Clinical Observation On Diterpene Ginkgolides Meglumine Injection For Syndrome Of Stagnant Phlegm Blocking Collaterals In Convalescence Of Ischemia Stroke

Objective:To evaluate the efficacy and safety of Diterpene Ginkgolides Meglumine Injection (DGMI) for syndrome of stagnant phlegm blocking collaterals in convalescence of ischemia stroke.Methods:The clinical trial was conducted by the methods of stratification and randomization, blinded, positive drug parallel contrast, multi-center clinical study.164 cases of patients with phlegm and blood stasis resistance in convalescence of ischemia stroke were stochastic segmented into experimental and the control group by the ratio of 3:1. Four cases in the test were taked off. Finally 160 cases were completed in the whole experiment, including experimental group 120 cases, control group 40 cases. The experimental group was treated by Diterpene Ginkgolides Meglumine Injection 5 ml (25 mg/amp) and the control group was treated by Shuxuening injection 20 ml (5 ml/amp). They were diluted into 250ml physiological saline,iv dirp,once daily for fourteen days. The dropping speed must be controlled as 10-15 drops/min for the first infusion. The dropping speed can be adjusted for not more than 30-40 drops/min, if the patient was uncomfortable in the thirty minutes of observation period. Observing two groups of clinical comprehensive curative effect and Chinese medicine syndrome curative effect, daily life ability scale (ADL integral) and clinical nerve function defect degree (NIHSS score), single neural function defect and TCM syndrome integral change. Safety indexes: blood and urine routine, stool routine and occult blood, blood coagulation function, electrocardiogram (ECG), liver and kidney function and the drug adverse reactions. Statistical analysis can use statistical software of SPSS19.0.All statistical inspection level:a=0.05. When the P is less than 0.05,the difference was statistically significant.Results:(1) The degree of nerve function defect score:experimental group in the before and after treatment scores were 14.17+5.52 and 8.44±5.41, the treatment effect is improved (P<0.05);The difference of experimental group compared with control group total score loss of change was statistically significant (P<0.01), and the experimental group is better than the control group.(2)The daily life ability score:the score in the before and after treatment were 66.65±21.45 and 79.70±19.61, the treatment effect is improved (P< 0.05); The difference of two groups score changes was no statistically significant (P>0.05).(3)The clinical comprehensive efficacy:total effectiveness of the experimental group was 85.00%, the rate of control group was 72.50%. Be comparing of two groups, the difference was statistically significant (P<0.05).(4)Syndromes curative effect:total effectiveness of the treatment group was 66.67%, the rate of experimental group was 57.50%. Be comparing of two groups, the difference was statistically significant (P<0.05).(5)The single neural function:single neural function indexes of both groups in the before and after treatment. The difference was statistically significant (P<0.05); On the comparison between the two groups, only such as lower limb movement and upper limb movement have significant statistical difference (P<0.05). The others were no significant statistical significance.(6)The doctor of traditional Chinese medicine syndrome:integral change in the before and after treatment has significant statistical difference (P<0.05); Comparison between groups, only found in the upper extremity, askew mouth, dizziness and phlegm and sticky indicators have significant statistical difference (P< 0.05), the others were no significant statistical significance.(7)The security evaluation:the treatment group of Diterpene Ginkgolides Meglumine Injection had two cases with adverse reactions, vital signs, Complete blood count, routine urine sediment, feces+occult blood, and clotting tests, bedside ecg, biochemical complete set, such as index before and after treatment comparison, there was no statistical difference (P>0.05).Conclus ion:Diterpene Ginkgolides Meglumine Injection for the treatment of ischemic stroke recovery phlegm and blood stasis resistance network card is safe, effective, reliable. It can be used in clinical treatment. The DGMI was superior to the Shuxuening injection. Diterpene Ginkgolides Meglumine Injection has a certain advantage in improving the total score of neural function, the total score of TCM syndromes, including the upper extremity, askew mouth, depending on the dizzy spin,pelegm and sticky.