Shima Yasuo, Ohtsu Atshushi, Shirao Kuniaki, Sasaki Yasutsuna
Palliative Care Unit, National Cancer Center Hospital East, Chiba, Japan.
Jpn J Clin Oncol. 2008 May;38(5):354-9. doi: 10.1093/jjco/hyn035.
In patients with advanced cancer, malignant bowel obstruction (MBO) causes gastrointestinal symptoms such as nausea and vomiting leading to severely impaired oral food intake. Thus, MBO markedly diminishes the quality of life (QOL) of these patients because placement of a nasogastric tube becomes necessary. Many studies have shown that octreotide (SMS201-995; SMS), a synthetic analog of somatostatin, is effective for controlling the symptoms of MBO. This study was conducted to assess the efficacy and safety of 300-microg/day initial dose of SMS in Japanese patients with MBO and to investigate the clinical benefit of patients achieved by the improvement of nausea/vomiting based on subjective assessment.
The subjects were patients with MBO that was refractory to other medical treatment and who had suffered at least two vomiting episodes per day for two consecutive days or had required a nasogastric tube. After enrollment, patients received SMS (300 microg/day) subcutaneously as a continuous injection for 6 days. Patients who responded to this 6-day course of treatment continued to receive the drug.
Among 25 patients who were enrolled, 11 (44.0%) responded to treatment with resolution or improvement of nausea/vomiting. Their symptomatic improvement was assessed by quantitatively measuring the level of control of nausea/vomiting and by using a self-administered QOL questionnaire that evaluated the frequency and severity of nausea/vomiting, the proportion of patients enjoying recreational activities and the overall patient satisfaction with the therapy. SMS was well tolerated, and nausea and agitation were the only adverse events potentially related to this drug.
The results of the study confirmed that the 300-microg/day dose of SMS is safe and effective for patients with MBO uncontrolled by other therapies and suggested that the relief of symptoms with nausea/vomiting by SMS could contribute to improvement of the QOL of patients.
在晚期癌症患者中，恶性肠梗阻（MBO）会引发恶心、呕吐等胃肠道症状，导致经口食物摄入量严重受损。因此，MBO会显著降低这些患者的生活质量（QOL），因为此时有必要放置鼻胃管。许多研究表明，生长抑素的合成类似物奥曲肽（SMS201 - 995；SMS）对控制MBO症状有效。本研究旨在评估初始剂量为300微克/天的SMS对日本MBO患者的疗效和安全性，并基于主观评估调查通过改善恶心/呕吐为患者带来的临床益处。
研究对象为对其他药物治疗无效且连续两天每天至少发生两次呕吐发作或需要鼻胃管的MBO患者。入组后，患者皮下连续注射SMS（300微克/天），共6天。对这6天治疗疗程有反应的患者继续接受该药物治疗。
在入组的25名患者中，11名（44.0%）对治疗有反应，恶心/呕吐症状得到缓解或改善。通过定量测量恶心/呕吐的控制水平以及使用自我管理的QOL问卷来评估他们的症状改善情况，该问卷评估恶心/呕吐的频率和严重程度、参与娱乐活动的患者比例以及患者对治疗的总体满意度。SMS耐受性良好，恶心和激动是仅有的可能与该药物相关的不良事件。
研究结果证实，对于其他疗法无法控制的MBO患者，300微克/天剂量的SMS安全有效，并且提示SMS缓解恶心/呕吐症状有助于改善患者的QOL。
