川芎油软胶囊治疗偏头痛（血瘀证）的临床观察
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摘要
目的：以安慰剂为对照,进一步评价川芎油软胶囊治疗偏头痛(血瘀证)的有效性与安全性。
方法：80例偏头痛患者随机分为治疗组和对照组。治疗组给予川芎油软胶囊,每次2粒,每天2次。对照组给予安慰剂每次2粒,每天2次,疗程各12周。观察川芎油软胶囊的疗效,并对其临床安全性作初步观察。
结果：用药后治疗组和对照组月平均头痛发作次数与月平均发作日数比较差异有显著性(P<0.05),中医证候改善治疗组明显优于对照组(P<0.05)。治疗组总有效率为78.69%,对照组总有效率为47.37%,两组比较差异有显著性(P<0.05),提示治疗组疗效优于对照组。安全性检测,观察患者血尿便常规、心电图、肝肾功能及不良反应,显示该药无任何毒副作用,使用安全。
结论：川芎油软胶囊通过提高患者的痛阈值,拮抗钙离子,降低外周血ET、5-HT的含量,降低血浆粘度,抑制血小板聚集,改善局部血液循环等多种途径来有效地控制偏头痛发作,减少发作次数和缩短发作时间,临床治疗偏头痛安全有效。
Objective:As compared with placebo, further evaluation of Chuanxiong oil soft capsule in treating migraine (blood stasis) the effectiveness and safety.
Methods:80 patients with migraine were randomly divided into treatment group and the control group. Treatment group Chuanxiong oil soft capsule,2 each,2 times a day. Every time the control group given placebo 2,2 times a day. Course of the 12 weeks. Chuanxiong oil soft capsule to observe the efficacy and safety of a preliminary clinical observation.
Results:After the treatment group and control group on the average number of headache attacks and, on average, significantly reduced the number of days of attacks, but the treatment group compared with the control group were significantly different (P＜0.05), improvement of traditional Chinese medicine syndromes of the treatment group was significantly better than the control group (P＜0.05). The total effective rate was 78.69 percent, control group, the total effective rate was 47.37 percent, a significant difference between the two groups (P＜0.05). Efficacy of the treatment group than the control group. Safety testing, observation of patients with hematuria will be conventional, electrocardiogram, liver and kidney function and adverse reactions, indicating the drug without any side effects, the use of safe and effective and reliable.
Conclusion:Chuanxiong oil soft capsule in patients with pain by raising the threshold, calcium antagonists reduce ET,5-HT in peripheral blood levels, lower plasma viscosity, inhibiting platelet aggregation, improve blood circulation and other local means to effectively control the partial headache attack, attack to reduce the frequency and shorten the onset time, clinical safe and effective in treating migraine.
方法：80例偏头痛患者随机分为治疗组和对照组。治疗组给予川芎油软胶囊,每次2粒,每天2次。对照组给予安慰剂每次2粒,每天2次,疗程各12周。观察川芎油软胶囊的疗效,并对其临床安全性作初步观察。
结果：用药后治疗组和对照组月平均头痛发作次数与月平均发作日数比较差异有显著性(P<0.05),中医证候改善治疗组明显优于对照组(P<0.05)。治疗组总有效率为78.69%,对照组总有效率为47.37%,两组比较差异有显著性(P<0.05),提示治疗组疗效优于对照组。安全性检测,观察患者血尿便常规、心电图、肝肾功能及不良反应,显示该药无任何毒副作用,使用安全。
结论：川芎油软胶囊通过提高患者的痛阈值,拮抗钙离子,降低外周血ET、5-HT的含量,降低血浆粘度,抑制血小板聚集,改善局部血液循环等多种途径来有效地控制偏头痛发作,减少发作次数和缩短发作时间,临床治疗偏头痛安全有效。
Objective:As compared with placebo, further evaluation of Chuanxiong oil soft capsule in treating migraine (blood stasis) the effectiveness and safety.
Methods:80 patients with migraine were randomly divided into treatment group and the control group. Treatment group Chuanxiong oil soft capsule,2 each,2 times a day. Every time the control group given placebo 2,2 times a day. Course of the 12 weeks. Chuanxiong oil soft capsule to observe the efficacy and safety of a preliminary clinical observation.
Results:After the treatment group and control group on the average number of headache attacks and, on average, significantly reduced the number of days of attacks, but the treatment group compared with the control group were significantly different (P＜0.05), improvement of traditional Chinese medicine syndromes of the treatment group was significantly better than the control group (P＜0.05). The total effective rate was 78.69 percent, control group, the total effective rate was 47.37 percent, a significant difference between the two groups (P＜0.05). Efficacy of the treatment group than the control group. Safety testing, observation of patients with hematuria will be conventional, electrocardiogram, liver and kidney function and adverse reactions, indicating the drug without any side effects, the use of safe and effective and reliable.
