更新于：2024-05-03
Etanercept biosimilar (Qilu Pharmaceutical)
依那西普生物类似药 (齐鲁制药)
更新于：2024-05-03
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Sequence Code 38320
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6
项与 依那西普生物类似药 (齐鲁制药) 相关的临床试验一项多中心、随机、双盲、平行比较QL0902与恩利在活动性类风湿关节炎患者中的有效性和安全性III期临床研究
QL0902与恩利在健康志愿者中的药代动力学和安全性比对研究
A randomized, double-blind, single-dose, two-cycle, double-crossover design trial of recombinant human type II tumor necrosis factor receptor-antibody fusion protein (QL0902) for injection and the pharmacokinetics of Enli? in healthy volunteers Safety comparison study
100 项与 依那西普生物类似药 (齐鲁制药) 相关的临床结果
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100 项与 依那西普生物类似药 (齐鲁制药) 相关的转化医学
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100 项与 依那西普生物类似药 (齐鲁制药) 相关的专利（医药）
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18
项与 依那西普生物类似药 (齐鲁制药) 相关的文献（医药）2023-04-01Journal of Children's Orthopaedics
Diagnosis and treatment of 10 cases of idiopathic chondrolysis of the hip
Article
作者: Li, Yue ; Fang, Bin ; Zhao, Dun ; Guan, Tianan ; Xiong, Hao
Objective::
To analyze the clinical characteristics, X-ray and magnetic resonance imaging manifestations, and treatment efficacy of idiopathic chondrolysis of the hip.
Methods::
Ten patients with idiopathic chondrolysis of the hip treated at our hospital from September 2013 to April 2022 were collected, and their clinical features, X-ray and magnetic resonance imaging manifestations, and treatment outcomes were analyzed.
Results::
Their main clinical features included single hip pain, claudication gait, and pelvic tilt, without specific clinical symptoms and signs. Laboratory tests such as blood analysis, erythrocyte sedimentation rate, C-reactive protein, rheumatoid factor, autoimmune test, coagulation function, interferon release test for tuberculosis infection, and tuberculosis antibody test were normal. In the late stage, the imaging shows degeneration or ankylosis of the joint. The disease progresses rapidly, and joint degeneration can occur in adolescence without effective treatment. Herein, seven patients were treated with recombinant human tumor necrosis factor receptor–antibody type II fusion protein. Among them, four (according to Camarnat magnetic resonance imaging classification, three were Stage I and one was Stage II) showed improved symptoms and function, while two (Stage III) had progressed. One patient (Stage I) who received recombinant human tumor necrosis factor receptor had no significant relief of symptoms, for whom anterior capsular release surgery significantly improved the hip joint motion. Of the four patients who underwent hip release surgery, three showed progression.
Conclusion::
Idiopathic chondrolysis of the hip has no specific clinical and laboratory tests and a high misdiagnosis rate. Thus, early magnetic resonance imaging is a critical reference for diagnosis. We recommend that patients with magnetic resonance imaging Stage II or earlier be actively treated with recombinant human tumor necrosis factor receptor and start treatment as early as possible. In the third stage, the treatment effect is mediocre, and the narrowed hip space is difficult to change.
2022-11-01Clinical Pharmacology in Drug Development
Pharmacokinetic Characteristics, Safety, and Tolerability of Telitacicept, an Injectable Recombinant Human B‐Lymphocyte Stimulating Factor Receptor‐Antibody Fusion Protein, in Healthy Chinese Subjects
Article
作者: Fan, Xiaoyun ; Ge, Qin ; Wang, Huaxue ; Chen, Xiao ; Liu, Yuanyuan ; Ma, Ling ; Chen, Juan ; Xie, Jing ; Wang, Ying ; He, Cuixia ; Zhu, Xingyu ; Zhu, Minhui ; Li, Zhijun ; Liu, Bingyan ; Zhu, Juan ; Fan, Ling ; Xie, Yunqiu ; Cao, Shugang ; Su, Yue ; Zhou, Huan
Abstract:
Telitacicept, an injectable recombinant human B‐lymphocyte stimulating factor receptor‐antibody fusion protein, is a new dual B lymphocyte stimulator (BLyS)/APRIL (a proliferation‐inducing ligand) inhibitor that effectively blocks proliferation of B lymphocytes. This study evaluates the pharmacokinetic characteristics, tolerability, and safety of a single subcutaneous injection of various doses (80, 160, and 240 mg) of telitacicept in healthy Chinese subjects. This trial is a single‐center, randomized, open‐label phase I clinical study that includes three dose groups (80, 160, and 240 mg) with 12 subjects in each dose group. The subjects were randomly assigned to different dose groups in a 1:1:1 ratio for a single subcutaneous administration trial. After a single dose, the maximum serum concentration (Cmax) of total and free telitacicept was reached within 0.5‐1 days. The elimination half‐lives of total and free telitacicept at doses of 80–240 mg were 10.9–11.9 days and 11–12.5 days, respectively. The formation and elimination of the BLyS‐telitacicept complex were much slower; the median time to Cmax was 15–57 days and was significantly prolonged with increasing dose. Only two of the 36 healthy subjects had positive antidrug antibodies with antibody titers of 1:15. The severity of adverse events was mild or moderate, and no higher treatment‐emergent adverse events were reported. In conclusion, total telitacicept within a dose range of 80–240 mg and free telitacicept within a dose range of 160–240 mg had linear pharmacokinetic characteristics.
