Nakamura Naoki, Sasano Nakashi, Yamashita Hideomi, Igaki Hiroshi, Shiraishi Kenshiro, Terahara Atsuro, Asakage Takahiro, Nakao Kazunari, Ebihara Yasuhiro, Ohtomo Kuni, Nakagawa Keiichi
Department of Radiology, Tokyo University Hospital, Tokyo, Japan.
Auris Nasus Larynx. 2009 Jun;36(3):310-3. doi: 10.1016/j.anl.2008.04.008. Epub 2008 Jul 16.
To evaluate Japanese tolerability to pilocarpine of 5 mg t.i.d.
From January 2006 to July 2006, 39 patients with xerostomia received 5 mg t.i.d. pilocarpine for at least for 12 weeks unless they had experienced unacceptable adverse effects. All patients received radiotherapy that included the parotid glands in the radiation field >50 Gy. The body weights of the patients ranged from 42 to 73 kg (median 60 kg).
Thirty-six of the 39 patients were evaluable. The tolerated rate was only 47%. Of the 25 patients whose body weights were less than 65 kg, the tolerated rate was 36%, whereas the rate of the 11 patients whose body weights were 65 kg or above was 72% (p=0.050). The most common adverse effect was sweating with an incidence of 64%. Response rate, which was defined as the total number of patients with an increase of at least 25 mm from the baseline in the VAS score divided by the number of maintaining patients among those who started pilocarpine after more than 4 months from the start of radiotherapy, was 40% at 12 weeks (n=15).
For Japanese, 5mg t.i.d. pilocarpine caused a high incidence of unacceptable adverse effects. A lower dose of pilocarpine needs to be considered.
评估日本患者对每日三次服用5毫克毛果芸香碱的耐受性。
从2006年1月至2006年7月，39例口干患者每日三次服用5毫克毛果芸香碱，至少服用12周，除非他们出现不可接受的不良反应。所有患者均接受了放疗，放疗野包括腮腺，剂量>50 Gy。患者体重范围为42至73千克（中位数60千克）。
39例患者中有36例可评估。耐受率仅为47%。在25例体重低于65千克的患者中，耐受率为36%，而11例体重65千克及以上患者的耐受率为72%（p = 0.050）。最常见的不良反应是出汗，发生率为64%。缓解率定义为VAS评分较基线至少增加25毫米的患者总数除以放疗开始后4个月以上开始服用毛果芸香碱的维持患者数，12周时为40%（n = 15）。
对于日本患者，每日三次服用5毫克毛果芸香碱会导致不可接受的不良反应发生率较高。需要考虑使用较低剂量的毛果芸香碱。
