Comparative study of the effects of Danhong injection with different doses on ischemic stroke: A substudy of hospital-based Danhong injection registry

IF 2 4区 医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE Journal of Traditional Chinese Medicine Pub Date : 2018-12-15 DOI:10.1016/S0254-6272(18)30992-0
Du Yawei , Wang Xiaoxia , Zhong Liqun , Wu Shengxian
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引用次数: 5

Abstract

OBJECTIVE

To compare the effects of Danhong injection (DHI) with different doses on ischemic stroke.

METHODS

Chinese hospital registered DHI study is a perspective observational study, in which a total of 1292 patients with ischemic stroke were treated with DHI. Two different doses of DHI were used in the present study. The patients were matched by acute phase of ischemic stroke (within 2 weeks after onset), partial anterior circulation infraction, sex, age, and National Institute of Health Stroke Scale (NIHSS) score. Finally 148 patients were grouped into the 20 or 40 mL DHI group with 74 in each. The primary endpoint was the improvement of NIHSS score at 14-day after treatment.

RESULTS

Of the 148 patients with ischemic stroke, the 74 in the 40 mL DHI group had clinically important improvements in the NIHSS score. The baseline and 14-day NIHSS score for the 40 mL DHI group were 6.6 ± 4.3 and 2.4 ± 2.5 respectively, versus 6.3 ± 5.7 and 3.6 ± 4.2, for the 20 mL DHI group (change from baseline in the 40 mL DHI group vs change from baseline in the 20 mL DHI group, −1.49 points; P = 0.029). Improvements were maintained after the baseline characteristics and other drugs were controlled (P = 0.012). No adverse events were observed.

CONCLUSION

Effects of DHI on partial anterior circulation infarction in patients with acute phase of ischemic stroke is dose-dependent; however, further studies with larger sample sizes are needed to validate our findings (Chinese Clinical Trial Register, Number: ChiCTR-ONC-13003230).

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不同剂量丹红注射液对缺血性脑卒中疗效的比较研究:以医院为基础的丹红注射液登记亚研究
目的比较不同剂量丹红注射液对缺血性脑卒中的治疗作用。方法中国医院注册DHI研究是一项前瞻性观察性研究,共1292例缺血性脑卒中患者接受DHI治疗。本研究中使用了两种不同剂量的DHI。根据缺血性卒中急性期(发病后2周内)、部分前循环梗塞、性别、年龄和美国国立卫生研究院卒中量表(NIHSS)评分进行匹配。148例患者被分为20和40 mL DHI组,每组74例。主要终点是治疗后14天NIHSS评分的改善。结果148例缺血性脑卒中患者中,40 mL DHI组74例患者NIHSS评分有显著改善。40 mL DHI组的基线和14天NIHSS评分分别为6.6±4.3和2.4±2.5,而20 mL DHI组为6.3±5.7和3.6±4.2 (40 mL DHI组与20 mL DHI组的基线变化,−1.49分;P = 0.029)。在基线特征和其他药物得到控制后,改善得以维持(P = 0.012)。未观察到不良事件。结论DHI对缺血性脑卒中急性期部分前循环梗死的影响呈剂量依赖性;然而,需要进一步的更大样本量的研究来验证我们的发现(中国临床试验注册,编号:ChiCTR-ONC-13003230)。
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来源期刊
Journal of Traditional Chinese Medicine
Journal of Traditional Chinese Medicine INTEGRATIVE & COMPLEMENTARY MEDICINE-
CiteScore
2.40
自引率
3.80%
发文量
32269
审稿时长
2 months
期刊介绍: Journal of Traditional Chinese Medicine(JTCM) is devoted to clinical and theortical research on the use of acupuncture and Oriental medicine. The main columns include Clinical Observations, Basic Investigations, Reviews, Questions and Answers, an Expert''s Forum, and Discussions of Clinical Cases. Its key topics include acupuncture and electro-acupuncture, herbal medicine, homeopathy, masseotherapy, mind-body therapies, palliative care, and other CAM therapies.
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