title: Efficacy of zinc-carnosine chelate compound, Polaprezinc, enemas in patients with ulcerative colitis.
abstract: OBJECTIVE
  Ulcerative colitis (UC) is a chronic, relapsing and remitting intestinal inflammatory disorder. Zinc is known to be efficacious for the repair of damaged tissue and has been shown to protect against gastric ulceration. This study focused on Polaprezinc (PZ), N-(3-aminopropionyl)-L-histidinato zinc, which accelerates ulcer healing through actions such as prostaglandin-independent cytoprotection and antioxidative activity.
  
  
  METHODS
  In this randomized, placebo-controlled, investigator-blinded trial, 28 patients with active UC at The Jikei University Hospital were randomly divided into two groups: one treated with a 150 mg PZ enema (n = 18) and the other not treated with a PZ enema (n = 10). All patients received usual induction therapy. Clinical symptoms, endoscopic findings and histological findings were evaluated at entry and one week later.
  
  
  RESULTS
  In the PZ group, modified Matts' endoscopic scores were significantly improved after treatment compared to baseline in the rectum (p = 0.004), sigmoid colon (p = 0.03) and descending colon (p = 0.04). In the non-PZ group, scores were not significantly improved in the rectum (p = 0.14) and descending colon (p = 0.34), but were improved in the sigmoid colon (p = 0.04). In the PZ group, the Mayo scores at baseline and at Day 8 were 9.1 ± 1.6 and 5.8 ± 2.7 (p = 0.00004), respectively, and in the placebo group, the scores were 8.9 ± 1.7 and 7.4 ± 2.1 (p = 0.009), respectively. Clinical response or remission was significantly better in the PZ group (71%) than in the placebo group (10%).
  
  
  CONCLUSIONS
  A zinc-carnosine chelate compound, PZ, enema may become a useful new add-on treatment to accelerate mucosal healing in UC.
authors.affiliation: Division of Gastroenterology and Hepatology, Department of Internal Medicine, The Jikei University School of Medicine , Tokyo , Japan.
authors.forename: Munenori
authors.initials: M
authors.lastname: Itagaki
authors.forename: Masayuki
authors.initials: M
authors.lastname: Saruta
authors.forename: Hiroki
authors.initials: H
authors.lastname: Saijo
authors.forename: Jimi
authors.initials: J
authors.lastname: Mitobe
authors.forename: Seiji
authors.initials: S
authors.lastname: Arihiro
authors.forename: Mika
authors.initials: M
authors.lastname: Matsuoka
authors.forename: Tomohiro
authors.initials: T
authors.lastname: Kato
authors.forename: Masahiro
authors.initials: M
authors.lastname: Ikegami
authors.forename: Hisao
authors.initials: H
authors.lastname: Tajiri
mesh_terms: D000328:Adult; D000368:Aged; D000897:Anti-Ulcer Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002336:Carnosine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D003093:Colitis, Ulcerative / Q000188:drug therapy* / Q000473:pathology; D044683:Colon, Descending / Q000473:pathology; D012809:Colon, Sigmoid / Q000473:pathology; D003113:Colonoscopy; D004733:Enema; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009942:Organometallic Compounds / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012007:Rectum / Q000473:pathology; D012720:Severity of Illness Index; D016037:Single-Blind Method; D055815:Young Adult; D017967:Zinc Compounds / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use
chemical_list: D000897:Anti-Ulcer Agents; D009942:Organometallic Compounds; D017967:Zinc Compounds; C061957:polaprezinc; D002336:Carnosine