| Objective:To observe and evaluate the clinical efficacy and safety of jianpihuayutongbi Chinese medicine-free fried particles in combination with aspirin (ASA) in the treatment of early lesions of arteriosclerosis obliterans (ASO).Method:ASO outpatients from Surgery and Cardiology clinic of Wangjing Hospital of China Academy of Chinese Traditional Medicine were selected between June2012and February2013.The ASO cases were randomly divided into a treatment group of27cases and a control group of25cases. Risk factors such as smoking, hypertension, hyperlipidemia were screened; ASA enteric-coated tablets100mg had been taken by patients in two groups once a day for four weeks in a row on the basis of conventional treatment. Patients in experimental group had taken jianpihuayutongbi Chinese medicine-free fried particles on the basis of the above drugs, everyday for4weeks. Comparative analysis of changes of patients’clinical symptoms and signs, Ankle-Brachial Index(ABI), the inner diameter of the dorsalis pedis artery and the Peak Systolic Velocity (PSV) of dorsalis pedis artery have been made before and after4weeks’treatment. And the occurrence of the heart, brain, vascular events (myocardial infarction, stroke, or pulmonary embolism), critical limb ischemia, clinical bleeding, and adverse drug reactions have been recorded during the treatment.SPSS19.0software package has been applicated for statistical analysis. Frequency count data and the percentage were used for statistical description. Mean±standard deviation (x±S) was used as statistical description for measurement data follow a normal distribution; The underlying value of the balance, are compared using the/-test and X2test; All statistical tests were two-sided test, differences of the same group before and after treatment using a paired t-test, while comparing the differences between the two groups before and after treatment using independent sample t-test and the wilcoxon rank sum test; Efficacy of the two groups were analyzed by rank sum test to assess its effectiveness. P value less than or equal to0.05has been considered the difference was statistically significant, while less than or equal to0.01has been considered the difference was highly statistically significant.Results:1The baseline consistent between the two groups were comparableThe proportion of general and risk factors such as gender, age, duration of disease, body mass index, symptoms and signs, ABI. dorsalis pedis artery diameter, and dorsalis pedis artery PSV were compared. There is no statistically significant difference (P>0.05) between the two groups. Patients in two groups were comparable.2The comparison of symptoms and signs of two groups before and after the treatmentThere were25cases of35side limbs in the control group and27cases of39side limbs in the test group.The difference of symptoms and signs score was not statistically significant (P>0.05) before the treatment. At the7th,14th,21st,28th day, the signs and symptoms score decreased in both of the two groups.At the21st and28th day of treatment, the symptom scores of patients in treatment groups significantly decreased (P<0.01) compared with scores before the treatment. At the28th day of treatment, the symptom scores of patients in control group significantly decreased (P<0.05). After4weeks of treatment, symptom scores of the treatment group decreased significantly (P<0.01) compared with the control group at the21st and28th day.3The comparison of ankle/brachial (Ankle-Brachial Index ABI) before and after the treatmentThe the ABI of35limbs in control group and39limbs treatment group respectively increased from0.77±0.03.0.77±0.02. before the treatment, to0.78±0.02.0.83±0.03after the treatment. The change of ABI in the control group was not statistically significance (P>0.05) before and after treatment, while in the treatment group the difference of ABI was statistically significant (P<0.01). The change of ABI in the treatment group was statistically significant (P<0.01) than the control group after treatment.4The comparison of the dorsalis pedis artery diameter and the dorsalis pedis artery peak velocity (Peak Systolic Velocity. PSV) before and after treatmentThe diameter of the foot dorsum artery of35limbs of the control group and the39limbs of the treatment group, before treatment respectively were2.31±0.10mm,2.27±0.13mm, after treatment respectively were2.31±0.10mm,2.28±0.13mm. The difference of the dorsalis pedis artery diameter was not statistically significant (P>0.05) before and after treatment; The PSV of35limbs of the control group and39limbs of the treatment group, before treatment respectively were0.39±0.09m/s,0.41±0.11m/s, and increased to0.40±0.10m/s,0.48±0.12m/s, in which the PSV of the control group was no significant difference (P>0.05) before and after treatment, while the difference of PSV was statistically significant (P<0.01) before and after treatment. The change of PSV in the treatment group was statistically significant (P<0.01) than the control group after treatment.5Therapeutic EvaluationAfter the treatment, statistics of the effective rate of symptoms and signs show that, the limb skin cold, cold sensation, skin color and abnormal clinical symptoms of the treatment group and the control group respectively were84.62%and34.29%, the effective rate of the treatment group was significantly higher than the control group(P<0.01).6Safety EvaluationResults of the blood routine examination, urine routine examination, stool routine examination and electrocardiogram (ECG) of all the cases before and after the treatment did not see obvious anomalies. Platelet count, coagulation, liver function, kidney function and other indicators of all selected cases, the change was not statistically significant (P>0.05) before and after treatment. Bleeding, cardiovascular and cerebral vascular accident, and adverse drug reactions have not been observed dyring the process.Conclusion:1Compared with conventional ASA antiplatelet therapy, increasing jianpihuayutongbi Chinese medicine-free fried particles in the treatment of the early lesions of ASO, can effectively reduce limb coldness, numbness, and other symptoms;2Compared with conventional ASA antiplatelet therapy, increasing jianpihuayutongbi Chinese medicine-free fried particles in the treatment of the early lesions of ASO, can effectively improve limb ABI;3Compared with conventional ASA antiplatelet therapy, increasing jianpihuayutongbi Chinese medicine-free fried particles in the treatment of the early lesions of ASO, can effectively increase limb PSV and improve the blood flow of the legs.4The jianpihuayutongbi Chinese medicine-free fried particles in combination with ASA therapy for the early lesions of ASO is safe. |
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