康柏西普玻璃体腔内注射联合阈值下微脉冲激光治疗糖尿病黄斑水肿的临床研究

doi:10.3877/cma.j.issn.2095-2007.2020.02.005

目的

观察玻璃体腔内注射康柏西普联合阈值下微脉冲激光(SMLP)治疗糖尿病黄斑水肿(DME)的临床疗效。

方法

选取2017年2月至2019年9月于北京市房山区良乡医院眼科就诊的DME患者47例(47只眼)作为研究对象。其中，男性25例(25只眼)，女性22例(22只眼)，年龄42~77岁，平均年龄(61.6±9.1)岁。根据治疗方法的不同将DME患者分为联合治疗组和注射药物组。其中，联合治疗组26例(26只眼)，注射药物组21例(21只眼)。联合治疗组，于SMLP治疗前1周行玻璃体腔内注射康柏西普治疗；注射药物组，单纯行1次玻璃体腔内注射康柏西普治疗。检测全部患者治疗前、治疗后1个月、治疗后2个月、治疗后3个月及治疗后4个月的的最佳矫正视力(BCVA)和黄斑中心凹视网膜厚度(CFT)。采用均数±标准差描述患者的年龄、眼压、BCVA及CFT。组间比较采用独立样本t检验；组内及组间治疗前后BCVA和CFT的比较，采用两因素重复测量方差分析。

结果

联合治疗组治疗后1个月、治疗后2个月、治疗后3个月及治疗后4个月的BCVA分别为(0.47±0.16)、(0.40±0.16)、(0.40±0.15)及(0.43±0.16)；CFT分别为(358.5±51.2)μm、(317.0±43.6)μm、(329.1±32.7)μm及(322.4±41.8)μm。注射药物组治疗后1个月、治疗后2个月、治疗后3个月及治疗后4个月的BCVA分别为(0.54±0.17)、(0.63±0.19)、(0.66±0.18)及(0.68±0.17)；CFT分别为(382.9±59.2)μm、(445.0±69.1)μm、(463.7±64.1)μm及(468.7±64.3)μm。SMLP治疗后1个月，两组患者BCVA和CFT的组间比较，差异均无统计学意义(t＝2.593，2.305；P>0.05)。SMLP治疗后2个月、治疗后3个月及治疗后4个月两组患者的BCVA比较，差异均有统计学意义(t＝21.683，29.321，25.948；P<0.05)；两组患者的CFT比较，差异有统计学意义(t＝59.960，86.855，88.537；P<0.05)。联合治疗组患者治疗后1个月、治疗后2个月、治疗后3个月及治疗后4个月的BCVA比治疗前提高，差异有统计学意义(t＝11.316，10.276，9.718，7.518；P<0.05)；患者的CFT比治疗前均下降，差异有统计学意义(t＝11.863，19.176，16.601，16.928；P<0.05)。注射药物组患者在治疗后1个月时BCVA有改善，差异有统计学意义(t＝5.966，P<0.05)；而治疗后2个月、治疗后3个月及治疗后4个月时与治疗前比较，BCVA差异无统计学意义(t＝1.826，-1.369，-1.826；P>0.05)；患者的CFT在治疗后1个月时显著改善，差异有统计学意义(t＝9.320，P<0.05)；而治疗后2个月、治疗后3个月及治疗后4个月时与治疗前比较，CFT差异无统计学意义(t＝1.725，-0.883，-1.777；P>0.05)。

结论

玻璃体腔内注射康柏西普联合SMLP疗法与单纯康柏西普玻璃体腔内注射疗法均能在短期内提高DME患者的视力，减轻其黄斑水肿，且具有良好的安全性，但前者的疗效更为稳定持久。

关键词: 糖尿病视网膜病变, 黄斑水肿, 血管生成抑制剂, 激光凝固术

Objective

The aim of this study was to observe the clinical efficacy of intravitreal injection of Conbercept combined with subthreshold micropulse laser (SMLP) in the treatment of diabetic macular edema (DME).

