背景:这项基于美国的真实世界索赔研究比较了成人慢性特发性便秘(CIC)患者使用普鲁卡必利之前和之后6个月的便秘相关症状和并发症。
方法:这种观察,回顾性队列分析使用IBMMarketScan®商业索赔和遭遇以及Medicare补充数据库(2015年1月至2020年6月).Prucalopride治疗的患者(≥18岁)有≥1个便秘相关的国际疾病分类,第十次修订,包括基线或研究期间的临床修改(ICD-10-CM)诊断代码。便秘相关症状(腹痛,腹胀[气态],排便不完全,和恶心)和便秘相关的并发症(肛裂和瘘管,肠梗阻,直肠脱垂,痔疮,肛周静脉血栓形成,肛周/直肠周围脓肿,和直肠出血)进行了检查。使用ICD-10-CM确定便秘相关症状和并发症,ICD-10-程序编码系统,或当前程序术语代码。数据按年龄分层(总体上,18-64岁,≥65岁)。
结果:这项研究包括690名患者:患者年龄平均(标准差)为48.0(14.7)岁,87.5%为女性。在普鲁卡洛必利开始治疗6个月后,便秘相关症状的患者比例总体下降(腹痛[50.4%vs33.3%,P<0.001;腹胀[气态][23.9%vs13.3%,P<0.001];恶心[22.6%vs17.7%,P<0.01];排便不完全没有改善)。同样,在普鲁卡洛必利开始治疗6个月后,便秘相关并发症的患者比例总体下降(肠梗阻[4.9%vs2.0%,P<0.001;痔疮[10.7%vs7.0%,P<0.05;直肠出血[4.1%vs1.7%,P<0.05])。
结论:这项研究表明,普鲁卡洛必利可能与治疗开始后6个月便秘相关症状和并发症的改善有关。
BACKGROUND: This real-world US-based claims study compared constipation-related symptoms and complications 6 months before and after prucalopride initiation in adults with chronic idiopathic constipation (CIC).
METHODS: This observational, retrospective cohort analysis used the IBM MarketScan Commercial Claims and Encounters Database and the Medicare Supplemental Database (January 2015-June 2020). Prucalopride-treated patients (≥18 years old) who had ≥1 constipation-related International Classification of Diseases, Tenth Revision, Clinical Modification ( ICD-10-CM ) diagnosis code during the baseline or study period were included. The proportions of patients with constipation-related symptoms (abdominal pain, abdominal distension [gaseous], incomplete defecation, and nausea) and constipation-related complications (anal fissure and fistula, intestinal obstruction, rectal prolapse, hemorrhoids, perianal venous thrombosis, perianal/perirectal abscess, and rectal bleeding) were examined. Constipation-related symptoms and complications were identified using ICD-10-CM , ICD-10 - Procedure Coding System , or Current Procedural Terminology codes. Data were stratified by age (overall, 18-64 years, and ≥65 years).
RESULTS: This study included 690 patients: The mean (SD) patient age was 48.0 (14.7) years, and 87.5% were women. The proportions of patients overall with constipation-related symptoms decreased 6 months after prucalopride initiation (abdominal pain [50.4% vs 33.3%, P < 0.001]; abdominal distension [gaseous] [23.9% vs 13.3%, P < 0.001]; and nausea [22.6% vs 17.7%, P < 0.01]; no improvements observed for incomplete defecation). Similarly, the proportions of patients overall with constipation-related complications decreased 6 months after prucalopride initiation (intestinal obstruction [4.9% vs 2.0%, P < 0.001]; hemorrhoids [10.7% vs 7.0%, P < 0.05]; and rectal bleeding [4.1% vs 1.7%, P < 0.05]).
CONCLUSIONS: This study suggests that prucalopride may be associated with improved constipation-related symptoms and complications 6 months after treatment initiation.