ABSTRACT
To evaluate the effectiveness and safety of Longxue Tongluo capsule on patients of atherosclerotic thrombotic cerebral infarction convalescence with blood-stasis syndrome, a double-blind, randomized controlled, multi-center clinical trial was conducted. A total of 160 eligible patients were randomly divided into treatment group and control group, with 80 patients in each group, and all of them were orally given Troxerutin pill(three pills each time, three times daily). Longxue Tongluo capsule was applied in the treatment group, while placebo was applied in the control group(two capsules each time, three times daily) for 4 weeks. Main outcomes were measured by ITT analysis. The neurological function deficits scale showed a decrease of 5.17±2.60 in the treatment group, while 4.31±2.31 in the control group, with significant differences between the two groups(P<0.05); the reduction rate in the treatment group (37.2±15.8)% was significantly higher than that in the control group (29.9±15.3)%(P<0.05). In terms of the comprehensive curative effect by ITT, the effective rates in the treatment and control group were 31.6% and 13.5%, respectively(P<0.05). With respect to the efficacy of traditional Chinese medicine syndrome by ITT, the total effective rate of the treatment group was significantly higher than the control group 88.2% vs 68.9%, P<0.05. Three cases of adverse events occurred in this study, including 1 case of diarrhea in treatment group and 2 cases of skin itch and upper respiratory infection in control group. In conclusion, Longxue Tongluo capsule is effective and safe in the treatment of patients of atherosclerotic thrombotic cerebral infarction convalescence with blood-stasis syndrome, and can effectively alleviate the patients' nerve function defect degree and invalidism, with a good effect on blood stasis syndrome.
ABSTRACT
<p><b>OBJECTIVE</b>To probe into long-term therapeutic effect and safety of Xingnao Kaiqiao acupuncture for treatment of cerebral infarction in restoration stage.</p><p><b>METHODS</b>Two hundred and thirty-four cases of cerebral infarction in restoration stage were randomly assigned to a Xingnao group and a routine group. The Xingnao group (n=116) were treated by Xingnao Kaiqiao acupuncture (once each day, for 4 weeks) and routine treatment of western medicine, and the routine group (n=118) were treated with routine acupuncture and the routine treatment of western medicine. They were followed-up for 6 months. The main indexes living, treatment and recurrence at the end of the following survey and the secondary indexes assessment of nervous functions at the end of the following survey, and the incidence rate of bad events in acupuncture were observed.</p><p><b>RESULTS</b>The death rate was 0.86% and the continuing treatment rate was 36.21% in the Xingnao group, and 1.69% and 36.44% in the routine group, with no significant difference between the two groups (both P>0.05) at the following-up of 6 months; the Xingnao group in decreasing recurrent rate and improving nervous function was better than the routine group (P<0.01); no severe adverse response was found in the 2 groups.</p><p><b>CONCLUSION</b>Xingnao Kaiqiao acupuncture is safe and it is superior to routine acupuncture in long-term therapeutic effect, decreasing recurrence rate, improving nervous function.</p>