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长效奥曲肽治疗肢端肥大症的疗效及不良事件:一项真实世界回顾性研究

Efficacy and adverse events of octreotide long-acting release in acromegaly: a real-world retrospective study.

作者信息

Zhao Zhe, Duan Lian, Gao Daihui, Yao Yong, Deng Kan, Xing Bing, Wang Xinfeng, Tang Yan, Zhu Huijuan, Chen Xiaoguang

机构信息

Department of Pharmacy, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.

State Key Laboratory of Bioactive Substrate and Function of Natural Medicine, Institute of Materia Medica, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.

出版信息

Ann Transl Med. 2022 Jul;10(13):734. doi: 10.21037/atm-22-414.

DOI:10.21037/atm-22-414
PMID:35957714
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9358514/
Abstract

BACKGROUND

Octreotide long-acting release (LAR) is a common drug used for acromegaly that aims to normalize serum growth hormone (GH) and insulin-like growth factor-1 (IGF-1). However, only a few studies have evaluated its efficacy and safety in Chinese patients. This retrospective study aimed to assess its efficacy and safety in a cohort of Chinese patients with acromegaly.

METHODS

A total of 163 patients with acromegaly, who received continuous and regular octreotide LAR treatment at least three times at Peking Union Medical College Hospital between 2010 and 2020, were enrolled. Clinical characteristics, acromegaly activity, and other laboratory tests before and after treatment were collected for analysis.

RESULTS

The study enrolled 163 patients, including 71 men (43.6%) with a mean age of 40.94±13.00 years. After octreotide LAR treatment, 34.4% of the patients achieved GH control (<2.5 ng/mL), while IGF-1 levels were normalized in 23.3% of the patients. Also, fasting GH levels were downregulated from 4.95 ng/mL [interquartile range (IQR) 2.225, 10.325 ng/mL] at baseline to 3.2 ng/mL (IQR 1.5, 6.6 ng/mL) (P<0.001), and IGF-1/upper limit of the normal (ULN) declined from 1.89 (IQR 1.22, 2.40) to 1.41 (IQR 0.97, 1.89) (P<0.001). In addition, 65 patients experienced moderate adverse events. During the follow-up, none of the patients discontinued octreotide LAR. Further logistic regression showed that comorbidity [odds ratio (OR), 3.19; 95% confidence interval (CI): 1.20-9.27; P=0.025] and previous surgery only (OR, 0.21; 95% CI: 0.08-0.58; P=0.003) were two risk factors for the development of adverse events.

CONCLUSIONS

Our findings revealed that octreotide LAR treatment is effective in normalizing GH and IGF-1 levels in Chinese patients with acromegaly. In addition, adverse events related to octreotide LAR use were moderate and well tolerated by the patients.

摘要

背景

长效奥曲肽(LAR)是一种用于治疗肢端肥大症的常用药物,旨在使血清生长激素(GH)和胰岛素样生长因子-1(IGF-1)恢复正常。然而,仅有少数研究评估了其在中国患者中的疗效和安全性。这项回顾性研究旨在评估其在一组中国肢端肥大症患者中的疗效和安全性。

方法

纳入2010年至2020年间在北京协和医院接受至少三次连续、规律长效奥曲肽治疗的163例肢端肥大症患者。收集治疗前后的临床特征、肢端肥大症活动情况及其他实验室检查结果进行分析。

结果

该研究共纳入163例患者,其中男性71例(43.6%),平均年龄40.94±13.00岁。长效奥曲肽治疗后,34.4%的患者实现了GH控制(<2.5 ng/mL),23.3%的患者IGF-1水平恢复正常。此外,空腹GH水平从基线时的4.95 ng/mL[四分位间距(IQR)2.225,10.325 ng/mL]下调至3.2 ng/mL(IQR 1.5,6.6 ng/mL)(P<0.001),IGF-1/正常上限(ULN)从1.89(IQR 1.22,2.40)降至1.41(IQR 0.97,1.89)(P<0.001)。另外,65例患者发生中度不良事件。随访期间,无患者停用长效奥曲肽。进一步的逻辑回归分析显示,合并症[比值比(OR),3.19;95%置信区间(CI):1.20 - 9.27;P = 0.025]和仅接受过既往手术(OR,0.21;95% CI:0.08 - 0.58;P = 0.003)是发生不良事件的两个危险因素。

结论

我们的研究结果表明,长效奥曲肽治疗可有效使中国肢端肥大症患者的GH和IGF-1水平恢复正常。此外,与使用长效奥曲肽相关的不良事件为中度,患者耐受性良好。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8e6c/9358514/7787160ce149/atm-10-13-734-f5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8e6c/9358514/500dc28961ce/atm-10-13-734-f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8e6c/9358514/7958c530a43f/atm-10-13-734-f4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8e6c/9358514/7787160ce149/atm-10-13-734-f5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8e6c/9358514/500dc28961ce/atm-10-13-734-f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8e6c/9358514/7958c530a43f/atm-10-13-734-f4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8e6c/9358514/7787160ce149/atm-10-13-734-f5.jpg

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