重组人骨形态发生蛋白6(Angitia Biopharmaceuticals Guangzhou)(Recombinant Human Bone Morphogenetic Protein 6(Angitia Biopharmaceuticals Guangzhou))

概要

基本信息

药物类型

蛋白类药物

别名-

靶点-

作用机制-

治疗领域

皮肤和肌肉骨骼疾病

在研适应症

椎间盘疾病

非在研适应症-

原研机构

安济盛生物医药技术（广州）有限公司

在研机构

安济盛生物医药技术（广州）有限公司

非在研机构-

最高研发阶段临床申请批准

首次获批日期-

最高研发阶段(中国)临床申请批准

特殊审评-

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关联

100 项与重组人骨形态发生蛋白6(Angitia Biopharmaceuticals Guangzhou) 相关的临床结果

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100 项与重组人骨形态发生蛋白6(Angitia Biopharmaceuticals Guangzhou) 相关的转化医学

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100 项与重组人骨形态发生蛋白6(Angitia Biopharmaceuticals Guangzhou) 相关的专利（医药）

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71

项与重组人骨形态发生蛋白6(Angitia Biopharmaceuticals Guangzhou) 相关的文献（医药）

2024-10-01·Cureus Journal of Medical Science

Healing of Humerus Non-union Fracture Using Recombinant Human Bone Morphogenetic Protein With Bone Graft Compared to Bone Graft Alone: A Systematic Review and Meta-Analysis.

Review

作者: Aleisa, Aljoharah I ; Alhakbani, Mohammed S ; AlTreef, Wail A ; AlQahtani, Abdulaziz A ; Al Gahtani, Haif K ; Alnasser, Mohammed N

Non-union fractures of the humerus present significant challenges in orthopedic surgery, often requiring advanced treatments to achieve successful bone healing. The study aimed to compare the use of recombinant human bone morphogenetic protein (rhBMP) with bone grafts versus bone grafts alone for treating humerus non-union fractures with regard to healing rate and complications. Six databases, PubMed, ScienceDirect, The Cochrane Library, Scopus, Web of Science, and Google Scholar, were searched for relevant literature using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and studies were selected according to the set eligibility criteria. Quality assessment was performed using the Mixed Methods Appraisal Tool for randomized controlled trials (RCTs) and non-RCTs. Review Manager (RevMan) version 5.4 (2020, The Cochrane Collaboration, London, United Kingdom) was utilized for meta-analysis at a significance level of 0.01. Eighteen research papers were included for qualitative and quantitative analysis. Due to the unavailability of RCTs, data from the two studies were combined. The pooled data from 16 studies for effectiveness regarding union achieved for rhBMP with bone graft versus bone graft alone was 0.65 (95%CI: 0.07-6.38, I² =67%, p=0.02). For rhBMP-2 and rhBMP-7 with bone graft, the pooled data was 0.09 (95%CI: 0.00-3.63) with high heterogeneity (I² =88%) and statistically significant differences (p<0.00001). In the sub-group analysis, the pooled data for infection rate was 1.18 (95%CI, 0.37-3.73) with 39% heterogeneity and a non-significant difference (p=0.10). Adding rhBMP to bone grafts may not significantly improve union rates compared to bone graft alone in humerus non-union fractures. However, the trend shows increased infection rates with rhBMP usage. Further high-quality RCTs are warranted to confirm these findings and elucidate the optimal management strategy for humerus non-union fractures.

2024-03-01·Journal of neurosurgery. Pediatrics

Association between structural rib autograft and the rate of arthrodesis in children undergoing occiput–C2 instrumentation and fusion

Article

作者: Anderson, Richard C E ; Cheung, Alexander T M ; Hedequist, Daniel ; Brockmeyer, Douglas ; Kurland, David B ; Rodriguez-Olaverri, Juan ; Harter, David H ; Samdani, Amer F ; Eremiev, Alexander ; Pahys, Joshua M ; Dastagirzada, Yosef ; Oetgen, Matthew ; Cook, Danielle

OBJECTIVE:

The purpose of this study was to identify factors associated with fusion success among pediatric patients undergoing occiput–C2 rigid instrumentation and fusion.