Conclusion:Chuanxiong oil soft capsule in patients with pain by raising the threshold, calcium antagonists reduce ET,5-HT in peripheral blood levels, lower plasma viscosity, inhibiting platelet aggregation, improve blood circulation and other local means to effectively control the partial headache attack, attack to reduce the frequency and shorten the onset time, clinical safe and effective in treating migraine.
引文
(1)郭述苏.中国偏头痛流行病学调查(J).临床神经病学杂志,1994,4(2)：65-67
(2)Headache Classification Committee of the International Headache Society.Classification and diagnostic criteria for headache disorders, cranial neural-gias and facial pain (J). Cephalalgia,2004,24 (Suppl 1): 1.
(3)郑筱英,中药新药临床研究指导原则,北京：中国医药科技出版社，2002：105-10
(4)刘晓颖.偏头痛辨证施治之我见(J).中国中医急症,2007,16(2)：243-244
(5)Lipton RB, Stewart WF.Migraine in the United States:Epidemiology and health care use, Neurology,1993,43(Suppl3):6-10
(6)Stewart WF,Lipton RB,Liberman J.Variation in migraine prevalence by race.Neurology,1996,16:231-238
(7)郭述苏.中国偏头痛流行病学调查.临床神经病学杂志,1991,4(2)：6
(8)黄培新,刘茂才.神经科专病中医临床诊治(M).第二版.人民卫生出版社：北京,2005
(9)Lauritzen M. Pathophysiology of the migraine aura the spreading depression theory. Brain,1994,117:199-210.
(10)Welch KM, Cutrer FM, Goadsby PJ Migraine pathogenesis. Neural and vascular mechanisms. Neurology,2003,60(7, Suppl2):S9-S14.
(11)叶小菊.偏头痛发病机制的研究进展(J).国外医学神经病学神经外科学分册,2005,32(3)：280～283
(12)石玲燕,郑荣远.偏头痛的药物治疗进展(J).药物流行病学杂志，2005,14(4)：210-214
(13)杨明山.偏头痛的药物治疗进展(J).医药导报,2005,24(2)：90-93
(14)毕京峰,段俊国,刘曾敏.安慰剂对照在中药临床研究中的作用探讨(J).中药药理与临床,2007,23(4)：59-61
(15)连凤梅,殷海波.安慰剂对照临床研究的伦理学要求(J).中国医学伦理学,2008,21(6)：121～122
(16)魏洪超,李蕾,川芎的研究进展(J).黑龙江医药,2008,21(5)：101-102
(17)舒冰,周重建,马迎辉等.中药川芎中有效成分的药理作用研究进展(J).中国药理学通报,2006,22(9)：1043～1046
(1)张道厚,张妍华,郑兴刚.从肝论治偏头痛体会(J).云南中医中药杂志,2005,26(1)：53～54
(2)金熙哲.从络病论治偏头痛(J).中国中医基础医学杂志,2005.11(4)：307
(3)刘晓颖.偏头痛辨证施治之我见(J)中国中医急症,2007,16(2)：243～244
(4)孙爱云，浅述从风瘀论治偏头痛(J〕，吉林中医药,2007,27(1)：1～2
(5)邸玉鹏,王发渭，偏头痛痰瘀证的机制与治疗初探(J),中华中医药杂志，2007,22(2)：81～83
(6)秦应娟.辨证分型治疗偏头痛70例临床观察(J).吉林中医药,2004,24(5)：20-21.
(7)刘伟,李忠远,宋昌红.分型辨治偏头痛70例体会(J).吉林中医药,2004,24(2)：13.
