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

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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 observe the effectiveness and safety of oxygen inhalation and soy isoflavones in the treatment of early stage altitude polycythemia (HAPC) in high-altitude population. Methods Eighty young men who migrated from 3500 to 5300 m in the plateau for 10 months or more and were confirmed to have hemoglobin (HGB) values ​​of 190 g / L ≤ Hgl <210 g / L after 3 examinations were divided into two groups: (N = 40), low-flow oxygen inhalation (1-2L / min), 1.5h / time, 2-4 times / d and drug group (n = 40) Flavonoids (20 mg, 2 / d) were treated. The clinical symptoms of chronic high altitude sickness (CMS) were scored before entering the trial. After 12 weeks, the blood routine was reviewed and the CMS scores were followed up. The changes of RBC, HGB, hematocrit (HCT) and CMS re-score were observed. Multiple linear regression analysis of many factors that affect the HGB value changes. Results After 12 weeks of follow-up, the HGB value of the primary end point index decreased by 8.76 ± 5.15g / L in the drug group and 4.16 ± 5.33g / L in the oxygen inhalation group. Compared with the oxygen group, the HGB in the drug group decreased more obviously (P <0.05). After treatment, the clinical symptoms and the CMS score of the drug group decreased significantly, that is, the clinical symptoms were significantly improved (P <0.05), while there was no significant difference between the groups before and after the improvement of the symptoms of oxygen inhalation group (P> 0.05). HGB values ​​were significantly correlated with test grouping. Before and after medical treatment, subjects had no abnormal changes of blood pressure, liver and kidney function, electrocardiogram and chest radiograph. Conclusions Early prevention of HAPC in high altitude areas is necessary. Oxygen inhalation and oral administration of isoflavones is an effective method of prevention.
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