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

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.