Pradalier A, Serratrice G, Collard M, Hirsch E, Feve J, Masson M, Masson C, Dry J, Koulikovsky G, Nguyen G
Hôpital Rothschild, Paris, France.
Cephalalgia. 1989 Dec;9(4):247-53. doi: 10.1046/j.1468-2982.1989.0904247.x.
The efficacy and safety of long-acting propranolol (LA.P), 160 mg once-daily, in the prophylactic treatment of migraine have been tested against placebo in a multicentric, double-blind, randomized study. The two groups are compared in a parallel manner over a treatment period of 12 weeks, following a 4-week placebo run-in period. Fifty-five of the 74 patients who entered the trial were included at the end of the run-in period. Forty-one patients completed the study. None of the 14 patients who withdrew from the study did so because of side effects. The statistical analysis was done according to the "intention to treat" principle. LA.P was significantly more effective than placebo in reducing the frequency of migraine attacks (p = 0.01 by variance analysis). LA.P reduced the average number of monthly crises by 48% on day 84. There was a slight but significant reduction of the systolic blood pressure and heart rate in the erect position, but there was no significant difference between LA.P and placebo regarding either the number of complaints or the number of side effects elicited out of a 17-item questionnaire. None of the observed side effects led to a withdrawal from treatment.
在一项多中心、双盲、随机研究中，对每日一次服用160毫克长效普萘洛尔（LA.P）预防性治疗偏头痛的疗效和安全性与安慰剂进行了对比测试。在为期4周的安慰剂导入期后，两组在12周的治疗期内以平行方式进行比较。进入试验的74名患者中有55名在导入期结束时被纳入研究。41名患者完成了研究。退出研究的14名患者中，无一例是因为副作用而退出。统计分析按照“意向性治疗”原则进行。在减少偏头痛发作频率方面，LA.P比安慰剂显著更有效（方差分析p = 0.01）。在第84天，LA.P使每月发作的平均次数减少了48%。直立位时收缩压和心率有轻微但显著的降低，但在一份包含17个项目的问卷中，LA.P和安慰剂在引发的不适数量或副作用数量方面没有显著差异。观察到的副作用均未导致患者退出治疗。
