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PubMed2002

(125)Iodine prostate brachytherapy: outcome from the first 100 consecutive patients and selection strategies incorporating urodynamics.

OBJECTIVE: To report the results from the first 100 consecutive patients treated with 125I transperineal interstitial prostate brachytherapy between March 1999 and June 2001, and to determine if the International Prostate Symptom Score (IPSS), prostate volume or urodynamic variables correlate with acute morbidity. PATIENTS AND METHODS: Patients were assessed prospectively by uroflowmetry, the IPSS, a physical examination and transrectal ultrasonography. Of the 100 patients, 57 had a full urodynamic assessment, 61 presented with lower urinary tract symptoms (LUTS), 25 were screen-detected and 14 presented with other problems. The IPSS was recorded at 1, 6 and 12 weeks, and then at 3-monthly intervals after treatment; significant events, e.g. acute urinary retention (AUR) and rectal symptoms, were recorded prospectively; the mean follow-up was 16 months. RESULTS: No patients were incontinent after treatment. There was a temporary deterioration in IPSS in 89% of patients. Peak symptoms occurred at 6 weeks and a statistically significant deterioration in IPSS persisted until 9 months, but continued to improve throughout the follow-up. AUR affected seven patients, with a further 20 using clean intermittent self-catheterization (CISC) for symptoms. In most patients the symptoms resolved spontaneously to the levels before treatment, with only two patients requiring surgery for bladder outlet obstruction. The IPSS before treatment did not predict urodynamic obstruction. Urodynamically unobstructed patients did not require catheterization. By 2 years after implantation the mean IPSS was better than before treatment. Five patients had mild, transient proctitis. CONCLUSION: Selecting patients with a low prostate volume and IPSS is likely to optimize the outcome of brachytherapy. Urodynamic studies may be helpful in predicting the risk of AUR and symptoms requiring CISC. Despite many patients presenting with LUTS, acute morbidity was no worse than that reported in large American series of predominantly screening-detected cancers. Prostate brachytherapy is well tolerated and may be safely delivered to patients with prostate cancer in the UK.

Aged↗
PubMed1998

Spontaneous inflammatory bowel disease in multiple mutant mouse lines: association with colonization by Helicobacter hepaticus.

BACKGROUND: Both genetic and microbial factors are thought to play a role in the development of inflammatory bowel disease (IBD): however, no causative microbial agent has been clearly defined for humans or animals. Normal flora or previously unrecognized intestinal pathogens may contribute to the development of disease in susceptible hosts. A newly recognized murine Helicobacter, H. hepaticus, causes hepatitis in mice and in one strain of mice is linked to liver cancer. This study investigates the association between colonization of the lower intestinal tract of multiple genetically altered lines of mice with H. hepaticus, and the occurrence of IBD. MATERIALS AND METHODS: Rectal prolapse noted clinically in multiple genetically altered mouse lines was evaluated for the presence of H. hepaticus and histologic evidence of IBD. Fifty-five mice representing 11 different genetic alterations were evaluated. RESULTS: H. hepaticus was detected in 85% of mutant mice with rectal prolapse. Histologic evidence of proliferative typhlitis, colitis or proctitis was present in 65% of the animals examined, 89% of which were positive for H. hepaticus as detected by species specific PCR. CONCLUSION: The presence of H. hepaticus in association with IBD in multiple lines of genetically altered mice suggests further studies are needed to test experimentally the role H. hepaticus plays in the development of IBD in susceptible mice. Additionally, specific mutant mouse lines infected with H. hepaticus in this study may provide additional models for elucidation of microbial and genetic factors in the pathogenesis of IBD.

Animals↗
PubMed1999

Combination of radiation therapy and interferon alpha-2b in patients with advanced cervical carcinoma: a pilot study.

