| Over the years, the mortality rate of cardia-cerebrovascular disease has been always ranked first. Along with the aging of social population structure, the incidence of cardia-cerebrovascular disease has risen sharply. Especially in our country, there was a high incidence of cerebrovascular accident (stroke). Statistics showed that the stroke incidence of the Han nationality in our country has reached up to 600.3/100 thousand, among which the cerebral infarction incidence accounted for a large proportion. Because of high disability rate, it has seriously affected patient’s living, operational capability, and social and psychological behavior, what was worse, seriously reducing the quality of life of patients. It was extremely important for improving the final outcome to correctly and effectively evaluate and find out the factors affecting the quality of life of stroke patients. In recent years, the evaluation of quality of life of stroke patients was paid more and more attention by researchers both at home and abroad. However, since the number of scales that can be chose was much, most of studies on quality of life evaluation chose scales casually or tend to be single, which undoubtedly brought certain problems to evaluate curative effect of traditional Chinese medicine treating stroke.TCM considered that the cause of ischemic cerebrovascular disease was qi and blood stasis or qi deficiency and blood stasis. Blood stasis can lead to the dysfunction of the nervous system. Based on the above theory, the therapeutic principle of TCM on treating ischemic stroke was to promote blood circulation to remove blood stasis. Flos Carthami is the flower of Carthamus tinctorius L., family Compositaewas, which was one of important Chinese medicines to promote blood circulation to remove blood stasis. It has the laudatory title of "the king herb of facilitating blood flow" and effect of promoting the circulation of blood and menstruation, remove blood stasis to alleviate pain such as activating blood, treating blood disorder, promoting circulation of blood and nourishing blood. Modern pharmacology study showed that Flos can reduce brain edema and has protective effect on brain tissue of cerebral infarction rats. The active ingredients with anti-cerebral infarction function in the Flos Carthami is hydroxysafflor yellow A (HSYA). A large number of pharmacological studies have shown that hydroxysafflor yellow A has obvious prevention and treatment effect on experimental whole brain and focal cerebral ischemia and cerebral ischemia and reperfusion model in animal experiments, and more obvious effect on increasing cerebral blood flow than that in peripheral vessels, and can prophylactic thrombosis. Also,study about clinical efficacy and safety of hydroxysafflor yellow A for injection was quite a lot, but there was relatively less about its effects on quality of life of stroke patients.Based on the above two aspects, in this study we aim to probe the effect of quality of life of acute ischemic stroke (blood stasis syndrome) patients treated by hydroxysafflor yellow A for injection and to further improve systematic comparison and evaluation among generic instrument of HRQL related to stroke, in order to provide certain reference and guidance for evaluating intervention of TCM in the quality of life.Object ive1. To evaluate curative effect on TCM symptoms of acute ischemic stroke (blood stasis syndrome) treated with hydroxysafflor yellow A for injection.2. To probe the influence on the quality of life of ischemic stroke (blood stasis syndrome) patients treated with hydroxysafflor yellow A for injection.3. To compare advantages and disadvantages between the SS-QOL and QOLISP scale in simplicity, availability, reliability and sensitivity, etc, and to compare correlation between the SS-QOL and QOLISP scale from different angles with the aim of choosing more suitable scale for evaluation of quality of life of patients with acute ischemic stroke after intervention of traditional Chinese medicine.4. To exploratory develop and improve QOLISP scale and make a preliminary evaluation of its effectiveness, reliability and sensitivity. Also to investigate scores correlation with the original QOLISP scale.5. To preliminarily explore the correlation between the living ability and quality of life in patients with acute ischemic stroke after intervention of traditional Chinese medicine.MethodsIn this study, based on literature analysis related to stroke scales, we took the randomized, double-blind, positive drug parallel controlled and multicentric II-period clinical trial on efficacy and safety of hydroxysafflor yellow A for injection in treatment of acute cerebral infarction as carrier.1. Scores of blood stasis syndrome from three different time points (before drug medication, after 30 days and 90 days) were regarded as indicators of clinical outcomes, by using general statistical method of clinical curative effect, covariance method and repeated measurement variance covariance analysis method were used to evaluate curative effect of TCM symptoms between the control group and the treatment group gave hydroxysafflor yellow A for injection in the treatment of acute ischemic stroke (blood stasis syndrome).2. On the basis of literature research, the two kinds of scale with different characteristics were screened out:SS-QOL and QOLISP scale. Difference scores of the SS-QOL and QOLISP scale between the treatment group and control group were compared at three different time points (before,30 days and 90 days after drug medication) after, respectively to study the influence on quality of life of patients with ischemic stroke (blood stasis syndrome) treated with hydroxysafflor yellow A for injection.3. Through analyzing the validity, reliability and sensitivity, respectively, to compare their advantages and disadvantages in these aspects, and combined with the analysis of variance, non-parametric test, correlation test and regression analysis and other statistical methods, the SS-QOL and QOLISP scale were compared from different angles (such like the total correlation, scoring difference, dropping rate, correlation analysis of similar dimension).4. In the process of this study, in view of problems found during filling out, the QOLISP scale was modified to create an reformative QOLISP scale, and its