D'Onofrio V, Miletto P, Leandro G, Iaquinto G
Gastroenterology and Digestive Endoscopy Service, I Nuclear Medicine Service, San G. Moscati Hospital, Avellino, Italy.
Dig Liver Dis. 2002 Feb;34(2):105-10. doi: 10.1016/s1590-8658(02)80238-9.
To evaluate long-term efficacy of intrasphincteric injection of botulinum toxin in untreated achalasia patients; to analyse whether age can be a predictor of response; and to verify whether any objective measurements correlate with symptom relief
A total of 37 patients (mean age 61.4+/-17.5 years) were enrolled, all of whom injected endoscopically with 100 U of botulinum toxin. Symptom score, oesophageal manometry and oesophageal radionuclide emptying were assessed prior to treatment and 4 weeks, 3 months and 1 year after botulinum toxin. In the case of failure or relapse (symptom score >2), treatment was repeated.
All but 6 patients (83.7%) were in clinical remission one month after botulinum toxin. At 12 months, mean symptom score was 0.9+/-0.5 (p<0.05 vs basal); mean lower oesophageal sphincter pressure was 22.0+/-6.3 (p<0.05 vs basal), and 10-min radionuclide retention was 14.0%+/-7.2 (p<0.05 vs basal). Of the 35 patients followed, 12 (34.3%) had a relapse and were re-treated; 4 out of 12 did not respond after re-treatment. Efficacy of first injection of botulinum toxin lasted for a mean period of 15.6 months (range 2-30). Up to day 31 (83.7%) patients were still in remission. We observed a trend towards a better response to botulinum toxin treatment in patients over 50 years (p=0.053). Moreover no correlation was found between any objective achalasia measurements and symptom relief (r coefficient between 0.1 and 0.5)
Results show that: 1) one or two intrasphincteric injections of botulinum toxin result in clinical and objective improvement in about 84% of achalasia patients and are not associated with serious side-effects; 2) patients over 50 years showed better benefit than younger patients; 3) no correlation was found between any objective measurements and symptom relief.
评估肉毒杆菌毒素括约肌内注射对未经治疗的贲门失弛缓症患者的长期疗效；分析年龄是否可作为反应的预测指标；并验证任何客观测量指标是否与症状缓解相关。
共纳入37例患者（平均年龄61.4±17.5岁），所有患者均在内镜下注射100 U肉毒杆菌毒素。在治疗前以及肉毒杆菌毒素注射后4周、3个月和1年评估症状评分、食管测压和食管放射性核素排空情况。若治疗失败或复发（症状评分>2），则重复治疗。
除6例患者外（83.7%），所有患者在肉毒杆菌毒素注射后1个月达到临床缓解。在12个月时，平均症状评分为0.9±0.5（与基线相比，p<0.05）；平均食管下括约肌压力为22.0±6.3（与基线相比，p<0.05），10分钟放射性核素潴留率为14.0%±7.2（与基线相比，p<0.05）。在随访的35例患者中，12例（34.3%）复发并接受了再次治疗；12例中有4例再次治疗后无反应。首次注射肉毒杆菌毒素的疗效平均持续15.6个月（范围2 - 30个月）。直至第31天，83.7%的患者仍处于缓解状态。我们观察到50岁以上患者对肉毒杆菌毒素治疗反应更好的趋势（p = 0.053）。此外，在任何贲门失弛缓症的客观测量指标与症状缓解之间未发现相关性（r系数在0.1至0.5之间）。
结果表明：1）一或两次括约肌内注射肉毒杆菌毒素可使约84%的贲门失弛缓症患者在临床和客观方面得到改善，且无严重副作用；2）50岁以上患者比年轻患者获益更多；3）任何客观测量指标与症状缓解之间均无相关性。