Methods

It was a retrospective analysis.Forty-seven patients (47 eyes) with diabetic macular edema (DME) were selected from Department of Ophthalmology in Liangxiang Hospital of Beijing Fangshan District from February 2017 to September 2019. Among them, 25 cases (25 eyes) were male, 22 cases (22 eyes) were female. The average age of the patients was (61.6±9.1) years-old. They were divided into combined treatment group (26 eyes) and injection group (21 eyes) according to the different clinical treatment. The patients in the combined treatment group were treated with intravitreal injection of Conbercept one week before SMLP and the patients in the injection group only were treated with intravitreal injection of Conbercept. There were 26 cases (26 eyes) in the combined treatment group, including 14 males (14 eyes) and 12 females (12 eyes), with an average age of (61.6±8.0) years. There were 21 patients (21 eyes) in the injection group, including 11 males (11 eyes) and 10 females (10 eyes), with an average age of (61.7±10.5) years-old. The best corrected visual acuity (BCVA) were measured by standard logarithmic visual acuity chart and central fovea retina thickness (CFT) were measured by optical coherence tomography (OCT). The CFT and BCVA were compared between two groups at 1, 2, 3 and 4 months after treatment. The data of age, intraocular pressure, BCVA and CFT of two groups were described by mean±standard deviation. Independent sample T test was used for comparison between groups. The BCVA and CMT within and between groups were compared by two-way ANOVA before and after treatment.

Results

In the combined treatment group, the BCVA at 1, 2, 3 and 4 months after treatment were (0.47±0.16), (0.40±0.16), (0.40±0.15), (0.43±0.16) and the CFT were (358.5±51.2) μm, (317.0±43.6) μm, (329.1±32.7) μm and (322.4±41.8) μm, respectively. In the injection group, the BCVA at 1, 2, 3 and 4 months after treatment were (0.54±0.17), (0.63±0.19), (0.66±0.18) and (0.68±0.17), respectively, and the CFT at 1, 2, 3 and 4 months after treatment were (382.9±59.2) μm, (445.0±69.1) μm, (463.7±64.1) μm and (468.7±64.3) μm, respectively. There was no significant difference in BCVA and CFT between two groups one month after SMLP treatment (t=2.593, 2.305; P>0.05). There was significant difference between two groups in terms of BCVA at 2, 3 and 4 months after SMLP treatment (t=21.683, 29.321, 25.948; P<0.05), and there was significant difference between two groups in terms of CFT at 2, 3 and 4 months after SMLP treatment(t=59.960, 86.855, 88.537; P<0.05). Compared with those before treatment, BCVA in the combined treatment group increased at 1, 2, 3 and 4 months after treatment with the significant difference between them (t=11.316, 10.276, 9.718, 7.518; P<0.05); and CFT decreased with the significant difference between them(t=11.863, 19.176, 16.601, 16.928; P<0.05). The injection group only showed an improvement in BCVA at 1 month after anti-VEGF treatment with the significant difference between them (t= 5.966, P<0.05). However, there was no significant difference in BCVA at 2, 3 and 4 months after treatment (t=1.826, -1.369, -1.826; P>0.05), CFT was significantly improved at 1 month after injection(t=9.320, P<0.05), but there was no significant difference at 2, 3 and 4 months after injection (t=1.725, -0.883, -1.777; P>0.05).

Conclusions

Both intravitreal injection of Conbercept combined with SMLP and single intravitreal injection of Conbercept could be of benefit to improve the visual acuity of DME patients in a short time, reduce their macular edema, and have good safety, but the effect of intravitreal injection was more stable and lasting.

