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PubMed1995

Consensus statement: octreotide dose titration in secretory diarrhea. Diarrhea Management Consensus Development Panel.

Octreotide is an effective therapeutic option in controlling secretory diarrhea of varied etiology. However, marked patient-to-patient differences in the antidiarrheal effects necessitate titration of octreotide dose in individual patients to achieve optimal symptom control. A consensus development panel established guidelines for octreotide dose titration in patients with secretory diarrhea. Overall, the panel recommended an aggressive approach in selecting the initial octreotide dose and in making subsequent dose escalations in patients with secretory diarrhea due to gastrointestinal tumors (eg, carcinoids, VIPomas), AIDS, dumping syndrome, short bowel syndrome, radiotherapy, or chemotherapy. To avoid hypoglycemia in patients with diabetes mellitus-associated secretory diarrhea, the panel recommended a low initial octreotide dose and a conservative titration regimen with close monitoring a blood glucose levels. The end point of therapy should focus on a reduction in diarrhea (frequency of bowel movements or stool volume) rather than normalization of hormonal profile. Overall, octreotide is well tolerated; principal side effects are transient injection site pain and gastrointestinal discomfort. For many patients with secretory diarrhea, octreotide therapy is expected to improve the overall health and quality of life and in the long run will lessen health care costs.

Carcinoid Tumor↗
PubMed1987

Familial polyposis coli. Results of mucosal proctectomy with ileoanal anastomosis.

The outcome of mucosal proctectomy with ileoanal anastomosis in patients with polyposis coli has not been well studied. A series of 25 patients with polyposis treated at the Mount Sinai Hospital over a period of ten years is reported. The mean age of the patients was 23 years. Early postoperative complications were present in seven patients and consisted of thrombophlebitis (three), pelvic sepsis (three), and retraction of the anastomosis (one). Intestinal obstruction requiring laparotomy occurred in another five patients. Twenty-three patients were followed for a mean of 47 months after closure of the ileostomy. Ninety-one percent are satisfied with the operative results. The mean number of bowel movements per 24 hours is 6.0. All patients are continent, but eight have occasional episodes of rectal seepage at night. Nearly 50 percent require some antidiarrheal medication. New adenomatous polyps have developed just above the dentate line in four patients. Patients with polyposis coli seem to have fewer serious complications requiring excision of the ileoanal anastomosis than patients with ulcerative colitis. They also should have lifelong surveillance of the entire gastrointestinal tract even after total colectomy with ileoanal anastomosis.

Adolescent↗
PubMed2002

Thalidomide in chronic graft-versus-host disease after stem cell transplantation: effects on quality of life.

Thalidomide is being increasingly used after stem cell transplantation as immunosuppression for patients with chronic graft-versus-host disease, as well as for antiangiogenesis effects in patients with multiple myeloma, brain tumors, leukemia, or other malignancies. The goal of this study was to determine if thalidomide improved the quality of life by virtue of its associated sleep-promoting, anxiety-reducing, antiwasting, and antidiarrheal effects. We therefore studied 28 patients with resistant chronic graft-versus-host disease who were treated with thalidomide (13 patients) or other immunosuppressive drugs (15) and compared them with healthy control subjects (16). All patients completed quality-of-life questionnaires prospectively before beginning regimens of thalidomide or other immunosuppressive drugs and completed similar questionnaires at 3- and 6-month intervals thereafter. The Transplant Symptom Frequency score was similar for healthy control subjects and both groups of patients with chronic graft-versus-host disease, regardless of whether they had received thalidomide or not. Quality of sleep was equally poor in patients who received or did not receive thalidomide. The most common complaint of patients with chronic graft-versus-host disease was fatigue, followed in frequency by overeating. The control group had similar concerns. This pilot study suggests that patients with chronic graft-versus-host disease have a quality of life similar to that of their health care workers, regardless of whether they are treated with thalidomide or other immunosuppressive drug, and that fatigue and overeating are the most common complaints.

Case-Control Studies↗
PubMed1997

[The use of sucralfate in radiation oncology].

