OBJECTIVETo evaluate the efficacy and safety of etanercept plus Tripterygium wilfordii polyglycoside (TWP) in elderly patients with active rheumatoid arthritis (RA).

METHODSTotally 46 elderly patients with active RA were randomly assigned to the treatment group (22 cases) and the control group (24 cases). All patients received subcutaneous injection of etanercept, 25 mg each time, twice per week. The dosage was reduced to once per week 3 months later. Patients in the treatment group took TWP Tablet (10 mg each time, three times per day), while those in the control group took methotrexate (MTX), 10 mg each time, once per week. The whole course lasted for 24 weeks. Patients' rest pain, tender joint number, swollen joint number, health assessment questionnaire (HAQ), patients' global assessment, physicians' global assessment, erythrocyte sediment rate (ESR), C reactive protein (CRP), rheumatic factor were assessed at week 0, 4, 8, 12, and 24. The curative effect was statistically evaluated by the United States Institute of Rheumatology ACR20, ACR50, and ACR70 improvement criteria. Meanwhile, any adverse event was recorded and evaluated.

RESULTSTotally 41 completed the trial, and 5 dropped off (3 in the treatment group and 2 in the control group). Compared with the control group, there was no statistical difference in ACR20, ACR50, or ACR70 in the treatment group (P > 0.05). Compared with before treatment in the same group, there was some improvement in tender joint number, swollen joint number, visual analogue scale (VAS) for patients' global assessment, VAS for physicians' global assessment, ESR, CRP, and HAQ between the two groups, showing statistical difference (P < 0.05). Compared with the control group in the same phase, there was no statistical difference in the treatment group (P > 0.05). There was no statistical difference in the occurrence of adverse events between the two groups.

CONCLUSIONSEtanercept plus TWP could achieve equivalent therapeutic effect to that of Etanercept plus MTX. The two regimens could improve clinical signs, symptoms, and QOL related to RA. They were well tolerated in the treatment of elderly patients with active RA.

Aged ; Antirheumatic Agents ; therapeutic use ; Arthritis, Rheumatoid ; drug therapy ; Drug Therapy, Combination ; Etanercept ; Female ; Glycosides ; therapeutic use ; Humans ; Immunoglobulin G ; therapeutic use ; Male ; Middle Aged ; Receptors, Tumor Necrosis Factor ; therapeutic use ; Treatment Outcome ; Tripterygium ; chemistry

OBJECTIVETo explore the effect of Telbivudine (LDT) Tablet combined with Jianpi Bushen Recipe (JBR) on serum hepatitis B virus (HBV) specific cytotoxic T lymphocyte (CTL) and HBeAg seroconversion in chronic hepatitis B (CHB) patients.

METHODSTotally 90 HBeAg-positive and human leukocyte antigen (HLA)-A2 positive CHB patients were randomly assigned to the treatment group and the control group, 45 cases in each group. Patients in the treatment group took LDT Tablet (600 mg, once per day) combined with JBR granule (twice per day), while those in the control group took LDT Tablet alone. The therapeutic course for all was one year. HBV DNA negative conversion rate, HBeAg seroconversion rate, and level of HBV specific CTL were compared after 1 year treatment; liver function, drug resistance mutations, and adverse reactions were also compared between the two groups.

RESULTSAfter 1 year treatment, HBV DNA negative conversion rate and HBeAg seroconversion rate were 88.89% (40/45) and 40.00% (18/45) in the treatment group, higher than those of the control group [68.89% (31/45) and 20.00% (9/45)], with statistical difference (P < 0.05). Level of HBV specific CTL in the treatment group was 0.78% +/- 0.09% after treatment, higher than that of the control group after 1 year treatment (0.54% +/- 0.11%) and that before treatment (0.36% +/- 0.07%), with statistical difference (P < 0.01). Level of HBV specific CTL in 27 patients with HBeAg seroconversion was 0.81% 0.10%, higher than that of 63 patients without HBeAg seroconversion (0.60% +/- 0.09%), with statistical difference (P < 0.01). ALT returned to normal in 44 cases of the treatment group (97.78%), while it was 42 cases (93.33%) of the control group, with no statistical difference between the two groups (P > 0.05). Total bilirubin (TBil) in the two groups all turned to normal. rtM204I variation occurred in 1 case (2.22%) of the treatment group and 2 cases (4.44%) in the control group. No obvious adverse reaction occurred in the two groups.

CONCLUSIONLDT Tablet combined with JBR could elevate levels of HBV specific CTL and HBeAg seroconversion in CHB patients.

