Prause J U
Scand J Rheumatol Suppl. 1986;61:261-3.
A double-blind cross-over comparative study on the effect of Lacrisert versus oculoguttae viscosae and saline has been conducted. Lacrisert is a soluble solid tear substitute which is applied once-a-day. The object was to compare the safety and patient acceptability of Lacrisert and oculoguttae viscosae, and to compare the efficacy of Lacrisert to oculoguttae viscosae and saline. Twenty-nine patients suffering from primary Sjögren's syndrome (Copenhagen criteria), 2 male and 27 female, age: median 56 years, range 32-79 years. Lacrisert was applied once-a-day, and saccharose crystals of similar appearance was used as placebo. All patients were treated for 4 periods of 3 weeks: Lacrisert + saline versus placebo + saline and Lacrisert + oculoguttae viscosae versus placebo + oculoguttae viscosae. The patients were examined before entering the study and after each of the 4 periods using: slit-lamp, corneal sensitivity, BUT, Schirmer-1-test and Rose-bengal staining. Comparing Lacrisert to saline a significant improvement in BUT (p less than 0.01) and in Rose-bengal staining (p less than 0.01) was found, whereas other patients were unchanged. Comparing Lacrisert with oculoguttae viscosae no significant difference in clinical parameters could be detected. The patients complained of minor discomfort. Most prominent was a tendency to loose the Lacrisert due to an inadequate solubilisation of the rod caused by the lack of aqueous tears. We conclude that Lacrisert may help patients with primary Sjögren's syndrome provided that they have some secretory capacity left in the tear glands.
已开展一项关于泪然(Lacrisert)与粘性眼液及生理盐水效果的双盲交叉对照研究。泪然是一种可溶性固体泪液替代物,每天使用一次。目的是比较泪然与粘性眼液的安全性及患者可接受性,并比较泪然与粘性眼液及生理盐水的疗效。29例原发性干燥综合征患者(符合哥本哈根标准),2例男性,27例女性,年龄:中位数56岁,范围32 - 79岁。泪然每天使用一次,外观相似的蔗糖晶体用作安慰剂。所有患者接受4个为期3周的治疗阶段:泪然 + 生理盐水与安慰剂 + 生理盐水,以及泪然 + 粘性眼液与安慰剂 + 粘性眼液。在进入研究前及4个阶段中的每个阶段结束后,使用裂隙灯、角膜敏感性、泪膜破裂时间(BUT)、Schirmer - 1试验和孟加拉玫瑰红染色对患者进行检查。将泪然与生理盐水比较,发现泪膜破裂时间有显著改善(p < 0.01),孟加拉玫瑰红染色也有显著改善(p < 0.01),而其他指标无变化。将泪然与粘性眼液比较,未发现临床参数有显著差异。患者抱怨有轻微不适。最突出的是由于缺乏泪液导致泪然棒溶解不充分,有泪然脱落的倾向。我们得出结论,泪然可能对原发性干燥综合征患者有帮助,前提是他们泪腺仍有一定的分泌能力。