估计丙泊酚镇静下行纤维支气管镜检查患者所需的奥利啶ED50和ED95：一项上下顺序分配试验

IF 5.1 2区医学 Q1 CHEMISTRY, MEDICINAL

Drug Design, Development and Therapy Pub Date : 2025-09-30 eCollection Date: 2025-01-01 DOI:10.2147/DDDT.S535435

Dongxue Wu, Yeqing Liao, Yanlin Qin, Yafeng Wang, Bing Xu, Qiuling Chen, Xianting Wang, Xiaoshan Wu, Yalan Li, Xuehai Guan

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引用次数: 0

摘要

背景：纤维支气管镜检查反应是纤维支气管镜检查（FOB）过程中的主要挑战。阿片类药物通常用于抑制支气管镜检查反应。本研究旨在评估在西泊酚深度镇静下，奥利匹啶抑制FOB期间支气管镜反应的中位有效剂量（ED50）。方法：采用上下序贯分配试验。患者分为男性组和女性组。初始剂量为40 μg/kg。根据患者先前对FOB的反应确定下一个剂量，步长为10 μg/kg。完成7个拐点后，终止招募。在给予单剂量奥利匹啶后，所有患者接受西哌泊酚（初始剂量：0.4 mg/kg），随后滴注速率在0.2至1.0 mg/kg/h之间滴定，以维持双谱指数（BIS）值在40-60范围内。当BIS≤60时，置入喉罩（LMA）。终点为支气管镜对FOB的反应。采用Dixon上下法计算缓解支气管镜反应所需的橄榄碱ED50和ED95。采用概率分析法生成剂量-反应曲线。结果：共纳入45例患者，其中男性23例，女性22例。异丙酚镇静作用下，雄鼠和雌鼠的ED50差异无统计学意义（中位数[四分位数间距，IQR] 35.00 [35.00 ~ 36.00] μg/kg），差异无统计学意义（P=0.0723）。Probit分析显示，在cipepofol深度镇静下，男性和女性抑制支气管镜对FOB反应所需的奥利匹啶ED50和ED95分别为30.20[95%可信区间（CI）：19.98 ~ 38.78]和40.47 [95% CI: 29.49 ~ 51.40] μg/kg和46.49 [95% CI: 38.23 ~ 105.37]和57.55 [95% CI: 48.50 ~ 141.34] μg/kg。结论：哌泊酚镇静下抑制支气管镜反应所需的胆碱ED50和ED95在男性和女性之间无差异。试验报名：Chictr.org.cn；标识符:ChiCTR2400086635。

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Estimation of ED₅₀ and ED₉₅ of Oliceridine Required to Suppress the Bronchoscopy Response in Patients Undergoing Fiberoptic Bronchoscopy Under Sedation with Cipepofol: An Up-and-Down Sequential Allocation Trial.

Background: Bronchoscopy response is the main challenge during fiberoptic bronchoscopy (FOB) procedure. Opioids are commonly used to suppress bronchoscopy response. This study aimed to estimate the median effective dose (ED₅₀) of oliceridine for suppressing bronchoscopy response during FOB under deep sedation with cipepofol.

Methods: This was an up-and-down sequential allocation trial. Patients were divided into male or female groups. The initial bolus of oliceridine was 40 μg/kg. The next dose of oliceridine was determined based on prior patient's response to FOB with 10 μg/kg step size. After seven inflection points were completed, recruitment was terminated. Following a single bolus of oliceridine, all patients received cipepofol (initial bolus:0.4 mg/kg), with infusion rates subsequently titrated between 0.2 and 1.0 mg/kg/h to maintain bispectral index (BIS) values within the 40-60 range. A laryngeal mask (LMA) was inserted when BIS ≤ 60. The endpoints were bronchoscopy response to FOB. Dixon's up-and-down method was used to calculate the ED₅₀ and ED₉₅ of oliceridine required to alleviate the bronchoscopy response. A dose-response curve was generated using probit analysis.

Results: A total of 45 patients (23 males, 22 females) were enrolled in the study. The ED₅₀ of oliceridine for suppressing the response to FOB under cipepofol sedation did not differ between males (median [interquartile range, IQR] 35.00 [35.00 to 36.00] μg/kg) and females (45.00 [35.00 to 45.00] μg/kg) (P=0.0723). Probit analysis showed the ED₅₀ and ED₉₅ of oliceridine required to suppress bronchoscopy response to FOB under deep sedation with cipepofol were 30.20 [95% confidence interval (CI):19.98 to 38.78] vs 40.47 [95% CI: 29.49 to 51.40] μg/kg and 46.49 [95% CI: 38.23 to 105.37] vs 57.55 [95% CI: 48.50 to 141.34] μg/kg in males and females respectively.

Conclusion: The ED₅₀ and ED₉₅ of oliceridine required to suppress bronchoscopy response under cipepofol sedation did not differ between males and females.

Trial registration: Chictr.org.cn; identifier: ChiCTR2400086635.

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来源期刊

Drug Design, Development and Therapy CHEMISTRY, MEDICINAL-PHARMACOLOGY & PHARMACY

CiteScore

9.00

自引率

0.00%

发文量

382

审稿时长

>12 weeks

期刊介绍： Drug Design, Development and Therapy is an international, peer-reviewed, open access journal that spans the spectrum of drug design, discovery and development through to clinical applications. The journal is characterized by the rapid reporting of high-quality original research, reviews, expert opinions, commentary and clinical studies in all therapeutic areas. Specific topics covered by the journal include: Drug target identification and validation Phenotypic screening and target deconvolution Biochemical analyses of drug targets and their pathways New methods or relevant applications in molecular/drug design and computer-aided drug discovery* Design, synthesis, and biological evaluation of novel biologically active compounds (including diagnostics or chemical probes) Structural or molecular biological studies elucidating molecular recognition processes Fragment-based drug discovery Pharmaceutical/red biotechnology Isolation, structural characterization, (bio)synthesis, bioengineering and pharmacological evaluation of natural products** Distribution, pharmacokinetics and metabolic transformations of drugs or biologically active compounds in drug development Drug delivery and formulation (design and characterization of dosage forms, release mechanisms and in vivo testing) Preclinical development studies Translational animal models Mechanisms of action and signalling pathways Toxicology Gene therapy, cell therapy and immunotherapy Personalized medicine and pharmacogenomics Clinical drug evaluation Patient safety and sustained use of medicines.