英夫利西單抗治療克羅恩病的療效、安全性觀察及影響因素分析
發(fā)布時間：2018-11-20 08:33
【摘要】：目的:觀察英夫利西單抗(IFX)治療克羅恩病(CD)的療效和安全性,探討其影響因素。方法:采用回顧性研究法,選擇2015年1-12月于我院住院行IFX治療的CD患者120例作為研究對象。所有患者均給予注射用IFX 5 mg/kg靜脈滴注,分別于0、2、6周及以后每隔8周給予相同劑量,持續(xù)用藥。比較患者用藥前后的體質(zhì)量、C反應(yīng)蛋白(CRP)、紅細(xì)胞沉降率(ESR)、白細(xì)胞計(jì)數(shù)(WBC)、內(nèi)鏡下黏膜愈合情況等療效指標(biāo),丙氨酸轉(zhuǎn)氨酶(ALT)、天冬氨酸轉(zhuǎn)氨酶(AST)、堿性磷酸酶(AKP)、γ-谷氨酰轉(zhuǎn)肽酶(γ-GT)、總膽紅素(TB)、直接膽紅素(DB)、尿肌酐(Cr)等肝腎功能指標(biāo),以及ADR發(fā)生時間、累及器官/系統(tǒng)、臨床表現(xiàn)和轉(zhuǎn)歸;分析其影響因素。結(jié)果:與用藥前比較,患者用藥后的體質(zhì)量顯著增加,ESR顯著下降,差異均有統(tǒng)計(jì)學(xué)意義(P0.05);且二者變化值呈顯著正相關(guān)(r=0.275,P=0.016)。78.57%的患者經(jīng)腸鏡評估示黏膜愈合�；颊哂盟幥昂蟮腁ST、AKP和Cr比較,雖然差異均有統(tǒng)計(jì)學(xué)意義(P0.05),但升高幅度較小,AST均未超過正常值上限2倍,AKP僅1例超過正常值上限2倍,Cr均未超過正常值上限。患者用藥前后的CRP、WBC及其余肝腎功能指標(biāo)比較,差異均無統(tǒng)計(jì)學(xué)意義(P0.05)。24例患者有ADR記錄,發(fā)生率為20.00%,累及呼吸、消化、皮膚黏膜、機(jī)體防御等器官/系統(tǒng),多表現(xiàn)為上呼吸道感染、肝功能指標(biāo)異常等;其中10例(41.67%)因ADR延遲給藥,6例(25.00%)停藥。規(guī)律/首次用藥患者的ESR達(dá)標(biāo)率(78.21%)高于有間歇用藥史者(57.14%),但差異無統(tǒng)計(jì)學(xué)意義(P0.05);合用美沙拉嗪對患者AST、AKP水平是否上升有顯著影響(P=0.002)。結(jié)論:IFX可顯著增加CD患者體質(zhì)量、降低ESR、改善黏膜愈合情況,療效明確。建議CD患者規(guī)律使用IFX。IFX總體安全性良好,但可能引起輸液反應(yīng)、肝功能指標(biāo)短暫升高,故輸液期間應(yīng)嚴(yán)密監(jiān)測患者情況,尤其是對有合并用藥(美沙拉嗪等)的患者應(yīng)監(jiān)測肝功能。
[Abstract]:Objective: to observe the efficacy and safety of infliximab (IFX) in the treatment of Crohn's disease (CD). Methods: a retrospective study was conducted on 120 CD patients who were hospitalized with IFX in our hospital from January to December 2015. All the patients were given IFX 5 mg/kg intravenous drip for 6 weeks and 8 weeks thereafter. Body mass, erythrocyte sedimentation rate of C-reactive protein (CRP), (ESR), leukocyte count, endoscopic mucosal healing under (WBC), and alanine aminotransferase (ALT), aspartate transaminase (AST), were compared before and after treatment. Alkaline phosphatase (AKP), 緯 -glutamyl transpeptidase (GT), total bilirubin (TB), direct bilirubin (DB), urine creatinine (Cr), etc.) and ADR occurrence time, involving organs / systems. Clinical manifestation and outcome; The influencing factors are analyzed. Results: compared with before treatment, the body weight of the patients increased significantly and the ESR decreased significantly after the treatment, the differences were statistically significant (P0.05). There was a significant positive correlation between the two changes (r = 0.275, P < 0.016). 78.57% of the patients showed mucosal healing by endoscopy. The difference between AST,AKP and Cr before and after treatment was statistically significant (P0.05), but the increase was small, AST was not more than 2 times of normal value, AKP was only 2 times above normal value. Cr did not exceed the upper limit of normal value. There was no significant difference in CRP,WBC and other indexes of liver and kidney function before and after treatment (P0.05). 24 patients had ADR records, the incidence rate was 20.00, involving respiration, digestion, skin and mucous membrane, Most of the organs / systems, such as body defense, showed upper respiratory tract infection, abnormal liver function and so on. Of them, 10 cases (41.67%) were delayed administration of ADR and 6 cases (25.00%) stopped administration. The rate of ESR in regular / first-time patients (78.21%) was higher than that in patients with intermittent medication (57.14%), but the difference was not statistically significant (P0.05). The combination of mesalazine had a significant effect on the increase of AST,AKP level (P0. 002). Conclusion: IFX can significantly increase the body mass of CD patients and reduce ESR, to improve mucosal healing. It is suggested that the general safety of regular use of IFX.IFX in patients with CD is good, but it may cause transfusion reaction and liver function index increase briefly. Therefore, the patients should be closely monitored during infusion. In particular, liver function should be monitored in patients with combined medication (mezalazine, etc.).
