Objective To investigate the effect of the serums containing Xuefuzhuyu capsules and Xuesetong capsules on the proliferation of vascular smooth muscle cells (VSMC) induced by 1ysophosphatidie acid (LPA). Methods Rat VSMCs were obtainded by tissue-piece inoculation and divided into seven groups:blank serum group, Xuefuzhuyu (Xuesetong) capsules-containing serum group, LPA+ Xuefuzhuyu (Xuesetong, captopril) containing serum group and LPA+blank serum group. Effects of different groups on the proliferation of VSMCs was evaluated by MTT colorimetry. Analysis of cell cycle and DNA content were performed by flow cytometry. Results The optical density (OD) and the S phase fraction (SPF) of LPA+blank serum group and Xuefuzhuyu capsules-containing serum group were more increased than the blank serum group (P 0.05, P 0.05). Conclusion Xuefuzhuyu capsules and LPA promoted the proliferation of VSMCs in vitro. Xuefuzhuyu and Xuesetong capsules can inhibit the proliferation induced by LPA, and effect of Xuesetong capsules was greater. Part of the mechanism may be associated with the inhibition of DNA synthesis and preventing the transition from G0/G1 to S phase of VSMCs.

In recent years, as the Chinese government and people pay more attention on the post-marketing research of Chinese Medicine, part of traditional Chinese medicine breed has or is about to begin after the listing of post-marketing evaluation study. In the post-marketing evaluation design, sample size calculation plays a decisive role. It not only ensures the accuracy and reliability of post-marketing evaluation. but also assures that the intended trials will have a desired power for correctly detecting a clinically meaningful difference of different medicine under study if such a difference truly exists. Up to now, there is no systemic method of sample size calculation in view of the traditional Chinese medicine. In this paper, according to the basic method of sample size calculation and the characteristic of the traditional Chinese medicine clinical evaluation, the sample size calculation methods of the Chinese medicine efficacy and safety are discussed respectively. We hope the paper would be beneficial to medical researchers, and pharmaceutical scientists who are engaged in the areas of Chinese medicine research.
Drug-Related Side Effects and Adverse Reactions ; Humans ; Medicine, Chinese Traditional ; adverse effects ; Product Surveillance, Postmarketing ; Sample Size

Sample size is one of important factors determining the results of a clinical trial, and the choice of sample size estimation methods is related to the specific design of clinical trials. On clinical safety reevaluation of postmarketing Chinese medicine, we often design cohort study, case-control study, nested case-control study or hospital centralized monitoring, which need large sample sizes. In evaluating the effectiveness of postmarketing Chinese medicine widely applied in the large population, pragmatic randomized controlled trial (PRCT) is more suitable than explanatory randomized controlled trial (ERCT). ERCT is necessary to conduct confirmatory study for new indications of postmarketing Chinese medicine. According to the specific purpose, design type and evaluation index, we choose the suitable sample size estimation method, and determine the corresponding parameters. We must estimate and determine the suitable sample size according to the specific clinical evaluation design, with comprehensive consideration of the test power, research cost and practical operability.
Cohort Studies ; Drug Therapy ; standards ; Drug-Related Side Effects and Adverse Reactions ; Drugs, Chinese Herbal ; adverse effects ; standards ; therapeutic use ; Humans ; Product Surveillance, Postmarketing ; Public Health ; Randomized Controlled Trials as Topic ; Sample Size

Currently massive researches have been launched about the safety, efficiency and economy of post-marketing Chinese patent medicine (CPM) proprietary Chinese medicine, but it was lack of a comprehensive interpretation. Establishing the risk evaluation index system and risk assessment model of CPM is the key to solve drug safety problems and protect people's health. The clinical risk factors of CPM exist similarities with the Western medicine, can draw lessons from foreign experience, but also have itself multi-factor multivariate multi-level complex features. Drug safety risk assessment for the uncertainty and complexity, using analytic hierarchy process (AHP) to empower the index weights, AHP-based fuzzy neural network to build post-marketing CPM risk evaluation index system and risk assessment model and constantly improving the application of traditional Chinese medicine characteristic is accord with the road and feasible beneficial exploration.
Drug-Related Side Effects and Adverse Reactions ; Fuzzy Logic ; Humans ; Neural Networks (Computer) ; Nonprescription Drugs ; adverse effects ; Product Surveillance, Postmarketing ; Risk Assessment

Objective: To determine whether T1 mapping could monitor the dynamic changes of injury in myocardial infarction (MI) and be histologically validated. Materials and Methods: In 22 pigs, MI was induced by ligating the left anterior descending artery and they underwent serial cardiovascular magnetic resonance examinations with modified Look-Locker inversion T1 mapping and extracellular volume (ECV) computation in acute (within 24 hours, n = 22), subacute (7 days, n = 13), and chronic (3 months, n = 7) phases of MI. Masson’s trichrome staining was performed for histological ECV calculation. Myocardial native T1 and ECV were obtained by region of interest measurement in infarcted, peri-infarct, and remote myocardium. Results: Native T1 and ECV in peri-infarct myocardium differed from remote myocardium in acute (1181 ± 62 ms vs. 1113 ± 64 ms, p = 0.002; 24 ± 4% vs. 19 ± 4%, p = 0.031) and subacute phases (1264 ± 41 ms vs. 1171 ± 56 ms, p < 0.001; 27 ± 4% vs. 22 ± 2%, p = 0.009) but not in chronic phase (1157 ± 57 ms vs. 1120 ± 54 ms, p = 0.934; 23 ± 2% vs. 20 ± 1%, p = 0.109). From acute to chronic MI, infarcted native T1 peaked in subacute phase (1275 ± 63 ms vs. 1637 ± 123 ms vs. 1471 ± 98 ms, p < 0.001), while ECV progressively increased with time (35 ± 7% vs. 46 ± 6% vs. 52 ± 4%,p < 0.001). Native T1 correlated well with histological findings (R2 = 0.65 to 0.89, all p < 0.001) so did ECV (R2 = 0.73 to 0.94, all p < 0.001). Conclusion T1 mapping allows the quantitative assessment of injury in MI and the noninvasive monitoring of tissue injury evolution, which correlates well with histological findings.

