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补阳还五汤加减联合盐酸氟桂利嗪治疗卵圆孔未闭相关偏头痛临床研究

Clinical Study on Modified Buyang Huanwu Decoction Combined with Flunarizine Hydrochloride in the Treatment of Patent Foramen Ovale-Related Migraine
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摘要 目的:观察补阳还五汤加减联合盐酸氟桂利嗪治疗卵圆孔未闭(PFO)相关偏头痛的临床疗效。方法:选取2023年12月—2025年3月广州中医药大学第七临床医学院脑病科诊治的PFO相关偏头痛患者共70例,根据随机数字表法分为观察组和对照组各35例。研究过程中,观察组脱落1例,对照组脱落4例。最终共65例完成试验,其中观察组纳入34例,对照组纳入31例。对照组给予盐酸氟桂利嗪胶囊治疗,观察组给予补阳还五汤加减联合盐酸氟桂利嗪胶囊治疗。连续治疗1个月,比较2组临床疗效和安全性,以及治疗前后偏头痛发作频次、疼痛视觉模拟评分法(VAS)评分、中医证候评分及头痛影响测评量表-6(HIT-6)评分、血液流变学指标水平。结果:治疗后,观察组总有效率为91.18%(31/34),对照组为58.06%(18/31),2组比较,差异有统计学意义(P<0.05)。治疗后,2组头痛发作频次均较治疗前下降(P<0.05);且观察组头痛发作频次少于对照组,降幅差值亦大于对照组,差异均有统计学意义(P<0.05)。治疗后,2组头VAS评分均较治疗前下降(P<0.05);且观察组VAS评分低于对照组,降幅差值亦大于对照组,差异均有统计学意义(P<0.05)。治疗后,2组中医证候评分均较治疗前下降(P<0.05);且观察组中医证候评分低于对照组,降幅差值亦大于对照组,差异均有统计学意义(P<0.05)。治疗后,2组HIT-6评分均较治疗前下降(P<0.05);且观察组HIT-6评分低于对照组,降幅差值亦大于对照组,差异均有统计学意义(P<0.05)。治疗后,观察组全血黏度(高切、低切)、血浆黏度及纤维蛋白原浓度均较治疗前下降(P<0.05);且4项指标水平低于对照组,各项指标降幅差值大于对照组,差异均有统计学意义(P<0.05)。治疗期间,2组患者均未发生严重不良反应。结论:补阳还五汤加减联合盐酸氟桂利嗪治疗PFO相关偏头痛疗效较好,可有效减少患者偏头痛发作频次及减轻疼痛程度,提高患者生活质量,改善气虚血瘀证证候及血液流变学状态。 Objective:To observe the clinical efficacy of modified Buyang Huanwu Decoction combined with Flunarizine Hydrochloride in the treatment of patent foramen ovale(PFO)-related migraine.Methods:A total of 70 patients with PFO-related migraine diagnosed and treated in the Department of Encephalopathy,the Seventh School of Clinical Medicine,Guangzhou University of Chinese Medicine from December 2023 to March 2025 were selected and divided into the observation group and the control group using the random number table method,with 35 cases in each group.During the study,one case in the observation group and four cases in the control group dropped out.Finally,65 patients completed the trial,including 34 in the observation group and 31 in the control group.The control group was treated with Flunarizine Hydrochloride Capsules,while the observation group was treated with modified Buyang Huanwu Decoction combined with Flunarizine Hydrochloride Capsules.After one month of continuous treatment,the clinical efficacy and safety were compared,and the changes in migraine attack frequency,Visual Analogue Scale(VAS)scores of pain,traditional Chinese medicine syndrome scores,Headache Impact Test-6(HIT-6)scores,hemorheological indicators were respectively compared between the two groups before and after treatment.Results:After treatment,the total effective rate was 91.18%(31/34)in the observation group and 58.06%(18/31)in the control group,with significant difference between the two groups(P<0.05).After treatment,the migraine attack frequency decreased in both groups compared to before treatment(P<0.05);the observation group showed a lower attack frequency and a greater reduction than the control group(P<0.05).After treatment,the VAS scores decreased in both groups compared to before treatment(P<0.05);the observation group showed lower VAS scores and a greater reduction than the control group(P<0.05).After treatment,the traditional Chinese medicine syndrome scores decreased in both groups compared to before treatment(P<0.05);the observation group showed lower scores and a greater reduction than the control group(P<0.05).After treatment,the HIT-6 scores decreased in both groups compared to before treatment(P<0.05);the observation group showed lower HIT-6 scores and a greater reduction than the control group(P<0.05).After treatment,the whole blood viscosity(at high-shear rate and low-shear rate),plasma viscosity,and fibrinogen concentration decreased in the observation group compared to before treatment(P<0.05);and the observation group had lower levels of these four indicators and a greater reduction in each indicator than the control group(P<0.05).No serious adverse reactions occurred in either group during the treatment.Conclusion:Modified Buyang Huanwu Decoction combined with Flunarizine Hydrochloride is effective in the treatment of PFO-related migraine.It can reduce the frequency and intensity of migraine attacks,improve the quality of life,alleviate the traditional Chinese medicine syndromes of qi deficiency and blood stasis,and improve the hemorheological status.
作者 简书洋 简雪珊 黄汝成 金远林 孔杰 JIAN Shuyang;JIAN Xueshan;HUANG Rucheng;JIN Yuanlin;KONG Jie(The Seventh School of Clinical Medicine,Guangzhou University of Chinese Medicine,Shenzhen Guangdong 518000,China;Shenzhen Bao'an Traditional Chinese Medicine Hospital,Shenzhen Guangdong 518000,China)
出处 《新中医》 2025年第24期23-28,共6页 New Chinese Medicine
基金 广东省名中医传承工作室建设项目(粤中医办函[2018]150号)。
关键词 偏头痛 卵圆孔未闭 补阳还五汤 盐酸氟桂利嗪胶囊 发作频次 Migraine Patent foramen ovale Buyang Huanwu Decoction Flunarizine Hydrochloride Capsules Attack frequency
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