【作者單位】： 上海交通大學(xué)醫(yī)學(xué)院附屬瑞金醫(yī)院藥劑科;上海交通大學(xué)醫(yī)學(xué)院附屬瑞金醫(yī)院消化內(nèi)科;
【基金】：上海市臨床藥學(xué)重點(diǎn)專科建設(shè)項(xiàng)目
【分類號】：R574.62
[Abstract]:Objective: to observe the efficacy and safety of infliximab (IFX) in the treatment of Crohn's disease (CD). Methods: a retrospective study was conducted on 120 CD patients who were hospitalized with IFX in our hospital from January to December 2015. All the patients were given IFX 5 mg/kg intravenous drip for 6 weeks and 8 weeks thereafter. Body mass, erythrocyte sedimentation rate of C-reactive protein (CRP), (ESR), leukocyte count, endoscopic mucosal healing under (WBC), and alanine aminotransferase (ALT), aspartate transaminase (AST), were compared before and after treatment. Alkaline phosphatase (AKP), 緯 -glutamyl transpeptidase (GT), total bilirubin (TB), direct bilirubin (DB), urine creatinine (Cr), etc.) and ADR occurrence time, involving organs / systems. Clinical manifestation and outcome; The influencing factors are analyzed. Results: compared with before treatment, the body weight of the patients increased significantly and the ESR decreased significantly after the treatment, the differences were statistically significant (P0.05). There was a significant positive correlation between the two changes (r = 0.275, P < 0.016). 78.57% of the patients showed mucosal healing by endoscopy. The difference between AST,AKP and Cr before and after treatment was statistically significant (P0.05), but the increase was small, AST was not more than 2 times of normal value, AKP was only 2 times above normal value. Cr did not exceed the upper limit of normal value. There was no significant difference in CRP,WBC and other indexes of liver and kidney function before and after treatment (P0.05). 24 patients had ADR records, the incidence rate was 20.00, involving respiration, digestion, skin and mucous membrane, Most of the organs / systems, such as body defense, showed upper respiratory tract infection, abnormal liver function and so on. Of them, 10 cases (41.67%) were delayed administration of ADR and 6 cases (25.00%) stopped administration. The rate of ESR in regular / first-time patients (78.21%) was higher than that in patients with intermittent medication (57.14%), but the difference was not statistically significant (P0.05). The combination of mesalazine had a significant effect on the increase of AST,AKP level (P0. 002). Conclusion: IFX can significantly increase the body mass of CD patients and reduce ESR, to improve mucosal healing. It is suggested that the general safety of regular use of IFX.IFX in patients with CD is good, but it may cause transfusion reaction and liver function index increase briefly. Therefore, the patients should be closely monitored during infusion. In particular, liver function should be monitored in patients with combined medication (mezalazine, etc.).
【作者單位】： 上海交通大學(xué)醫(yī)學(xué)院附屬瑞金醫(yī)院藥劑科;上海交通大學(xué)醫(yī)學(xué)院附屬瑞金醫(yī)院消化內(nèi)科;
【基金】：上海市臨床藥學(xué)重點(diǎn)專科建設(shè)項(xiàng)目
【分類號】：R574.62
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