【摘要】：目的:為舒尼替尼臨床安全使用提供參考。方法:以"舒尼替尼""不良反應(yīng)"等為檢索詞,檢索2006年1月-2017年3月Pub Med、維普、中國(guó)知網(wǎng)和萬方數(shù)據(jù)庫(kù)關(guān)于舒尼替尼致不良反應(yīng)(ADR)文獻(xiàn)的個(gè)案報(bào)道和病例系列報(bào)道,篩選后采用回顧性研究的方法,對(duì)患者基本情況、疾病信息、ADR累及器官/系統(tǒng)及臨床表現(xiàn)、ADR關(guān)聯(lián)性評(píng)價(jià)及轉(zhuǎn)歸進(jìn)行統(tǒng)計(jì)分析。結(jié)果:共納入文獻(xiàn)57篇,涉及66個(gè)病例,其中新的不良反應(yīng)15例;患者中男性34例(51.52%)、女性32例(48.48%),男女比例為1.06∶1,平均年齡(63.4±10.5)歲。舒尼替尼主要用于治療腎透明細(xì)胞癌,占65.15%;其次是胃腸間質(zhì)瘤,占21.21%。用藥8～14 d和22～28 d時(shí)ADR發(fā)生率最高(27.27%、22.73%)。ADR累及器官/系統(tǒng)以內(nèi)分泌系統(tǒng)為主(25.76%),主要臨床表現(xiàn)為甲狀腺功能減退;其次為皮膚及其附件(21.21%)和血液淋巴系統(tǒng)(16.67%),主要臨床表現(xiàn)為手足綜合征和血小板減少癥(以4度骨髓抑制為主)。因果關(guān)系評(píng)價(jià)為肯定9例,很可能57例。舒尼替尼致ADR停藥后自然好轉(zhuǎn)的有14例(21.21%);停藥并經(jīng)藥物治療后好轉(zhuǎn)的有27例(40.91%);需經(jīng)手術(shù)治療,嚴(yán)重延長(zhǎng)病程或治療后仍有后遺癥的有17例(25.76%);死亡的有8例(12.12%)。結(jié)論:舒尼替尼所致的不良反應(yīng)涉及全身多個(gè)器官/系統(tǒng),不乏嚴(yán)重致死病例;在臨床用藥過程中應(yīng)加強(qiáng)觀察監(jiān)測(cè),及時(shí)處理ADR,保障患者安全。
[Abstract]:Objective: to provide reference for the safe use of sunitinib. Methods: using "sulnitinib" and "adverse reaction" as the key words, we searched the case reports and case series reports on the (ADR) literature of sulnitinib induced adverse reactions from January 2006 to March 2017 in Pub Med, Wiper, China Zhiwang and Wanfang database. After screening, the patients' basic condition, disease information, ADR involvement organ / system and clinical manifestation, ADR correlation evaluation and outcome were statistically analyzed by retrospective study. Results: a total of 57 articles were included, involving 66 cases, including 15 cases of new adverse reactions, of which 34 cases (51.52%) were male and 32 cases (48.48%) were female. The ratio of male to female was 1.06: 1, with an average age of (63.4 鹵10.5) years. Sunitinib was mainly used in the treatment of renal clear cell carcinoma (65.15%), followed by gastrointestinal stromal tumor (21.21). The incidence of ADR was the highest (27.27% 22.73%) with endocrine system (25.76%). The main clinical manifestation was hypothyroidism. The second was skin and its appendages (21.21%) and hemolymph system (16.67%). The main clinical manifestations were hand and foot syndrome and thrombocytopenia (mainly 4-degree bone marrow suppression). Causality was evaluated as positive in 9 cases and most likely in 57 cases. There were 14 cases (21.21%) of the patients who naturally improved after the withdrawal of sulnitinib, 27 cases (40.91%) of the patients who stopped taking the drug and treated with drugs, 17 cases (25.76%) needed surgical treatment, 17 cases (25.76%) had severe prolongation of the course of disease or still had sequelae after treatment, and 8 cases (12.12%) died. Conclusion: the adverse reactions caused by sunitinib involve many organs / systems of the whole body, and there are many serious fatal cases. The observation and monitoring should be strengthened in the course of clinical administration to ensure the safety of patients with ADR,.
【作者單位】： 國(guó)家食品藥品監(jiān)督管理總局高級(jí)研修學(xué)院;國(guó)家食品藥品監(jiān)督管理總局食品藥品查驗(yàn)中心;
【分類號(hào)】：G353.1;R969.3

【相似文獻(xiàn)】

相關(guān)期刊論文 前10條

1 呂金玲;趙臨襄;;蘋果酸舒尼替尼(sunitinib malate)[J];中國(guó)藥物化學(xué)雜志;2007年03期

2 方正;韋萍;楊照;;舒尼替尼合成路線圖解[J];中國(guó)醫(yī)藥工業(yè)雜志;2007年11期

3 陳逢生;石敏;羅榮城;;多靶點(diǎn)酪氨酸激酶抑制劑舒尼替尼的研究進(jìn)展[J];臨床腫瘤學(xué)雜志;2008年03期

4 王爾兵;王肇炎;;多靶點(diǎn)酪氨酸激酶抑制劑舒尼替尼臨床評(píng)價(jià)[J];世界臨床藥物;2007年05期

5 劉彪;林蓉;廖健宇;李子成;陳珂磊;;舒尼替尼的合成[J];中國(guó)醫(yī)藥工業(yè)雜志;2007年08期

6 楊梅;湯致強(qiáng);;蘋果酸舒尼替尼膠囊[J];中國(guó)新藥雜志;2009年04期

7 吳小艷;;貝伐單抗和舒尼替尼可導(dǎo)致頜骨壞死[J];藥物不良反應(yīng)雜志;2011年01期

8 張文婷;桂玲;貢雪們;劉東;;蘋果酸舒尼替尼致不良反應(yīng)30例調(diào)查分析[J];中國(guó)醫(yī)院藥學(xué)雜志;2013年05期

9 李星煒;;蘋果酸舒尼替尼可能導(dǎo)致嚴(yán)重皮膚反應(yīng)[J];藥物不良反應(yīng)雜志;2013年05期

10 周愛萍;馮奉儀;;多靶點(diǎn)抗腫瘤藥物舒尼替尼研究進(jìn)展[J];臨床藥物治療雜志;2009年01期

相關(guān)重要報(bào)紙文章 前1條

1 駐京記者 王丹;舒尼替尼納入英國(guó)健保體系[N];醫(yī)藥經(jīng)濟(jì)報(bào);2009年

相關(guān)碩士學(xué)位論文 前5條

1 江超;雷公藤多苷干預(yù)舒尼替尼引起的小鼠腎足細(xì)胞凋亡及相關(guān)蛋白表達(dá)的機(jī)制研究[D];安徽醫(yī)科大學(xué);2016年

2 陳孫慧;功能性生物蛋白分子納米化制劑的研究[D];天津醫(yī)科大學(xué);2016年

3 劉長(zhǎng)姣;舒尼替尼在荷腎癌裸鼠體內(nèi)的時(shí)辰藥理學(xué)研究[D];大連醫(yī)科大學(xué);2017年

4 劉翔宇;腫瘤靶向治療藥物蘋果酸舒尼替尼的合成研究[D];中國(guó)醫(yī)科大學(xué);2008年

5 張汝濤;多靶點(diǎn)酪氨酸激酶抑制劑舒尼替尼及其衍生物的合成與分子設(shè)計(jì)研究[D];北京化工大學(xué);2012年

，

本文編號(hào)：2274397