Colao A, Marzullo P, Ferone D, Marinò V, Pivonello R, Di Somma C, Di Sarno A, Giaccio A, Lombardi G
Dipartimento di Endocrinologia ed Oncologia Molecolare e Clinica, Federico II University of Napoli, Italy.
J Endocrinol Invest. 1999 Jan;22(1):40-7. doi: 10.1007/BF03345477.
This single-center open sequential study aimed at comparing the efficacy of a 6-month treatment with lanreotide (LAN) (60-90 mg/month i.m.), to that of octreotide (OCT) (0.3-0.6 mg/day s.c.) in 45 patients with active acromegaly (GH, 63.2+/-12.1 ng/ml, IGF-I, 757+/-67.1 ng/ml). After 6 months of OCT treatment, safe GH (fasting <2.5, glucose suppressed <1 ng/ml) and IGF-I (normalized for age) levels were achieved in 23 patients. After treatment withdrawal, GH levels significantly increased in all patients, though remaining slightly lower than pre-OCT therapy (39.2+/-5.8 ng/ml) while plasma IGF-I levels were unchanged (654+/-59.4 ng/ml). After 6 months of LAN treatment, safe GH and IGF-I levels were achieved in 26 patients (57.7%). After OCT or LAN treatments, no significant difference was found between nadir GH (6+/-1 vs 5.9+/-1.1 ng/ml) and IGF-I levels (281+/-23.3 vs 262+/-20.6 ng/ml). Four out of the 20 patients poorly responsive to OCT achieved safe GH and IGF-I levels after LAN treatment. Among the 20 non-operated patients, a significant tumor shrinkage was documented by CT and/or MRI in 5 patients after OCT and in 1 patient after LAN treatment. All patients referred a notable improvement of soft tissue swelling, arthralgia, headache and weakness, both after OCT and LAN treatments. During the first days of OCT treatment, abdominal discomfort was referred by 12 patients and steatorrhea by 5 patients: side effects disappeared spontaneously in 6 cases while during treatment with pancreatic enzymes in the remaining ones. After the first injections of LAN, abdominal discomfort was referred by 10 patients and steatorrhea by 2 of them. No difference in the prevalence of both early and late side effects was noted after treatment with OCT and LAN (chi2, 0.49). The majority of these poorly tolerant patients had side effects with both compounds. During LAN treatment, side effects were mild and spontaneously disappeared but recurred after the injection of the drug in six patients. Gallstones were detected in one patient during OCT and in another during LAN, sludge was noted in 6 patients after OCT and in 2 after LAN treatment. In conclusion, the treatment with LAN allowed to achieve safe GH and IGF-I levels in 57.7% of acromegalics with an excellent patients' compliance. LAN treatment possessed similar efficacy and caused side effects with a similar incidence of OCT treatment. The recurrence of side effects after LAN injection suggests the necessity of a careful monitoring of adverse reactions.
这项单中心开放性序贯研究旨在比较45例活动性肢端肥大症患者（生长激素[GH]，63.2±12.1 ng/ml，胰岛素样生长因子-I[IGF-I]，757±67.1 ng/ml）接受6个月兰瑞肽（LAN）（60 - 90 mg/月，肌肉注射）治疗与奥曲肽（OCT）（0.3 - 0.6 mg/天，皮下注射）治疗的疗效。奥曲肽治疗6个月后，23例患者实现了安全的GH水平（空腹<2.5，葡萄糖抑制后<1 ng/ml）和IGF-I水平（根据年龄标准化）。停药后，所有患者的GH水平均显著升高，尽管仍略低于奥曲肽治疗前水平（39.2±5.8 ng/ml），而血浆IGF-I水平未改变（654±59.4 ng/ml）。兰瑞肽治疗6个月后，26例患者（57.7%）实现了安全的GH和IGF-I水平。奥曲肽或兰瑞肽治疗后，最低GH水平（6±1 vs 5.9±1.1 ng/ml）和IGF-I水平（281±23.3 vs 262±20.6 ng/ml）之间未发现显著差异。奥曲肽治疗反应不佳的20例患者中有4例在接受兰瑞肽治疗后实现了安全的GH和IGF-I水平。在20例未接受手术的患者中，CT和/或MRI显示奥曲肽治疗后5例患者肿瘤显著缩小，兰瑞肽治疗后1例患者肿瘤显著缩小。所有患者均表示奥曲肽和兰瑞肽治疗后软组织肿胀、关节痛、头痛和乏力均有明显改善。奥曲肽治疗的最初几天，12例患者出现腹部不适，5例患者出现脂肪泻：6例患者的副作用自行消失，其余患者接受胰酶治疗。首次注射兰瑞肽后，10例患者出现腹部不适，其中2例出现脂肪泻。奥曲肽和兰瑞肽治疗后，早期和晚期副作用的发生率无差异（卡方检验，0.49）。这些耐受性差的患者中大多数对两种药物均有副作用。兰瑞肽治疗期间，副作用较轻且自行消失，但6例患者注射药物后副作用复发。奥曲肽治疗期间1例患者检测到胆结石，兰瑞肽治疗期间另1例患者检测到胆结石，奥曲肽治疗后6例患者发现胆囊泥沙样改变，兰瑞肽治疗后2例患者发现胆囊泥沙样改变。总之，兰瑞肽治疗使57.7%的肢端肥大症患者实现了安全的GH和IGF-I水平，患者依从性良好。兰瑞肽治疗具有相似的疗效，且引起副作用的发生率与奥曲肽治疗相似。兰瑞肽注射后副作用复发提示有必要仔细监测不良反应。
