Siatkowski R Michael, Cotter Susan, Miller Joseph M, Scher Colin A, Crockett R Stephens, Novack Gary D
Department of Ophthalmology, University of Oklahoma, and Dean A. McGee Eye Institute, Oklahoma City 73104, USA.
Arch Ophthalmol. 2004 Nov;122(11):1667-74. doi: 10.1001/archopht.122.11.1667.
To evaluate the safety and efficacy of the relatively selective M(1) antagonist pirenzepine hydrochloride in slowing the progression of myopia in school-aged children.
This was a parallel-group, placebo-controlled, double-masked study in healthy children, aged 8 to 12 years, with a spherical equivalent of -0.75 to -4.00 diopters (D) and astigmatism of 1.00 D or less. Patients underwent a baseline complete eye examination and regular examinations during a 1-year period. The setting was 13 US academic clinics and private practices. Patients were randomized in a 2:1 ratio to receive 2% pirenzepine ophthalmic gel or a placebo control twice daily for 1 year.
At study entry, the spherical equivalent was mean +/- SD -2.098 +/- 0.903 D for the pirenzepine group (n = 117) and -1.933 +/- 0.825 D for the placebo group (n = 57, P = .22). At 1 year, there was a mean increase in myopia of 0.26 D in the pirenzepine group vs 0.53 D in the placebo group (P < .001). No patients in the placebo group and 13 (11%) of 117 patients in the pirenzepine group discontinued participation in the study because of adverse effects (5 [4%] of 117 due to excessive antimuscarinic effects).
Pirenzepine is effective and relatively safe in slowing the progression of myopia during a 1-year treatment period.
评估相对选择性M（1）拮抗剂盐酸哌仑西平在减缓学龄儿童近视进展方面的安全性和有效性。
这是一项平行组、安慰剂对照、双盲研究，研究对象为8至12岁的健康儿童，等效球镜度数为-0.75至-4.00屈光度（D），散光度数为1.00 D或更低。患者在基线时进行了全面的眼部检查，并在1年期间接受定期检查。研究地点为美国的13家学术诊所和私人诊所。患者按2:1的比例随机分组，接受2%哌仑西平眼用凝胶或安慰剂对照，每日两次，持续1年。
研究开始时，哌仑西平组（n = 117）的等效球镜度数平均为-2.098 ± 0.903 D，安慰剂组（n = 57，P = 0.22）为-1.933 ± 0.825 D。1年后，哌仑西平组近视平均增加0.26 D，而安慰剂组为0.53 D（P < 0.001）。安慰剂组没有患者因不良反应而退出研究，哌仑西平组117名患者中有13名（11%）因不良反应（117名中有5名[4%]因抗毒蕈碱作用过度）退出研究。
在1年的治疗期内，哌仑西平在减缓近视进展方面有效且相对安全。
