Background: Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). This study assessed the efficacy and safety of tofacitinib in Chinese patients with RA enrolled in Phase 3 and long-term extension (LTE) studies. Methods: ORAL Sync was a 1-year, randomized, placebo-controlled, Phase 3 trial. Patients received tofacitinib 5 or 10 mg twice daily (BID) or placebo advanced to tofacitinib 5 or 10 mg BID at 3 or 6 months. All patients remained on ≥1 background conventional synthetic disease-modifying antirheumatic drug. ORAL Sequel is an open-label LTE study (data-cut: March 2015; data collection and analyses were ongoing, and study database was not locked at the time of analysis; study was closed in 2017). Efficacy outcomes: American College of Rheumatology (ACR) 20/50/70 response rates and Disease Activity Score in 28 joints using erythrocyte sedimentation rate (DAS28-4 [ESR]). Patient- and physician-reported outcomes: Health Assessment Questionnaire-Disability Index (HAQ-DI), Patient and Physician Global Assessment of Arthritis, and pain (visual analog scale). Safety was assessed throughout. Results: ORAL Sync included 218 patients; 192 were subsequently enrolled into ORAL Sequel. In ORAL Sync, more patients achieved ACR20 (tofacitinib 5 mg BID, 67.4%; 10 mg BID, 70.6%; placebo, 34.1%) and DAS28-4 (ESR) <2.6 (tofacitinib 5 mg BID, 7.1%; 10 mg BID, 13.1%; placebo, 2.3%) with tofacitinib versus placebo at Month 6. Mean changes from baseline in HAQ-DI were greater with tofacitinib versus placebo at Month 6. In ORAL Sequel, efficacy was consistent to Month 48. Incidence rates for adverse events of special interest in tofacitinib-treated patients were similar to the global population. Conclusions: Tofacitinib significantly reduced signs/symptoms and improved physical function and quality of life in Chinese patients with moderate-to-severely active RA up to Month 48. The safety profile was consistent with the global population. Clinical Trial Identifier NCT00856544 and NCT00413699.
Administration, Oral ; Adult ; Aged ; Arthritis, Rheumatoid ; drug therapy ; Asian Continental Ancestry Group ; Female ; Humans ; Male ; Middle Aged ; Piperidines ; adverse effects ; therapeutic use ; Protein Kinase Inhibitors ; adverse effects ; therapeutic use ; Pyrimidines ; adverse effects ; therapeutic use ; Pyrroles ; adverse effects ; therapeutic use ; Surveys and Questionnaires ; Young Adult

OBJECTIVE: To observe the impact of energy saving light,incandescent light and circadian light on the ethology of depressive rats and explore its possible mechanism on affecting the secretion of melatonin. METHODS: Thirty rats aged 6weeks were randomly selected from 40 specific pathogen free health female SD rats after they adapted to the living environment,depressive rat models were established in the rats by bilateral ovariectomy combined with isolated living and chronic unpredictable mild stress stimulation at the age of 11-14 weeks. Then these 30 ovariectomized rats were randomly divided into 3 intervention groups,including an energy saving light group,an incandescent light group and a circadian light group,with 10 rats in each group. The rats in these 3 groups were given specific experimental light intervention for 3 weeks respectively at the age of 17 weeks. The other 10 rats were raised in conventional environment as the control group. Their body weights were measured at the age of 17,19,20 and 21 weeks. The ethology tests were carried out by sucrose preference test and the open-field test at the age of 7,14 and 20 weeks respectively. The melatonin levels in peripheral blood of 7 time points from 19: 30 to 8: 30 were measured in the rats at age of 21 weeks. One rat in each group at every time point was randomly selected for examination. RESULTS: At the age of 17 weeks before light-intervention,the body weights of rats in 4 groups showed no significant difference( P > 0. 05). After light-intervention,at the age of 17-20 weeks,the body weights of rats in 3 intervention groups were gradually increased with the increase of age( P < 0. 05).There was no significant difference between body weights of rats at the age of 21 weeks and those at the age of 20 weeks in each group( P > 0. 05). At age of 7 weeks,no significant differences were found in sucrose consumption and standing scores among these 4 groups( P > 0. 05). After the depressive models were established,at the age of 14 weeks before light-intervention,in rats of these 3 intervention groups,the sucrose consumption and standing scores were lower than those of the control group( P < 0. 05),and there was no significant difference found in the above 2 indexes among these 3intervention groups( P > 0. 05). At the age of 20 weeks after light-intervention,the sucrose consumption and standing scores were not significantly different from each other among the 4 groups( P > 0. 05). The peak levels of melatonin in the peripheral blood of rats in these 3 intervention groups were higher than that in the control group. The peak levels onsets of melatonin in peripheral blood of rats in the circadian light group and the energy saving light group were earlier or 2 hours delayed compared to that of control group,while it was similar between the incandescent light group and control group.CONCLUSION: The circadian light,the energy saving light and the incandescent light are similarly effective in improving the behaviors of depressive rats. The circadian light can delay the onset of peak level of melatonin in peripheral blood.

