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At least 523 records · Page 29Linked to original sources
PubMed1998

Phase I trial of continuous infusion flavopiridol, a novel cyclin-dependent kinase inhibitor, in patients with refractory neoplasms.

PURPOSE: We conducted a phase I trial of the cyclin-dependent kinase inhibitor, flavopiridol (National Service Center [NSC] 649890), to determine the maximum-tolerated dose (MTD), toxicity profile, and pharmacology of flavopiridol given as a 72-hour infusion every 2 weeks. PATIENTS AND METHODS: Seventy-six patients with refractory malignancies with prior disease progression were treated with flavopiridol, with first-cycle pharmacokinetic sampling. RESULTS: Forty-nine patients defined our first MTD, 50 mg/m2/d x 3 with dose-limiting toxicity (DLT) of secretory diarrhea at 62.5 mg/kg/d x 3. Subsequent patients received antidiarrheal prophylaxis (ADP) to define a second MTD, 78 mg/m2/d x 3 with DLT of hypotension at 98 mg/m2/d x 3. Other toxicities included a proinflammatory syndrome with alterations in acute-phase reactants, particularly at doses >50 mg/ m2/d x 3, which in some patients prevented chronic therapy every 2 weeks. In some patients, ADP was not successful, requiring dose-deescalation. Although approximately 70% of patients displayed predictable flavopiridol pharmacology, we observed unexpected interpatient variability and postinfusion peaks in approximately 30% of cases. At the two MTDs, we achieved a mean plasma flavopiridol concentration of 271 nM (50 mg/m2/d x 3) and 344 nM (78 mg/m2/d x 3), respectively. One partial response in a patient with renal cancer and minor responses (n=3) in patients with non-Hodgkin's lymphoma, colon, and renal cancer occurred. CONCLUSION: The MTD of infusional flavopiridol is 50 mg/m2/d x 3 with dose-limiting secretory diarrhea at 62.5 mg/m2/d x 3. With ADP, 78 mg/m2/d x 3 was the MTD, with dose-limiting hypotension at 98 mg/m2/d x 3. Based on chronic tolerability, 50 mg/m2/d x 3 is the recommended phase II dose without ADP. Antitumor effect was observed in certain patients with renal, prostate, and colon cancer, and non-Hodgkin's lymphoma. Concentrations of flavopiridol (200 to 400 nM) needed for cyclin-dependent kinase inhibition in preclinical models were achieved safely.

Adult↗
PubMed2003

Phase II study of oral vinorelbine in first-line advanced breast cancer chemotherapy.

PURPOSE: A phase II trial was performed to evaluate the efficacy, tolerance, and pharmacokinetic profiles of oral vinorelbine (Navelbine). Oral Navelbine (NVB; Pierre Fabre Médicament, Boulogne, France) was given as first-line chemotherapy for locally advanced or metastatic breast carcinoma (ABC). PATIENTS AND METHODS: Sixty-four patients were entered to receive oral NVB on a weekly basis for a total of 8 weeks unless progression or toxicity occurred. Oral NVB was given at 60 mg/m(2) weekly for the first three administrations and was increased to 80 mg/m(2) for the subsequent administrations if there was no grade 4 neutropenia or no more than one episode of grade 3 neutropenia. Patients with objective response or stable disease continued treatment up to a total of 12 weeks or more. RESULTS: Fifty-eight evaluable patients were included in our study. Four patients (6.9%) had complete responses, and 14 (24.1%) had partial responses, for an overall response rate of 31% (95% CI, 19% to 43%). Median progression-free survival was 17.4 weeks. Median overall survival is not yet reached. There were no treatment-related deaths. The main toxicity was neutropenia: grade 4 in 17.2% of the patients, and 1.8% of administrations and associated clinical serious events in 4 patients (6.2%). Grade 3 and 4 nausea and/or vomiting were noted in 3.1% and 4.6% of the patients, respectively. Only one patient developed grade 3 neuroconstipation. An analysis of Quality of Life Questionnaire C30 forms revealed no significant alteration between baseline and weeks 8 and 16 in global quality of life. CONCLUSION: Oral NVB at this schedule is an effective and well-tolerated agent in the treatment of ABC and offers a promising alternative to the intravenous route. Combination studies are ongoing.

Administration, Oral↗
PubMed2004

Phase II study of activated charcoal to prevent irinotecan-induced diarrhea.

