伴有卒中相关危险因素的头痛患者口服甲磺酸双氢麦角毒碱片的双盲对照研究

Double-blind controlled study of using oral mesylate dihydroergotamine tablets in headache sufferers with stroke-related risk factors

摘要:

目的：探讨甲磺酸双氢麦角毒碱片是否具有改善伴有卒中相关危险因素患者头痛病情的作用；观察患者健康相关生活质量（health-related quality of life，HRQoL）的变化。方法：将伴有卒中相关危险因素的头痛患者随机分为2组：试验组给予口服甲磺酸双氢麦角毒碱片（简称双氢麦角碱片）；对照组给予口服安慰剂。采用简要头痛日记记录头痛病情（头痛频率、头痛持续时间及疼痛程度及急性止痛药物的使用情况）。采用SF-36健康调查量表评估患者治疗期间HRQoL的变化，观察时间为4周。结果：共有77例患者完成试验，试验组53例，对照组24例。试验组和对照组患者HRQoL以及头痛病情均较给药前有不同程度改善，且试验组优于对照组。其中，心理综合得分、情感职能和躯体综合得分差异较大[效应量（effect size，ES）分别为：0.76∶0.56、0.56∶0.40、0.68∶0.57]，急性止痛药用量更少（ES 0.65∶0.43）。结论：双氢麦角碱片能明显改善伴有卒中相关危险因素的头痛患者HRQoL，减轻头痛病情，减少急性止痛药的使用。

Abstract:

Objective：To discuss whether dihydroergotamine can improve the condition of headache sufferers with stroke-related risk factors and to observe changes of health-related quality of life（HRQoL） in patients. Methods：The patients with headache were ran－domly divided into two groups. Experimental group received oral dihydroergotamine tablets while the control group received oral pla-cebo. The brief diary was used to record patient’s condition of headache（including headache frequency，headache duration and degree of pain and the use of acute pain medication）. Results：A total of 77 patients completed the study，53 patients in experimental group and 24 patients in control group. HRQoL and headache condition were improved to varying degrees among patients in both exper－imental group and control group，and the effect was much better in experiment group than in control group. The comprehensive mental score and the comprehensive emotional and physical score were quite different between two groups（effective size：0.76 vs. 0.56，0.56 vs. 0.40，0.68 vs. 0.57）. The dosage of analgesic was different between two groups（effective size：0.65 vs. 0.43）. Conclusion：Dihydroergotamine can improve the patient’s condition and HRQoL score of headache sufferers with stroke-related risk factors，using less acute analgesic.