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目的:评价参麦注射液对气虚证或(和)阴虚证的临床疗效及安全性。方法:将符合气虚证或(和)阴虚证诊断且同意使用参麦注射液(20～100 mL参麦注射液+5%葡萄糖注射液或0.9%氯化钠注射液250 mL静脉点滴,qd,连续2周)的患者作为观察组,共442例;同期病种相同且证候相同、未使用参麦注射液的患者设为对照组,共645例。结果:参麦注射液能降低气虚证、阴虚证及气阴两虚证证侯积分(P<0.01);对气虚证、阴虚证及气阴两虚证总有效率分别为90.9%,89.4%,89.9%,优于对照组的55.1%,46%,48.5%(P<0.01);观察组共发生2例不良反应,均为轻度。结论:参麦注射液对气虚证、阴虚证及气阴两虚证的治疗是安全、有效的。
Objective: To evaluate the clinical efficacy and safety of Shenmai injection on qi deficiency syndrome and / or yin deficiency syndrome. Methods: In line with qi deficiency syndrome or yin deficiency syndrome diagnosis and agreed to use shenmai injection (20 ~ 100 mL shenmai injection + 5% glucose injection or 0.9% sodium chloride injection 250 mL intravenous, qd , For 2 consecutive weeks) as the observation group, a total of 442 cases; the same period the same type of disease and syndromes, not using Shenmai injection of patients as the control group, a total of 645 cases. Results: Shenmai injection can reduce Hou Qi integral of qi deficiency syndrome, yin deficiency syndrome and deficiency of both qi and yin syndrome (P <0.01). The total effective rates of qi deficiency syndrome, yin deficiency syndrome and qi and yin deficiency syndrome were 90.9% 89.4% and 89.9%, respectively, which was better than 55.1%, 46% and 48.5% (P <0.01) of the control group. There were two adverse reactions in the observation group, all of which were mild. Conclusion: Shenmai injection is safe and effective for the treatment of qi deficiency syndrome, yin deficiency syndrome and qi and yin deficiency syndrome.