PURPOSE: The dose-limiting toxicity of irinotecan (CPT-11; Camptosar) is delayed-onset diarrhea, with an incidence at the grade 3 to 4 level of 20% to 35%. SN38, its active moiety, is responsible by a direct effect on mucosal topoisomerase-I. The aim of this study was to assess whether activated charcoal (AC), possibly by adsorbing free lumenal SN38, can reduce irinotecan-induced diarrhea (CID) and optimize its dose-intensity. PATIENTS AND METHODS: Patients with advanced colorectal cancer receiving irinotecan 125 mg/m(2) intravenously once a week for 4 weeks every 6 weeks were studied. In cycle 1, patients received irinotecan plus AC (5 mL aqueous Charcodote [1,000 mg AC] plus 25 mL water) given the evening before the irinotecan dose and then tid for 48 hours after the dose. In cycle 2, no AC was given. National Cancer Institute Common Toxicity Criteria diarrhea grade, irinotecan dose-intensity, and loperamide consumption were recorded prospectively in both cycles. RESULTS: Twenty-eight patients had completed cycle 1 with AC; 24 subsequently completed cycle 2 without AC. Grade 3 to 4 diarrhea was 7.1% v 25%, and grade 0 diarrhea was 46.4% v 20.8% in cycles 1 and 2, respectively. Median percent planned dose delivered was 98% v 70% in cycles 1 and 2, respectively. In cycles 1 and 2, respectively, 25% v 54% patients took more than 10 loperamide tablets. AC was well tolerated with excellent compliance. CONCLUSION: The administration of AC with irinotecan reduced the incidence of grade 3 to 4 diarrhea and antidiarrheal medication consumption and increased irinotecan dose-intensity. Prophylactic AC may have a role in reducing dose-limiting CID and optimizing irinotecan therapy.

Adult↗
PubMed1998

Effects of Hange-shashin-to on cholera toxin-induced fluid secretion in the small intestine of rats.

The effects of Hange-shashin-to (TJ-14) on cholera toxin-induced intestinal fluid secretion were studied to elucidate the mechanism by which this kampo medicine manifests antidiarrheal effects. TJ-14 suppressed the intestinal fluid secretion induced by cholera toxin (1 microg/rat) in a dose-dependent manner at doses between 125 and 1000 mg/kg. It also inhibited the luminal prostaglandin E2 (PGE2) level. On the other hand, serotonin (5-HT) release was not affected by TJ-14. Subcutaneous injection of indomethacin at 10 mg/kg or ondansetron at 100 microg/kg significantly suppressed intestinal secretion. The luminal PGE2 level was also inhibited by indomethacin (10 mg/kg, s.c.). TJ-14, even at 10(-4) g/ml, had little effect on the phasic contraction of isolated guinea pig ileum induced by 5-HT (2 x 10(-6) g/ml), while ondansetron suppressed the phasic contraction caused by 5-HT. These results indicate that TJ-14 is useful in suppressing cholera toxin-stimulated intestinal fluid secretion, and that this effect is partially due to its suppressive action on the PGE2 level.

Animals↗
PubMed1990

Studies of aloe. III. Mechanism of cathartic effect. (2).

The mechanism of action of aloe-emodin-9-anthrone, a decomposition product of barbaloin, in causing a significant increase in the water content of the rat large intestine, was investigated. Aloe-emodin-9-anthrone inhibited rat colonic Na+, K(+)-adenosine triphosphatase (ATPase) in vitro, and increased the paracellular permeability across the rat colonic mucosa in vivo. Therefore, it seemed that the increase in water content of the rat large intestine produced by aloe-emodin-9-anthrone was due to both inhibition of absorption and stimulation of secretion without stimulation of peristalsis. Furthermore, pretreatment with loperamide, an antidiarrheal agent, completely prevented the increase of paracellular permeability induced by aloe-emodin-9-anthrone but did not completely reduce the concomitant increase in residual fluid volume. These findings suggest that aloe-emodin-9-anthrone has multiple mechanisms of action involved in the increase of water content in the rat large intestine.

Aloe↗
PubMed1990

[Anticholinergic action of Paeony root and its active constituents].

Anticholinergic action of Paeony root was examined in in vivo experiments with rat in order to substantiate the presence of analgesic, antispasmic and antidiarrheal properties. The 50% methanol extract of Paeony root was found to be effective. Fractionation of 50% methanol extract through column chromatography revealed that paeoniflorin was one of the active constituents in anticholinergic action in vivo, but in vitro, paeoniflorin had no effect on contractile responses of isolated rat proximal colon to the carbachol and KCl.

Animals↗
PubMed2001

Use of sucralfate in renal failure.

