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

Background The current epidemiology study had shown the prevalence of age and sex adjusted dry eye was higher in patients with diabetes than population without diabetes.Further researches demonstrated that the tear film disturbance is common after the phacoemulsification or photocoagulation in the eyes of diabetic patients.Objective The aim of this study was to characterize the clinical features of tear film instability in diabetes patients.Methods One hundred and sixty-two patients with tear-film abnormality referred to Tongren Eye Center from January 1,2010 to September 1,2010 underwent questionnaire about diabetes and other diseases,BUT,Schirmer test.Tear film instability was diagnosed as abnormality of either Schirmer test or BUT and showed as M ( Q25,Q75 ).The right eyes of 162 dry eye patients meeting with the including criteria were enrolled.The patients were assigned to two groups according to with ( 80 patients) or without ( 82 patients) diabetes mellitum.DEQ questionnaire were scored.The percentage of cases with meibomain gland abnormal score ＞ 1 was calculated.Mann-Whitney U analysis and Chisquare analysis were used to compare the difference between the two groups.Results The Schirmer test in diabetic group was 8 ( qualities:5,9 )mm and was longer than 6 ( qualities:5,7 ) mm in non-diabetic patients ( U =2452,P =0.00).The result of BUT test was 3 ( qualities:2,4 ) seconds in diabetic patients and was shorter than 4 (qualities:3,5) seconds in non-diabetic patients( U=2104,P＜0.01 ).The DEQ score of diabetic patients was 15 ( qualities:1 0,19,which was less than21 ( qualities:19,23.25 ) in non-diabetic patients.51.2 ％ ( 41/80 ) diabetic participants and 32.9％ (27/82) nondiabetic participants appeared meibography ( grade larger than 1 ) (x2 =16.07,P=0.00).The percentages of dry eyes were 51.2％ (41/80) and 93.9％ (77/82) respectively in diabetes and nondiabetes groups(x2 =37.24,P＜0.01 ).No significant correlation was found between the diabetes course and DEQ score or meibography( r =0.16,P =0.16 ; r =0.10,P =0.36 ).Conclusions Diabetes patients with tear film instability have longer Schirmer test results,shorter BUT,more severe meibomain glands damage and lower DEQ scores.The dry eye symptom is lack in the diabetic patients though appearing the tear film and meibomain glands damage.Therefore,more attention should be given to ocular surface health in diabetes patients.

Described in this paper are the contents and objectives of embedded information service for research on aviation medicine in light of information access, identification and analysis in persons engaged in research on aviation medicine.

Objective To evaluate the value of contrast-enhanced ultrasound(CEUS) in diagnosis of placental increta.Methods Twenty seven suspected patients with placental increta were examined with CEUS after routine ultrasound examination.SonoVue was injected intravenously as bolus and a real time CEUS was performed.The characteristics of contrast perfusion was analysised.Results Among the three antepartum CEUS cases,two had a clear boundary between the placenta and uterine wall,there was no residual placenta after induced labor;one had a blur boundary between the local placenta and uterine wail,and the local placenta adherenced to the uterine wall tightly when cesarean section was performed after induction failure.Comparison between CEUS and uterine curettage in 20 cases,5 cases had a dear boundary between residual disease in uterine cavity and uterine wall.The boundary between residual disease in uterine cavity and uterine wall disappeared in other 15 cases.Four cases performed total and subtotal hysterectomy,the uterine myometrium of placenta affixing part were very thin (3 - 5 mm),and the boundary between the placenta and uterine wall disappeared,and placental increta was proved by intraoperative and pathology.Conclusions When the boundary between residual placenta and uterine wall disappeared and/or the local uterine wall became thin,placental increta was suggested intensively.

