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兰瑞肽长效凝胶120mg在不同给药间隔对曾接受奥曲肽长效注射剂治疗的肢端肥大症患者的疗效及可接受性

Efficacy and acceptability of lanreotide Autogel® 120 mg at different dose intervals in patients with acromegaly previously treated with octreotide LAR.

作者信息

Schopohl J, Strasburger C J, Caird D, Badenhoop K, Beuschlein F, Droste M, Plöckinger U, Petersenn S

机构信息

Medizinische Klinik Innenstadt, Ludwig-Maximilians University, Munich, Germany.

出版信息

Exp Clin Endocrinol Diabetes. 2011 Mar;119(3):156-62. doi: 10.1055/s-0030-1267244. Epub 2010 Nov 17.

Abstract

OBJECTIVE

To assess the efficacy of different dosing intervals of lanreotide, Somatuline Autogel® (Lan-ATG) 120 mg in patients with acromegaly, previously treated with octreotide, long-acting release (Oct-LAR).

PATIENTS AND STUDY DESIGN

Patients previously on Oct-LAR 10, 20, or 30 mg were switched to 6 repeated deep subcutaneous injections of Lan-ATG 120 mg at intervals of 56, 42, or 28 days, respectively. After the third injection, dose intervals were adjusted on the basis of insulin-like growth factor 1 (IGF-1) levels.

RESULTS

The ITT (Intention To Treat) population comprised 35 patients who received at least one dose of study medication and at least one post-baseline efficacy assessment. Overall, 62.9% (n=22) of patients had normalised IGF-1 levels with Lan-ATG at study end (one injection interval after the 6 (th) injection of Lan-ATG), which was similar to the proportion at baseline (60.0% [n=21]). QoL did not change from baseline to study end. Patient preference for Lan-ATG was highest in the 56-day dosing interval group: 71%, 54% and 41% of the patients in the 56, 42 and 28 day groups, respectively, expressed a preference for treatment with Lan-ATG (preference for Oct-LAR: 29%, 9% and 35%, respectively, while the remainder had no preference).

CONCLUSION

Lan-ATG 120 mg injected at intervals of 56, 42 and 28 days provided equivalent hormonal control and QoL to Oct-LAR 10, 20 and 30 mg injected every 28 days, respectively. The proportion of patients preferring Lan-ATG treatment was greater in the longer injection interval groups.

摘要

目的

评估善龙(索马杜林自动凝胶®,Lan-ATG)120mg不同给药间隔在曾接受长效奥曲肽(Oct-LAR)治疗的肢端肥大症患者中的疗效。

患者与研究设计

既往使用10mg、20mg或30mg Oct-LAR的患者,分别改为每56天、42天或28天重复进行6次Lan-ATG 120mg皮下深部注射。第三次注射后,根据胰岛素样生长因子1(IGF-1)水平调整给药间隔。

结果

意向性分析(ITT)人群包括35例接受了至少一剂研究药物且至少进行了一次基线后疗效评估的患者。总体而言,62.9%(n = 22)的患者在研究结束时(Lan-ATG第6次注射后的一个注射间隔)IGF-1水平恢复正常,这与基线时的比例(60.0% [n = 21])相似。生活质量从基线到研究结束未发生变化。患者对Lan-ATG的偏好以56天给药间隔组最高:56天、42天和28天组分别有71%、54%和41%的患者表示倾向于接受Lan-ATG治疗(倾向于Oct-LAR治疗的比例分别为29%、9%和35%,其余患者无偏好)。

结论

每56天、42天和28天注射一次120mg Lan-ATG,在激素控制和生活质量方面分别与每28天注射一次10mg、20mg和30mg Oct-LAR相当。注射间隔较长的组中,倾向于Lan-ATG治疗的患者比例更高。

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