英夫利西单抗治疗克罗恩病的疗效、安全性观察及影响因素分析
发布时间：2018-11-20 08:33
【摘要】：目的:观察英夫利西单抗(IFX)治疗克罗恩病(CD)的疗效和安全性,探讨其影响因素。方法:采用回顾性研究法,选择2015年1-12月于我院住院行IFX治疗的CD患者120例作为研究对象。所有患者均给予注射用IFX 5 mg/kg静脉滴注,分别于0、2、6周及以后每隔8周给予相同剂量,持续用药。比较患者用药前后的体质量、C反应蛋白(CRP)、红细胞沉降率(ESR)、白细胞计数(WBC)、内镜下黏膜愈合情况等疗效指标,丙氨酸转氨酶(ALT)、天冬氨酸转氨酶(AST)、碱性磷酸酶(AKP)、γ-谷氨酰转肽酶(γ-GT)、总胆红素(TB)、直接胆红素(DB)、尿肌酐(Cr)等肝肾功能指标,以及ADR发生时间、累及器官/系统、临床表现和转归;分析其影响因素。结果:与用药前比较,患者用药后的体质量显著增加,ESR显著下降,差异均有统计学意义(P0.05);且二者变化值呈显著正相关(r=0.275,P=0.016)。78.57%的患者经肠镜评估示黏膜愈合。患者用药前后的AST、AKP和Cr比较,虽然差异均有统计学意义(P0.05),但升高幅度较小,AST均未超过正常值上限2倍,AKP仅1例超过正常值上限2倍,Cr均未超过正常值上限。患者用药前后的CRP、WBC及其余肝肾功能指标比较,差异均无统计学意义(P0.05)。24例患者有ADR记录,发生率为20.00%,累及呼吸、消化、皮肤黏膜、机体防御等器官/系统,多表现为上呼吸道感染、肝功能指标异常等;其中10例(41.67%)因ADR延迟给药,6例(25.00%)停药。规律/首次用药患者的ESR达标率(78.21%)高于有间歇用药史者(57.14%),但差异无统计学意义(P0.05);合用美沙拉嗪对患者AST、AKP水平是否上升有显著影响(P=0.002)。结论:IFX可显著增加CD患者体质量、降低ESR、改善黏膜愈合情况,疗效明确。建议CD患者规律使用IFX。IFX总体安全性良好,但可能引起输液反应、肝功能指标短暂升高,故输液期间应严密监测患者情况,尤其是对有合并用药(美沙拉嗪等)的患者应监测肝功能。
[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), 纬 -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.).
【作者单位】： 上海交通大学医学院附属瑞金医院药剂科;上海交通大学医学院附属瑞金医院消化内科;
【基金】：上海市临床药学重点专科建设项目
【分类号】：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), 纬 -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.).
【作者单位】： 上海交通大学医学院附属瑞金医院药剂科;上海交通大学医学院附属瑞金医院消化内科;
【基金】：上海市临床药学重点专科建设项目
【分类号】：R574.62
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