Inoue Sachiko, Kawashima Motoko, Hisamura Ryuji, Imada Toshihiro, Izuta Yusuke, Nakamura Shigeru, Ito Masataka, Tsubota Kazuo
Department of Ophthalmology, Keio University School of Medicine, Shinjuku-ku, Tokyo, Japan.
Haneginomori Eye Clinic, Daita, Setagaya-ku, Tokyo, Japan.
PLoS One. 2017 Jan 6;12(1):e0169069. doi: 10.1371/journal.pone.0169069. eCollection 2017.
Dry eye is a multifactorial disease characterized by ocular discomfort and visual impairment. Lacrimal gland function has been shown to decrease with aging, a known potent risk factor for dry eye. We have previously found that orally administrated royal jelly (RJ) restored tear secretion in a rat model of dry eye.
We examined the effects of RJ oral administration on dry eye in this prospective, randomized, double-blind, placebo-controlled study. Forty-three Japanese patients aged 20-60 years with subjective dry eye symptoms were randomized to an RJ group (1200 mg/tablet, six tablets daily) or a placebo group for 8 weeks. Keratoconjunctival epithelial damage, tear film break-up time, tear secretion volume, meibum grade, biochemical data, and subjective dry eye symptoms based on a questionnaire were investigated at baseline, and at 4 and 8 weeks after intervention. Adverse events were reported via medical interviews. In the RJ group, tear volume significantly increased after intervention (p = 0.0009). In particular, patients with a baseline Schirmer value of ≤10 mm showed a significant increase compared with baseline volume (p = 0.0005) and volume in the placebo group (p = 0.0051). No adverse events were reported. We also investigated the effect of RJ (300 mg/kg per day) administration using a mouse model of dry eye. Orally repeated administration of RJ preserved tear secretion, potentially through direct activation of the secretory function of the lacrimal glands.
Our results suggest that RJ improves tear volume in patients with dry eye.
Registered NO. the University Hospital Medical Information Network in Japan (UMIN000014446).
干眼症是一种以眼部不适和视力损害为特征的多因素疾病。泪腺功能已被证明会随着年龄增长而下降，而年龄增长是干眼症已知的一个重要风险因素。我们之前发现，口服蜂王浆（RJ）可使干眼症大鼠模型的泪液分泌恢复正常。
在这项前瞻性、随机、双盲、安慰剂对照研究中，我们研究了口服RJ对干眼症的影响。43名年龄在20至60岁之间、有主观干眼症状的日本患者被随机分为RJ组（1200毫克/片，每日6片）或安慰剂组，为期8周。在基线时以及干预后4周和8周，对角膜结膜上皮损伤、泪膜破裂时间、泪液分泌量、睑脂等级、生化数据以及基于问卷的主观干眼症状进行了调查。通过医学访谈报告不良事件。在RJ组中，干预后泪液量显著增加（p = 0.0009）。特别是，基线Schirmer值≤10毫米的患者与基线量相比有显著增加（p = 0.0005），且与安慰剂组的量相比也有显著增加（p = 0.0051）。未报告不良事件。我们还使用干眼症小鼠模型研究了RJ（每天300毫克/千克）给药的效果。口服重复给予RJ可维持泪液分泌，可能是通过直接激活泪腺的分泌功能。
我们的结果表明，RJ可改善干眼症患者的泪液量。
在日本大学医院医学信息网络注册（UMIN000014446）。