Objective: To determine whether T1 mapping could monitor the dynamic changes of injury in myocardial infarction (MI) and be histologically validated. Materials and Methods: In 22 pigs, MI was induced by ligating the left anterior descending artery and they underwent serial cardiovascular magnetic resonance examinations with modified Look-Locker inversion T1 mapping and extracellular volume (ECV) computation in acute (within 24 hours, n = 22), subacute (7 days, n = 13), and chronic (3 months, n = 7) phases of MI. Masson’s trichrome staining was performed for histological ECV calculation. Myocardial native T1 and ECV were obtained by region of interest measurement in infarcted, peri-infarct, and remote myocardium. Results: Native T1 and ECV in peri-infarct myocardium differed from remote myocardium in acute (1181 ± 62 ms vs. 1113 ± 64 ms, p = 0.002; 24 ± 4% vs. 19 ± 4%, p = 0.031) and subacute phases (1264 ± 41 ms vs. 1171 ± 56 ms, p < 0.001; 27 ± 4% vs. 22 ± 2%, p = 0.009) but not in chronic phase (1157 ± 57 ms vs. 1120 ± 54 ms, p = 0.934; 23 ± 2% vs. 20 ± 1%, p = 0.109). From acute to chronic MI, infarcted native T1 peaked in subacute phase (1275 ± 63 ms vs. 1637 ± 123 ms vs. 1471 ± 98 ms, p < 0.001), while ECV progressively increased with time (35 ± 7% vs. 46 ± 6% vs. 52 ± 4%,p < 0.001). Native T1 correlated well with histological findings (R2 = 0.65 to 0.89, all p < 0.001) so did ECV (R2 = 0.73 to 0.94, all p < 0.001). Conclusion T1 mapping allows the quantitative assessment of injury in MI and the noninvasive monitoring of tissue injury evolution, which correlates well with histological findings.

Objective:To explore the diagnostic accuracy and application value of 3.0 T non-contrast coronary magnetic resonance angiography (CMRA) in evaluating coronary artery in children with Kawasaki disease (KD).Methods:From May 2019 to January 2022, 75 children diagnosed with KD in our hospital were enrolled. All the patients underwent CMRA and transthoracic echocardiography (TTE) in one week, twenty-six of whom underwent coronary CT angiography (CCTA) or invasive coronary angiography (ICA) within two weeks. The diagnostic performance of CMRA and TTE was evaluated with CCTA/ICA as reference standard by per-patient basis, per-vessel basis, per-segment basis. Sensitivity and specificity of CMRA and TTE was compared by paired chi square test.The distribution of coronary artery aneurysm (CAA), thrombosis and other pathological changes of coronary artery were recorded and compared between two methods. The patients′ height and weight were collected to calculate the Z value. Z value>2.5 was defined as CAA.Results:All patients successfully completed CMRA examinations. Among the 26 patients, the sensitivity of CMRA was significantly higher than that of TTE by per coronary artery[97.7%(43/44)vs.84.1%(37/44), χ2=4.17, P<0.05]. CMRA showed a higher sensitivity than that of TTE both by proximal segments and middle/distal segments [97.7%(43/44)vs. 84.1%(37/44), 100%(21/21) vs. 52.4%(11/21), χ2=10.08, 7.11, both P<0.05). A total of 115 CAAs was found by CMRA, while only 87 (75.7%) CAAs were observed by TTE. Of the 28 (24.3%) CAAs missed by TTE, 16 (57.1%) were located in right coronary artery (RCA), 2(7.1%) in left main coronary artery, 7(25.0%) in left anterior ascending coronary artery (LAD) and 3(10.7%) in left circumflex coronary artery (LCX). Eleven (39.3%) missed CAAs by TTE were located in the proximal segment of RCA, LMCA, LAD and LCX, and 17 (60.7%) missed CAAs were located in the middle and distal segments. TTE missed coronary thrombosis in 5 patients compared with CMRA. Conclusions:3.0 T non-contrast CMRA is non-invasive and non-radiation, and the image quality can meet the needs of diagnosis, especially for detection of CAAs in RCA or in middle and distal segments of coronary artery in KD patients.

Coronary disease is one of the highest mortality diseases in the world,and interventional therapy has been the best treatment choice for its low risks,high efficiency,less wound and rapid recovery after the operation.Thrombus aspiration catheter is one of the most important equipment in the interventional therapy instrument of coronary disease.This paper is based on the demand of clinical and market,designed and manufactured aspirated catheter for the treatment of coronary thrombosis.Through the performance comparison of the material,confirmed the main material quality of thrombus aspiration catheter and its organization.We also made the appraisement for the function of the material and the main performance of the thrombus aspiration catheter.The experiment turned out that our catheter performance is stable and also with highly reliable,which is absolutely fit for the using requirements of the clinical.
Catheters ; Coronary Angiography ; Coronary Thrombosis ; therapy ; Humans ; Suction ; Thrombectomy ; instrumentation ; Treatment Outcome

Humans ; Muscular Dystrophy, Duchenne/epidemiology* ; Prevalence ; Myocardium