参附通脉胶囊的制备与临床研究  

Preparation and Clinical Study on Shenfu Circulation Capsules

作　　者：张娟[1] 姚庆强[2] 汪海洋[3] 

机构地区：[1]济南大学山东省医学科学院医学与生命科学学院,山东济南250062 [2]山东省医学科学院药物研究所,山东济南250062 [3]济南市第四人民医院,山东济南250031

出　　处：《中国药物评价》2014年第4期209-211,共3页Chinese Journal of Drug Evaluation

摘　　要：目的：研究参附通脉胶囊的制备与临床治疗效果。方法：提供参附通脉胶囊制备工艺和质控方法。选取门诊及住院患者198例，随机分为两组，治疗组138例，口服参附通脉胶囊，每次2粒，tid，1月为1疗程；对照组60例，口服心宝，每次3～4粒，tid，1月为1疗程。治疗前3d及治疗期间停用其他影响心率的药物。数据用SPSS20.0进行统计分析。结果：比较两组临床治疗效果，在治疗组中，显效的有78例，有效的有51例，无效的有9例，总有效率为93.48％；在对照组中，显效的有18例，有效的有33例，无效的有9例，总有效率为85.0％。结果表明，治疗组与对照组的治疗效果之间有差异（ P＜0.05）。比较两组治疗前后心率、SNRT、SACT的变化，在治疗组中，治疗后的平静心率、最慢心率、平均心率和SNRT高于治疗前，且存在显著差异（ P＜0.01），而SACT低于治疗前，且存在差异（ P＜0.05）。在对照组中，平静心率、最慢心率、平均心率、SNRT和SACT都高于治疗前，且存在差异（ P＜0.05）。比较治疗后在治疗组与对照组中的效果，平静心率、最慢心率、平均心率和SNRT在治疗组中高于对照组，且存在差异（ P＜0.05）。结果表明，参附通脉胶囊能明显改善患者临床症状，提高心率，缩短SNRT及SACT。临床疗效和各项指标改善情况均明显优于对照组。结论：参附通脉胶囊制备工艺、质控方法简便可靠，临床疗效稳定，是治疗缓慢性心律失常的有效制剂。Objective：To study preparation and clinical effect of Shenfu circulation capsules.Methods： Provided Shenfu circulation capsules preparation process and quality control methods .198 cases of inpatients and outpatients were randomly divided into two groups , the treatment group 138 cases, oral Shenfu circulation capsules , every two, tid, 1 month course of treatment;the control group, 60 cases of oral heart treasure , each 3 to 4, tid, 1 month course of treatment.Disable other drugs affect the heart rate during the pre-treatment and treatment of 3 d.Data were analyzed using SPSS 20.0.Results：Clinical outcomes were compared .In the treatment group , there were 78 cases markedly , 51 cases effective and 9 cases invalidly , the total effective rate was 93.48%.In the control group , there were 18 cases markedly , 33 cases effectively and 9 cases invalidly , the total effective rate was 85.0%.The results showed that there was a difference （ P〈0.05 ） between the treatment group and the control treated group.Heart rate were compared before and after treatment , SNRT, change SACT in the treatment group , calm the heart rate after treatment , the slowest heart rate , average heart rate and SNRT higher be-fore treatment, and there was a significant difference （P〈0.01）, while the low SACT prior to treatment, and there were differences （P〈0.05 ）.In the control group , calm the heart rate , the slowest heart rate , average heart rate , SNRT and SACT were higher than before treatment, and there were differences （P〈0.05）.Comparing the therapeutic effect in the treatment group and control group , calm heart rate, the slowest heart rate, average heart rate and SNRT higher in the treatment group , and differences（P〈0.05）.The results showed that Shenfu circulation capsule can significantly improve the clinical symptoms , increase heart rate , shorten SNRT and SACT.Clinical ef-ficacy and improvement of the indicators were significantly better than the control group.Conclusion：Shenfu circulation ca

关 键 词：参附通脉胶囊 处方 质量控制 

分 类 号：R283.6[医药卫生—中药学]