PURPOSE: Radiotherapy, a cornerstone in the management of head and neck cancer, pelvic cancer, and esophageal cancer is associated with a marked mucosal toxicity. Pain, malnutrition and diarrhea are the most prevalent clinical symptoms of radiation induced mucosal damage. Because there is no known way to obviate radiation mucositis all efforts to prevent aggravation and accelerate healing of mucosal changes are of great importance. Numerous agents including antimicrobials, local and systemic analgesics, antiinflammatory drugs, antidiarrheal drugs, in combination with intensive dietetic care are used to relieve symptoms. Recently coating agents like the polyaluminum-sucrose complex sucralfate were suggested for the prevention and treatment of mucosal reactions. Since sucralfate protects ulcerated epithelium by coating, liberates protective prostaglandins and increases the local availability of protective factors this drug might directly interact with the pathogenesis of mucositis. PATIENTS AND METHOD: The results of available studies are analysed and discussed. RESULTS: The results of several studies indicate that sucralfate treatment especially during radiotherapy for pelvic cancer leads to a significant amelioration of clinical symptoms and morphological changes. An application of sucralfate during radiotherapy of head and neck cancer reveals only limited benefits in most studies performed. CONCLUSION: Nevertheless sucralfate is a safe, cheap and active drug for the prevention and treatment of radiation mucositis especially in patients with pelvic irradiation.

Head and Neck Neoplasms↗
PubMed2001

[Gastroenteritis due to Plesiomonas shigelloides--rare cases in the Western world].

BACKGROUND: Plesiomonas shigelloides is a common pathogen in tropical regions, whereas it is rarely isolated in temperate climates. It is most often found in surface water and fish. During the last 10 years it was found to cause gastroenteritis 6 times in Ludwigshafen. Not all of these patients reported a trip to foreign countries. CASE REPORT: A 54-year-old male patient was hospitalized after a trip to Malaysia with strong greenish watery diarrhea and chills. On physical examination we saw a dehydrated patient in severely reduced general condition. The stool frequency was 30/d. The laboratory examinations only showed elevated parameters of inflammation. Plesiomonas shigelloides was cultivated in the stool cultures. With appropriate substitution of fluid and electrolytes, and antidiarrheal therapy the patient resumed a normal diet without any complications. Three days later his bowel movements were normal and his general condition was greatly improved. We withheld antibiotic therapy because of the noncomplicated course of illness. CONCLUSION: In Germany infections with Plesiomonas shigelloides are rare, an increase is observed because of increasing tourism to tropical regions. The course of infection is sometimes asymptomatic, but usually patients develop an acute gastroenteritis. Especially immunocompromised patients can show serious courses of infection. Plesiomonas shigelloides should be included in the differential diagnosis of acute gastroenteritis after journeys to tropical regions. Some of our patients, however, denied traveling to tropical regions. They also denied consuming seafood, which indicates a risk of infection in Germany. Still an infection with Plesiomonas shigelloides seems to be rare in northern European countries.

Diarrhea↗
PubMed2000

Changes in intestinal transit time after proctocolectomy assessed by the lactulose breath test.

After proctocolectomy with ileal pouch-anal anastomosis (IPAA) patients have increased stool frequency and intermittently use antidiarrheal medication. In addition to other factors, gastrointestinal transit time (MTT) could influence stool frequency. The aim of this study was to investigate how MTT changes after IPAA and to study whether MTT has an influence on daily stool frequency. In a prospective trial MTT was investigated with the lactulose breath test in 12 patients undergoing surgery for chronic ulcerative colitis (CUC) or familial adenomatous polyposis coli (FAPC) at different stages: before proctocolectomy, after IPAA with loop ileostomy, and 3 months and 1 year after ileostomy closure. MTT was also measured in 12 patients with IPAA, 12 patients with subtotal colectomy and ileorectal anastomosis (IRA), and 8 patients with conventional proctocolectomy and Brooke ileostomy (CPC) several years after surgery. Twelve healthy volunteers served as controls. Before IPAA, MTT was prolonged in CUC versus FAPC and controls. After restoration of gut continuity MTT was markedly accelerated. After 1 year MTT was slowed again, though values before proctocolectomy and those in controls were not reached. Several years after surgery MTT was significantly prolonged in IPAA and IRA versus controls. In CPC, MTT could not be determined by lactulose breath test. Stool frequency showed an inverse correlation to MTT in IPAA. In conclusion, this study shows that orocecal and oropouch transit are accelerated in the early postoperative period after (procto)colectomy but prolonged in the long-term course. Adaptation of the small bowel takes longer than 1 year. Impairment of stool frequency may be partly due to this adaptation.

