A型肉毒毒素治疗慢性每日头痛的疗效与安全性

Safety and efficacy of botulinum toxin type a in the treatment of chronic daily headache

目的 观察A型肉毒毒素治疗慢性每日头痛的疗效与安全性.方法 治疗组给予A型肉毒毒素50 U,对照组给矛利多卡因加泼尼松龙5 ml.2组均用固定位点注射,分别于0、30、60、90 d观察头痛发作时间、头痛程度、生活质量及不良反应.结果 （1）治疗后30、60、90 d时,每月头痛发作天数在肉毒毒素治疗组为（14.0 ±7.8）d、（13.0±6.8）d和（13.0±6.4）d,对照组为（19.0±6.1）d、（21.0±6.1）d和（21.0±5.8）d,组间差异有统计学意义（Z=2.895、4.544、4.878,P＜0.01）.（2）治疗后30 d肉毒毒素治疗组VAS评分为（3.6±1.5）分,对照组为（3.8±1.3）分,差异无统计学意义（Z=1.254,P=0.210） 而60、90 d时肉毒毒素治疗组为（3.2±1.5）分和（3.1±1.6）分,对照组为（4.7±1.3）分和（5.0±1.5）分,差异有统计学意义（Z=4.950、5.096,均P=0.000）.（3）2组生活质量均稍有改善.（4）肉毒毒素治疗组治疗慢性偏头痛效果好,未服预防性药物者效果较好.（5）各组不良反应均较轻.结论 A型肉毒毒素治疗慢性每日头痛有效、安全.

Objective To test the safety and efficacy of using Botulinum Toxin Type A（BTX-A）in the treatment of chronic daily headache（CDH）. Methods Thirty-eight patients in the treatment group injected BTX-A 50 U at 10 positions at the muscles including frontalis, temporalis, splenius capitis and occipitalis. Forty-four patients in the control group were given 2% lidocaine 3 ml plus prednisolone acetate 75 mg（2 ml）at the same muscles sites as in the treatment group. Frequency of headache, headache intensity（evaluated by visual analogue scale, VAS）, quality of life（by WHO Qol-8 questionnaire）and adverse reactions were assessed on 0, 30, 60, 90 days after the treatment. Results At follow-up of 30,60, 90 days, the number of headache days per month reduced in both groups. BTX-A group had 14. 0 ±7.8, 13. 0 ±6. 8 and 13.0 ±6. 4 days per month, while the control group had 19. 0 ±6. 1, 21.0 ±6. 1 and 21.0 ±5.8, days at the follow-up of 30, 60 and 90 days, respectively, showing significant difference in the two groups（Z = 2. 895, 4. 544 and 4. 878, all P 〈 0. 01）. At 30 days, VAS scores in the treatment and control groups were 3.6 ± 1.5 and 3. 8 ± 1.3 respectively, showing no significant difference（Z = 1. 254,P =0. 210） At 60 days and 90 days, VAS scores in the BTX-A group were 3.2 ± 1.5 and 3. 1 ± 1.6 respectively, and in the control group were 4. 7 ± 1.3 and 5.0 ± 1.5 respectively, showing significant difference（Z =4. 950 and 5. 096, both P =0. 000）. Quality of life in the two groups was slightly improved.After the treatment, 1 case（2. 6%）in BTX-A group occurred brow ptosis. The other patients didn＇t report any treatment related adverse events. Conclusion BTX-A is an effective and relative safe treatment in patients with CDH.