RESULTS Fifty-nine patients with ulcerative colitis and primary sclerosing cholangitis were enrolled in the colonoscopic surveillance program. Forty-one patients 69% ; had used ursodiol, and 18 31% ; had never used ursodiol. Characteristics of ursodiol users and nonusers are shown in Table 1. Twenty-six patients 44% ; had a.
What is the problem and what is known about it so far? Ulcerative colitis UC ; is a disease in which chronic inflammation of the colon leads to diarrhea, bleeding into the stool, abdominal pain, difficulties with nutrition, and an increased risk for colon cancer. Primary sclerosing cholangitis PSC ; is an inflammatory disease of the biliary tract, the system that brings bile from the liver to the gut. Approximately 2% to 4% of patients with UC also have PSC. Nearly half of patients with both UC and PSC will develop colon cancer or precancerous changes of the colon dysplasia ; within 25 years of diagnosis of UC. This risk for cancer is so high that some patients are willing to have their colons removed surgically as a preventive measure. Strategies to decrease the risk for colon cancer, other than removal of the colon, could benefit patients with both UC and PSC. Usodiol is a drug that has been useful in treating liver abnormalities in patients with PSC. Ursodiil decreases the amount of bile acids that reach the colon; this is important because bile acids may play a role in the development of colon cancer. Why did the researchers do this particular study? To find out whether patients with UC and PSC who receive ursodiol are less likely to develop colon cancer or precancerous changes of the colon than those who do not. Who was studied? Fifty-nine patients with UC and PSC who received care in a teaching hospital. How was the study done? The researchers determined whether patients were taking ursodiol and collected information about their medical histories. All of the patients had a procedure that examined the inside of the colon colonoscopy ; every 1 to 3 years to look for cancer or precancerous changes. What did the researchers find? Patients who took ursodiol were less likely to develop colon cancer or precancerous changes than those who did not. This relationship remained even after accounting for the patients' age, duration of UC and PSC, severity of liver disease, and use of other medications. What were the limitations of the study? It is unclear whether similar results would occur in patients who have UC only. The decision to treat with ursodiol was made by patients' individual doctors rather than as part of a randomized study. Patients who received ursodiol may therefore have differed from those who did not in ways that the researchers could not account for. What are the implications of the study? Patients with UC and PSC who take ursodiol appear less likely to develop cancer or precancerous changes of the colon than those who do not take ursodiol. A randomized trial should be done to determine whether ursodiol is effective prevention for colon cancer in patients with UC.
Table 2. Angiographic and Procedural Data of Patients With Diabetes Mellitus Versus Patients Without Diabetes Mellitus With Restenosis After Successful Coronary Atherectomy Patients With Diabetes n 18 ; Angiographic data Reference diameter mm ; MLD before DCA mm ; Stenosis before DCA MLD after DCA mm ; Stenosis after DCA Interval weeks ; * No. of vessels Pieces per sample DCA French size 3.5 0.89 71 Patients Without Diabetes n 18 ; 3.2 0.93 73 p Value 0.32 0.75 tous core was present in 4 of the 18 samples from patients with DM and in 1 of the 18 samples from patients without DM p NS ; Thrombus was present in 6 of the 18 samples from patients with DM and in 7 of the 18 samples from patients without DM p NS ; identify possible differences in coronary plaque composition among diabetic patients with or without pharmacologic therapy, a subgroup analysis was performed Table 4 ; . There were no significant differences in total area, hypercellular tissue, collagen-rich sclerotic tissue, atheromatous tissue or thrombus between diabetic patients treated with insulin or oral hypoglycemic medication and diabetic patients treated with diet alone.
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2002, 9 6 ; : 849-86 doi: 1 1089 1066527026051831 scott doniger brown university, mcb department, box g-j2, providence, ri 02912 thomas hofmann brown university, department of computer science, box 1910, providence, ri 02912 joanne yeh brown university, mcb department, box g-j2, providence, ri 02912; brown university, department of chemistry, providence, ri 02912 two different machine-learning algorithms have been used to predict the blood– brain barrier permeability of different classes of molecules, to develop a method to predict the ability of drug compounds to penetrate the cns and valproic.