OBJECTIVETo compare clinical results of treating Neer two- and three-part of proximal humeral fractures between anterolateral acromial approach and deltopectoral approach.

METHODSFrom January 2009 to December 2012, 49 patients with Neer two- and three-part of proximal humeral fractures were treated with locked plate fixation. In anterolateral acromial approach group, there were 22 patients including 9 males and 13 females with an average of (63.2±7.6) years old, while 27 patients in deltopectoral approach including 12 males and 15 females with an average of (62.9±7.0) years old. Operative time, blood loss during operation, fracture healing time and complications were observed and compared, postoperative Constant-Murley scoring and VAS scoring were applied for evaluate function of shoulder joint and pain at 3 months, 1 and 2 years respectively.

RESULTSAll patients were followed up from 24 to 41 months with an average of 34.5 months. Operative time, blood loss, fracture healing time in anterolateral acromial approach group was (68.20±7.04) min, (151.30±20.57) ml, (10.88±4.90) weeks respectively, and better than that of in deltopectoral approach group which was (75.81±13.70) min, (242.10±37.25) ml and (13.60±2.45) weeks. Three months after operation, Constant-Murley scoring and VAS score in anterolateral acromial approach group was 88.32±5.45, 0.41±0.63 and better that of in deltopectoral approach group which was 63.53±8.31, 1.65±1.02. There was no significant differences between two groups in Constant-Murley scoring and VAS score at 1 and 2 years after operation. Each group has one case occurred loss of length humerus head height, and there was 1 case with subacromial impingement, 1 case with bolt loose and 2 cases with delayed union in deltopectoral approach. No axillary nerve injury, humeral head necrosis and breakage of internal fixation occurred both of two groups.

CONCLUSIONBoth of anterolateral acromial approach and deltopectoral approach are effective in treating Neer two- and three-part of proximal humeral fractures, and can obtain excellent outcomes. Moreover, anterolateral acromial approach has advantage of less trauma, less blood loss, shorter operative time, rapid recovery of shoulder joint function and fracture.

Aged ; Case-Control Studies ; Female ; Fracture Fixation, Internal ; methods ; Fracture Healing ; Humans ; Male ; Middle Aged ; Recovery of Function ; Shoulder Fractures ; physiopathology ; surgery

Cervical Vertebrae ; injuries ; surgery ; Fracture Fixation, Internal ; Humans ; Male ; Middle Aged ; Paralysis ; etiology ; Postoperative Complications ; etiology

OBJECTIVETo assess the performance of FibroScan in evaluating the curative effects of traditional Chinese medicine (TCM) on liver fibrosis, and to analyze factors influencing the diagnostic accuracy.