Carcinoma of the uterine cervix is the most frequent malignancy in women in developing countries. Based on the possible synergistic effect of the combination of interferon and radiotherapy, a clinical trial was conducted in patients with advanced cervical cancer. The objective was to evaluate the efficacy and security of such a therapeutic approach. This prospective phase II trial was done at the Instituto Nacional de Cancerología in Mexico City. The study included 17 consecutive patients with previously untreated squamous cell cervical cancer, clinical stages III and IV, and tumor mean size of 9.7 cm. The patients received radiotherapy and interferon alpha-2b at a dose of 5 x 106 IU/m2 3 times a week for 6 weeks. Eleven (64%) complete responses were obtained among these patients. Long-term survival was observed in 4 patients (24%) who achieved complete response and are alive after 10 years of follow-up. Immediate toxicity was mild. Late toxicity included the development of proctitis in 13 patients, colostomy was performed in 3 (23%) of them. Our results indicate that the combination of radiotherapy and this cytokine is an active therapy for squamous cell carcinoma of the uterine cervix.

Journal Article↗
PubMed2003

Feasibility of amifostine administration in conjunction with high-dose rate brachytherapy.

This ongoing study was initiated to determine the feasibility of administering amifostine (Ethyol, WR-2721; MedImmune, Inc, Gaithersburg, MD) with monomodal high-dose rate (mHDR) brachytherapy and to assess the tolerability and side effects of this combination. To date, 18 patients suitable for prostate implant brachytherapy (<or=T2aN0; prostate-specific antigen <or= 10 ng/mL; Gleason score <or= 6) have been treated with mHDR brachytherapy, receiving four 9-Gy fractions administered twice daily for 2 days. Amifostine (500 mg) is administered subcutaneously on the day before implant and 30 to 60 minutes before the first and third mHDR treatments. All 18 patients have received amifostine and brachytherapy as planned. Nausea was manageable with oral prochlorperazine in the pretreatment phase and our standard antiemesis protocol (intravenous promethazine, with granisetron if needed) during the implant; hypotension and asthenia were not problematic. During the 2-week post-treatment phase, grade 1 cystitis occurred in eight of 18 patients; grades 1 and 2 proctitis occurred in six of 18 and five of 18 patients, respectively. Six patients developed urinary obstruction symptoms. Preliminary results support the feasibility and tolerability of subcutaneous amifostine in conjunction with mHDR brachytherapy. Total accrual goal is 50 patients to assess long-term efficacy. Additional studies of HDR with amifostine are planned for patients with recurrent prostate and gynecologic cancer.

Amifostine↗
PubMed2002

Intrarectal application of amifostine for the prevention of radiation-induced rectal injury.

Clinically symptomatic late injury to the rectal wall occurs in about one third of patients with prostate cancer treated with external beam irradiation. Reducing the physical dose to the anterior rectal wall without a similar reduction in the posterior peripheral zone is difficult because of the proximity of these structures. Based on our previous observations that intrarectal application of amifostine resulted in very high concentrations of amifostine and its active metabolite WR-1065 in the rectal wall of Copenhagen rats, the authors initiated a phase I clinical trial in 1998. Twenty-nine patients with localized prostate cancer were accrued. Eligibility criteria included histologically confirmed adenocarcinoma, a Karnofsky performance status of > or =70, and no pelvic lymphadenopathy or distant metastases. The total dose to the prostate was 70.2 Gy (20 patients) and 73.8 Gy (9 patients). Therapy was delivered using a 4-field axial technique and 3-dimensional conformal planning. Amifostine was administered intrarectally as an aqueous solution 30 minutes before irradiation on the first 15 days of therapy. Amifostine dose was escalated, in cohorts, from 500 mg to 2,500 mg. Toxicity was evaluated using the Radiation Therapy Oncology Group late morbidity scale. All patients completed therapy with no amifostine-related toxicity at any dose level. The application was feasible and well tolerated. With a median follow-up time of 21 months, 9 patients (33%) had rectal bleeding (8 grade 1, 1 grade 2). Four patients (14%) had symptoms suggestive of radiation injury, which proved to be secondary to nonrelated processes. These included preexisting nonspecific proctitis (1 patient), diverticular disease of the sigmoid colon, rectal polyp (1 patient), and ulcerative colitis (1 patient). Symptoms developed significantly more often in patients receiving 500 to 1,000 mg than in patients receiving 1,500 to 2,500 mg amifostine (7 of 14 [50%] versus 2 of 13 [15%]; P =.0325, 1-sided chi(2) test). Intrarectal application of amifostine is feasible and well tolerated. A complete lack of systemic toxicity obviates the need for close monitoring of patients during and after administration. Rectal symptomatology after external beam radiotherapy to the pelvis cannot be assumed to reflect late radiation damage, because it often is a manifestation of an unrelated pathologic process. The preliminary efficacy data are encouraging and suggest that intrarectal administration of amifostine may reduce radiation damage. Further clinical studies are warranted.

