Protective effect of Danqijing granules on acute high altitude exposure: A field cohort study on plateau
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摘要:
背景 急进高原作训如果减少阶梯习服或低氧预适应训练,会增加急性高原病(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的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发生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天开始口服,共给予14天。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(TNF-α)、白细胞介素-6(IL-6)、白细胞介素-8(IL-8)水平及药物安全性指标。 结果 两组受试者的收缩压(mm/Hg),舒张压(mm/Hg),心率(次/分),SpO2(%)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天中医证候积分与本组进驻高原后第1天比较均下降显著(P<0.05),且治疗组较对照组下降显著(P<0.01)。与进驻第1天比较,在进驻第3天、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 if steps or hypoxic preconditioning training is reduced. AMS is a potentially fatal disease caused by acute hypoxia that can directly lead to training force reductions. 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 (mm/Hg), diastolic blood pressure (mm/Hg), heart rate (times/min), SpO 2 (%) between the two groups at each time point (all P>0.05). The scores of TCM symptoms on day 7 after the two groups 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 decreased significantly (P<0.01) on the first and seventh days after entering the plateau. 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 better than the control group (P<0.05). There were no significant differences in IL-8 level and AMS incidence among 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. -
Key words:
- Danqijing granule /
- acute plateau exposure /
- TCM syndrome /
- TNF-α /
- IL-6
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表 1 两组基线资料比较
Table 1. Comparison of baseline data between the two groups
指标 治疗组(n=40) 对照组(n=40) t值 P值 年 龄/岁 24.20 ± 3.33 25.60 ± 3.91 1.725 0.089 身 高/cm 173.48 ± 5.12 173.40 ± 5.77 0.062 0.951 体 重/kg 66.32 ± 8.45 69.46 ± 8.37 1.669 0.099 心 率/(次/分) 75.13 ± 8.82 73.18 ± 11.18 0.866 0.389 收缩压/(mmHg) 117.88 ± 8.13 116.00 ± 8.96 0.980 0.330 舒张压/(mmHg) 71.70 ± 9.27 68.58 ± 7.27 1.677 0.097 SpO2/% 96.23 ± 4.33 96.50 ± 2.05 0.363 0.718 表 2 两组干预后基础指标比较
Table 2. Comparison of general conditions before and after treatment between the two groups
指标 时间点 治疗组(n=40) 对照组(n=40) 球形检验(Huynh-Feldt ε) 组间(F,P) 时间(F,P) 交互(F,P) 收缩压/(mmHg) T1 127.42 ± 10.70 123.98 ± 11.61 0.982 0.847,0.363 1.261,0.295 0.447,0.643 T2 126.05 ± 8.21 123.63 ± 10.38 T3 125.78 ± 8.90 124.28 ± 7.11 舒张压/(mmHg) T1 81.25 ± 9.19 79.00 ± 8.94 0.935 1.536,0.223 2.681,0.081 0.134,0.875 T2 78.65 ± 8.44 77.28 ± 8.91 T3 80.30 ± 9.28 78.18 ± 7.97 心率/(次/分) T1 82.85 ± 12.45 82.53 ± 10.16 0.976 0.071,0.931 0.038,0.846 1.116,0.338 T2 82.08 ± 9.40 84.33 ± 11.07 T3 83.53 ± 10.42 82.73 ± 8.87 SpO2/% T1 85.45 ± 5.44 86.53 ± 4.90 1.000 0.436,0.513 0.429,0.654 1.573,0.221 T2 86.55 ± 4.86 84.93 ± 7.28 T3 86.82 ± 4.34 85.93 ± 4.00 表 3 进驻高原后两组AMS发生率比较[例(%)]
Table 3. Comparison of AMS severity in two groups at different time points after rushing to plateau (n [%])
指标 时间点 治疗组(n=40) 对照组(n=40) χ2值 P值 T1 无症状 39(97.50) 35(87.50) 8.000 0.238 轻度 1(2.50) 2(5.00) 中度 0(0) 0(0) 重度 0(0) 3(7.50) T2 无症状 37(92.50) 36(90.00) 12.000 0.213 轻度 2(5.00) 1(2.50) 中度 1(2.50) 3(7.50) 重度 0(0) 0(0) T3 无症状 40(100.00) 37(92.50) 4.000 0.135 轻度 0(0) 3(7.50) 中度 0(0) 0(0) 重度 0(0) 0(0) 表 4 两组干预后中医证候分级量化表评分比较[Md(IQR), 分]
Table 4. Comparison of TCM syndrome grading scale scores before and after treatment between the two groups (Md[IQR],score)
组 别 中医证候分级量化表评分 t P 治疗组(n=40) 对照组(n=40) T1 1.80 ± 1.99 1.70 ± 2.11 0.218 0.828 T7 0.38 ± 0.63 0.88 ± 1.38 2.085
0.0400
t 4.320 2.066 P <0.001 0.042 表 5 两组干预后血清炎症因子相关指标比较(pg/mL)
Table 5. Comparison of serum inflammatory cytokines before and after treatment between the two groups (pg/mL)
指标 时间点 治疗组(n=40) 对照组(n=40) 球形检验(Huynh-Feldt ε) 组间(F, P) 时间(F, P) 交互(F, P) IL-6 T1 32.25 ± 11.93 33.60 ± 16.68 0.995 732.53,
<0.001143.93,
<0.0014.990,
0.009T2 38.58 ± 10.91 37.72 ± 11.41 T3 14.77 ± 7.39 21.45 ± 12.40a IL-8 T1 414.03 ± 164.00 418.22 ± 358.05 0.830 1.085,
0.30113.217,
<0.0012.487,
0.086T2 502.93 ± 218.18 668.75 ± 882.85 T3 349.21 ± 210.41 481.14 ± 572.68a TNF-a T1 37.03 ± 11.83 44.85 ± 23.06 0.973 5.064,
0.02697.039,
<0.0013.339,
0.041T2 43.97 ± 13.27 48.78 ± 26.06 T3 19.93 ± 8.96 32.53 ± 22.40 aP<0.05, vs 治疗组 -
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