OBJECTIVE: To assess the potential for the development of aluminum toxicity in patients with renal insufficiency or chronic renal failure who are taking sucralfate. DATA SOURCES: Clinical literature accessed through MEDLINE (1966-December 1999) and International Pharmaceutical Abstracts (1970-December 1999). Key search terms included sucralfate, renal failure, renal insufficiency, and end-stage renal disease. DATA SYNTHESIS: Urinary excretion is an important route of elimination for systemically absorbed aluminum. Accumulation of aluminum in patients with impaired renal function may lead to significant toxicity. A potential source of aluminum is the antiulcer medication sucralfate. Studies and case reports evaluating the use and toxicity of sucralfate in patients with normal renal function, as well as those with renal failure or renal insufficiency, were reviewed. CONCLUSIONS: Aluminum accumulation and toxicity have been reported with the use of sucralfate in patients with compromised renal function. The risk of toxicity most likely represents a long-term complication of sucralfate use in this patient population. Toxicity may be enhanced by concurrent use of other aluminum-containing medications, such as phosphate binders or antidiarrheal preparations. These medications, in addition to sucralfate, should be avoided if possible in patients with end-stage renal disease. Patients with renal failure or renal insufficiency who are undergoing prolonged sucralfate therapy should be monitored for potential signs of aluminum toxicity.

Aluminum↗
PubMed2004

Treatment of pain symptoms in irritable bowel syndrome patients.

Irritable bowel syndrome represents a common gastrointestinal disorder that significantly impacts patients' lives. It is defined by Rome II criteria and characterized by abdominal pain and bloating associated with changes in bowel habit. Visceral hypersensitivity is currently considered a biological marker for the disease. Current therapeutic treatments include the use of fiber supplements, antidiarrheal agents, laxatives, antispasmodics, tricyclic antidepressants and serotonergic agents. Through a proper understanding of the diagnostic criteria, pathophysiology and treatment options, this disorder can be treated effectively in many patients.

Abdominal Pain↗
PubMed1977

[Effects of loperamide on the gastric and intestinal motilities in the guinea pig and dog (author's transl)].

In anesthetized dogs, intravenous administration or intrajejunal infusion of Loperamide produced the excitatory effect of gastric, small and large bowel motilities accompanied with elevation of the muscle tone. The excitatory response was slightly suppressed by administration of atropine. Such effects were similar to those of morphine and methadone. In non-anesthetized spinal guinea pigs, Loperamide increased colonic motility accompanied with the augmentation of the colonic muscle tone, but the conduction of the contraction waves was prevented. In anesthetized guinea pigs, intravenous administration of Loperamide reduced the rate of the rhythmic contraction waves of the small intestine, but its effect on the muscle tone was not evident. The activity of Loperamide as an antidiarrheal agent was discussed.

Animals↗
PubMed2002

Lactobacillus therapy for acute infectious diarrhea in children: a meta-analysis.

OBJECTIVE: Childhood diarrhea accounts for substantial morbidity and mortality worldwide. Multiple studies in children have shown that Lactobacillus, administered orally, may have antidiarrheal properties. We conducted a meta-analysis of randomized, controlled studies to assess whether treatment with Lactobacillus improves clinical outcomes in children with acute infectious diarrhea. METHODS: Studies were sought in bibliographic databases of traditional biomedical as well as complementary and alternative medicine literature published from 1966 to 2000. Search terms were "competitive inhibition," "diarrhea," "gastroenteritis," "Lactobacillus," "probiotic," "rotavirus," and "yog(h)urt." We included studies that were adequately randomized, blinded, controlled trials in which the treatment group received Lactobacillus and the control group received an adequate placebo and that reported clinical outcome measures of diarrhea intensity. These inclusion criteria were applied by blind review and consensus. The original search yielded 26 studies, 9 of which met the criteria. Multiple observers independently extracted study characteristics and clinical outcomes. Data sufficient to perform meta-analysis of the effect of Lactobacillus on diarrhea duration and diarrhea frequency on day 2 were contained in 7 and 3 of the included studies, respectively. RESULTS: Summary point estimates indicate a reduction in diarrhea duration of 0.7 days (95% confidence interval: 0.3-1.2 days) and a reduction in diarrhea frequency of 1.6 stools on day 2 of treatment (95% confidence interval: 0.7-2.6 fewer stools) in the participants who received Lactobacillus compared with those who received placebo. Details of treatment protocols varied among the studies. A preplanned subanalysis suggests a dose-effect relationship. CONCLUSION: The results of this meta-analysis suggest that Lactobacillus is safe and effective as a treatment for children with acute infectious diarrhea.

Administration, Oral↗
PubMed2006

Akt-and CREB-mediated prostate cancer cell proliferation inhibition by Nexrutine, a Phellodendron amurense extract.