Drug Therapy, Combination ; Drugs, Chinese Herbal ; therapeutic use ; Hepatitis B e Antigens ; blood ; Hepatitis B virus ; Hepatitis B, Chronic ; drug therapy ; Humans ; Seroconversion ; T-Lymphocytes, Cytotoxic ; immunology ; Tablets ; Thymidine ; analogs & derivatives ; therapeutic use

Data quality management system is essential to ensure accurate, complete, consistent, and reliable data collection in clinical research. This paper is devoted to various choices of data quality metrics. They are categorized by study status, e.g. study start up, conduct, and close-out. In each category, metrics for different purposes are listed according to ALCOA+ principles such us completeness, accuracy, timeliness, traceability, etc. Some general quality metrics frequently used are also introduced. This paper contains detail information as much as possible to each metric by providing definition, purpose, evaluation, referenced benchmark, and recommended targets in favor of real practice. It is important that sponsors and data management service providers establish a robust integrated clinical trial data quality management system to ensure sustainable high quality of clinical trial deliverables. It will also support enterprise level of data evaluation and bench marking the quality of data across projects, sponsors, data management service providers by using objective metrics from the real clinical trials. We hope this will be a significant input to accelerate the improvement of clinical trial data quality in the industry.
Benchmarking ; Clinical Trials as Topic ; Data Collection ; standards ; Information Storage and Retrieval ; standards ; Quality Control

OBJECTIVETo observe the effect of Ginkgo Leaves Tablet (GLT) on memory quotient (MQ) of mild cognitive impairment (MCI) patients.

METHODSOne hundred and thirteen patients were randomly assigned to the control group (55 cases) and the treatment group (58 cases). Patients in the control group received dietetic therapy and physical exercises, while those in the treatment group additionally took GLT, 19.2 mg each time, three times daily. The treatment course was 12 months for all. The MQ of all the patients was assessed by WMS-RC before treatment,at 6-month of treatment, and 12-month of treatment.

RESULTSCompared with the control group, the improvement of MQ increased in the treatment group 0.5 and 1 year after treatment (P < 0.05). The clinical efficiency of MQ obviously increased in the treatment group (48.28% and 50.00%), showing statistical difference when compared with the control group (30.91% and 27.27%, P < 0.05, P < 0.01). There was statistical difference in added scores of recognition, regeneration, understanding, and recitation test at 6-month of treatment and 12-month of treatment between the treatment group and the control group (P < 0.05, P < 0.01).

CONCLUSIONGLT was effective in improving MQ of MCI patients, especially in improving recognition, regeneration, understanding, and recitation test.

Aged ; Aged, 80 and over ; Cognitive Dysfunction ; drug therapy ; psychology ; Drugs, Chinese Herbal ; therapeutic use ; Female ; Ginkgo biloba ; chemistry ; Humans ; Male ; Memory ; Middle Aged ; Phytotherapy

Objective To explore the effect of uhrasound-phoresis of Chinese herb in the treatment of frac- ture healing on rats.Methods The animal model of femur fracture was established in 36 rats,who were divided in- to 4 groups after operation.The rats in the ultrasound group were given ultrasound treatment daily.The herbal group was given Chinese herb applied on the fracture site.The experimental group was given uhrasound-phoresis of Chinese herb on the site of fracture.The control group was housed without any treatment.All rats were sacrificed at 30 days and the bony callus were harvested and observed with histological anti immunohistoehemical examination.Results The histological examination showed that the appearance of cartilaginous and bony callus in the experimental group were earlier than those in other groups,Immunohistochemical examination showed that the expression of collagenⅠin the experimental group was significantly higher than that in ultrasound group and herbal group(P

AlM: To investigate the association between the degree of anterioruveitis and related factors including inflammatory markers as well as sacroiliac joint imaging in patients with ankylosing spondylitis ( AS) .
METHODS: Anterior changes evaluated by slit lamp, erythrocyte sedimentation rate ( ESR ) , C - reactive protein ( CRP ) and magnetic resonance imaging of 55 cases with AS associateduveitis were retrospectively analyzed. A modified endotoxin-induced uveitis ( ElU ) clinical standard was used for uveitis grading. SPARCC sacroiliac scoring was used to evaluate bone edema of sacroiliac joint. The correlation between the degree of uveitis and sacroiliitis was assessed.
RESULTS: ln the 55 patients with AS, ElU grading scored 2-10, and SPARCC index scored 0-22. Further analysis showed that the severity of uveitis was significantly correlated with ESR (r=0. 869, P<0. 001) and CRP (r=0. 485, P<0. 001). The degree of anterior uveitis in AS patients was not correlated with inflammation of sacroiliac joint (r=0. 237, P=0. 081).
CONCLUSlON: Local autoimmunity of uveitis and sacroiliac joint inflammation with subsequent bone formation in AS might be mutually independent processes.

