【摘要】：目的:通過對(duì)舒心寧悸飲治療早搏(氣陰兩虛兼瘀阻心脈證)的臨床療效及安全性觀察,為其臨床應(yīng)用提供客觀依據(jù)。方法:挑選經(jīng)西醫(yī)診斷為心律失常--早搏,中醫(yī)辨病為心悸,辨證為氣陰兩虛兼瘀阻心脈,且符合本研究納入、排除標(biāo)準(zhǔn)的60例輕中度患者。根據(jù)實(shí)驗(yàn)設(shè)計(jì)的對(duì)照、隨機(jī)化、重復(fù)三大基本原則,將其分為實(shí)驗(yàn)組和對(duì)照組,各30例。對(duì)照組口服由阿斯利康制藥有限公司生產(chǎn)的酒石酸美托洛爾片(倍他樂克,國(guó)藥準(zhǔn)字H32025391),25mg/次,2次/日,早、晚餐后服。治療組在服用西藥倍他樂克片的基礎(chǔ)上,再予以中藥治療。中藥治療:口服由山西醫(yī)科大學(xué)第二醫(yī)院中藥制劑室配制的自擬方舒心寧悸飲(紅景天20g、太子參15g、麥冬15g、五味子10g、丹參15g、三七參6g、川芎10g、黃連6g),150ml/次,2次/日,早、晚餐后服;兩組治療周期均為4周。統(tǒng)計(jì)分析兩組治療前后臨床癥狀積分、早搏數(shù)、24小時(shí)動(dòng)態(tài)心電圖、中醫(yī)證候療效等數(shù)據(jù),以檢驗(yàn)其臨床應(yīng)用的可行性。結(jié)果:1.治療前,兩組患者基線資料(早搏類型、中醫(yī)癥狀積分、病程、早搏數(shù)、性別、年齡等)比較,無(wú)明顯差異(P0.05),可以認(rèn)為兩組基本情況具有均衡性。2.對(duì)照組和治療組動(dòng)態(tài)心電圖療效總有效率分別為76.7%、90.0%;兩組對(duì)比,差異有統(tǒng)計(jì)學(xué)意義(P0.05)。以上結(jié)果提示兩組均可有效改善患者動(dòng)態(tài)心電圖,治療組明顯優(yōu)于對(duì)照組。3.兩組患者動(dòng)態(tài)心電圖早搏數(shù)比較,對(duì)照組患者治療前早搏數(shù)平均4741.37±2094.678個(gè),治療后2494.67±1994.426個(gè);治療組患者治療前早搏數(shù)平均4846.70±2343.675個(gè),治療后1248.59±1051.627個(gè);兩組組內(nèi)、組間比較,差異有統(tǒng)計(jì)學(xué)意義(P0.05)。以上提示兩組均能減少早搏發(fā)生數(shù)量,治療組控制早搏效果好于對(duì)照組。4.治療組中醫(yī)證候積分?jǐn)?shù)值在治療前平均積分10.13±1.655,治療后3.43±2.542;對(duì)照組治療前平均積分9.97±1.520,治療后6.27±3.759;兩組組內(nèi)、組間比較,差異有統(tǒng)計(jì)學(xué)意義(P0.05)。以上提示兩組均能改善患者臨床癥狀,治療組效果更佳。5.治療組中醫(yī)證候總療效總有效率為90.0%,對(duì)照組中醫(yī)證候總療效總有效率為60.0%,兩組比較,差異有統(tǒng)計(jì)學(xué)意義(P0.05)。以上提示兩組均能改善患者臨床癥狀,治療組療效更佳。6.安全性觀察:治療組和對(duì)照組患者在臨床觀察期間均未發(fā)生明顯不良反應(yīng),安全性指標(biāo)亦無(wú)明顯異常。結(jié)論:單用西藥倍他樂克片,可以有效控制早搏的發(fā)作,改善患者心悸癥狀,而中藥舒心寧悸飲治療,更有助于療效的提高。
[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 鹵2094.678 before treatment and 2494.67 鹵1994.426 after treatment, while that in the treatment group was 4846.70 鹵2343.675 and 1248.59 鹵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 鹵1.655 before treatment and 3.43 鹵2.542 after treatment, while that in the control group was 9.97 鹵1.520 before treatment and 6.27 鹵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.
【學(xué)位授予單位】：山西醫(yī)科大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2017
【分類號(hào)】：R259

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