Jacobsen M B, Hanssen L E
Medical Department A. Rikshospitalet, University of Oslo, Norway.
J Intern Med. 1995 Mar;237(3):269-75. doi: 10.1111/j.1365-2796.1995.tb01175.x.
To compare the effect of octreotide with f placebo on symptoms, tumour marker and quality of life in patients with gastrointestinal neuroendocrine tumours and liver metastases.
A blinded, placebo-controlled, cross-over study was performed. The number of flushing epidodes and diarrhoea episodes were registered for 1 week prior to the study and for the 8-week duration of the study. Quality of life and 24-h urinary 5-hydroxyindoleacetic acid (5-HIAA) excretion were measured before the start, and at 4 and 8 weeks. Quality of life was registered with the Psychosocial Adjustment to Illness Scale (PAIS) and 5-HIAA measured by high-performance chromatography with electrochemical detection. 5-HIAA values exceeding 45 mumol 24 h-1 were considered to be elevated.
The study was performed in a tertiary referral centre.
Twelve patients were approached; eleven patients were included, with a mean age of 56.5 (range 30-72) years. The primary tumour originated from the small intestine in nine and from the pancreas in two patients. The main symptoms were diarrhoea, flushing and nausea. The 24-h excretion of 5-HIAA was increased in all patients.
Patients were treated for 4 weeks with octreotide (100 micrograms) subcutaneously, twice daily, and for 4 weeks on placebo (octreotide vehicle) in random starting order.
The main outcome measures were the number of episodes of the main clinical symptom(s) and 24-h 5-HIAA excretion.
Octreotide lowered diarrhoea and flushing frequency significantly compared to placebo. 5-HIAA excretion was reduced during treatment with the active drug. Two domains of the PAIS were significantly improved, indicating that the reduction of tumour marker and symptoms were clinically important.
The clinical effect of octreotide on symptoms in patients with neuroendocrine tumours was demonstrated in a controlled, prospective trial.
比较奥曲肽与安慰剂对胃肠神经内分泌肿瘤及肝转移患者症状、肿瘤标志物和生活质量的影响。
进行了一项双盲、安慰剂对照的交叉研究。在研究前1周以及研究的8周期间记录潮红发作次数和腹泻发作次数。在开始前、第4周和第8周测量生活质量和24小时尿5-羟吲哚乙酸（5-HIAA）排泄量。生活质量采用疾病心理社会适应量表（PAIS）进行记录，5-HIAA采用高效液相色谱电化学检测法测量。5-HIAA值超过45μmol 24 h-1被认为升高。
该研究在一家三级转诊中心进行。
共联系了12名患者；纳入了11名患者，平均年龄为56.5岁（范围30-72岁）。原发性肿瘤9例起源于小肠，2例起源于胰腺。主要症状为腹泻、潮红和恶心。所有患者的24小时5-HIAA排泄量均增加。
患者随机接受奥曲肽（100微克）皮下注射，每日两次，治疗4周，然后接受安慰剂（奥曲肽溶媒）治疗4周。
主要观察指标为主要临床症状发作次数和24小时5-HIAA排泄量。
与安慰剂相比，奥曲肽显著降低了腹泻和潮红频率。使用活性药物治疗期间5-HIAA排泄量减少。PAIS的两个领域有显著改善，表明肿瘤标志物和症状的降低具有临床重要性。
在一项对照的前瞻性试验中证明了奥曲肽对神经内分泌肿瘤患者症状的临床疗效。
