INTRAMUSCULAR INJECTIONS OF SLOW-RELEASE LANREOTIDE (BIM-23014) IN ACROMEGALIC PATIENTS PREVIOUSLY TREATED WITH CONTINUOUS SUBCUTANEOUS INFUSION OF OCTREOTIDE (SMS-201-995)

INTRAMUSCULAR INJECTIONS OF SLOW-RELEASE LANREOTIDE (BIM-23014) IN ACROMEGALIC PATIENTS PREVIOUSLY TREATED WITH CONTINUOUS SUBCUTANEOUS INFUSION OF OCTREOTIDE (SMS-201-995)
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DOI:
10.1530/eje.0.1320320
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发表时间:
1995-03-01
影响因子:
5.8
通讯作者:
BAYARD, F
BAYARD, F
中科院分区:
医学1区
文献类型:
--
作者:
CARON, P;COGNE, M;BAYARD, F

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9名肢端肥大症患者(5名女性和4名男性),平均年龄50 ± 4岁,表现为大腺瘤(N = 7)、微腺瘤(N = 1)或正常计算机断层扫描(N = 1)。患者接受奥曲肽连续皮下输注治疗(范围200-600 μ g/天)。在7天的洗脱期后,患者在第一个月每10天肌肉注射30 mg缓释兰瑞肽,然后每月两次。在3个月时生长激素(GH)水平升高的情况下,患者在接下来的三个月内每10天注射一次。奥曲肽治疗期间,所有患者的血浆GH和胰岛素样生长因子I(IGH-I)均下降。奥曲肽治疗6个月后,7名患者被认为控制良好(平均8小时GH < 5 μ g/l,IGF-I正常),而2名患者的平均8小时GH和/或IGF-I水平仍然升高。停药后血清GH和IGH-I升高。1例患者在缓释兰瑞肽给药期间血清GH和IGF-I升高,45天后停止注射。兰瑞肽治疗3个月后,3例患者控制良好,而5例患者GH或IGF-I水平未正常化。在6个月时,5名患者每月注射两次,3名患者每10天注射一次。6例患者控制良好,2例患者的平均8小时GH水平仍然增加。在奥曲肽治疗期间,两名患者的垂体瘤体积缩小了20-30%,在缓释兰瑞肽治疗期间,另一名患者的垂体瘤体积缩小了20-30%。除了在治疗早期出现轻微的消化问题或注射部位出现轻度疼痛外,缓释兰瑞肽耐受性良好。奥曲肽和兰瑞肽治疗期间,胆囊回声检查正常,但奥曲肽治疗期间发生胆结石的1例患者除外。总之,这项临床研究表明,在肢端肥大症患者中,肌肉注射缓释兰瑞肽(每月2或3次)耐受性良好,在控制GH高分泌方面与连续皮下输注奥曲肽一样有效。因此,缓释兰瑞肽似乎是一个有用的治疗工具,以改善肢端肥大症患者的生活质量。
Nine acromegalic patients (five females and four males), mean age 50+/-4 years, presented macroadenomas (N = 7), microadenoma (N = 1) or normal computed tomography scans (N = 1). Patients were treated with continuous subcutaneous infusion of octreotide (range 200-600 mu g/day). Following a washout period of 7 days, the patients were injected im with 30 mg slow-release lanreotide every 10 days for the first month and then twice monthly. In case of elevated growth hormone (GH) levels at 3 months, the patients were injected every 10 days for the next three months. Plasma GH and insulin-like growth factor I (IGH-I) decreased in all patients during octreotide treatment. After 6 months of octreotide treatment, seven patients were considered as well controlled (mean 8 h GH < 5 mu g/l, IGF-I normal) whereas in two patients the mean 8-h GH and/or IGF-I levels remained increased. Serum GH and IGH-I increased after octreotide withdrawal. In one patient, serum GH and IGF-I increased during slow-release lanreotide administration and injections were stopped after 45 days. After 3 months of lanreotide, three patients were well controlled while in five patients GH or IGF-I levels were not normalized. At 6 months, five patients were injected twice monthly and three patients had one injection every 10 days. Six patients were well controlled and in two patients the mean 8-h GH level remained increased. The pituitary tumor volume decreased by 20-30% in two patients during octreotide, as well as in one other during slow-release lanreotide therapy. Slow-release lanreotide was well tolerated except for minor digestive problems during the early days of treatment or mild pain at the site of injection. Gallbladder echographies were normal during octreotide and lanreotide therapies, except in one patient in whom gallstones occurred during octreotide treatment. In conclusion, this clinical study shows that in acromegalic patients, im injections of slow-release lanreotide (two or three per month) are well tolerated and are as effective as continuous subcutaneous infusion of octreotide in the control of GH hypersecretion. Therefore, slow-release lanreotide would appear to be a useful therapeutic tool to improve the quality of life in patients with acromegaly.