Evidence from epidemiological studies suggests that plant-based diets can reduce the risk of prostate cancer. However, very little information is available concerning the use of botanicals in preventing prostate cancer. As a first step toward developing botanicals as prostate cancer preventives, we examined the effect of Nexrutine on human prostate cancer cells. Nexrutine is a herbal extract developed from Phellodendron amurense. Phellodendron extracts have been used traditionally in Chinese medicine for hundreds of years as an antidiarrheal, astringent, and anti-inflammatory agent. The present study investigated its potential antitumor effect on human prostate cancer cells. Our results suggest that it inhibits tumor cell proliferation through apoptosis induction and inhibition of cell survival signaling. The results of the present study indicate that Nexrutine treatment 1) inhibits the proliferation of both androgen-responsive and androgen-independent human prostate cancer cells through induction of apoptosis; 2) reduces levels of pAkt, phosphorylated cAMP response-binding protein (pCREB) and CREB DNA-binding activity; and 3) induces apoptosis in prostate cancer cells stably overexpressing Bcl-2. Further, Akt kinase activity was reduced in cells treated with Nexrutine, and ectopic expression of myristoylated Akt protected from Nexrutine induced inhibition of proliferation, implicating a role for Akt signaling.

Antineoplastic Agents↗
PubMed1986

Epidemic campylobacteriosis associated with a community water supply.

In May 1983, an estimated 865 cases of epidemic gastrointestinal disease occurred in Greenville, Florida. Surveillance of pharmacy sales of antidiarrheal medicines suggested that the outbreak was confined to Greenville and its immediate vicinity. Surveys demonstrated that the gastrointestinal illness attack rates inside and outside the city limits were 56 per cent (72/128) and 9 per cent (7/77), respectively (relative risk (RR) = 6.2); consumption of city water was associated with illness (RR = 12); and as water consumption increased, the attack rate also increased (p less than 0.001). Four adults were hospitalized and one outbreak-related case of Guillain-Barre' syndrome was identified. Campylobacter jejuni was isolated from specimens from 11 ill persons; serologic studies showed the development of Campylobacter-specific antibodies. Fecal coliforms were found in water samples, but Campylobacter was not recovered from water. The city water plant, a deep well system, had numerous deficiencies including an unlicensed operator, a failure of chlorination, and open-top treatment towers. Birds were observed perching on the open-top treatment tower. Of 38 birds trapped seven weeks later, 37 per cent harbored C. jejuni; however, plasmid and serotyping studies showed that strains were not the same as the common strain from ill persons. This outbreak suggests that water systems that are unprotected from contact with birds may become contaminated and a source of outbreaks of human campylobacteriosis.

Adult↗
PubMed2005

Evaluation of risk factors for development of catheter-associated jugular thrombophlebitis in horses: 50 cases (1993-1998).

OBJECTIVE: To evaluate risk factors associated with development of catheter-associated jugular thrombophlebitis in hospitalized horses. DESIGN: Retrospective case-control study. ANIMALS: 50 horses with thrombophlebitis and 100 control horses. PROCEDURE: Medical records from 1993 through 1998 were searched for horses with thrombophlebitis. Horses that were hospitalized for at least 5 days, had an i.v. catheter placed in a jugular vein (other than for solely anesthetic purposes), and had no evidence of thrombophlebitis during admission or hospitalization were chosen as controls. Signalment, history, clinicopathologic findings, primary illness, and treatment were obtained from the medical records. Data were analyzed by use of logistic regression to perform univariate and multivariate analyses. RESULTS: For a horse with endotoxemia, the odds of developing thrombophlebitis were 18 times those for a similar horse without endotoxemia. For a horse with salmonellosis, the odds of developing thrombophlebitis were 68 times those for a similar horse without salmonellosis. For a horse with hypoproteinemia, the odds of developing thrombophlebitis were almost 5 times those for a similar horse without hypoproteinemia. For a horse in the medicine section, the odds of developing thrombophlebitis were 16 times those for a similar horse in the surgery section. For a horse with large intestinal dise, the odds of developing thrombophlebitis were 4 times those for a similar horse without large intestinal disease. For a horse receiving antidiarrheal or antiulcerative medications, the odds of developing thrombophlebitis were 31 times those for a similar horse not receiving these medications. CONCLUSIONS AND CLINICAL RELEVANCE: Results indicated that patient factors, including large intestinal disease, hypoproteinemia, salmonellosis, and endotoxemia, were associated with development of catheter-associated thrombophlebitis in horses.

Animals↗
PubMed1995

Quality of life during pelvic radiotherapy.

