7 results on '"Dong-Hai Wu"'
Search Results
2. Etoricoxib versus indometacin in the treatment of Chinese patients with acute gouty arthritis: a randomized double-blind trial
- Author
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Ting, Li, Shun-le, Chen, Qing, Dai, Xing-Hai, Han, Zhan-Guo, Li, Dong-Hai, Wu, Xiao, Zhang, Jie-Ruo, Gu, Nan-Ping, Yang, Ling-Yun, Sun, Miu-Jia, Zhang, Xing-Fu, Li, and Chun-de, Bao
- Subjects
Adult ,Male ,Etoricoxib ,Double-Blind Method ,Arthritis, Gouty ,Pyridines ,Indomethacin ,Humans ,Cyclooxygenase Inhibitors ,Female ,Sulfones ,Middle Aged ,Aged - Abstract
Acute gout is an intensely painful, inflammatory arthritis. Although the non-steroidal anti-inflammatory drugs (NSAIDs) are widely used for this condition, the efficacy is based on only a few studies, particularly in China. We tried to assess the safety and efficacy of etoricoxib in the treatment of acute gouty arthritis in China.A randomized, double-blind, active comparator study was conducted at 10 sites in China. Patients (n = 178; ≥ 18 years of age) with acute gouty attack (48 hours) were treated for 5 days with etoricoxib (120 mg/d; n = 89) or indometacin (75 mg twice daily; n = 89). The primary efficacy end point was self-assessed pain in the affected joint (0-4 point Likert scale) from days 2 - 5. Secondary end points included investigator assessments of tenderness and swelling, patient/ investigator global assessments of response to therapy, and patients discontinuing treatment. Safety was assessed by adverse events (AEs).Etoricoxib and indometacin had comparable primary and secondary end points. Mean change difference from baseline from days 2 - 5 was 0.03 (95% confidence interval (CI) -0.19 to 0.25; P = 0.6364), which fell within the prespecified comparative bounds of -0.5 to 0.5. No severe AEs were associated with etoricoxib use. Non-severe AEs were mainly digestive and general, and most (73.7%) were mild, although they caused withdrawal of two subjects in the etoricoxib group, due to bilateral renal calculi and uronephrosis of the left kidney (unrelated to etoricoxib) and fever and chills (potentially etoricoxib-related). Overall, AEs were similar, although the absolute number of AEs in the etoricoxib group (n = 31) was less than the indometacin group (n = 34).Etoricoxib (120 mg once daily) is effective in treating acute gout, is generally safe and well-tolerated, and is comparable in efficacy to indometacin (75 mg twice daily).
- Published
- 2013
3. [The safety of hydroxychloroquine in pregnant patients with systemic lupus erythematosus]
- Author
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Lu, Zhang, Li, Ma, Bing, Lin, Dong-hai, Wu, and Guo-chun, Wang
- Subjects
Adult ,Pregnancy Complications ,Young Adult ,Pregnancy ,Humans ,Lupus Erythematosus, Systemic ,Female ,Hydroxychloroquine ,Retrospective Studies - Abstract
To evaluate the efficacy and safety of hydroxychloroquine (HCQ) in pregnant patients with systemic lupus erythematosus (SLE).Twenty-four pregnant patients with SLE treated with HCQ during pregnancy from May, 2006 to February, 2011 were studied retrospectively. All babies were followed up during early infancy for growth development.Of them, 22 patients were treated with HCQ throughout the whole pregnancy with no lupus flare occurred in 21 patients (95.4%), while temporary discontinuation of HCQ precipitated a flare of disease in two patients. Three patients (12.5%) had premature delivery, and pregnancy induced hypertension happened in 3 patients (12.5%). No congenital abnormalities occurred and mean follow-up of 26 months (range 1 - 47 months) revealed no abnormalities in these children.Our findings reinforce the safety of HCQ therapy during pregancy and HCQ should probably be maintained throughout the pregancy in patients with SLE.
- Published
- 2012
4. [A multicenter, double-blind, placebo-controlled, randomized, phase III clinical study of etanercept in treatment of ankylosing spondylitis]
- Author
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Feng, Huang, Jie, Zhang, Jian-lin, Huang, Dong-hai, Wu, Zhan-guo, Li, Shun-le, Chen, Yun-feng, Pan, Li, Ma, Shi, Chen, Liang-jing, Lü, and Zun-ming, Yang
- Subjects
Adult ,Male ,Young Adult ,Double-Blind Method ,Endpoint Determination ,Immunoglobulin G ,Anti-Inflammatory Agents, Non-Steroidal ,Humans ,Female ,Spondylitis, Ankylosing ,Receptors, Tumor Necrosis Factor ,Etanercept - Abstract
To evaluate the short-term efficacy and safety of etanercept treatment in Chinese patients with active ankylosing spondylitis (AS).This was a 12-week multicenter, double-blind, placebo-controlled, randomized phase III clinical study. The first part was a 6-week placebo-controlled period followed by a 6-week open-label period. The primary efficacy endpoint was the percentage of subjects achieving a 20% improvement in assessment in ankylosing spondylitis (ASAS) (ASAS 20). The secondary efficacy endpoints were the percentage of patients achieving a 40% improvement in ASAS (ASAS 40), achieving a 50% improvement in ASAS (ASAS 50), achieving a 70% improvement in ASAS (ASAS 70), and ASAS 5/6 responses at all visits, and the improvement in subject global assessment, physician global assessment, nocturnal and total back pain, bath AS functional index (BASFI), bath AS disease activity index (BASDAI), spinal mobility, joint assessment and quality of life assessment. All subjects in the study were evaluated for safety.The primary endpoint, ASAS 20 at week 6, was achieved by 86.5% (64/74) patients in the etanercept group compared to 29.5% (23/78) patients in the placebo group (P0.001). As early as week 2, the percentages of patients achieving the ASAS 20 between the two groups were significantly different. Furthermore, the majority of secondary efficacy end points were also significantly improved. Most of adverse events (AE) were mild in nature, the commonest adverse events were elevated liver function levels, injection site reactions and nasopharyngitis. No death or serious AE were observed.Etanercept can improve symptoms fastly, significantly and safely in Chinese patients with active AS.
