| BackgroundAcute ischemic stroke, also known as cerebral infarction, is a cerebral vascular disease caused by various reasons, the blood supply of the brain artery was blockage, making the local cerebral tissue irreversible damage, leading to cerebral ischemia, hypoxia necrosis. The disease has the characteristics of high incidence, high mortality and high morbidity.As the brain structure is fine and important, blood-brain barrier and trail of drug pharmacological studies, modern medical treatments had no ideal drug and methods on it. Acute ischemic stroke is equivalent to the "stroke" of Chinese medicine, the Chinese medicine treatment of stroke had more than two thousand years of history, and Confirmed more effective. Nasal therapy is one type of External therapy in traditional Chinese medicine。Nasal therapy (Nasal administration) to treat cerebral vascular disease was the current hot topic of cerebrovascular disease. Naoqing penbi weiru was made by traditional Chinese medicine combined with modern pharmaceutical technology, had clinical efficacy and easy using on Acute ischemic stroke, it is worth further study.ObjectiveTo study clinical efficacy of the Naoqing penbi weiru treat Acute ischemic stroke by Nasal administration, combined with literature research initially proved its efficacy mechanism, at the same time, to determine the preparation of Naoqing penbi weiru.MethodsA total of 80 cases of acute stroke patients were Observed in the study, were randomly divided into treatment group and control group,40 patients of each group, two groups patients were given basic treatment (including the adjustment of blood pressure, control blood sugar, oral Aspirin and Nimodipine tablets, if necessary, to dehydration, anti-infection.) Treatment group were treated with Naoqing penbi weiru by Nasal administration,2 spray each and 3 times a day; the control group were treated with placebo,2 spray each and 3 times a day. Course of treatment was 14 days.To Screen the best prescription of Naoqing penbi weiru by pseudo-ternary phase diagram, to electe appropriate production process by the single factor test, to determine the surfactant, cosurfactant and Km values, and to determine the composition and proportion of prescriptions Ratio, and effective drug content testing. Results1 The study of prescription and production process of Naoqing penbi weiru, to Screen the best prescription of Naoqing penbi weiru by pseudo-ternary phase diagram, determining the surfactant, cosurfactant and Km values, and to determine the composition and proportion of prescriptions Ratio, and effective drug content testing, muscone concentration was 0.060 mg/g.2 Clinical efficacy of treatment group were superior to control group,p <0.05. Treatment group had 40 cases, fully recovered in 12 cases, effective in 17 cases,9 cases of effective, ineffective and worse in 1 case, the total effective rate was 95%;Control group had 40 cases, fully recovered in 7 cases, effective in 8 cases,22 cases of effective,2 cases of ineffective and deteriorated in 1 case, the total effective rate was 92.5%. The total effective rate were similar, but different level of data distribution, the ridit analysis, statistics u=2.5126, p=0.0120, p<0.05, prompt treatment group were superior to the control group.3 Two groups of patients 7 days and 14 days after treatment NIHSS scores were significantly lower, suggesting that the treatment effect is good. Two groups of patients 14 days after the NIHSS score was significantly lower than for 7 days, p<0.01; NIHSS score of 7 days after treatment was significantly lower than before treatment, p<0.01. The NIHSS score of Treated group were superior to the control group For 7 days and 14 days after treatment, p<0.01 (0.05).4 Symptom score of traditional Chinese medicine beteen the two groups of before and after treatment. Treated group were significantly improve symptoms of Chinese medicine, symptom scores of 7 days after stroke was significantly lower than before treatment, p<0.01; treatment 14 days after stroke symptom score was significantly lower than for 7 days, p<0.01 (0.05). Control group also had obvious improvement in stroke symptom score of Chinese medicine before treatment and 7 days after treatment,14 days after treatment, Chinese medicine symptom score did not change significantly, p<0.01. Between the two groups after the treatment,7 days,14 days after treatment, Chinese medicine symptom score of Treated group was significantly lower than the control group, p<0.01.5 The fasting blood glucose, triglycerides, total cholesterol levels in two groups before and after treatment:The fasting blood glucose, triglycerides, total cholesterol levels in two groups before treatment were higher. After treatment, fasting blood glucose, triglycerides, total cholesterol decreased significantly, compared with before treatment were statistically significant. However, differences between groups was not significant.6 The D-dimer, ESR, hs-Crp level of Two groups before and after treatment: D-dimer, ESR, hs-Crp levels of Two groups before treatment are increased in both, including ESR and hs-Crp level were higher than the average upper limit of normal. After treatment, D-dimer, ESR and hs-Crp level were significantly decreased compared with that before treatment, p<0.01. Between the two groups, 14 days after treatment, hs-Crp level and ESR were significantly lower than the control group, p<0.01 (0.05); between the two groups, the D-dimer levels in 14 days after treatment had no statistically significant.7 lipid peroxides, superoxide di-smutase, glutathione peroxidase, compared homocysteine levels of The two groups before and after treatment:Before treatment, both groups of lipid peroxides, superoxide dismutase, glutathione peroxidase, homocysteine are abnormal, mainly lipid peroxides and homocysteine levels increased, while superoxide dismutase and glutathione peroxidase decreased. After treatment, both groups of lipid peroxides, homocysteine levels are decreased compared with that before treatment, p<0.01 (0.05);superoxide dismutase and glutathione peroxide increased physical activity levels, compared with that before treatment, p<0.01 (0.05). Between the two groups, the treatment group decreased lipid peroxidation, increased superoxide dismutase and glutathione peroxidase levels were superior to the control group, p<0.01 (0.05); but in the homocysteine levels with the control group had no significant difference, p>0.05.8 Adverse reaction observation:Before and after treatment, the blood, urine, stool test, liver and kidney function and ECG had no significant changes. After treatment, patients treated with nasal cases:7 cases in the first 3 days of had nasal itching, sneezing and so on, but did not affect the course of treatment.5 cases of nasal mucosa shows mild flushing, congestion, there is a little discharge attachment. After treatment, patients treated with placebo cases:2 cases in the first 3 days of had nasal itching, sneezing and so on, but did not affect the course of treatment.1 cases of nasal mucosa shows mild flushing, congestion, there is a little discharge attachment.ConclusionThe clinical efficacy of the Naoqing penbi weiru on acute ischemic stroke by Nasal administration were superior to placebo, and safety, the possible effect mechanisms, for Chinese medicine, including effectively Playing drug effects to promot blood circulation, activating blood and dredging meridine, opening orifices and resuscitation, and to stimulate the meridians, regulate internal organs (including brain) function; for modern medicine, including the neuroprotective mechanisms of improve cerebral blood circulation, anti-oxygen free radical damage, anti-inflammatory reaction.
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