头痛宁胶囊治疗紧张型头痛的临床有效性和安全性研究
摘要
目的观察头痛宁胶囊治疗发作期紧张型头痛(tension-type headache,TTH)的临床疗效及安全性,初步探讨其可能作用机制。方法将我院门诊115例处于发作期的紧张型头痛患者随机分为头痛宁组、氟桂利嗪组和两种药物的联合组,均治疗一个疗程。观察3组治疗前后症状改善情况及血常规,肝肾功能,血清电解质,血浆甲硫脑啡肽( methionine enkephalin,MEK)浓度的变化情况。结果头痛宁组总有效率84.62%,氟桂利嗪组总有效率54.29%,联合组总有效率87.80%,三组比较疗效有显著性差异﹙P<0.05﹚。头痛宁组优于氟桂利嗪组,有显著性差异﹙P<0.05﹚,联合组优于氟桂利嗪组,有显著性差异﹙P<0.05﹚。联合组总有效率高于头痛宁组,但两组比较无显著性差异﹙P>0.05﹚。在减少头痛发作次数上三组无显著性差异﹙P>0.05﹚。在减少头痛程度及持续时间上,头痛宁组优于氟桂利嗪组,有显著性差异﹙P<0.05﹚,联合组优于氟桂利嗪组有显著性差异﹙P<0.05﹚。治疗前后在伴随症状上,三组的心悸、失眠症状均有所改善(P<0.01),头痛宁组在改善心烦易怒、颈肌压痛的症状上也有显著性差异(P<0.01),氟桂利嗪组对头晕也有改善(P<0.01),联合组对上述伴随症状都有所改善(P<0.01)。治疗后三组间比较除了心悸的改善外其余症状体征评分均有不同(P<0.05);两组间症状分别比较,对于改善睡眠上,头痛宁组与氟桂利嗪组相比,无显著性差异(P>0.05);对于改善心烦易怒、颈肌压痛上,头痛宁组优于氟桂利嗪组,有显著性差异(P<0.05),对于改善头晕上,氟桂利嗪组优于头痛宁组,有显著性差异(P<0.05);对于改善头晕、失眠上,联合组优于头痛宁组,有显著性差异(P<0.05);在改善心烦易怒、颈肌压痛上,联合组优于氟桂利嗪组,有显著性差异(P<0.05)。头痛宁组与联合组在降低血清K~+浓度、血浆MEK浓度、升高Mg~(2+)浓度上优于氟桂利嗪组,有显著性差异(P<0.01)。头痛宁组未出现严重不良反应,治疗前后血常规、肝肾功能无显著性差异(P>0.05)。结论头痛宁胶囊对发作期紧张型头痛治疗安全有效,降低血清中K~+浓度,升高Mg~(2+)浓度及降低血浆MEK浓度可能是其作用机制之一;头痛宁联合氟桂利嗪治疗紧张型头痛疗效较好,但应注意不良反应的发生。
Object To observe the therapeutic effect and safety of Toutongning collocystis on the patients suffering from tension-type headache and explore the mechanism. Methods 115 patients with tension-type headache were randomly divided into the Toutongning group、Flunarizine group and common group.Three groups were treated for 28 days and then being compared with their Symptoms,physical signs andblood rout、Liver function、renal function、blood serum electrolytes、plasma MEK before and after treatment. Results The statistic analysis revealed that Toutongning collocystis is safe and effective to cure tension-type headache. The total effective rate is 97.44%;while the Flunarizine group is 62.86% and the common group is 97.56%. There was quite significant difference﹙P<0.05﹚.There was quite significant difference between the Toutongning group、Flunarizine group﹙P<0.05﹚.There was significant difference between the Flunarizine group and common group﹙P<0.05﹚.There was not significant difference between the Toutongning group and common group﹙P>0.05﹚. In the simultaneous phenomenon before and after treatment,the three groups were improved in cardiopalmus and anhypni(aP<0.01).While,the Toutongning group also can improve upset and cervical muscle tenderness(P<0.01). The Flunarizine group can improve dizziness.All accompanied signs and symptoms improved in the common group(P<0.01).Comparison the three groups after treatment,in addition to improved cardiopalmus,another simultaneous phenomenon are significant difference(P<0.05).Comparison between the groups,for improving agrypnia was not significant difference(P>0.05﹚between the Toutongning group and the Flunarizine group.For improving upset、cervical muscle tenderness and dizziness were significant difference between them(P<0.05).For improving dizziness and anhypnia were significant differenc(eP>0.05﹚between the Toutongning group and the common group .For improving upset and cervical muscle tenderness were significant difference (P<0.05)between the Flunarizine group and common group.The Toutongning group can decreased blood K~+ and plasma MEK and advanced blood Mg~(2+)(P<0.05).While,the Flunarizine group was not significant difference(P>0.05).The Toutongning group had not significant difference for blood routine、liver and renal function、urine routine(.P>0.05) Conclusion The toutongning collocystis could evidently reduce the headache by appeasing upset and agrypnia ,eliminating the cervical muscle tenderness and cardiopalmus and decreased blood K~+ and plasma MEK and advanced blood Mg~(2+).Decresed blood K~+ and plasma MEK and advanced blood Mg~(2+) may be the mechanism.
Object To observe the therapeutic effect and safety of Toutongning collocystis on the patients suffering from tension-type headache and explore the mechanism. Methods 115 patients with tension-type headache were randomly divided into the Toutongning group、Flunarizine group and common group.Three groups were treated for 28 days and then being compared with their Symptoms,physical signs andblood rout、Liver function、renal function、blood serum electrolytes、plasma MEK before and after treatment. Results The statistic analysis revealed that Toutongning collocystis is safe and effective to cure tension-type headache. The total effective rate is 97.44%;while the Flunarizine group is 62.86% and the common group is 97.56%. There was quite significant difference﹙P<0.05﹚.There was quite significant difference between the Toutongning group、Flunarizine group﹙P<0.05﹚.There was significant difference between the Flunarizine group and common group﹙P<0.05﹚.There was not significant difference between the Toutongning group and common group﹙P>0.05﹚. In the simultaneous phenomenon before and after treatment,the three groups were improved in cardiopalmus and anhypni(aP<0.01).While,the Toutongning group also can improve upset and cervical muscle tenderness(P<0.01). The Flunarizine group can improve dizziness.All accompanied signs and symptoms improved in the common group(P<0.01).Comparison the three groups after treatment,in addition to improved cardiopalmus,another simultaneous phenomenon are significant difference(P<0.05).Comparison between the groups,for improving agrypnia was not significant difference(P>0.05﹚between the Toutongning group and the Flunarizine group.For improving upset、cervical muscle tenderness and dizziness were significant difference between them(P<0.05).For improving dizziness and anhypnia were significant differenc(eP>0.05﹚between the Toutongning group and the common group .For improving upset and cervical muscle tenderness were significant difference (P<0.05)between the Flunarizine group and common group.The Toutongning group can decreased blood K~+ and plasma MEK and advanced blood Mg~(2+)(P<0.05).While,the Flunarizine group was not significant difference(P>0.05).The Toutongning group had not significant difference for blood routine、liver and renal function、urine routine(.P>0.05) Conclusion The toutongning collocystis could evidently reduce the headache by appeasing upset and agrypnia ,eliminating the cervical muscle tenderness and cardiopalmus and decreased blood K~+ and plasma MEK and advanced blood Mg~(2+).Decresed blood K~+ and plasma MEK and advanced blood Mg~(2+) may be the mechanism.
引文
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