【摘要】：目的：觀察銀杏內(nèi)酯注射液治療缺血性腦卒中恢復期的臨床療效及安全性。 方法：將符合診斷標準的56例缺血性腦卒中恢復期患者，采用隨機法分為銀杏內(nèi)酯注射液治療組25例和銀杏達莫注射液對照組31例。因病例脫落，最后完成臨床研究觀察的患者共54例，分別為治療組24例、對照組30例。治療組采用銀杏內(nèi)酯注射液50mg+0.9%氯化鈉250ml靜脈滴注，每天1次，1個療程為2周。對照組采用銀杏達莫注射液20ml+0.9%氯化鈉250ml靜脈滴注，每天1次，1個療程為2周。觀察患者神經(jīng)功能缺損程度、日常生活活動能力、臨床綜合療效、血液學指標及用藥不良反應方面的變化。 結(jié)果：（1）神經(jīng)功能缺損評分：銀杏內(nèi)酯注射液治療組治療前后評分分別為3.1±2.953、2.5±2.782，治療后較治療前有改善（P0.05)。（2）日常生活活動能力評分：銀杏內(nèi)酯注射液治療組治療前后評分分別為1.8±1.203、1.3±0.963治療后較治療前有改善(P0.05)。（3）臨床綜合療效：銀杏內(nèi)酯注射液治療組有1例基本痊愈，4例顯著進步，2例進步，17例無效，總有效率29.0％；銀杏達莫注射液對照組有3例基本痊愈，5例顯著進步，2例進步，20例無效，總有效率34.0％，兩組治療均有效，兩組治療有效率有統(tǒng)計學差異(P0.05)，，對照組臨床綜合療效改善優(yōu)于治療組。（4）安全性評估：銀杏內(nèi)酯注射液治療組有2例出現(xiàn)不良反應，生命體征、血常規(guī)、尿常規(guī)、心肌酶、凝血功能、心電圖、大便常規(guī)+OB等指標進行治療前后對比，P0.05，無統(tǒng)計學差異。TBIL治療前后比較分別為3.4±5.670、11.2±3.733, P0.05，有統(tǒng)計學差異，BUN治療前后比較分別為5.3±1.512、4.6±1.257，P0.05，有統(tǒng)計學差異，說明該藥能改善肝腎功能。ALT、AST、GGT、ALP、Cr、尿酸等指標兩組治療前后對比，P0.05，無統(tǒng)計學差異。 結(jié)論：銀杏內(nèi)酯注射液治療恢復期缺血性腦卒中是有效的，能促進神經(jīng)功能缺損恢復，提高日常生活活動能力，同時能改善肝腎功能，安全性有待擴大樣本量進一步驗證。
[Abstract]:Objective: to observe the clinical efficacy and safety of ginkgolide injection in the convalescence of ischemic stroke. Methods: 56 patients with ischemic stroke in convalescence were randomly divided into Ginkgolide injection group (n = 25) and Ginkgo biloba injection control group (n = 31). A total of 54 patients, 24 in the treatment group and 30 in the control group, completed the clinical observation because of the abscission of the cases. Ginkgolide injection 50mg 0.9% sodium chloride 250ml was injected intravenously once a day for 2 weeks in the treatment group. The control group was treated with 20ml 0.9% sodium chloride 250ml once a day for 2 weeks. The degree of neurological deficit, activity of daily living, clinical efficacy, hematologic indexes and adverse drug reactions were observed. Results: (1) neurological deficit score: the scores of Ginkgolide injection group before and after treatment were 3.1 鹵2.953 鹵2.782, which were improved after treatment (P0.05). (2): Ginkgolide injection treatment group before and after treatment The scores were 1.8 鹵1.203 鹵0.963 after treatment (P0.05). (3). In Ginkgolide injection group, 1 case was basically cured and 2 cases improved significantly. 17 cases were ineffective. The total effective rate was 29.0. In the Ginkgo biloba injection group, 3 cases were basically cured, 5 cases were significantly improved, 20 cases were ineffective, and the total effective rate was 34.0.The treatment was effective in both groups. There was significant difference in the effective rate between the two groups (P0.05). The improvement of comprehensive clinical efficacy in the control group was better than that in the treatment group. (4) Safety evaluation: there were 2 cases of adverse reactions, vital signs, blood routine, urine routine, myocardial enzymes in the treatment group with ginkgolide injection. Coagulation function, electrocardiogram (ECG) and routine stool OB were compared before and after treatment (P 0.05). There was no statistical difference. TBIL was 3.4 鹵5.670,11.2 鹵3.733 before and after treatment, P 0.05.The difference before and after treatment was 5.3 鹵1.512 鹵4.6 鹵1.257P0.05, respectively. The results showed that the drug could improve the liver and kidney function. The liver and kidney function of the two groups were improved. There was no statistical difference between the two groups before and after treatment. Conclusion: ginkgolide injection is effective in the treatment of ischemic stroke in convalescent stage. It can promote the recovery of neurological function, improve the ability of daily life, and improve the function of liver and kidney. The safety of Ginkgolide injection needs to be further verified.
【學位授予單位】：遵義醫(yī)學院
【學位級別】：碩士
【學位授予年份】：2014
【分類號】：R743.3

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