参附注射液辅助西医综合疗法对血管迷走神经性晕厥患者预后及生活质量的影响

Effect of Shenfu injection on prognosis and quality of life of patients with vasovagal syncope

目的 观察参附注射液辅助西医综合疗法对血管迷走神经性晕厥(vasovagal syncope, VVS)患者预后及生活质量的影响.方法 将符合入选标准的126例VVS患者采用随机数字表法分为对照组38例,参附注射液低、高剂量组各44例.对照组采用西药+倾斜训练治疗,参附注射液低、高剂量组在对照组基础上分别静脉滴注日用量为40、120 ml的参附注射液.2组均治疗14 d,随访1年.观察治疗后血压及心率稳定时间、自主神经紊乱恢复时间,记录随访期间晕厥复发情况,采用社会支持评定量表评估患者生活质量,评价临床疗效.结果 对照组总有效率为 47.4%(18/38),参附注射液低剂量组为 72.7%(32/44)、参附注射液高剂量组为 90.9%(40/44),3 组比较差异有统计学意义(χ^2=18.997,P<0.01),且参附注射液高剂量组总有效率高于低剂量组(P<0.05).治疗后,3组血压及心率稳定时间、自主神经紊乱恢复时间比较,差异有统计学意义(F值分别为19.165、158.428、33.405,P值均<0.01),且参附注射液高剂量组各指标改善情况均优于参附注射液低剂量组(t 值分别为-4.020、-5.180、-5.307,P<0.05).随访1年,对照组晕厥复发率为61.1%(11/18)、参附注射液低剂量组为18.8%(6/32)、参附注射液高剂量组为5%(2/40),3组比较,差异有统计学意义(χ^2=20.886,P<0.01).随访1年,3组生活质量评分比较,差异有统计学意义(F=23.025,P<0.01).结论 参附注射液辅助西医综合疗法可有效改善VVS患者的预后及生活质量,且参附注射液高剂量组各项指标改善情况优于参附注射液低剂量组.

Objective To observe the effect of different doses of Shenfu injection on prognosis and quality of life for patients with vasovagal syncope (VVS). Methods A total of 126 patients were randomly divided into 3 groups. The control group (n=38) were treated by western medicine comprehensive therapy with tilting training. The low and high dose Shenfu injection groups were treated by Shenfu injection 40 ml/d (n=44) and 120 ml/d (n=44) on the treatment basis of control group. All the groups were treated for 14 days. The patients were followed up for 1 year after discharge. The relapse rate of syncope, quality of life social support rating scale (SSRS), effective rate of treatment, time of stable blood pressure, time of stable heart rate, recovery time of autonomic nervous disorder and adverse reactions were observed in each groups. Results The total effective rate was 47.4% (18/38) in the control group, 72.7% (32/44) in the low dose group, and 90.9% (40/44) in the high dose group. The difference between the three groups was statistically significant (χ2=18.997, P<0.01), and the total effective rate of Shenfu injection high-dose group was significantly higher than that of low-dose group (P<0.05). After treatment, there were significant differences in the recovery time of blood pressure, heart rate and autonomic nervous disorder among the three groups (F=19.165, 158.428, 33.405, P<0.01). The above indicators in the high dose group of Shenfu injection were significantly higher than the low dose group (t=-4.020, -5.180, -5.307, P<0.05). After 1 year of follow-up, the recurrence rate of the control group was 61.1% (11/18), the low-dose group was 18.8% (6/32), and the high-dose group was 5% (2/40), where there was significant difference among all the groups (χ2=20.886, P<0.01). The quality of life scores were compared for 1 year among the 3 groups, and the difference was statistically significant (F=23.025, P<0.01). Conclusions The Shenfu injection combined with Western medicine comprehensive therapy can improve the prognosis and quality of life of patients with VVS, and the improvement of each indicator of daily dosage of 120 ml is better than the daily dosage of 40 ml Shenfu injection.