BACKGROUND: A randomized clinical trial was carried out to evaluate the effect of a diet low in fat and lactose to prevent acute radiation-induced diarrhea. The effect of the diet treatment on the patients' health related quality of life was studied. METHODS: 143 women with gynecological malignancies were included. The daily number and consistency of stools, use of antidiarrheal agents and quality of life measured by using the EORTC Core Quality of life Questionnaire 36 item version, were recorded before therapy, in the last week of treatment, six weeks after end of radiotherapy and every eight weeks during one year's follow up. RESULTS: Fourteen patients (23%) in the intervention group reported diarrhea during radiotherapy, compared to 32 (48%) in the control group (p < 0.01). This difference was not seen with the EORTC questionnaire. The diet intervention did not interfere with emotional and social well-being. Within the control group diarrhea was associated with higher scores on the physical functioning scale (p < 0.01), and fatigue and malaise scale (p < 0.01) indicating more pronounced dysfunction of symptoms. CONCLUSION: When measuring specific phenomena such as diarrhea in a clinical trial, the EORTC questionnaire does not seem to be as sensitive as specific trial-related instruments. Diet intervention during radiotherapy might influence the patients' ability to cope with diarrhea by giving them more control over their own situation.

Acute Disease↗
PubMed1985

Total colectomy, mucosal proctectomy, and an ileal reservoir to an anal anastomosis. A comparison of short and long efferent legs.

In a consecutive series of 46 possible candidates for total colectomy, mucosal proctectomy, and ileal reservoir to an anal anastomosis, we have compared the clinical outcome of group I, with a long efferent leg (12 cm), and group II, with a short efferent leg (3-5 cm). The surgical procedure was done in three steps: first, a total colectomy; second, mucosal proctectomy and construction of an 'S-shaped' ileal reservoir with a temporary loop ileostomy; and, third, closing of the ileostomy. Nine patients with a long efferent leg and eight patients with a short leg were observed for 2-51 months with a functioning ileal reservoir. The overall mortality was zero. The results showed that the short efferent leg was important for low fecal urgency, spontaneous evacuation of stools, minimal soiling, independence of reservoir catheterization, and use of antidiarrheal drugs. The length of the efferent leg did not influence the function of the anal sphincter itself. The postoperative sexual life was unchanged, and all patients in group II had a better resocialization than those in group I. The selection of candidates for ileal reservoir operations from among patients with ulcerative colitis or familiar polyposis is most important because of a relatively long postoperative course and high incidence of surgical complications.

Adolescent↗
PubMed1994

Ketanserin and granisetron reduce cholera toxin-induced hypersecretion in pig jejunum.

BACKGROUND: Serotonin antagonists have been proven antisecretory in cholera toxin (CT)-induced hypersecretion in the small intestine of rodents. The pig small intestine is a good model for the human small intestine with regard to physiologic and pharmacologic processes. METHODS: The antisecretory effect of intraluminally administered methysergide, renzapride, ketanserin, granisetron, and tropisetron on CT-induced hypersecretion was tested in isolated pig jejunal loops in vivo. RESULTS: Methysergide, ketanserin, and granisetron reduced the hypersecretory effect of CT maximally by 25%, 80%, and 50%, respectively. Tropisetron enhanced whereas renzapride did not alter the CT response. Combination of ketanserin and granisetron gave a maximal inhibitory effect of about 85%. Surprisingly, renzapride, granisetron, and tropisetron each induced hypersecretion. Taking into account the hypersecretory effect of the antagonists, they all reduced this CT-elicited hypersecretion. CONCLUSIONS: Results suggest involvement of the 5-hydroxytryptamine-2 and 5-hydroxytryptamine-3 receptor subtypes as mediators in CT-induced hypersecretion in pig jejunum, and antidiarrheal therapeutic potentials of ketanserin and granisetron.

Animals↗
PubMed1977

Use of difenoximide (SC-26100) for narcotic detoxification: a preliminary tolerance and efficacy study.

Difenoximide (SC-26100) is closely related to the antidiarrheal agent, diphenoxylate, which is a chemical congener of meperidine. It has been shown to have a greater ability than methadone to suppress opiate withdrawal in addicted mice, and it has produced less physical dependence than morphine and methadone in laboratory animals. In this study difenoximide was administered to nine active heroin addicts. A dose of 4 mg administered 4 times per day for 3 days effectively suppressed opiate withdrawal, while a dose of 8 mg produced symptoms resembling those of narcotic excess in subjects who had recently self-administered heroin. No side effect were observed at the therapeutic dosage level, and the drug was well accepted by subjects. Difenoximide was shown to be a potentially useful narcotic treatment agent in this impatient study.

Adolescent↗