A Phase II Trial of Human Secretin Infusion for Refractory Type B Pain in Chronic Pancreatitis

作者：Levenick John M; Andrews Catherine L; Purich Edward D; Gordon Stuart R; Gardner Timothy B^*

来源：Pancreas, 2013, 42(4): 596-600.

DOI：10.1097/MPA.0b013e318273f3ec

• chronic pancreatitis
• pain
• secretin
• quality of life

Objective: We aimed to determine if intravenous synthetic human secretin (sHS) improves refractory type B pain in patients with chronic pancreatitis (CP).
Methods: In a phase II dose escalation trial, patients with CP received sHS of varying doses (0.05-0.8 mu g/kg) for 3 days. The primary outcomes were changes in the visual analogue pain score (VAS), short form (SF) - 36, and opiate use from baseline at 30 days after infusion.
Results: Twelve patients (mean age, 42 years, 6 men) were included. Mean pain scores (VAS) were 5.79, 4.80, 4.72, and 4.90, at baseline, day 4, day 10, and day 30, respectively (P = 0.25, 0.19, and 0.27 when compared with baseline, respectively). Daily opiate use (oral morphine equivalents) decreased throughout the study from a baseline value of 136 to 111 mg on day 4 (P = 0.52) and to 104 mg on day 30 (P = 0.34). In subgroup analysis, women had the most improvement (VAS baseline, 5.42 vs VAS day 30, 3.67; P = 0.07; baseline morphine equivalents, 107 mg vs. 84 mg; P = 0.21).
Conclusions: In patients, especially women, with refractory type B pain from CP, intravenous sHS administration demonstrated a trend toward improvement in self-reported pain and opiate use at 30 days after infusion, although statistical significance was not achieved (clinicaltrials. gov registration number NCT01265875).

• 出版日期2013-5