ObjectiveBy using the randomized, controlled prospective research methods, comparing effects of combined therapy and conventional therapy in the treatment of atrial fibrillation of Qi deficiency and blood stasis. To evaluate the efficacy and safety of the method of replenishing qi and activating blood circulation in treating atrial fibrillation of deficiency of Qi deficiency and blood stasis.Methods70 patients of Guangdong Provincial TCM hospital diagnosed as artial fibrillation and palpitation of Qi deficiency and blood stasis were randomly divided into two groups, test group (combined therapy group) and control group (conventional therapy group). The control group were treated with the basic treatment. On the basis of treatment on primary diseases and anticoagulation and antiarrhythmia, the test group were treated with traditional Chinese medicinal broth, one dose daily po. The treatment lasted 4 weeks.ECG, APTT, PT, and FIB efficacy and clinical symptomatic improvement were compared before and after treatment between tow groups. The safty and adverse reactions of tow groups were also observed synchronically.Result1.The comparison of ECG efficacy:The total effective rate was 74.3% in tested group and 68.6% in the controlld group. There was no significant difference between two groups(P>0.05). 2. The comparison of APTT, PT, and FIB levels before and after treatment: The levels of APTT and PT in tested group were higher than they in the controlld group. There was significant difference between two groups(P<0.05). The level of FIB in tested group was lower than that in the controlld group. There was significant difference between two groups(P<0.05).3. The comparison of integrated TCM syndrome efficacy:The total effective rate was 82.8% in tested group and 54.3% in controlled group. The two groups had significant difference in improving TCM syndrome, the difference had statistical significance(P<0.05). The tested group had better efficacy in improving TCM syndrome.4.The comparison of single symptom efficacy:The tested group can significantly improve the symptom of palpitation, chest distress, shortness of breath, dizziness, hypodynamia(P<0.05). Statistical study showed the curative effect of two groups had a significant difference(P<0.05).5. The patients in tested group and controlled group did not find obvious side effects and toxicity. Patients in the two groups had hematology,uria and fecal's conventional test, and liver and kidney's function test before and after the examination. There was no abnormal histological examination.ConclusionThere was no significant diference on ECG efficacy in two groups. The levels of APTT and PT in tested group were higher than they in the controlled group.The level of FIB in tested group was lower than that in the controlld group. There were significant difference between two groups(P<0.05).The two groups have significant difference in improving TCM syndrome and main symptom of atrial fibrillation. The results show that the method of replenishing qi and activating blood circulation is effective on the treatment of atrial fibrillation,especially on improving the symptom of palpitation, chest distress, shortness of breath, dizziness, hypodynamia and integrated TCM syndrome. Safety monitoring shows no adverse reactions and toxic side effects. the method of replenishing qi and activating blood circulation is effective, safety and reliability for clinical use.
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