COMPARATIVE STUDY
JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL

[Experience with the use of 13C-breath test for the evaluation of the efficacy of enzyme substitution therapy with microencapsulated pancreatinin in patients with severe primary pancreatic insufficiency]

S I Rapoport, I V Maev, Iu A Kucheriavyĭ, N A Shubina, N V Semenova, N Iu Stukova, A I Archakov
Klinicheskaia Meditsina 2009, 87 (1): 53-7
19256262
The aim of the study was to evaluate efficiency of creon substitution therapy of severe primary pancreatic insufficiency in the 13C-breath test. It included 32 patients (mean age 48.2 +/- 6.8 yr) with chronic pancreatitis and severe primary exocrine insufficiency. The patients ingested naturally enriched 13C-maize starch and creon (25000 U) before breakfast. Samples of exhaled air were taken before and every 30 min for 4 hours after intake (total: 9). Creon metabolic rate and capacity were measured. Creon accumulation (in %) was assessed by statistical analysis. It significantly decreased in patients with exocrine pancreatic insufficiency suggesting close relationship between clinical symptoms and results of the breath test. Symptom severity score positively correlated with dose accumulation. Only 8 patients showed satisfactory results of the breath test indicative of acceptable outcome of substitution therapy. 75% of the patients proved to receive inadequate treatment. Therefore, they were prescribed a 25 or 50% higher creon dose and the test was repeated. It revealed a dose-dependent rise in the accumulated dose compared with initial values. It is concluded that the lack of clinical markers of exocrine pancreatic insufficiency can not be regarded as a criterion for the efficiency of substitution enzyme therapy.

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