Adenocarcinoma↗
PubMed2000

[Budesonide foam as a new therapeutic principle in distal ulcerative colitis in comparison with mesalazine enema. An open, controlled, randomized and prospective multicenter pilot study].

Budesonide is a locally acting steroid with a high first-pass metabolism in the liver and low systemic effects. We performed the first pilot study comparing budesonide foam (1 mg/50 ml b.i.d.) with mesalazine enemas (4 g/60 ml o.d.). 33 patients from 3 centres were enrolled in this open randomized clinical trial. 16 patients got budesonide foam and 17 got mesalazine enemas. The drugs were administered for 4 weeks. Histological index (HI) and endoscopic index (EI) were assessed at day 1 and day 28, clinical activity index (CAI) at day 1, 14 and 28. For patients with left-sided colitis and proctosigmoiditis improvement was defined as decrease in CAI of > or = 2 points. For patients with proctitis improvement was defined as decrease in HI of > or = 1 point. The primary efficacy evaluation was performed with the intention to treat population (n = 32). Improvement was found in 67% of the patients in the budesonide group compared to 71% in the mesalazine group. There was no statistically significant difference between the groups. Adverse events were mild and rare in both groups. Both treatments had no significant influence on plasma cortisol. In this pilot study for distal ulcerative colitis budesonide foam is as safe and effective as mesalazine enema.

Administration, Rectal↗
PubMed2001

Determination of glutaraldehyde residues on flexible endoscopes after chemothermal treatment in an endoscope washer-disinfector.

BACKGROUND AND STUDY AIMS: Although there are several cases of glutaraldehyde-induced colitis following colonoscopy there is only one study on residues after disinfecting. Our report describes the determination of water-soluble glutaraldehyde residues after processing endoscopes with a glutaraldehyde-containing disinfectant. MATERIALS AND METHODS: A gastroscope and a colonoscope were processed in a washer-disinfector and then immersed in 201 of NaCl solution. Glutaraldehyde was determined by high performance liquid chromatography in 84 samples. Samples were taken after immersing the endoscopes for 5 h and 24 h with and without rinsing the channels. RESULTS: After 5 h and with the channels having been rinsed, the median for colonoscopes was only 0.409 mg/l. The highest level of glutaraldehyde was 0.846 mg/l. CONCLUSIONS: After endoscopes have been processed in the washer-disinfector there is no risk of a glutaraldehyde-induced colitis, proctitis or diarrhoea.

Colonoscopes↗
PubMed2001

[Pouch reconstruction after resection of the rectum].

