Objective: To analyze the published domestic documents of the clinical trial for treatment of anal fissure in past 10 years, to evaluate the quality of literatures about anal fissure randomized controlled clinical trials, and to provide references of clinical studies for the treatments of anal fissure in Traditional Chinese Medicine (TCM). Methods: In term of principles of evidence-based medicine, we evaluate the published domestic literatures of the randomized controlled clinical trial for treatments of anal f issure in past 10 years. Results: We analyze 52 literatures which are in the method of randomized controlled clinical studies. 28 literatures (accounting for 53.85%) record diagnostic criteria, 38 literatures (accounting for 73.08%) make sure standards of evaluating the effect and 18 literatures (accounting for 34.62%) mention comparability between groups without describing the baseline statistics. Only 5 are marked as a funded research projects. Conclusion: in current published literatures of randomized controlled study for treatments of anal fi ssure, the problems are focused on: ① Experimental idea is unclear and design is unreasonable, ② The description of implemented process in randomized control is unspecif ic, ③ Signifi cant parameters in statistical data are missed and with less credibility, ④ Criteria of diagnosis and effi cacy are different, ⑤ Evaluation indicators are fuzzy. All above clue to the quality of clinical research needs to be improved rapidly, and standardized evaluation of eff icacy also needs to be created urgently.

The sub-health status is closely related to the functions and activities of heart in traditional Chinese medicine (TCM). The sub-health is commonly presented with a series of heart system symptoms such as palpitation, chest distress, shortness of breath, fatigue, fidgets and insomnia. It may also be accompanied with arrhythmia or blood pressure value between normal and high level. This heart system sub-health status can be transformed into re-lated heart system diseases with high possibility. This article made a review from aspects of theoretical literature, an-imal experiment, curative effect observation and clinical evaluation on the research progress of heart system sub-health status.

Neuropsychiatric systemic lupus erythematosus (NP-SLE) is more common in young woman but not yet in people over 75 years old.We report a case of NP-SLE in an old woman,who complained of tremor,hypermyotonia and gatism.The lab examinations showed strong positive (1∶3200) ANA,decreased levels of CH50,C3,C4,WBC,RBC,PLT,anti-ds-DNA(+),anti-Sm(+),SSA(+),PO(+),RO-52(+),urine blood (+) and protein (+).The proteins,MBPand IgGin CSF were increased.Head MRI scan showed many demyelination in bilateral intra ventricular and multiple patchy irregular long T1 and T2 signal under right parietal subcortical.The patient was immediately given methylprednisolone hormone therapy,combined with gamma globulin and hydroxychloroquine.After 4 days of treatment,most symptoms such as tremor and hypermyotonia disappeared.Laboratory tests showed that all immune markers changed better in three weeks.The patient was discharged in 4 weeks.it must be identified with cerebrovascular disease,Parkinson's disease and other common diseases in elderly people.It can be improved if the diagnosis and treatment of NP-SLE is immediately and the illness is well controlled.

In this paper, the Fourier transform based minimum mean square error (FT-based MMSE) method is used to calculate the regional cerebral blood volume (rCBV) in magnetic resonance (MR) perfusion imaging, and the method is improved to handle the existing noise in the imaging process. In the experiments with signal-to-noise ratio (SNR) of 50 dB, the rCBV values were compared with the results using MMSE method. The effects of different SNRs on the estimation of rCBV were analyzed. The experimental results showed that MMSE was a simple way to filter the measurement noise, and could calculate rCBV accurately. Compared with other existing methods, the present method is not sensitive to environment, and furthermore, it is suitable to deal with the perfusion images acquired from the environment with larger SNR.
Blood Volume ; Brain ; blood supply ; Fourier Analysis ; Humans ; Magnetic Resonance Angiography

Clinical evaluation proceedings from patient-reported outcomes (PRO) are being concerned increasingly. Based on the concept of PRO, the report discusses the findings in the research recently made at home and abroad. PRO from apoplexy patients with spastic paralysis was taken as an example in the exploration of how to evaluate the curative effects in clinical practice on the basis of PRO.

