Objective To investigate the plasma level of D-dimer in healthy population and hospitalized patients, and to analyze the cut-off value of D-dimer levels in different age groups for the exclusion of venous thromboembolism (VTE) in older patients. Methods A total of 6 717 healthy individuals and 2 976 hospitalized patients were included in the study. The blood level of D-dimer was detected by the Biomerieux VIDAS fluor-euzymelinked immunoassay analyzer assay. Results The blood level of D-dimer was significantly increased with age in healthy people aged over 40 and different age groups of hospitalized patients (P<0.01). The incidence of venous thromboembolism was also increased with age. The cut-off value for the diagnosis of VTE with D-dimer was 504 μg/L in patient group aged ≤40 years, and the sensitivity was 100.0%. The cut-off value was 565μg/L in 41~60-year group, and the sensitivity was 96.2%. The cut-off value was 817μg/L in 61~74-year group, and the sensitivity was 80.8%. The cut-off value was 1 024μg/L in≥75-year group, and the sensitivity was 73.1%. Conclusion The plasma D-dimer level increased with age. The D-dimer cur-off value was higher in older patients than that of other age groups, but the sensitivity in diagnosis was decreased obviously.

Purpose:To investigate the relationships between the biological behavior of human transitional cell carcinomas(TCCs) and the protein expression of transforming growth factor ?1(TGF?1) as well as its'related receptors.Methods:The expression of TGF?1 ,T?RⅠ,T?RⅡ and PCNA were examined in 74 specimens of TCCs by S P immunohistochemistry staining.Results:The positive expression rate of TGF?1 , T?RⅠ and T?R Ⅱ were 89.2%,70.3% and 48.6%,respectively. Superficial tumors had lower overexpression rate of TGF?1 (33.3%) than muscle invasive TCCs (83.8%) ( P

Objective To investigate the expression of c-kit and analyze its relationship with proliferating cell nuclear antigen (PCNA) in RCC subtypes and its clinical progression. Methods Expression of c-kit protein was retrospectively studied with immunohistochemistry in paraffin sections from 137 cases of clear renal cell carcinoma (CCRCC), 82 papillary renal cell carcinoma (PRCC), 51 chromophobe renal cell carcinoma (ChRCC). Results The positive rate of c-kit in ChRCC was 94.1%(48/51), it was statistically higher than that in CCRCC (16. 1%, 22/137) and PRCC (28.1 %, 23/82)(P=0. 001 ). In ChRCC, the positive expression of c-kit was related with TNM stages. The positive expression of PCNA was related with the grade in CCRCC and PRCC. But there was no relationship between PCNA expression and grade of ChRCC. It also had the relationship with the metastasis in CCRCC. Conclusions The expression of c-kit in ChRCC is higher than in other subtype of RCC, and associated with tumor local progression. That makes c-kit as a helpful marker to discriminate different subtypes of kidney cancer.

Objective To study the effect of macrophage, its stimulating factor, granulocyte macrophage colony-stimulating factor (GM-CSF), the combination of GM-CSF and macrophage on the survival of rat deep epigastric perforator flap (DEP). Methods The stable animal model of DEP flap in Sprague-Dawley rat mimicing human deep inferior epigastric perforator flap in breast reconstruction was established. The rats were treated with subcutaneous injection of recombined rat GM-CSF or rat peritoneal macrophages, respectively, or combination of GM-CSF/ Macrophages. Normal saline was used as parallel negative control. The rats were sacrificed and flap specimens were harvested on day 7 after operation, the flaps survival area were measured by the method of rubbings and the survival proportion of flaps were calculated, Von Will brand factor were detected by immunohistochemistry and microvessel density (MVD), and were calculated with microscopic study, and collagen were stained and quantified by Masson staining. Results Survival proportion of flaps in group GM-CSF (53.08% ± 8. 76% ) was not different with that in macrophages group (47. 95% ± 4. 92% ), and both of these two groups were significantly higher than parallel negative control group (43.28% ± 5.27% ) but significantly lower than combination GM-CSF/ macrophages group ( 61.68% ± 6. 60% ). For MVD, flap in GM-CSF group ( 24. 82 ± 4. 18 ) was not significantly different with macrophages group (24.30 ± 3.02 ), and both of these two groups were significantly higher than group parallel negative control (21.37 ± 2.65 ) but significantly lower than combination GM-CSF/macrophages group ( 29. 82 ± 4. 74). Collagen deposition in the flaps in GM-CSF group (17. 25% ± 2. 85% ) were significantly higher than parallel negative control group (14.41% ± 2. 89% ), macrophages group ( 12. 69% ± 3.55% ) were lower than parallel negative control group but there was no significant difference. That in combination GM-CSF/macrophages group (20.31% ± 3.01% )was significantly higher than GM-CSF group ( P < 0. 05 ). Conclusion Treatment with rat GM-CSF or macrophage can significantly promote the survival of the flaps. Combined application of GM-CSF and macrophage could synergetically promote the survival of the flaps, the vasculogenesis and the collagen deposition.

