EFFECT OF LEUPROLIDE ACETATE IN PATIENTS WITH MODERATE TO SEVERE FUNCTIONAL BOWEL-DISEASE - DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY

被引:67
作者
MATHIAS, JR
CLENCH, MH
REEVESDARBY, VG
FOX, LM
HSU, PH
ROBERTS, PH
SMITH, LL
STIGLICH, NJ
机构
[1] UNIV TEXAS,MED BRANCH,DEPT OBSTET & GYNECOL,GALVESTON,TX 77555
[2] TAP PHARMACEUT INC,DEERFIELD,IL 60015
[3] ABBOTT LABS,ABBOTT PK,IL 60064
关键词
FUNCTIONAL BOWEL DISEASE; IRRITABLE BOWEL SYNDROME; LEUPROLIDE ACETATE; GONADOTROPIN-RELEASING HORMONE; MIGRATING MOTOR COMPLEX;
D O I
10.1007/BF02093778
中图分类号
R57 [消化系及腹部疾病];
学科分类号
摘要
Moderate to severe functional bowel disease results in debilitating abdominal pain, nausea, intermittent vomiting, early satiety, bloating, abdominal distension, and/or altered bowel habits. Because it occurs similar to 20-30 times more frequently in women than in men and its symptoms often coincide with the menstrual cycle, we hypothesized that reproductive steroids may antagonize diseased nerves of the gastrointestinal tract, enhancing the expression of symptoms. No effective or consistent therapy has existed for these patients. We prospectively investigated the effect of a gonadotropin-releasing hormone analog, leuprolide acetate, in 30 women with symptoms of moderate to severe functional bowel disease. The study was phase II, randomized, double blind, and placebo controlled. Lupron Depot 3.75 mg (which delivers a continuous low dose of drug for one month) or placebo were given intramuscularly monthly for three months. Symptom scores were assessed at each four-week visit. Follicle-stimulating hormone luteinizing hormone estradiol, and progesterone levels were assessed before and after therapy. Patients treated with low-dose leuprolide improved progressively and significantly in scores for nausea, vomiting, bloating, abdominal pain, and early satiety, and for overall symptoms (P < 0.01-0.05). All hormone levels decreased significantly (P < 0.05) except luteinizing hormone (P = 0.054).
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页码:1155 / 1162
页数:8
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