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舒心宁悸饮治疗早搏的临床观察

发布时间:2018-08-06 14:12
【摘要】:目的:通过对舒心宁悸饮治疗早搏(气阴两虚兼瘀阻心脉证)的临床疗效及安全性观察,为其临床应用提供客观依据。方法:挑选经西医诊断为心律失常--早搏,中医辨病为心悸,辨证为气阴两虚兼瘀阻心脉,且符合本研究纳入、排除标准的60例轻中度患者。根据实验设计的对照、随机化、重复三大基本原则,将其分为实验组和对照组,各30例。对照组口服由阿斯利康制药有限公司生产的酒石酸美托洛尔片(倍他乐克,国药准字H32025391),25mg/次,2次/日,早、晚餐后服。治疗组在服用西药倍他乐克片的基础上,再予以中药治疗。中药治疗:口服由山西医科大学第二医院中药制剂室配制的自拟方舒心宁悸饮(红景天20g、太子参15g、麦冬15g、五味子10g、丹参15g、三七参6g、川芎10g、黄连6g),150ml/次,2次/日,早、晚餐后服;两组治疗周期均为4周。统计分析两组治疗前后临床症状积分、早搏数、24小时动态心电图、中医证候疗效等数据,以检验其临床应用的可行性。结果:1.治疗前,两组患者基线资料(早搏类型、中医症状积分、病程、早搏数、性别、年龄等)比较,无明显差异(P0.05),可以认为两组基本情况具有均衡性。2.对照组和治疗组动态心电图疗效总有效率分别为76.7%、90.0%;两组对比,差异有统计学意义(P0.05)。以上结果提示两组均可有效改善患者动态心电图,治疗组明显优于对照组。3.两组患者动态心电图早搏数比较,对照组患者治疗前早搏数平均4741.37±2094.678个,治疗后2494.67±1994.426个;治疗组患者治疗前早搏数平均4846.70±2343.675个,治疗后1248.59±1051.627个;两组组内、组间比较,差异有统计学意义(P0.05)。以上提示两组均能减少早搏发生数量,治疗组控制早搏效果好于对照组。4.治疗组中医证候积分数值在治疗前平均积分10.13±1.655,治疗后3.43±2.542;对照组治疗前平均积分9.97±1.520,治疗后6.27±3.759;两组组内、组间比较,差异有统计学意义(P0.05)。以上提示两组均能改善患者临床症状,治疗组效果更佳。5.治疗组中医证候总疗效总有效率为90.0%,对照组中医证候总疗效总有效率为60.0%,两组比较,差异有统计学意义(P0.05)。以上提示两组均能改善患者临床症状,治疗组疗效更佳。6.安全性观察:治疗组和对照组患者在临床观察期间均未发生明显不良反应,安全性指标亦无明显异常。结论:单用西药倍他乐克片,可以有效控制早搏的发作,改善患者心悸症状,而中药舒心宁悸饮治疗,更有助于疗效的提高。
[Abstract]:Objective: to observe the clinical efficacy and safety of Shuxinning palpitation decoction in the treatment of premature beats (deficiency of qi and yin and stagnation of heart pulse), and to provide objective basis for its clinical application. Methods: 60 patients who were diagnosed as arrhythmia-premature beat by western medicine, palpitations in TCM, deficiency of qi and yin and stagnation of heart pulse were selected, and 60 patients with mild to moderate degree were included in this study and excluded. According to the three basic principles of control, randomization and repetition, the experimental group and control group were divided into experimental group and control group, each with 30 cases. The control group was given metoprolol tartrate tablets (Betaloc, H32025391) twice a day by AstraZeneca Pharmaceutical Co., Ltd. The treatment group was treated with traditional Chinese medicine on the basis of western medicine Betaloc tablets. Chinese medicine treatment: oral preparation of Fang Shu Xinning palpitation drink (Rhodiola 20g, Pseudostellariae 15g, Radix Ophiopogonis 15g, Schisandra chinensis 10g, Salvia miltiorrhiza 15g, Panax notoginseng 6g, Ligusticum chuanxiong 10g, Coptis chinensis 6g) 2 times a day. The treatment cycle was 4 weeks in both groups. The clinical symptom score, 24 hour ambulatory electrocardiogram (ECG) of premature beats and the curative effect of TCM syndrome were statistically analyzed before and after treatment in order to test the feasibility of its clinical application. The result is 1: 1. Before treatment, there was no significant difference in baseline data (type of premature beat, score of TCM symptoms, course of disease, number of premature beats, sex, age and so on) between the two groups (P0.05). The total effective rate of dynamic electrocardiogram in control group and treatment group was 76.70.The difference between the two groups was statistically significant (P0.05). The above results suggest that the two groups can effectively improve the dynamic electrocardiogram, the treatment group is significantly better than the control group. 3. The average number of premature beats in the control group was 4741.37 卤2094.678 before treatment and 2494.67 卤1994.426 after treatment, while that in the treatment group was 4846.70 卤2343.675 and 1248.59 卤1051.627 before treatment, respectively. The difference was statistically significant (P0.05). These results suggest that both groups can reduce the number of premature beats, and the effect of controlling premature beats in treatment group is better than that in control group. 4. 4. The average score of TCM syndromes in the treatment group was 10.13 卤1.655 before treatment and 3.43 卤2.542 after treatment, while that in the control group was 9.97 卤1.520 before treatment and 6.27 卤3.759 after treatment. The difference between the two groups was statistically significant (P0.05). The above suggested that both groups can improve the clinical symptoms, the treatment group is better. 5. 5. The total effective rate of TCM syndromes in the treatment group was 90.0 and the total effective rate in the control group was 60.0.The difference between the two groups was statistically significant (P0.05). The above suggested that both groups can improve the clinical symptoms, the treatment group is better. 6. 6. Safety observation: there were no obvious adverse reactions and no abnormal safety indexes in the treatment group and the control group. Conclusion: Betaloc tablets alone can effectively control the onset of premature beats and improve palpitation symptoms of patients, and Shuxinning palpitation decoction treatment is more helpful to improve the curative effect.
【学位授予单位】:山西医科大学
【学位级别】:硕士
【学位授予年份】:2017
【分类号】:R259

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