validity, reliability and sensitivity was statistically analyzed by collecting related data from the same patient, at the same time and under the same condition to make a preliminary evaluation of its effectiveness, reliability and sensitivity and to compare scores with the original QOLISP scale for examining the correlation.5. Through gathering scores of the BI and the SS-QOL and QOLISP scale in all the included patients before and 30 days and 90 days after giving drug, and correlation and regression analysis, and comparing correlation between the BI score and two quality of life scale score at three different point, respectively, the correlation between the living ability and survival quality of stroke patients after intervention of Chinese traditional medicine was preliminarily discussed.Results1. Comparison of the Chinese medicine symptom curative effect:the effective rate of the treatment group was 22.9%(8/35), which was higher than that of control group (5.6%,2/36), so there was a significant difference (P =0.046), which meant the curative effect on treating blood stasis syndrome in the treatment group was better than that in the control group.2. Covariance analysis of TCM syndrome showed that:After 30 days treatment, the average dropping rate of the treatment group was 0.69+2.48 points, which was higher than that in the control group (0.28+1.16 points). By using the general linear model after correcting baseline, the difference between the treatment group and the control group was statistically significant (P=0.024), which meant the curative effect in the treatment group was better than that in the control group after 30 days. After 90 days treatment, the average dropping rate of the treatment group was 1.17±2.68 points, which was higher than that in the control group (0.42±1.40 points). By using the general linear model after correcting baseline, the difference between the two groups was statistically significant (P=0.005), which meant the curative effect in the treatment group was better after 90 days.3. Repeated measures analysis of variance of TCM syndrome showed:There was an interactive effect between different group and different time. Difference of TCM syndrome scores between the two groups at different time points was statistically significant (P< 0.05).4. Covariance analysis of SS-QOL scale showed:After 30 days treatment, the average increasing score of the treatment group was 57.43±42.5 points, which was higher the average increasing score of the control group (19.89±13.1 points), after correcting baseline, there was a statistic difference between the treatment group and the control group (P= 0.006), which suggested that the score of the SSQOL scale in the treatment group was higher than that in the control group after 30 days. After 90 days treatment, the average increasing score of the treatment group was 72.3±37.67 points, which was higher the average increasing score of the control group (33.39±15.36 points), after correcting baseline, there was a statistic difference between the treatment group and the control group (P= 0.009), which suggested that the score of the SSQOL scale in the treatment group was higher than that in the control group after 90 days.5. Covariance analysis of the QOLISP scale showed:After 30 days treatment, the average increasing score of the treatment group was 13.46±8.01 points, which was higher the average increasing score of the control group (7.00±3.88 points), after correcting baseline, there was a statistic difference between the treatment group and the control group (P-0.016), which indicated that the score of the QOLISP scale in the treatment group was higher than that in the control group after 30 days. After 90 days treatment, the average increasing score of the treatment group was 20.2±10.55 points, which was higher the average increasing score of the control group (12.31±4.82 points), after correcting baseline, there was a statistic difference between the treatment group and the control group (P= 0.031), which indicated that the score of the QOLISP scale in the treatment group was higher than that in the control group after 90 days.6. Repeated measures analysis of variance of quality of life showed:There was an interactive effect between different group and different time. Scores of the SS-QOL scale and QOLISP scale at different time points were both statistically significant (P< 0.05).7. Analysis of reliability, validity and sensitivity of the SS-QOL scale showed:the reliability of the SS-QOL scale before treatment was measured by the whole Cronbach alpha coefficient (r=0.803), which have reached a very reliable standard. To do test-retest reliability after excluding the thinking and vision item, the whole Cronbacha coefficient of the rest part was 0.855, which proved this part of the questionnaire was more reliable.10 common factors were extracted out of validity analysis. The total variance of the add-up explains rate was 81.957%, which was more than 70%. The load conditions after finishing factor orthogonal rotation showed that the minimum load of each factor was 0.510 (>0.3). So the comprehensive test results told the validity of SS-QOL scale was good. There was a significant difference between the total score before and after treatment for 30 days (P<0.05), and which were positively correlated (r=0.379); Differences of 10 dimensions before and after 30 days treatment were statistically significant (P<0.01), which suggested that the SS-QOL scale reaction degree was good.8. Analysis of reliability, validity, sensitivity analysis of the QOLISP scale showed:the reliability of the SS-QOL scale before treatment was measured by the whole Cronbach alpha coefficient (r=0.877), which have reached a very reliable standard and every CITC index standard was higher than 0.5 and the four dimensions were positively correlated, which indicated that the reliability before treatment of the QOLISP scale was good.11 common factors were extracted out of validity analysis. The total variance of the add-up explains rate was 73.394%, which was more than 70%. The load conditions after finishing factor orthogonal rotation showed that the minimum load of each factor was 0.362 (>0.3). So the comprehensive test results told the validity of QOLISP scale was good. There was a significant difference between the total score before and after