A multicentre randomised study of intrasphincteric botulinum toxin in patients with oesophageal achalasia

被引:151
作者
Annese, V
Bassotti, G
Coccia, G
Dinelli, M
D'Onofrio, V
Gatto, G
Leandro, G
Repici, A
Testoni, PA
Andriulli, A
机构
[1] Osped CSS IRCCS, Div Gastroenterol, I-71013 San Giovanni Rotondo, Fg, Italy
[2] Univ Perugia, Dipartimento Med Clin & Sperimentale, Sez Gastroenterol & Epatol, Lab Motilita Intestinale, I-06100 Perugia, Italy
[3] Osped Galliera, Div Gastroenterol, Genoa, Italy
[4] Osped S Raffaele, Serv Endoscopia Digest, Milan, Italy
[5] Osped Avellino, Div Gastroenterol, Avellino, Italy
[6] Osped Cervello, Serv Gastroenterol, Palermo, Italy
[7] Osped IRCCS De Bellis, Div Med, Castellana, Grotte, Italy
[8] Univ Turin, Dipartimento Gastroenterol, I-10124 Turin, Italy
[9] Policlin S Marco, Reparto Gastroenterol, Zingonia, Italy
关键词
achalasia; botulinum toxin; oesophagus; dose ranging study;
D O I
10.1136/gut.46.5.597
中图分类号
R57 [消化系及腹部疾病];
学科分类号
摘要
Background-Intrasphincteric injection of botulinum toxin (Botx) has been proposed as treatment for oesophageal achalasia. However, the predictors of response and optimal dose remain unclear. Aims-To compare the effect of different doses of Botx and to identify predictors of response. Patients/methods-A total of 118 achalasic patients were randomised to receive one of three doses of Botx in a single injection: 50 U (n=40), 100 U (n=38), and 200 U (n=40). Of those who received 100 U, responsive patients were reinjected with an identical dose after 30 days. Clinical and manometric assessments were performed at baseline, 30 days after the initial injection of botulinum toxin, and at the end of follow up (mean 12 months; range 7-24 months). Results-Thirty days after the initial injection, 82% of patients were considered responders without a clear dose related effect. At the end of follow up however, relapse of symptoms was evident in 19% of patients who received two injections of 100 U compared with 47% and 43% in the 50 U and 200 U groups, respectively. Using Kaplan-Meier analysis, patients in the 100x2 U group were more likely to remain in remission at any time (p<0.04), with 68% (95% CI 59-83) still in remission at 24 months. In a multiple adjusted model, response to Botx was independently predicted by the occurrence of vigorous achalasia (odds ratio 3.3) and the 100x2 U regimen (odds ratio 3.2). Conclusions-Two injections of 100 U of Botx 30 days apart appeared to be the most effective therapeutic schedule. The presence of vigorous achalasia was the principal determinant of the response to Botx.
引用
收藏
页码:597 / 600
页数:4
相关论文
共 21 条
[1]   Controlled trial of botulinum toxin injection versus placebo and pneumatic dilation in achalasia [J].
Annese, V ;
Basciani, M ;
Perri, F ;
Lombardi, G ;
Frusciante, V ;
Simone, P ;
Andriulli, A ;
Vantrappen, G .
GASTROENTEROLOGY, 1996, 111 (06) :1418-1424
[2]   Perendoscopic injection of botulinum toxin is effective in achalasia after failure of myotomy or pneumatic dilation [J].
Annese, V ;
Basciani, M ;
Lombardi, G ;
Caruso, N ;
Perri, F ;
Simone, P ;
Andriulli, A .
GASTROINTESTINAL ENDOSCOPY, 1996, 44 (04) :461-465
[3]  
Annese V, 1998, MUSCLE NERVE, V21, P1540, DOI 10.1002/(SICI)1097-4598(199811)21:11<1540::AID-MUS27>3.3.CO
[4]  
2-T
[5]   Esophageal dysfunction in scleroderma - Relationship with disease subsets [J].
Bassotti, G ;
Battaglia, E ;
Debernardi, V ;
Germani, U ;
Quiriconi, F ;
Dughera, L ;
Buonafede, G ;
Puiatti, P ;
Morelli, A ;
Spinozzi, F ;
Mioli, PR ;
Emanuelli, G .
ARTHRITIS AND RHEUMATISM, 1997, 40 (12) :2252-2259
[6]  
BRIN ME, 1997, MUSCLE NERVE S7, V7, pS146
[7]   Botulinum toxin for achalasia: To be or not to be? [J].
Castell, DO ;
Katzka, DA .
GASTROENTEROLOGY, 1996, 110 (05) :1650-1652
[8]   TREATMENT OF ACHALASIA - FROM WHALEBONE TO BOTULINUM TOXIN [J].
COHEN, S ;
PARKMAN, HP .
NEW ENGLAND JOURNAL OF MEDICINE, 1995, 332 (12) :815-816
[9]   Achalasia: Outcome of patients treated with intrasphincteric injection of botulinum toxin [J].
Cuilliere, C ;
Ducrotte, P ;
Zerbib, F ;
Metman, EH ;
deLooze, D ;
Guillemot, F ;
Hudziak, H ;
Lamouliatte, H ;
Grimaud, JC ;
Ropert, A ;
Dapoigny, M ;
Bost, R ;
Lemann, M ;
Bigard, MA ;
Denis, P ;
Auget, JL ;
Galmiche, JP ;
desVarannes, SB .
GUT, 1997, 41 (01) :87-92
[10]  
Fishman VM, 1996, AM J GASTROENTEROL, V91, P1724