[Comparison of Imaging Efficacy and Patient Tolerability Between a Novel Cellulose-Based anda Conventional Starch-Based Oral Contrast Agent: A Prospective Randomized Controlled Trial].

内容摘要

Objective To compare the imaging efficacy and patient tolerability of a novel cellulose-based oral contrast agent with a conventional starch-based agent in gastric contrast-enhanced ultrasound,thus providing evidence-based support for clinical practice. Methods A prospective,single-center,double-blind,randomized controlled trial was conducted,enrolling 100 healthy volunteers who were randomly assigned to either the experimental group (cellulose-based agent,n=50) or the control group (starch-based agent,n=50).All examinations were performed by the same sonographer.The clarity of gastric wall layers,homogeneity of the contrast agent,and degree of bubble interference were scored.The time required for oral contrast intake was recorded,and a questionnaire was used to evaluate taste acceptability and subjective tolerability after the examination. Results Baseline characteristics were balanced between the two groups.There were no statistically significant differences in image quality scores for various gastric regions,contrast agent homogeneity,or bubble interference scores (all P>0.05).No significant difference was observed in oral contrast agent intake time (P=0.081).Neither taste acceptability (96% of participants in both groups scored≥2) nor subjective tolerability (92% in the experimental group vs. 82% in the control group scored≥3) showed significant between-group differences (P>0.05). Conclusions In gastric contrast-enhanced ultrasound,the novel cellulose-based contrast agent shows no significant difference from the conventional starch-based contrast agent in terms of imaging efficiency and patient tolerability.With ready-to-use and easy-to-operate features,it holds significant potential for clinical adoption. 目的 比较新型纤维素类与传统淀粉类造影剂在胃超声造影检查中的成像效果及患者耐受性,为临床选择提供循证依据。方法 采用前瞻性、单中心、双盲、随机对照设计,共纳入100例健康志愿者,随机分为试验组(纤维素类)和对照组(淀粉类)各50例。由同一名超声医师完成检查,对胃壁层次清晰度、造影剂均匀度及气泡干扰情况进行评分,记录口服造影剂时间,并通过问卷调查评估口感接受度及检查后主观耐受性。结果 两组受试者基线资料均衡。胃各部位图像质量评分、造影剂均匀度及气泡干扰评分组间差异均无统计学意义(P均>0.05)。口服造影剂时间差异无统计学意义(P=0.081),口感接受度(评分≥2分者均为96%)与主观耐受性(评分≥3分者试验组92% 比对照组82%)组间差异亦无统计学意义(P>0.05)。结论 在胃超声造影检查中,新型纤维素类造影剂在成像效果及患者耐受性方面与传统淀粉类造影剂相比无显著差异,且具备即用即取、操作简便的特点,具有一定的临床推广价值。.