Brief Introduction of Pharmacovigilance System in the United States and Its Implication for China / 医药导报

Objective To make suggestions for China's drug safety supervision through an introduction of the status of pharmacovigilance system in the United States (US).Methods Through legal research and document research,the author introduced and analyzed the current situation of pharmacovigilance system in the US from the organization and responsibilities of Food and Drug Administration,system of laws and regulations,risk management and evaluation methods of post-marketing drugs etc.Results The US has now established a relatively mature pharmacovigilance system.This system has a perfect drug safety supervision organization structure,a sound system of laws and regulations and a scientific evaluation system of drug risk management.Conclusion The relevant experience of the US can be learned by China,such as the communication & collaboration between pre-and post-market drug regulatory agencies,instillation of drug risk management and establishment of guidance for industry to promote the development and improvement of China's drug safety supervision.

Application study of an intelligent three-dimensional ultrasound imaging in obtaining for fetal cranial mid-sagittal view / 中华超声影像学杂志

Objective To evaluate the feasibility of an intelligent three-dimensional ultrasound technique (Smart mid-sagittal planes,Smart MSP) in automatically detecting the fetal cranial mid-sagittal view.Methods Two hundred and forty pregnant women with singleton pregnancies were imaged to display the mid-sagittal view of fetal head using the Smart MSP by six doctors divided into three groups according the different experiences.Another two doctors were then invited to score the images acquired and to compare the successful rates of 6 doctors for acquiring fetal cranial mild-sagittal view according to the doctors' experience.Results The overall successful rate of acquiring the mid-sagittal view was 97.08％ (233/240) with the bipartial diameter plane (BPD plane) as the starting plane and 98.33(237/240) with the trans-cerebellum plane as the starting plane by using Smart MSP program.The successful rates in three groups were similar but the consumed times were different(P ＜0.05).The experienced doctors consumed less time than non-experienced doctors.The scores were also different in three groups.The scores of experienced doctors (group B and C) were significantly higher than that of non-experienced doctors (Group A) (P ＜0.05).There was no significant difference in the scores between experienced doctors (group B and C) (P＞0.05).Conclusions Smart MSP is a novel and feasible method for the automatic visualization of fetal cranial mid-sagittal plane,which may become an effective tool to screen the fetal midline anomalies in future.

Interpretation and Thinking about Global Vaccine Safety Blueprint / 中国药房

OBJECTIVE:To improve the ability of vaccine post-marketing surveillance,and clearly define the development di-rection of it in China. METHODS:Though introducing the background,strategic objective and operation objective of Global Vac-cine Safety Blueprint,the situation of vaccine post-marketing surveillance in China was analyzed. RESULTS&CONCLUSIONS:Vaccine post-marketing surveillance have developed fast in China recent years and get generally confirmation. However,compared with the goals in the blueprint,there are some activities should be strengthened,such as active surveillance,signal analysis and da-ta standardization,etc. We should take use of the opportunity offered by WHO and other international organizations to shrink the gap between our country and the advanced countries. Drawing support from WHO and other international institutions,vaccine post-marketing surveillance can step on the new level in China.