Pouch reconstruction after resection of the rectum. Functional results after low anterior resection of the rectum and straight end-to-end coloanal anastomosis are often poor. Patients are frequently troubled by the so called "anterior resection syndrome" which comprises faecal incontinence, urge, frequency and fragmentation. To investigate the potential functional benefit of a coloanal pouch reconstruction we conducted a prospective study. Some 55 patients [29 men; median age 66,4 (30-85)] underwent low anterior resection of the rectum followed by coloanal J-pouch reconstruction. Pouch size was 5-7 cm, a temporary stoma was fashioned in 32 patients. Indications for the operation were: 1. rectal cancer: n = 51, 2. recurrent adenoma n = 2, 3. recto-vaginal fistula n = 1 and 4. severe non-specific proctitis n = 1. We observed 5 anastomotic leakages of which two patients required reoperation. A pelvic abscess was encountered in three patients as well as one pelvic haematoma. Micturition was impaired in five patients. To date 47 patients have completed 12 months follow-up after reversal of the ileostomy. Patients were seen at three-monthly intervals. Mean stool frequency/day was 3.9 after 3 and 2.6 after 12 months. After 3 months 38 patients (69 %) reported complete continence which increased to 83 % at 1 year. 18 Patients (33 %) complained of urge defaecation initially, which decreased to 14.5 % after 1 year. Fragmentation was observed in 40 % at 3 and and 22 % at 12 months, respectively. In conclusion, our initial experience with colonic J-pouch reconstruction shows good functional results.

Adult↗
PubMed2006

[Aminosalicylates and steroids in the treatment ot chronic inflammatory bowel diseases--consensus paper of the Working Group for Chronic Inflammatory Bowel Diseases of the OGGH].

5-aminosalicylates (5-ASA) and steroids constitute a cornerstone of medical therapy in patients with inflammatory bowel diseases (IBD). Whereas the efficacy of 5-ASA in Crohn's disease (CD) is equivocal, ulcerative colitis (UC) is the main indication for this drug. In UC, 5-ASA is effective in the treatment of mild to moderate acute disease and in maintenance of remission. Furthermore, 5-ASA topical therapy is an important treatment option in patients with mild to moderate proctitis and/or left-sided UC and shows additive efficacy to oral therapy. From retrospective data a chemo-preventative activity of long-term 5-ASA therapy in UC is delineated. Steroids are treatment of first choice for moderate to severe cases of CD and UC. Budesonide, a modified steroid with less side effects, plays a major role in the treatment of ileocolonic CD +/- involvement of the right colon and is used as treatment of choice in mild-to-moderate cases. In case of acute, severe disease conventional steroids are superior compared to budesonide and therefore budesonide should only be used after considerable improvement of disease activity. The necessity to apply steroids in a given patient represents a negative prognostic indicator for the course of disease and should incite the early introduction of immunosuppressive therapy in this case. Steroids are only effective as short term therapy of IBD and are to be avoided for maintenance treatment. In all cases of steroid therapy an osteoporosis prophylaxis with calcium and vitamin D is recommended. Topical steroid treatment is less effective in left-sided UC compared to 5-ASA.

Aminosalicylic Acids↗
PubMed1986

[Afterloading short-term irradiation of the vagina following radical surgery of uterine cancer].

A report is given of results and complications following postoperative irradiation in endometrial carcinoma via monitored high-dose afterloading therapy (iridium 192). Intravaginal irradiation was performed in all operated cases. In advanced cases or in cases with poor prognosis (deep infiltration of the myometrium, tumour grading 1-2) percutaneous irradiation (cobalt 60) was employed additionally. 327 patients with endometrial carcinoma were treated by postoperative irradiation between 1981 to 1985 and could then be followed up for at least 12 months to 5 years. Evaluation was done with regard to recurrence-free survival rate and side effects. With the postoperative afterloading iridium 192 technique, the 3-year recurrence-free rates were 91% in stage I and 78% in advanced stages. All of the patients in stage I with a control time of 5 years survived. The incidence of radiation side effects in the overall group was: cystitis 4%, proctitis 7% and fistulas 0.6%. No further severe complications occurred with the optimal intravaginal fraction dose of 700 cGy (twice). The afterloading therapy with high dose rates and remote control monitoring reduces the risk of radiation exposure of the medical staff and also places less strain on the patients because of the short-term irradiation. Intravaginal applications were performed without anaesthesia or any drugs, and treatment on an outpatient basis was possible in almost all of the cases.

