title: Efficacy and safety of phlogenzym--a protease formulation, in sepsis in children.
abstract: BACKGROUND
  Infections are a major cause of hospitalisation wherein the host mounts an inflammatory response against the infecting agent. Administration of proteolytic enzymes could regulate the host's immune system and help early recovery from sepsis.
  
  
  OBJECTIVE
  To test the efficacy and safety of an oral enzyme formulation, Phlogenzym (Mucos Pharma GmbH, Geretsried, Germany; constituents of each enteric-coated tablet were bromelain 90 mg, trypsin 48 mg, rutin 100 mg) as adjuvant therapy in treatment of sepsis in children.
  
  
  METHODS
  Double-blind, randomised, controlled phase III study at a tertiary care centre wherein 60 eligible children aged one month to 12 years with sepsis were randomised to receive either phlogenzym (n=30; 17 boys) or placebo (n=30; 22 boys) tablets (1 tablet/10 kg body weight up to maximum six tablets a day in two or three divided doses for 14-21 days) along with appropriate antibiotics and supportive treatment.
  
  
  RESULTS
  Median time taken for fever to subside was three days (range 1-12; 95% CI--1.14 to 7.14) in the phlogenzym group vs four days (range 1-18; 95% CI--3.52 to 11.52) in the placebo group (p < 0.05); haemodynamic support was needed for two days (range 1-3; 95% CI--0.84 to 3.16) in the phlogenzym group but three days (range 1-8; 95% CI--0.76 to 5.24) in the placebo group (p < 0.05). The modified Glasgow coma scale score normalized in three days (range 1-14; 95% CI--4.62 to 9.62) in the phlogenzym group vs 5.5 days (range 1-18; 95% CI--2.52 to 13.52) in the placebo group (p > 0.05). Oral feeds could be started in four days (range 1-15; 95% CI--1.74 to 9.74) in the phlogenzym group vs five days (range 1-11; 95% CI--1.26 to 11.26) in the placebo group (p > 0.05). Two patients died in the placebo group.
  
  
  CONCLUSIONS
  Phlogenzym is effective as an adjuvant with antibiotics and supportive treatment for early improvement of pediatric patients with sepsis.
authors.affiliation: LTMMC and LTMG Hospital and Medical College, Mumbai.
authors.forename: S K
authors.initials: SK
authors.lastname: Shahid
authors.forename: N H
authors.initials: NH
authors.lastname: Turakhia
authors.forename: M
authors.initials: M
authors.lastname: Kundra
authors.forename: P
authors.initials: P
authors.lastname: Shanbag
authors.forename: G V
authors.initials: GV
authors.lastname: Daftary
authors.forename: W
authors.initials: W
authors.lastname: Schiess
mesh_terms: D000276:Adjuvants, Immunologic / Q000627:therapeutic use; D001963:Bromelains / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006801:Humans; D007155:Immunologic Factors / Q000627:therapeutic use*; D007223:Infant; D008297:Male; D012431:Rutin / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D018805:Sepsis / Q000628:therapy*; D014357:Trypsin / Q000627:therapeutic use*
chemical_list: D000276:Adjuvants, Immunologic; D004338:Drug Combinations; D007155:Immunologic Factors; C119937:Phlogenzym; D012431:Rutin; D001963:Bromelains; D014357:Trypsin