Adenomatous Polyposis Coli↗
PubMed2003

Citrate enhances the protective effect of orally administered bismuth subnitrate against the nephrotoxicity of cis-diamminedichloroplatinum.

Attenuation of the renal toxicity of cis-diamminedichloroplatinum (CDDP) is important in the use of this effective but cytotoxic anticancer agent. We have previously shown that the renal toxicity of CDDP can be efficiently reduced by the induction of metallothionein (MT) by preadministration of bismuth compounds in mice. Bismuth subnitrate (BSN) is used as an antigastric ulcer agent and as an antidiarrheic agent, and is suitable for inducing MT in the kidney in cancer patients. However, due to the low absorption rate of Bi from the gastrointestinal tract, the efficacy of BSN in inducing renal MT is low. In the present study, we examined the effects of citrate as a vehicle for oral administration of BSN on the tissue distribution of Bi and induction of MT in the kidneys and tumors in mice inoculated with Meth-A fibrosarcoma. Renal levels of MT and Bi were markedly increased in the mice given BSN dissolved in citrate solution compared with those given BSN suspended in saline. On the other hand, the use of citrate increased Bi accumulation in the tumor only slightly and did not increase tumor MT levels. Administration of BSN with citrate efficiently depressed the renal toxicity of CDDP, but did not affect its antitumor activity. Since both BSN and citrate are used clinically as pharmaceuticals, the combination regimen of BSN and citrate may be readily applicable as a countermeasure against the adverse side effects of CDDP without affecting its antitumor activity.

Administration, Oral↗
PubMed2000

Outcome of ileal pouch after secondary diagnosis of Crohn's disease.

Ileal-pouch anal anastomosis is sometimes performed inappropriately in Crohn's disease patients. The aim of this study was to evaluate long-term results in this subset. In 54 ileal-pouch anal anastomoses performed between 1985 and 1997 for CUD the patient was eventually diagnosed as having Crohn's disease in seven cases. A retrospective review was performed. Definitive diagnosis was established on histopathology, endoscopy, and clinical presentation. The principal outcome factors were pouch failure, reason for failure, and functional results in cases of retained pouch. Patients ranked their quality of life between 1 and 10. We found three failures due to pelvic abscess, anoperineal disease, and anovulvar fistula. The pouch was excised in the latter patient; four patients retained their pouch. Functional results were good in the four (7 year follow-up): 7.25 bowel movements per day, ability to discriminate flatus from feces in three, soiling in one, urgency in one, perianal pad in one, ability to differ bowel movement for 66 min, diet, and antidiarrheal medication all four, pouchitis in one, sexual troubles in one woman, no urinary or obstetric trouble. Quality of life was judged satisfactory by six of the seven patients. Our 13% rate of inadvertent ileal-pouch anal anastomosis is higher than results usually reported. This difference is explained by the diagnostic criteria, whose validity is controversial. Three-stage surgery to decrease inadvertent restorative coloproctectomy is worth considering. Even if results are good when the pouch is functioning, Crohn's disease remains a contraindication to ileal-pouch anal anastomosis because of its high rate of failure and excision.

Adolescent↗
PubMed2000

Characterization of delta-opioid receptors and effect of enkephalins on IRD 98 rat epithelial intestinal cell line.

