银杏达莫注射液联合高压氧治疗缺血性视神经病变的临床效果及安全性分析

Clinical effect and safety of Ginkgo-Diyidamolum injection combined with hyperbaric oxygen in the treatment of ischemic optic neuropathy

目的探讨银杏达莫注射液联合高压氧治疗缺血性视神经病变(ION)的临床效果及安全性。方法选取2018年11月至2019年12月陕健医二一五医院收治的102例ION患者,按随机数表法分为观察组与对照组,每组51例,对照组患者给予银杏达莫注射液治疗,观察组患者给予银杏达莫注射液联合高压氧治疗,以12 d作为一个疗程,疗程间隔时间为6 d,共进行3个疗程,比较两组患者3个疗程结束后的临床疗效,以及治疗前后的视力、视野、血流变学指标和不良反应发生情况。结果观察组患者的临床治疗总有效率为92.16%,明显高于对照组的76.47%,差异有统计学意义(P<0.05);观察组患者治疗后视力分布<0.1者8例,0.1~0.4者9例,0.4~0.6者14例,0.6~0.8者20例,对照组视力分布<0.1者13例,0.1~0.4者16例,0.4~0.6者11例,0.6~0.8者21例,观察组视力改善优于对照组,差异有统计学意义(P<0.05);观察组患者治疗后视野的丢失差异值(LV)和视野平均缺损(MD)水平分别为(15.46±1.53)dB、(5.39±0.52)dB,明显低于对照组的(18.77±1.79)dB、(7.24±0.70)dB,光敏感度(MS)水平为(19.20±1.89)dB,明显高于对照组的(16.89±1.64)dB,差异均有统计学意义(P<0.05);观察组患者治疗后的纤维蛋白原、全血高切黏度、全血低切黏度、血浆黏度水平分别为(2.64±0.39)g/L、(5.20±0.74)mPa·s、(8.41±0.73)mPa·s、(1.17±0.30)mPa·s,明显低于对照组的(3.70±0.41)g/L、(6.33±0.51)mPa·s、(9.64±0.92)mPa·s、(1.66±0.34)mPa·s,差异均有统计学意义(P<0.05);两组患者的不良反应发生率比较差异无统计学意义(P>0.05)。结论银杏达莫注射液联合高压氧可有效提高ION患者的视力、视野水平,改善血液流变学,疗效显著,安全性高。

Objective To explore the clinical effect and safety of Ginkgo-Diyidamolum injection combined with hyperbaric oxygen(HBO)in the treatment of ischemic optic neuropathy(ION).Methods A total of 102 patients with ION admitted to Shaanxi Healthcare 215th Hospital were enrolled between November 2018 and December 2019.According to random number table method,they were divided into observation group and control group,with 51 patients in each group.The control group was treated with Ginkgo-Diyidamolum injection,while the observation group was additionally treated with HBO.12 d was defined as a course of treatment,the interval between two courses was 6 d.The patients were all treated for 3 courses.The clinical curative effect at the end of 3 courses,visual acuity,visual field,hemorheological indexes before and after treatment,and the occurrence of adverse reactions were compared between the two groups.Results The total response rate of clinical treatment in the observation group was significantly higher than that in the control group(92.16%vs 76.47%,P<0.05).After treatment,there were 8 cases with visual acuity lower than 0.1,9 cases within 0.1-0.4,14 cases within 0.4-0.6,and 20 cases within 0.6-0.8 in the observation group,and in the control group,there were 13 cases with visual acuity lower than 0.1,16 within 0.1-0.4,11 cases within 0.4-0.6,and 21 cases within 0.6-0.8.After treatment,improvement of visual acuity in observation group was better than that in control group(P<0.05).After treatment,loss variance(LV)and mean deviation(MD)of visual field in the observation group were(15.46±1.53)dB,(5.39±0.52)dB,significantly lower than(18.77±1.79)dB,(7.24±0.70)dB in the control group,while mean sensitivity(MS)was(19.20±1.89)dB,significantly higher than(16.89±1.64)dB in the control group(P<0.05).After treatment,levels of fibrinogen,whole blood high-shear viscosity,whole blood low-shear viscosity,and plasma viscosity in the observation group were(2.64±0.39)g/L,(5.20±0.74)mPa·s,(8.41±0.73)mPa·s,(1.17±0.30)mPa·s,significantly lower than(3.70±0.41)g/L,(6.33±0.51)mPa·s,(9.64±0.92)mPa·s,(1.66±0.34)mPa·s in the control group(P<0.05).There was no significant difference in the incidence of adverse reactions between the two groups(P>0.05).Conclusion Ginkgo-Diyidamolum injection combined with HBO can effectively improve visual acuity,visual field and hemorheology in ION patients,with significant curative effect and high safety.