Puerariae Lobatae Radix, also known as Gegen, is a root derived from Pueraria lobata. Based on field investigation and the developmental anatomy of root tuber, we have elucidated the relationship between the growth of root tuber and the anomalous structure. The results of analysis showed that the root system of P. lobata was developed from seed and adventitious root and there existed root tuber, adventitious root and conductive root according to morphology and function. The root tuber was developed from adventitious root, its secondary structure conformed to the secondary structure of dicotyledon's root. With the development of root, the secondary phloem of root tuber appeared abnormal vascular tissue, which was distributed like ring in the outside of secondary vascular tissue. The root tuber might have 4-6 concentric circular permutation abnormal vascular tissuelobate, and was formed by the internal development of abnormal vascular tissue. The xylem and phloem of abnormal vascular tissue were the main body of the root tuber. The results reveal the abnormal anatomical structure development of P. lobata, also provides the theoretical basis for reasonable harvest medicinal parts and promoting sustainable utilization of resources of P. lobata.
Plant Roots ; anatomy & histology ; growth & development ; Plant Tubers ; anatomy & histology ; growth & development ; Pueraria ; anatomy & histology ; growth & development

Objective To investigate the status and influencing factors of quality of life among diabetes patients in Nanchang,and to explore the relationships between the quality of life and community health care demands.Methods Totally 292 diabetes patients were recruited by multi-stage sampling method from thee community health service centers in Nanchang city.They were investigated with Diabetes-specific Quality of Life Scale(DSQL) and a self-designed questionnaire of community health care demands.The results underwent analysis.Results The total score of the DSQL in Nanchang was(66.88±15.44) points,which was relatively poor.The main factors affected patients' quality of life were the complications of diabetes,diabetic macroangiopathy,diabetic foot,hypertension and patients' career.The total and the every dimension of the scores of the DSQL were positively correlated with the scores of disease nursing needs and community health care demands.Conclusions To improve diabetes patients' quality of life,community diabetic care should focus on the different affected factors of patients' quality of life and the demands of patients.

Objective To explore the efficacy of acupuncture in the treatment of nonalcoholic fatty liver disease by using magnetic resonance iterative decomposition of water and fat with echo asymmetry and least-squares estimation-quantitative FAT/R2 * imaging (IDEAL-IQ) technique.Methods Totally 36 patients with nonalcoholic fatty liver were divided into acupuncture group (25 cases) and control group (11cases).The patients were performed liver magnetic resonance IDEAL-IQ and the liver fatty component value (F value) was measured before and after the treatment,at the same time clinical indicators of liver function and blood lipid were measured.The Spearman correlation analysis was used to compare the consistency of F value and blood lipid in all patients.The t test was used to compare the differences of liver F values,liver function,blood lipids and other clinical indicators of two groups before and after the treatment.Results There were significantly positive correlation between the fat component and triglyceride (TG),total cholesterol (TC) level (r =0.836,0.852,P ＜ 0.05),and significant negative correlation between the fat component and high density lipoprotein (HDL) level in the fatty liver group (r =-0.735,P ＜0.05),The liver F values,alanine aminotransferase (ALT) and aspartate aminotransferase (AST) contents and TG,HDL,low density lipoprotein (LDL) and TC contents of the acupuncture group after treatment were statistically significant (P ＜ 0.05).Comparison of each index in the acupuncture group after treatment with the control group,the differences were statistically significant (P ＜ 0.05).Conclusions Acupuncture is an effective approach to treat nonalcoholic fatty liver disease,as it can improve liver function and down-regulate lipid level.Magnetic resonance IDEAL-IQ technique can quantitatively detect its therapeutic efficacy.

Halophilic microorganisms play important rules in salt field ecosystem and salt production. In this study, halophilic bacteria and haloarchaea from soils of Lianyungang Taibei and Yancheng Sanwei salt fields were analyzed. The halophilic bacterial and haloarchaeal types from both the soils were similar, but each soil had its distinctive species. A total of 17 halophilic bacteria were identified, among them, Halomonas was found from both the soils, while Pontibacillus and Halobacillus were isolated from Sanwei salt field only. Using uncultured 16S rRNA gene library technology, 13 haloarchaeal soil 16S rRNA genes were identified from both the saline soils. Halobacterium and Haloplanus were found from Taibei salt field, while Halobac- terium, Natronobacterium, Halogeometricum and Haloarcula were identified from Sanwei salt field. Ten haloarchaeal 16S rRNA gene sequences showed 92%~97% identities with the GenBank sequences that ap- pear to represent novel soil haloarchaeal species. This study provides important information that is useful for further investigation and application of halophiles of saline soil fields.

