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PubMed2003

CBP 1011: Colirest, Hematrol.

InKine Pharmaceutical Co. is developing an oral compound, CBP 1011, for the treatment of immune thrombocytopenic purpura (ITP) [Hematrol] and for the treatment of inflammatory bowel disorders, ulcerative colitis and Crohn's disease (Colirest). This profile has been selected from R&D Insight, a pharmaceutical intelligence database produced by Adis International Ltd. CBP 1011 or medroxyprogesterone, is a progesterone agonist and inhibits pro-inflammatory mediators such as interleukin-6 and tumour necrosis factor (TNF). CBP 1011 was originally developed by CorBec Pharmaceuticals, which in 1997 was aquired by Panax and then intergrated into InKine Pharmaceuticals. According to a company spokesperson, InKline is pursuing outlicensing opportunities for Hematrol since the company's current commercial focus is on gastrointestinal products. In June 2000, InKine announced the completion of a study comparing the bioavailability of a commercially viable tablet formulation of CBP 1011 to the original capsule formulation that is currently being used in the company's phase III studies in patients with idiopathic thrombocytopenic purpura. Preliminary results from this study indicate that the bioavailability of the tablet formulation does not differ significantly from that of the capsule formulation. The trial enrolled ITP patients (i) who are HIV positive, (ii) who are chronic ITP sufferers despite having had a splenectomy, (iii) who are older, or (iv) who have less severe thrombocytopenia. In preclinical trials, CBP 1011 was shown to decrease lymphocyte infiltration into the bowel compared with the control. Studies also show that it possibly offers safety benefits over steroid therapies. In June 2001, InKine commenced enrolment for a pivotal phase III trial in the treatment of Crohn's disease. This randomised, double-blind trial will enrol approximately 250 patients and will compare two doses of CBP 1011 (400 and 1000mg) with placebo. In April 2003, the US Patent and Trademark Office granted InKine Pharmaceutical a 'Notice of Allowance' for the 'Method of Treating Inflammatory Conditions with Progesterone or Progesterone Analogs'. This patent for medroxyprogesterone (Colirest) provides InKine patent protection for the use of Colirest in treating patients with Crohn's disease, ulcerative colitis, proctitis, microscopic colitis, allergic eosinophilic gastroenteritis, food allergies, drug-induced oesophagitis, coeliac disease, recurrent polyps and haemorrhoids. The patent protection also covers Colirest in a variety of delivery forms such as tablet, enema, suppository, foam, gel, ointment and suspension.

Administration, Oral↗
PubMed2004

WF 10: Macrokine, TCDO, tetrachlorodecaoxide.

WF 10 [TCDO, Oxoferin, Immunokine, Macrokine] is a 1:10 dilution of tetrachlorodecaoxide formulated for IV delivery. It was developed by Oxo Chemie in Switzerland as an adjunctive therapy to combination antiretroviral and opportunistic infection prophylaxis regimens in AIDS patients. WF 10 specifically targets macrophages. Oxo Chemie has worldwide patent rights to WF 10 and Dimethaid Research has an exclusive licence for marketing and distribution in Canada. In May 2002, Oxo Chemie was acquired by Dimethaid Research. Oxo completed a trial in 72 cervical cancer patients undergoing radiation therapy in 1989. Results from this trial demonstrated complete remission in 75% of patients receiving WF 10. A follow-up placebo controlled trial in 1996 produced similar results. WF 10 has received regulatory approval in Thailand for postradiation cystitis following a trial completed in 1998 in 20 patients following radiation treatment for cervical carcinoma. This authorisation also allows limited availability of WF 10 at the physician's request in Germany. WF 10 is also available under Health Canada's Special Access Program. Oxo Chemie has completed a controlled randomised, crossover study in France in 1991 that examined the effects of 103 patients with acute radiation dermatitis and radiation- or chemotherapy-induced mucositis. Results demonstrated that WF 10 significantly improved lesions and accelerated recovery without side effects. Topical tetrachlorodecaoxide in a less concentrated formulation (1:55) is marketed in many countries as Oxoferin for wound healing. WF 10 is approved for use in Thailand under the name IMMUNOKINE in patients with postradiation chronic inflammatory disease including cystitis, proctitis and mucositis. In July 2003, the European examiners informed Oxo Chemie that they intend to grant the company additional patents to the technology platform that supports WF 10, extending the European protection granted in 1992 to cover a much broader range of diseases. The patents will be granted in Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Liechtenstein, Luxembourg, Monaco, the Netherlands, Portugal, Spain, Sweden, Switzerland and the UK. Patent claims cover potential treatment for autoimmune disease, organ transplant or graft rejection, lymphoma and inflammation manifested as hepatitis or chronic obstructive pulmonary disease.

