Ann Endocrinol (Paris). 1988;49(4-5):323-30.
SMS 201-995 was administered to 40 acromegalic patients, in a multicentric study. Some of the results have been analyzed from 37 patients who remained under a long term treatment. Clinical improvement was noted in most patients, especially as concerns soft tissue swelling, sweating, headache. Digestive adverse effects were noted, leading to the drop-out from the protocol (in 4 patients) or in most patients to a slight discomfort related to increasing doses. There was an effect for all the doses used (300, 600, 900, 1500 micrograms in 3 subcutaneous injections per day), compared with pretreatment values, if we consider the mean GH value of each cycle obtained under the different dosages. The highest dose was most effective than the lowest in some cases. However in most patients the 300 micrograms dose was efficient. We could not obtain normalization of GH secretion. However 22/37 patients could reach a good score as concerns the number of GH values less than 5 micrograms/l, during circadian evaluations. In 5/37 patients, the antisecretory effect was insufficient (mean GH above 50% of the pretreatment level). Reduction in tumor volume was highly significant (more than 50%) in 2/11 patients. In conclusion, this study shows the efficacy of SMS 201-995 in improving clinical signs and symptoms of acromegaly, and GH hypersecretion in approximately 80% of the patients. General and metabolic tolerance are rather good. Some points concerning tolerance remain to be investigated.
在一项多中心研究中,对40例肢端肥大症患者使用了SMS 201-995。对37例接受长期治疗的患者的部分结果进行了分析。多数患者出现临床改善,尤其是在软组织肿胀、出汗、头痛方面。观察到有消化系统不良反应,导致4例患者退出试验方案,或多数患者因剂量增加出现轻微不适。如果考虑不同剂量下每个周期的平均生长激素(GH)值,与治疗前值相比,所用的所有剂量(每天3次皮下注射,剂量分别为300、600、900、1500微克)均有效果。在某些情况下,最高剂量比最低剂量更有效。然而,多数患者使用300微克剂量有效。我们未能使GH分泌正常化。然而,在昼夜评估期间,37例患者中有22例在GH值低于5微克/升的数量方面可达到良好评分。37例患者中有5例抗分泌效果不足(平均GH高于治疗前水平的50%)。11例患者中有2例肿瘤体积显著缩小(超过50%)。总之,本研究表明SMS 201-995在改善肢端肥大症的临床体征和症状以及约80%患者的GH分泌过多方面有效。总体和代谢耐受性相当好。关于耐受性的一些问题仍有待研究。