Sweeney M P, Bagg J, Baxter W P, Aitchison T C
Renfrewshire Healthcare NHS Trust, University of Glasgow, UK.
Palliat Med. 1997 May;11(3):225-32. doi: 10.1177/026921639701100307.
Thirty-five hospice patients complaining of dry mouth entered a double-blind, single-phase placebo-controlled trial of a mucin-containing oral spray (Saliva Orthana) for the relief of xerostomia. The sprays were administered ad libitum for two weeks by the patients themselves, with nursing help as necessary. A detailed history and examination were undertaken, together with collection of microbiological specimens, at entry and after seven and 14 days of spray usage, respectively. Thirty-one patients were available for follow-up at seven days and 26 patients after 14 days. Relief of oral dryness during the day was reported by 9/15 patients on Saliva Orthana and 10/16 patients on placebo by day 7, with a similar degree of improvement maintained to day 14. The corresponding figures by day 7 for relief of dryness at night were 8/15 for Saliva Orthana and 8/16 for placebo. There were no statistically significant differences between those on active and those on placebo spray for any of the oral symptoms recorded. Neither spray had any major impact on the oral microflora. However, the majority of patients in both treatment groups wished to continue using a mouth spray at the end of their involvement in the trial. Whilst the data from this study provide no evidence for increased benefit of a mucin-containing spray over a mucin-free placebo among xerostomic hospice patients, it is clear that both sprays provided worthwhile symptomatic relief of oral dryness for many of the participants.
35名主诉口干的临终关怀患者进入了一项双盲、单阶段、安慰剂对照试验，该试验使用一种含粘蛋白的口腔喷雾剂（Saliva Orthana）来缓解口干症。喷雾剂由患者自行按需使用两周，必要时由护士协助。分别在入组时以及使用喷雾剂7天和14天后，进行了详细的病史询问和检查，并采集了微生物标本。31名患者在7天时可进行随访，26名患者在14天后可进行随访。到第7天时，使用Saliva Orthana的15名患者中有9名报告白天口腔干燥得到缓解，使用安慰剂的16名患者中有10名报告缓解，到第14天时保持了相似的改善程度。第7天时，Saliva Orthana夜间口干缓解的相应数字为8/15，安慰剂为8/16。在记录的任何口腔症状方面，使用活性喷雾剂的患者和使用安慰剂喷雾剂的患者之间均无统计学显著差异。两种喷雾剂对口腔微生物群均无重大影响。然而，两个治疗组中的大多数患者在试验结束时都希望继续使用口腔喷雾剂。虽然该研究的数据没有提供证据表明含粘蛋白喷雾剂比不含粘蛋白的安慰剂对口干的临终关怀患者有更大益处，但很明显，两种喷雾剂都为许多参与者提供了值得的口腔干燥症状缓解。