METHODSData of FibroScan values, types of disease, use of drug, liver function indexes, prothrombin time (PT) and international normalized ratio (INR) were collected at both pre- (1 month prior) and post-FibroScan for 102 patients who underwent at least two FibroScan procedures. Patients were subgrouped according to presence of fibrosis, presence of cirrhosis, and TCM formulation and statistically analyzed.

RESULTSThe pre- and post-FibroScan mean liver stiffness measurements (LSMs) were significantly different when the variation of LSM was more than or equal to2 kPa for the non-fibrotic group (vs. the fibrotic group), or when the variation wasmore than or equal to4 kPa for the cirrhotic group (vs. the non-cirrhotic group). In addition, the three TCM formulation groups showed significant differences, with the most robust difference exhibited between the FuZheng HuaYu formulation group and the other treatment groups (P = 0.010). No significant differences were observed for the liver function indexes, PT, or INR. However, the post-FibroScan levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), and gamma-glutamyltransferase (GGT) was significantly reduced in patients with reduced LSM.

CONCLUSIONFibroScan may be a useful non-invasive clinical tool for evaluating the comprehensive curative effect of treatments for chronic liver diseases, and its performance is not obviously impacted by ALT, AST, GGT, PT, and INR. The criteria for efficacy established by FibroScan are 2 kPa for the patients without liver fibrosis and 4 kPa for patients with liver cirrhosis.

OBJECTIVETo explore the protective effect of baicalin against rotenone-induced injury on PC12 cells, and the po-tential mechanism of action action was also explored.

METHODPC12 cells were injured by rotenone and were treated with different concentrations (0.1, 1, 10 μmol x L(-1)) of baicalin at the same time. Cell viability was analyzed by MTT, and morphology was observed by phase-contrast microscopy. The cell apoptosis was detected by flow cytometry by Annexin V-FITC/PI staining. The intracellular ROS level was determined by fluorescence microscope with DCF-DA staining. The expression of Bcl-2, Bax and Caspase-3 was analyzed by Western blot.

RESULTThe viability of PC12 cells exposure to rotenone for 24 hour was gradually decreased with dose escalating and 1.5 μmol x L was adopted to do the following experiment. Baicalin increased cell viability, improved cell morphology and decreased intracellular ROS level. Moreover, FACS indicated baicalin attenuated the apoptosis induced by rotenone significantly. Western blot showed that Bcl-2, Bax and Caspase-3 expression in rotenone-induced PC12 cells was reversed by baicalin.

CONCLUSIONThis study has demonstrated that baicalin protects PC12 cells against rotenone-induced apoptosis, at least in part, by scavenging excessive ROS and inhibiting the mitochondrion-dependent apoptotic pathway.

Animals ; Apoptosis ; drug effects ; Caspase 3 ; metabolism ; Cell Survival ; drug effects ; Cytoprotection ; drug effects ; Flavonoids ; pharmacology ; Gene Expression Regulation ; drug effects ; Intracellular Space ; drug effects ; metabolism ; PC12 Cells ; Proto-Oncogene Proteins c-bcl-2 ; metabolism ; Rats ; Reactive Oxygen Species ; metabolism ; Rotenone ; pharmacology ; bcl-2-Associated X Protein ; metabolism

Objective To study the relation between serum calcium level and elevated BaPWV in Chinese subjects.
Methods The relation between serum calcium level and elevated BaPWV was studied in 9 615 subjects. The mean value of left and right BaPWV was analyzed. BaPWV was defined as high when it was31 752.5 cm/s (the upper quartile) either side.
Results The BaPWV and its elevated percentage progressively increased across the quartiles of the serum calcium level (P<0.05). The prevalence of elevated BaPWV was significantly higher in subjects of the second, third and highest quartiles than in those of the lowest quartile (26.9%, 28.4%, and 33.2%vs 23.7%, P=0.0116, P=0.0004, and P<0.0001). Logistic regression analysis revealed that the risk of elevated BaPWV was 1.32- fold higher in subjects of the highest quartile than in those of the lowest quartile (OR=1.32, 95%CI:1.08-1.60).
Conclusion The elevated serum calcium level is related to an elevated BaPWV and a higher risk of arterial stiffness, independent of conventional risk factors, in middle-aged and elderly Chinese subjects.

