Somatostatin analogs are recommended for pharmacotherapy of TSH-secreting pituitary adenoma (TSHoma). A multicenter clinical trial was conducted to evaluate the efficacy and safety of lanreotide autogel treatment for TSHoma. A total of 13 Japanese patients with TSHoma were enrolled from February to December 2018 and treated with lanreotide autogel 90 mg every 4 weeks, with dose adjustments to 60 mg or 120 mg. Analysis was performed on data from patients receiving preoperative treatment (n = 6) up to 24 weeks and from those receiving primary or postoperative treatment (n = 7) up to 52 weeks. The primary efficacy endpoints were serum concentrations of TSH, free triiodothyronine (FT3), and free thyroxine (FT4). The secondary efficacy endpoints were pituitary tumor size and clinical symptoms. The serum concentrations of TSH, FT3, and FT4 decreased with treatment, and euthyroid status was maintained until final assessment. FT4 at final assessment was within reference ranges in 10/13 patients. The median (interquartile range) percent change in pituitary tumor size from baseline at final assessment was –23.8% (–38.1, –19.8). The clinical symptoms were also improved. The patients receiving preoperative treatment did not develop perioperative thyroid storm. Regarding safety, adverse events were observed in 12/13 patients, but none discontinued treatment. The common adverse events were gastrointestinal disorders (12/13 patients) and administration site reactions (5/13 patients). Lanreotide autogel may be effective for controlling thyroid function and reducing the pituitary tumor size, and is tolerable in patients with TSHoma (Japic Clinical Trials Information; JapicCTI-173772).

生长抑素类似物被推荐用于 TSH 分泌垂体腺瘤 (TSHoma) 的药物治疗。进行了一项多中心临床试验，以评估兰瑞肽自凝胶治疗 TSHoma 的疗效和安全性。2018 年 2 月至 2018 年 12 月共招募了 13 名日本 TSHoma 患者，每 4 周接受一次 90 毫克兰瑞肽 autogel 治疗，剂量调整为 60 毫克或 120 毫克。对接受术前治疗 ( n = 6) 长达 24 周的患者和接受初级或术后治疗 ( n= 7) 长达 52 周。主要疗效终点是 TSH、游离三碘甲状腺原氨酸 (FT3) 和游离甲状腺素 (FT4) 的血清浓度。次要疗效终点是垂体肿瘤大小和临床症状。TSH、FT3 和 FT4 的血清浓度随着治疗而降低，甲状腺功能正常状态一直保持到最终评估。最终评估的 FT4 在 10/13 患者的参考范围内。最终评估时垂体肿瘤大小与基线相比的中位（四分位间距）百分比变化为 –23.8%（–38.1，–19.8）。临床症状也有所改善。接受术前治疗的患者未出现围手术期甲状腺危象。关于安全性，在 12/13 名患者中观察到不良事件，但没有人停止治疗。常见的不良事件是胃肠道疾病（12/13 名患者）和给药部位反应（5/13 名患者）。Lanreotide autogel 可能对控制甲状腺功能和减小垂体肿瘤大小有效，并且在 TSHoma 患者中是可以耐受的（Japic 临床试验信息；JapicCTI-173772）。