Research progress of pharmacological actions and clinical applications of diterpene ginkgolides meglumine injection
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摘要:
银杏是银杏科银杏属植物，其根、叶、果实均可入药，具有活血养心、敛肺涩肠的功效，临床上广泛用于改善血液循环。银杏二萜内酯葡胺注射液是基于银杏叶的主要提取物银杏内酯类成分研发的中药五类新药。研究发现银杏二萜内酯葡胺注射液药理作用广泛，具有抗氧化、抑制血小板聚集、改善记忆、心肌细胞保护及炎症损伤保护等作用，临床上广泛用于治疗心脑血管疾病、糖尿病并发症、脑梗死合并症等，其作用机制和靶点也有深入的研究，具有较好的应用前景。本文对银杏二萜内酯葡胺注射液的临床应用和药理作用进行综述，为临床药物选择和深入研发提供参考依据。
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关键词:
- 银杏二萜内酯葡胺注射液 /
- 药理作用 /
- 临床应用 /
- 神经保护 /
- 心肌保护
Abstract:Ginkgo biloba L. is a plant belonging to the Ginkgoaceae family and the ginkgo genus, and its roots, leaves and fruits can be used as medicine, with the effects of activating blood and nourishing heart, and tonifying the lung and intestine. Diterpene ginkgolides meglumine injection is based on the ginkgolide, which is the main extract of ginkgo leaf and is a Class V new drug of traditional Chinese medicine. Studies have shown that diterpene ginkgolides meglumine injection has a wide range of pharmacological effects, including anti-oxidation, inhibition of platelet aggregation, improvement of memory, protection of cardiomyocytes and protection of inflammatory damage, etc. It is widely used in clinical treatment of cardiovascular and cerebrovascular diseases, complications of diabetes, and complications of cerebral infarction, etc. Its mechanism of action and targets have also been extensively studied, with a good application prospect. This paper summarizes the clinical application and pharmacological actions of diterpene ginkgolides meglumine injection, in the hope of providing some reference for clinical drug selection and further research and development.
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表 1 银杏二萜内酯葡胺注射液的临床应用研究
疾 病 治疗方案 观察指标 研究结论 对照组 治疗组 脑梗死伴不稳定性心绞痛[52] 常规治疗 常规治疗+DGMI 25 mg/d，14 d NIHSS评分、血脂相关指标、血清NSE、hs-CRP水平、心绞痛发作情况、心电图、心功能指标 DGMI可提高脑梗死合并不稳定心绞痛患者治疗效果，降低血脂指标 脑血栓合并高血脂[56] 常规治疗 常规治疗+DGMI，28 d 血脂水平、血浆纤维蛋白原、全血黏度 DGMI可改善脑血栓合并高血脂患者实验室指标，疗效显著 脑卒中[30] 阿替普酶 0.9 mg/kg 阿替普酶0.9 mg/kg+DGMI 25 mg/d，14 d NIHSS评分、Sestrin2蛋白水平、Hcy水平血浆黏度、红细胞比容、血小板黏附率 DGMI联合阿替普酶可改善脑梗死患者的神经功能、血液流变学指标，降低Sestrin2蛋白、Hcy水平 脑卒中[31] 阿替普酶 0.9 mg/kg 阿替普酶 0.9 mg/kg+DGMI 25 mg/d，14 d NIHSS评分、mRS量表评分、Barthel指数、hs-CRP和PON-1水平 DGMI联合溶栓治疗效果显著，可改善患者神经功能和血清指标，提高日常生活能力 脑卒中[32] 阿替普酶 0.9 mg/kg 阿替普酶 0.9 mg/kg+DGMI 25 mg/d，28 d NIHSS评分、Barthel指数、CRP、IL-1β、Hcy、IL-2水平、颈总动脉斑块情况、ADR 在脑梗死窗口期使用DGMI联合溶栓治疗，效果显著且安全 脑卒中[33] 阿替普酶 0.6