2022-09-12Zhongguo zhen jiu = Chinese acupuncture & moxibustion
[Effect on ankylosing spondylitis at early-middle stage and bone marrow edema of sacroiliac joint treated with acupuncture and governor vessel moxibustion].
Article
作者: Chen, Qing-Wei ; Zhang, Xue ; Bu, He ; Lv, Hong-Yan ; Yan, Hui-Ming ; Wang, Zi-Xuan ; Ma, Yao
OBJECTIVE:
To observe the efficacy of the combined treatment with acupuncture and governor vessel moxibustion on ankylosing spondylitis (AS) at early-middle stage and investigate the effect on bone marrow edema of sacroiliac joint.
METHODS:
Seventy patients of AS at early-middle stage were randomized into an observation group (35 cases) and a control group (35 cases, 1 case dropped off ). In the control group, the recombinant human tumor necrosis factor receptor-antibody of type Ⅱ fusion protein for injection was injected subcutaneously, 25 mg each time, once on every Monday and Friday, consecutively for 3 weeks. In the observation group, on the base of the intervention as the control group, acupuncture combined with governor vessel moxibustion were provided. Acupuncture was applied to Dazhui (GV 14), Changqiang (GV 1), Zhibian (BL 54), Baihui (GV 20), etc.; the thermal needling technique was adopted at Dazhui (GV 4) and Changqiang (GV 1) for promoting the circulation of the governor vessel, and the ginger-isolated moxibustion on the governor vessel was combined. Such intervention measure was provided once daily. One treatment session contained 7 treatments and 3 sessions were required. Before and after treatment, the scores of Spondyloarthritis Research Consortium of Canada (SPARCC), Bath ankylosing spondylitis disease activity index (BASDAI) and Bath ankylosing spondylitis functional index (BASFI) and Bath ankylosing spondylitis patient global score (BAS-G) were observed in the two groups separately. The efficacy and adverse effects were assessed in the two groups after treatment.
RESULTS:
The scores of SPARCC, BASDAI, BASFI and BAS-G were all reduced after treatment compared with those before treatment in the two groups (P<0.05), and those in the observation group were lower than the control group (P<0.05). The total effective rate was 97.1% (34/35) in the observation group, higher than 82.4% (28/34) in the control group (P<0.05). There were 4 cases of gastrointestinal reactions and 1 case of skin rashes in the control group; and 3 cases of local skin redness and pruritus after governor vessel moxibustion, no any drug adverse effect was found in the observation group.
CONCLUSION:
Based on the western medicine treatment, the combined therapy of acupuncture and governor vessel moxibustion may relieve bone marrow edema of sacroiliac joint in patients with AS at early-middle stage, control the progression of disease and improve the daily life activity. This therapy is relatively safe and effective.
100 项与 依那西普生物类似药 (齐鲁制药) 相关的药物交易
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临床结果
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临床1期 | - | 68 | 衊糧憲鹹繭簾襯構夢積(憲醖淵餘糧願鬱鹽鑰築) = 構範窪構鑰鬱蓋憲鑰鹽 壓壓積願醖範簾艱齋憲 (選艱窪壓廠膚鑰襯顧蓋 ) 更多 | - | 2020-03-21 | ||
Reference Etanercept | 衊糧憲鹹繭簾襯構夢積(憲醖淵餘糧願鬱鹽鑰築) = 鏇積簾廠網齋製鏇積廠 壓壓積願醖範簾艱齋憲 (選艱窪壓廠膚鑰襯顧蓋 ) 更多 |
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