摘要:
目的 评价中药复方制剂麻芎舒痛方治疗偏头痛的安全性和有效性及颅脑MRI评价脑白质病变 (WML) 的价值.方法 共纳入122例偏头痛患者随机分为对照组和观察组各61例, 对照组采用西药盐酸氟桂利嗪胶囊治疗, 10 mg/次, 每晚服用1次;观察组口服麻芎舒痛方中药复方制剂, 3粒/d, 1次/d;均连续服用4周;比较2组偏头痛证候积分、总有效率和不良反应发生率, 血清5-羟色胺 (5-HT) 、NF-κB和IL-6、TNF-α水平, 采用颅脑MRI评价WML发生及严重程度.结果 治疗后观察组的偏头痛证候积分明显低于对照组, 总有效率明显高于对照组, 差异有统计学意义 (P<0.05) , 2组均未出现严重并发症.观察组血清5-HT、NF-κB和IL-6、TNF-α水平明显低于对照组, WML总阳性率明显低于对照组, 差异有统计学意义 (P<0.05) .结论 麻芎舒痛方治疗偏头痛有较好的安全性和有效性, 可降低血清5-HT、NF-κB和IL-6、TNF-α水平, 改善脑白质病变.
Abstract:
Objective To study the safety and effectiveness of Ma Xiong Shu Tong Fang for migraine and evaluate the white matter lesions (WML) by brain MRI.Methods A total of 122 consecutives were randomly divided into control and observation groups and each group had 61 cases.The patients in control group received Flunarizine Hydrochloride Capsules 10 mg/d, and the patients in observation group adopted Ma Xiong Shu Tong Fang three particles per day, and the course was four weeks. Then we compared TCM syndrome integrals, total effective rate and incidence of adverse reactions, serum 5-HT, NF-κB, IL-6 and TNF-αlevels, positive rate and degrees of WML by MRI. Results The TCM syndrome integrals after treatment in observation group was significantly lower than control group (P <0.05) . There were no severe complications in the two groups. The serum 5-HT, NF-κB, IL-6 and TNF-αlevels in observation group were all lower, positive rate of WML was also lower (P<0.05) . Conclusion Ma Xiong Shu Tong Fang is safe and effective for mgraine, it can reduce serum levels of 5-HT, NF-κB, IL-6 and TNF-αand improve WML.
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