脑心清片治疗缺血性脑卒中恢复期多中心随机双盲对照研究

Effect of Naoxinqing Tablet in the Treatment of Convalescent Stroke:A Multicenter,Randomized,Double-Blind,Control Trial

目的 观察脑心清片治疗缺血性脑卒中恢复期的有效性及安全性。方法 本研究方案在中国临床试验中心注册(No.ChiCTR-TRC-13003968)。筛选721例受试者,选择缺血性脑卒中发病2周~3个月瘀血阻络证患者654例,采用随机对照方法,使用SAS软件区组随机分为试验组、对照组和安慰剂组,各218例,在西医常规治疗基础上,分别给予脑心清片+银杏叶片模拟剂(试验组)、脑心清片模拟剂+银杏叶片(对照组)和脑心清片模拟剂+银杏叶片模拟剂(安慰剂组),三组用法用量均为3片/次,3次/日,疗程12周。观察美国国立卫生研究院卒中量表NIHSS评分、卒中专门生命质量SSQOL量表评分、改良Rankin评分、日常生活能力Barthel指数、中医证候评分及不良反应发生率。结果 本研究共纳入分析654例,各组均为218例。治疗6周及12周后,试验组在改善NIHSS评分、SSQOL评分、改良Rankin量表评分、Barthel指数方面与对照组疗效相当(P>0.0167),但均优于安慰剂组(P<0.0167)。治疗12周后试验组中医证候有效率高于对照组、安慰剂组(P<0.0167);在治疗6周及12周后对失眠多梦的有效率试验组高于对照组(P<0.0167);在治疗12周后对下肢不遂、上肢不遂、口唇紫暗的有效率试验组高于安慰剂组(P<0.0167)。治疗12周后三组患者凝血四项(PT,APTT,TT,FIB)、血脂四项(TC,TG, LDL-C,HDL-C)、血糖及血液流变学指标疗后差值,组间差异均无统计学意义(P>0.05)。不良事件试验组9例(4.13%),对照组3例(1.38%),安慰剂组8例(3.67%,P=0.2021),不良反应安慰剂组1例,其他两组未发生不良反应。结论 脑心清片能改善缺血性脑卒中恢复期患者的神经功能缺损症状,提高患者生活质量和生活能力,降低致残率,改善中医证候,其疗效与银杏叶片相当,且安全性良好。

Objective To observe the efficacy and safety of Naoxinqing Tablet(NXQT)on convalescent ischemic stroke. Methods The protocol was registered in Chinese Clinical Trial Registry(No.ChiCTR-TRC-13003968). A total of 721 patients were screened,654 patients with ischemic stroke for 2 weeks to 3 months were randomly allocated to the trial group(218 cases),control group(218 cases)and placebo group(218cases)by SAS software. All patients received conventional treatment. Patients in trial group took NXQT+GLTS(Ginkgo leaf Tablets simulant),patients in control group took NXQTS(NXQT simulant)+GLT(Ginkgo leaf Tablets),and patients in placebo group took NXQTS+GLTS. The therapeutic course for all was 12 weeks and the usage and dosage were 3 tablets,3 times daily. The NIHSS score,SSQOL score,modified Rankin Scale score,Barthel index,Chinese medicine(CM)syndrome score and the incidence of adverse reactions were observed.Results A total of 654 cases were included in this study for analysis, with 218 cases in each group. After 6 and 12 weeks of treatment,compared with the control group,the trial group showed a similar effect in improving NIHSS score,SSQOL score,modified Rankin Scale score and Barthel index(P>0.0167),but all were superior to the placebo group(P<0.0167). After 12 weeks of treatment,the effective rate of CM syndrome in the trial group was higher than that in the control group and the placebo group(P<0.0167);After 6 and 12 weeks of treatment,the effective rate of insomnia and dreamful sleep in the trial group was higher than that in control group(P<0.0167). For uper and lower limbs failure and dark-purplish lip, after 12 weeks of treatment, the effective rate of the experimental group was significantly higher than that of the placebo group(P<0.0167). After 12 weeks of treatment,there was no statistical difference in levels of coagulation(PT,APTT,TT,and FIB),blood lipids(TC,TG,LDL-C and HDL-C),fasting blood glucose and hemorheology among the three groups(P>0.05). Adverse events occurred in 9 cases(4.13%)in the trial group,and 3 cases(1.38%) and 8 cases(3.67%) in the control group and placebo group, respectively(P=0.2021). One case of adverse reaction occurred in placebo group,and there were no adverse reactions in the other two groups. Conclusions NXQT can improve the symptoms of neurological deficit in patients with ischemic stroke,improve their quality of life and ability,reduce the disability rate and improve CM syndromes. Its curative effect is equivalent to that of Ginkgo biloba,and it showed a good safety profile.