Huatuo Zaozao Pill Clinical Observation Of Treatment Of Cerebral Infarction Convalescence

[Purpose]The subject in the past Huatuo Zaizao pills clinical application and research, based on the right Huatuo Zaizao pill treatment for stroke patients in the meridians of the efficacy and safety of conducting clinical re-evaluation, through changes in clinical efficacy compared to efficacy evaluation of TCM and clinical evaluation of neurological deficits, activities of daily living scale, improved Rakin scale and coagulation changes in such indicators as to explore the drug for stroke TCM syndromes, and thus objective and comprehensive assessment of the drug the clinical efficacy, for the drug in the secondary prevention of stroke in the application lay the foundation for enhancing the clinical efficacy and prevention of cerebral vascular disease of great significance.[Method]Would be consistent with the inclusion criteria of patients with ischemic stroke of 56 cases, in accordance with the order entry group were randomly divided into two groups (treatment group, control group) of the 28 cases, a comparative study. A randomized, placebo-controlled, double-blind clinical study design. Oral treatment group Erigeron Shengmai Capsule (from Yunnan Valley Breviscapine Biology Medicine Co., Ltd. Production:Drug lot number Z20026439), each piece costs 0.18g, each two, half an hour postprandial oral,2 times daily; the control group oral comfort agent capsule (Yunnan Valley Breviscapine Biology Medicine Co., Ltd. production), each piece costs 0.18g, each two, half an hour postprandial oral, 2 times daily; two groups of Chinese and Western medicine on the basis of treatment with reference to relevant standards; these drugs were Continuous treatment for 3 months. Pre-treatment of two groups of gender, age, course of disease, basic diseases, basic information such as clinical score were compared by statistical treatment no significant difference (P> 0.05), note the two groups are comparable; after treatment according to clinical efficacy, TCM Syndrome Evaluation, plasma fibrinogen, blood lipids, as well as recurrence rate, mortality rate, incidence of adverse reactions, such as indicators for evaluation, statistical analysis, to evaluate Erigeron Shengmai Capsule on secondary prevention of ischemic stroke patients.[Results]1. Cases of selected objects1.1 The diagnosis of cerebral infarction in line with Western standards, and the unconscious barriers to persons;1.2 The age of 35 to 75 years of age (calculated by date of birth) persons;1.3 Stroke disease 2 weeks to a month, and the income left over from a certain group of fashion symptoms of neurological deficit (NIHSS score "0 points); Who meet the above-patients or out-patient cases can be included in clinical trials.2. Cases to exclude objects2.1 Transient ischemic attack (TIA);2.2 Nearly 6 months, with cerebral hemorrhage;2.3 During pregnancy or breast-feeding women;2.4 The ingredients of this drug allergy and allergic persons;2.5 Upon examination confirmed by a brain tumor, brain trauma, blood diseases caused by stroke patients;2.6 Due to cerebral embolism caused by rheumatic heart disease;2.7Combined with liver, kidney, hematopoietic system, endocrine system, serious illnesses such as persons;2.8 Merge osteoarthritis patients;2.9 Mental patients;2.10 Past history of a stroke and left with severe symptoms, affect treatment evaluator;2.11 Is participating in clinical trials of other drugs were.3. Excluding three cases the standard3.1 Included found those who do not meet the inclusion criteria;3.2 After the drug has not been incorporated into persons;3.3 The combined use of the program prohibit the use of Chinese and Western medicine, or midway, or add their own medication with other drugs;4. All cases the Department in July 2009-2010 years, Chinese medicine hospital in Hubei Province in March of neurology clinics and hospitalized patients, a total of 60 cases, according to admission order, using the principle of double-blind, randomized, divided into treatment group and control group, which treatment group 30 cases,30 cases of the control group.5. Dosage regimenThe basis of treatment:the light in 2005 "China cerebrovascular disease prevention and treatment guidelines", taking Aspirin enteric-coated tablets,100mg/ day, every night one time, to regulate acupuncture and rehabilitation treatment; combined with high blood pressure, high blood sugar, hyperlipidemia, atrial fibrillation, coronary atherosclerotic heart disease who may be symptomatic treatment. Basic treatment, medicines to be recorded in detail.Test Group:Huatuo Zaizao pills, oral, daily 2 times, each time 4 grams; Control group:Huatuo Zaizao pills simulated agents, taken orally,2 times a day, every 4 grams6. Complication of the treatment principles:6.1 Combined with infection can be symptomatic antibiotic treatment.6.2 If they can not eat, can intravenous infusion, or nasal feeding, maintaining heat, water, electrolyte and acid-base balance.6.3 Shall not permit the use of treatment of the disease to other Chinese medicine or Chinese medicine.6.4 Continuous drug treatment groups for 24 weeks.7. Safety Observation7.1 General physical examination;7.1.2 