Using 3H-Tyr-D-Ala-Gly-Phe-D-Leu-OH (3H-DADLE) as a radioligand, delta-opioid binding sites on the IRD 98 rat epithelial cell line were identified. These sites were found to be reversible, saturable, specific and displayed high affinity for DADLE. Scatchard analysis revealed a dissociation constant (Kd) of 4.9+/-0.5 nmol/l, a maximum binding capacity (Bmax) of 1.7 pmol/mg protein, and 5x10(5) binding sites per cell. The presence of opioid receptors suggests the possibility that enkephalins directly control ion transport in enterocytes. In order to verify this hypothesis, investigations were designed to determine whether these receptors are functional and whether enkephalins can inhibit the stimulation of adenosine 3',5' cyclic monophosphate (cAMP) synthesis induced by cholera toxin. The increase in cAMP synthesis induced by cholera toxin was inhibited in a dose-dependent manner by H-Tyr-D-Ser-Gly-Phe-Leu-Thr-OH (DSLET), a delta-agonist. The enkephalinase inhibitor thiorphan potentiated this effect on IRD 98 cells, which contain enkephalinase. The action of DSLET was increased by 40% in the presence of this inhibitor. This effect was reversed by naltrindole, a potent delta-antagonist. Enkephalins can regulate intestinal secretion by acting directly on enterocytes: they thus have an antidiarrheal role, especially in the presence of an enkephalinase inhibitor.

Analgesics, Opioid↗
PubMed2001

Chemical coding of neurons expressing delta- and kappa-opioid receptor and type I vanilloid receptor immunoreactivities in the porcine ileum.

Opioid drugs have profound antidiarrheal and constipating actions in the intestinal tract and are effective in mitigating abdominal pain. Mediators of intestinal inflammation and allergy produce increased mucosal secretion, altered bowel motility and pain due to their ability to evoke enteric secretomotor reflexes through primary afferent neurons. In this study, the distribution of delta- and kappa-opioid receptor (DOR and KOR, respectively) immunoreactivities in chemically identified neurons of the porcine ileum was compared with that of the capsaicin-sensitive type 1 vanilloid receptor (VR1). DOR and VR1 immunoreactivities were observed to be highly localized in choline acetyltransferase (ChAT)- and calcitonin gene-related peptide (CGRP)-positive neurons and nerve fibers of the submucosal and myenteric plexuses and both receptors exhibited frequent colocalization. In the inner submucosal plexus, they also were colocalized in substance P (SP)-positive neurons. Neurons in the outer submucosal plexus expressed DOR immunoreactivity alone or in combination with VR1. KOR-immunoreactive neurons were found only in the myenteric plexus; these cells coexpressed immunoreactivity to ChAT, CGRP, vasoactive intestinal peptide (VIP) or nitric oxide synthase (NOS). In addition, some KOR-positive neurons coexpressed immunoreactivities to DOR and VR1. Based on their neurochemical coding, opioid and vanilloid receptor-immunoreactive neurons in the submucosal and myenteric plexuses may include primary afferents and constitute novel therapeutic targets for the palliation of painful intestinal inflammatory, hypersensitivity and dysmotility states.

Animals↗
PubMed2004

Resolution of refractory chemotherapy-induced diarrhea (CID) with octreotide long-acting formulation in cancer patients: 11 case studies.

PURPOSE: Subcutaneous (SC) octreotide has been shown to effectively relieve chemotherapy-induced diarrhea (CID) refractory to conventional therapy but requires t.i.d. injections. A microencapsulated, long-acting formulation (LAR) of octreotide has been developed for once-monthly intramuscular (IM) dosing. Efficacy in resolving severe diarrhea and preventing further episodes of diarrhea in cancer patients was explored. PATIENTS AND METHODS: Patients with advanced cancer who developed CID and failed conventional antidiarrheal therapy (loperamide + diphenoxylate-atropine) received octreotide LAR IM. The starting dose was either 20 or 30 mg with possible dose escalation from 20 to 30 mg and from 30 to 40 mg. Treatment was repeated every 28 days during chemotherapy. RESULTS: Complete resolution of diarrhea within 1 to 4 weeks from injection time was seen in all cases with octreotide LAR 30 mg. With a subsequent prophylactic injection once every 28 days, CID was limited to NCI grade 1. This resulted in increased patient quality of life (QOL) and allowed better patient compliance with therapy. Therapy could then be completed at full dose and on schedule after resolution of often debilitating diarrhea. CONCLUSION: The ability of octreotide LAR 30 mg to speed the resolution of CID and limit further episodes of diarrhea to infrequent NCI grade 1 controlled with loperamide (prn) suggests that long-acting somatostatin homologues have the potential to be useful in the secondary prevention of diarrhea in patients undergoing chemotherapy.