(8)张海缨,史永奋,王丹华.四物汤化裁治疗偏头痛31例临床观察(J),中国临床医生,2004,32(10)：49-51
(9)主红娟,阮绍萍.杨秀清主任医师治疗偏头痛的辨治经验(J),陕西中医学院学报,2006,29(3)：17～18
(10)叶淑清.中医辨证治疗偏头痛临床体会(J),中国民间疗法,2007,15(6)：32-33
(11)全亚萍.天宁饮治疗偏头痛58例临床研究(J),江苏中医药,2004,25(9)：20-21
(12)张玲,朱雪珍.芎芷羌活汤治疗偏头痛58例(J),时珍国医国药,2005,16(7)： 647-648
(13)应乔麟.钩藤川芎汤治疗偏头痛88例(J),浙江中医杂志,2006,41(9)：514
(14)曾国洋.中医治疗偏头痛122例疗效观察(J),四川中医,2007,25(4)：64-65
(15)刘冬玲,白彩娥,徐军锋.新头痛宁方治疗偏头痛120例(J),陕西中医,2008,29(6)：668～669
(16)李功营,李小兵.祛风通络活血汤治疗偏头痛38例(J),新中医，2006,38(8)：72-73
(17)游建明.加味通窍活血汤治疗偏头痛65例临床观察(J),实用中医内科杂志，2006,20(3)：289～290
(18)程传浩,马云枝.通心络胶囊治疗偏头痛40例疗效观察(J〕,山东中医杂志，2007,26(5)：311-313
(19)师会,王磊：宁痛片治疗偏头痛93例临床疗效观察(J),天津中医药,2008,25(4)：281～282
(20)王爱风,王伟民,赵彦青.清脑熄风消痛颗粒治疗偏头痛36例(J),上海中医药杂志，2008，42(9)：20-22
(21)孙韶华,郑素英.中西医结合治疗偏头痛60例〔J),陕西中医,2004,25(6)：542～543
(22)陶世行,陈兴泉,张俊.中西医结合治疗偏头痛32例临床观察(J),江苏中医药,2005,26(1)：26
(23)王文红.中西药结合治疗偏头痛51例临床观察(J),中草药,2006.37(8)：1228～1230
(24)李崇高.养血清脑颗粒合氟桂利嗪治疗偏头痛45例(J),中西医结合心脑血管病杂志,2008,6(7)：787-789
(25)崔芮,王麟鹏,林威,等.贺氏三通法治疗偏头痛疗效观察(J)中国针灸,2004,24(1)：21～23
(26)古英,路瑜，透刺为主治疗偏头痛的临床观察(J),上海针灸杂志，2008,27(5)：24～25
(27)张敏尚,王秋景,王山.针刺治疗偏头痛30例疗效观察(J),四川中医，2005,23(1)：91～92
(28)吕明，刘晓艳.针灸结合推拿治疗偏头痛临床观察(J),辽宁中医杂志，2006,33(5)：604
(29)单秋华,韩晶,杨佃会.耳穴疗法治疗发作期与缓解期偏头痛的疗效观察(J),2007,26(11)：13～15
(30)耿立梅,成立,马丽.搐鼻散治疗偏头痛74例疗效观察(J),河北中医,2004,26(3)：176～177
(31)陈颖.割治法治疗偏头痛100例、临床观察(J),北京中医药大学学报,2005,12(2)：15-16
(32)张庆力，刺络疗法治疗偏头痛疗效观察(J),山东中医杂志,2007,26(3)：175-176
(33)田丽琼,殷耀兰.穴位埋线治疗偏头痛42例临床观察(J),中医药导报,2006,12(1)：53～54
(2)Headache Classification Committee of the International Headache Society.Classification and diagnostic criteria for headache disorders, cranial neural-gias and facial pain (J). Cephalalgia,2004,24 (Suppl 1): 1.
(3)郑筱英,中药新药临床研究指导原则,北京：中国医药科技出版社，2002：105-10
(4)刘晓颖.偏头痛辨证施治之我见(J).中国中医急症,2007,16(2)：243-244
(5)Lipton RB, Stewart WF.Migraine in the United States:Epidemiology and health care use, Neurology,1993,43(Suppl3):6-10
(6)Stewart WF,Lipton RB,Liberman J.Variation in migraine prevalence by race.Neurology,1996,16:231-238
(7)郭述苏.中国偏头痛流行病学调查.临床神经病学杂志,1991,4(2)：6
(8)黄培新,刘茂才.神经科专病中医临床诊治(M).第二版.人民卫生出版社：北京,2005
(9)Lauritzen M. Pathophysiology of the migraine aura the spreading depression theory. Brain,1994,117:199-210.
(10)Welch KM, Cutrer FM, Goadsby PJ Migraine pathogenesis. Neural and vascular mechanisms. Neurology,2003,60(7, Suppl2):S9-S14.
