Efficacy and safety of pancreatic enzyme replacement therapy on exocrine pancreatic insufficiency: a meta-analysis

Abstract

BackgroundPancreatic enzyme replacement therapy (PERT) is widely applied to patients with exocrine pancreatic insufficiency (EPI), but its effect and safety has not been quantified. Therefore we performed a meta-analysis to determine the efficacy and tolerance of PERT on patients with EPI.Materials and MethodsPubMed, Medline, Cochrane library database, Evidence-based medicine/clinical trials published before December 2016 were searched by two independent reviewers to identify prospective randomized controlled trials (RCTs).ResultsSeven RCTs, randomizing a total of 282 patients, were filtrated and assessed qualitatively (Jadad score). PERT increased CFA (WMD: 26.56, 20.35 to 32.76, I2 = 79.6%, P < 0.001) compared with baseline, and CFA (WMD: 17.97, 12.61 to 23.34, I2 = 76.7%, P < 0.001) vs. placebo. Meanwhile, CNA, SFE, SNE and SW were significantly improved in PERT compared with baseline and placebo, with no statistical differences in adverse events. Subgroup analysis indicated that standard forms of PERT displayed more effectiveness with significantly decreased heterogeneity, and large sample size also reduced the heterogeneity to some degree.ConclusionsPERT is demonstrated to be effective and tolerable in patients with EPI, especially using standard administration of PERT. Larger and higher quality studies on EPI are demanded to long-term effect of standard PERT treatment.

Challenges in the management of pancreatic exocrine insufficiency

“…Side effects: PERT is generally well tolerated[ 41 ]. Fibrosing colonopathy is a much discussed but rarely seen complication that has been reported in children with cystic fibrosis using large doses of PERT[ 42 - 45 ].…”

Prevalence and risk of bone fractures in patients with chronic pancreatitis: meta-analysis

“…Именно компенсация абсолютного дефицита панкреатических ферментов на фоне применения ЗФТ является единственно возможным путем коррекции экзокринной недостаточности поджелудочной железы и профилактики мальнутриции [36][37][38]. Эффективность ЗФТ в разрешении признаков панкреатической недостаточности и нивелировании синдрома мальабсорбции у пациентов с ХП подтверждена двумя независимыми метаанализами [39,40]. В проспективном исследовании S. Haas и соавт.…”

Exocrine pancreas insufficiency: clinical significance and approaches to correction from evidence medicine

“…продемонстрировал, что обобщенная частота саркопении у пациентов с ХП составляет 42,09% (95% ДИ 27,845-57,055) [40]. В недавнем проспективном исследовании с участием 182 пациентов выявлено, что саркопения повышает риск госпитализации (ОР 2,2, 95% ДИ 0,9-5,0; p=0,07) и летальности при ХП [46]. В другом метаанализе, в котором обобщены результаты 14 рандомизированных контролируемых исследований, показано, что ЗФТ у пациентов с ХП способствует значительному увеличению коэффициента абсорбции жира в сравнении с плацебо (83,2±5,5 против 67,4±7,0; СРС 1,67; 0,81 до 2,53; p=0,0001).…”