复方樟柳碱治疗原发性和继发性缺血性视神经视网膜脉络膜病变

Clinical observation of the effects of compound anisodine on treatment of primary and se-condary ischemic optic neuropathy and choroidoretinopathy

目的 观察复方樟柳碱注射液对原发性和继发性缺血性视神经视网膜脉络膜病变的疗效和安全性。 方法 采用多中心、随机对照方法 ,将原发性和继发性缺血性视神经视网膜脉络膜病变患者 (分别为 2 17例和 186例 ) 4 0 3例随机分为对照组 (112例 )、治疗组 (112例 )和开放组 (179例 ) ,对照组采用妥拉苏林注射液 2 5 mg,治疗组及开放组采用复方樟柳碱注射液 2 ml,均作患眼侧颞浅动脉旁皮下注射 ,每日 1次 ,疗程为 2 1d。以视力、视野、眼底改变为疗效判断指标 ,以眼压、血压、心电图、肝肾功能及血、尿常规等检测作为安全性的判断指标。对照组与治疗组治疗前各项主要指标具有可比性 (P>0 .0 5 )。 结果 有效率治疗组为 82 .14% ,对照组为 36 .6 1% ,二者比较 ,差异有显著性意义 (χ2 =48.14,P=0 .0 0 0 0 ) ,开放组的有效率为 80 .45 %。治疗组中原发性患者有效率为 87.0 4% ,继发性患者有效率为 77.5 9% ,均优于对照组(35 .19%和 37.93% ) ,其差异有显著性意义 (χ2 分别为 30 .5 5和 18.6 9,P=0 .0 0 0 0 )。各单位治疗结果经Ridit分析差异无显著性意义。除患者有短暂口干外 ,各安全性指标治疗前、后比较均无明显变化。 结论 复方樟柳碱注射液对原发性和继发性缺血性视神经视网膜脉络膜病变的治疗是?

Objective [WT5”BZ]To investigate the effects and the safety of compound anisodine injection on treatment of primary and secondary ischemic optic neuropathy and choroidoretinopathy. [WT5”HZ]Methods [WT5”BZ]A multicentered,random,controlled study was applied on 403 patients,including 217 patients of primary ischemic optic neuropathy and choroidoretinopathy,and 186 patients of secondary ischemic optic neuropathy and choroidoretinopathy.All the patients were assigned into 3 groups randomly:112 patients in control group and treatment group respectively,179 patients in open group.Compound anisodine 2 ml was injected subcutaneously around superficial temporal artery to the patient in treatment and open group once every day,while tolazoline 25 mg was given in the same way to the patient in control group for 21 days.Visual acuity,visual field and fundus condition are examined to evaluate the effects of treatment,and intraocular pressure,blood pressure,electrocardiography,blood and urine routine examination,blood test for renal and liver function are taken to study the safety of the treatment.The main subjects of the control and treatment group before treatment were comparable (P>0.05). [WT5”HZ]Results [WT5”BZ]The difference of effective rate between treatment group (82.14%) and control group (36.61%) was significant (χ 2=48.14,P=0.0000).The effective rate of open group is 80.45%.The effects on both primary and secondary patients in treatment group (87.04% and 77.59%) were better than those in control group (35.19% and 37.93%),and the difference was significant (P=0.0000) .The difference of the results in different centers was not significant according to Ridit analysis.There was few side effect except temporary dry mouth in some patients and the parameters of safety had no significant change before and after treatment. [WT5”HZ]Conclusion [WT5”BZ]Compound anisodine is a safe and effective drug to treat primary and secondary ischemic optic neuropathy and choroidoretinopathy. [WT5”HZ]