Objective To study the efficacy and safety of estradiol and drospirenone tablets (Angeliq)in treatment of menopausal symptoms among postmenopausal Chinese healthy women.Methods Total 244 postmenopausal Chinese healthy women who had moderate to severe hot flushes were randomly assigned for 16 weeks in this randomized multi-center double-blind placebo-controlled study.During the trial.the follow-up visits were conducted at week 4,8,12,16 of treatment and 2 weeks after treatment respectively.Height,weight,vital signs,hot flushes,other relevant menopausal symptoms and vaginal bleeding were observed in each follow-up visit,while the clinical global impression scale Was assessed at 16 weeks as well.Results It showed that hot flushes were reduced significantly more in observation group than that in placebo group ( P＜0.01 ), although both treatments were effective. The absolute values of mean severity index of total hot flushes decreased by - 0. 6± 0. 5 in observation group and - 0. 4 ± 0. 4 in placebo group from baseline respectively, which reached significant difference ( P ＜ 0. 05 ). However, the absolute values of mean severity index of moderate to severe hot flushes decreased by - 0. 6± 0. 8 in observation group and -0. 3± 0.6 in placebo group from baseline respectively, which had no significant difference (P ＞ 0. 05 ).After 16 weeks treatment, it also showed that estradiol and drospirenone had significant better efficacy than placebo on moderate to severe sweating, vaginal dryness and clinical global impression scale (P ＜0. 01 ).During the trial, blood pressure in observation group was stable. The rate of vaginal bleeding in observation group was higher than that in the placebo group, especially during the week 4 to week 8 when 48. 9% (87/178) in observation group and 10. 7% (6/56) in placebo group of patients bled. Although the cumulative amenorrhea rate of observation group was lower than that of placebo group in each cycle (28 days), it increased gradually along with duration of the treatment. The commonest adverse event in observation group was breast tenderness which accounted for 12.0% (22/183 ). The level of serum potassium was in the normal range in observation group mostly. Meanwhile, the other adverse events rate was low. Serious adverse events reported in this trial were assessed as not study drug related or as unlikely study drug related. Conclusion Estradiol and drospirenone tablets which could effectively alleviate menopausal symptoms in postmeuopausal Chinese healthy women is a novel hormone replacement therapy regimen with high safety and efficacy.

Abstract: The aim of this study was to prepare a high drug-carrying capacity micellar drug delivery system (CTD@Sol) of the polymer zebra tetracycline and to preliminarily investigate the feasibility of this drug delivery system for the treatment of breast cancer. Firstly, CTD@Sol was prepared using sol as the carrier material and CTD as the model drug, and its pharmacological properties such as appearance and morphology, particle size, potential and in vitro release were evaluated. The growth inhibitory and apoptotic effects of CTD@Sol on breast cancer (4T1) cells were investigated by MTT assay and Annexin V-FITC/PI double staining assay; the uptake efficiency of 4T1 to this delivery system was investigated by flow cytometry; and the in vivo tissue distribution of the delivery system and the targeting of tumour tissues were investigated by small animal in vivo imaging technique. The results showed that CTD@Sol appeared as a light pale blue creamy white colour, with an average particle size of (159.73 ± 1.96) nm, a PDI of 0.198 ± 0.006, Zeta potential of –(47.60 ± 1.77) mV, an encapsulation rate of (90.29 ± 1.69)% and a drug loading capacity of (45.00 ± 0. 84)%; the in vitro release and haemolysis experiments showed that the drug release rate of CTD@Sol in acidic environment (pH 5.5) was significantly faster than that in neutral environment (pH 7.4), suggesting that the system is acid-sensitive and has good biosafety under endocytosed pH conditions. Cellular uptake, cytotoxicity and apoptosis experiments showed that CTD@Sol was more lethal to 4T1 cells, and the sol-gel polymer micelles as a drug delivery vehicle could significantly improve the cellular uptake efficiency of the drug; in vivo experiments showed that the delivery system had a significant targeting effect on tumour tissues.In conclusion, this study has successfully produced a CTD@Sol drug delivery system with high drug loading capacity (>45%), good pharmacological performance, strong targeting and biosafety, which has the potential to be used in the treatment of breast cancer.

