1.Diagnostic value of cardiovascular magnetic resonance in children with myocarditis
Binghua CHEN ; Yumin ZHONG ; Aimin SUN ; Qian WANG ; Ming ZHU ; Jinglei WANG ; Wei GAO ; Meirong HUANG ; Guilong WANG
Chinese Journal of Radiology 2015;(6):435-439
Objective To determine the diagnostic value of cardiovascular magnetic resonance (CMR) in children with myocarditis. Methods A total of 27 children with myocarditis were examined with cardiac MRI, including 16 new?onset cases and 11 chronic cases, as well as 14 cases with non?myocarditis. Sequences included SSFP in axial, two chamber, four chamber and short axis, T2?weighted triple inversion recovery, T1?weighted spin echo before and after gadolinium injection, and inversion recovery?gradient echo after gadolinium injection(late gadolinium enhancement, LGE) in axial and short axis. Qualitative and quantitative image analysis was performed to obtain focal T2 signal intensity and early enhancement signal intensity(SI) ratio of myocardium to skeletal muscleon EGE and LGE.The sensitivity, specificity and accuracy were calculated. Mann?Whitney and χ2 test were used for statistical comparison. Results The median value of EF was 60.20%(44.40%,70.20%), median value of T2W SI ratio was 2.50(2.04, 3.79),and there were 13 cases with LGE positive findings in myocarditis group. The median value of EF was 73.60%(65.40%,75.85%), the median value of T2WI SI ratio was 1.85(1.77, 2.15), and one case presented LGE positive sign in non?myocarditis group. There were significant statistical differences between the two groups (Z=-2.94,-2.52 ,χ2=5.19 ,P<0.05). The sensitivities for T2WI, EGE, LGE were 81.5%(22/27), 14.8%(4/27) and 48.1%(13/27) respectively. The specificities for T2WI, EGE, LGE were 57.1%(8/14), 100.0%(14/14)and 92.9%(13/14) respectively. The diagnostic accuracies for T2WI, EGE, LGE were 73.2%(30/41), 43.9%(18/41) and 63.4%(26/41) respectively. The best diagnostic performance was obtained when“any?two”of the three sequences were positive in the same patient, yielding a 51.9%(14/27)sensitivity, 92.9%(13/14) specificity, and 65.9%(27/41) diagnostic accuracy.Conclusions The combined CMR approach using T2?weighted imaging, early and late gadolinium enhancement, provides a high diagnostic accuracy and is a useful tool in the diagnosis and assessment of children with myocarditis.
2.Reflections on the Establishment of Clinical Comprehensive Evaluation Mechanism for Drugs in China
Xiuyuan SHI ; Rui ZHAO ; Fan LI ; Chunping LIU ; Jinglei GAO ; Kun ZHAO
China Pharmacy 2020;31(23):2828-2833
OBJECTIVE:To prom ote the implementation of clinical comprehensive evaluation of drugs in China ,promote the return of drugs to clinical value ,improve the utilization efficiency of limited resources ,and provide reference for decision makers of health departments. METHODS :By combing the relevant policy documents and literatures of clinical comprehensive evaluation of drugs,the evolution and research progress of relevant policies in China were introduced ;the advanced experiences (including evaluation subjects ,evaluation value dimensions ,evaluation methods ,evaluation procedures and results applications )of Canada ,the United States ,the United Kingdom ,Australia,Europe,International Society for Pharmacoeconomics and Outcomes Research and other countries (regions/organizations)were analyzed and summarized ;relevant suggestions on the construction of China ’s clinical comprehensive evaluation mechanism for drugs were put forward. RESULTS & CONCLUSIONS :It is suggested that the following measures should be taken to construct the clinical comprehensive evaluation mechanism of drugs in China including that the development goal and orientation of clinical comprehensive evaluation of drugs should be further clarified with the guidance of decision-making needs ;the government should play a leading role and strengthen inter departmental cooperation and policy coordination;the traceability quality control system of internal and external standards should be established ,adhere to openness , fairness and fair ;at the same time ,it is suggested to give full play to the role of informatization and big data ,strengthen the exploration of evaluation methodology and standards ,strengthen the transformation and application of evaluation results ,and promote the service of evaluation results to policy decision-making.