A型肉毒毒素治疗慢性每日头痛的疗效与安全性

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.

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

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.