Aged↗
PubMed1989

[Granulomatous colitis with pseudopolyp in schistosomiasis].

A 26-year-old Arab had epigastric pain and bloody mucous stools. At coloscopy distal proctitis and a polyp at the rectosigmoid junction were discovered. The polyp had granulomatous inflammatory changes and eggs of Schistosoma mansoni with a characteristic egg shell, central miracidium and lateral spine. Bilharziasis should be considered in the differential diagnosis of chronic inflammatory disease of the intestines.

Adult↗
PubMed1990

Ulcerative colitis and colorectal cancer. A population-based study.

BACKGROUND: The risk of colorectal cancer is increased among patients with ulcerative colitis. The magnitude of this increase in risk and the effects of the length of follow-up, the extent of disease at diagnosis, and age at diagnosis vary substantially in different studies. METHODS: To provide accurate estimates of the risk of colorectal cancer among patients with ulcerative colitis, we studied a population-based cohort of 3117 patients given a diagnosis of ulcerative colitis from 1922 through 1983 who were followed up through 1984. RESULTS: Ninety-two cases of colorectal cancer occurred in 91 patients. As compared with the expected incidence, the incidence of colorectal cancer in the cohort was increased (standardized incidence ratio [ratio of observed to expected cases] = 5.7; 95 percent confidence interval, 4.6 to 7.0). Less extensive disease at diagnosis was associated with a lower risk; for patients with ulcerative proctitis, the standardized incidence ratio was 1.7 (95 percent confidence interval, 0.8 to 3.2); for those with left-sided colitis, 2.8 (95 percent confidence interval, 1.6 to 4.4); and for those with pancolitis (extensive colitis, or inflammation of the entire colon), 14.8 (95 percent confidence interval, 11.4 to 18.9). Age at diagnosis and the extent of disease at diagnosis were strong and independent risk factors for colorectal cancer. For each increase in age group at diagnosis (less than 15 years, 15 to 29 years, 30 to 39 years, 40 to 49 years, 50 to 59 years, and greater than or equal to 60 years), the relative risk of colorectal cancer, adjusted for the extent of disease at diagnosis, decreased by about half (adjusted standardized incidence ratio = 0.51; 95 percent confidence interval, 0.46 to 0.56). The absolute risk of colorectal cancer 35 years after diagnosis was 30 percent for patients with pancolitis at diagnosis and 40 percent for those given this diagnosis at less than 15 years of age. CONCLUSIONS: Close surveillance and perhaps even prophylactic proctocolectomy should be recommended for patients given a diagnosis of pancolitis, especially those who are less than 15 years of age at diagnosis.

Adolescent↗
PubMed2001

Primary closure of complicated perineal wounds with myocutaneous and fasciocutaneous flaps after proctectomy for Crohn's disease.

BACKGROUND: The purpose of this study is to detail the use of advanced tissue transfer techniques to achieve primary closure of the perineal wound after proctectomy for Crohn's disease. METHODS: Between October 1984 and March 2000, we performed proctectomy with permanent intestinal stoma in 97 patients with Crohn's disease. Twelve of these patients (12.4%) required at least 1 myocutaneous flap to achieve primary closure of the perineal wound. Details of each patient's perioperative course were recorded prospectively. RESULTS: All 12 patients had fistulizing perineal Crohn's disease combined with Crohn's proctitis. Two patients had a simultaneous anal adenocarcinoma. Indications for flap closure included management of large perineal skin defects (n = 11), reconstruction of the posterior vaginal wall (n = 2), and the need to fill a large pelvic dead space (n = 3). (Three patients had a combination of the previous indications). In total, 6 rectus abdominis, 5 gluteus maximus, 1 posterior thigh, 3 chimeric posterior thigh, and 1 latissimus dorsi flaps were performed. Six patients required more than 1 flap. Three patients had complications develop related to the flaps (2 wound hematomas and 1 seroma). Complete perineal healing was achieved in all patients. CONCLUSIONS: Complex tissue flap closure of the perineal wound after proctectomy for perineal complications of Crohn's disease should be considered when simple closure is not possible or when reconstruction of the posterior wall of the vagina is necessary.

