阿达木单抗与英夫利昔单抗治疗溃疡性结肠炎的疗效：EQ-5D、视觉模拟量表和 IBDQ-9 测量的应用：一项前瞻性观察研究。

Adalimumab Infliximab Treatment Outcome in Ulcerative Colitis: Application of EQ-5D, Visual Analogue Scale, and IBDQ-9 Measures: A Prospective Observational Study.

机构信息

Department of Health Economics' School of Health Management and Information Sciences' Iran University of Medical Sciences' Tehran' Iran.

Health Promotion Research Center' Iran University of Medical Sciences' Tehran' Iran.

出版信息

Curr Drug Saf. 2023;18(4):484-495. doi: 10.2174/1574886317666220526153518.

DOI:10.2174/1574886317666220526153518

PMID:36029076

Abstract

BACKGROUND

Ulcerative colitis (UC) is a chronic global disease, and its incidence and prevalence are increasing worldwide.

OBJECTIVE

Our objective was to compare the secondary outcome of treatment with Infliximab (IFX) and Adalimumab (ADA) in the UC patients.

METHODS

This was a one-year prospective observational study of moderate- to -severe UC patients treated with ADA or IFX. Patients' secondary health outcomes were measured using the EQ-5D 3L, EQ-VAS, and IBDQ-9 tools. T-test, Mann-Whitney, chi-square, and Fisher's exact tests were used to compare health-related quality of life (HRQoL) among UC patients. HRQoL predictor variables were identified by multivariate linear regression and multivariate logistic regression.

RESULTS

A total of 238 UC patients (patients taking IFX: 78, patients taking ADA: 160) with a mean age of 37.66 and a mean disease duration of 9.29 years were enrolled. The EQ-5D index, EQ-VAS, and IBDQ-9 scores of patients taking IFX were 0.65, 55.93 and, 37.42, respectively. Similarly, patients taking ADA were 0.68, 59.27 and, 36.61, respectively. The highest problem reports were in P/D: 86.1% and A/D: 73.5%. The main independent predictors of HRQoL were: education over 12 years (β = 0.054 [EQ-5D index], β = 13.63 [EQ-VAS], OR: 0.28 [MO], OR: 0.07 [SC]), education between 6-12 years (β = 11.23 [EQ-VAS]), and having "other chronic diseases" (β = -0.074 [EQ-5D index], β = -5.29 [IBDQ-9], OR: 2.84 [UA], OR: 3.80 [A/D]).

CONCLUSION

There was no significant difference between the effect of ADA and IFX on secondary health outcomes in patients with moderate-to-severe UC.

摘要

背景

溃疡性结肠炎（UC）是一种慢性全球性疾病，其发病率和患病率在全球范围内呈上升趋势。

目的

我们的目的是比较英夫利昔单抗（IFX）和阿达木单抗（ADA）治疗溃疡性结肠炎患者的次要结局。

方法

这是一项为期一年的前瞻性观察性研究，纳入了接受 ADA 或 IFX 治疗的中重度 UC 患者。使用 EQ-5D 3L、EQ-VAS 和 IBDQ-9 工具测量患者的次要健康结局。使用 t 检验、Mann-Whitney 检验、卡方检验和 Fisher 精确检验比较 UC 患者的健康相关生活质量（HRQoL）。通过多元线性回归和多元逻辑回归确定 HRQoL 预测变量。

结果

共纳入 238 例 UC 患者（接受 IFX 治疗的患者：78 例，接受 ADA 治疗的患者：160 例），平均年龄为 37.66 岁，平均病程为 9.29 年。接受 IFX 治疗的患者的 EQ-5D 指数、EQ-VAS 和 IBDQ-9 评分分别为 0.65、55.93 和 37.42，接受 ADA 治疗的患者分别为 0.68、59.27 和 36.61。报告的最高问题是在 P/D：86.1%和 A/D：73.5%。HRQoL 的主要独立预测因素为：教育程度超过 12 年（β=0.054[EQ-5D 指数]，β=13.63[EQ-VAS]，OR：0.28[MO]，OR：0.07[SC]），教育程度在 6-12 年之间（β=11.23[EQ-VAS]），以及患有“其他慢性疾病”（β=-0.074[EQ-5D 指数]，β=-5.29[IBDQ-9]，OR：2.84[UA]，OR：3.80[A/D]）。