ABSTRACT
Since 2016, a number of studies have been published on standard decoctions used in Chinese medicine. However, there is little research on statistical issues related to establishing the quality standards for standard decoctions. In view of the currently established quality standard methods for standard decoctions, an improvement scheme is proposed from a statistical perspective. This review explores the requirements for dry matter yield rate data and index component transfer data for the application of two methods specified in “Technical Requirements for Quality Control and Standard Establishment of Chinese Medicine Formula Granules,” which include the average value plus or minus three times the standard deviation (X-±3SD) or 70% to 130% of the average value (X-±30%X-). The square-root arcsine transformation method is used as an approach to solve the problem of unreasonable standard ranges of standard decoctions. This review also proposes the use of merged data to establish a standard. A method to judge whether multiple sets of standard decoction data can be merged is also provided. When multiple sets of data have a similar central tendency and a similar discrete tendency, they can be merged to establish a more reliable quality standard. Assuming that the dry matter yield rate and transfer rate conform to a binomial distribution, the number of batches of prepared slices that are needed to establish the standard decoction quality standard is estimated. It is recommended that no less than 30 batches of prepared slices should be used for the establishment of standard decoction quality standards.
ABSTRACT
<p><b>OBJECTIVE</b>To explore the value of mean platelet volume (MPV) and Gensini score on predicting short-term prognosis of patients with acute ST segment elevation myocardial infarction (STEMI) post emergency percutaneous coronary intervention (PCI).</p><p><b>METHODS</b>From September 2011 to June 2013, 102 consecutive hospitalized STEMI patients undergoing emergency PCI were included. All patients routine blood test was made immediately after admission, and Gensini score was calculated according to the results of coronary angiography. Incidence of major adverse cardiac events (MACE) during hospitalization and 6 months after PCI was observed.</p><p><b>RESULTS</b>MPV, Gensini score and percent of coronary artery three vessel lesions were significantly higher in MACE patients than in patients without MACE(P < 0.05 or 0.01). Area under the curve (AUC) of MPV plus Gensini score for predicting in hospital MACE and at 6 months post PCI was 0.836 (95%CI:0.706-0.966, P = 0.003) and 0.718 (95%CI:0.571-0.866, P = 0.006) , respectively. Kaplan-Meier survival analysis showed that incidence of without MACE at 6 months post PCI was significantly lower in patients with high MPV (>10.65 fl) than in patients with low MPV ( ≤ 10.65 fl) at admission (log-rank = 4.272, P = 0.039), and in patients with high Gensini score (>89) than in low Gensini score ( ≤ 89) (log-rank = 7.355, P = 0.007) at admission.</p><p><b>CONCLUSIONS</b>High MPV and Gensini score are associated with lower MACE during hospitalization and at 6 months after PCI in acute STEMI patient. These two parameters could thus be used to predict short-term MACE in STEMI patients post PCI.</p>