Adjuvants, Immunologic↗
PubMed2002

Ulcerative colitis in monozygotic twin sisters.

We present a rare occurrence of woman monozygotic twins with ulcerative colitis (UC). A 21-year-old woman came to our hospital because of diarrhea, abdominal pain and hematochezia. We diagnosed this case as proctitis type UC by endoscopic and histological findings. Six months later, her twin sister developed total colitis type UC. Both twins had HLA-A24, B52, DR2, and DQ1 serological types, and had DRB1*1502 DNA type, previously shown to be associated with UC. This case report suggested an association of genetic factor together with environmental factors in the etiology for UC.

Adult↗
PubMed1994

Gastrointestinal manifestations of AIDS in children.

The gastrointestinal manifestations of AIDS in children are related to opportunistic infections, lymphoproliferative disease, and cancer. The infections that affect the gastrointestinal tract at different sites also occur in patients without AIDS. However, in children with AIDS, the infections are more severe, often relapse, and are harder to eradicate. Candidiasis is the most common infection in the esophagus, but infections caused by herpes simplex virus and cytomegalovirus also are common. Radiologic findings include ulcerations, a cobblestone appearance, and disordered motility. Gastritis and enteritis are usually caused by cytomegalovirus. Lesions produced by this virus include ulcerations caused by ischemic necrosis as a result of vasculitis. Barium studies show increased nodularity and effacement of mucosa. Other organisms (typically found in all immunocompromised patients) include Mycobacterium avium-intracellulare, Mycobacterium tuberculosis, Campylobacter, Giardia, and Cryptosporidium. Colitis and proctitis are caused by many of the same enteric pathogens. Cytomegalovirus is the most virulent, causing necrosis, perforation, and often death. Lymphoma, smooth muscle tumors, and Kaposi's sarcoma are the most common neoplasms encountered in children with AIDS.

AIDS-Related Opportunistic Infections↗
PubMed2005

Radiotherapy in prostate cancer treatment.

Prostate cancer is a complex disease, with many controversial aspects of management in almost all stages of disease. The natural history of this tumor is variable and is influenced by multiple prognostic factors. Radical prostatectomy and radiotherapy are standard treatment options for disease limited to the prostate. The data in literature does not provide clear- cut evidence for the superiority of any treatment. Neo- adjuvant or adjuvant hormonal therapy improves local control and survival in locally advanced disease. The patients treated with radiotherapy would have a relatively long life expectancy, not great risk factors for radiation toxicity and a preference for radiotherapy. The advantages of radiotherapy are that it has a significant potential for cure, it is well tolerated in the majority of men especially when the modern techniques of conformal radiotherapy and intensity modulated therapy are used and it is non-invasive therapeutic options with no anesthesia risk. Expected complications like radiation cystitis, impotence and proctitis are registered in about 1% of patients.

Combined Modality Therapy↗
PubMed1981

Elective surgery for ulcerative colitis: colectomy in 158 patients.

