[2%盐酸卡替洛尔长效眼用溶液IV期研究——有效性、安全性及血药浓度调查]
[Long-acting carteolol hydrochloride 2% ophthalmic solution phase IV study--investigation of the effectiveness, safety and plasma concentration].
作者信息
Kawase Kazuhide, Yamamoto Tetsuya, Muramatsu Tomoyuki, Ono Junji, Nakajima Toru, Matsuhisa Atsuko, Sugiura Torao, Migita Masayoshi, Ishikawa Yuji
机构信息
Department of Ophthalmology, Gifu University School of Medicine, 1-1 Yanagido, Gifu-shi, Gifu-ken 501-1194, Japan.
出版信息
Nippon Ganka Gakkai Zasshi. 2010 Nov;114(11):976-82.
PURPOSE
We investigated the effectiveness, safety and plasma concentration of long-acting carteolol hydrochloride 2% ophthalmic solution (LA) as compared with the original carteolol hydrochloride 2% ophthalmic solution(CA).
METHODS
Patients with primary open angle glaucoma and ocular hypertension were randomized to 62 patients of LA group (LA once a day) and 62 patients of CA group (CA twice a day) in this multicenter, open-label trial. The intraocular pressure (IOP), pulse rate, blood pressure and plasma concentration were examined for 8 weeks.
RESULTS
The IOP reduction and reduction rate were not significant at any point between the two groups. Systolic blood pressure decreased significantly in both groups, however, diastolic blood pressure decreased only in the CA group. The plasma concentration of the LA group was significantly lower than that of the CA group.
CONCLUSIONS
The IOP reduction effect of the LA group was the same as the CA group. This study suggests that long-acting treatment with alginic acid can be useful for reducing systemic side effects.
目的
我们研究了2%长效盐酸卡替洛尔滴眼液（LA）与原2%盐酸卡替洛尔滴眼液（CA）相比的有效性、安全性和血浆浓度。
方法
在这项多中心、开放标签试验中，将原发性开角型青光眼和高眼压症患者随机分为LA组62例（每天一次LA）和CA组62例（每天两次CA）。对眼压（IOP）、脉搏率、血压和血浆浓度进行了8周的检测。
结果
两组之间在任何时间点的眼压降低幅度和降低率均无显著差异。两组的收缩压均显著下降，然而，仅CA组的舒张压下降。LA组的血浆浓度显著低于CA组。
结论
LA组的眼压降低效果与CA组相同。本研究表明，藻酸长效治疗有助于减少全身副作用。
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