RÉSUMÉ
ObjectiveTo investigate the characteristics of traditional Chinese medicine syndrome and the evolution of pathogenesis in different stages of atherosclerotic thrombotic cerebral infarction （ATCI）. MethodsClinical data of 3088 ATCI patients from 8 hospitals in 6 provinces and cities were collected from the hospital information system during January 1， 2015 to December 31， 2019. After staging and counting clinical symptoms， common factors were extracted using the principal component analysis method in factor analysis. Cluster analysis was then carried out on the basis of the factor analysis. The results of the combination of the evidence element identification， cluster analysis and expert discussion were used to discuss the evidence of the different disease stages of atherosclerotic cerebral infarction. ResultsOf the 3088 ATCI patients included， 2290 cases were in the acute phase and 798 in the non-acute phase. Excluding the main symptoms of ischaemic stroke， such as numbness and weakness of limbs， unfavourable movement， unfavourable speech and dizziness， we identified 84 indicators with a frequency ≥5% of the four diagnostic information variables. Of these， 36 indicators were observed in the acute phase and 35 in the non-acute phase. Factor analysis extracted 14 common factors from each phase. We selected factors with a loading coefficient ＞0.3 for evidence determination. These 14 groups of common factors were used as variables for clustering. After clustering， the acute， non-acute phase were each divided into 5 categories. Based on a combination of clinical practice and expert opinion， the symptoms identified in the acute period were syndrome of deficiency of both qi and yin， syndrome of blockade of wind-phlegm-static blood （36.07%）， syndrome of qi deficiency and blood stasis （20.74%）， syndrome of upward disturbance of wind-fire （15.15%）， syndrome of stirring wind due to yin deficiency （9.43%）， and syndrome of spleen deficiency and liver hyperactivity （3.80%）. In the non-acute phase， the symptoms were qi and yin deficiency with syndrome of qi stagnation and blood stasis （45.49%）， syndrome of deficiency of both qi and yin （20.05%）， syndrome of qi stagnation and blood stasis （16.42%）， spleen-kidney deficiency syndrome （8.52%）， and syndrome of hyperactivity of liver yang （4.89%）. ConclusionThe acute phase of AICI is mainly characterized by blood stasis， fire， internal wind， hyperactivity of yang， qi deficiency and yin deficiency， while the non-acute phase is characterized by yin deficiency， qi deficiency， blood stasis and qi stagnation. The main pathomechanism of ATCI involves deficiency of qi and yin， as well as obstruction of the channels by phlegm and blood stasis， and the fundamental pathomechanism is deficiency of qi and yin.
RÉSUMÉ
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.
RÉSUMÉ
Objective: To evaluate the efficacy and safety of Diterpene Ginkgolides Meglumine Injection (DGMI) in the treatment of recovered stroke with syndrome of stagnant phlegm blocking collaterals, especially the clinical efficacy in improving the function of language and movements. Methods: The clinical trial was carried out by the methods of stratification and r andomization (416 cases of patients with atherosclerotic thrombotic cerebral infarction (ATCI) were r andomly divided into experimental and control groups by the ratio of 3:1), blindness, and positive parallel control of Shuxuening Injection (SI), and multi-center clinical study. DGMI (25 mg, 5 mL/amp) or SI (5 mL/amp) was diluted into 250 mL physiological saline, iv drip, once daily for 14 d. The dropping speed must be controlled as 10-15 drops/min for the first infusion. Results: There was statistical difference (P=0.000 1) for the variations of inducing rate of the defect extent of nervous functions before and after the treatment in the experimental and control groups. The experimental group was superior to the control group. There was no statistical difference for the variation of scales of the patient living ability in the two groups (P>0.05). For the comprehensive efficacy of cerebral infarction, the total effective rates were 85.39% and 73.27% in the experimental and control groups, respectively, with statistical difference (P=0.0001). For the efficacy of syndrome of traditional Chinese medicine (TCM), the total effective rates were 62.99% and 40.59% in the experimental and control groups, respectively, with the statistical difference (P=0.0001). For the single indicator of nervous functions, such as arm movements, h and movements, extremity movements, walking, as well as the syndromes of TCM, such as upper limb disable, lower limb disable, deviated tongue, aphasia, abate or deficiency of feeling, dizziness, more and turbid phlegm, abnormal tongue and pulse manifestation, the experimental group was superior to the control group with statistified difference. Conclusion: It is safe and effective for DGMI in the treatment of the syndrome of stagnant phlegm blocking collaterals in convalescence of ATCI. Meanwhile, it is also manifested that DGMI has the certain superiorities in the fields, such as improving the total score of nervous function deficiency for the patients with stroke, the nervous function, the total score of TCM syndromes, including upper limb disable, deviated tongue, dizziness, more and turbid phlegm, white coat of tongue, abnormal pulse, etc.