Chronic ulcerative colitis was treated by elective colectomy in 158 patients. Proctocolectomy and ileostomy was performed in 140 patients and colectomy and ileorectal anastomosis (CIRA) in 18 patients. The operative mortality was 2.5%, and postoperative complications, mostly infections, occurred in 38%. Within a 2-year postoperative period another 1.9% of the patients died, and late complications occurred in 18%. Colorectal carcinoma was present at the time of colectomy in 5.1% and developed some years later in another two patients primarily operated on with CIRA. Half of the cancer patients died of malignancy. Most extracolic complications, present in 25% of patients before colectomy, regressed or disappeared after operation. Half of the patients operated on with CIRA needed to have their rectum removed within a few years because of cancer or proctitis, and few of the rest had lasting relief of symptoms.

Adolescent↗
PubMed1993

Serum selenium, copper, and zinc concentrations in Crohn's disease and ulcerative colitis.

Serum selenium, copper, and zinc levels were studied in 47 patients with Crohn's disease, 117 patients with ulcerative colitis, and 123 age- and sex-matched healthy controls. Serum selenium levels were lower and serum copper levels were higher in men and women with Crohn's disease than in controls (p < 0.001 and p < 0.01, respectively). Trace element levels were not significantly influenced by extent or localization of Crohn's disease. Men and women with ulcerative colitis had higher levels of copper and zinc than did controls (p < 0.01 and p < 0.05, respectively). Men with pancolitis had significantly lower selenium and higher copper levels than men with proctitis. The implications of abnormal trace element status in patients with inflammatory bowel disease are discussed.

Adult↗
PubMed1995

Ulcerative colitis and indeterminate colitis in the city of Malmö, Sweden. A 25-year incidence study.

BACKGROUND: This study was designed to assess time trends in the incidence of ulcerative colitis and indeterminate colitis in an urban population. METHODS: Medical records of in- and out-patients with inflammatory bowel disease were reviewed by a panel to establish the diagnosis. All histopathologic specimens and almost all radiographs were re-examined. RESULTS: During the time period 1958 to 1982 there were 354 new cases of definite ulcerative colitis, 117 of probable ulcerative colitis, and 100 of indeterminate colitis. This corresponds to an average annual incidence per 100,000 of 5.5, 1.8, and 1.6, respectively. The incidence was higher in men than in women. Peak incidence was between 20 and 29 years, but indeterminate colitis was most common in 10- to 19-year-old males. The incidence was stable from 1958 to 1972 but then increased in almost all age groups in both sexes. The increase in annual incidence of definite ulcerative colitis from 4.2 to 9.4/10(5) corresponds to an average annual increase of about 5% (p < 0.001). The increase in the incidence of definite ulcerative colitis was due to an increased proportion of patients with proctitis. CONCLUSIONS: This study has shown an increased incidence of ulcerative colitis and indeterminate colitis, and we have found no reason to believe that this is a spurious finding.

Adolescent↗
PubMed1996

Changes in extent of ulcerative colitis: a study on the course and prognostic factors.

BACKGROUND: The prognosis of patients with ulcerative colitis (UC) has previously been described with regard to mortality, cancer occurrence, and need for colectomy on the basis of an annual follow-up of a regional cohort of UC patients in Copenhagen County diagnosed in 1962-87. The objective of this study was to examine the prognosis with regard to spread of disease and to evaluate possible prognostic factors with regard to spread of disease and colectomy by multivariate regression analysis. METHODS: An inception cohort of 1161 patients with UC was examined by actuarial analysis and by multivariate regression analysis of a subgroup of 467 patients diagnosed in 1979-87. RESULTS: The probability for further progression of proctosigmoiditis, evaluated by sigmoidoscopy and radiology, was 53% after 25 years. The probability for regression was 76.8% for substantial colitis and 75.7% for pancolitis after 25 years. Multivariate regression analysis showed that the occurrence of the symptoms abdominal pain and diarrhoea was prognostically unfavourable with regard to the progression from proctosigmoiditis. Age influenced the regression probability in extensive disease. With regard to colectomy the following variables influenced the prognosis: fever, general condition, serum albumin, mucopus in stools, and diarrhoea at onset. CONCLUSIONS: Disease extent in UC is not static but changes with time in approximately half of the patients. This finding should have implications for the follow-up. Ulcerative proctitis should be considered the same disease as UC and needs the same long-term follow-up.

