大豆异黄酮对早期高原红细胞增多症疗效的临床研究：80例多中心临床研究  

The effect of soy isoflavones on early high altitude polycythemia:a multicenter clinical study of 80 cases

作　　者：于前进 孔佩艳[1] 崔建华 曾东风[1] 文朝远[3] 李佳丽[1] 宋虎[4] 沈照华[1] 陈建[3] 胥全宏 

机构地区：[1]第三军医大学新桥医院全军血液病中心,重庆400037 [2]解放军18医院高山病研究所,新疆叶城844900 [3]解放军第8医院内科,西藏日喀则857000 [4]解放军41医院内科,西藏山南856000

出　　处：《解放军医学杂志》2014年第11期902-907,共6页Medical Journal of Chinese People's Liberation Army

基　　金：“十一五”国家科技支撑计划(2009BAI85B02)~~

摘　　要：目的观察吸氧＋大豆异黄酮对移居高海拔人群中早期高原红细胞增多症（HAPC）人群治疗的有效性及安全性。方法筛选移居3500-5300m高原地区10个月以上,经3次检查确认血红蛋白（HGB）值在190g/L≤HGB〈210g/L的80例青年男性,分为吸氧组与药物组,吸氧组（n=40）低流量吸氧（1-2L/min）,1.5h/次,2-4次/d;药物组（n=40）吸氧（方法同吸氧组）＋口服大豆异黄酮（20mg,2/d）治疗。两组均进行慢性高原病（CMS）临床症状评分后进入试验,12周后复查血常规并随访CMS评分,观察RBC、HGB、血细胞比容（HCT）数值变化及CMS再评分。应用多元线性回归分析影响HGB值变化的诸多因素。结果经12周随访观察,主要终点指标HGB值变化：药物组下降8.76±5.15g/L,吸氧组下降4.16±5.33g/L。对比吸氧组,药物组HGB下降较为明显（P〈0.05）。治疗后临床症状,药物组CMS评分降低明显,即临床症状显著改善（P〈0.05）,而吸氧组症状改善治疗前后差异无统计学意义（P〉0.05）。HGB值变化与试验分组有显著关联性。药物治疗前后,受试者血压、肝肾功能、心电图、胸片等均无异常变化。结论在高海拔高原地区进行HAPC的早期预防是必要的,吸氧＋口服大豆异黄酮是有效的预防方法。Objective To evaluate the efficacy and safety of oxygen inhalation combined with oral administration of soy isoflavones on people who migrated from plains to high altitude area suffering from polycythemia.Methods Eighty young men,who migrated to the area of altitude of 3500-5300m for more than ten months,and their hemoglobin（HGB） level was verified in the range of 190g/L≤HGB 210g/L,which was confirmed by blood routine examination for three times,were randomly divided into 2 groups：oxygen group（n=37） and oxygen plus soy isoflavones group（n=37）.For the former,the subjects were given low flow oxygen inhalation（1-2L/min） for 1.5 hours,2-4 times per day;for the latter,the subjects were given low flow oxygen therapy（same as the former） combined with oral administration of 40 mg soy isoflavones per day.After 12 weeks,all the subjects were rechecked with blood routine examination and the clinical symptoms of chronic mountain sickness（CMS） score,to evaluate the improvement in red blood cell（RBC）,hemoglobin（HGB）,hematocrit（HCT）,and the clinical symptoms.Results After 12 weeks of follow-up,the value of HGB in oxygen plus soy isoflavones group was lowered by 8.76±5.15g/L,while in oxygen group it was lowered by 4.16±5.33g/L,and the magnitude of lowering was significantly different between the two groups（P〈0.05）.The degree of improvement of clinical symptoms after the intervention was observed in the two groups,and it was found that obvious improvement was observed in the oxygen plus soy isoflavones group（P〈0.05）,but no obvious improvement was observed in oxygen group（P〉0.05）.Multiple linear regression analysis revealed that the affecting factors of HGB that the change in HGB values was significantly associated with test grouping.In addition,there were no obvious side effects and changes in BP,ECG,chest X-ray,liver and kidney functions before and after soy isoflavones intake.Conclusion In high-altitude area,oxygen and oral administration of soy isoflavones are safe an

关 键 词：吸氧 大豆异黄酮 早期高原红细胞增多症 有效性 

分 类 号：R555.1[医药卫生—血液循环系统疾病] R598.6[医药卫生—内科学]