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| 번호 | 제목 | 등록일 | 조회수 |
|---|---|---|---|
| 33 | A Randomized Trial of Oral vs. Topical Diltiazem for Chronic Anal Fissures [2001년 8월 DCR] | 2011-11-17 | 3509 |
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Marion Jonas, F.R.C.S., Keith R. Neal, M.R.C.P., M.F.P.H.M., John F. Abercrombie, F.R.C.S., John H. Scholefield, Ch.M., F.R.C.S.
From the University of Nottingham, Nottingham, United Kingdom
INTRODUCTION: Chemical sphincterotomy has proved effective in treating chronic anal fissure. Glyceryl trinitrate is the most widely used agent, and topical 0.2 percent glyceryl trinitrate ointment heals up to two thirds of chronic anal fissures. Unfortunately, however, many patients experience troublesome headaches as a side effect of this treatment. This study assessed the effectiveness of oral and topical
dlltiazem in heating chronic fissures. METHODS: Fifty consecutive patients with chronic anal fissures were randomly assigned to receive oral (60 rag) or topical (2 percent gel) dfltiazem twice daily for up to eight weeks. Anal manometry was performed before and after the first dose, and blood pressure was recorded at 15-minute intervals. Patients were reviewed fortnightly, pain was expressed with a visual linear analog scale, blood pressure was recorded, fissure healing was assessed, and side effects were noted.
RESULTS: Twenty-four patients received oral diltiazem, and 26 received topical diltiazem. Mean (_+ standard error of the mean) maximum resting anal pressures fell by 15 and 23 percent from 95 -+ 4 to 81 + 4 and from 102 + 5 to 79 -+ 5 cm H20 in the two groups, respectively. There was no significant reduction in blood pressure during the study or at follow-up in either group. Fissure healing was complete in 9 patients (38 percent) receiving oral diltiazem and 15 (65 percent) on topical treatment by eight weeks. Oral diltiazem caused side effects in eight patients (rash, two; headaches, two; nausea or vomiting, three; reduced smell and taste, one), whereas no side effects were seen in those receiving topical therapy (P = 0.001).
CONCLUSION: Oral and topical diltiazem heal chronic anal fissures. Topical diltiazem is more effective, achieving healing rates comparable to those reported with topical nitrates, with significantly
fewer side effects. Chronic anal fissure is a common condition that affects all age groups and causes considerable
morbidity in an otherwise generally healthy population. Patients generally have raised resting anal canal pressure, secondary to hypertonia of the internal anal sphincter, and treatment is directed at reducing this. The gold standard surgical treatment, internal anal sphincterotomy, lowers anal resting pressure and effectively heals the majority of fissures but may permanently impair anal continence in up to one third of patients and is often performed under general anesthesia. Certain pharmacologic agents also lower anal resting pressure, producing a "chemical sphincterotomy"
without causing permanent damage to the anal sphincter mechanism, and have largely replaced surgery as first-line therapy. Topical glyceryl trinitrate (GTN) is probably the most widely used drug treatment for chronic fissures, and 0.2 percent ointment applied twice daily to the anal verge heals 60 to 70 percent of cases within eight weeks. However, there are drawbacks. Over half of those patients using topical 0.2 percent GTN experience headaches that lead to discontinuation of treatment in some cases and probably to reduced compliance in others. The phenomenon of nitrate tolerance, well recognized with other applications of GTN, may also be a potential problem with its use as a treatment for fissures, and higher doses of GTN are likely to result in an increased frequency and severity of side effects. Botulinum toxin injected into the anal sphincter reportedly heals more than 90 percent of chronic
fissures but is both more invasive than GTN therapy and more expensive. Injection may be painful and may lead to perianal sepsis or fecal incontinence that persists until there has been local neuronal regeneration. Diltiazem, a calcium channel blocker, causes relaxation of vascular smooth muscle and vasodilation; it is widely and safely used in clinical practice as an antihypertensive and antianginal therapy with few side effects. Oral and topical preparations of diltiazem have recently been shown to lower anal resting pressure in volunteers, probably by relaxing the internal anal sphincter. The present study aimed to determine the efficacy of diltiazem in the treatment of chronic anal fissures and to compare oral with topical preparations of diltiazem.
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