或0.9 mg/kg阿替普酶 0.6或0.9 mg/kg+DGMI 25 mg/d NIHSS评分、mRS量表评分、出血转归的病例数、90天预后 DGMI联合溶栓治疗有利于神经功能的恢复，改善患者远期预后 脑卒中[35] DGMI 25 mg/d DGMI 25 mg/d+丁苯酞软胶囊200 mg，7~14 d NIHSS评分、临床疗效、ADR、血流动力学指标 DGMI联合丁苯酞软胶囊改善脑梗死患者疗效效果显著且安全 脑卒中[36] 丁苯酞注射液
100 mL，2次/日，14 d丁苯酞注射液 100 mL，
2次/d+DGMI 25 mg/d，14 dNIHSS评分、Barthel指数、临床
疗效、血液流变学指标、侧支循环评估DGMI联合丁苯酞注射液治疗脑梗死效果显著，可提高侧支循环数量和分级 脑卒中[37] 依达拉奉15 mg/d，
14 d依达拉奉15 mg/d+DGMI
25 mg/d，14 dNIHSS评分、临床疗效、氧化应激指标、血清炎症因子 DGMI联合依达拉奉治疗脑梗死疗效确切，可显著改善炎症因子及氧化应激 脑卒中[38] 依达拉奉30 mg/d，
14 d依达拉奉30 mg/d+DGMI
25 mg/d，14 dNIHSS评分、疗效 DGMI联合依达拉奉对脑梗死患者疗效显著 脑卒中[39] 依达拉奉30 mg，
2次/日，14 d依达拉奉30 mg，
2次/日+DGMI 25 mg/d，14 dNIHSS评分、Hcy、NSE DGMI联合依达拉奉可显著改善神经功能缺损并下调血清同型半胱氨酸（Hcy）、血清神经元特异性烯醇化酶（NSE） 脑卒中[40] 丁苯酞软胶囊
60 mg，bid+依达拉奉30 mL/d，28 d丁苯酞软胶囊60 mg，bid+
依达拉奉30 mL/d+DGMI
25 mg，28 dNIHSS评分、Barthel指数、Fugl-Meyer评分、血清中氨基酸、神经递质、细胞因子含量、临床疗效、ADR 三种药联合使用可改善患者神经功能、肢体运动能力及生活能力，安全有效 DPN[43] 甲钴胺 0.5 mg，tid，28 d 甲钴胺 0.5 mg，tid，28 d+DGMI 25 mg/d，28 d 临床疗效、氧化应激指标、神经传导功能 DGMI联合甲钴胺治疗DPN能改善机体氧化应激，提高神经传导速度，疗效确切 DPN[42] 降糖药物治疗+丹参川芎嗪注射液
10 mL，1次/日，10 d降糖药物治疗+DGMI 10 mL/d，10 d 血糖水平、神经系统评分、临床疗效评估、神经传导速度 DGMI可明显改善DPN患者临床症状评分和神经传导速度 DN[45] 常规治疗 常规治疗+DGMI 25 mg/d+水蛭胶囊4粒，tid，28 d 临床疗效、血生化指标、中医症状积分、ADR DGMI联合水蛭胶囊辅助治疗DN安全有效 脑梗死合并多发性颅内动脉狭窄[46] 舒血宁注射液
20 mL/d，14 dDGMI 20 mL/d，14 d ET水平、NO、NIHSS评分、临床
疗效DGMI可促进内皮功能和神经功能的改善，阻止动脉粥样硬化进展 脑梗死合并多发性颅内动脉狭窄[47] 舒血宁注射液
20 mL/d，15 dDGMI 20 mL/d，14 d NIHSS评分、NO、ET-1水平 DGMI可通过调节NO和ET-1比例，改善血管内皮功能来延缓疾病
进展多发颅内动脉狭窄[48] 奥扎格雷50~70 mg，2次/d，28 d 奥扎格雷50~70 mg，2次/d+DGMI 25 mg/d，28 d NIHSS评分、Barthel指数、临床疗效、NO、ET、脂联素、过氧化氢酶 DGMI联合奥扎格雷治疗多发颅内动脉狭窄患者可改善内皮功能及神经功能，提高疗效。 冠心病合并脑梗死[49] 氯吡格雷75 mg，qd，14周 氯吡格雷75 mg，qd，14周+DGMI 25 mg/d 临床疗效、脑梗死中医症候积分、认知功能评价、血小板聚集率、ADR DGMI联合氯吡格雷治疗冠心病合并脑梗死疗效确切，能有效改善患者动脉粥样硬化，安全性高 脑卒中后抑郁[50] 盐酸氟西汀胶囊
20 mg/d，6周盐酸氟西汀胶囊20 mg/d，6周+DGMI 25 mg，14 d HAMD评分、DA、NE、BDNF水平、Barthel指数、ADR DGMI联合氟西汀可提高轻中度脑卒中后抑郁治疗效果，降低血清神经递质水平，安全有效 DVT[54] 注射用丹参
400 mg/d，14 dDGMI 25 mg/d，14 d 临床疗效、D-D水平、APTT、PT、FDP DGMI可改善DVT患者的凝血功能，对DVT治疗效果良好 DVT[55] 注射用丹参
400 mg/d，15 dDGMI 25 mg/d，15 d 临床疗效、炎症指标、应激指标 DGMI治疗老年DVT效果显著，可减轻机体应激及炎症 DGMI：银杏二萜内酯葡胺注射液；NIHSS：神经功能缺损；NSE：神经元特异性烯醇化酶；hs-CRP：超敏C反应蛋白；Sestrin2：一种抗氧化应激蛋白；Hcy：同型半胱氨酸；mRS量表：改良Rankin量表；Barthel指数：巴氏日常生活指数；PON-1：对氧磷酶-1；CRP：C反应蛋白；IL-1β：白介素-1β；IL-2：白介素-2；ADR：药物不良反应；DPN：糖尿病周围神经病变；DN：糖尿病肾病；Qd：每日一次；Tid：每次3次；Bid：每日两次；NO：一氧化氮；ET：内皮素；HAMD：汉密顿抑郁量表；DA：多巴胺；NE：去甲肾上腺素；BDNF：脑源性神经营养因子；DVT：下肢深静脉血栓形成；D：Ｄ－二聚体；APTT：活化部分凝血活酶时间；PT：凝血酶原时间；FDP：纤维蛋白（原）降解产物 
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