Drug safety has always been a global focus. Discovery and accurate information acquisition of adverse drug reaction have been the most crucial concern. Terminology of adverse drug reaction makes adverse reaction medical report meaningful, standardized and accurate. This paper discussed the domestic use of the terminology WHOART and MedDRA in terms of content, structure, and application situation. It also analysed the differences between the two terminologies and discusses the future trend of application in our country
Dictionaries, Medical ; Drug-Related Side Effects and Adverse Reactions ; Terminology as Topic ; World Health Organization

Animals ; Apoptosis ; radiation effects ; Electromagnetic Fields ; adverse effects ; Hippocampus ; pathology ; radiation effects ; Male ; Maze Learning ; radiation effects ; Rats ; Rats, Wistar

Objective: To determine the concentration of linezolid in human plasma by high performance liquid chromatagraphy-tandem mass spectrometry(HPLC-MS/MS) so as to provide evidence for the rational administration in clinic. Methods: The plasma was extracted by acetonitrile with telmisartan as internal standard(IS). The mobile phase was 1 mmol/L ammonium acetate with 0.1% formic acid-acetonitrile with gradient elution. Quantitative analysis of [M+H]+ ions was m/z 338.1→m/z 296.3 (linezolid) and m/z 515.3→m/z 276.3 (telmisartan,the IS). Results: Excellent linear relationship was obtained from 0.23 to 46 µg/ml with correlation coefficient value of 0.9993. The lowest limit of quantitation was 46 ng/ml, the extraction recovery was from 87% to 109%. The intra- and inter- day precisions (relative standard deviations) ranged from 2.5% to 8.6%. Conclusion: The method is specific, sensitive and simple and can be used to determine the concentration of linezolid in clinic.

Objective To evaluate the diagnostic value of EUS in patients with chronic abdominal pain of suspected pancreatic origin.Methods The EUS findings and related clinical data of 106 patients with chronic abdominal pain of suspected pancreatic origin(excluding the patients with suspected pancreatic malignancies)from 1991 to 2004 in PUMCH were retrospectively analyzed.Results(1)The principal dis- ease interpreting the chronic abdominal pain of suspected pancreatic origin(excluding pancreatic malignan- cies)was chronic pancreatitis(CP)(57.5%),the following contributions were other pancreatic diseases (18.9%)and unknown diseases(11.3%).(2)The sensitivity and specificity of EUS for diagnosing CP was 95.1% and 64.4% respectively,the positive predictive value(PPV)and negative predictive value (NPV)was 78.4% and 90.6% respectively.(3)Abhormalities of pancreatic parenchyma structure based on EUS were the main findings(90.2%)in patients with CP and non-homogeneous echo pattern combined with hyper echoic dots or calcification was the predominant feature(52.5%).The value of isolated inhomo- geneity and focal enhanced eehogenicity for diagnosing CP were limited(P＞0.05).Abnormalities of pan- ereatic ductal system were presented in 63.9% of patients with CP and dilation of pancreatic duct was the major feature(34.4%).CP with focal mass(inflammatory pseudotumor)was usually presented as hypo e- choic mass in the pancreatic head based on EUS(90%),which was similar to the EUS feature of pancreatic cancer.(4)The general accordant rate based on EUS with ERCP or BT-PABA were 77.8% and 70.4% re- spectively,and the correct rate based on combine diagnosis were 100% and 95.2%.Conclusion CP is the main source of chronic abdominal pain of suspected pancreatic origin(excluding pancreatic malignancies). EUS has good sensitivity but inadequate specificity for diagnosing CP,while ERCP may be more sensitive than EUS for detecting pancreatic ductal lesions.Pancreatic parenchymal abnormalities contribute the major EUS features of CP but the value of isolated inhomogeneity and focal enhanced echogenicity for diagnosing CP are limited.