Objective To identify the types of pulmonary complications after pancreaticoduodenectomy,and to discuss the prevention and management of these complications.Methods Clinical data of 165 cases of pancreaticoduodenectomy in our hospital were retrospectively analyzed.Pulmonary complications were identified,therapeutic effects were observed.Results The incidence rate of pulmonary complications was 19.4％ ( 32/165),case-fatality rate was 6.25％ (2/32),two patients died from pneumonia,respiratory failure and ARDS.Complications mainly included pneumonia 13.9％ (23/165),pleural effusion 4.2％ (7/165),atelectasis 3.6％ (6/165),pneumothorax 1.8％ ( 3/165 ),respiratory failure 2.4％ (4/165) and ARDS 1.2％ (2/165).Conclusion Pulmonary complications after pancreaticoduodenectomy are not rare,especially for pulmonary infection and most are hospital acquired pneumonia.To understand rules and particularity of respiratory physiopathological changes after pancreaticoduodenectomy is very important for patients to safely pass over the perioperative period.

Objective To explore the clinical characteristics,management and pregnancy outcome in patients with ovarian tumor and ovarian tumor like condition complicated with pregnancy.Methods The clinical data of 248 patients with ovarian tumor and ovarian tumor like condition eomplicated with pregnancy who treated,operated and pathology conducted from January 2003 to December 2009 was analyzed retrospectively.Results Among of 248 patients,8 patients were found by pelrioscopy,184 patients were found by sonography.The rate of ovarian tumor and ovarian tumor like condition during pregnancy was 0.49％ (248/50 652),about 52.82％(131/248)were diagnosed as benign tumor,most of them were ovarian mature teratoma(22.18％,55/248).About 45.56％(113/248)were diagnosed as ovarian tumor like condition,most of them were ovarian chocolatecyst(23.79％,59/248).Four patients(1.61％,4/248)were ovarian malignant tumor.Two hundred and sixteen received operation,term birth was in 164 patients,premature birth was in 19 patients,miscarriage was in 33 patients.Conclusions Pelvioscopy and sonogaraphy are principally important in the diagnosis and detection of ovarian tumor during pregnancy.Pregnancy complicated with ovarian tumor or ovarian tumor like condition should be treated by tumor resection.Suitable surgery intervention during second trimester is safe.

ObjectiveTo study the characteristics and the impact of lymph node metastasis on radical resection for pancreatic head cancer to provide a theoretical basis for lymphadenectomy in radical resection.To study the reliability of using a surgical microscope to detect lymph nodes in radically resected specimens of pancreatic head cancer.MethodsLymph nodes in the specimens after radical pancreaticoduodeneetomy (pancreaticoduodenectomy + D2 regional lymphadenectomy) were identified using a surgical microscope and they were grouped using the JPS standard.The position and the frequency of the lymph nodes retrieved,and their association with other clinicopathologic factors were analysed.The results were compared with the data published in 2004 on 46 patients to evaluate the reliability of using a surgical microscope.ResultsLymph node metastasis was detected histopathologically in 101 patients (67.3％).The median number of lymph nodes retrieved in the specimens as detected using the surgical microscope was 38.2.The most commonly involved lymph node groups were No.13 (64.5％),No.14 (51.7％),No.17 (38.6％),No.12 (25.8％),No.16 (20.8％).Lymph node metastasis was significantly associated with tumour T stage,tumour invasion and differentiation,preoperative serum level of CA19-9 and CA72-4,but not with patient age,sex,or tumour location.There were no significant differences between the results and the data of the previous study in 2004.ConclusionsExtended lymphadenectomy is necessary because extensive lymph node metastasis was common.Surgical microscopy is an effective and reliable method to detect lymph nodes in resected specimens of pancreatic head cancer for accurate pathologic staging.