醋酸奥曲肽微球治疗肢端肥大症的长期疗效及安全性分析

目的 回顾性分析注射用醋酸奥曲肽微球治疗肢端肥大症的长期临床疗效及安全性, 探讨醋酸奥曲肽微球长期应用的可行性。方法 从2010年1月至2020年12月在北京协和医院就诊的肢端肥大症患者中筛选出接受注射用醋酸奥曲肽微球20 mg/(1~3)月]治疗至少30疗程的29例患者作为研究对象。采集所有患者基线信息及10、20、30、40、50、60疗程空腹生长激素(GH,ng·mL^-1)、胰岛素样生长因子-1(IGF-1,ng·mL^-1)、心电图及超声心动图、胆道系统检查结果及血常规等资料,将药物治疗后的病情活动性生化指标(GH和IGF-1)与基线水平进行比较。结果 纳入研究的患者平均年龄(40.2±12.8)岁,平均用药疗程为(51.4±17.7)次,最长可达112次。经过长期规律地应用醋酸奥曲肽微球,23例患者的临床症状明显好转,GH及IGF-1水平得到不同程度的下降,并且与基线相比差异有统计学意义( P＜0. 05),另6例患者在初始单独使用醋酸奥曲肽微球后,GH和IGF-1水平有下降,但未控制达标(P＞0.05),联合溴隐亭后临床症状进一步好转,GH和IGF-1水平进一步下降(P＜0. 05)。胃肠道反应及胆道系统不适为醋酸奥曲肽微球使用后最常见的不良反应,12例用药初期出现腹痛、腹泻,8例出现胆道系统不适,其中仅有3例患者为用药30程后出现胆囊结石,3例在长期用药过程中出现白细胞降低。结论 对于不适合手术、或拒绝手术或放疗,及手术或放疗后未缓解的肢端肥大症患者,长期单用醋酸奥曲肽微球或联合使用多巴胺受体激动剂是一种安全有效的治疗方法,长期使用过程中应定期监测药物不良反应的发生,特别是关注胆道及血液系统相关的不良反应。

Efficacy and Safety of Long-Term Use of Octreotide Acetate Microspheres in Acromegaly Patients

OBJECTIVE To study on the effectiveness and safety of octreotide acetate microspheres treatment in acromegaly patients and explore the feasibility of long-term use of octreotide. METHODS Medical records of 29 acromegaly patients receiving octreotide acetate microspheres treatment(20 mg, once 1-3 months,at least 30 courses of treatment) from Jan 2010 to Dec 2020 in Peking union medical college hospital were retrospectively analyzed. The biochemical parameters such as growth hormone(GH) and insulin-like growth factor-1(IGF-1) level were measured at baseline and after 10, 20, 30, 40, 50 and 60 courses of treatment, respectively.Simultaneously, the related indicators of possible adverse reactions were also monitored. RESULTS The study included 29 patients(mean age±SD, 40.2±12.8 years) treated with octreotide acetate microspheres for a mean of 51.4±17.7 courses. Through long-term regular application of the octreotide acetate microspheres, clinical symptoms and biochemical parameters(GH, IGF-1) have different degrees of improvement of 23 patient, and the difference was significant differences compared with the baseline( P＜0. 05). The other 6 patients with initial treatment of octreotide acetate microspheres, biochemical indicators were not improved with significant differences. After adding bromocriptine, the difference was statistically significant(P＜0.05). Gastrointestinal reactions and biliary system discomfort were the most common adverse reactions after octreotide acetate microspheres use. 12 patients had abdominal pain and diarrhea at the beginning of treatment, 8 patients had biliary system discomfort, and only 3 patients had gallstones after 30 courses of treatment, 3 patients had leucopenia during long-term medication. CONCLUSION The results support the long-term efficacy and safety of octreotide acetate microspheres for acromegaly. The incidence of some adverse reactions maybe increase after long term use of octreotide acetate microspheres. Therefore,it is necessary to carry out regular monitoring of possible adverse reactions.