Pharmacodynamic (PD) studies play an important role in research and development of new traditonal Chinese medicines (TCMs). Phamacologic and toxicologic studies that aim to research drug ability can provide supporting data for the clinical trials and reduce the risk of clinical trials. In recent years, PD studies in TCMs are developing and progressing, but there are still some problems affecting the value of PD studies in the development of new TCMs. The value of PD studies depends on scientific and rational study design. This article summaries some defects in PD study design of new TCMs that are common in the application data, including defects in study type, testing targets, dosing, duration of administration, control group, testing time. This article also discusses some points of concern and specific requirements for PD study design of new TCMs.
Humans ; Medicine, Chinese Traditional ; methods ; Pharmacokinetics

To briefly introduce the basic course of training,practice and lecture for volunteers in AIDS Youth Companion Education Activity held by Melbourne University of Australia and School of Public Health of Sichuan University,and to discuss the existing problems in the Companion Education as well as personal experiences.

Bronchi ; Diagnostic Errors ; Female ; Foreign Bodies ; Humans ; Middle Aged

ObjectiveTo observe the curative effect of Xiangshaliujunzi decoction on critically ill patients with gastrointestinal dysfunction accompanied by spleen deficiency syndrome of traditional Chinese medicine (TCM) and its influence on tumor necrosis factor-α(TNF-α) and interleukin-6 (IL-6).Methods Forty-eight critically ill patients admitted to Department of Emergency Intensive Care Unit (EICU) in Zhejiang Provincal Hospital of Traditional Chinese Medicine Xiasha Campus from February to December 2015 were enrolled, and they were randomly divided into observation group (26 cases) and control group (22 cases) by random number table method. The patients in both groups were given routine emergency western therapy, and in the observation group, additionally, Xiangshaliujunzi decoction (ingredients: codonopsis pilosula 20 g, atractylodes macrocephala koidz 12 g, poria cocos 12 g, radix glycyrrhizae preparata 4 g, rhizoma pinelliae preparatum 6 g, pericarpium citri reticulatae 5 g, fructus amomi villosi 5 g, radix aucklandiae 4 g, rhizoma zingiberis recens 3 pieces) 80 mL was prepared and divided into two parts for nasal feeding, once 40 mL, twice a day, while the patients in the control group received the nasal feeding with the same amount of warm boiled water. Before treatment and 3 days and 5 days after treatment, the gastrointestinal function scores were assessed, and the changes of the levels of plasma TNF-α, IL-6 were recorded.Results There were no statistical significant differences in gastrointestinal function scores, the levels of TNF-α and IL-6 between the two groups before treatment and 3 days after treatment (allP ﹥ 0.05). But 5 days after the treatment, the gastrointestinal function scores, the levels of TNF-α and IL-6 were obviously decreased in two groups, and the degree of decrease in observation group was more significant [gastrointestinal function score: 0.92±0.85 vs. 2.27±0.77, TNF-α (ng/L): 17.7±2.4 vs. 25.0±4.2, IL-6 (ng/L): 16.9±2.4 vs. 25.0±3.4, allP < 0.01].Conclusion Xiangshaliujunzi decoction has therapeutic effect on critically ill patients with gastrointestinal dysfunction and accompanied by spleen deficiency in TCM, the mechanism may be related to decreasing the levels of TNF-α and IL-6, thereby depressing the inflammation.

Abstract: Objective　To analyze the drug sensitivity and the carrying of carbapenem resistant gene of Acinetobacter baumannii isolated from clinical patients and clinical objects, and analyze the homology of strains to provide support for the control of nosocomial infection. Methods　A total of 38 strains of Acinetobacter baumannii isolated from patients and clinical objects surface were collected from January 2019 to August 2020. The antimicrobial susceptibility was tested by the minimum inhibitory concentration method. In addition, the resistance related genes were detected by polymerase chain reaction method, and homology analysis was performed by enterobacterial repetitive Enterobacterial Repetitive Intergenic Consensus Polymerase Chain Reaction (ERIC-PCR). Results All 34 strains of Acinetobacter baumannii isolated from Clinical patients and 4 strains isolated from clinical objects carried blaOXA-51 and imp resistance genes, neither of them carried blaVIM gene. 32 Acinetobacter baumannii carrying blaOXA-23 gene, 28 strains carrying blaTEM gene, 7 strains carrying blaOXA-58 gene. After cluster analysis, 38 Acinetobacter baumannii isolates were classified into 7 genotypes (expressed A, B, C, D, E, F, G), and cluster E and cluster G were the main clusters, containing 12 strains (12/38, 31.6%) and 18 strains (18/38, 47.4%), respectively, as the main prevalent clonal strains. Conclusions　Acinetobacter baumannii isolated from different sources have the significant differences in drug resistance and carry different resistance genes. There is no direct correlation between patients and environmental isolates of Acinetobacter baumannii belonging to different clonal strains. Also, there aren’t significant correlation between clinical patients infected with Acinetobacter baumannii.

