主要目的：以盐酸布比卡因注射液为对照，评价HYR-PB21用于单侧全膝关节置换术后镇痛治疗的有效性。次要目的：（1）观察试验药物和阳性对照药AE发生情况，评价HYR-PB21用于单侧全膝关节置换术后镇痛治疗的安全性。（2）考察单侧全膝关节置换术中关节周围局部浸润给药途径下，HYR-PB21的血浆布比卡因药代动力学特征。

开始日期2024-06-04

申办/合作机构

合肥合源药业有限公司

100 项与 HYR-PB21 相关的临床结果

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100 项与 HYR-PB21 相关的转化医学

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100 项与 HYR-PB21 相关的专利（医药）

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项与 HYR-PB21 相关的文献（医药）

2022-12-01·British Journal of Anaesthesia

Local infiltration of HYR-PB21, a sustained-release formulation of bupivacaine, provides analgesia and reduces opioid requirement after haemorrhoidectomy: a randomised controlled trial

Article

作者: Xu, Qing ; Sun, Jinwen ; Wang, Zhenjun ; Zhang, Shanchun ; Huang, Wei ; Yu, Yunxian ; Cui, Jinjie ; Yu, Zhengya ; Zheng, Yi ; Gao, Shu

BACKGROUNDHYR-PB21 is a new sustained-release formulation of bupivacaine indicated for controlling postoperative pain. The objectives of this study were to investigate the analgesic efficacy and safety profile of HYR-PB21 in patients after haemorrhoidectomy.METHODSThis was a multicentre, randomised, double-blind, positive-controlled trial. Patients were assigned randomly to receive a single dose of HYR-PB21 (150 mg or 300 mg) or bupivacaine HCl (75 mg) after surgery for prolapsing haemorrhoids. Postoperative pain was evaluated using a numeric rating scale at rest to calculate a cumulative pain score. Total rescue opioid usage and the proportion of subjects receiving rescue opioid were also assessed.RESULTSWe enrolled 72 patients with haemorrhoidectomy, and 71 patients completed the study. The average cumulative pain score through 72 h after surgery in the 300 mg HYR-PB21 group (87 scores) was lower than in the bupivacaine HCl group (166 scores) in an intention-to-treat analysis (P<0.001). There was a dose-response effect in reducing total opioid usage and the proportion of rescue opioid use between the 150 mg and 300 mg HYR-PB21 groups, with bupivacaine HCl as a reference group. The HYR-PB21 groups did not show more adverse effects than the bupivacaine HCl group.CONCLUSIONSLocal infiltration of a single dose of HYR-PB21 sustained-release bupivacaine had better efficacy in controlling postoperative pain, with similar adverse effects, compared with a single dose of bupivacaine HCl in patients after haemorrhoidectomy.CLINICAL TRIAL REGISTRATIONChiCTR2000041318 (Chinese Clinical Trial Registry).

2020-05-01·Regional Anesthesia & Pain Medicine2区 · 医学

HYR-PB21-LA, a potential extended-release bupivacaine formulation, produces long-lasting local anesthesia in rats and guinea pigs

2区 · 医学

Article

作者: Liu, Jingjing ; Zhang, Shanchun ; Lu, Xiaorong ; Gao, Shu ; Sun, Hongzhang ; Yu, Yunxian ; Wang, Yihua ; Peng, Jiashi ; Liu, Chang

BackgroundEffective postoperative pain management plays a key role in enhancing recovery of patients after surgery. Bupivacaine hydrochloride is one of the most commonly local anesthetics used for the postoperative pain control. However, the relatively short anesthesia duration of bupivacaine preparations limited their clinical application.MethodsBoth guinea pig pin-prick study and rat tail-flick test were performed to evaluate the local anesthesia efficacy of HYR-PB21-LA, a new microparticle suspension injection of bupivacaine pamoate.ResultsIn the pin-prick test, the complete cutaneous trunci muscle reflex inhibitions were observed at 30 min in all treatment groups containing bupivacaine. In comparison with 6.7 mg/mL HYR-PB21-LA, both 10 and 20 mg/mL HYR-PB21-LA groups had significantly higher area under effect time curve (AUEC) values (p<0.001 and p<0.0001) and slower offset time (p<0.0001). Significantly higher AUEC (p<0.0001) and slower offset time (p<0.0001) were also found in 10 mg/mL HYR-PB21-LA treatment group compared with bupivacaine liposome injectable suspension (liposomal bupivacaine). In the rat tail-flick test, significantly increased local anesthesia effect was lasted for 5 hours after 2.5 mg/mL HYR-PB21-LA administration, which was fivefold longer than bupivacaine hydrochloride. The longer lasted efficacy of significantly increased local anesthesia was also observed in 5 mg/mLHYR-PB21-LA than those in liposomal bupivacaine (8 hour vs 1 hour).ConclusionsThe results demonstrated that the HYR-PB21-LA produced longer local anesthesia effect than current clinical preparations of bupivacaine in two animal models. These findings raise the potential clinical value of HYR-PB21-LA as a long-lasting local anesthesia for controlling postsurgical pain in humans.

100 项与 HYR-PB21 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
麻醉	临床3期	中国	合肥合源药业有限公司	2024-01-24
术后疼痛	临床3期	中国	合肥合源药业有限公司	2024-01-24
带状疱疹	临床3期	中国	合肥合源药业有限公司	2021-06-15
神经痛	临床3期	中国	合肥合源药业有限公司	2021-06-15
镇痛	临床3期	中国	合肥合源药业有限公司	2021-03-24
痔疮	临床3期	中国	合肥合源药业有限公司	2021-03-24