10A NCAC 13F .1310 OTHER APPLICABLE RULES FOR SPECIAL CARE UNITS In addition to specific rules pertaining to special care units for residents in this Section, such units shall also meet all other applicable requirements governing the operation of adult care homes as set forth in this Subchapter. History Note: Authority G.S. 131D-2; 131D-4.5; 131D-4.6; S.L. 1999-0334; Temporary Adoption Eff. December 1, 1999; Eff. July 1, 2000. SECTION .1400 SPECIAL CARE UNITS FOR MENTAL HEALTH DISORDERS 10A NCAC 13F .1401 DEFINITIONS APPLICABLE TO SPECIAL CARE UNITS The following definitions shall apply throughout this Section: 1 ; "Special care unit for persons with a mental health disability" means an entire facility or any section, wing or hallway within an adult care home separated by closed doors from the rest of the home a special care unit as defined in G.S. 131D-4.6, that is, "a wing or hallway within an adult care home, or a program provided by an adult care home, " that is designated or advertised especially for special care of residents with a mental health disability. 2 ; "Care coordinator" means a staff person in a special care unit who oversees resident care and coordinates, supervises and evaluates resident services to assure that each resident receives services appropriate to the individual's needs. 3 ; "Mental health disability" means a lessened capacity to use self-control, judgment, and discretion in the conduct of an individual's affairs and social relations that is related to a diagnosed mental illness and which makes it necessary or advisable for the individual to be under treatment for the mental illness and to receive care, supervision, and guidance. History Note: Authority G.S. 131D-2; 131D-4.5; 131D-4.6; S.L. 1999-0334; Temporary Adoption Eff. December 1, 1999; Eff. July 1, 2000.
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3.2.2 Future v The formulae proposed for fixing equitable prices for bulk drugs and their formulations, include cost plus margins model, negotiated prices, differential prices, reference prices, and bulk purchase prices. v The MAPE have been increased to 150% from 100%, with an extra 50% for products of R&D intensive companies. v Imported drugs would be allowed 50% margin on the landed costs. v To avoid a sudden spurt in prices of the current list of 74 drugs under price control their MAPE will remain unchanged for one year. v New patented drugs would be exempted from price control for 10 years post commercialization.
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| Ursodiol costSo far, there is no evidence that ursodiol can harm an unborn baby; but to be safe, ursofalk is not recommended during pregnancy.
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Fire and Explosion Health This product is classified as flammable. Caution - Potent pharmaceutical agent. Exposure might occur via skin; ingestion; eyes. Possible effects of overexposure in the workplace include: symptoms similar to alcohol intoxication; cardiovascular effects. Health effects information is based on hazards of components. No information is available about the potential of this product to produce adverse environmental effects, for example, ursodiol suspension.
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Over 25 million Americans suffer from gallstones. Women between the ages of 20 and 60 are three times more likely to develop gallstones as are men. Women who are overweight, have been pregnant, or who have used oral menopausal estrogen therapy are at risk of developing gallstones. Gallstones can also develop in women soon after they lose weight. Symptoms of gallstones include intense abdominal pain, bloating, gas, nausea, and discomfort following the consumption of fatty foods. Currently, oral Uesodiol is used to dissolve stones, however, there is a 70% recurrence rate. Cholecystectomy, the surgical removal of the gallbladder, is one of the most common surgical procedures. But this should be a last resort since surgery weakens the body, and puts the patient at risk for developing secondary infections associated with hospital visits. Finally, removal of the gallbladder may have energetic consequences that we do not yet fully understand. An empirical formula, GB 6 , is used in China to prevent and eliminate gallstones, and to treat the discomfort associated with gallbladder inflammation. In Chinese clinics, after an acute attack which is treated with decoctions, GB-6 is administered as a follow-up therapy for three months. American practitioners have given this formula as a 1 oriental medicine journal 6.
26. Yoshizawa K, Cioca DP, Kawa S, Tanaka E, Kiyosawa K. Peroxisome proliferator-activated receptor g ligand troglitazone induces cell cycle arrest and apoptosis of hepatocellular carcinoma cell lines. Cancer 2002; 95: 2243 Yang W, Furcht H. Activation of the PPAR pathway induces apoptosis and COX-2 inhibition in HT-29 human colon cancer cells. Carcinogenesis 2001; 22: 1379 Martelli ML, Iuliano R, Pera IL, et al. Inhibitory effects of peroxisome proliferator-activated receptor g on thyroid carcinoma cell growth. J Clin Endrocrinol Metab 2002; 87: 4728 Ohta K, Endo T, Haraguchi K, Hershman JM, Onaya T. Ligands for peroxisome proliferator-activated receptor g inhibit growth and induce apoptosis of human papillary thyroid carcinoma cells. J Clin Endrocrinol Metab 2001; 86: 2170 and darvon.