OBJECTIVETo observe the therapeutic effect and relevant mechanism of shuxuening Injection (SI) in treating patients with active ulcerative colitis (UC).

METHODSTotally 91 patients with active UC were randomly assigned to 2 groups, 44 in the control group and 47 in the treatment group. Patients in the control group received routine treatment, while patients in the treatment group additionally received intravenous injection of SI (15 mL), twice daily for 14 days in total. Colonoscopy was performed before and after treatment. The therapeutic effect was assessed by Mayo scoring system and the grading of activities evaluated by Baron endoscope. Serum levels of IL-6 and TNF-α were detected by ELISA. The activity of SOD was detected by xanthine oxidase method. The content of MDA was detected by thiobarbituricacid (TBA). Besides, 20 healthy subjects were recruited as the healthy control group.

RESULTSTotally 82 patients completed the study (40 in the control group and 42 in the treatment group). There was no statistical difference in serum levels of IL-6, TNF-α, SOD, MDA, the Mayo score and endoscope grading between the two groups before treatment (P >0. 05). Compared with the healthy control group, serum levels of IL-6, TNF-α, MDA significantly increased (P <0.01), and the serum SOD level decreased (P < 0. 05) in the treatment grup and the control group before treatment. Compared with before treatment in the same group, serum levels of IL-6, TNF-α, MDA, the Mayo score and endoscope grading all decreased in the treatment group and the control group after treatment (P <0. 01, P <0. 05). Compared with the control group after treatment, serum levels of IL-6, TNF-α, MDA, the Mayo score and endoscope grading all decreased (P <0.01, P <0.05), the serum SOD level increased (P <0.05) in the treatment group after treatment. The serum SOD level was obviously negative correlated with serum levels of IL-6, TNF-a, Mayo score, and endoscope score (r = -0. 621, -0.638, -0. 509, -0.787, P <0.01). The serum MDA level was obviously positive correlated with serum levels of IL-6, TNF-α, Mayo score, and endoscope score (r =0.711, 0. 882, 0. 525, 0. 639, P <0.01).

CONCLUSIONSI could improve inflammatory injury and clinical symptoms of patients with active UC, and its mechanism might be associated with antioxidant and scavenging oxygen free radicals.

Colitis, Ulcerative ; blood ; drug therapy ; Drugs, Chinese Herbal ; therapeutic use ; Humans ; Inflammation ; drug therapy ; Interleukin-6 ; blood ; Tumor Necrosis Factor-alpha ; blood

Objective To evaluate the role of gamma curve fitting technique of contrast-enhanced ultrasound in quantitative analysis of microcirculation in renal solid lesions. Methods A total of fifty patients with renal parenchyma solid lesions were performed contrast-enhanced ultrasound. The images were analysed by computer with gamma fitting analysis of contrast-enhanced ultrasonic system. The quantitative parameters were obtained by the time-intensity curves, such as ascending slope (a3), descending slope (a2), arrival time (AT), time to peak intensity (TTP), basic intensity (BI), peak intensity, amplification (AMP), area under the curve (AUC), mean transit time (MTT) and perfusion index (PI). The parameters were compared between renal malignant and benign solid lesions. Results Fast-in and fast-out was the main perfusion mode in renal malignant tumors while slow-in and slow-out was found in renal angiomyolipoma (AML). The perfusion modes in renal malignant tumors and renal AML were fast-in and fast-out in 28 cases and 0 case, fast-in and slow-out in 4 cases and 1 case, slow-in and fast-out in 5 cases and 1 case, and slow-in and slow-out in 1 case and 10 cases, respectively. There were significant differences in the quantitative parameters such as a2, AUC and PI between renal malignant tumors and renal AML obtained by the time-intensity curves (P<0.05). Conclusion Gamma fitting analysis of contrast-enhanced ultrasound system can provide quantitative information of microcirculation of renal tumors, which helps to differentiate benign renal tumors from malignant ones.