Adult↗
PubMed2004

Comparison of functional results and quality of life between intersphincteric resection and conventional coloanal anastomosis for low rectal cancer.

PURPOSE: The technique of intersphincteric resection permits sphincter preservation with good oncologic results in very low rectal cancer. This study aimed to investigate functional results and quality of life after intersphincteric resection compared with conventional coloanal anastomoses. METHODS: From 1990 to 2000, 170 patients underwent total mesorectal excision with coloanal anastomosis for low rectal tumors. Questionnaires were obtained from 77 patients alive without colostomy: 37 had a conventional coloanal anastomosis and 40 had intersphincteric resection. Both groups were similar according to age, gender, anastomotic stenosis, colonic pouch, anastomotic leakage, preoperative radiotherapy, and follow-up (median, 56 months). Assessment included one functional and two quality-of-life questionnaires: the SF-36 Health Status and the Fecal Incontinence Quality of Life score. RESULTS: There was no difference in stool frequency, fragmentation, urgency, dyschesia, and alimentary restriction between patients with and without intersphincteric resection. Patients with intersphincteric resection had significantly worse continence (Wexner score, 10.8 vs. 6.9; P < 0.001) and needed more antidiarrheal drugs (60 vs. 35 percent; P = 0.04) than those without. Compared with conventional coloanal anastomoses, quality of life was altered by intersphincteric resection for the subscale embarrassment ( P < 0.01) in the Fecal Incontinence Quality of Life score, whereas no difference of quality of life was observed with SF-36. CONCLUSIONS: Compared with conventional coloanal anastomoses, patients with intersphincteric resection have a higher risk of fecal incontinence and a slightly altered quality of life.

Adult↗
PubMed2005

Quality of life, functional outcome, and complications of coloplasty pouch after low anterior resection.

PURPOSE: The colonic J-pouch has been used to improve bowel function in patients undergoing low colorectal or coloanal anastomosis. However, a narrow pelvis, difficulties in reach, a long anal canal with prominent sphincters, or a fatty mesentery may turn this technique into a technically challenging procedure in certain patients. In these circumstances, "coloplasty" offers an alternative to a straight anastomosis. The purpose of this study was to compare the quality of life, functional outcome, and complications between patients undergoing coloplasty, colonic J-pouch, or straight anastomosis. METHODS: Altogether, 162 patients who underwent coloanal or low colorectal anastomosis between 1998 and 2001 were studied. Data collected included demographics, length of follow-up, technique and type of anastomosis, complications, quality of life, and functional outcome. Results were analyzed according to use of a coloplasty (n = 69), colonic J-pouch (n = 43), or straight anastomosis (n = 50). The choice of the technique was based on the surgeon's preference. Usually coloplasty or straight anastomosis was favored in male patients with a narrow pelvis or when a handsewn anastomosis was used. RESULTS: Quality of life assessment with the short form-36 questionnaire revealed better scores in coloplasty and colonic J-pouch groups. The coloplasty (1.0 +/- 1.7) and colonic J-pouch (1.0 +/- 1.2) groups had fewer night bowel movements than the straight anastomosis group (1.5 +/- 2.0) (P < 0.05). The coloplasty group also had fewer bowel movements per day than the straight anastomosis group (3.8 +/- 2.9 vs. 4.8 +/- 3.6; P < 0.05); also, less clustering and less antidiarrheal medication use were observed than in the straight anastomosis group. Colonic J-pouch patients with handsewn anastomosis had a higher anastomotic leak rate (44 percent) than the patients in the coloplasty with handsewn anastomosis group (3.6 percent). CONCLUSIONS: Coloplasty seems to be a safe, effective technique for improving the outcome of low colorectal or coloanal anastomosis. It is especially applicable when a colonic J-pouch anastomosis is technically difficult.

