OBJECTIVE:To discuss the necessity of compensation system in clinical trial of medicine in China.METH?ODS:The legal attributes of clinical trial of medicine were analyzed based on the report of"Korean Ginseng Bolus Event"in Haining,the relation of rights and obligations between the subjects and researchers and the current problems in clinical trial in China were discussed.RESULTS&CONCLUSIONS:With the development of clinical trial of medicine in China,laws should be established to enforce compulsory insurance for the subjects and carry out no fault responsibility in order to ensure their legal rights.

Objective To observe the clinical effect of traditional Chinese medicine of Wuling San pulvis for treating brain edema.MethodsA total of 60 patients with cerebral contusion and laceration were divided into control group and treatment group ccording to different treatment methods, with 30 cases in each group.The control group was given dehydration agent, hemostatic agent, nutritional nerve drugs and other conventional treatment measures,and the treatment group was give the treatment of Wuling San in addition to the conventional therapy.The changes of brain edema and GCS score in two groups were observed.ResultsThe brain edema volume of patients in treatment group on days 7,10 and 14 of treatment was significantly smaller than that in control group(P<0.05).The midline shift of the brain of patients in treatment group on days 7,10 and 14 of treatment was significantly less than that in the control group(P<0.05).The GCS score of patients in treatment group on days 7,10 and 14 of treatment was significantly higher than that in the control group(P<0.05), the difference was statistically significant.ConclusionThe traditional Chinese medicine prescription of Wuling San pulvis can obviously reduce the brain edema.It is beneficial to the treatment of brain edema.

By using the method of eross-sectional anatomy, we examined human eerebral asymmetries in 31 Chinese adult brain.The left cortical language areas is larger than the right. The distribution of the hemispheric asymmetries is compatible with that reported by CT scan.The asymmetry of the posterior language areas mainly reflect the asymmetry of the occipital length and the asymmetries of the wide occipital lobe and the wide occipital horn might be in relation to the handedness. Though both the anterior and the posterior language area are mostly larger on the left hemisphere,there is no relationship between them

At a study of the cortical language areas in 31 Chinese adult brain by means ol sectional anatomy, We found that there is good relationship between the language structure and the lateral ventricle, and that the frontal opercula, the sulcus of He-schel and the posterior ramus of Sylvian fissure are the significant landmarks to certify the structure of the language areas. These results may be an anatomical basis for the clinical application of the sectional image

Objective:To find out the safe actuality and research trend of herbal medicine injection so as to pro- vide corresponding information for health professionals and herbal medicine researchers.Method:A bibliometrical analysis was performed of the categories and distributions of time,journals,authors and resources of 1048 literatures with correlative subjects retrieved from database of China National Knowledge Infrastructure(CNKI).Result:An increasing emphasis of the ADRs of herbal medicine injections was made by health professionals; however,the categories and distributions of these literatures were distributed non-homogeneously,and the kernel journals and kernel group of authors not formed.Conclu- sion:There is a growing need to investigate and monitor the use of herbal medicine injections,and also to think over and study the problems about how to improve the concern of some related enterprises and R&D agencies for the drug safety dur- ing the establishment of pharmacovigilance.

Arthralgia ; etiology ; Arthroplasty, Replacement, Knee ; adverse effects ; Humans ; Knee Joint ; surgery ; Pain, Postoperative ; etiology

Objective To systematically verify the detection method for multiple pathogens in plasma of convalescent patients(CPs)with Coronavirus Disease 2019(COVID-19).Methods According to the actual situation of plasma samples and the requirements of kit,the molecular biological detection method for multiple pathogens in plasma of CPs with COVID-19 was systematically verified for specificity,reproducibility,intermediate precision and limit of detection(LOD),and confirmed for applicability by detecting 50 plasma samples of CPs with COVID-19.Results The results of interference test and cross test showed that the detection of positive samples and negative samples were not affected;The RSDs of melting temperature values(Tm)of the positive control four pathogens by the same or different test personnels at different time under the same test conditions were 0.07%,0.14%,0.07%,0.14% and 0.06%,0.23%,0.23%,0.20%,and those of internal control(IC)and amplification control(AC)1 and 2 were 0.07%,0.01%,0.07%,0.14% and 0.11%,0.10%,0.15%,0.22%,respectively.Meanwhile,the RSDs of reproducibility and intermediate precision were less than 15% and20% respectively,which met the requirements;The minimum LOD of 22 pathogens were determined;No pathogen was detected in 50 plasma samples of CPs with COVID-19.Conclusion The method for detecting pathogens in plasma of CPs with COVID-19 was specific,stable,reliable and reproducible,which was suitable for the detection of pathogens in plasma of CPs with COVID-19.