Objective To study the mutations of outer-membrane porin gerte (oprD) in imipenem-resistant Pseudomonas aeruginosa.Methods The PCR was applied to detect the oprD gene from the 34 clinical imipenem-resistant Pseudomonas aeruginosa.DNA sequence was proceeded to analysis the nuclentide sequence of the oprD gene and the deduced amino acid sequence.To analysis the mutation and the function of the oprD domain,those mutations were compaired with the standard Pseudomonas aeruginosa ATCC27853 and 2 clinical imipenem-susceptibility isolates.Results oprD gene mutation was wide and diverse.The rate of the mutation was 92.3% (12/13),mutations were concluded dot mutation,deletion mutation and insert mutation,those result in the amino sequence change and frame shift in L2 and L3 loops of outer membrane protein D,hampering the combine of oprD and imipenem.Some new mutations were found.They were 1 079,1 114,1 196,1 206,1 288,1 300,1 301 bases and 115,127,154,158,185,189 aminos.All above mutations were not deteced in ATCC 27853 and 2 clinical imipenem-susoeptibility isolates.Conclusions The wide and diverse mutations in oprD gene result in amino acid change and/or frame shift L2 and L3 loops,hampering the binding of IMP and oprD.Those may result in resistance to imipenem in Pseudomonas aeruginosa.

Objective To study the changes of subgroups of peripheral blood T lymphocytes in the patients infected with the 2009 pandemic influenza A ( H1N1 ) virus of different severity type. Method A total of 66 patients infected by H1N1 evidenced by RT-PCR admitted from September 2009 to January 2010 were divided into three groups: mild type ( B group, n = 47 ), cured patients of severe and critical severe type ( C group, n = 14) and died patients ( D group, n =5), according to the severity and prognosis. A total of 20 healthy volunteers served as control group( A group). Peripheral blood lymphocyte count, CD3+,CD4+ and CD8+ T lymphocyte count were detected by flow cytometry at the different time points. Fever duration and H1N1 virus negative time were compared. Statistical analysis were performed by using SAS version 9.13 software and the data were processed with ANOVA and SNK test. Results Lymphocyte count, CD3+,CD4+ and CD8+ T lymphocyte count declined in the early period in all the groups, and there were significant differences compared with A group (P＜0. 05), while rised with the clinical progression in group B and C,and those of C group were lower than B group ( P ＜ 0.05 ), but those of D group were always low. Fever duration and H1N1 virus negative time were (4.4 ± 1.6) days vs. (4.4 ± 1. 4) days, ( 12.9 ± 3. 1 ) days vs.( 10.2 ± 2.6) days and ( 15.2 ± 7.3 ) days vs. ( 13.3 ± 2.9 ) days respectively, and there were significant differences among the three groups ( P ＜ 0.05 ). Conclusions The cellular immune function was seriously damaged when patients were infected with H1N1. Further more, the changes of lymphocyte count, CD3+ , CD4+and CD8+ T lymphocyte count were tightly related with the degree of severity and prognosis. These findings can be used for clinical diagnosis and treatment.

AIM: To observe the activity and distribution of astrocytes and glial fibrillary acid protein(GFAP) after middle cerebral artery occlusion (MCAO). METHODS: The rat MCAO model was made by two-kidney, tow clip renovascular hypertensive rat stroke prone(RHRSP). Rats were killed and brain samples were collected at the end of 1,3,6 and 9 weeks after MCAO, respectively. The ultrastructure of astrocytes was determined at broder of infarct (A area); distant of infarct (B area) and opposite of hemisphere (C area) by electron microscope. The number and optical density of GFAP-positive cells were also observed. RESULTS: The astrocyte proliferation distributed in the whole brain after MCAO. The highest numbers of GFAP-positive cells were observed at A area, then B area. The lowest numbers of GFAP positive cells were found in C area. The time course of GFAP-positive cell change was that the highest number was observed at 1 week after MCAO, then decreased by time from 3, 6 weeks to 9 weeks. The optical density of GFAP-positive cells showed the same patterns. CONCLUSION: The correlation between astrocyte proliferation and tissue damage after MCAO can be estimated by GFAP expression. The astrocyte proliferation plays an important role in healing process after MCAO.