基于BMI及性别的个体化剂量与传统剂量胃超声助显剂的成像效果比较研究

Comparison of imaging quality between individualized BMI- and sex-based dosing and conventional dosing of gastric ultrasound contrast agents

  • 摘要:
    背景 临床胃超声检查中通常采用统一口服500 mL助显剂。患者胃容量较小易出现腹胀等不适,胃容量较大者则胃充盈不足,皱襞伪影干扰图像质量,难以满足患者个体化及临床需要。
    目的 探讨基于体质量指数(body mass index,BMI)及性别的超声助显剂个体化剂量在改善胃超声成像及病变诊断中的临床价值。
    方法 采用两阶段设计。剂量研究纳入2022年1 — 4月在解放军总医院第二医学中心及首都医科大学附属北京友谊医院行胃超声检查的健康受试者,自400 mL起每次追加50 mL,以腹胀Likert评分1 ~ 2分且超声图像质量达"良好"为双重达标标准确定实际剂量,分析剂量与BMI分层、性别的关系并构建个体化剂量方案。诊断能力研究纳入相同机构2022年5月— 2023年10月行胃超声检查后经胃镜(及病理)确诊胃部疾病的患者,随机分为传统剂量组(口服500 mL)和个体化剂量组(按上述方案口服400 ~ 700 mL);以图像质量良好率、病变检出率为评价指标。
    结果 剂量研究纳入50例健康受试者,其中男28例、女22例,年龄(51.7±20.4)岁;建立的个体化方案剂量范围为400 ~ 700 mL,剂量随BMI分层递增,男性高于女性,老年(≥60岁)适当下调。诊断能力研究共纳入102例,传统剂量组50例、个体化剂量组52例,两组年龄(50.0±19.7)岁vs (45.9±21.5)岁,P=0.319、性别构成(男/女:17/33 vs 13/39,P=0.322)、BMI(23.8±4.1) kg/m2 vs (22.9±2.8) kg/m2,P=0.203比较,差异均无统计学意义。个体化剂量组图像质量良好率高于传统剂量组(38.5% vs 12.0%,P=0.002),病变检出率亦高于传统剂量组(73.1% vs 52.0%,P=0.046)。
    结论 本研究初步显示,基于BMI分层联合性别指导的胃超声助显剂个体化剂量可改善胃超声图像质量,并提升胃超声病变检出率。

     

    Abstract:
    Background In clinical gastric ultrasound examinations, a uniform oral dose of 500 mL of ultrasound contrast agent is conventionally administered. Patients with a small gastric volume may experience abdominal distension and other discomforts, while those with a large gastric volume present insufficient gastric wall distension and fold artifacts that interfere with image quality, which can hardly meet clinical requirements.
    Objective To investigate the clinical value of an individualized dose of ultrasound contrast agent based on body mass index (BMI) and gender in improving gastric wall visualization and the diagnosis of gastric lesions.
    Methods A two-stage design was adopted. In the dose-finding study, healthy subjects who underwent gastric ultrasound examination at the Second Medical Center of PLA General Hospital and Beijing Friendship Hospital, Capital Medical University from January to April 2022 were enrolled. Starting from an initial dose of 400 mL, the contrast agent was added in 50 mL increments, and the actual dose was determined when both criteria were met: an abdominal distension Likert score of 1 - 2 and "good" ultrasonic image quality. The associations of the dose with BMI category and sex were analyzed to construct an individualized dosing regimen. In the diagnostic performance study, patients who underwent gastric ultrasound examination at the same institutions from May 2022 to October 2023 and were subsequently diagnosed with gastric diseases by gastroscopy (and pathology) were enrolled and randomly divided into a conventional-dose group (oral administration of 500 mL) and an individualized-dose group (oral administration of 400 - 700 mL according to the above regimen). The rate of good image quality and the lesion detection rate were evaluated and compared.
    Results A total of 50 subjects were enrolled in the dose-finding stage, including 28 men and 22 women, with a mean age of (51.7±20.4) years and a mean BMI of (24.4±4.3) kg/m2. The established individualized dosing regimen ranged from 400 to 700 mL, with the dose increasing across BMI categories, higher in men than in women, and appropriately reduced in elderly subjects (≥60 years). A total of 102 patients were enrolled in the diagnostic performance stage, with 50 in the conventional-dose group and 52 in the individualized-dose group. No significant differences were found between the two groups in age (50.0±19.7 years vs 45.9±21.5 years, P=0.319), sex composition (male/female: 17/33 vs 13/39, P=0.322), BMI (23.8±4.1) kg/m2 vs (22.9±2.8) kg/m2, P=0.203, or disease spectrum (P=0.730), indicating that the two groups were comparable. The rate of good image quality in the individualized-dose group was higher than that in the conventional-dose group (38.5% vs 12.0%, P=0.002), and the lesion detection rate was also higher (73.1% vs 52.0%, P=0.046).
    Conclusion This preliminary study suggests that an individualized dosing range of gastric ultrasound contrast agent guided by BMI stratification combined with sex may improve gastric ultrasound image quality and increase the detection rate of gastric lesions.

     

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