Adenocarcinoma↗
PubMed2006

Anorectal lymphogranuloma venereum in a Melbourne man.

We report the first case of anorectal lymphogranuloma venereum (LGV) in a man who has sex with men (MSM) in Australia in the setting of the recent emergence of LGV among MSM in Europe and the USA. A 33-year-old man presented with a 2 month history of mild external anal discomfort. He gave a history of unprotected receptive and insertive anal intercourse with one partner in Europe during the preceding 6 months. No symptoms suggested proctitis and examination revealed two small anal fissures. An anal swab was positive for Chlamydia trachomatis; investigation for other STIs including HIV were negative. On review 6 days later, he was investigated and treated presumptively for LGV. The LGV diagnosis was confirmed by identifying the L2 serovar of C. trachomatis using a genotype test on the original anal specimen. This case is in keeping with the more recent reports of LGV from Europe, and has demonstrated the need for a high index of suspicion for asymptomatic or minimally symptomatic anorectal LGV.

Adult↗
PubMed1978

Isolation and characterization of colonic tissue-bound antibodies from patients with idiopathic ulcerative colitis.

To determine if specific anticolon antibodies bound to colonic mucosa occur in ulcerative colitis, we obtained surgical specimens of colon from five patients with ulcerative colitis, one patient with diverticulitis, and three control subjects with carcinoma. Two specimens of ileum and cecum were also obtained from patients with Crohn ileocolitis. Tissue was homogenized and washed and bound Ig was eluted by citrate buffer, pH 3.2. Concentrated eluates of all specimens from patients with ulcerative colitis reacted with antisera to kappa and gamma and not with antisera to alpha and mu chains. Corresponding eluates from all other specimens did not react with these antisera, but did react with antialbumin. The presence of IgG in ulcerative colitis eluates was also determined by immunoelectrophoresis, immunocoprecipitation, and affinity chromatography with antisera against human IgG. Indirect immunofluorescence and uptake of radiolabeled antibody demonstrated antigenic sites in diseased colonic epithelium of biopsy specimens obtained from six additional patients with ulcerative colitis and three patients with idiopathic proctitis, but not in patients with Crohn disease, nonspecific diarrhea, and bacillary dysentery and control subjects. Although the role of colitis colon-bound antibody in the pathogenesis of ulcerative colitis is unclear, local antibody-antigen complexes may initiate colonic epithelial cytolysis by various immunologically mediated mechanisms.

Autoantibodies↗
PubMed2002

Altered expression of beta-catenin during radiation-induced colonic carcinogenesis.

Radiotherapy for malignant pelvic disease is commonly accompanied by treatment-induced proctitis, and rarely by colorectal cancer. Translocation of the beta-catenin protein, which is a key downstream effector of the Wnt signal transduction pathway, is frequently found in colorectal cancer. Nuclear beta-catenin enhances transcriptional activity of the cyclin D1 gene in cancer cells. Here, we evaluate the involvement of the Wnt pathway in radiation-induced colon carcinogenesis with rats (n = 36). Beta-catenin, APC, and cyclin D1 expression profiles were analyzed by immunohistochemistry in radiation-induced chronic colon injury including cancers and ulcerative lesions in rats (n = 12 in treated group, n = 12 in control group). In total, 3 cases of invasive adenocarcinomas were developed in the irradiated portion 50 weeks after a single dose of 36 Gy irradiation. Nuclear translocation of beta-catenin was observed in all radiation-induced colon cancers, whereas this protein was also found in the cytoplasm and/or nucleus of 9 cases of non-neoplastic irradiated colonocytes. Nuclear translocation of beta-catenin correlated with loss of APC and gain of cyclin D1 expression, suggesting activation of the Wnt pathway during radiation-induced colorectal carcinogenesis. A single dose of 10 Gy was also given for acute injury (n = 12: 3 each in days 0, 3, 5, and 7, respectively). Beta-catenin expression was distributed in the cytoplasm of degenerating glands at day 3 and 5, and was observed in the cell membrane of those glands with histological normalization at day 7 after irradiation. Because translocation of beta-catenin was found in irradiated-colonic mucosa as well as colon cancer, disruption of beta-catenin expression might be one of the early events in radiation-induced colonic carcinogenesis.

