Johnson J T, Ferretti G A, Nethery W J, Valdez I H, Fox P C, Ng D, Muscoplat C C, Gallagher S C
Department of Otolaryngology, University of Pittsburgh, PA.
N Engl J Med. 1993 Aug 5;329(6):390-5. doi: 10.1056/NEJM199308053290603.
We evaluated pilocarpine hydrochloride for the treatment of radiation-induced xerostomia, a common complication of irradiation of the head and neck. A prospective, randomized, double-blind, placebo-controlled trial was undertaken to test the safety and efficacy of pilocarpine, particularly in reversing the decrease in the production of saliva and other manifestations of xerostomia. Patients received either placebo or pilocarpine (5 mg or 10 mg orally three times a day) for 12 weeks and were evaluated at base line and every 4 weeks.
We studied 207 patients who had each received > or = 4000 cGy of radiation to the head and neck. In the patients receiving the 5-mg dose of pilocarpine, oral dryness improved in 44 percent, as compared with 25 percent of the patients receiving placebo (P = 0.027). There was overall improvement in 54 percent of the 5-mg group as compared with 25 percent of the placebo group (P = 0.003), and 31 percent of the 5-mg group had improved comfort of the mouth and tongue, as compared with 10 percent of the placebo group (P = 0.002). Speaking ability improved in 33 percent of the 5-mg group as compared with 18 percent of the placebo group (P = 0.037). Saliva production was improved, but it did not correlate with symptomatic relief. There were comparable improvements in the group receiving the 10-mg dose. The primary adverse effect was sweating, in addition to other minor cholinergic effects. Six and 29 percent of the patients in the 5-mg and 10-mg groups, respectively, withdrew from the study because of adverse effects. There were no serious adverse effects related to pilocarpine.
Pilocarpine improved saliva production and relieved symptoms of xerostomia after irradiation for cancer of the head and neck, with minor side effects that were predominantly limited to sweating.
我们评估了盐酸毛果芸香碱对头颈部放疗常见并发症放射性口干症的治疗效果。开展了一项前瞻性、随机、双盲、安慰剂对照试验，以测试毛果芸香碱的安全性和有效性，尤其是在逆转唾液分泌减少及其他口干症表现方面。患者接受安慰剂或毛果芸香碱（口服5毫克或10毫克，每日三次）治疗12周，并在基线及每4周时进行评估。
我们研究了207例头颈部接受≥4000厘戈瑞辐射的患者。接受5毫克剂量毛果芸香碱的患者中，44%的患者口腔干燥有所改善，而接受安慰剂的患者中这一比例为25%（P = 0.027）。5毫克组中54%的患者总体情况有所改善，而安慰剂组为25%（P = 0.003），5毫克组中31%的患者口腔和舌头舒适度提高，而安慰剂组为10%（P = 0.002）。5毫克组中33%的患者说话能力提高，而安慰剂组为18%（P = 0.037）。唾液分泌有所改善，但与症状缓解无相关性。接受10毫克剂量的组也有类似改善。主要不良反应为出汗，此外还有其他轻微的胆碱能效应。5毫克组和10毫克组分别有6%和29%的患者因不良反应退出研究。未出现与毛果芸香碱相关的严重不良反应。
毛果芸香碱改善了头颈部癌症放疗后的唾液分泌，缓解了口干症症状，副作用轻微，主要局限于出汗。