Adult↗
PubMed2002

Prospective, randomized trial comparing sigmoid vs. descending colonic J-pouch after total rectal excision.

PURPOSE: The aim of this study was to compare the bowel function of sigmoid vs. descending colonic J-pouches after ultralow anterior resection for rectal cancer. METHODS: A prospective, randomized trial was conducted from March 1998 to September 1999. Ninety-two consecutive patients undergoing ultralow anterior resection for cancers arising from 3 to 10 cm from the anal verge were recruited. Forty-eight patients were males; the mean ages (standard error of the mean) for patients with sigmoid and descending colon pouches, respectively, were 65.2 (3.1) years and 62.3 (3.1) years. A total of 46 patients were randomly assigned to each group. Two patients from each group were excluded; abdominoperineal resection was performed for two patients in the sigmoid pouch group and one patient in the descending pouch group. One patient in the descending pouch group had a transanal resection of a benign polyp. Dukes staging and use of postoperative chemoradiotherapy were statistically similar in both groups. All patients underwent a standardized ultralow anterior resection. A defunctioning loop ileostomy was used routinely. Anorectal physiology and bowel function questionnaires were performed at six weeks after ileostomy closure and again at 6 and 12 months after surgery. RESULTS: Median follow-up was 12 (range, 7 to 25) and 12 (range, 6 to 25) months, respectively, for sigmoid and descending pouch groups. Median tumor and anastomotic heights, time to ileostomy closure, operative time, and postoperative stay were statistically similar in both groups. There were no significant differences in stool frequency, incontinence, urgency, use of pads and antidiarrheals, sensation of incomplete evacuation, and anorectal physiology results between groups (P > 0.05). CONCLUSION: Pouches made from sigmoid or descending colon give similar bowel function after ultralow anterior resection for rectal cancers.

Adenocarcinoma↗
PubMed2002

Long-term outcomes of pelvic floor exercise and biofeedback treatment for patients with fecal incontinence.

PURPOSE: The aim of this study was to assess the long-term clinical and quality of life outcomes for patients after referral to a four-month treatment program for fecal incontinence based on pelvic floor exercises and biofeedback. Secondary objectives were to document patients' subsequent treatment activities and their perception of the biofeedback training; to establish the long-term outcomes and initial predictors for the subset of patients who did not complete the treatment, or who failed to improve during the program; and to correlate changes in clinical outcome measures and quality of life over time. METHODS: Patients were contacted by telephone to determine their perception of progress subsequent to the treatment program, any subsequent treatment or activities relating to their fecal incontinence, and which aspect of the treatment program they believed was most helpful. St. Mark's and Pescatori fecal incontinence scores were also recorded, along with patients' self-assessments of their incontinence severity and quality of life. RESULTS: Eighty-three (69 percent) patients were contacted for interviews at a median of 42 (range, 26-56) months after program completion. At the time of follow-up, patients who completed the program continued to enjoy strongly significant improvements in all outcome measures, with 75 percent perceiving a symptomatic improvement and 83 percent reporting improved quality of life. For many patients, improvement continued subsequent to program completion. Patients whose incontinence scores became worse during treatment still reported improvement in their quality of life and perceived incontinence severity during the same time period; many experienced some degree of "catch-up" in their continence scores during the follow-up period. Fourteen patients (17 percent) went on to have surgery for fecal incontinence; of these, 6 (7 percent) had a stoma. Twenty (24 percent) regularly took antidiarrheal medication. Thirty program completers (41 percent) were continuing pelvic floor exercises. CONCLUSIONS: This study confirms the long-term improvement in fecal incontinence achieved through treatment with biofeedback and pelvic floor exercises. In this study, patients also continued to improve after treatment completion, possibly because of the strong emphasis placed on patients during treatment to continue the pelvic floor exercises on their own. The poor correlation between quality of life and quantitative scores of fecal incontinence suggests that there are important aspects of continence that are not being appropriately recognized.