- Published
- 2010
5. [Adalimumab plus methotrexate for the treatment of rheumatoid arthritis: a multi-center randomized, double-blind, placebo-controlled clinical study.]
- Author
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Feng, Huang, Feng-Chun, Zhang, Chun-de, Bao, Yi, Tao, Jie-Ruo, Gu, Jian-Hua, Xu, Ping, Zhu, Hu-Ji, Xu, Zhi-Yi, Zhang, Dong-Bao, Zhao, and Dong-Hai, Wu
- Subjects
Arthritis, Rheumatoid ,Methotrexate ,Treatment Outcome ,Double-Blind Method ,Tumor Necrosis Factor-alpha ,Antirheumatic Agents ,Adalimumab ,Quality of Life ,Antibodies, Monoclonal ,Humans ,Drug Therapy, Combination ,Antibodies, Monoclonal, Humanized - Abstract
To investigate the efficacy and safety of adalimumab plus methotrexate (MTX) for the treatment of rheumatoid arthritis (RA).This is a multi-center, randomized, double-blind, parallel-group, and placebo-controlled clinical study, included a total of 302 cases of active rheumatoid arthritis, randomized into three groups of observation: 40 mg adalimumab (121 cases), 80 mg adalimumab (121 cases), or placebo (60 cases). Upon enrollment, all subjects had been previously treated with MTX for at least 3 months, and their doses of drug had remained stable for at least 28 days. The double-blind phase lasted for 12 weeks, during which the subjects were administered with adalimumab or placebo subcutaneously every other week. Then the subjects entered into another 12 weeks of open-label study, which included subcutaneous injection of 40 mg adalimumab every other week. In both the double-blind and the open-label periods, all subjects were maintained concomitantly with MTX that had already been used before this study. The primary efficacy variables were evaluated on basis of American College of Rheumatology (ACR)20 response rate at week 12. The secondary efficacy variables included: ACR20 response rate at week 24; ACR50 and ACR70 response rates at weeks 12 and 24; and changes at weeks 12 and 24 compared with baseline observations for tender and swollen joint counts, as well as the assessment of pain with visual analog scale (VAS), the physician's and the patient's global assessment of disease activity (VAS), and the analysis on health assessment questionnaire (HAQ) and health related quality of life (HRQL) measured by Short Form-36 (SF-36); The safety variables mainly included adverse events (AE).During the double-blind period, subjects treated with 40 mg of adalimumab, 57.0% achieved ACR20 response at week 12 (P = 0.004 versus placebo), and subjects treated with 80 mg of adalimumab, 51.2% achieved ACR20 response at week 12 (P = 0.026 versus placebo), and only 35.0% of subjects treated with placebo achieved ACR20 response at week 12. On the other hand, 32.2% of subjects receiving 40 mg of adalimumab achieved ACR50 response (P = 0.009 versus placebo), and 15.7% achieved ACR70 response (P = 0.007 versus placebo) at week 12. Subjects treated with 40 mg of adalimumab got a better result versus placebo at week 12 for tender joint count, swollen joint count, and improvement in C-reactive protein; and subjects treated with 80 mg of adalimumab were also seen an amelioration versus placebo at week 12 for swollen joint count, and improvement in C-reactive protein; all of these findings were statistically significant in differences. During the open-label period all subjects received 40 mg of adalimumab, and response rates for ACR20, ACR50, and ACR70 in the two treatment groups of 40 mg and 80 mg adalimumab were maintained or improved from week 12 to week 24 (being 73.1%, 40.3% and 17.6% respectively for 40 mg group; 71.1%, 39.5% and 17.5% respectively for 80 mg group); while response in the original placebo group (being 67.8%, 44.1% and 18.6%) increased during the 12-week open-label period to match that of the original adalimumab treatment groups. While for changes in tender and swollen joint counts, VAS, HAQ, SF-36, a significant improvement was seen at week 24 when compared with baseline and week 12 values. Throughout the double-blind and open-label period, adverse events reported in/= 5% of subjects at least possibly associated with the study drug were upper respiratory tract infection, nasopharyngitis, and injection site itching, mostly being mild to moderate in severity. There were 3 cases of tuberculosis reported during this study. And 3 cases of serious adverse event (SAE) were reported among the adalimumab subjects during the double-blind period, which were determined as unrelated or probably unrelated to the study drug. And 8 cases (2.7%) of SAE were seen among the adalimumab subjects during the open-label period, 3 of which were at least possibly unrelated with the study drug. All SAEs reported were consistent to those seen in other adalimumab trials. No other unexpected safety signals were reported.Adalimumab plus MTX is better than single MTX in efficacy for the treatment of RA. Being generally safe and well tolerated, adalimumab plus MTX can significantly increase the response rate, continuously reduce the arthritic signs, symptoms and the inflammatory factors in patients, and also be helpful for reducing disabilities and improving the global quality of life for the patients.