This study was aimed to discuss the ways of converting clinical data entered in the Case Report Form (CRF) to Study Data Tabulation Model (SDTM) database format in clinical research of traditional Chinese medicine (TCM). Currently, there were three approaches for implementing SDTM, which were the pure SDTM approach, submission-only approach and database-only approach. This article compared and analyzed advantages and disadvantages of three approaches and introduced experiences of the Clinical Evaluation Center of China Academy of Chinese Medical Sciences using database-only approach for SDTM implementation. The results showed that pure SDTM approach can maximally embrace SDTM standards. However, the current process and software system should be modified. Therefore, it was time-consuming and expensive. The submission-only approach was the most economic way in the application of SDTM standards. However, the data quality and traceability may not be guaranteed. The database-only approach built the study database based on the SDTM standard by writing transformed program before data entry while the data collection system was not SDTM-compatible. It was concluded that database-only approach for implementation SDTM was a suitable and practical way to TCM clinical research.

This study was aimed to compare the criteria on quality of questionnaire development and psychometric property evaluation. The references listed in the ISOQOL and consequent included criteria were searched. Two reviewers independently screened papers to include articles with inclusion criteria as follows: fully evaluating the questionnaire development and/or psychometric property; published or unpublished, but not book. Two reviewers independently extracted the information which contained criteria name, types of questionnaire assessed, criteria purpose, research methods, content, evaluation method and etc. Qualitative analysis was conducted to synthesize common characteristics of criteria, and to compare what each criterion emphasized on. The results showed that 9 included criteria sharing the same purpose which evaluated the questionnaire development process and/or psychometric properties of the health related quality of life questionnaire or patient reported outcome. Experts consensus based on previous studies were the criteria development methods. The standard content included conceptual framework, targeted population, content validity, internal consistency, test-retest reliability, structure validity and responsiveness with interpretability. Assessment scoring system used in the criteria was categorized as 2- or 4-point Likert scales. Or document of evaluation evidence was required to be provided. It was concluded that nine criteria can be used to develop new questionnaires, evaluate existed/new questionnaires, or choose the right questionnaires for clinic, based on the following elements such as their research purpose, trials types, questionnaire types or questionnaire administrations.

HepG2 cells were pre-incubated with insulin (Ins 0,1,0. 1,0.01 μol/L) and dexamethasone ( Dex 0,3,0. 3,0.03 μol/L) alone or together for 24 h to induce insulin resistance (IR) in vitro, the resistant level was estimated by glucose consumption, the optimal model of insulin resitance was chosen, and at the same time its lasting time of resistance was determined. In order to investigate the effects and mechanisms of mifepristone on in sulin-resistant HepG2 cells induced by insulin and dexamethasone, mifepristone and pioglitazone were adminis tered 24 h after the optimal model of insulin-resistant HepG2 cells was established. The glucose consumption, in tracellular concentrations of glucose, glycogen, ATP, and free fatty acid (FFA) in each group were detected. The expression of InsR-mRNA and GR-mRNA was detected by semi-quantitative reverse transcription and polymerase chain reaction (SqRT-PCR). Results revealed that pretreatment with insulin (0. 1 μmol/L) and dexamethasone (0.3 (μol/L) for 24 h caused optimal insulin resistance of HepG2 cells which lasted for 36 h. Compared with control group, the glucose consumption, intracellular glucose, glycogen, ATP contents and the level of InsR-mRNA in model cells decreased while FFAs concentrations and GR-mRNA increased. However, the tendency of insulin resistant HepG2 cells was obviously attenuated by pioglitazone at the concentration of 0. 2 mmol/L and mifepris tone at 200μmol/L and 20 μol/L while mifepristone at 2 μol/L had no effect on insulin-resistant cells. The findings indicated that mifepristone at 200 μol/L and 20 μol/L improved the insulin resistance via modulating intracellular glucolipid metabolism and the expression of InsR-mRNA and GR-mRNA.

