Salvatori Roberto, Woodmansee Whitney W, Molitch Mark, Gordon Murray B, Lomax Kathleen G
Division of Endocrinology, Johns Hopkins University, 1830 East Monument Street #333, Baltimore, MD, 21287, USA,
Pituitary. 2014 Feb;17(1):13-21. doi: 10.1007/s11102-012-0460-2.
Lanreotide depot (LD; commercial name Somatuline(®) Depot) is an injectable, extended-release formulation of the synthetic somatostatin analog (SSA) lanreotide. In recent clinical trials, LD was found to be suitable for self or partner administration, avoiding the need to travel to a medical facility. The Somatuline(®) Depot for Acromegaly (SODA) study is an ongoing, multicenter, observational study in the US investigating the efficacy, safety, convenience and symptom relief provided by LD in patients with acromegaly. Sub-analyses explore outcomes according to who administered the injection: patient, partner, healthcare provider (HCP) or a combination. Data reported here reflect one year of patient experience. Patients are eligible for inclusion if they have a diagnosis of acromegaly, are treated with LD and can give signed informed consent. Baseline data include patient demographics, previous acromegaly treatment and investigations, GH and IGF-I levels, LD dose and dose adjustment frequency. Symptom frequency, injection pain and treatment convenience are assessed using patient-reported questionnaires. As of 18 April 2012, 166 patients had enrolled in SODA. Most (72 %) achieved normal IGF-I levels after 12 months of LD treatment. Disease control was similar in self or partner injectors and in patients who received injections from their HCP, although self or partner injecting was deemed more convenient. LD was well-tolerated irrespective of who performed the injection. Self injection led to more injection-site reactions, but this did not increase the rate of treatment interruption. Acromegaly symptoms remained stable. Biochemical, safety and convenience data support the clinical validity of injecting LD at home.
长效兰瑞肽(LD;商品名索马杜林(®)长效注射剂)是一种合成生长抑素类似物(SSA)兰瑞肽的注射用缓释制剂。在最近的临床试验中,发现长效兰瑞肽适合患者自行注射或由其伴侣注射,无需前往医疗机构。“用于肢端肥大症的索马杜林(®)长效注射剂(SODA)研究”是美国一项正在进行的多中心观察性研究,旨在调查长效兰瑞肽在肢端肥大症患者中的疗效、安全性、便利性及症状缓解情况。亚组分析根据注射者的不同(患者、伴侣、医护人员(HCP)或多种情况组合)来探究结果。此处报告的数据反映了患者一年的用药体验。若患者被诊断为肢端肥大症、正在接受长效兰瑞肽治疗且能签署知情同意书,则符合纳入标准。基线数据包括患者人口统计学信息、既往肢端肥大症治疗及检查情况、生长激素(GH)和胰岛素样生长因子 -I(IGF -I)水平、长效兰瑞肽剂量及剂量调整频率。使用患者报告问卷评估症状发生频率、注射疼痛及治疗便利性。截至2012年4月18日,166例患者已纳入SODA研究。大多数患者(72%)在接受长效兰瑞肽治疗12个月后IGF -I水平恢复正常。自我注射或由伴侣注射的患者与接受医护人员注射的患者疾病控制情况相似,不过自我注射或由伴侣注射被认为更方便。无论由谁进行注射,长效兰瑞肽的耐受性都良好。自我注射导致更多注射部位反应,但这并未增加治疗中断率。肢端肥大症症状保持稳定。生化、安全性及便利性数据支持在家自行注射长效兰瑞肽的临床有效性。