Development of Thrombus Aspiration Catheter / 中国医疗器械杂志

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.

Discussion on methods of sample size estimation in conducting clinical reevaluation of postmarketing Chinese medicine / 中国中药杂志

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.

Study on building index system of risk assessment of post-marketing Chinese patent medicine based on AHP-fuzzy neural network / 中国中药杂志

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.

Sample size calculation in clinical post-marketing evaluation of traditional Chinese medicine / 中国中药杂志

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.

Effect of Serums Containing Xuefuzhuyu Capsules and Xuesetong Capsules on the Proliferation of Vascular Smooth Muscle Cells Induced by Lysophosphatidie Acid / 中国中医药信息杂志

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.