更新于：2024-11-01

Yigu Capsule

益骨胶囊

更新于：2024-11-01

概要

概要

基本信息

药物类型

中药

别名-

靶点-

作用机制-

治疗领域

内分泌与代谢疾病皮肤和肌肉骨骼疾病

在研适应症

骨质疏松症

非在研适应症-

原研机构-

在研机构

济南开发区金方生物医药研究所北京世佳九生源药业科技有限公司

非在研机构-

最高研发阶段临床2期

首次获批日期-

最高研发阶段(中国)临床2期

特殊审评-

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关联

项与益骨胶囊相关的临床试验

CTR20140585 / Not yet recruiting临床2期

益骨胶囊治疗绝经后骨质疏松症（肾阳亏虚证）的随机、双盲、剂量平行对照、多中心Ⅱa期临床试验

初步探索益骨胶囊治疗绝经后骨质疏松症（肾阳虚证）的有效性和安全性，同时对剂量与有效性和安全性的关系进行初步评价，为下一阶段临床试验提供依据。

开始日期-

申办/合作机构

济南开发区金方生物医药研究所

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100 项与益骨胶囊相关的临床结果

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100 项与益骨胶囊相关的转化医学

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100 项与益骨胶囊相关的专利（医药）

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项与益骨胶囊相关的文献（医药）

2022-12-01·Archives of Osteoporosis3区 · 医学

Efficacy of Yigu® versus Aclasta® in Chinese postmenopausal women with osteoporosis: a multicenter prospective study

3区 · 医学

Article

作者: Xu, Jin ; Xia, Wei-Bo ; Huo, Ya-Nan ; He, Liang ; Yan, Shi-Gui ; Liu, Feng ; Xue, Qing-Yun ; Chao, Ai-Jun ; Xu, You-Jia ; Cheng, Qun ; Jin, Hui ; Li, Mei ; Lin, Jian-Hua ; Zhang, Zhen-Lin ; Jin, Xiao-Lan

AbstractSummaryZoledronic acid (ZOL) is a therapy inhibiting bone resorption. In this study, generic ZOL (Yigu®) showed its clinical efficacy consistency with original ZOL (Aclasta®) in Chinese postmenopausal women with osteoporosis. This study provides a practical basis for the application of Yigu® in Chinese population.IntroductionYigu® has been approved its bioequivalence to Aclasta®. However, the clinical efficacy and safety of Yigu® have not been evaluated yet. Here, we compared the effectiveness and safety between Yigu® and Aclasta® in Chinese postmenopausal women with osteoporosis and assessed the efficacy of intravenous infusion of ZOL.MethodsThis was a randomized open-label, active-controlled study in postmenopausal women with osteoporosis of 14 clinical centers in China. Postmenopausal women with osteoporosis were recruited and randomized to receive a single infusion of 5 mg Yigu® or Aclasta®. The primary endpoint was the percentage change in bone mineral density (BMD) at lumbar spine after 12 months of treatment and was assessed for equivalence. The secondary endpoint was the percentage change in BMD at proximal femur after 12 months. Additional secondary endpoints were percentage changes in BMD at the above sites after 6 months of treatment and changes in bone turnover biomarkers during ZOL treatment. Safety was also evaluated and compared between two groups.ResultsA total of 458 postmenopausal women with osteoporosis were enrolled (n = 227, Yigu®; n = 231, Aclasta®). The mean percentage change in the BMD had no statistical difference at the lumbar spine (5.32% vs 5.18%), total hip (2.72% vs 2.83%), and femoral neck (2.37% vs 2.81%) between Yigu® and Aclasta® groups after 12 months of treatment. The mean difference of BMD change at the lumbar spine after 12 months between two groups was 0.15% (95% CI: − 0.71 to 1.00, equivalence margin: − 1.5%, 1.5%), demonstrating the treatments were equivalent. Meanwhile, the decreases in the P1NP and β-CTX showed no difference between two groups after 14 days and 6 and 12 months of treatment. As regards the whole sample, BMD significantly increased after 12 months of treatment. Also, serum C-terminal telopeptide of type 1 collagen (β-CTX) and procollagen 1 N-terminal peptide (P1NP) significantly decreased at each visit period. The overall adverse events were comparable and quite well between two groups.ConclusionIntravenous infusion of zoledronic acid achieved the potent anti-resorptive effects which led to significant increase in BMD of Chinese postmenopausal women with osteoporosis. Yigu® was equivalent to Aclasta® with respect to efficacy and safety.

2012-04-01·Zhongguo Zhong xi yi jie he za zhi Zhongguo Zhongxiyi jiehe zazhi = Chinese journal of integrated traditional and Western medicine

[Effects of yigu capsule containing serum on the osteoblast differentiation and the expressions of osteoprotegerin and bone morphogenetic protein 2 after treatment by advanced glycation end products in vitro].

