Sugisaki Takahito, Kawakami Kazuyoshi, Nemoto Maki, Kawata Keiji, Ishibashi Michiko, Fujiki Yukako, Mishima Yuko, Yokoyama Masahiro, Takahashi Shunji, Hatake Kiyohiko, Hama Toshihiro
Dept. of Pharmacy, Cancer Institute Hospital.
Gan To Kagaku Ryoho. 2011 May;38(5):783-7.
We measured the effectiveness of the prophylactic administration of a polaprezinc suspension dispersed in sodium alginate solution (P-AG) by dividing it into two courses in the same patients, and measured the stomatitis induced by Docetaxel/Cisplatin/Fluorouracil (DCF) chemotherapy. We then evaluated the results. We defined the therapeutic course as the course where P-AG was given therapeutically for stomatitis induced after DCF chemotherapy. We defined the prophylactic course as when P-AG was prophylactically given before any incidences of stomatitis after the therapeutic course. We compared the incidences of stomatitis in the prophylactic courses with those of the therapeutic courses. The incidences of stomatitis that were higher than Grade 1 were 17 out of 17 patients (100%) in the therapeutic course. On the other hand, they were 15 out of 17 patients (88. 2%) in the prophylactic course. Compared with the mean of the Grade of Stomatitis by the Common Terminology Criteria for Adverse Events version 3. 0 (CTCAE v. 3. 0), the maximal Grade of stomatitis significantly decreased in the prophylactic courses compared to those of the therapeutic courses(p<0. 05). Therefore, these results suggested that we were able to decrease the severity of stomatitis by using P-AG prophylactically, as opposed to using P-AG therapeutically.
我们通过在同一患者中分为两个疗程来测量藻酸钠溶液分散的聚普瑞锌混悬液(P-AG)预防性给药的效果,并测量多西他赛/顺铂/氟尿嘧啶(DCF)化疗引起的口腔炎。然后我们评估结果。我们将治疗疗程定义为在DCF化疗后对口腔炎进行治疗性给予P-AG的疗程。我们将预防疗程定义为在治疗疗程后在任何口腔炎发生之前预防性给予P-AG的情况。我们比较了预防疗程和治疗疗程中口腔炎的发生率。在治疗疗程中,17名患者中有17名(100%)口腔炎发生率高于1级。另一方面,在预防疗程中,17名患者中有15名(88.2%)。与不良事件通用术语标准第3.0版(CTCAE v.3.0)的口腔炎分级平均值相比,预防疗程中口腔炎的最大分级与治疗疗程相比显著降低(p<0.05)。因此,这些结果表明,与治疗性使用P-AG相比,预防性使用P-AG能够降低口腔炎的严重程度。