treatment for 30 days (P<0.05), and which were positively correlated (r=0.886); Differences of 4 dimensions before and after 30 days treatment were statistically significant (P<0.01), which suggested that the QOLISP scale reaction degree was good.9. Analysis of reliability, validity, sensitivity analysis of the improved QOLISP scale showed:the reliability of the improved QOLISP scale before treatment was measured by the whole Cronbach alpha coefficient (r=0.882), which have reached a very reliable standard and every CITC index standard was higher than 0.5 and the four dimensions were positively correlated, which indicated that the reliability of the improved QOLISP scale before treatment was very reliable. In validity test, a total of 12 common factors were extracted out. The total variance of cumulative explains was 75.875%, which was higher than 70%. The load conditions after finishing factor orthogonal rotation showed that the minimum load of each factor was 0.406 (>0.3). So the comprehensive test results told the validity of improved QOLISP scale was good. There was a significant difference between the total score before and after treatment for 30 days (P<0.05), and which were positively correlated (r=0.837); Differences of 4 dimensions before and after 30 days treatment were statistically significant (P<0.01), which indicated that the sensitivity of the improved QOLISP scale was good.10. Compared difference between the SS-QOL and QOLISP scale:①The correlation of the total score between the two scales showed there are significant positive correlation between the two scales at three different time points (the correlation coefficient were 0.789,0.607 and 0.664, respectively); ②Comparing the different scores in the two scale showed that there were significant overall difference at three different time points of the total scores in the two scales(r=0.680, P= 0.000); ③Correlation analysis of similar dimensions hinted that at the aspect of physiological function, the correlation between the two scales was statistically significant (r=0.680, P= 0.000), and there was a positive association at the aspect of social function (r=0.360, P-0.004); But there was no statistically significant correlation between the two scales at the aspect of the psychological conditions (r=0.249, P=0.053),11. Correlation between the improved and original QOLISP scale showed that: The correlation coefficient of physical and TCM syndrome dimension of the QOLISP scale before and after improved were greater than 0.85, there was a positive correlation.12. Correlation and regression analysis between the BI scale and the SS-QOL and QOLISP scale showed:Results of regression analysis between the BI scale and the SS-QOL and QOLISP scale at three different time points indicated that the BI scale has significant influence on the SS-QOL and QOLISP scale from the analysis at different time point, which were all positive influence that can be identified through the regression coefficients. It can be speculated that the degree of influence would increase as time goes on. Results of correlation analysis between the SS-QOL and QOLISP scale and the BI scale in three different test period told that the three different correlation analysis results shown highly significant difference between them, which were significant positive correlation that can be identified through correlation coefficients.Conclusion1. Clinical symptoms of patients with blood stasis syndrome can be improved by HSYA and Erigeron breviscapus for injection to varying degrees. Both of them have showed certain curative effect for blood stasis syndrome. What is more, the curative effect in the HSYA group (the treatment group) is superior to that in the Erigeron breviscapus group (the control group).2. The improvement of the quality of life of patients with acute ischemic stroke (blood stasis syndrome) in the HSYA group is better than that in the Erigeron breviscapus group. But given influence factors such like the sample size included was less in this study and the fillout of scales has certain subjectivity, and follow-up lasting for a long time, conclusions in this study has certain limitations with poorer extrapolation.3. All of the SS-QOL scale and the QOLISP scale displayed high degree of validity, reliability and sensitivity. And the degree of correlation between them is high. Both scales have their respective advantages.In terms of reliability, QOLISP scale shows superiority,but in terms of validity,the SS-QOL scale shows higher total variance of the add-up explains rate, so the composite application was considered in clinical application, or the selection of SS-QOL scale is more suitable when giving intervention treatment of western medicine, while giving intervention therapy of traditional Chinese medicine, the QOLISP scale or its modified scale possessing TCM characteristics can consider to be chose, which can make the evaluation of the curative effect of traditional Chinese medicine on quality of life scale to be more advanced, or to do comprehensive evaluation combining with the SS-QOL in order to make a more comprehensive curative effect evaluation. But according to the results of this study showed that correlation of the two scales on the psychological dimension is poorer, there may be existed differences in content. So if assessing patient’s mental condition by a single scale may turn to be one-sided.4. The QOLISP scale has showed high degree of validity, reliability and sensitivity after improvement and its scoring system was highly related to the original scale. But due to the relatively insufficient sample size, and only to adjust individual items in the scale, it cannot be sure that the modified scale was better than the primary QOLISP scale combined with the data in this research. The improved QOLISP scale should still need to be explored and improved further, which will need a large number of clinical investigations and statistical analysis with large sample and high quality.5. There was a high correlation between the SS-QOL and QOLISP scale and the BI scale that was used to test patients’living ability, which showed that subjective evaluation results on the quality of life of patients via the SS-QOL and QOLISP scale can reflect patient’s health condition real and objectively. |
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