Actuarial Analysis↗
PubMed1996

Epidemiology of inflammatory bowel disease: an update.

What have epidemiologic studies on IBD taught so far? Consistent findings are as follows: A high incidence of both CD and UC in industrialized countries and an increase in these areas of the incidence of CD during the years 1960-80 followed by a plateau phase, and a more stable pattern in UC during the same period have been found. A greater number of mild cases have probably been diagnosed recently. This also helps to explain the differences in severity and survival between community and referral centre groups. The male to female ratio is greater than 1 in UC, and this is the opposite in CD. Mortality of IBD has decreased during the past decades. As young people are especially prone to develop IBD, most of those affected will have their disease for many years. In developing IBD, genetic influences are of importance. However, epidemiologic studies strongly point to possible interactions between genetically determined features and environmental or other factors. Of these exogenic factors smoking is the most consistent, being of negative influence in CD and protective in UC. Diet and oral contraceptives may influence disease expression, and perinatal events such as viral infections may alter adult susceptibility. The question remains open whether UC and CD are one diseases entity. Similarities in the epidemiologic features of UC and CD support the idea of IBD being one disease. Other findings suggest dividing UC and CD into further subgroups: in CD it has been suggested that fibrostenotic, penetrating, and inflammatory behaviour should be considered different disease entities; in UC some groups consider ulcerative proctitis a disease entity on its own, separating it from the proximally extending colitis. In therapeutic trials this approach has proved to be of importance, and it is not inconceivable that in subgroups, with regard to aetiopathogenetic mechanisms, different factors have to be looked for.

Adolescent↗
PubMed1979

Carcinoma of the uterine cervix. Results of treatment in 2 248 cases.

Data on the survival of 2 248 patients with cervical carcinoma, treated between1966 and 1972 at 3 oncologic centers in Cuba, are presented. Intracavitary radium application combined with external 60Co irradiation was the main treatment method. The most frequent complication was radiation proctitis, but fistulas occurred only in 1.6 per cent.

Adenocarcinoma↗
PubMed1987

Orgotein in radiation treatment of bladder cancer. A report on allergic reactions and lack of radioprotective effect.

The possible protective effect of orgotein (a superoxide dismutase) on radiation cystitis and proctitis was studied in patients with carcinoma of the urinary bladder. A double-blind study in 60 patients was planned but due to unacceptable side effects only 30 patients were included. Radiation treatment was given with curative intent at a dose of 63 Gy in 30 fractions. Orgotein was injected 15 min after each daily radiation treatment at a dose of 4 or 8 mg. No effect of orgotein on tumour radiation response or on the acute radiation reactions in the bladder and rectum was detected. Marked subcutaneous infiltration and redness was seen at the local injection site in 5 patients. No general symptoms were observed. Intradermal tests and antibody titration tests showed that the local reactions were due to allergic reactions to the drug itself. The lack of radioprotective effect and the high frequency of unacceptable side effects makes orgotein an unsuitable drug in clinical radiation therapy.

Actuarial Analysis↗
PubMed1991

Radiotherapy for postoperative recurrent uterine cervical carcinoma.

