HERNICORE 1.25units（Condoliase）注射剂由日本[生化学工业]公司研发的新药，直接注射腰椎的椎间盘突出。本品也是世界上第一个治疗椎间盘突出压迫神经,导致背痛或脚麻的新疗法。 ヘルニコア椎間板注用1.25単位 英文名：Condoliase 商标名：HERNICORE 1.25units for Intradiscal inj. 生产商：Seikagaku Corporation 药物分类名称 腰椎间盘突出症治疗 批准日期：2018年5月 商標名 HERNICORE 1.25units for Intradiscal inj. 一般名：コンドリアーゼ, Condoliase（JAN） 構造式：コンドリアーゼは、グラム陰性桿菌の一種であるProteus vulgarisから分離・精製された、次に示す構造を持つ単量体でアミノ酸残基997個からなるタンパク質である。 Ala-Thr-Ser-Asn-Pro-Ala-Phe-Asp-Pro-Lys-［Amino acid］n-Pro 分子式；C5039H7770N1360O1525S22 分子量約；11万 处理注意事项 由于必须保护光屏蔽，因此本产品应存放在单个盒子（外盒）中。 批准条件 制定药品风险管理计划并适当实施。 药用药理学 1.药理作用 （1）当对正常兔鞘内注射避孕药时，确认椎间盘内水含量降低，椎间盘高度变窄6）。 （2）当对正常绵羊进行腹内注射避孕药时，发现椎间盘内压和椎间盘高度的下降变窄7）。 （3）当对患有椎间盘突出症的狗进行皮内给药时，确认了临床症状（姿势反应，脊髓反射和受累疼痛的改善）。 2.作用机制 软骨素酶显示硫酸软骨素，软骨素和透明质酸的分解作用，分解椎间盘髓核中的糖胺聚糖，降低髓核的持水能力，降低椎间盘内压。 据信可以改善疝气的临床症状。 适应症 腰椎间盘突出症是后纵韧带逃逸型，保守治疗无法获得足够的改善 用法与用量 通常，成人在单个高剂量椎间盘中接受1.25单位的Condolase作为症状的原因。 临床结果 临床疗效对于腰椎间盘突出症患者，安慰剂对照双盲组比较研究（国内III期试验）的主要效果。 包装 椎间盘注1.25单位：1小瓶 制造供应商 Seikagaku公司 联盟 科研製薬株式会社 注：使用以原处方资料为准【附件】：http://www.info.pmda.go.jp/go/pack/3999447D1020_1_01/ Hernica® intervertebral disc for the treatment of lumbar disc herniation 1.25 units Accepted approval application for world's first lumbar disc herniation treatment "Hernicoa intervertebral disc injection" The Ministry of Health, Labor and Welfare's Pharmaceutical Affairs and Food Hygiene Council, Pharmaceuticals Division I subcommittee approved manufacturing and marketing approval on January 30, 2014 from Seikagaku Corporation (headquarters: Marunouchi, Tokyo) on March 1, The application was being issued, "Longitudinal ligament (Kojuu Juntaito) lower esophagus type lumbar disc herniation" "which can not obtain adequate improvement by conservative therapy" as "efficacy/effect", "Hernicoa intervertebral disc injection note 1.25 We acknowledge the manufacturing and marketing approval in Japan of the unit (common name: condolase/development code: SI-6603) ". Lumbar disc herniation refers to the portion of the bone of the spinal canal called the five lumbar vertebrae through which the nerve of the lumbar region passes and the "intervertebral disc" which is the cushioning material between the hip bones deforms and jumps out, I will point it. However, even if a hernia is confirmed by diagnostic imaging, it does not necessarily lead to symptoms immediately, there are many cases where the hernia mass naturally disappears or shrinks asymptomatically for a long time. Of the low back pain, 85% is said to be unknown, and it is said that only 5% of the remaining 15% can be identified as caused by disc herniation. [Sawai Pharmaceutical/From causes and symptoms of intervertebral disc herniation] Diagnosis of pathology of lumbar disc herniation is carried out by "neurological examination" and "image examination" [bulge / protruding type] [posterior longitudinal ligament underpressure type] [posterior longitudinal ligament (breakthrough) escape type] [free escape type 】, But this drug can be used only for esophageal type under posterior longitudinal ligament. As lumbar disc herniation often reduces symptoms over time, the principle of treatment is conservative therapy, and conservative therapy includes pain relief such as NSAIDs (nonsteroidal anti-inflammatory drugs) Drug administration, neuroblocks using steroids or local anesthetics, physical therapy are mainly performed. Currently, there is no drug therapy which is the fundamental treatment of lumbar disc herniation, so in case of severe ineffectiveness with these conservative therapies, we have undergone surgery to remove the hernia, but this requires a high cost In addition to the burden, hospitalization for several weeks and rehabilitation are necessary. "1.25 units for Hernicoa intervertebral disc injection" is a drug that can be expected to improve the symptoms as much as surgery in one administration, and is expected to contribute to the reduction of physical burden on patients. 【About lumbar intervertebral disk hernia remedy "Hironicore intervertebral disc injection 1.25 units (SI-6603)"】 Lumbar disc herniation is a disease that causes pain or numbness by compressing the nerves around the spine by protruding part of the nucleus pulposus in the central part of the intervertebral disc and the outer annulus. This medicine is an injection medicine utilizing an enzyme called condolase (Condoliase) which specifically degrades glycosaminoglycan (* GAG) which is a constituent component of the nucleus pulposus, and by direct administration into the intervertebral disc, GAG By reducing the nucleus pulposus by decomposing it, it is expected to reduce the pressure on nerves. Also, since it does not decompose proteins, it is thought not to affect peripheral tissues such as blood vessels and nerves. * Glycosaminoglycan (GAG): One of the major components of glycoconjugates. Chondroitin sulfate, hyaluronic acid, etc. Phase III clinical trial was also conducted in the US in the United States, but the statistically significant improvement effect was not observed in reduction of lower limb pain at 13 weeks after the main evaluation item was administered, and the US Food and Drug Administration There are no countries that have been approved abroad such as FDA. For this reason, Seikagaku Kogyo Co., Ltd. and Ferring Pharmaceuticals Co., Ltd. reflected February 19, 2018 knowledge obtained from the previous randomized double-blind placebo-controlled parallel group comparison test results , Announced that Phase III clinical trial (additional study) in the United States has started. In an additional Phase III clinical trial, cases of cases in which the efficacy of this drug is more likely to be implemented are carried out, and dosages and the like with higher therapeutic effect are confirmed for Americans with larger physique. Regarding this point, the official of the Ministry of Health, Labor and Welfare said, "The final evaluation after considering the test results in the United States of Japan (passing through the subcommittee in Japan.) Looking heavily at the test results at the Japanese, It was decided that it would be safe to approve.