Lancranjan I, Bruns C, Grass P, Jaquet P, Jervell J, Kendall-Taylor P, Lamberts S W, Marbach P, Orskov H, Pagani G, Sheppard M, Simionescu L
Department of Oncology, Sandoz Pharma Ltd, Basel, Switzerland.
Metabolism. 1996 Aug;45(8 Suppl 1):67-71. doi: 10.1016/s0026-0495(96)90087-6.
A stable and sustained suppression of growth hormone (GH) secretion was noted in 101 patients treated long term with individual doses (20 and 30 mg in 89 patients, 40 mg in 12 patients) of Sandostatin LAR (Sandoz Pharma Ltd, Basel, Switzerland). Doses of 20 mg and 30 mg at 4-week intervals delivered average octreotide concentrations of 1,348 +/- 483 ng/L and 2,631 +/- 1,026 ng/L, respectively, in steady-state conditions and provided adequate control of patients who had been well controlled during treatment with 0.1 mg and 0.2 mg thrice-daily subcutaneous (SC) Sandostatin. Suppression of GH serum concentrations to less than 5 micrograms, 2 micrograms, and even 1 microgram/L was recorded in more patients and more consistently during long-term treatment with Sandostatin LAR than Sandostatin. A marked decrease or even a normalization of insulin-like growth factor-1 (IGF-1) serum concentrations was observed after the first double-blind 10-, 20-, or 30-mg dose of Sandostatin LAR. A progressive improvement was recorded during long-term treatment, with normalization of IGF-1 serum concentrations in 65.3% of patients. A marked clinical improvement was observed in parallel, with 36 of 101 patients (35.6%) becoming asymptomatic after the nineteenth injection of Sandostatin LAR. A greater than 20% shrinkage of the GH-secreting adenoma was also recorded in 12 of 14 patients treated with Sandostatin LAR after receiving only 2 to 4 weeks of treatment with SC Sandostatin and in 11 of 18 patients receiving Sandostatin LAR as adjuvant therapy after failure of surgery. The systemic tolerability of Sandostatin LAR was good, and most adverse events were mild and short term (1 to 2 days). No impairment of thyroid function was detected. Newly occurring gallstones were recorded in four of 101 patients and microlithiasis in four of 101 after up to 30 months of treatment with Sandostatin LAR. Due to its excellent efficacy, good tolerability, convenience of administration, and acceptability by patients, Sandostatin LAR is considered a promising therapeutic tool in the management of acromegalic patients.
101例长期接受不同剂量（89例患者接受20毫克和30毫克，12例患者接受40毫克）善龙（瑞士巴塞尔山德士制药有限公司）治疗的患者，生长激素（GH）分泌得到稳定且持续的抑制。在稳态条件下，每4周注射一次20毫克和30毫克剂量的善龙，奥曲肽平均浓度分别为1348±483纳克/升和2631±1026纳克/升，这为那些在用0.1毫克和0.2毫克善宁每日三次皮下注射治疗期间病情得到良好控制的患者提供了充分的控制。与善宁相比，在用善龙进行长期治疗期间，更多患者的GH血清浓度被抑制到低于5微克/升、2微克/升甚至1微克/升，且更为持续。在首次双盲给予10毫克、20毫克或30毫克善龙后，观察到胰岛素样生长因子-1（IGF-1）血清浓度显著下降甚至恢复正常。在长期治疗期间记录到病情逐步改善，65.3%的患者IGF-1血清浓度恢复正常。同时观察到显著的临床改善，101例患者中有36例（35.6%）在第十九次注射善龙后无症状。在仅接受2至4周皮下注射善宁治疗后接受善龙治疗的14例患者中，有12例，以及在手术失败后接受善龙辅助治疗的18例患者中，有11例，其分泌GH的腺瘤缩小超过20%。善龙的全身耐受性良好，大多数不良事件轻微且为短期（1至2天）。未检测到甲状腺功能受损。在接受善龙治疗长达30个月后，101例患者中有4例出现新发胆结石，101例中有4例出现微结石症。由于其卓越的疗效、良好的耐受性、给药便利性以及患者的接受度，善龙被认为是治疗肢端肥大症患者的一种有前景的治疗工具。
