Buscar en
Farmacia Hospitalaria (English Edition)
Toda la web
Inicio Farmacia Hospitalaria (English Edition) Efficacy and safety of topical diltiazem 2% in anal fissure
Journal Information
Vol. 33. Issue 2.
Pages 80-88 (January 2009)
Share
Share
Download PDF
More article options
Vol. 33. Issue 2.
Pages 80-88 (January 2009)
Full text access
Efficacy and safety of topical diltiazem 2% in anal fissure
Efectividad y seguridad de diltiazem 2% tópico en fisura anal
Visits
...
M.I. Fernández García??
Corresponding author
isabelfg_81@hotmail.com

Corresponding author.
, R. Albornoz López, I. Pérez Rodrigo, J. Abellón Ruiz
Servicio de Farmacia, Hospital Universitario Reina Sofía, Córdoba, Spain
Article information
Abstract
Bibliography
Download PDF
Statistics
Abstract
Objectives

To evaluate the effectiveness and safety of 2% diltiazem ointment in the treatment of anal fissure. To analyse the relationship between healing and diagnosis, and duration of the treatment, and the number of applications.

Methods

A prospective observational study of all patients diagnosed with anal fissure that began treatment with topical diltiazem between January and June in 2007. Diltiazem ointment was prepared in the Pharmacy Service. Effectiveness and safety were assessed by a telephone survey conducted with each patient after 8 weeks of treatment, adding it to the patient's clinical records. The variables that were analysed were healing, adverse effects, diagnosis, duration of treatment, and number of applications, among others. Follow-up was carried out for up to 1 year until complete healing of the fissure. The data analysis was carried out by descriptive statistics, crosstabs, and x2.

Results

A total of 70 patients were included in the study and anal fissure healed in 48.6% of them. Healing occurred in 54.5% of patients with anal fissure and in 33.3% of patients with anal fissure and haemorrhoids. Some adverse effects occurred in 30% of patients. Therapy was abandoned due to adverse reactions for 5.7%. The fissure was cured for 60% of patients who underwent treatment for a month or more. More than twice-daily applications did not lead to improved healing. There were no significant statistical differences in these results.

Conclusions

Despite not having found statistical differences between the analysed variables, treatment of anal fissures with 2% diltiazem ointment has avoided surgery in nearly 50% of patients, with few adverse effects.

Keywords:
Anal fissure
Haemorrhoids
Diltiazem
Effectiveness and drug safety
Observational study
Resumen
Objetivo

Evaluar la efectividad y la seguridad de la pomada de diltiazem al 2% en el tratamiento de la fisura anal. Analizar la relación entre la cicatrización de la fisura y diagnóstico, duración del tratamiento y número de aplicaciones.

Métodos

Estudio prospectivo observacional de todos los pacientes diagnosticados de fisura anal que comenzaron tratamiento con diltiazem tópico entre enero y junio de 2007. La pomada de diltiazem al 2% se preparó como fórmula magistral en el servicio de farmacia. La efectividad y la seguridad se evaluó mediante encuesta telefónica a cada paciente tras 8 semanas de tratamiento, completándose con la historia clínica del paciente. Las variables analizadas fueron cicatrización, efectos adversos, diagnóstico, duración del tratamiento y número de aplicaciones, entre otras. Se realizó seguimiento hasta resolución de la fisura hasta un período de 1 año. El análisis de los datos se realizó mediante estadística descriptiva y frecuencia, tablas de contingencia y x2.

Resultados

Se incluyó a un total de 70 pacientes y se produjo cicatrización en el 48,6% de éstos. Cicatrizó en el 54,5% de los pacientes con fisura anal y en el 33,3% con fisura anal y hemorroides. El 30% experimentó efectos adversos. El 5,7% abandonó el tratamiento por reacción adversa. La fisura cicatrizó en el 60% de los pacientes que estuvieron más de 1 mes en tratamiento. No hubo más cicatrización con más de 2 aplicaciones diarias. En ninguno de estos resultados hubo diferencias estadísticamente significativas.

Conclusiones

A pesar de no encontrarse diferencias significativas entre las variables estudiadas, el tratamiento de la fisura anal con la pomada de diltiazem al 2% ha evitado la intervención quirúrgica casi en un 50% de los pacientes, con efectos adversos poco frecuentes.

