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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
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| 篇名： | 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 |
| TITLE： | |
| 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（P＜0.05）；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（P＜0.05），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（P＞0.05）。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（P＞0.05）；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 therapeutic efficacy and safety of infliximab （IFX） in the treatment of Crohn’s disease （CD）， and to investigate its influential factors. METHODS： In retrospective study， a total of 120 CD patients received IFX treatment in our hospital during Jan.-Dec. 2015 were selected as research objects. All patients were given IFX for injection 5 mg/kg intravenously at 0， 2nd， 6th week and later every 8 weeks continously. Therapeutic efficacy indexes （body weight， CRP， ESR， WBC， mucosal healing under endoscope）， liver and renal indexes （ALT， AST， AKP， γ-GT， TB， DB， Cr）， the occurrence time of ADR， organs/systems involved， clinical manifestations and outcomes were compared before and after treatment. Influential factors were analyzed. RESULTS： Compared with before medication， body weight of patients were increased significantly， while ESR were decreased significantly， with statistical significance （P＜0.05）. There was positively correlation between above two indexes （r＝0.275，P＝0.016）. Mucosal healing was found in 78.57％ of patients by colonoscopy. There was statistical significance in the levels of AST， AKP and Cr before and after treatment （P＜0.05）， but those indexes were increased slightly. AKP exceeded 2 times the upper limit of normal value in only 1 case， but AST did not exceed 2 times the upper limit of normal limit， Cr did not exceed the upper limit of normal value. There was no statistical significance in CRP， WBC or other liver and renal function indexes before and after treatment （P＞0.05）. There were 24 cases of ADR with incidence of 20.00％. Respiratory system， digestive system， skin mucous membrane， body defense and other organs/systems were involved， mainly manifestating as uper respiratory tract infetion， liver function indexes order etc. Ten patients （41.67％） delayed the treatment， and 6 cases （25.00％） discontinued. Standard rate of ESR in patients with regular/primary medication （78.21％） was higher than those with intermittent medication history （57.14％）， but without statistical significance （P＞0.05）. Combined use of mesalazine had no significant effect on the increase of AST and AKP （P＝0.002）. CONCLUSIONS： IFX significantly increases body weight of CD patients， decreases ESR and improves mucosal healing. It shows definite therapeutic efficacy. It is suggested that CD patients should use IFX regularly. The overall safety of IFX is good， but it may cause transfusion reaction and transient increase of liver function index. So， the patient’s condition should be closely monitored during the infusion. [especially for liver function of those with drug combination （mesalazine， etc.）] |
| 期刊： | 2017年第28卷第35期 |
| 作者： | 陈禾凤，杨婉花，姚玮艳 |
| AUTHORS： | CHEN Hefeng，YANG Wanhua，YAO Weiyan |
| 关键字： | 英夫利西单抗；克罗恩病；疗效；安全性；影响因素 |
| KEYWORDS： | Infliximab； Crohn’s disease； Therapeutic efficacy； Safety； Influential factor |
| 阅读数： | 412 次 |
| 本月下载数： | 2 次 |
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