title: Preparation and clinical evaluation of a novel lozenge containing polaprezinc, a zinc-L-carnosine, for prevention of oral mucositis in patients with hematological cancer who received high-dose chemotherapy.
abstract: We previously reported that oral ingestion of polaprezinc, a zinc-L-carnosine, suspended in sodium alginate solution prevents oral mucositis in patients receiving radiotherapy or high-dose chemotherapy. In the present study, we developed a novel preparation of polaprezinc and evaluated clinical effect of the lozenge preparation in patients receiving high-dose chemotherapy for hematopoietic stem cell transplantation. The preparation contained 18.75 mg polaprezinc in a tablet and showed an excellent uniformity and stability up to 24 weeks after storage under room temperature. The incidence rate of grade ≥ 2 oral mucositis was 74 % in patients without premedication, whereas the rate was remarkably reduced in patients receiving the suspension (23 %) or lozenge (13 %) of polaprezinc (P < 0.01). The use of non-opioid analgesic drugs such as anti-inflammatory agents and local anesthetics for oral pain was also greatly reduced by polaprezinc suspension or its lozenge (16 % for suspension and 13 % for lozenge compared with 89 % with no premedication, P < 0.01). These findings suggest that polaprezinc lozenge is simple to apply and highly effective for prevention of oral mucositis associated with high-dose chemotherapy for hematopoietic stem cell transplantation.
authors.affiliation: Department of Pharmacy, Gifu University Hospital, 1-1 Yanagido, Gifu, 501-1194, Japan.
authors.forename: Hiroko
authors.initials: H
authors.lastname: Hayashi
authors.affiliation: Department of Pharmacy, Gifu University Hospital, 1-1 Yanagido, Gifu, 501-1194, Japan.
authors.forename: Ryo
authors.initials: R
authors.lastname: Kobayashi
authors.affiliation: Department of Pharmacy, Gifu University Hospital, 1-1 Yanagido, Gifu, 501-1194, Japan. akio@gifu-u.ac.jp.
authors.forename: Akio
authors.identifier: http://orcid.org/0000-0003-2106-2123
authors.initials: A
authors.lastname: Suzuki
authors.affiliation: Department of Pharmacy, Gifu University Hospital, 1-1 Yanagido, Gifu, 501-1194, Japan.
authors.forename: Yuto
authors.initials: Y
authors.lastname: Yamada
authors.affiliation: Department of Pharmacy, Gifu University Hospital, 1-1 Yanagido, Gifu, 501-1194, Japan.
authors.forename: Masayuki
authors.initials: M
authors.lastname: Ishida
authors.affiliation: Laboratory of Pharmacy Practice and Social Science, Gifu Pharmaceutical University, Gifu, Japan.
authors.forename: Toshinobu
authors.initials: T
authors.lastname: Shakui
authors.affiliation: First Department of Internal Medicine, Gifu University Graduate School of Medicine, Gifu, Japan.
authors.forename: Junichi
authors.initials: J
authors.lastname: Kitagawa
authors.affiliation: Laboratory of Pharmacy Practice and Social Science, Gifu Pharmaceutical University, Gifu, Japan.
authors.forename: Hideki
authors.initials: H
authors.lastname: Hayashi
authors.affiliation: Laboratory of Pharmacy Practice and Social Science, Gifu Pharmaceutical University, Gifu, Japan.
authors.forename: Tadashi
authors.initials: T
authors.lastname: Sugiyama
authors.affiliation: Laboratory of Pharmaceutical Engineering, Gifu Pharmaceutical University, Gifu, Japan.
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Takeuchi
authors.affiliation: First Department of Internal Medicine, Gifu University Graduate School of Medicine, Gifu, Japan.
authors.forename: Hisashi
authors.initials: H
authors.lastname: Tsurumi
authors.affiliation: Department of Pharmacy, Gifu University Hospital, 1-1 Yanagido, Gifu, 501-1194, Japan.
authors.forename: Yoshinori
authors.initials: Y
authors.lastname: Itoh
mesh_terms: D000328:Adult; D000368:Aged; D000897:Anti-Ulcer Agents / Q000008:administration & dosage*; D000970:Antineoplastic Agents / Q000009:adverse effects*; D002336:Carnosine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D005260:Female; D019337:Hematologic Neoplasms / Q000628:therapy; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D008297:Male; D008875:Middle Aged; D009942:Organometallic Compounds / Q000008:administration & dosage*; D013280:Stomatitis / Q000139:chemically induced / Q000517:prevention & control*; D013607:Tablets / Q000138:chemical synthesis; D019172:Transplantation Conditioning / Q000009:adverse effects*; D055815:Young Adult; D017967:Zinc Compounds / Q000008:administration & dosage
chemical_list: D000897:Anti-Ulcer Agents; D000970:Antineoplastic Agents; D009942:Organometallic Compounds; D013607:Tablets; D017967:Zinc Compounds; C061957:polaprezinc; D002336:Carnosine
keywords: Analgesic; Hematopoietic stem cell transplantation; High-dose chemotherapy; Lozenge; Oral mucositis; Polaprezinc