摘要
目的:观察芪参益气滴丸联合低剂量利伐沙班治疗高危非瓣膜性房颤(Non-Valvular Atrial Fibrillation,NVAF)患者的临床疗效及安全性.方法:采用随机数字表法将符合标准的60例高危NVAF患者随机分为对照组和治疗组,每组各30例;对照组予10mg利伐沙班qd,治疗组在对照组基础上联合芪参益气滴丸1袋,3次/d;观察2组患者治疗前后血小板、D-二聚体、活化部分凝血酶原时间(APTT)、血浆凝血酶原时间(PT)、生活质量评分、中医症候积分、EHRA房颤症状评分、房颤负荷以及栓塞事件、出血事件的发生率.结果:治疗后2组患者血小板、D-二聚体、中医症候积分、房颤负荷、EHRA房颤症状评分均下降(P<0.05),生活质量评分上升(P<0.05),差异具有统计学意义,且治疗组上述指标改善程度较对照组更优(P<0.05);APTT、PT均较治疗前延长(P<0.05),差异有统计学意义;但治疗组与对照组相比PT、APTT延长并不明显,无统计学意义(P>0.05);治疗后2组患者栓塞事件、出血事件比较未见明显差异(P>0.05),无统计学意义.结论:芪参益气滴丸与低剂量利伐沙班联合治疗高危NVAF患者具有确切的临床疗效,能够有效地预防卒中事件发生、提高患者生活质量水平,且安全性较高.
Abstract
Objective: To observe the clinical efficacy and safety of Qishen Yiqi Dropping Pills combined with low-dose rivaroxaban in the treatment of high-risk patients with non-valvular atrial fibrillation (NVAF). Methods: Using the random number table method, 60 patients with high-risk non-valvular atrial fibrillation who met the criteria were randomly divided into a control group and a treatment group, with 30 cases in each group. The control group was given 10 mg rivaroxaban qd, and the treatment group was given 10 mg rivaroxaban qd. Basically, combined with 1 bag of Qishen Yiqi Dropping Pills, tid; observed the platelet (PLT), D-dimer (D-D), activated partial prothrombin time (APTT), plasma prothrombin time ( PT), quality of life score, TCM symptom score, EHRA atrial fibrillation symptom score, atrial fibrillation burden, and the incidence of embolic events and bleeding events. Results: After treatment, the PLT, D-D, TCM symptom scores, atrial fibrillation burden, and EHRA atrial fibrillation symptom scores of the two groups of pa-tients all decreased (P<0.05), and the quality of life scores increased (P<0.05). The difference was statistically signifi-cant, and after treatment The improvement degree of the above indicators in the treatment group was better than that in the control group (P<0.05); APTT and PT were both longer than before treatment (P<0.05), and the difference was statistically significant; but compared with the control group, the PT and APTT were not longer in the treatment group. Obviously, there was no statistical significance (P>0.05); there was no significant difference in embolic events and bleeding events between the two groups after treatment (P>0.05), which was not statistically significant. Conclusion: Qishen Yiqi Dropping Pills combined with low-dose rivaroxaban has definite clinical efficacy in the treatment of high-risk non-valvular atrial fibrillation patients, can effectively prevent stroke events, improve patients' quality of life, and is highly safe.
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