Department of Hematology, Sir Gangaram Hospital & GRIPMER, Rajinder Nagar, New Delhi, 110060, India.
Commandant Hospital, Leh and Consultant Comm Med & Epidemiologist.
Thromb Res. 2015 Oct;136(4):758-62. doi: 10.1016/j.thromres.2015.08.001. Epub 2015 Aug 4.
A higher risk of thrombosis has been reported on prolonged stay at high altitude (HAA). Lowering of homocysteine (Hcy) has been found to reduce the risk of venous thrombosis. A randomized field trial was conducted with primary question whether Hcy lowering agents have any effect on the incidence of thrombosis at HAA amongst Indian soldiers as compared to existing interventions.
All units freshly inducted to HAA were randomized into intervention (Vit B12 1000 microgram/day, B6 3mg/day & folic acid 5mg/day) and control arms, with a sample size of 12,000 person-years in each arm.
At the end of one year stay at HAA, Folate and B 12 levels decreased significantly in control arm. The levels of Hcy, fibrinogen and plasminogen activator inhibitor (PAI 1) were lower and nitric oxide higher in intervention arm as compared to control arm (p<0.05). At the end of 2years, 5 thrombotic episodes occurred in the intervention arm and 17 in control arm with RR of 0.29 (95% CI 0.11-0.80), attributable fraction % (AFe) 70.59%, Population attributable risk percent 54.55% and Protective Fraction 240%.
Intervention with B12 and folic acid is effective in reducing Hcy, PAI 1, fibrinogen levels and increasing NO levels at 1yr as compared to control arm and reducing the incidence of thrombosis at 2years of stay at HAA. Thus, vitamin B 12, B6 and folic acid intervention is safe and effective method of reducing morbidity and mortality caused by HAA induced coagulopathy.
在高海拔地区(HAA)停留时间较长会增加血栓形成的风险。降低同型半胱氨酸(Hcy)已被发现可降低静脉血栓形成的风险。一项随机现场试验的主要问题是,与现有的干预措施相比,Hcy 降低剂是否会对印度士兵在 HAA 时的血栓形成发生率产生影响。
所有新入伍到 HAA 的部队均随机分为干预组(每天 1000 微克维生素 B12、3 毫克 B6 和 5 毫克叶酸)和对照组,每组 12000 人年。
在 HAA 停留一年后,对照组叶酸和 B12 水平显著下降。与对照组相比,干预组 Hcy、纤维蛋白原和纤溶酶原激活物抑制剂(PAI 1)水平较低,一氧化氮水平较高(p<0.05)。在 2 年结束时,干预组发生 5 例血栓形成事件,对照组发生 17 例,RR 为 0.29(95%CI 0.11-0.80),归因分数%(AFe)为 70.59%,人群归因风险百分比为 54.55%,保护分数为 240%。
与对照组相比,在 1 年时,B12 和叶酸的干预可有效降低 Hcy、PAI 1、纤维蛋白原水平,增加一氧化氮水平,并降低 2 年 HAA 停留期间的血栓形成发生率。因此,维生素 B12、B6 和叶酸干预是降低 HAA 诱导的凝血功能障碍引起的发病率和死亡率的安全有效方法。