BACKGROUND: Reversion total hip arthroplasty for inflammatory pseudotumor is little reported.OBJECTIVE: To investigate the prognosis of the reversion total hip arthroplasty for inflammatory pseudotumor and the related factors.METHODS: Eighty-one patients failed metal-on-metal hip arthroplasty were recruited, the medical history, baseline data and information of primary arthroplasty were collected, and all preoperative examinations were completed prior to reversion. The postoperative joint function was evaluated by Hospital for Special Surgery score, and the morphology of prosthesis was observed by radiology. Additionally, the serum levels of cobalt and chromium ions were detected, as well as the incidence of complications and the related factors were analyzed.RESULTS AND CONCLUSION: (1) There was a significant increase in Hospital for Special Surgery hip score and significant decrease in serum levels of cobalt and chromium ions after reversion (P=0.000). (2) The postoperative incidence of complications and secondary reversion rate was 16% and 6%, respectively. (3) Preoperative prosthesis loosening (P=0.012), tissue cirrhosis revealed on MRI (P=0.000) and the injury degree of tissue (P=0.049) were found to be related to the incidence of complications. (4) Kaplan-Meier curve showed that the survival rate of prosthesis was 88% at 30 months postoperatively. (5) These results suggest that the prognosis of reversion total hip arthroplasty is poor,which is related to the preoperative aseptic loosening, tissue cirrhosis surrounding the joint and intraoperative tissue injury, thus providing guidance for surgeons to make an appropriate operative scheme.

Objective To explore which category of pictures could induce neutral emotion better for male and female respectively,and investigate the effects of inducing neutral emotion with eight categories of neutral pictures,including the nature,plants,animals,humans,culture,death-waste,food and computer graphics.Methods Using selected stimuli from the simple version (revised by Huang and Luo(2004)) of the International Affective Picture System (IAPS),the rating of calm-mood degree were collected for 135 neutral pictures based on 186 undergraduate students (78 male and 108 female).Results The pictures in the categories of plants(6.87 ±1.53),nature(7.00 ± 1.73) and culture(6.93 ± 1.37) induced neutral emotion significantly better than human (5.89 ± 1.49),computer graphics (5.94 ± 1.93) and food (5.87 ± 2.03) (P ＜ 0.05) which were better than animals (5.03 ± 1.70) and death-waste (4.71 ± 1.94) (P ＜ 0.05).In addition,gender difference was found in rating calm-mood degree for death-waste,people and animals categories.For these categories males showed higher rating for the calm-mood degree than females (P＜ 0.05),while for the other categories,there was no gender difference.Conclusion The ideal categories of neutral pictures that inducing neutral emotion are plants,nature and culture.This study provide empirical evidences for selecting and using pictures to induce relative calm mood in the emotional study,and the contribution of this study to the clinical research is discussed.

Objective To study the cutoff point of chronic nasal sinusitis with nasal polyps(CRSwNP) classified by the tissue eosinophils(Eos).Methods 140 CRSwNP patients were enrolled in this study.The data of their clinical feature were collectted before surgery.Mucosal specimens were assessed for the presence of tissue eosinophil cells.Follow up and record the data at 3 months and 6 months after surgery.Results When the tissue Eos grouped by 50/HPF, the VAS, nasal sinus CT ,endoscopic preoperative score,and the endoscopic postoperative score at 3 months and 6 months showed significant difference(P<0.05).The tissue Eos between skin prick test(SPT) positive group and SPT negative group showed no significant difference.The tissues Eos was sighificantly correlated with the peripheral Eos(ρ=0.459,0.473,P<0.01).Conclusion The most meaningful cutoff point may be 50 Eos/HPF nearby to distinguish ECRS and non-ECRS(taken nasal polyps,by random HPF).Allergic factors may have no effect or little effect on the increase in Eos of nasal polyps in patients with CRSwNP;peripheral blood Eos may be an indicator of the level of Eos in tissues.