From January 1980 to December 1985, a total of 110 patients with postoperative recurrent uterine cervical carcinoma were treated with radiotherapy. The mean age was 53 years. Ten patients were excluded due to incomplete treatment. The population was grouped according to the classification by Ciatto et al. into patients with central recurrence (n = 48), with peripheral limited recurrence (n = 43), and with peripheral massive recurrence (n = 9). The midpelvic dose given to patients with central recurrence was 40 to 45 Gy, followed by a boost given either by perineal teletherapy with 30 Gy or brachytherapy with 30 Gy at 0.5 cm. beneath the vaginal mucosa. For the peripheral group, the midpelvic dose was 50 Gy followed by a boost of 10 Gy through reduced portals. Further boost to the vaginal mucosa was given by either of the two methods mentioned above. The overall 5-year survival rate was 28%. In the group with central recurrence, it was 42% and in the group with peripheral recurrence 15%. Sixteen patients had persistent local tumor and 15 patients developed distant metastasis. Complications noted were proctitis (5%), cystitis (2%), vesicovaginal fistula (2%) and rectovaginal fistula (2%). Our data clearly indicate that radiotherapy was effective in controlling central recurrence, but for peripheral recurrence, control rate and prognosis were less favorable.

Adult↗
PubMed1994

A phase I-II study of cyclophosphamide, epidoxorubicin, levofolinic acid/5-fluorouracil and recombinant human granulocyte colony stimulating factor in metastatic breast carcinoma.

Thirty patients with measurable metastatic breast carcinoma were treated with a combination of cyclophosphamide 600 mg/m2 on day 1, levofolinic acid 100 mg/m2 plus 5-fluorouracil 375 mg/m2 on days 1-3, and epidoxorubicin (EDXR) in three refracted doses on days 1-3 with G-CSF rescue for 10 days. In the phase I part of the study, groups of 3 patients received EDXR 20, 25, 30, 35, and 40 mg/m2/day until the dose limiting toxicity (DLT) was reached. At the dose of 40 mg/m2/day prolonged grade 4 leukopenia, severe proctitis, and grade 3 diarrhea represented the DLT. All subsequent patients were treated at the maximal tolerated dose of EDXR (35 mg/m2/day). In the group of 18 patients treated at 35 mg/m2/day the overall response rate was 78%, with 22% CR and 56% PR. Four patients did not respond. Objective responses were seen at all tumor sites including bone and viscera, which usually are rather chemotherapy insensitive. Toxicity was generally acceptable. Although the response rate was quite high, the duration of objective tumor regression and patients' survival were not impressive. In conclusion, we do not recommend routine use of such an aggressive regimen for palliation of advanced breast cancer. Results of the present and similar studies may, however, be useful for planning of neoadjuvant or adjuvant trials with curative intent.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed2004

Drug therapy for ulcerative colitis.

Ulcerative colitis (UC) is an inflammatory destructive disease of the large intestine occurred usually in the rectum and lower part of the colon as well as the entire colon. Drug therapy is not the only choice for UC treatment and medical management should be as a comprehensive whole. Azulfidine, Asacol, Pentasa, Dipentum, and Rowasa all contain 5-aminosalicylic acid (5-ASA), which is the topical anti-inflammatory ingredient. Pentasa is more commonly used in treating Crohn's ileitis because Pentasa capsules release more 5-ASA into the small intestine than Asacol tablets. Pentasa can also be used for treating mild to moderate UC. Rowasa enemas are safe and effective in treating ulcerative proctitis and proctosigmoiditis. The sulfa-free 5-ASA agents (Asacol, Pentasa, Dipentum and Rowasa) have fewer side effects than sulfa-containing Azulfidine. In UC patients with moderate to severe disease and in patients who failed to respond to 5-ASA compounds, systemic (oral) corticosteroids should be used. Systemic corticosteroids (prednisone, prednisolone, cortisone, etc.) are potent and fast-acting drugs for treating UC, Crohn's ileitis and ileocolitis. Systemic corticosteroids are not effective in maintaining remission in patients with UC. Serious side effects can result from prolonged corticosteroid treatment. To minimize side effects, corticosteroids should be gradually reduced as soon as the disease remission is achieved. In patients with corticosteroid-dependent or unresponsive to corticosteroid treatment, surgery or immunomodulator is considered. Immunomodulators used for treating severe UC include azathioprine/6-MP, methotrexate, and cyclosporine. Integrated traditional Chinese and Western medicine is safe and effective in maintaining remission in patients with UC.