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Hald, T. 1989 ; Urodynamics in benign prostatic hyperplasia: a survey. Prostate Suppl 2: 69-77 Hald, T., Brading, A. F., Elbadawi, A., Horn, T., Keuppens, F., Rocha, F. t., Steers, W., Throff, J., van Mastrigt, R., Wein, A., Levin, R. 1998 ; Pathophysiology of the Urinary Bladder in Obstruction and Ageing. In: Denis, L., Griffiths, K., Khoury, S., Cockett, A. T. K., McConnell, J., Chatelain, C., Murphy, G., Yoshida, O. eds ; Proceedings - 4th International Consultation on BPH, Paris July 2-5, 1997 Hsing, A. W., et al. 2000 ; International trends and patterns of prostate cancer incidence and mortality. Int J Cancer 85: 60-7 Hubacher, S. 2002 ; Entzndungshemmende Wirkungen verschiedener Pflanzenextrakte - Enzymaktivittsbestimmung von Cyclooxygenasen COX1 COX-2 ; und 5-Lipoxygenase in vitro. Diplomarbeit Institut fr Pharmazeutische Biologie, Universitt Basel Iehl, C., Delos, S., Guirou, O., Tate, R., Raynaud, J. P., Martin, P. M. 1995 ; Human prostatic steroid 5 alpha-reductase isoforms--a comparative study of selective inhibitors. J Steroid Biochem Mol Biol 54: 273-9 Iguchi, K., Okumura, N., Usui, S., Sajiki, H., Hirota, K., Hirano, K. 2001 ; Myristoleic acid, a cytotoxic component in the extract from Serenoa repens, induces apoptosis and necrosis in human prostatic LNCaP cells. Prostate 47: 59-65 Ishii, K., Usui, S., Sugimura, Y., Yamamoto, H., Yoshikawa, K., Hiran, K. 2001 ; Extract from Serenoa repens suppresses the invasion activity of human urological cancer cells by inhibiting urokinase-type plasminogen activator. Biol Pharm Bull 24: 188-90 Jarry, H., Leonhardt, S., Gorkow, C., Wuttke, W. 1994 ; In vitro prolactin but not LH and FSH release is inhibited by compounds in extracts of Agnus castus: direct evidence for a dopaminergic principle by the dopamine receptor assay. Exp Clin Endocrinol 102: 448-54 Jarry, H., Spengler, B., Porzel, A., Schmidt, J., Wuttke, W., Christoffel, V. 2003 ; Evidence for estrogen receptor beta-selective activity of Vitex agnus-castus and isolated flavones. Planta Med 69: 945-7 Kaplan, S. A., Goluboff, E. T., Olsson, C. A., Deverka, P. A., Chmiel, J. J. 1995 ; Effect of demographic factors, urinary peak flow rates, and Boyarsky symptom scores on patient treatment choice in benign prostatic hyperplasia. Urology 45: 398-405 Kirschenbaum, A., Klausner, A. P., Lee, R., Unger, P., Yao, S., Liu, X. H., Levine, A. C. 2000 ; Expression of cyclooxygenase-1 and cyclooxygenase-2 in the human prostate. Urology 56: 671-6 Liu, J., Burdette, J. E., Xu, H., Gu, C., van Breemen, R. B., Bhat, K. P., Booth, N., Constantinou, A. I., Pezzuto, J. M., Fong, H. H., Farnsworth, N. R., Bolton, J. L. 2001 ; Evaluation of estrogenic activity of plant extracts for the potential treatment of menopausal symptoms. J Agric Food Chem 49: 2472-9 Lowe, F. C., Fagelman, E. 2002 ; Phytotherapy in the treatment of benign prostatic hyperplasia. Curr Opin Urol 12: 15-8 and deltasone.
However, ursodiiol is efficiently absorbed in the small intestine and extensively biotransformed by intestinal bacteria to lca, factors that reduce delivery to the colon and produce pro-carcinogenic bile acids.
Inhibition of intestinal CYP3A4 and PGP. However, the amount of grapefruit juice needed to obtain measurable effects both in vitro and in vivo ; is not well established and seems to vary from 250 ml to several glasses of either fresh or "double-strength reconstituted" lyophilized grapefruit juice 20, 22, 23, ; . Maybe the dose used in this study was too low. Moreover, grapefruit juice recently has been shown to inhibit organic anion transporter protein, a protein that is structurally related to PGP, but results Table 5. Summary of drug-induced influences on CYP3A4 and PGP activity expressed as relative change of m values in healthy volunteers at baseline conditions and desyrel and ursodiol, for example, side affects!
