Huys J, Troch M, Bourguignon R P, Smets P
Curr Med Res Opin. 1985;9(6):400-6. doi: 10.1185/03007998509109611.
A double-blind, randomized crossover trial was carried out in 44 cancer patients receiving chemotherapy with cis-platinum to compare the anti-emetic effectiveness and tolerance of alizapride and domperidone given in high dosage. Patients received 5 administrations of either 4 mg alizapride/kg body weight or 0.6 mg domperidone/kg during a chemotherapy session and then the alternative anti-emetic during the next session. Treatment order was randomized. Patients were followed-up for 12 hours and details recorded of the total time during which there was some nausea, the duration of mild and severe nausea, and the number of episodes of mild and severe vomiting. A note was also made of the duration of mild and moderate sedation, and the incidence and severity of any other side-effects either probably or possibly related to anti-emetic medication. The investigator gave an overall assessment of the severity of nausea and vomiting experienced during each chemotherapy session and an opinion on the comparative effectiveness of the two anti-emetics. At the end of the two sessions, patients were asked to state a preference, if any, for one or other treatment and to select which they would like to have for their next chemotherapy session. The results showed that whilst both alizapride and domperidone appeared to be equally effective in limiting mild nausea, alizapride was significantly better in preventing severe nausea and episodes of vomiting. In those cases where a positive choice between treatments was made, alizapride was considered to be significantly better than domperidone by the investigator and more patients preferred alizapride and would select it for their next session.(ABSTRACT TRUNCATED AT 250 WORDS)
对44名接受顺铂化疗的癌症患者进行了一项双盲随机交叉试验,以比较高剂量阿立必利和多潘立酮的止吐效果及耐受性。在一个化疗疗程中,患者接受5次给药,每次剂量为阿立必利4mg/kg体重或多潘立酮0.6mg/kg,然后在下一个疗程中换用另一种止吐药。治疗顺序随机安排。对患者进行12小时随访,记录有恶心症状的总时长、轻度和重度恶心的持续时间以及轻度和重度呕吐的发作次数。还记录了轻度和中度镇静的持续时间以及任何可能或与止吐药物相关的其他副作用的发生率和严重程度。研究者对每个化疗疗程中经历的恶心和呕吐严重程度进行总体评估,并对两种止吐药的相对疗效发表意见。在两个疗程结束时,询问患者对一种或另一种治疗是否有偏好,并选择他们下一次化疗想要使用的药物。结果显示,虽然阿立必利和多潘立酮在减轻轻度恶心方面似乎同样有效,但阿立必利在预防严重恶心和呕吐发作方面明显更好。在那些对治疗做出明确选择的病例中,研究者认为阿立必利明显优于多潘立酮,更多患者更喜欢阿立必利,并会选择它用于下一次疗程。(摘要截选至250字)