背景:关于老年人治疗的疗效数据很少,而溃疡性结肠炎(UC)患病率的增幅最大的是40~65岁和≥65岁的年龄组.
目的:我们评估了接受美沙拉嗪治疗的UC成人(≤60岁)和老年人(>60岁)的临床和内镜反应和缓解率的差异。
方法:我们在一项双盲和开放标签研究中,对817名接受美沙拉嗪治疗8周和另外26周的UC患者的3期非劣效性试验的数据进行了事后分析。分别。我们使用Wilcoxon秩和或卡方检验来分析组间差异,并使用多变量逻辑回归来确定内镜缓解作为结果(Mayo内镜子评分[MES]=0或≤1)与包括疾病持续时间在内的独立变量之间的关联。基线MES,年龄,性别,喜剧,和合并症。
结果:老年人的病程较长,更多的合并症,合并用药,和较高的基线MES(2.38±0.486在老年人和2.26±0.439在成人;P=.008)相比成人。我们观察到临床和内镜联合缓解率没有差异,临床缓解和反应,以及治疗后第8周和第38周的内镜缓解和反应。除了其他众所周知的预后较差的预测因素外,在第8周和第38周时,有≥3项病因的患者MES=0,在第38周时MES≤1.
结论:我们观察到美沙拉嗪在成人和老年UC患者中的疗效相似。增加的昏迷人数而不是年龄可能会降低UC药物的有效性,强调健康衰老的重要性。
我们调查了口服美沙拉嗪治疗的成人(≤60岁)和老年人(>60岁)溃疡性结肠炎患者的临床和内镜反应率;我们的结果表明年龄不影响疗效和安全性。
BACKGROUND: The efficacy data on treatment in older adults are scarce, while the greatest increase in ulcerative colitis (UC) prevalence is observed in age groups of individuals 40 to 65 years of age and ≥65 years of age.
OBJECTIVE: We assessed the difference in rates of clinical and endoscopic response and remission in UC adults (≤60 years) and older adults (>60 years) treated with
mesalazine.
METHODS: We performed a post hoc analysis of data from a phase 3 noninferiority
trial of 817 UC patients treated with
mesalazine for 8 and additional 26 weeks in a double-blind and open-label
study, respectively. We used Wilcoxon rank sum or chi-square test to analyze differences between groups and multivariable logistic regression to determine the associations between endoscopic remission as outcome (Mayo endoscopic subscore [MES] = 0 or ≤1) and independent variables including disease duration, baseline MES, age, sex, comedications, and comorbidities.
RESULTS: Older adults had a longer disease duration, a higher number of comorbidities, concomitant medications, and higher baseline MES (2.38 ± 0.486 in older adults vs 2.26 ± 0.439 in adults; P = .008) compared with adults. We observed no difference in rates of combined clinical and endoscopic remission, clinical remission and response, and endoscopic remission and response at week 8 and 38 post-treatment. In addition to other well-known predictors of worse outcome, patients with ≥3 comedications were less likely to achieve an MES = 0 at week 8 and 38 and an MES ≤1 at week 38.
CONCLUSIONS: We observed similar efficacy of
mesalazine in adult and older adult UC patients. The increased comedication number rather than age may decrease effectiveness of UC medications, highlighting the importance of healthy aging.
We investigated the rates of clinical and endoscopic response in adult (≤60 years) and older adult (>60 years) ulcerative colitis patients treated with oral
mesalazine; our results demonstrated that age did not influence the efficacy and safety.