Background & Aims: Treatment of intrahepatic cholestasis of pregnancy with ursodeoxycholic acid appears promising, but data are limited so far. The aim of this randomized study was to evaluate the efficacy and saf...Background & Aims: Treatment of intrahepatic cholestasis of pregnancy with ursodeoxycholic acid appears promising, but data are limited so far. The aim of this randomized study was to evaluate the efficacy and safety of ursodeoxycholic acid in comparison with cholestyramine. Methods: Eighty-four symptomatic patients with intrahepatic choles-tasis of pregnancywere randomized to receive either ursodeoxycholic acid, 8- 10 mg/kg body weight daily (n = 42), or cholestyramine, 8 g daily (n = 42), for 14 days. The primary end point was a reduction of pruritus by more than 50% after 14 days of treatment as evaluated by a pruritus score. Secondary end points were outcome of pregnancy, reduction of serum aminotransferase activities and serum bile acid levels, and drug safety. Intention-to-treat analysis was applied. Results: Pruritus was more effectively reduced by ursodeoxycholic acid than cholestyramine (66.6% vs 19.0% , respectively; P < .005). Babies were delivered significantly closer to term by patients treated with ursodeoxycholic acid than those treated with cholestyramine (38.7 ± 1.7 vs 37.4 ± 1.5 weeks, respectively, P < .05). Serum alanine and aspartate aminotransferase activities were markedly reduced by 78.5% and 73.8% , respectively, after ursodeoxycholic acid, but by only 21.4% , each, after cholestyramine therapy (P < .01 vs ursodeoxycholic acid). Endogenous serum bile acid levels decreased by 59.5% and 19.0% , respectively (P < .02). Ursodeoxycholic acid, but not cholestyramine was free of adverse effects. Conclusions: Ursodeoxycholic acid is safe and more effective than cholestyramine in intrahepatic cholestasis of pregnancy.展开更多
Objective. The laryngopharyngeal form of gastroesophageal reflux disease (LF GERD) is a frequent manifestation of supraesophageal GERD. Diagnosis of LF GERD is difficult: most of the common diagnostic methods of GERD ...Objective. The laryngopharyngeal form of gastroesophageal reflux disease (LF GERD) is a frequent manifestation of supraesophageal GERD. Diagnosis of LF GERD is difficult: most of the common diagnostic methods of GERD have insufficient accuracy in establishing LF GERD. The purpose of this study was to evaluate the role of endoscopic and laryngologic examination in the diagnosis of LF GERD and to create a laryngoscopic reflux index (LRI). Material and methods. A total of 108 LF GERD patients and 90 controls were investigated. The criteria for LF GERD were: complaints, reflux-laryngitis, and esophagitis (endoscopic-ally or histologically proven). Lesions in four laryngeal regions were evaluated: arytenoids (A), intraarytenoid notch (IAN), vestibular folds (VF), and vocal cords (VC). Three types of mucosal lesions were evaluated on a points basis: alterations of the epithelium, erythema, and edema. Total LRI was calculated by summing-up the indices in the separate laryngeal areas. Results. The LRI mean value (11.48±3.78 points) of LF GERD patients was statistically significantly greater than that (1.64±1.93 points) of the controls. The most significant laryngoscopic changes of LF GERD were: mucosal lesions of IAN, mucosal lesions of VC, and edema of VC. A combination of these three findings reliably distinguishes the LF GERD patients from controls in 95.9%of cases. The mucosal lesions of IAN have the greatest importance in diagnosing LF GERD: the odds ratio to LF GERD -21.32, p < 0.001. Endoscopic esophagitis was established in 36 (33.3%) cases. The severity of esophagitis did not correlate with the severity of the laryngeal findings. Conclusions. Laryngoscopy is superior to endoscopy in diagnosing LF GERD. Endoscopy has limited value in the diagnosis of LF GERD. Establishing the LRI could be helpful in the differential diagnosis of the disease in the everyday clinical practice.展开更多
文摘Background & Aims: Treatment of intrahepatic cholestasis of pregnancy with ursodeoxycholic acid appears promising, but data are limited so far. The aim of this randomized study was to evaluate the efficacy and safety of ursodeoxycholic acid in comparison with cholestyramine. Methods: Eighty-four symptomatic patients with intrahepatic choles-tasis of pregnancywere randomized to receive either ursodeoxycholic acid, 8- 10 mg/kg body weight daily (n = 42), or cholestyramine, 8 g daily (n = 42), for 14 days. The primary end point was a reduction of pruritus by more than 50% after 14 days of treatment as evaluated by a pruritus score. Secondary end points were outcome of pregnancy, reduction of serum aminotransferase activities and serum bile acid levels, and drug safety. Intention-to-treat analysis was applied. Results: Pruritus was more effectively reduced by ursodeoxycholic acid than cholestyramine (66.6% vs 19.0% , respectively; P < .005). Babies were delivered significantly closer to term by patients treated with ursodeoxycholic acid than those treated with cholestyramine (38.7 ± 1.7 vs 37.4 ± 1.5 weeks, respectively, P < .05). Serum alanine and aspartate aminotransferase activities were markedly reduced by 78.5% and 73.8% , respectively, after ursodeoxycholic acid, but by only 21.4% , each, after cholestyramine therapy (P < .01 vs ursodeoxycholic acid). Endogenous serum bile acid levels decreased by 59.5% and 19.0% , respectively (P < .02). Ursodeoxycholic acid, but not cholestyramine was free of adverse effects. Conclusions: Ursodeoxycholic acid is safe and more effective than cholestyramine in intrahepatic cholestasis of pregnancy.
文摘Objective. The laryngopharyngeal form of gastroesophageal reflux disease (LF GERD) is a frequent manifestation of supraesophageal GERD. Diagnosis of LF GERD is difficult: most of the common diagnostic methods of GERD have insufficient accuracy in establishing LF GERD. The purpose of this study was to evaluate the role of endoscopic and laryngologic examination in the diagnosis of LF GERD and to create a laryngoscopic reflux index (LRI). Material and methods. A total of 108 LF GERD patients and 90 controls were investigated. The criteria for LF GERD were: complaints, reflux-laryngitis, and esophagitis (endoscopic-ally or histologically proven). Lesions in four laryngeal regions were evaluated: arytenoids (A), intraarytenoid notch (IAN), vestibular folds (VF), and vocal cords (VC). Three types of mucosal lesions were evaluated on a points basis: alterations of the epithelium, erythema, and edema. Total LRI was calculated by summing-up the indices in the separate laryngeal areas. Results. The LRI mean value (11.48±3.78 points) of LF GERD patients was statistically significantly greater than that (1.64±1.93 points) of the controls. The most significant laryngoscopic changes of LF GERD were: mucosal lesions of IAN, mucosal lesions of VC, and edema of VC. A combination of these three findings reliably distinguishes the LF GERD patients from controls in 95.9%of cases. The mucosal lesions of IAN have the greatest importance in diagnosing LF GERD: the odds ratio to LF GERD -21.32, p < 0.001. Endoscopic esophagitis was established in 36 (33.3%) cases. The severity of esophagitis did not correlate with the severity of the laryngeal findings. Conclusions. Laryngoscopy is superior to endoscopy in diagnosing LF GERD. Endoscopy has limited value in the diagnosis of LF GERD. Establishing the LRI could be helpful in the differential diagnosis of the disease in the everyday clinical practice.