Adrenal Cortex Hormones↗
PubMed2005

Incidence of ulcerative colitis in Central Greece: a prospective study.

AIM: To study the incidence of ulcerative colitis UC in the prefecture of Trikala, Central Greece. METHODS: A prospective and population based epidemiological study of UC from 1990 to the end of 1994 was conducted. Trikala is a semirural prefecture of Central Greece with a population of 138 946 (census 1991). Three gastroenterologists (one hospital based, two private doctors) of the prefecture participated in this study. RESULTS: During the study period, 66 new histologically verified cases of UC were recorded. The mean annual incidence of the disease in 1990-1994 was 11.2 per 10(5) inhabitants (95%CI: 8.7-14.3). There was no difference between men and women (annual incidence: 10.5 and 12.0 per 10(5) inhabitants respectively), either among urban, semirural or rural populations (annual incidence: 11.7, 17.1 and 9.9 per 10(5) inhabitants respectively). The majority (56%) of the patients never smoked and a quarter were ex-smokers. About a half of all cases had proctitis. CONCLUSION: UC is common in Central Greece and its incidence is similar to that in North-Western European countries.

Adolescent↗
PubMed2002

An analysis of 10218 ulcerative colitis cases in China.

AIM: To analyze the characteristics of ulcerative colitis(UC) in China. METHODS: From 1981 to 2000, a total of 10218 patients of UC reported in Chinese medical literature and including our cases diagnosed were analyzed according to the diagnostic criteria of Lennard-Jones. RESULTS: The number of cases increased by 3.08 times over the past 10 years (2506 patients were diagnosed from 1981 to 1990 while 7512 patients were diagnosed from 1991 to 2000). Lesion range were described in 7966 patients, 5592 (70.20%) were proctosigmoiditis or proctitis, 1792(22.50%) left-sided colitis, 582(7.30%) pancolitis. Among the 8122 patients, 2826 (34.8%) had first episode, 4272 (52.6%) had chronic relapse, 869 (10.7%) were of chronic persist type, 154 (1.9%) were of acute fulminant type. The course of the illness were described in 5867 patients, 4427(75.5%) were less than 5 years, 910 (15.5%) between 5 and 10 years,530 (9.1%) more than 10 years. Six hundred and sixteen patients 618 patients(6.1%) had extraintestinal manifestations. The mean age at the diagnosis was 40.7 years( range 6-80 years, and the peak ages 30-49 years). The male to female ratio was 1.09. Among 270 patients diagnosed in our hospital,36 had histories of smoking, there was no negative association between the severity of UC and smoking(P>0.05), 21 smokers were followed up for one year, 15 of them had given up smoking when the disease were diagnosed, and one year later, 7 patients relapsed, another 6 patients continued smoking, and one year later,2 patients relapsed. Among 270 UC patients diagnosed in our hospital, 4 patients(1.48%) from 2 families had familial history of UC. Treatment was mentioned in 6859 patients, only 5-ASA and/or corticosteroid only in 1276 patients(18.6%), only Chinese herbs in 1377 patients(20.1%), combined Chinese and western medicine in 4056 patients(59.1%), surgery was performed in 87 patients(1.3%),other treatments in 63 patients(0.9%). CONCLUSIONS: In China, number of UC patients increased significantly in the past 10 years. Lesions are commonly located to left side colon. The course is short with rare extraintestinal manifestations. The age of onset is relatively high. Males and females are nearly equally affected. No negative relation was found between smoking and severity of the disease. Familial relatives are rarely involved Traditional Chinese medicine(TCM) is widely used in the treatment of UC.

China↗