الملخص
Objective:To develop the minimal clinically important difference (MCID) of Quality of Life Instruments for Cancer Patients-Leukemia (QLICP-LE) (V2.0).Methods:The quality of life of 101 patients with leukemia in First Affiliated Hospital of Kunming Medical University and First People′s Hospital of Yunnan Province from October 2011 to May 2012 were measured. The QLICP-LE (V2.0) was used for data collection, and the MCID for the overall score and scores of various domains of QLICP-LE (V2.0) were established by using the distribution-based approach including indexes of effect size, standard error of measurement (SEM), reliable change index, standardized response mean and responsiveness statistic, and the recommended values of MCID were determined through the consensus method.Results:The MCID formulated by the above five indexes were as follows: the total scale 1.4-9.3, physical functional domain 1.6-15.6, psychological functional domain 2.9-15.6, social functional domain 2.2-18.0, common symptoms and side-effects domain 1.7-17.1, common module 1.8-10.0, and the specific module 1.1-12.1. Through the expert consensus method, it was recommended to use the MCID results calculated by 1.96SEM: the total scale was 4, physical domain was 8, psychological domain was 8, social domain was 9, common symptoms and side-effects domain was 9, common module was 4, and the specific module was 6.Conclusion:Each index of distribution-based approach has its own advantages and disadvantages, which can be selected based on actual conditions. There is clinical significance when the score change of QLICP-LE (V2.0) of leukemia patients after treatment exceeds its MCID.
الملخص
OBJECTIVE：To study the spectrum-ef fect relationship of anti-hepatoma effect of C Ⅱ-3 extract from Periplaneta americana，and to preliminarily clarify the anti-hepatoma active components of it. METHODS ：Based on UHPLC fingerprints of 10 batches of C Ⅱ-3 samples，with the help of UHPL C-Q-TOF/MS，the compounds corresponding to each chromatographic peak were identified qualitatively by standard substances and related literatures. Using the IC 50 value of each batch of C Ⅱ-3 sample against human hepatoma cells HepG 2 as anti-hepatoma activity index ，the spectrum-effect relationship of fingerprint and anti-hepatoma effect was established and analyzed by the combination of grey relational analysis （GRA）and orthogonal partial least squares（OPLS）. RESULTS ：There were 25 common peaks in UHPLC fingerprints of 10 batches of C Ⅱ-3 samples，and 10 chemical compounds were identified ，which were cyclo- （Tyr-Pro）（peak 24），cyclo-（Gly-Phe）（peak 15），hypoxanthine（peak 3）， adenine（peak 7），phenylalanine（peak 10），inosine（peak 11），N-acetyldopamine（peak 16），cyclo-（Pro-Ala）（peak 13），2-hydroxy propionyl（peak 22），cyclo-（Pro-Ser）（peak 6）. The IC 50 of 10 batches of C Ⅱ-3 samples to HepG 2 cells was 70.550-200.303 μg/mL. Among 25 common peaks ，the order of GRA correlation （r）of anti-hepatoma activity was peak 20＞23＞24＞15，all of r values were greater than 0.7；the order of variable importance projection （VIP）of OPLS analysis was peak 23＞18＞15＞24＞7＞14＞6＞ 2＞20，all of VIP values were greater than 1. The standard regression coefficients of peak 7，15，20，23，24 were all greater than 0；while the standard regression coefficients of peak 2，6，14，18 were all less than 0. Conjoint analysis shows that the order of anti-hepatoma activity was peak 20＞23＞24＞15. CONCLUSIONS：unknown chemical ingredients （peak 20， ），cyclo-（Tyr-Pro）（peak 24）and cyclo- （Gly-Phe）（peak 15） in C Ⅱ-3 may be main anti-hepatoma active components.