Dose titration to reduce dipyridamole-related headache
Dose titration to reduce dipyridamole-related headache
复制标题
DOI：
10.1159/000094013
复制
发表时间：
2006-01-01
影响因子：
2.9
通讯作者：
Lee, Tsong-Hai
中科院分区：
文献类型：
--
作者：
Chang, Yeu-Jhy;Ryu, Shan-Jin;Lee, Tsong-Hai
背景：与单用阿司匹林相比，低剂量阿司匹林与缓释双嘧达莫 (ASA+MR-DP) 的组合在预防卒中方面的益处显着增加。然而，与接受安慰剂的患者相比，接受含双嘧达莫药物的患者出现头痛的情况较多。我们进行了一项随机、双盲、安慰剂对照试验来评估 ASA+MR-DP 哪种给药方案具有更好的耐受性。方法：该试验将 146 名有缺血性脑血管病史的患者随机分为三组：安慰剂组（第 1-28 天）、减少剂量组（第 1-4 天服用安慰剂，第 5-14 天睡前每日一次 ASA+MR-DP，第 15-28 天每日两次）和常规剂量（第 1-4 天服用安慰剂，第 7 天每天两次 ASA+MR-DP）。 5-28）。使用中国日记卡，将头痛评估为研究期间的平均累积头痛（西格玛频率 x 强度/发生天数 x 研究天数），并根据癌症治疗评估计划，通用毒性标准，2.0 版分级为 0 - 4 级。结果：随机分组后意向治疗的患者为安慰剂组 46 名、减少剂量组 45 名、常规剂量组 49 名。在常见报告的不良反应中，与其他两组相比，常规剂量组中任何级别的头痛发生率显着增加（38.8%）（p < 0.05）。第 5-14 天期间，常规剂量组的平均累积头痛高于减量组 (p < 0.05)。在 27 名退出的患者中，有 15 名（55.6%）因头痛而退出，在常规剂量中退出的人数要多得多（8 名，53.3%），但差异在统计学上不显着。结论：与常规剂量相比，首次减少 ASA+MR-DP 剂量治疗可能会减少头痛，并且那些易受磷酸二酯酶抑制剂诱发头痛的患者的耐受性似乎更好。版权所有 (c) 2006 S. Karger AG，巴塞尔。
Background: Combination of low-dose aspirin and modified-release dipyridamole (ASA+MR-DP) provides a significantly increased benefit in stroke prevention over aspirin alone. However, headaches were reported in more patients receiving dipyridamole-containing agents than in those receiving placebo. We undertook a randomized, double-blind, placebo-controlled trial to evaluate which dosing regimens of ASA+MR-DP have better tolerance. Methods: This trial randomized 146 patients with a history of ischemic cerebrovascular disease into three groups: placebo (days 1-28), reduced dose (placebo on days 1-4, ASA+MR-DP once daily before bed during days 5-14, and b.i.d. on days 15-28), and regular dose (placebo on days 1-4, and ASA+MR-DP b.i.d. on days 5-28). Using Chinese diary card, headache was assessed as mean cumulated headache (Sigma frequency x intensity/occurrence days x study days) over the study period, and was graded 0 - 4 according to Cancer Therapy Evaluation Program, Common Toxicity Criteria, Version 2.0. Results: Intent-to-treat patients after randomization was 46 in placebo group, 45, reduced dose, and 49, regular dose. Among commonly reported adverse effects, headache of any grade occurred significantly more in the regular dose group (38.8%), as compared to the other two groups (p < 0.05). Mean cumulated headache was higher (p < 0.05) in the regular dose group than in the reduced group during days 5-14. Of 27 patients who dropped out, 15 (55.6%) were due to headache, which was substantially more in regular dose (8, 53.3%), though the difference was statistically insignificant. Conclusions: Initial reduced dose treatment with ASA+MR-DP may cause fewer headaches than regular dosing, and seems better tolerated by those susceptible to phosphodiesterase inhibitor-induced headache. Copyright (c) 2006 S. Karger AG, Basel.