Objecfive To detect the functional repair of metanephric mesenchymal cells (MMCs) transplantation in adriamycin (ADR)-induced glomerulopathy rats. Methods A total of 90 Sprague-Dawley female rats were randomly divided into three groups:ADR group (n=40,rats were injected via the tail vein with O.25 mg ADR/100 g body weight on days 1 and 21),ADR- MMCs group(n=40,rats were injected via the tail vein with 5×10~6-7×10~6 MMCs 8 weeks after the second ADR administration),control(n=10).All the rats were scarified 8 weeks after MMCsinjection.Pathology and collagen IV expression in renal tissue were examined.Moreover,matrix metalloproteinases 2 (MMP-2) and matrix metallopmteinases 9 (MMP-9) expression in the renal tissue were also detected with immunohistochemistry,and quantity analysis of protein and gene was further demonstrated with Westem blot and RT-PCR analysis,respectively. Results There were no significant differences in tubulointerstitial injury score and glomerulosclerosis degree between ADR group and ADR-MMCs group(P>0.05).Compared with ADR group,collagen Ⅳ and MMP-2 expression decreased, MMP-9 expression incrased in renal tissue of ADR-MMCs group, and the difference was significant (P<0.05). Conclusion MMCs transplantation may have potentially therapeutic effect on renal tissue fibrosis of adriamyein-induced glomerulopathy in rats, and the signaling pathways of MMPs appear to be involved in these processes.

OBJECTIVETo investigate the value of MRI follow-up in pediatric patients with spinal tuberculosis.

METHODSFrom February 2004 to April 2013, MRI imaging data in 21 children with spinal tuberculosis by pathologically and clinically proven were retrospectively analysed. There were 11 males and 10 males, with an average age of 9.4 years old ranging from 2 to 14 years old. Eighteen patients were received conservative treatment, 3 patients were treated by surgical operation. The course of disease ranged from 2 months to 3 years. All cases underwent two or more MRI examinations for follow-up. MRI findings of the first and second examination were comparatively analyzed,including signal changes of vertebral body and intervertebral, paraspinal abscess and the change of kyphosis angle.

RESULTSIn the 21 cases with tuberculosis, 85 vertebral bodies were affected in total, including 10.6%(9/85), 49.4%(42/85) and 40%(34/85) vertebral bodies separately in the cervical,thoracic, lumbosacral spine. Follow-up MRI showed vertebral body shape and signal had no obvious change during or after treatment, 15 cases with vertebral bodies changed flat or cuneate, 10 cases with disc involvement,and intervertebral space became narrowing at different level. Among 13 patients with kyphosis angle greater than 0°, 7 were located on thoracic, 2, 3, 1 were on thoracolumbar, lumbar and cervical spine, respectively. Among 18 cases with conservative treatment,kyphosis angle were 0° on the first and the follow up MRI of 8 patients. One case of mild (<10°) kyphosis,follow-up MRI during therapy showed the angle slightly increased; 5 cases with moderate (10° to 30°), follow-up MRI during therapy showed no obvious change; 4 cases with severe (>30°), follow-up MRI during and after therapy showed kyphosis increased in varying degrees.

CONCLUSIONFollow-up MRI can make a big difference in the spinal tuberculosis of children; it can clearly show the change of the vertebral body and intervertebral space, paraspinal abscess and the kyphosis angle after the treatment,which can provide reference for clinical treatment and estimating prognosis.

Adolescent ; Anti-Bacterial Agents ; therapeutic use ; Child ; Child, Preschool ; Drug Monitoring ; Female ; Follow-Up Studies ; Humans ; Magnetic Resonance Imaging ; Male ; Radiography ; Retrospective Studies ; Spine ; diagnostic imaging ; Tuberculosis, Spinal ; diagnostic imaging ; drug therapy ; surgery