民族、年齡、身高(cm)、體重(Kg)、身體質(zhì)量指數(shù)、職業(yè)、體溫(℃)、脈搏(次/分)、呼吸(次/分)、血壓(mmHg)、血白細(xì)胞(10^9/L)、血紅細(xì)胞(10^12/L)、血紅蛋白(g/L)、中性細(xì)胞比率(%)、淋巴細(xì)胞比率(%)、單核細(xì)胞比率(%)、血小板計(jì)數(shù)(10^9/L)、尿白細(xì)胞(/ul)、尿紅細(xì)胞(/ul)、上皮細(xì)胞計(jì)數(shù)(/ul)、管型計(jì)數(shù)(/ul)、細(xì)菌計(jì)數(shù)(/ul)、尿白細(xì)胞（高倍視野）個(gè)/HP、尿紅細(xì)胞（高倍視野）個(gè)/HP、尿管型細(xì)胞（低倍視野）個(gè)/HP、尿膽原、膽紅素、酮體、隱血、尿蛋白、葡萄糖、谷丙轉(zhuǎn)氨酶(IU/L)、谷草轉(zhuǎn)氨酶(IU/L)、尿素氮(mmol/L)、肌酐(umol/L)、心電圖等等。 結(jié)果：各項(xiàng)化驗(yàn)室指標(biāo)全部正常的病例數(shù)為56例；實(shí)驗(yàn)室檢查結(jié)果有異常但無(wú)臨床意義的例數(shù)為98例；實(shí)際納入的受試者例數(shù)為154例。通過(guò)統(tǒng)計(jì)學(xué)分析均得出它們的最大值、最小值、平均值、標(biāo)準(zhǔn)差、參考值范圍（B）x±1.96s和A∪B的范圍。 結(jié)論：按照目前規(guī)定的化驗(yàn)室指標(biāo)來(lái)判斷人的健康與否，理想的健康人比率較低，可考慮選擇指標(biāo)稍有異常但無(wú)臨床意義的受試者作為I期臨床試驗(yàn)的健康受試者。目前的I期臨床試驗(yàn)受試者篩選指標(biāo)參考值范圍尚有欠缺，該研究為小樣本探索性、回顧性研究期待為新藥I期臨床試驗(yàn)篩選正常值指標(biāo)參考值范圍的閾值提供微小依據(jù)。
[Abstract]:Objective: to retrospectively analyze the laboratory indexes of young healthy volunteers in the phase I clinical trial of the new drug, and to obtain the range of their reference values (x 鹵1.96 s in 95% confidence interval). To calculate the upper and lower limits of the reference range of the normal values which accord with the present experimental conditions of our laboratory, to provide the basis for the limit of the normal range of clinical tests which make it conform to the specific conditions of our laboratory, and to provide a new standard for the operation of clinical tests. Through the study of the process and data of screening subjects in phase I clinical trials of drugs, this paper discusses the normal range of subjects' population in accordance with the specific conditions of our laboratory, and provides the basis for the revision of threshold values in this field. Methods: a total of 154 healthy adult men were enrolled in the phase I clinical trial of new drug, and their basic conditions and related laboratory indexes were analyzed statistically. The reference range of 95% confidence interval is summarized, that is, the reference range of the normal value of the actual test index. These include: sex, nationality, age, height, (cm), weight, (Kg), body mass index, occupation, body temperature (鈩

本文編號(hào)：2351806