- Published
- 2010
6. [Efficacy and safety of infliximab in patients with rheumatoid arthritis]
- Author
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Wen, Zhang, Qun, Shi, Dong-hai, Wu, Chun-de, Bao, Nan-ping, Yang, Zhan-guo, Li, Ping, Zhu, Xiao, Zhang, Ci-bo, Huang, Dong-yi, He, Zhi-zhong, Ye, Yi, Tao, Yong-fei, Fang, Jie-ruo, Gu, Hua-xiang, Wu, Ling-yun, Sun, Xiu-yan, Yang, Feng, Huang, Hu-ji, Xu, Dong-bao, Zhao, Miao-jia, Zhang, Yi, Zheng, Mai-xing, Ai, Jun, Lu, and Feng-chun, Zhang
- Subjects
Adult ,Arthritis, Rheumatoid ,Male ,Young Adult ,Methotrexate ,Antirheumatic Agents ,Antibodies, Monoclonal ,Humans ,Female ,Prospective Studies ,Middle Aged ,Infliximab ,Aged - Abstract
To investigate the efficacy and safety of Infliximab (IFX) plus methotrexate (MTX) combination therapy in patients with rheumatoid arthritis (RA).Prospectively observe refractory RA patients who were treated with combination therapy of MTX and IFX. IFX was infused at the dosage of 3 mg/kg, in week 0, 2, 6, and then every 8 weeks. During treatment, clinical variables, disease activity and adverse effects were evaluated.After treatment, 69.8%, 52.4%, 29.5% and 7.2% RA patients achieved ACR20, ACR50, ACR70 and ACR90 respectively. There were significant statistical differences in the changes of swollen joint counts, tender joint counts, VAS scale, patient' s global assessment, and physician's global assessment before and after therapy.Infliximab plus MTX achieved significant efficacy and safety in refractory RA patients.
- Published
- 2009
7. Evaluation of efficacy and safety of diacerein in knee osteoarthritis in Chinese patients
- Author
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Wen-Jie, Zheng, Fu-Lin, Tang, Jun, Li, Feng-Chun, Zhang, Zhan-Guo, Li, Yin, Su, Dong-Hai, Wu, Li, Ma, Hui-Qiong, Zhou, Feng, Huang, Jiang-Lin, Zhang, Dong-Feng, Liang, Yi-Xiong, Zhou, and Hui, Xu
- Subjects
Adult ,Male ,Diclofenac ,Double-Blind Method ,Anti-Inflammatory Agents, Non-Steroidal ,Humans ,Anthraquinones ,Female ,Middle Aged ,Osteoarthritis, Knee ,Safety ,Aged - Abstract
To evaluate the efficacy and safety of diacerein in patients with knee osteoarthritis (OA).A total of 223 patients satisfying the American College of Rheumatology criteria for knee OA were chosen for this 17-week, randomized, double-dummy, diclofenac sodium-controlled trial, with diacerein dosage of 100 mg/d and diclofenac sodium of 75mg/d. Efficacy and safety of both drugs were evaluated.Totally 106 patients in the diacerein group and 107 patients in the diclofenac group were considered qualified for the evaluation. After 12 weeks of treatment, the total effective rates of patients/physicians' overall assessment in diacerein and diclofenac groups were 65.4%/61.6% and 61.2%/61.2%, respectively (P0.05). The primary efficacy parameter [visual analog scale (VAS) assessment of pain on 20 metres walking] and the secondary efficacy parameters [tenderness on palpation, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and 36-item Short-Form (SF-36) Health Survey] significantly improved compared with baseline in both groups (P0.05). In the follow-up period, there were no obvious changes in above parameters in diacerein group. However, in diclofenac group, pain on 20 metres walking, tenderness on palpation, and WOMAC became aggravated after withdrawing the drug for 4 weeks (P0.05). Moreover, the consumption of paracetamol was significantly lower in diacerein group than in diclofenac group during follow-up (P0. 001). The incidences of related adverse events were 35.7% in diacerein and 45.1% in diclofenac group, respectively. Mild-to-moderate gastrointestinal disorders were the most frequent adverse events.Diacerein is as effective as diclofenac sodium in treating patients with knee OA. Furthermore, it has better extended effect and a good safety profile. It is generally well tolerated and has no severe adverse effect.
- Published
- 2006
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