Objective To observe the clinical efficacy of enhanced external counterpulsation (ECP) in the treatment of non-proliferative diabetic retinopathy (NPDR).Methods It was a case-control study.83 patients (166 eyes) of NPDR were randomly divided into ECP treatment group (ECP group) and conventional therapy group (drug group) by date of visit odd and even number,each with 42 patients of 84 eyes and 41 patients of 82 eyes respectively.The blood glucose,glycated hemoglobin (HbAlc),low-density lipoprotein (LDL-C),corrected visual acuity,stages of diabetic retinopathy (DR) and hemodynamic index such as peak systolic velocity (PSV),diastolic velocity (EDV),resistance index (RI) of ophthalmic artery (OA) and central retinal artery (CRA) were not statistically different between these two groups (P＞ 0.05).All patients were regularly educated for lifestyle management and diabetes mellitus.The following parameters were controlled by drugs including blood glucose＜8.0 mmol/L,HbA1c＜7.5 ％,blood pressure ＜140/90 mmHg (1 mmHg=0.133 kPa) and LDL-C＜3.1 mmol/L.The ECP group received both ECP and medical treatments.The ECP parameters were gasbag pressure 0.35-0.45 kg/cm2,40 min/each time,1 time/d.35 days of ECP was one course,one course each year for 3 years.The treatment effectiveness was determined at the end of follow-up after 3 years of treatment.The blood glucose,HbA1c,blood pressure,LDL-C,visual acuity,fundus changes and hemodynamic index of OA and CRA before and after treatment were comparatively analyzed.Improved or stable visual acuity and fundus condition was judged as effective treatment.Results At latest follow up,the differences of blood glucose,HbA1c,blood pressure and LDL-C were not statistically significant (P＞0.05).Compared to drug group,the PSV and EDV of OA and CRA were increased,but RI of OA and CRA was decreased in ECP group (P＜0.05).The vision effective ratio was 91.67％ and 30.49％ in ECP group and drug group respectively with a significant different (x2 =65.56,P＜0.05).The fundus effective ratio was 92.86％ and 48.78％ in ECP group and drug group respectively with a significant different (x2 =43.38,P＜ 0.05).During follow-up,1 eye (1.19％) progressed to proliferative DR (PDR) in ECP group,while 6 eyes (7.32％) progressed to PDR in drug group.The difference of PDR incidence rate between two groups was significant (x2 =3.87,P＜ 0.05).During the ECP treatment,there were 2 patients with small blisters in the skin of lower limb and cured finally.There were no other treatment-related complications.Conclusion ECP in the treatment for NPDR can improve PSV and EDV,reduce RI of OA and CRA;improve vision and fundus state,reduce the incidence of PDR.%目的 观察体外反搏(ECP)治疗非增生型糖尿病视网膜病变(NPDR)的临床疗效.方法 前瞻性随机病例对照研究.临床确诊为NPDR的83例166只眼纳入研究.按就诊日期奇偶数顺序将患者随机分为ECP治疗组(ECP组)和常规药物治疗组(药物组),分别为42例84只眼、41例82只眼.两组患者的血糖、糖化血红蛋白(HbA1c)、低密度脂蛋白胆固醇(LDL-C)、眼动脉和视网膜中央动脉收缩期峰值血流速度(PSV)、舒张末期速度(EDV)、阻力指数(RI)、矫正视力、糖尿病视网膜病变(DR)分期比较,差异均无统计学意义(P＞0.05).两组患者均定期给予糖尿病生活管理和宣教.药物控制血糖＜8.0 mmol/L;HbA1c＜7.5％;血压＜140/90 mmHg(1 mmHg=0.133 kPa);LDL-C＜3.1 mmol/L.ECP组在药物组基础上加用ECP治疗.气囊压力0.35～0.45 kg/cm2,40 min/次,1次/d.以35 d为1个疗程,每年进行1个疗程,共治疗3年.以治疗3年后末次随访为疗效判定时间点,对比分析患者治疗前后血糖、HbA1c、血压、LDL-C、矫正视力、眼底变化情况以及末次随访时患眼眼动脉和视网膜中央动脉PSV、EDV、R1等血流动力学指标.以视力提高、稳定、下降判定视力变化;以眼底病变改善、稳定、恶化判定眼底变化.视力提高或无变化、眼底改善或稳定均视为治疗有效.结果 末次随访时,两组患者血糖、HbA1c、血压、LDL-C比较,差异均无统计学意义(P＞0.05).ECP组患眼眼动脉、视网膜中央动脉PSV、EDV明显高于药物组,RI明显低于药物组,差异均有统计学意义(P＜0.05).ECP组、药物组患眼视力治疗有效率分别为91.67％、30.49％;两组患眼视力治疗有效率比较,差异有统计学意义(x2=65.56,P＜0.05).ECP组、药物组患眼眼底治疗有效率分别为92.86％、48.78％;两组患眼眼底治疗有效率比较,差异有统计学意义(x2=43.38,P＜0.05).随访观察期间,ECP组1只眼发生增生型DR(PDR),占1.19％;药物组6只眼发生PDR,占7.32％.两组PDR发生率比较,差异有统计学意义(x2=3.87,P＜0.05).ECP组ECP治疗过程中,2例患者双下肢皮肤出现小水泡,给予碘伏涂擦后痊愈,不影响治疗.其余患者未见与治疗相关的并发症发生.结论 ECP治疗NPDR,可提高患眼眼动脉和视网膜中央动脉PSV、EDV,降低RI;提高视力,改善眼底状况,降低PDR的发生率.
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