香丹注射液对气滞血瘀证疗效与安全性再评价

目的:评价香丹注射液对气滞血瘀证的临床疗效与安全性。方法:采用队列研究方法,将不同疾病符合气滞血瘀证诊断且同意使用香丹注射液的患者形成的自然队列作为观察组,共142例,而未使用香丹注射液的患者96例作为对照组。结果:香丹注射液能降低气滞血瘀证证候积分(P<0.01),对气滞血瘀证总有效分别为89.43%,优于对照组的72.91%(P<0.01);观察组共出现8例不良反应,不良发生率5.63%,均为轻/中度。结论:香丹注射液对气滞血瘀证的治疗是有效的,但临床使用需要注意其安全性。

Re-evaluation on Safety and Efficacy of Xiangdan Injection for Treating the Syndrome of Qi Deficiency and Blood Stasis

Objective: To evaluate the safety and efficacy of Xiangdan injection for treating the syndrome of qi deficiency and blood stasis. Method: Using cohort study method, 142 patients with different diseases agreed to the syndrome of qi deficiency and blood stasis, and also agreed to use Xiangdan injection were regarded as the observation group by natural queue. Other 96 patients without Xiangdan injection treatment composed the control group. Result: Xiangdan injection could reduce the scores of the syndrome of qi deficiency and blood stasis (P<0.01), and the total effectiveness was 89.43%, better than 72.91% in control group (P<0.01). In the observation group, eight cases (5.63%)showed mild-moderate adverse reaction. Conclusion: Xiangdan injection for treating the syndrome of qi deficiency and blood stasis is effective, but needs to pay attention to the safety in clinical use.