Key words: Diabetic retinopathy, Macular edema, Angiogenesis inhibitors, Laser coagulation

表1 联合治疗组与注射药物组患者一般资料的比较(±s)

组别	例数	平均年龄(岁)	糖尿病病程(年)	眼压(mmHg)	CFT(μm)	LogMAR BCVA
联合治疗组	26	61.6± 8.0	12.6±3.9	15.5±2.9	457.3±51.7	0.63±0.19
注射药物组	21	61.7±10.5	11.5±3.4	16.8±2.8	458.8±60.6	0.65±0.20
t值		-0.05	1.01	-1.50	-0.09	-0.29
P值		>0.05	>0.05	>0.05	>0.05	>0.05

表1 联合治疗组与注射药物组患者一般资料的比较(±s)

组别	例数	平均年龄(岁)	糖尿病病程(年)	眼压(mmHg)	CFT(μm)	LogMAR BCVA
联合治疗组	26	61.6± 8.0	12.6±3.9	15.5±2.9	457.3±51.7	0.63±0.19
注射药物组	21	61.7±10.5	11.5±3.4	16.8±2.8	458.8±60.6	0.65±0.20
t值		-0.05	1.01	-1.50	-0.09	-0.29
P值		>0.05	>0.05	>0.05	>0.05	>0.05

表2 两组患者治疗前后最佳矫正视力的比较(±s)

组别	例数	治疗前BCVA	治疗后1个月BCVA	治疗后2个月BCVA	治疗后3个月BCVA	治疗后4个月BCVA
联合治疗组	26	0.63±0.19	0.47±0.16^*	0.40±0.16^*	0.40±0.15^*	0.43±0.16^*
注射药物组	21	0.65±0.20	0.54±0.17^*	0.63±0.19	0.66±0.18	0.68±0.17
t值		-0.29	-1.61	21.68	29.32	25.95
P值		>0.05	>0.05	<0.05	<0.05	<0.05

表2 两组患者治疗前后最佳矫正视力的比较(±s)

组别	例数	治疗前BCVA	治疗后1个月BCVA	治疗后2个月BCVA	治疗后3个月BCVA	治疗后4个月BCVA
联合治疗组	26	0.63±0.19	0.47±0.16^*	0.40±0.16^*	0.40±0.15^*	0.43±0.16^*
注射药物组	21	0.65±0.20	0.54±0.17^*	0.63±0.19	0.66±0.18	0.68±0.17
t值		-0.29	-1.61	21.68	29.32	25.95
P值		>0.05	>0.05	<0.05	<0.05	<0.05

图2 两组患者治疗前后黄斑中心凹视网膜厚度的比较　图中a、b、c及d，以字母标记法展示的时间点的组内比较；▲表示联合治疗组与注射药物组的组间比较

表3 两组患者治疗前后黄斑中心凹视网膜厚度的比较(±s，μm)

组别	例数	治疗前CFT	治疗后1个月CFT	治疗后2个月CFT	治疗后3个月CFT	治疗后4个月CFT
联合治疗组	26	457.3±51.7	358.5±51.2^*	317.0±43.6^*	329.1±32.7^*	322.4±41.8^*
注射药物组	21	458.8±60.6	382.9±59.2^*	445.0±69.1	463.7±64.1	468.7±64.3
t值		-0.09	-1.51	59.96	86.86	88.53
P值		>0.05	>0.05	<0.05	<0.05	<0.05

表3 两组患者治疗前后黄斑中心凹视网膜厚度的比较(±s，μm)

组别	例数	治疗前CFT	治疗后1个月CFT	治疗后2个月CFT	治疗后3个月CFT	治疗后4个月CFT
联合治疗组	26	457.3±51.7	358.5±51.2^*	317.0±43.6^*	329.1±32.7^*	322.4±41.8^*
注射药物组	21	458.8±60.6	382.9±59.2^*	445.0±69.1	463.7±64.1	468.7±64.3
t值		-0.09	-1.51	59.96	86.86	88.53
P值		>0.05	>0.05	<0.05	<0.05	<0.05

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The effect of Conbercept combined with subthreshold micropulse laser photocoaguIation on diabetic macular edema

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The effect of Conbercept combined with subthreshold micropulse laser photocoaguIation on diabetic macular edema