There are few articles or reports collecting evidence about Kudiezi injection from premarketing and postmarketing research or studies systematically. This article is an exact miniature of a systematical report about Kudiezi injection. We analyzed information from four aspects, such as quality control reports, non-clinical premarketing safety experiments, postmarketing research (efficacy studies, hospital information system data and national spontaneous reporting system data), and literature analysis. All the four aspects build an evidence body for Kudiezi injection in order to inform its safety use in clinical practice and further study.
Drugs, Chinese Herbal ; administration & dosage ; adverse effects ; Hospital Information Systems ; Humans ; Injections

In recent 10 years, clinical trials of Chinese medicine and pharmacy (cMP) at clinicalTrials.gov.(USA) are gradually increasing. In order to analyze features of CMP clinical register, ClinicalTrials.gov register database were comprehensively retrieved in this study. Included clinical trials were input one item after another using EXCEL. A final of 348 CMP clinical trials were included. Results showed that China occupied the first place in CMP clinical register, followed by USA. CMP clinical trials, sponsored mainly by colleges/universities and hospitals, mostly covered interventional studies on evaluating safety/effectiveness of CMP. The proportions of studies, sponsored by mainland China and companies, recruitment trials and multi-center clinical trials in interventional trials were increasing. The proportions of studies sponsored by Hong Kong and Taiwan, research completed trials, unclear research status, phase III clinical trials, and published research trials in interventional trials were decreasing. Published ratios of CMP clinical trials were quite low. There were more missing types and higher proportions in trial register information.
Biomedical Research ; China ; Clinical Trials as Topic ; Databases, Factual ; Humans ; Medicine, Chinese Traditional ; United States

International clinical trials register is one of the global measures to realize transparency in clinical trials and also one of a powerful measure to improve the quality of clinical trials. Many scholars studying the quality of TCM clinical trials find that they are poor in quality and lack transparency. Furthermore, they find that TCM clinical trial registry has many problems. We must base on the successful experiences of WHO and international clinical trial registry to establish technical specifications for registry of traditional Chinese medicine clinical study of their own. Then, it can effectively improve the overall level of TCM clinical studies. We have suggested some concrete and feasible measures to establish technical specifications for registry of traditional Chinese medicine clinical study of their own based on the problems of TCM clinical trial registry.
Biomedical Research ; Humans ; Medicine, Chinese Traditional ; standards ; Registries

Objective To investigate the changes of quantitative parameters of dynamic enhanced CT in non-small cell lung cancer before and after targeted therapy,and compare them with the traditional evaluation criteria,in order to find the parameters which can be exploited for timely,objective evaluation of the effect of targeted therapy.Methods The study included 21 patients with targeted therapy who had received dynamic enhanced CT before and after treatment.Enhancement time-density curves were obtained based on the CT values of the lesion at individual time points,and the functional indices:peak height (PH),the time to peak height (Tp),the ratio of PH of the mass to aorta (M/A) and perfusion value were calculated.The effects of the treatment on these indices were evaluated and compared with the effect of the treatment on lesion diameter. Results Twenty-one patients had 33 rechecking results. There was a statistically significant agreement between lesion diameter-based treatment evaluation and perfusion-based treatment evaluation ( U =8.761,P ＜ 0.01 ). The perfusion value decreased in patients with disease regression[before treatment:(0.28 ±0.11 ) ml · min-1 · ml-1,after targeted therapy(0.18 ±0.09) ml ·min-1 · ml-1,t =- 3.2722,P =0.0042],but increased in patients with disease progression[before treatment(0.21 ±0.08) ml · min-1 · ml-1,after targeted therapy:(0.34 ±0.11 ) ml · min-1 · ml-1,t =2.6064,P =0.0403].Conclusions On dynamic enhanced CT in non-small cell lung cancer patients after targeted therapy,perfusion value changed in the same trend as the diameter of tumor.The effectiveness of targeted therapy may be evaluated by perfusion value changes.

Exercise Test ; Female ; Heart Sounds ; physiology ; Humans ; Male ; Phonocardiography ; methods ; Pregnancy ; Stress, Physiological ; physiology ; Young Adult

0.05).ConclusionThe neoadjuvant radiochemotherapy can improve the sphincter-saving rate,probably can improve the resection rate and reduce the recurrence rate for the middle-lower rectal carcinoma.