丹芪精颗粒对急进高原人员的防护作用研究

李敏; 陆柏辰; 齐小荣; 王鹏; 秦丽

doi:10.12435/j.issn.2095-5227.2023.002

摘要:

背景急进高原作训如果缺少阶梯习服或低氧预适应训练，会增加急性高原病(acute mountain sickness，AMS)的发生风险。AMS是因急性缺氧而引起的潜在致命性疾病，可直接导致作训减员。因此，积极进行药物研发，预防AMS发生具有十分重要的意义。目的　观察口服丹芪精颗粒对快速进入高原地区人员急性高原反应的防护作用。

方法以2022年6月某部参加高原训练分队的男性官兵为研究对象，采用前瞻性、随机、对照临床试验设计，共纳入80例18 ~ 35岁官兵，随机分为治疗组和对照组，每组40例。治疗组口服丹芪精颗粒(主要由黄芪、丹参、黄精等药物组成)，对照组口服红景天胶囊(主要成分为红景天)，于进驻高原前7 d开始口服，共给予14 d。比较两组在进驻高原后第1天(T1)、第3天(T2)、第7天(T3)时一般情况、中医证候分级量化表和AMS量表评分、血清肿瘤坏死因子-α(tumor necrosis factor-α，TNF-α)、白细胞介素-6(interleukin-6，IL-6)、IL-8水平及药物安全性指标。

结果两组受试者的收缩压、舒张压、心率、血氧饱和度在各个时间点比较无统计学意义(P＞0.05)。两组进驻高原后第7天中医证候积分与第1天比较均显著下降(P＜0.05)，组间比较治疗组低于对照组，但差异无统计学意义(P=0.088)。与进驻第1天比较，在进驻第3天、第7天时两组TNF-α、IL-6水平均降低(P＜0.01)，且治疗组优于对照组(P＜0.05)。IL-8水平及AMS发生率组间差异无统计学意义(P＞0.05)。肝、肾等指标两组均未见异常。

结论丹芪精颗粒可减少中医证候分级量化表评分，改善急进高原人员临床症状；可能通过降低血清TNF-α、IL-6水平，对急性高原暴露人员发生AMS起到防护作用。

Abstract:

Background The risk of acute mountain sickness (AMS) will increase without steps or hypoxic preconditioning training. AMS is a potentially fatal disease caused by acute hypoxia that can directly lead to trainee attrtion. Therefore, it is of great significance to actively conduct drug research and development to prevent AMS.

Objective To observe the protective effect of oral Danqijing granules on acute altitude sickness in people who quickly enter plateau area.

Methods A prospective, randomized, controlled clinical trial design was conducted to select 80 male officers and soldiers (18-35 years old) who participated in altitude training in June 2022, and they were randomly divided into treatment group and control group with 40 cases in each group. The treatment group was given Danqijing granules (mainly composed of Radix Astragalus, Salvia miltiorrhiza, Huangjing), while the control group was given Rhodiola Rosea capsules (mainly composed of Rhodiola Rosea), starting from 7 days before entering the plateau, for a total of 14 days. The general conditions of the two groups on day 1 (T1), day 3 (T2) and day 7 (T3) after admission to plateau were compared, including the TCM syndrome grading scale, AMS scale score, serum Tumor Necrosis Factor-α(TNF-α), Interleukin-6 (IL-6), Interleukin-8 (IL-8) levels and drug safety indexes.

Results There were no significant differences in systolic blood pressure (mmHg), diastolic blood pressure, heart rate, SpO₂ between the two groups at each time point (all P>0.05). The scores of TCM symptoms on day 7 decreased significantly compared with that on day 1 after the two groups were stationed at the plateau (P<0.05). Compared with the control group, the scores of TCM symptoms in the treatment group were less on day 7, but the difference were not statistically significant (P=0.088) . Compared with day 1, the levels of TNF-αand IL-6 in both groups were decreased on day 3 and day 7 (P<0.01), and the treatment group was greater than those in the control group (P<0.05). There were no significant differences in IL-8 level and AMS incidence between the two groups (P>0.05). Liver, kidney and other indicators were all normal.

Conclusion Danqijing granules can reduce the score of TCM syndrome grading scale and improve the clinical symptoms of patients who rush to plateau. It may reduce the serum levels of TNF-α and IL-6 to protect against AMS in people with acute altitude exposure.

丹芪精颗粒对急进高原人员的防护作用研究

Protective effect of Danqijing granules on acute high altitude exposure