Blood routine, urine routine:Before the test, into the group of 12 weeks and end of the trial were examined blood and urine routine;7.1.3 Conventional+stool occult blood:Test before and end of the trial were examined conventional+stool occult blood;7.1.4Heart function test:test before and end of the trial were examined electrocardiogram;7.1.5 Liver and kidney function tests:test prior to 12 weeks into the group and the end of the trial were examined liver function (ALT, AST), renal function (BUN, Cr) and blood sugar;7.1.6 Adverse reactions symptoms, signs, observation.7.2 Demographic data and general7.2.1 Demographic information7.2.2 Patients with past history of the disease with the, combined7.2.3 The patient's vital signs7.3 Clinical observation7.3.1 The degree of neurological deficit score (NIHSS) (for each observation point are evaluation)7.3.2 Activities of daily living score (BI) (0,12 weeks,24 weeks).7.3.3 Modified Rankin Scale (mRS) (0,12 weeks,24 weeks)TCM.7.3.4 Changes ("Stroke Syndrome Diagnostic Criteria") (each observation point are evaluation)According to syndrome factor score changes, observe the evolution of characteristics of syndromes, from the perspective of the evolution of syndromes clinical evaluation.7.3.5 Hemagglutination+D-dimer change (0,12 weeks,24 weeks).7.3.6 Recurrence of the occurrence of serious adverse outcomes (one for each observation point are evaluation).7.4 Observation point Into the group,4 weeks±3 days,8 weeks±3 days,12 weeks±3 days,16 weeks±3 days,20 weeks±3 days,24 weeks±3 days.8. Treatment after reviewing a variety of scales by the same doctor, after statistical analysis to compare before and after treatment in each group of the total effective cure rate.9. Efficacy and safety assessment standards9.1 Efficacy assessment standards9.1.1 changes in neurological deficit;9.1.2 changes in activities of daily living;9.1.3 Patients with recurrence;9.1.4 relapse rate in patients with cerebral infarction and the occurrence of adverse outcomes;9.1.5 TCM changes9.2 Safety Evaluation Criteria9.2.1: Safety, without any adverse reactions.9.2.2: To compare the safety, if any adverse reactions do not need to do any processing can continue to administration.9.2.3: There are security issues, there is moderate adverse reactions, so treatment can continue to delivery. Level9.2.4: Adverse reactions due to the suspension testThe two groups before treatment were gender, age, course of disease, underlying diseases, clinical and other basic data points were compared, no statistical significant difference (P>0.05), shows the two groups are comparable; treated according to clinical efficacy, TCM Clinical evaluation and blood coagulation and other indicators to carry out assessment, carried out statistical analysis to pairs of Huatuo Zaizao pills treatment of cerebral infarction convalescence for efficacy and safety of clinical re-evaluation studies.[Conclusion]1. Clinical comparison:treatment group, the basic recovery in 6 cases, significant improvement in 10 cases, progress in 9 cases, no change in 5 cases, the total effective rate 83.34%; control group, the basic recovery in 4 cases, significant improvement in 8 cases, progress in 10 cases, no changes in 8 cases, deterioration in 3 cases, with a total effective rate 73.43%. Upon examination▲P<0.05, shows treatment group than the control group.2. TCM integral comparison:the two groups before treatment TCM points of comparison, there was no significant differenceDifferent (p> 0.05); the two groups after treatment itself TCM points of comparison, significant difference (p<0.05); the two groups after treatment TCM points, the difference was significant (p<0.01).3. Points of clinical neurological deficits comparison:the treatment group before treatment points 13.69±5.89, after treatment points 10.87±5.24; points in control group before treatment 13.78±6.63, after treatment points 10.76±6.33. The paired t test, the treatment group after treatment than before treatment to improve the nerve function defect integral differences were significant (P <0.01), and the difference between the two groups after treatment also significantly (P<0.05).4. Coagulation function:to improve the PT, TT, APTT, the treatment group before and after treatment are also reduced but the difference was not significant decrease (P> 0.05); the control group before and after treatment and no significant differences (P> 0.05). Treatment group, compared with the control group after treatment than before treatment FG significantly lower (P<0.05), between the two groups after treatment FG was no significant difference between the value.The clinical trials of a random, double-blind, placebo-controlled research methods, studies have shown, the application with the blood stasis, phlegm Tong Luo, Qi analgesic effect of Huatuo Zaizao pills may regulate recovery phase of ischemic stroke in patients with clotting function and reduce plasma fibrinogen levels, lower blood viscosity; be able to effectively improve neurological function, relieve symptoms, and fewer adverse reactions, the treatment of ischemic stroke recovery of the safe and effective drugs, and for ischemic stroke the efficacy of the prevention of certain.