目的：比较0.01%和0.05%阿托品滴眼液对近视儿童瞳孔直径和眼压的影响。

方法：前瞻性非随机对照研究。收集2021-03/2022-02于濮阳市第二人民医院眼科就诊的近视患者232例，根据患者意愿分为0.01%阿托品滴眼液组81例，0.05%阿托品滴眼液组77例和对照组74例使用安慰剂滴眼液(等渗赋形剂)。分别于用药前，用药后6、12 mo测量三组患者的瞳孔直径和眼压。

结果：最终181例181眼(均取右眼数据纳入研究)完成1 a随访，失访率为22.0%(51/232)，其中0.01%阿托品滴眼液组62例62眼，0.05%阿托品滴眼液组54例54眼，对照组65例65眼。三组患者基线瞳孔直径和眼压比较无差异(均P<0.05)。用药12 mo后，0.01%阿托品滴眼液组、0.05%阿托品滴眼液组和对照组患者的瞳孔直径变化量分别为0.79±0.70、1.29±0.66和0.06±0.74 mm(P<0.001)，0.05%阿托品滴眼液组的瞳孔直径变化显著高于0.01%阿托品滴眼液组和对照组，0.01%阿托品滴眼液组的瞳孔直径变化显著高于对照组(均P<0.05)。用药12 mo后，0.01%阿托品滴眼液组、0.05%阿托品滴眼液组和对照组患者的眼压变化分别为-0.70±1.94、-0.22±1.79和0.25±2.03 mmHg(P<0.05)，0.05%阿托品滴眼液组的眼压变化与0.01%阿托品滴眼液组和对照组比较均有差异(均P>0.05)，0.01%阿托品滴眼液组的眼压变化与对照组比较有差异(P<0.05)。多因素线性回归分析，基线近视屈光度越小、基线瞳孔直径越小，使用阿托品滴眼液后瞳孔直径变化越明显(β=0.230，95%CI：0.005-0.455，SE=0.114，t=2.025，P=0.045； β=-0.562，95%CI：-0.729--0.396，SE=0.084，t=6.697，P<0.001)。基线眼压越小，使用阿托品滴眼液后眼压变化越明显(β=-0.285，95%CI：-0.439--0.131，SE=0.078，t=3.662，P<0.001)。

结论：使用0.01%和0.05%阿托品滴眼液后近视儿童的瞳孔直径增大，且使用0.05%阿托品滴眼液的瞳孔直径变化显著高于0.01%阿托品滴眼液，未发现0.01%和0.05%阿托品滴眼液的应用与眼压升高存在风险关系。

METHODS: Prospective non-randomized controlled study. A total of 232 myopic children who treated at the Department of Ophthalmology, the Second People's Hospital of Puyang from March 2021 to February 2022 were included. They were divided into 0.01% atropine eye drops group(81 cases), 0.05% atropine eye drops group(77 cases), and control group(74 cases)according to patients' will, respectively. The control group received placebo eye drops(isotonic excipient). The PD and IOP of the three groups of patients were measured before medication and at 6 and 12 mo after medication.

RESULTS: Finally, 181 cases(181 eyes)(with all right eye data included in the study)completed a 1-year follow-up, with a loss to follow-up rate of 22.0%(51/232). Among them, 62 cases(62 eyes)belonged to the 0.01% atropine eye drops group, 54 cases(54 eyes)belonged to the 0.05% atropine eye drops group, and 65 cases(65 eyes)belonged to the control group. There was no significant difference in baseline PD and IOP among the three groups(all P<0.05). After 12 mo of medication, the changes in PD among the 0.01% atropine eye drops group, 0.05% atropine eye drops group, and control group were 0.79±0.70, 1.29±0.66, and 0.06±0.74 mm, respectively(P<0.001). The change in PD in the 0.05% atropine eye drops group was significantly greater than that in both the 0.01% atropine eye drops group and the control group. Similarly, the change in PD in the 0.01% atropine eye drops group was significantly greater than that in the control group(all P<0.05). After 12 mo of medication, the changes in IOP among the 0.01% atropine eye drops group, 0.05% atropine eye drops group, and control group were -0.70±1.94, -0.22±1.79, and 0.25±2.03 mmHg, respectively(P<0.05). The changes in IOP in the 0.05% atropine eye drops group showed statistically significant difference compared to both the 0.01% atropine eye drops group and the control group(all P>0.05), and the changes in IOP in the 0.01% atropine eye drops group were statistically significant compared to the control group(P<0.05). Multivariate linear regression analysis revealed that baseline refractive error and baseline PD were significant factors influencing the change in PD among children treated with atropine eye drops(β=0.230, 95%CI: 0.005-0.455, SE=0.114, t=2.025, P=0.045; β=-0.562, 95%CI: -0.729--0.396, SE=0.084, t=6.697, P<0.001). Additionally, baseline IOP was significant factor influencing the change in IOP among children in the atropine eye drop groups(β=-0.285, 95%CI: -0.439--0.131, SE=0.078, t=3.662, P<0.001).

CONCLUSION: The PD of myopic children increased after using 0.01% and 0.05% atropine eye drops, and the change in PD after using 0.05% atropine eye drops was significantly greater than that of 0.01% atropine eye drops. No risk was found in the use of 0.01% and 0.05% atropine eye drops and elevated IOP.