Palabras clave:
Fisura anal
Hemorroides
Diltiazem
Efectividad y seguridad
Estudio observacional
Full text is only aviable in PDF
References
[1.]
N. Griffin, A.G. Acheson, P. Tung, C. Sheard, C. Glazebrook, J.H. Scholefield.
Quality of life in patients with chronic anal fissure.
Colorectal Dis, 6 (2004), pp. 39-44
[2.]
I.P. Linehan.
The patient with anal problems.
Practitioner, 244 (2000), pp. 329-334
[3.]
R. Sales, P. Martínez, T. López, P. Culell, P. Fons, L. Ballús, et al.
Cirugía de la fisura anal crónica: resultados a largo plazo.
Cir Esp, 68 (2000), pp. 467-470
[4.]
R.L. Nelson.
A systematic review of medical therapy for anal fissure.
Dis Colon Rectum, 47 (2004), pp. 422-431
[5.]
M. Jonas, J.H. Scholefield.
Anal fissure.
Gastroenterol Clin North Am, 30 (2001), pp. 167-181
[6.]
C. Oh, C.M. Divino, R.M. Steinhagen.
Anal fissure. 20-year experience.
Dis Colon Rectum, 38 (1995), pp. 378-382
[7.]
M.A. Kamm.
Diagnosis, pharmacological, surgical and behaviour developments in benign anorectal disease.
Eur J Surg, 582 (1998), pp. 119-123
[8.]
E. García-Granero, E. Muñoz-Forner, M. Mínguez, C. Ballester, S. García-Botello, S. Lledó.
Tratamientos de la fisura anal crónica.
Cir Esp, 78 (2005), pp. 24-27
[9.]
R. Bhardwaj, M.C. Parker.
Modern perspectives in the treatmentof chronic anal fissures.
Ann R Coll Surg Engl, 89 (2007), pp. 472-478
[10.]
R.L. Nelson.
Operative procedures for fissure in ano.
Cochrane Database of Systematic Reviews, (2005),
[11.]
A. Arroyo, F. Pérez-Vicente, P. Serrano, F. Candela, A. Sánchez, M.T. Pérez-Vázquez, et al.
Tratamiento de la fisura anal crónica.
Cir Esp, 78 (2005), pp. 68-74
[12.]
D. Simkovic, K. Smejkal, P. Hladik.
Evaluación de los efectos de esfinterotomía en los enfermos tratados por fisura anal crónica.
Rev Esp Enferm Dig, 92 (2000), pp. 399-404
[13.]
C. Orsay, J. Rakinic, W.B. Perry, N. Hyman, D. Buie, P. Cataldo, et al.
Practice parameters for the management of anal fissure.
Dis Colon Rectum, 47 (2004), pp. 2003-2007
[14.]
R.D. Madoff, J.W. Fleshman.
AGA technical review on the diagnosis and care of patients with anal fissure.
Gastroenterology, 124 (2003), pp. 235-245
[15.]
J.N. Lund, P.O. Nyström, G. Coremans, A. Herold, I. Karaitianos, M. Spyrou, et al.
An evidence based treatment algorithm for anal fissure.
Tech Coloproctol, 10 (2006), pp. 177-180
[16.]
A.P. Zbar, M. Pescatori.
Functional outcome following lateral internal anal sphincterotomy for chronic anal fissure.
Colorectal Dis, 6 (2004), pp. 210-211
[17.]
S. Dhawan, S. Chopra.
Nonsurgical approaches for the treatment of anal fissures.
Am J Gastroenterol, 102 (2007), pp. 1312-1321
[18.]
R. Calpena, P. Serrano, A. Sánchez, F. Pérez, E. Miranda, A. Arroyo.
Tratamiento de la proctalgia en el síndrome fisurario anal.
Rev Soc Esp Dolor, 14 (2007), pp. 204-210
[19.]
R.L. Nelson.
Non surgical therapy for anal fissure.
Cochrane Database of Systematic Reviews., (2006),
[20.]
G. Brisinda, G. María.
Oral nifedipine reduces resting anal pressures and heals chronic anal fissure.
[21.]
M.V. Gil Navarro, C. Álvarez del Vayo, S. Flores Moreno, M. Nieto Guindo, E. Espejo Gutiérrez de Tena.
Diltiazem tópico en el tratamiento de la fisura anal.
XLIX Congreso nacional de la SEFH, Huelva, 28 (2004), pp. 76
[22.]
M.S. Sajid, J. Rimple, E. Cheek, M.K. Baig.
The efficacy of diltiazem and glyceryltrinitrate for the medical management of chronic anal fissure: a metaanalysis.
Int J Colorectal Dis, 23 (2008), pp. 1-6
[23.]
U.K. Shrivastava, B.K. Jain, P. Kumar, Y. Saifee.
A comparison of the effects of diltiazem and glyceryltrinitrate ointment in the treatment of chronic anal fissure: a randomized clinical trial.
Surg Today, 37 (2007), pp. 482-485
[24.]
K. Bielecki, M. Kolodziejczak.
A prospective randomized trial of diltiazem and glyceryltrinitrate ointment in the treatment of chronic anal fissure.
Colorectal Dis, 5 (2003), pp. 256-257
[25.]
G.F. Nash, K. Kapoor, K. Saeb-Parsy, T. Kunanadam, P.M. Dawson.
The long-term results of diltiazem treatment for anal fissure.
Int J Clin Pract, 60 (2006), pp. 1411-1413
[26.]
A. Arroyo, F. Pérez, P. Serrano, F. Candela, R. Calpena.
Long-term results of botulinum toxin for the treatment of chronic anal fissure. Prospective clinical and manometric study.
Int J Colorectal Dis, 20 (2005), pp. 267-271
[27.]
A. Arroyo, F. Pérez, P. Serrano, F. Candela, J. Lacueva, R. Calpena.
Surgical vs chemical (botulinum toxin) sphincterotomy for chronic anal fissure. Long-term results of a prospective randomized clinical and manometric study.
Am J Surg, 189 (2005), pp. 421-434
[28.]
D.C. Nyam, J.H. Pemberton.
Long-term results of lateral internal sphincterotomy for chronic anal fissure with particular referente to incidence of fecal incontinence.
Dis Colon Rectum, 42 (1999), pp. 1306-1310
[29.]
C. Placer, J.L. Elósegui, I. Irureta, J.A. Mújica, I. Goena, J.M. Enríquez Navascués.
Inicial response to topical diltiazem can predict outcome of chronic anal fissure.
Cir Esp, 82 (2007), pp. 16-20
Copyright © 2009. Sociedad Española de Farmacia Hospitalaria
Article options
Tools