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Toms associated with gallstones. Mason surveyed significantly less frequent in the patients given ursomembers of the American Society for Bariatric diol compared with those given ibuprofen. Surgery and found that only 30% of surgeons The authors have evaluated the gallbladder preopremove normal-appearing gallbladders at the time eratively using abdominal ultrasound in bariatric of Roux-en-Y gastric bypass surgery while the surgical patients. Those who were demonstrated to majority adopt a selective approach.11 Jones reporthave gallstones underwent simultaneous cholecysed that only 9% of 673 consecutive Roux-en-Y gastectomy at the time of gastric bypass in this study. tric bypass patients required subsequent cholecysPatients without cholelithiasis were given oral ursotectomy, usually several years following gastric diol 600 mg daily for 6 months for prevention of bypass.12 He advocated selecting patients for simulgallstones. Delivered by Ingenta to taneous cholecystectomy on the basis of family hisTo our knowledge, this is the first study to evaluUNIVERSITY OF PITTSBURGH cid 85007663 ; tory of biliary tract disease requiring cholecystectoate 198.55.14.30 outcomes for selective laparoscopic cholecystecmy and clinical evidence of chronic cholecystitis at tomy during Date: 2004.07.14.01.41.laparoscopic gastric bypass. In our the time of surgery. While some surgeons perform series, all patients with gallstones found on routine cholecystectomy for those bariatric surgical patients preoperative ultrasound underwent concomitant diagnosed with gallstones preoperatively, others do cholecystectomy at the time of LGBP regardless of not obtain preoperative abdominal ultrasound and symptoms. We found no significant difference in instead select patients solely based on the presence gender distribution between those who underwent of symptoms. Advocates for concomitant cholecyscholecystectomy and those who did not. Adding tectomy solely in patients with symptomatic disease cholecystectomy neither affected conversion rates to argue that the majority of patients undergoing laparotomy nor increased the incidence of biliaryRoux-en-Y gastric bypass do not develop symptoms related complications such as bile leaks, bile duct of biliary colic postoperatively despite the presence injury, or bleeding from the gallbladder fossa. The of gallstones. Therefore, according to this philosostudy size n 94 ; , however, may be inadequate to phy, subjecting patients with asymptomatic galldetect rare but significant cholecystectomy-related stones to the added risks of cholecystectomy is complications. unwarranted, especially when cholecystectomy is There was no significant difference in the early technically more difficult and may pose higher risks minor postoperative complication rate P 0.70 ; . in the morbidly obese patient. The early major complication rate was higher for For patients not undergoing concomitant cholethe combined LGBP LC group P 0.004 however, cystectomy, pharmacologic prevention of postoperbecause this is not a prospective randomized study, ative gallstone formation has been shown to be the two groups were not equivalent and factors other effective. Ursodeoxycholic acid decreases gallstone than the additional cholecystectomy may have conformation in the setting of rapid weight loss by tributed to a higher major complication rate in this decreasing biliary cholesterol saturation.7 In a mulgroup. The patients in the LGBP LC group were ticenter, randomized, double-blind prospective trial significantly older than the LGBP patients P 0.01 ; . by Sugerman et al, 13 a 6-month course of oral ursoA larger proportion of the patients who had diol 600 mg daily ; was found to be significantly LGBP LC had additional procedures compared to more effective than placebo in preventing gallstone the LGBP group 58.5% versus 42.1% ; . formation 32% for ursodiol versus 2% for placebo, Furthermore, none of the early major complications P 0.001 ; . However, compliance with the preventive were related to the biliary tract. Thus, based on this medications may be problematic. A study by Wudel data, one cannot necessarily conclude that adding and colleagues14 randomized 60 bariatric surgery cholecystectomy to the LGBP increases the postoppatients without gallstones to ursodiol 600 erative complication rate. mg day ; , ibuprofen 600 mg day ; , or placebo in a Adding laparoscopic cholecystectomy, however, double-blind fashion. Only 28% 17 out of 60 ; were increased operating time by nearly 50 minutes, compliant in taking the medication. Forty-one which appears longer than expected. This may be a 68.3% ; completed the study; 29 71% ; developed result of an increase in technical difficulty related to gallstones postoperatively. Gallstone formation was severe obesity such as hepatomegaly, poor exposure.
Section 4, the Date Index, organizes drugs under patent by date of patent expiration from January 1, 2007 forward. In addition, the manufacturer, generic name and patent number for each drug are indicated. Please refer to Section 1, the Company Index, for complete information on each drug product, because drug information.
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