| Purpose:This study applies the conception of comparative effectiveness research, conducts hospital practicality registration study, analyses and evaluates the characteristics of the practical application、clinical efficacy and safety of Danhong injection in treating cerebral infarction.Method:This study applies the method of clinical registration. The selected objects must be in acute phase or recovery of cerebral infarction and must be accord with indications and the specifications of Danhong injection. Once the patients began to be selected, must be continuously enrolled, you can’t pick and leak selected objects, until this study reaches the pre-designed number. This study has registered1,012cases of cerebral infarction. analyzed and evaluated the demographic data and general clinical data, outcome measures, security indexs. Natural grouping, divided into acute cerebral infarction group and the recovery group, age>75age group and age<75years old group, to assess demographic data and clinical data, NIHSS score, Barthel Index score, improved RANKIN total score, symptoms and signs, TCM syndrome, adverse reaction rates during treatment, and other indicators at the end of treatment.Results:1. Demographic information and general clinical dataGender:male to female ratio was1.2:1; Ethnic composition:the Han nationality accounted for99.2%, others0.8%; Occupation:physical occupation (27.4%), non-manual occupation (72.6%); Marriage:Married patients and others ratio of9.2:1.The mean age was67.05±11.78years, mean height was166.07±8.03cm, mean weight was66.87±11.23kg, average waist was85.11±14.74cm.Diabetes (26.3%), hyperlipidemia(24.6%), hypertens ion(73.3%), coronary artery disease(30.6%), arrhythmia (13.1%), stroke (38.4%).Diagnosis way:Brain CT (72.5%); Brain MAI (21.3%), Brain MRI and Brain CT (6.2%).OCSP clinical class if i cat ion:complete pre-clinical geno typing5.2%; partial anterior circulation infarct46.1%; posterior circulation infarction15.5%; lacunar infarction33.2%.The main symptoms:hemiplegia53.1%; dizziness55.7%; headache21.7%; numbness of39.0%.2. Results Evaluation2.1NIHSS score At the end of treatment, the mean±tandard deviation of NIHSS score and baseline difference was-1.95±3.04, NIHSS score improved. The mean±standard deviation of the acute cerebral infarction group was-2.12±3.14and the recovery group’s was-1.05±2.25, the difference of the difference of NIHSS score and baseline between the two groups was statistically significant (P=0.000). The mean±standard deviation of age>75age group was-1.85±3.09and age<75years old group’s was-1.98±3.04,the difference of the difference of NIHSS score and baseline between the two groups was not statistically significant (P=0.586).2.2Barthel IndexAt the end of treatment,the mean±standard deviation of Barthel index and baseline difference was10.85±18.14points,Barthel index improved. The mean±standard deviation of the acute cerebral infarction group was12.00±19.00and the recovery group’s was4.41±9.76, the difference of the difference of Barthel index and baseline between the two groups was statistically significant (P=0.000). The mean±standard deviation of age>75age group was11.80±18.18and ge<75years old group’s was10.48±8.13, the difference of the difference of Barthel index and baseline between the two groups was not statistically significant (P=0.342).2.3RANKIN scoreAt the end of treatment, the mean of RANKIN score and baseline difference was-0.76, RANKIN score improved. The mean of the acute cerebral infarction group was-0.8and the recovery group’s was-0.15,the difference of the difference of RANKIN score and baseline between the two groups was statistically significant (P=0.001).The mean of age>75age group was-0.69and age<75years old group’ s was-0.79, the difference of the difference of RANKIN score and baseline between the two groups was statistically significant (P=0.022).2.4TCM symptoms efficacyThe total efficiency of the acute group and the recovery group was97.4%and97.5%respectively, the difference of the total efficiency between the two groups was not statistically significant (P>0.05). The total efficiency of the Age>75age group and the age<75years old group was98.2%and97.5%, the total effective rate between the two groups showed no significant difference (P>0.05).2.5The incidence of deathsAt the end of treatment, the incidence of deaths was0.3%.2.6Patients and doctors SatisfactionPatient satisfaction rate of98.0%, doctor satisfaction rate of98.9%.3. Safety Evaluation3.1The incidence of adverse events During the medication, the incidence of adverse events was1.1%. The incidence of adverse events of the acute phase group and convalescence group were0.9%and2.8%respectively, the incidence of adverse events between the two groups showed no significant difference (p=0.206).The incidence of adverse events of age>75age group and age<75years old group were1.3%and1.0%respectively, the incidence of adverse events between the two groups was no statistical difference.3.2The incidence of adverse reactionsDuring the medication, the incidence of adverse reactions was0.5%. The incidence of adverse reactions ofthe acute phase group and convalescence group were0.1%and2.8%respectively, the incidence of adverse reactions between the two groups was statistically significant difference (p=0.009). The incidence of adverse reactions of age>75age group and age<75years old group were0.9%and0.3%, respectively,the incidence of adverse reactions between the two groups was no statistical difference (p=0.681).Conclusion:This study observed1012patients with cerebral infarction who used Danhong injection, analyze data, draw the following conclusions:1. Danhong injection is effective in the treatment of cerebral infarction comprehensive treatment program in clinical practice.2. Danhong injection applied in the treatment of cerebral infarction in clinical practice in a comprehensive treatment program, the curative effect of acute phase is superior to the convalescence’s.3. Danhong injection applied in the treatment of cerebral infarction in clinical practice in the comprehensive treatment program, on improving RANKIN score, age <75-year-old patient is superior to the age of75or more.4. Danhong injection applied in the treatment of cerebral infarction in clinical practice in the comprehensive treatment program, higher safety, but also has certain risk, the acute phase’s saftey is superior to the recovery’s, between aged over75and less than75-year-old patient, there was no evident difference... |
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