摘要
背景:在缺血性脑卒中急性期和恢复期皆可见血小板处于活化状态,环磷酸腺苷和环磷酸鸟苷与血小板功能密切相关。目的:观察复方丹参滴丸预防治疗短暂性脑缺血发作的临床疗效及对血浆环磷酸腺苷、环磷酸鸟苷的影响。设计:随机对照实验。单位:滨州医学院附属医院神经科。对象:选择2000-09/2001-04滨州医学院附属医院神经科门诊180例自愿参加本实验的短暂性脑缺血发作患者。采用随机数字表将患者按给予复方丹参滴丸剂量大小分为3组。给药10粒/d组60例,男35例,女25例;年龄50～70岁,平均(54.3±7.2)岁;给药20粒/d组60例,男32例,女28例;年龄49～62岁,平均(55.7±5.1)岁。给药30粒/d组60例,男33例,女27例;年龄52～69岁,平均(54.9±5.5)岁。方法:给药10粒/d组,1次/d,10粒/次;给药20粒/d组,2次/d,10粒/次;给药30粒/d组,3次/d,10粒/次。患者均在服药4周后,晨抽血3mL,采用放射免疫分析法,测定三组血浆中的环磷酸腺苷、环磷酸尿苷含量。每例患者均3个月随访一次,共随访18个月:①观察短暂性脑缺血发作的发作次数及发作形式。②发生缺血性脑卒中例数(包括心、脑卒中)。③副作用:消化道反应,牙龈出血、鼻出血、皮下出血、口麻、头痛、头晕等。主要观察指标:①各组患者短暂性脑缺血发作的发作形式。②各组患者发生缺血性脑卒中例数。③各组患者副作用发生情况。④各组患者血浆中环磷酸腺苷,环磷酸鸟苷水平。结果:180例患者均进入结果分析。①发生短暂性脑缺血发作的发作例数:给药10粒/d组,发生颈内动脉系统短暂性脑缺血发作的1例;发生椎动脉系统短暂性脑缺血发作的2例;发生脑梗死的1例;发生心肌梗死的2例;给药20粒/d组,分别为2,2,1例;给药30粒/d组,分别为1,2,1例。②发生缺血性脑卒中例数:3组分别发生脑卒中的例数为6,5,4例。③各组患者副作用发生情况:三组不良事件及副反应分别为1,2,4例,其中给药10粒/d组出现口周麻木1例,给药20粒/d组出现口周麻木和头痛各1例,给药30粒/d组出现胃肠道反应1例,口周麻木2例,头晕1例;未出现牙龈出血、鼻出血及皮下出血病例,同时患者亦未因上述副作用退出治疗。各组比较,无显著性差异(P>0.05)。④各组患者血浆中环磷酸腺苷,环磷酸鸟苷水平:3组环磷酸腺苷分别为(21.22±3.94),(22.5±3.67),(23.1±7.7)ng/L;环磷酸鸟苷分别为(3.67±1.18),(4.74±2.12),(4.6±0.7)ng/L,(P>0.05)。结论:复方丹参滴丸在短暂性脑缺血发作的二级预防中,有肯定的疗效,各剂量比较疗效基本一致,同时无明显副作用。
BACKGROUND： Blood platelet is active commonly appeared in both acute and recovery, stages in ischemic cerebral apoplexy. Cyclic adenosine monophosphate （cAMP） and cyclic guanosine monophosphate （cGMP） are closely correlated with the blood platelet function. OBJECTIVE： To observe the therapeutic effects of compound danshen drop on clinical prevention and treatment of transient cerebral ischemic attack （T1A） and the influence on serum cAMP and cGMP. DESIGN： Randomized control experiment. SETTING： Department of Neurology of Binzhou Medical College affiliated Hospital PARTICIPANTS： Totally 180 TIA patients participated in the experiment in volunteer in the clinic of Neurological Department of Affiliated Hospital of Binzhou Medical College from September 2000 to April 2001. Based on randomized number scale, 3 groups were divided according to dosages of compound danshen drop. In 10 drops/d group, there were 60 eases, of which 35 eases were male and 25 eases female, aged varied from 50 to 70 years, averagely （54.3±7.2） years old. In 20 drops/d group, there were 60 cases, of which, 32 cases were male and 28 cases female, aged varied from 49 to 62 years, averagely （55.7±5.1） years old. In 30 drops/d group, there were 60 eases, of which, 33 cases were male and 27 eases female, aged varied from 52 to 69 years, averagely （54.9±5.5） years old. METHODS： In 10 drops/d group, the drug was given once per day, 10 drops each time. In 20 drops/d group, the drug was given twice per day, 10 drops each time. In 30 drops/d group, the drug was given three times per day, 10 drops each time. Four weeks after medication, 3 mL blood was collected from each patient in the morning. With radioimmunoassay, the contents of cAMP and cGMP in serum were determined. Each ease was follow-up visited for 3 months, totally 18 months：① Observation of frequency and attack form of TIA, ② Cases of ischemie cerebral apoplexy （including heart and cerebral apoplexy）, ③ Side effects： digestive reactions, gem bleeding, epistaxis, subcutaneous bleeding, mouth numbness, headache, dizziness, etc. MAIN OUTCOME MEASURES： ① TIA forms in every group;② cases of ischemic cerebral apoplexy in every group;③ side effects in every group; ④ contents of cAMP and cGMP in serum of every group. RESULTS： All of 180 cases entered result analysis. ① Cases of TIA attack： In 10 drops/d group, there were 1 ease in internal carotid arterial system, 2 cases in vertebral arterial system, 1 case of cerebral infarction and 2 eases of myocardial infarction. In 20 drops/d group, it was 2, 2 and 1 cases successively and in 30 drops/d group, it was 1, 2, 1 eases successively. ② Cases of ischemie eerebral apoplexy： There were 6, 5 and 4 eases of cerebral apoplexy in 3 groups successively. ③ Side effects in every group： There were 1, 2 and 4 cases of harmful accident and side effects in three groups successively, of which, peripheral numbness of mouth 1 ease in 10 drops/d group, 1 case of either peripheral numbness of mouth or headache in 20 drops/d group, gastrointestinal reaction 1 case, peripheral numbness of mouth 2 cases and dizziness 1 case in 30 drops/d group. There was no gem bleeding, epistaxis and subcutaneous bleeding, and no patient was withdrawn the treatment due to above-mentioned side effects. With comparison among groups, significant difference was not indicated （P 〉 0.05）.④ Contents of cAMP and cGMP in serum of every group： The contents of cAMP were （21.22±3,94）, （22.5±3.67）, （23.1±7.7） ng/Land cGMP were （3.67±1.18）, （4.74±2.12）, （4.6±0.7） ng/L successively in three groups （P 〉 0.05）. CONCLUSION： During second-grade prevention of TIA, compound danshen drop presents definite therapeutic effects, which is basically same in comparison of dosages. Simuhaneously, no remarkable side effects appear.
出处
《中国临床康复》
CSCD
北大核心
2005年第33期144-146,共3页
Chinese Journal of Clinical Rehabilitation