Adenocarcinoma↗
PubMed2001

Lymph folliculitis in ulcerative colitis.

Preferential involvement of the appendix has recently been confirmed in ulcerative colitis. Since the appendix is an aggregate of lymph follicles, this new observation implies a critical role of the lymph follicles, of both the large bowel and the appendix, in an etiopathogenesis of ulcerative colitis. This report presents two cases of ulcerative colitis in which lymph folliculitis and lymphoid hyperplasia were observed. Lymph folliculitis was observed endoscopically in a border between an established lesion and an uninvolved area. Case 1, proctitis type, relapsing remitting, mild in severity, showed lymph folliculitis in a proximal border of an established rectal lesion. Case 2, with left-sided colitis, mild in severity, had a skip appendiceal orifice inflammation. Lymph folliculitis was observed in the cecum surrounding established appendiceal orifice inflammation. In both cases, lymphoid hyperplasia was observed in an uninvolved area with clear vascular patterns. These two cases clearly demonstrate the involvement of gut lymph follicles in ulcerative colitis. Lymph folliculitis and/or lymphoid hyperplasia was proposed to be early lesions in ulcerative colitis. In addition, the need for microbiology targeting lymph follicles of the large bowel and appendix is stressed in order to disclose the casual microbial agents in ulcerative colitis.

Adult↗
PubMed2006

Treatment of perianal fistulas in Crohn's disease by local injection of antibody to TNF-alpha accounts for a favourable clinical response in selected cases: a pilot study.

OBJECTIVE: Intravenously administered infliximab, a monoclonal antibody directed against tumor necrosis factor-alpha, has been proven to be efficacious in the treatment of fistulas in patients with Crohn's disease. It has recently been suggested that local injections of infliximab might be beneficial as well. The aim of this study was to assess whether infliximab could play an effective role in the local treatment of perianal fistulas in Crohn's disease. MATERIAL AND METHODS: Local infliximab injections were administered to 11 patients suffering from Crohn's disease complicated by perianal disease. Eligible subjects included Crohn's disease patients with single or multiple draining fistulas, regardless of status of luminal disease at baseline. Patients, however, were excluded from the study if they had perianal or rectal complications, such as abscesses or proctitis or if they had previously been treated with infliximab. Twenty-milligram doses of infliximab were injected along the fistula tract and around both orifices at baseline and then every 4 weeks for up to 16 weeks or until complete cessation of drainage. No further doses were administered to patients who did not respond after three injections. Efficacy was measured in terms of response (a reduction in fistula drainage of 50% or more) and remission (complete cessation of fistula drainage for at least 4 weeks). Time to loss of response and health-related quality of life were also evaluated. RESULTS: Overall, 8/11 patients (72.7%) responded to the therapy and 4/11 (36.4%) reached remission, whereas 3/11 patients (27.2%) showed no response. Response or remission was very much dependent on the location of the fistulas, and time to loss of response was generally longer for patients who reached remission compared to patients in response. Changes in health-related quality of life, as assessed by the Inflammatory Bowel Disease Questionnaire (IBDQ), also reflected response or remission, with more marked improvements associated with remission. After a mean 10.5 months' follow-up (range 7-18 months), 6/11 patients (54.5%) are in response and 4/11 patients (36.4%) are in remission. No adverse events have been observed in this cohort of patients. CONCLUSIONS: Local injections of infliximab along the fistula tract seem to be an effective and safe treatment of perianal fistulas in Crohn's disease. However, further controlled clinical investigations are warranted.

Adult↗