奥曲肽经动脉给药安全性初步临床研究

Clinical investigation of safety of octreotide infused through artery

目的:探讨奥曲肽经肝动脉给药的安全剂量,以期将该药真正用于实体肿瘤的临床治疗。方法:18例肝癌根治术后患者经肝动脉埋泵给药。首日推注奥曲肽200μg、顺铂碘油混悬液18ml(顺铂40mg+超液化碘油10ml)。次日再推注奥曲肽200μg。每隔4～8周重复给药1次。观察给药前后患者的生命体征、一般情况和各项实验室常规检查。结果:不良反应主要为消化道症状:恶心呕吐(66.67％),食欲减退(77.78％),便秘(27.78％),腹胀(72.22％),右上腹痛(61.11％),脸部潮热(88.89％,其中55.56％同时伴全身潮热),胸闷、心悸(22.22％),肝功能异常(77.78％),血小板减少、血PT降低(5.56％),短暂发热(16.67％),麻痹性肠梗阻(5.56％)。未发现明显的心肌损伤和肾功能损害。结论:①经肝动脉1次给予200μg奥曲肽是安全的,未出现明显的毒副作用。②脸部潮热伴或不伴全身潮热是观察到的奥曲肽经动脉给药唯一的机体反应,呈一过性。③奥曲肽对预防肝癌根治术后复发转移是否有效,尚待进一步验证。

Objective: To discuss the safe dosage of octreotide given through hepatic artery. Method: 18 cases who accepted radical excision of liver cancer were given drugs through hepatic artery pump. The first day's dosages were octreotide 200μg, suspension of CDDP and lipiodol 18ml (CDDP 40mg and superliquefied lipiodol 10ml), and the following day only octreotide 200fig. The remedy repeated every 4-8 weeks. Their vital signs, general condition, and routine laboratory examination were observed before and after the administration of drugs. Results: The adverse reactions were mostly symptoms of alimentary tract: nausea and vomiting (66.67%), anorexia (77.78%), constipation (27.78%), abdominal distention (72.22%), pain in right hypochondria! region (61.11%), facial hectic fever (88.89%, among them 55.56 % suffered hectic fever of whole body), palpitation (22.22%), hepatic function disorder (77.78%), thrombocytopenia and decreased PT (5.56%), transient fever (16.67%), paralytic ileus (5.56%) . Any transparent problems of myocardium and renal function didn't be found. Conclusion: 1.Administration of octreotide 200fμg through hepatic artery is safe. 2.Facial hectic fever or whole body hectic fever seems to be the only and transient body reaction to octreotide given through artery. 3. It is needed to be further confirmed whether octreotide is helpful to the prevention of relapse and metastasis after radical excision of liver cancer.