【摘要】：目的評價重組人血小板生成素(rhTPO)治療糖皮質(zhì)激素?zé)o效的特發(fā)性血小板減少性紫癜(ITP)患者的有效性和安全性。方法采用多中心、隨機(jī)開放、空白對照方法,將糖皮質(zhì)激素治療無效的患者隨機(jī)分為試驗(yàn)組(rhTPO+達(dá)那唑)和對照組(達(dá)那唑)。兩組患者在整個試驗(yàn)階段均口服達(dá)那唑0.2g/次,3次/d。試驗(yàn)組皮下注射rhTPO1.0μg/kg,1次/d,療程14d,停用rhTPO后觀察14d。對照組口服達(dá)那唑14d后,如血小板仍≤20×109/L接受rhTPO治療,用法如前,停用rhTPO后觀察14d。試驗(yàn)的主要終點(diǎn)是比較兩組間第一階段(前14d內(nèi))血小板計(jì)數(shù)增加的最高值和血小板計(jì)數(shù)的曲線下面積;次要終點(diǎn)是比較兩組間第一階段的顯效率和有效率,對照組第二階段應(yīng)用rhTPO前后的血小板計(jì)數(shù)、顯效率和有效率。結(jié)果入選患者140例,試驗(yàn)組和對照組分別為73例和67例,最終進(jìn)入FAS集者分別為73例和63例,進(jìn)入PPS集者分別為60例和50例。主要終點(diǎn)FAS結(jié)果顯示:試驗(yàn)組rhTPO治療后血小板計(jì)數(shù)最高值平均增加101.2×109/L,顯著高于對照組的33.3×109/L(P=0.0060);試驗(yàn)組血小板計(jì)數(shù)的曲線下面積749.6,顯著高于對照組的316.2(P=0.0000)。次要終點(diǎn)FAS結(jié)果顯示:試驗(yàn)組第一階段的顯效率和有效率(顯效+良效)分別為38.4%和60.3%,明顯高于對照組的7.9%(P=0.0003)和36.5%(P=0.0104);對照組第一階段第14天血小板計(jì)數(shù)≤20×109/L的患者,接受rhTPO治療后顯效率和有效率分別達(dá)到31.1%和66.7%。試驗(yàn)組停用rhTPO后血小板計(jì)數(shù)逐漸下降,但停藥14d時仍維持在50×109/L左右。rhTPO對白細(xì)胞計(jì)數(shù)、血紅蛋白、膽紅素、凝血試驗(yàn)、抗GPⅡb/Ⅲa和GPⅠb自身抗體無明顯影響。不良事件的發(fā)生率,試驗(yàn)組和對照組分別為34.3%和26.2%,其中以肝膽指標(biāo)異常最常見,分別為15.1%和16.9%。rhTPO相關(guān)的不良事件發(fā)生率13.6%,主要有輕度嗜睡、頭暈、短暫性視野缺損、過敏樣反應(yīng)和乏力等。結(jié)論 rhTPO是一種治療慢性ITP的療效確切、較為安全的藥物。
[Abstract]:Objective to evaluate the efficacy and safety of recombinant human thrombopoietin (rhTPO) in the treatment of idiopathic thrombocytopenic purpura (ITP) patients with ineffective glucocorticoid. Methods the patients with ineffective glucocorticoid therapy were randomly divided into two groups: trial group (rhTPO danazol) and control group (danazol). The patients in both groups were given danazol 0.2g/ 3 times per day during the whole trial phase. The experimental group was subcutaneously injected with rhTPO 1.0 渭 g / kg,1 per day for 14 days. After the treatment with rhTPO, it was observed for 14 days. After oral administration of danazol for 14 days in the control group, if the platelet was still 鈮，

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