| Objective: Qiangxin Fumai Granule is a new pharmaceutical preparation in accordance with clinical experience of famous TCM veteran doctor Liu Zhi-ming in treating SSS, and it had been showed in clinical practice to have an excellent therapeutic effect on SSS. To evaluate the efficacy and safety of Qiangxin Fumai granule (QFG) in treating sick sinus syndrome (SSS). To study the effect and its mechanism of the Chinese medicine Qiangxin Fumai Granule on electrophysiological functions of the sinoatrial node during ischemia-reperfusion (IR) of the right coronary artery in rabbits.Methods:1.Clinical study: One hundred and ten cases ranging in age from 18 to 70 years were divided into two groups randomly. Sixty cases in treatment group were given QFG(9g), twice a day. Fifty cases in control group were given atropine(0. 3mg), thrice a day. The therapeutic course was four weeks in each group. The changes of clinical syndromes, blood pressure, ECG, Holter monitor and adverse events were compared between two groups.2. Experimental study: The right coronary artery IR model in rabbits was adopted. The forty modeled rabbits were randomly divided into 5 groups: the control group, the model group, the atropine group, the high-dose QFG group, and the low-dose QFG group, with 10 animals in each group. The electrophysiological functions of QFG on the sinoatrial node, including the AA interval, Heart Rate(HR), the sinoatrial conduction time (SACT), the sinus node recovery time (SNRT), the corrected sinus node recovery time (CSNRT) and the index of sinus node recovery time (ISNRT) were recorded using polygraph through animal experiment in vivo.Results:1.Clinical study:1.1Comparison of the clinical syndrome curative efficiency on two groups of patients: The total effective rate in the improvementof clinical syndrome in the treatment group and the control group were respectively 98. 3% and 46. 0%, and there was a significant difference between two groups on palpitation, chest distress, short breath, dizziness, body cold, hypodynamia, spontaneous sweating(P<0. 01), so QFG group had better effect than atropine group.1.2Comparison of the Holter monitor curative efficiency on two groups of patients: The total effective rate of Holter monitor in the treatment group and the control group were respectively 83. 3% and 32. 0%, there was a significant difference between two groups in improving the 24hour total heart rate, the average heart rate and the highest heart rate(P<0. 01), so QFG group had better effect than atropine group.1.3Comparison of the long R-R intervals curative efficiency on two groups of patients: The total effective rate of long R-R intervals in the treatment group and the control group were respectively100% and 23. 1%, there was a significant difference between two groups(P<0. 01). Suggesting that QFG can decrease R-R intervals, having better effect than atropine group.1.4Comparison of the resting state herte rate curative efficiency on two groups of patients: the resting state herte rate in the QFG group and the atropine group was increased, there was a significant difference between two groups (P<0. 01). Suggesting that QFG can increase HR, having better effect than atropine group.1.5Comparison of changing in the blood pressure on two groups of patients: there was no significant difference between two groups on the systolic pressure and diastolic pressure (P>0. 05), whatever the patiernts taken anti-hypertensive drugs or not. Suggesting that QFG had no influence on blood perssure.1.60bserving adverse events: There were no obvious changes in the routine test of blood, urine, dejecta, the liver and kidney function.1.7Analyzing the occuring time bucket of the highest heart rate and the lowest heart rate in the Holter monitor on one hundred and ten cases: the median of the highest heart rate was occur in the period of the day from 9 am to 11 am, the median of the lowest heart rate was occur in the period of the day from 3 am to 5 am.2.Experimental study:2.1Changes in AA Interval and Heart Rate: The AA intervals in the HQFG and LQFG groups and the atropine group were significantly lower than those in the model group at different time points of IR period (P<0.01 or P< 0.05, respectively). And HDQG can increase HR more significantly than the atropine group (P<0. 01 or P<0. 05) . Suggesting that QFG can decrease AA intervals and increase HR, having better effect than atropine group.2.2Changes in SACT: Compared with the model group, the value of SACT in the HDQG and LDQG groups and the atropine group was reduced to different extents at different time points (P<0.01 or P<0.05). The HQFG group and the LQFG group also had better effect than atropine group. Suggesting that QFG can improve the conduction function of SN, having better effect than atropine group.2. 3Changes in SNRT, CSNRT and ISNRT: The values of SNRT, CSNRT, and ISNRT in HDQG, LDQG and atropine group had decreased to different extents (P <0.01 or P<0.05). The decrease of SNRT in HDQG was more significant than atropine group. Suggesting that QFG can improve the automaticity of SN, having better effect than atropine group.2. 4Changes of score about arrhythmia: The score about arrhythmia at the same ischemia time interval in both HDQ and LDQG groups was lower than the model group(P < 0.01 or P < 0.05), and there was no obvious dosage-dependability between HDQ and LDQG groups. In each group, there was one case in which the boundary escaped rhythm transferred to sinus rhythm, and the other sinus irregularity restored to normal 10 minutes after ischemia. Score about arrhythmia in both groups restored to normal 60 minutes after reperfusion, only I°atrial ventricular block in one case and recovered after that. The effect in the time interval of 15～30 minutes and 30～60 minutes after reperfusion in both HDQ and LDQG groups was more significant than the atropine group(P<0. 05), suggesting that Qiangxin Fumai Granule can effectively reduce arrhythmia caused by ischemia-reperfusion of the right coronary artery in rabbits, having more significant effect than atropine.Conclusions:1. QFG can obviously alleviate the clinical syndrome of the patients, increase heart rate, shorten R-R intervals, and no influence on blood perssure, the routine test of blood, urine, dejecta, the liver and kidney function. It has been proved to be an effecive and safe in treating SSS.2. QFG can shorten AA intervals, increase heart rate in the right coronary artery IR model in rabbits, reduce arrhythmia caused by ischemia-reperfusion of the right coronary artery in rabbits, and can improve the automaticity and conduction function of SN. |
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