Objective To observe the value of virtual tough tissue imaging quantification (VTIQ) in differential diagnosis of thyroid imaging reporting and data system(TI-RADS) 4 thyroid nodules.Methods A total of 185 patients with 192 TI-RADS 4 nodules were included in this study.The nodules were divided into three groups according to the maximum size as follows:Group Ⅰ,the maximum size≤0.6 cm;Group Ⅱ,0.6 cm＜ the maximum size≤ 1.0 cm;Group Ⅲ,the maximum size ＞ 1.0 cm.Shear wave velocities (SWV) of nodules were measured by means of VTIQ technique.With pathological diagnosis as the gold standard,SWV value of benign and malignant nodules were analyzed and ROC curve was drawn to assess the diagnostic efficiency.Results By the ROC curve test,at SWV cut-off values of 2.44 m/s for group Ⅰ and group Ⅱ,2.49 m/s for group Ⅲ,the sensitivity were 79.0 ％,76.0 ％,88.6％,specificity were 88.6％,89.5 ％,93.7 ％,accuracy were 83.5 ％,81.8 ％,90.1％,Youden index were 0.68,0.66,0.82,respectively.Conclusions VTIQ can reflect the hardness of TI-RADS 4 nodules,the value of the differential diagnosis of such nodules is high,convenient,noninvasive and not limited by the size of nodules.

Objective To evaluate the effects of low blood sugar production index (LGI) combined with low blood sugar production burden (LGL) dietary intervention on blood glucose, oxidative stress and anthropometric indicators in type 2 diabetes mellitus. Methods A total of 150 cases of type 2 diabetes were randomly divided into two groups,maintain the original treatment plan of two groups,75 patients in the control group were given traditional food interchange method for dietary intervention;the experimental group of 75 patients, provide food education based on LGI+LGI food exchange method , the time period of 3 months. Fasting blood glucose (FPG)、2h postprandial blood glucose (2hPG), Glycated hemoglobin (HbAlc), Superoxide dismutase (SOD), Malondialdehyde (MDA), Vitamin C, Vitamin E, Body Mass Index (BMI), Waist circumference (WC) Upper arm muscle circumference (AMC), Triceps skin fold thickness (TSF) were observed before and after the intervention. Results There were no significant differences in blood glucose, oxidative stress and anthropometry between the two groups (P>0.05). After intervention, in the control group: FPG, 2hPG, HbAlc, SOD, MDA, Vitamin C, Vitamin E, BMI, WC, AMC, TSF were (10.27 ± 2.67) mmol/L, (11.51 ± 2.54) mmol/L, (8.78 ± 1.95)%, (322.73 ± 51.97) kU/L, (5.80 ± 1.76)μmol/L, (40.78±4.86)μmol/L, (19.33±4.79)μmol/L, (23.94±3.18) kg/m2, (89.57±10.23) cm, (24.10± 3.01) cm, (18.38 ± 3.79)mm respectively. In the experimental group: they were (8.76 ± 2.77) mmol/L, (10.63 ± 1.76) mmol/L, (7.96 ± 1.86)%, (357.29 ± 60.04) kU/L, (5.26 ± 1.33)μmol/L, (44.01 ± 7.06)μmol/L, (21.58 ± 5.25) μmol/L, (22.93 ± 2.75) kg/m2, (86.05 ± 10.79) cm, (22.75 ± 2.86) cm, (16.98 ± 4.48) mm respectively. There was significant difference between the two groups after intervention (t=2.049-3.769, all P < 0.05). In the experimental group, the improvement of blood sugar, oxidative stress and anthropometry was better than that of the control group (P < 0.05). Conclusions LGI combined with LGL diet intervention is better than the traditional method of food interchange, the blood glucose, oxidative stress and anthropometric indicators have improved, which can improve treatment efficacy in type 2 diabetes and easy for home self-management.