The effective quality control in clinical practices is an effective guarantee for the authenticity and scientificity of the findings. The post-marketing reevaluation for traditional Chinese medicines (TCM) focuses on the efficacy, adverse reaction, combined medication and effective dose of drugs in the market by expanded clinical trials, and requires a larger sample size and a wider range of patients. Therefore, this increases the difficulty of quality control in clinical practices. With the experience in quality control in clinical practices for the post-marketing reevaluation for Kangbingdu oral for cold, researchers in this study reviewed the study purpose, project, scheme design and clinical practice process from an overall point of view, analyzed the study characteristics of the post-marketing reevaluation for TCMs and the quality control risks, designed the quality control contents with quality impacting factors, defined key review contents and summarized the precautions in clinical practices, with the aim to improve the efficiency of quality control of clinical practices. This study can provide reference to clinical units and quality control-related personnel in the post-marketing reevaluation for TCMs.
Drugs, Chinese Herbal ; adverse effects ; economics ; therapeutic use ; Humans ; Medicine, Chinese Traditional ; Product Surveillance, Postmarketing ; methods ; Quality Control ; Randomized Controlled Trials as Topic ; Respiratory Tract Infections ; drug therapy

Diagnosis, Differential ; Endophthalmitis ; diagnosis ; diagnostic imaging ; etiology ; pathology ; Humans ; Infant, Newborn ; Male ; Meningoencephalitis ; complications ; diagnosis ; diagnostic imaging ; pathology ; Suppuration ; Tomography, X-Ray Computed

Carcinoma, Non-Small-Cell Lung ; diagnostic imaging ; Humans ; Lung ; diagnostic imaging ; Lung Neoplasms ; diagnostic imaging ; Perfusion Imaging ; Radiotherapy, Intensity-Modulated ; methods ; Tomography, Emission-Computed, Single-Photon ; methods

Humans ; Outcome Assessment (Health Care)

Humans ; Immunoglobulin E ; Mouth Diseases ; Syndrome

Objective To investigate the best MR technique for detecting small epidermoids in the cerebellopontine angle.Methods 7 patients with pathologically-proved small epidermoids only located in the cerebellopontine angle were collected. The imaging techniques included:conventional T1WI and T2WI, fluid attenuated inversion recovery(FLAIR),diffusion weighted imaging(DWI) and balanced fast field echo(B-FFE) .The findings were retrospectively analyzed.Results 6 of 7 cases of epidermoid tumours localized at the cerebellopontine angle and exhibited the similar signal intensity as the cerebrospinal fluid(CSF) on T1WI and T2WI.The remaining case was slightly isointense on either T1WI or T2WI.On FLAIR images in 6 cases,3 cases showed slightly hyperintensity, 1 case showed doubtful heterogeneous signal intensity and 2 cases did not reveal any abnormal signal intensity.3 cases were hyperintense differenting from CSF on DW images. All of seven cases showed heterogeneous signal characteristics and were quite different from CFS on B-FFE.Meanwhile B-FFE also produced clearly the tissue contrast of trigeminus embedded in epidermoids of the cerebellopontine angle.Conclusion B-FFE is much more useful for the early diagnosis of epidermoids in the cerebellopontine angle and it also can provide precise preoperative information about the trigeminus encasement.

OBJECTIVETo observe the efficacy of Xingnaojing Injection (XI) in treatment of sepsis-associated encephalopathy (SAE).

METHODSTotally 65 SAE patients were retrospectively analyzed at EICU from September 2010 to September 2013. They were assigned to the control group (32 cases) and the treatment group (33 cases) according to whether they received XI. Patients in the control group received anti-infection and symptomatic support, while those in the treatment group were intravenously injected with XI at 20 mL per day for additional 7-10 days. The fever clearance time, Glasgow coma scale (GCS), C-reactive protein (CRP), neuron-specific enolase (NSE), and improvement of electroen-cephalogram (EEG) were observed in the two groups.

RESULTSCompared with the control group, the fever clearance time was shortened, CRP levels decreased, GCS score and efficacy of EEG was alleviated in the treatment group after treatment with statistical difference (P < 0.05). No adverse reaction occurred during medication.

CONCLUSIONX1 was safe and effective in treatment of SAE.

C-Reactive Protein ; metabolism ; Drugs, Chinese Herbal ; administration & dosage ; therapeutic use ; Humans ; Injections ; Phosphopyruvate Hydratase ; metabolism ; Sepsis-Associated Encephalopathy ; drug therapy ; Treatment Outcome

How to expand and deepen the educational function of library of college and university of traditional Chinese medicine by giving play to its strong points was analyzed in the new model of students'independent study , and measures to improve the information literacy and comprehensive literacy of students were elaborated, such as developing teaching reference books database, performing guidance for different readers, carrying out different activities that make entertainment a medium of education , in order to help students to acquire special knowledge outside of classroom .

Objective To analyze blood lipid components in simple obesity children and to explore the effects of obesity in the lipid metabolism and its clinical significance.Methods A total of 90 children,including 50 simple obesity children(obesity group)and 40 normal children(control group),were enrolled in this study.The age ranged from 2.5 to 16.0 years.Their blood lipid profiles of all the children were analyzed.The blood lipid profiles were examined by biochemical analysis,including triglyeride(TG),total cholesterol(TC),low density lipoprotein(LDL) and high density lipoprotein(HDL),and the livers of all the children were analyzed.The blood lipid profiles were examined by ultrasonograph.Results 1.There were no significant differences in age and height in obesity group and control group,but there were significant differences in body mass index(BMI) and blood pressure(P0.05),which had no statistical meaning.3.Liver ultra sonogram showed that 18 cases had fatty liver(36%) in simple obesity children.Conclusions Metabolic disorder of blood lipid is present in simple obesity children,who have a tendency to get fatty liver.LDL is markedly elevated in obesity group.Arteriosclerotic cardiovascular disease should be prevented at earlier period of childhood.