韦氏活血通络方对气虚血瘀型前部缺血性视神经病变患者视野的影响

Effect of Wei's Huoxue Tongluo Formula on Anterior Ischemic Optic Neuropathy Patients with Qi Deficiency and Blood Stasis

  • 摘要: 目的 评价韦氏活血通络方对气虚血瘀型前部缺血性视神经病变(AION)视野的影响。方法 采用前瞻性随机对照试验的研究方法,观察2014年1月至2018年12月在北京中医药大学东方医院眼科门诊就诊的AION患者,纳入患者需同时符合AION和中医证型气虚血瘀型的诊断标准,共纳入患者63例99眼,随机分为试验组32例51眼,对照组31例48眼。试验组给予韦氏活血通络方中药配方颗粒剂冲服,对照组给予复方血栓通胶囊及甲钴胺片口服。治疗4周后,检测患者的视野平均缺损(MD)、丢失方差(LV)、平均敏感度(MS)、最佳矫正视力(BCVA)、化验指标等,进行疗效和安全性评价。结果 患者视野缺损的形态主要包括以水平线为界的上方或下方近半盲(42.4%)、神经束样(含扇形、象限性)缺损(27.3%)、中心/类中心暗点(13.1%)等。治疗后,试验组和对照组采用G2程序检测的患者平均缺损(MD)值中位数分别为7.1 dB及10.8 dB,2组有显著性差异(P<0.05),但丢失方差(LV)值无明显差异。治疗前后试验组MD改善幅度明显高于对照组(P<0.01),治疗前后试验组最佳矫正视力的改善幅度明显高于对照组(P<0.05)。采用LVC程序检测的患者治疗前后及组间平均敏感度(MS)值无统计学差异(P>0.05)。试验组头或眼刺痛、气短、倦怠懒言、舌淡或瘀斑、脉细涩等症状出现频次均明显低于对照组(P<0.05)。全部患者治疗期间未发生明显不良事件。结论 AION的典型视野损害特征为水平半盲、神经束样缺损及中心/类中心暗点,韦氏活血通络方治疗可改善部分气虚血瘀型AION患者中医证候,提高患者视力、视野。

     

    Abstract: OBJECTIVE To evaluate the effect of Wei's Huoxue Tongluo formula on anterior ischemic optic neuropathy (AION) patients with qi deficiency and blood stasis. METHODS A prospective randomized controlled trial was conducted to observe the AION outpatients admitted in the Ophthalmology Department, Dongfang Hospital, Beijing University of Chinese Medicine from January 2014 to December 2018. The patients enrolled in the study were required to meet the diagnostic criteria of AION and TCM syndrome of qi deficiency and blood stasis. 63 patients (99 eyes) were included in the study. They were randomly divided into 32 cases (51 eyes) in the trial group and 31 cases (48 eyes) in the control group. The trial group was given Wei's Huoxue Tongluo formula granule, while the control group was given Complex Thrombolysis capsule and Mecobalamin tablets. After 4 weeks' treatment, the mean defect (MD), loss variance (LV), mean sensitivity (MS) of visual field, and, best corrected visual acuity (BCVA) and whole blood count, serum transaminase and creatinine were measured to evaluate the efficacy and safety. RESULTS The visual field defects of the patients mainly included nearly half-blind (42.4%) in upper or lower field of the horizontal line, fascicular (including fan-shaped and quadrantal) defects (27.3%), and central or quasi central scotoma(13.1%). After treatment, the median values of MD in the trial group and the control group were 7.1 db and 10.8 db, respectively. There was a significant difference between the two groups (P<0.05), but no significant difference in LV. After treatment, the improvement of MD in the trial group was significantly higher than that in the control group (P<0.01), and the improvement of BCVA in the trial group was significantly higher than that in the control group (P<0.05). There was no significant difference in MS before and after treatment and between groups (P>0.05). The frequency of symptoms such as head or eye tingling, shortness of breath, languor and laziness, light tongue or ecchymosis, thin and rough pulse in the trial group was significantly lower than that in the control group (P<0.05). No side effects occurred in patients during the treatment. CONCLUSION The typical visual field defect of AION are horizontal hemiblindness, fascicular defect and center or quasi center scotoma. The treatment of Wei's Huoxue Tongluo formula can improve some TCM symptoms for AION patients with qi deficiency and blood stasis, and improve their vision acuity and visual field.

     

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