(11)叶小菊.偏头痛发病机制的研究进展(J).国外医学神经病学神经外科学分册,2005,32(3)：280～283
(12)石玲燕,郑荣远.偏头痛的药物治疗进展(J).药物流行病学杂志，2005,14(4)：210-214
(13)杨明山.偏头痛的药物治疗进展(J).医药导报,2005,24(2)：90-93
(14)毕京峰,段俊国,刘曾敏.安慰剂对照在中药临床研究中的作用探讨(J).中药药理与临床,2007,23(4)：59-61
(15)连凤梅,殷海波.安慰剂对照临床研究的伦理学要求(J).中国医学伦理学,2008,21(6)：121～122
(16)魏洪超,李蕾,川芎的研究进展(J).黑龙江医药,2008,21(5)：101-102
(17)舒冰,周重建,马迎辉等.中药川芎中有效成分的药理作用研究进展(J).中国药理学通报,2006,22(9)：1043～1046
(1)张道厚,张妍华,郑兴刚.从肝论治偏头痛体会(J).云南中医中药杂志,2005,26(1)：53～54
(2)金熙哲.从络病论治偏头痛(J).中国中医基础医学杂志,2005.11(4)：307
(3)刘晓颖.偏头痛辨证施治之我见(J)中国中医急症,2007,16(2)：243～244
(4)孙爱云，浅述从风瘀论治偏头痛(J〕，吉林中医药,2007,27(1)：1～2
(5)邸玉鹏,王发渭，偏头痛痰瘀证的机制与治疗初探(J),中华中医药杂志，2007,22(2)：81～83
(6)秦应娟.辨证分型治疗偏头痛70例临床观察(J).吉林中医药,2004,24(5)：20-21.
(7)刘伟,李忠远,宋昌红.分型辨治偏头痛70例体会(J).吉林中医药,2004,24(2)：13.
(8)张海缨,史永奋,王丹华.四物汤化裁治疗偏头痛31例临床观察(J),中国临床医生,2004,32(10)：49-51
(9)主红娟,阮绍萍.杨秀清主任医师治疗偏头痛的辨治经验(J),陕西中医学院学报,2006,29(3)：17～18
(10)叶淑清.中医辨证治疗偏头痛临床体会(J),中国民间疗法,2007,15(6)：32-33
(11)全亚萍.天宁饮治疗偏头痛58例临床研究(J),江苏中医药,2004,25(9)：20-21
(12)张玲,朱雪珍.芎芷羌活汤治疗偏头痛58例(J),时珍国医国药,2005,16(7)： 647-648
(13)应乔麟.钩藤川芎汤治疗偏头痛88例(J),浙江中医杂志,2006,41(9)：514
(14)曾国洋.中医治疗偏头痛122例疗效观察(J),四川中医,2007,25(4)：64-65
(15)刘冬玲,白彩娥,徐军锋.新头痛宁方治疗偏头痛120例(J),陕西中医,2008,29(6)：668～669
(16)李功营,李小兵.祛风通络活血汤治疗偏头痛38例(J),新中医，2006,38(8)：72-73
(17)游建明.加味通窍活血汤治疗偏头痛65例临床观察(J),实用中医内科杂志，2006,20(3)：289～290
(18)程传浩,马云枝.通心络胶囊治疗偏头痛40例疗效观察(J〕,山东中医杂志，2007,26(5)：311-313
(19)师会,王磊：宁痛片治疗偏头痛93例临床疗效观察(J),天津中医药,2008,25(4)：281～282
(20)王爱风,王伟民,赵彦青.清脑熄风消痛颗粒治疗偏头痛36例(J),上海中医药杂志，2008，42(9)：20-22
(21)孙韶华,郑素英.中西医结合治疗偏头痛60例〔J),陕西中医,2004,25(6)：542～543
(22)陶世行,陈兴泉,张俊.中西医结合治疗偏头痛32例临床观察(J),江苏中医药,2005,26(1)：26
(23)王文红.中西药结合治疗偏头痛51例临床观察(J),中草药,2006.37(8)：1228～1230
(24)李崇高.养血清脑颗粒合氟桂利嗪治疗偏头痛45例(J),中西医结合心脑血管病杂志,2008,6(7)：787-789
(25)崔芮,王麟鹏,林威,等.贺氏三通法治疗偏头痛疗效观察(J)中国针灸,2004,24(1)：21～23
(26)古英,路瑜，透刺为主治疗偏头痛的临床观察(J),上海针灸杂志，2008,27(5)：24～25
(27)张敏尚,王秋景,王山.针刺治疗偏头痛30例疗效观察(J),四川中医，2005,23(1)：91～92
(28)吕明，刘晓艳.针灸结合推拿治疗偏头痛临床观察(J),辽宁中医杂志，2006,33(5)：604
(29)单秋华,韩晶,杨佃会.耳穴疗法治疗发作期与缓解期偏头痛的疗效观察(J),2007,26(11)：13～15
(30)耿立梅,成立,马丽.搐鼻散治疗偏头痛74例疗效观察(J),河北中医,2004,26(3)：176～177
(31)陈颖.割治法治疗偏头痛100例、临床观察(J),北京中医药大学学报,2005,12(2)：15-16
(32)张庆力，刺络疗法治疗偏头痛疗效观察(J),山东中医杂志,2007,26(3)：175-176
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