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.
Hiroko HayashiRyo KobayashiAkio SuzukiYuto YamadaMasayuki IshidaToshinobu ShakuiJunichi KitagawaHideki HayashiTadashi SugiyamaHirofumi TakeuchiHisashi TsurumiYoshinori ItohPublished in: Medical oncology (Northwood, London, England) (2016)
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.
Keyphrases
- high dose
- locally advanced
- radiation induced
- low dose
- chemotherapy induced
- stem cell transplantation
- room temperature
- anti inflammatory
- clinical evaluation
- molecularly imprinted
- pain management
- squamous cell carcinoma
- radiation therapy
- acute myeloid leukemia
- end stage renal disease
- newly diagnosed
- risk factors
- chronic kidney disease
- neuropathic pain
- young adults
- ionic liquid
- rectal cancer
- spinal cord
- spinal cord injury
- high resolution
- postoperative pain