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
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
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DOI：
10.1007/s12032-016-0795-z
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发表时间：
2016-08-01
期刊：
影响因子：
3.4
通讯作者：
Itoh, Yoshinori
中科院分区：
文献类型：
--
作者：
Hayashi, Hiroko;Kobayashi, Ryo;Itoh, Yoshinori
我们以前报道，口服Polaprezinc，一种锌-L-肌肽，悬浮在海藻酸钠溶液中，可预防接受放疗或高剂量化疗的患者的口腔粘膜炎。在本研究中，我们开发了一种新的Polaprezinc制剂，并评估了接受大剂量化疗的造血干细胞移植患者的临床效果。该制剂在片剂中含有18.75 mg Polaprezinc，在室温下储存长达24周后显示出优异的均匀度和稳定性。在未术前用药的患者中，≥ 2级口腔粘膜炎的发生率为74%，而在接受Polaprezinc混悬液（23%）或锭剂（13%）的患者中，该发生率显著降低（P < 0.01）。Polaprezinc混悬液或其含片也大大减少了非阿片类镇痛药（如抗炎药和局部麻醉药）用于口腔疼痛的使用（混悬液为16%，含片为13%，而无前驱用药的为89%，P < 0.01）。这些结果表明，Polaprezinc含片应用简单，对预防造血干细胞移植大剂量化疗相关的口腔粘膜炎非常有效。
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.