Objective To observe the analgesic effects of mild moxibustion on primary dysmenorrhea(PD)rats with cold and dampness stagnation syndrome and its effect on BDNF/TrkB signaling pathway in hypothalamus;To explore its mechanism for the treatment of PD.Methods A total of 32 Wistar non-pregnant female rats were randomly divided into blank group,model group,Western medicine group and mild moxibustion group,with 8 rats in each group.Except for the blank group,the other groups received estradiol benzoate intraperitoneal injection combined with ice bath treatment + oxytocin intraperitoneal injection to establish PD with cold and dampness stagnation syndrome model.The mild moxibustion group received treatment at"Shenque"and"Guanyuan"from the eighth day of modeling for 10 min,and the Western medicine group was given ibuprofen solution intragastically for 4 days.The latency period of rats twisting was observed and the twisting score was calculated,Western blot and PCR were used to detect the expressions of c-fos,BDNF,TrkB protein and mRNA in hypothalamic tissue.Results Compared with the blank group,the model group showed a shortened latency period and an increased twisting score(P<0.01),the expressions of c-fos,BDNF,TrkB protein and mRNA in hypothalamic tissue increased(P<0.01,P<0.05).Compared with the model group,the mild moxibustion group had a longer latency period and lower twisting score(P<0.01),while the expressions of c-fos,BDNF,TrkB protein and mRNA in hypothalamic tissue increased(P<0.01,P<0.05).Conclusion Mild moxibustion may effectively improve the pain state of PD rats with cold and dampness stagnation syndrome.This mechanism may be related to downregulating c-fos expression,inhibiting BDNF/TrkB signaling pathway activation,thereby inhibiting pain signal transmission,regulating pain occurrence and maintenance.

This paper summarized clinical experience of Professor Peng Qinghua in the staged treatment of autoimmune uveitis （AU）. The pathogenesis of AU is always based on root-cause deficiency and manifestation excess， with weakness of healthy qi as the root， and accumulation of wind， dampness and blood stasis as the minifestation. Syndrome differentiation and treatment is usually carried out according to different stages of disease. During the acute stage， deficiency of healthy qi and stagnation of wind-dampness are the key pathomechanisms， so the treatment is to replenish qi and activate blood， dispel wind and remove dampness， and self-made Yiqi Huoxue Qufeng Chushi Decoction （益气活血祛风除湿方） can be used. During remission stage， deficiency of spleen and kidney is the key mechanism， so the treatment is to tonify the spleen and kidney， replenish the essence and brighten the eyes， and self-made Yijing Mingmu Decoction （益精明目汤） can be used. Meanwhile， it was recommened to treat early， prevent and interrupt the disease， commonly combine with Chinese patent medicine Zhengqing Fengtongning tablets （正清风痛宁缓释片）， and promote regulation of living to prevent recurrence.

Type inspection is a necessary precondition of technical evaluation of medical device. The implementation of The Provisions for Administration of Self-Test for Medical Device Registration facilitates the registration pathway for applicants. How to improve the effectiveness of registration self-test has drawn attention from many stakeholders. In this study, we analyzed and discussed the factors affecting the validity of registration self-test from technical evaluation perspective, and proposed suggestions for improvement accordingly. The aim of this article is to boost the reliability and effectiveness of registration self-test and offer a reference for applicants to carry out registration self-test.
Medical Device Legislation

The prevalence and severity of hepatitis D virus (HDV) infection have always been underestimated, and the low screening and diagnosis rates may bring severe disease burden. HDV RNA, as the direct evidence of viral replication, is of great importance for the diagnosis and management of hepatitis D. This article summarizes the clinical significance of HDV RNA detection and introduces the advances in detection methods, in order to facilitate the screening and diagnosing of hepatitis D.