Article

作者: Wang, Ting-Chun ; Zhang, Rong-Hua ; Zhu, Xiao-Feng

OBJECTIVETo observe the effects of Yigu Capsule (YGC) containing serum on the differentiation and the expressions of osteoprotegerin (OPG) and bone morphogenetic protein 2 (BMP-2) in osteoblasts after treatment by advanced glycation end products (AGEs), and to explore the mechanisms of YGC for treating osteoporosis (OP).METHODSForty 10-month-old female Sprague Dawley (SD) rats were randomly divided into four groups equally, i.e., the low dose YGC group, the moderate dose YGC group, the high dose YGC group, and the blank control group. The YGC containing serum and the control serum were prepared with the method of gastric perfusion. Primary osteoblasts of newborn SD rats was extracted and cultured, then they were passaged and divided into five groups, i. e., the vehicle control group, the model group, the low dose YGC group, the moderate dose YGC group, and the high dose YGC group. The model group was treated by AGEs (400 mg/L), the three YGC groups were treated by AGEs (400 mg/L) and YGC containing serum at different concentrations. Alkaline phosphatase (ALP) activity, type I collagen (ColI), bone gla protein (BGP), and mineralization of osteoblasts were tested using pNPP, ELISA, and Alizarin dyeing. The mRNA and protein levels of BMP-2 and OPG were respectively determined using RT-PCR and ELISA.RESULTSPrimary osteoblasts from newborn SD rats could be used well in this experiment. Compared with the vehicle control group, the ALP, ColI, BGP, the mRNA and protein levels of BMP-2 and OPG of osteoblasts decreased in the model group, and the mineralized nodes were reduced, showing statistical difference (P<0.01). Compared with the model group, the ALP, ColI, BGP, the mRNA and protein levels of BMP-2 and OPG of osteoblasts increased in the three YGC groups, and the mineralized nodes increased in a dose-dependent manner, showing statistical difference (P<0.05, P<0.01).CONCLUSIONSYGC containing serum could promote the differentiation and mineralization of osteoblasts, and improve the expressions of OPG and BMP-2 after treatment by AGEs. These might be one of YGC's mechanisms for treating OP.

2009-12-15·Journal of Chinese Integrative Medicine

Yunchang Capsule in treatment of functional constipation: a randomized, double-blinded controlled, multicenter trial

Article

作者: Lin, Bing-hui ; Wang, Lei ; Huang, Zong-wen ; Diao, Jun-cheng ; Liu, Song-shan ; Zhang, Rui-ming ; Guo, Jia ; Hu, Si-yuan

BACKGROUNDAlthough there are some Chinese herbal medicines in treatment of constipation, but no multi-center randomized controlled trials have been carried out to prove their effectiveness.OBJECTIVETo evaluate the safety and efficacy of Yunchang Capsule in treatment of functional constipation with deficiency of both qi and yin and internal accumulation of poisonous pathogenic factors syndrome, and to explore the clinical dosage.DESIGN, SETTING, PARTICIPANTS AND INTERVENTIONSA randomized, double-blinded controlled, multicenter trial was conducted. A total of 240 patients with functional constipation from West China Hospital of Sichuan University, Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine, the First Affiliated Hospital of Tianjing University of Traditional Chinese Medicine and Fujian Academy of Traditional Chinese Medicine were randomly divided into three groups: low dose group (80 cases), high dose group (80 cases) and control group (80 cases). Patients in the low dose group were treated with two pills (0.35 g/pill) of Yunchang Capsule and one pill of Yunchang Capsule simulant for three times daily; patients in the high dose group were treated with three pills (0.35 g/pill) of Yunchang Capsule for three times daily; and patients in the control group were treated with three pills (0.35 g/pill) of Biantong Capsule for three times daily. The therapeutic course was 14 days.MAIN OUTCOME MEASURESClinical symptoms, syndromes, and adverse effects were observed before and after the treatment, and blood, urine and stool tests, hepatorenal function and electrocardiogram were also examined.RESULTSTwo cases were excluded, eleven cases were lost to follow-up, and there were 234 patients entered to intention-to-treat (ITT) analysis. After the treatment, the therapeutic effects were calculated by full analysis set (FAS) and per-protocol population set (PPS) analysis respectively. The effects on functional constipation in FAS showed the response rates in the low dose, high dose and control groups were 86.25% (69/80), 82.90% (63/76), and 70.52% (55/78) respectively, and PPS analysis showed the response rates were 85.71% (66/77), 83.56% (61/73), and 70.13% (54/77) respectively. There were no significant differences among the three groups (P>0.05). The effects on traditional Chinese medicine syndrome in FAS showed the response rates in the low dose, high dose and control groups were 78.75% (63/80), 69.74% (53/76), and 67.95% (53/78) respectively, and PPS analysis showed the response rates were 77.92% (60/77), 69.87%(51/73), and 67.53% (52/77) respectively. There were also no significant differences among the three groups (P>0.05). No severe adverse events were observed.CONCLUSIONBoth low dose and high dose of Yunchang Capsule are effective and safe in treatment of functional constipation with deficiency of both qi and yin and internal accumulation of poisonous pathogenic factors syndrome.

100 项与益骨胶囊相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
骨质疏松症	临床2期	中国	北京世佳九生源药业科技有限公司	2014-09-26
骨质疏松症	临床2期	中国	济南开发区金方生物医药研究所	2014-09-26