Hayashi Hiroko, Kobayashi Ryo, Suzuki Akio, Yamada Yuto, Ishida Masayuki, Shakui Toshinobu, Kitagawa Junichi, Hayashi Hideki, Sugiyama Tadashi, Takeuchi Hirofumi, Tsurumi Hisashi, Itoh Yoshinori
Department of Pharmacy, Gifu University Hospital, 1-1 Yanagido, Gifu, 501-1194, Japan.
Laboratory of Pharmacy Practice and Social Science, Gifu Pharmaceutical University, Gifu, Japan.
Med Oncol. 2016 Aug;33(8):91. doi: 10.1007/s12032-016-0795-z. Epub 2016 Jul 14.
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.
我们之前报道过，口服藻酸钠溶液混悬的聚普瑞锌（一种锌-L-肌肽）可预防接受放疗或大剂量化疗患者的口腔黏膜炎。在本研究中，我们研发了一种新型聚普瑞锌制剂，并评估了该含片制剂对接受造血干细胞移植大剂量化疗患者的临床效果。该制剂每片含18.75 mg聚普瑞锌，在室温储存长达24周时显示出优异的均匀性和稳定性。未进行预处理的患者中≥2级口腔黏膜炎的发生率为74%，而接受聚普瑞锌混悬液（23%）或含片（13%）治疗的患者该发生率显著降低（P<0.01）。聚普瑞锌混悬液或含片还大幅减少了用于缓解口腔疼痛（如抗炎药和局部麻醉药等非阿片类镇痛药）的使用（混悬液为16%，含片为13%，未预处理组为89%，P<0.01）。这些结果表明，聚普瑞锌含片应用简便，对预防造血干细胞移植大剂量化疗相关的口腔黏膜炎非常有效。