The aim of this study was to examine the priming effect of sphingosine 1-phosphate (S1P) on fMLP-activated neutrophils, mainly to detect the neutrophil respiratory burst products, and to investigate the signaling pathway involved in S1P activity. Flow cytometry was used to evaluate the new isolated neutrophil; the superoxide anion output was detected indirectly by cytochrome C reduction in respiratory burst; the dihydro-rhodamine 123 was used to detect the intensity of respiratory burst; the signal transduction pathways of neutrophil respiratory burst were explored by Western blot. The results showed that after pretreated with S1P, the level of superoxide anion released by fMLP-activated neutrophils significantly increased; the Rhodamine 123 mean fluorescence intensity in S1P primed fMLP-activated neutrophils group was significantly higher than that in fMLP treatment group; PI3K and Akt proteins involved in the signal pathway of neutrophil respiratory burst. It is concluded that S1P is a new priming reagent, which primes respiratory burst of fMLP-activated neutrophils; this signal pathway may be that S1P interacts with its receptor, activates PI3K, then activates Akt-transmitting signals through NADPH oxidase, finally results in the respiratory burst.
Cells, Cultured ; Humans ; Lysophospholipids ; metabolism ; NADPH Oxidases ; metabolism ; Neutrophils ; metabolism ; physiology ; Proto-Oncogene Proteins c-akt ; metabolism ; Receptors, Lysosphingolipid ; metabolism ; Respiratory Burst ; Signal Transduction ; Sphingosine ; analogs & derivatives ; metabolism ; Superoxides ; metabolism

OBJECTIVETo analyze the effects and side effects of paclitaxel liposome formula on breast cancer and non-small cell lung cancer, compared with traditional taxol.

METHODS129 patients from multicenters were prospectively randomized into a test group, given paclitaxel liposome at 135 mg/m(2) each session, and a control group, given traditional taxol at 135 mg/m(2) each session. Both groups received these regimens combined with ADM or DDP for two cycles (3 weeks per cycle).

RESULTSOf 129 cases, 128 were eligible for the analysis of side effects and 126 for the overall response rate. The complete remission rate, partial remission rate and overall response rate were 1.6%, 33.3%, 34.9% in the test group and 6.3%, 22.2%, 28.6% in the control group. There was no significant difference between the two groups. Though there was no significant difference in hematological toxicity between the two groups, the toxicity from the mixed solvent of polyethoxylated castor oil and ethanol was significantly lower in the test group than that in the control group.

CONCLUSIONPaclitaxel liposome combined with ADM or DDP in the treatment of advanced breast cancer and non-small-cell lung cancer, being similarly effective as taxol, can significantly lower the incidence of serious hypersensitive reactions.

Adult ; Aged ; Breast Neoplasms ; drug therapy ; Carcinoma, Non-Small-Cell Lung ; drug therapy ; Female ; Humans ; Liposomes ; Lung Neoplasms ; drug therapy ; Male ; Middle Aged ; Paclitaxel ; administration & dosage ; adverse effects ; therapeutic use ; Prospective Studies

Objective To investigate the expression and clinical value of immunohistochemistry in endometrial stromal tumors.Methods Immunohistochemical technique(Envision method)was applied to de- tect the expression of CD_(10),SM-MHC,h-caldesmon,AE1/3,CD_(99),Ki-67,CD_(34),c-kit,ER and PR in 15 cases of endomertrial stromal sarcoma and 3 metastases.The clinical pathological data,including the histological characteristics,histochemical and immunohistochemical staining features,complication,differential diagnosis and prognosis of endometrial stromal tumours were analyzed.Results Among the 18 cases of endometrial stromal tumor,17 cases had shown positive for CD_(10),including 13 cases diffuse positive and 4 muitifocal,7 cases with smooth muscle differentiation,3 cases with epithelial differentiation,7 cases with sex-cord differ- entiation.13 cases of ER and 16 cases of PR were positive expression in endometrial stromal sarcoma.Ki-67 in range 36 %～78 %.Conclusion Endometrial stromal tumour can display multi-differentiation.They show various pathomorphological features,Smooth muscle and sex-coed differentiation,the most common types. CD_(10) can be expressed consistently in endometrial stromal tumors.CD_(10) with h-caldesmon and SM-MHC can be used to make differential diagnosis between the endometrial stromal tumors and cellular leiomy0ma.ER and PR should be routinely estimated and be a prognostic predictor for endometrial stromal sarcoma.

OBJECTIVETo investigate the chemical constituents of Tibetan medicine Phyllanthus emblica.

METHODVarious chromatographic techniques were employed for isolation and purification of the constituents, and the structures were elucidated by chemical and spectral analyses.

RESULT11 compounds were isolated and identified as gallic acid (I), ellagic acid (II), 1-O-galloyl-beta-D-glucose (III), 3,6-di-O-galloyl-D-glucose (IV), chebulinic acid (V), quercetin (VI), chebulagic acid (VII), corilagin (VIII), 3-ethylgallic acid (3-ethoxy-4,5-dihydroxy-benzoic acid, IX), isostrictiniin (X), 1,6-di-O-galloyl-beta-D-glucose (XI).

CONCLUSION3-Ethylgallic acid (3-ethoxy-4,5-dihydroxy-benzoic acid) is a novel compound, and isostrictiniin was found from P. emblica for the first time.

Ellagic Acid ; chemistry ; isolation & purification ; Fruit ; chemistry ; Gallic Acid ; analogs & derivatives ; chemistry ; isolation & purification ; Phyllanthus emblica ; chemistry ; Plants, Medicinal ; chemistry ; Tibet