METHODS:

The Pediatric Spine Study Group registry was queried to identify patients ≤ 21 years of age who underwent occiput–C2 posterior spinal rigid instrumentation and fusion and had a 2-year minimum clinical and radiographic (postoperative lateral cervical radiograph or CT scan) follow-up. Fusion failure was defined clinically if a patient underwent hardware revision surgery > 30 days after the index procedure or radiographically by the presence of hardware failure or screw haloing on the most recent follow-up imaging study. Univariate comparisons and multivariable logistic regression analyses were subsequently performed.

RESULTS:

Seventy-six patients met inclusion criteria. The median age at surgery was 9 years (range 1.5–17.2 years), and 51% of the cohort was male. Overall, 75% of patients had syndromic (n = 41) or congenital (n = 15) etiologies, with the most frequent diagnoses of Down syndrome (28%), Chiari malformation (13%), and Klippel-Feil syndrome (12%). Data were available to determine if there was a fusion failure in 97% (74/76) of patients. Overall, 38% (28/74) of patients had fusion failure (95% CI 27%–50%). Univariate analysis demonstrated that use of a rigid cervical collar postoperatively (p = 0.04) and structural rib autograft (p = 0.02) were associated with successful fusion. Multivariable logistic regression analysis determined that patients who had rib autograft used in surgery had a 73% decrease in the odds of fusion failure (OR 0.27, 95% CI 0.09–0.82; p = 0.02). Age, etiology including Down syndrome, instrumentation type, unilateral instrumentation, use of recombinant human bone morphogenetic protein, and other variables did not influence the risk for fusion failure.

CONCLUSIONS:

In this multicenter, multidisciplinary, international registry of children undergoing occiput–C2 instrumentation and fusion, fusion failure was seen in 38% of patients, a higher rate than previously reported in the literature. The authors’ data suggest that postoperative immobilization in a rigid cervical collar may be beneficial, and the use of structural rib autograft should be considered, as rib autograft was associated with a 75% higher chance of successful fusion.

2023-08-01·The surgeon : journal of the Royal Colleges of Surgeons of Edinburgh and Ireland

Recombinant human bone morphogenetic protein is a valid alternative to autologous bone graft for long bone non-unions: a systematic review and meta-analysis

Review

作者: Yu, Chengqiang ; Huang, Yu ; Xie, Chengxin ; Huang, Wenwen ; Yin, Dong ; Li, Qinglong ; Wang, Chenglong

OBJECTIVE:

To compare the efficacy of recombinant human bone morphogenetic proteins (rhBMPs) and autologous bone graft (ABG) on the healing of long bone non-union.

METHODS:

A systematic literature search was conducted on PubMed, Web of Science, Cochrane Library, and CNKI up to December 2021. Two authors independently screened the studies, extracted data, and assessed the quality of the trials. A Meta-analysis was performed using state software (version 12.0).

RESULTS:

A total of 14 studies were included in this meta-analysis. Overall, there was no significant difference between the rhBMPs group and the ABG group in terms of healing rate (RR = 1.04, 95% CI = 0.96-1.12, p = 0.365) and healing time (SMD = -0.31, 95% CI = -0.76-0.14, p = 0.175). Subgroup analysis showed rhBMPs lead to higher healing rates (RR = 1.35, 95% CI = 1.17-1.56, p < 0.001), and shorter healing time (SMD = -0.65, 95% CI = -1.08 to -0.22, p = 0.003) in the subgroup of moderate-quality studies. Sensitivity analysis proved that our conclusions were relatively robust. No significant publication bias was recognized in all studies (Begg's test, p = 0.193; Egger's test, p = 0.307).

CONCLUSIONS:

RhBMPs or combined with allografts bone, inorganic bone was a valid alternative to ABG for the treatment of long bone non-union.

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