Adult↗
PubMed2003

Clostridium difficile infection--an unusual cause of refractory pouchitis: report of a case.

PURPOSE: Ileal pouch-anal anastomosis is the surgical procedure of choice for selected patients with severe ulcerative colitis. Pouchitis is a common complication of this procedure, with most cases responding to treatment with metronidazole, possibly with the addition of 5-aminosalicylic acid drugs and steroids. can frequently colonize the colon after treatment with broad-spectrum antibiotics, giving rise to diarrhea or colitis. The aim of this report was to describe the first case of -associated diarrhea manifest as pouchitis. METHODS: The management of refractory pouchitis in a 35-year-old female with toxin in the stool is described followed by a literature review of small-intestinal infection. RESULTS: Assays for toxin on stool sent during an episode considered to be caused by idiopathic chronic pouchitis were positive, and treatment with oral vancomycin was initiated. The patient responded with a reduction in bowel frequency to twice daily, a successful discontinuation of her antidiarrheal medication, and a rapid increase in weight. A subsequent stool assay was negative for the toxin. CONCLUSIONS: infection can complicate pouchitis in patients with an ileal pouch-anal anastomosis and should be considered in patients who fail to respond to standard treatment, including metronidazole. In cases of refractory pouchitis, superadded infection with should be excluded before initiation of potent anti-inflammatory drugs.

Adult↗
PubMed2006

Phase I study of gefitinib, oxaliplatin, 5-fluorouracil, and leucovorin (IFOX) in patients with advanced solid malignancies.

PURPOSE: Aphase 1 study of gefitinib in combination with oxaliplatin, 5-fluorouracil and leucovorin (IFOX)was conducted to evaluate the safety and feasibility of this regimen. PATIENTS AND METHODS: Patients with advanced solid malignancies were treated with escalating doses of gefitinib (250 mg or 500 mg once daily) in combination with FOLFOX (oxaliplatin, 5-fluorouracil, and leucovorin). The initial dose of oxaliplatin was 70 mg/m2 with sequential dose escalation to 85 mg/m2. RESULTS: Sixteen patients received a total of 138 14-day courses of daily gefitinib in combination with FOLFOX. Escalation of gefitinib from 250 mg/d to 500 mg/d with FOLFOX was well-tolerated. In addition, no severe toxicities precluded subsequent dose escalation of oxaliplatin from 70 mg/m2 to 85 mg/m2 at which no dose-limiting toxicity was seen. No further dose escalation was performed as this represented the oxaliplatin dose administered in the standard FOLFOX-4 regimen. The most predominant toxicity was diarrhea, which was well controlled with oral antidiarrheal agents. Four partial remissions occurred in patients with metastatic colorectal cancer. CONCLUSIONS: Gefitinib as a 500 mg daily continuous dose was well tolerated in combination with full doses of FOLFOX-4.

Adult↗
PubMed2001

Small Intestinal Infections.

The differential diagnosis of small intestinal infections is broad, making the identification and management of these disorders challenging. The majority of cases of acute diarrhea are self-limited and do not require diagnostic evaluation or treatment. Most patients do not require specific therapy, and treatment should focus on fluid and electrolyte replacement. In patients with severe, persistent, or chronic diarrhea, a careful medical history and routine stool testing are helpful in determining the cause. Pathogen-specific therapy should be given in patients in whom a pathogen is identified. In those without an identifiable pathogen, antidiarrheal agents are helpful in reducing the number of bowel movements and preventing further dehydration. Endoscopy may be helpful in patients with severe diarrhea and a negative stool evaluation, particularly in HIV-infected patients with chronic diarrhea. Surgery has a limited role in the management of small intestinal infections, but may be lifesaving in patients with intestinal perforation or small bowel obstruction.

Journal Article↗