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Gallstone dissolution with chenodeoxycholic acid

A clinical study

Gallensteinauflösung mit Chenodesoxycholsäure

Eine klinische Studie

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Zusammenfassung

Von 95 Patienten mit röntgenologisch nichtschattengebenden Gallensteinen, die an einer klinischen Studie zur medikamentösen Steinauflösung mit Chenodesoxycholsäure (CDC) teilnahmen, wurden 75 Patienten mit Cholecystolithiasis über 12 Monate behandelt. Als Nebenwirkung bemerkten 31% der Patienten intermittierend Durchfall, der jedoch nicht zum Absetzen der Behandlung oder Arbeitsausfall führte. Die Häufigkeit der Gallenkoliken war während der Behandlung deutlich herabgesetzt im Vergleich zum vorangehenden Jahr. Von über 20 Laborwerten, die vor Beginn und alle 3 Monate während der Therapie überprüft wurden, stiegen nur die Aminotransferasen bei 20% der Patienten bis zum dreifachen der Norm. γ-GT war vor der Behandlung bei 31% der Patienten erhöht und verbesserte sich bei der Hälfte dieser Patienten während der Therapie. Eine Auflösung der Gallensteine, definiert als Verkleinerung der Gallensteinfläche auf vergleichbaren Röntgenbildern um 30% oder mehr, wurde bei 40% der Patienten beobachtet. Die Analyse der Faktoren zeigte, daß Gallensteine über 2 cm Durchmesser sich nicht auflösten. Wenn die CDC-Dosis retrospektiv auf das Körpergewicht bezogen wurde, fand sich die höchste Erfolgsrate mit 68% in jener Patientengruppe, die über 13 mg CDC/kg/Tag einnahm. Der lithogene Index, der nach 6 und 12 Monaten Behandlung bestimmt wurde, war nach 6 Monaten signifikant vermindert bei Patienten mit Gallensteinauflösung.

Diese Studie zeigt, daß die medikamentöse Auflösung von Gallensteinen mit Chenodesoxycholsäure bei Patienten mit nichtschattengebenden Gallensteinen von weniger als 2 cm Durchmesser durchgeführt werden sollte mit einer Dosierung von mehr als 13 mg CDC/kg Körpergewicht/Tag. Unter diesen Bedingungen liegt die Erfolgsrate über 60% bei gleichzeitig minimalen Nebenwirkungen.

Summary

Out of 95 patients with radiolucent gallstones who enrolled in a clinical study with chenodeoxycholic acid (CDC) for gallstone dissolution 75 patients with cholecystolithiasis completed 12 months of treatment. As a side effect 31% of patients reported intermittent diarrhea which did not cause cessation of therapy or missing of work. The incidence of biliary colic was markedly decreased during treatment in comparison to the rate in the year before. From more than 20 laboratory values checked before start and every 3 months during therapy only aminotransferases increased up to 3 fold in 20% of patients. γ-GT elevated in 31% of patients before treatment improved in half of these patients during therapy. Gallstone dissolution defined as 30% or more diminution of the gallstone area on comparable x-rays occurred in 40% of patients. Analysis of factors showed that gallstones above 2 cm in diameter did not dissolve. When the dose of CDC was retrospectively related to body weight a success rate of 68% was found in the group taking more than 13 mg CDC/kg/day. The lithogenic index determined at 6 and 12 months had significantly decreased after 6 months in patients with success. This study demonstrates that medical dissolution of gallstones with chenodeoxycholic acid should be performed in patients with radiolucent stones of less than 2 cm in diameter and with a dose above 13 mg CDC/kg body weight/day. Under these conditions the success rate is above 60% accompanied by minimal side effects.

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To Prof. Dr. H.P. Wolff on the occasion of his 65th birthday

This study was supported by the Deutsche Forschungsgemeinschaft (We 410/5)

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Weis, H.J., Holtermüller, K.H. & Gilsdorf, P. Gallstone dissolution with chenodeoxycholic acid. Klin Wochenschr 58, 313–320 (1980). https://doi.org/10.1007/BF01476574

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