Study on the efficacy of compound porcine cerebroside and ganglioside injection in patients with ischemic stroke: A randomized, single-center, open-label, prospective study

Ibrain Pub Date : 2023-07-15 DOI:10.1002/ibra.12120
Ya Chen, Xia Zhang, Hai-Qing Zhang, Zhong Luo, Xue-Jiao Zhou, Tao Liang, Fei Yang, Jun Zhang, Zu-Cai Xu
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Abstract

Compound porcine perebroside and ganglioside injection (CPCGI) was used to treat stroke. The study was initiated because of the high incidence of low-does CPCGI use in our area. However, no research has confirmed the effectiveness of CPCGI below the standard dose. Therefore, the aim of this study was to provide a reference for the clinical selection of different dose treatments. We collected ischemic stroke patients and divided them into three groups (low-dose group: Group A = 4 mL, Group B = 6 mL, standard-dose group: Group C = 10 mL). The modified Rankin Scale (mRS) scores, the National Institutes of Health Stroke Scale (NIHSS) scores, and the Barthel Index (BI) scores were performed before treatment and 14 days and 90 days post CPCGI treatment. For 90 days, the primary outcomes were calculated including the degree of disability, neurological recovery, and activities of daily living. All data were compared between pretherapy and posttreatment and among groups. NIHSS, mRS and BI scores improved on 14 and 90 days in each group. Group B and C improved than Group A on 14 and 90 days. The difference between groups B and C was not statistically significant. On 90 days, there were differences in the degree of disability, the recovery of neurological function, and the ability of daily living among groups. No drug-related adverse reactions occurred in the groups. Although 4 or 6 mL CPCGI had some neuroprotective effects, the standard dose of 10 mL CPCGI had the best effect on reducing the degree of disability and improving abilities of daily living.

Abstract Image

复方猪脑苷神经节苷注射液对缺血性脑卒中患者的疗效研究:一项随机、单中心、开放标签、前瞻性研究
采用复方猪桂皮苷神经节苷脂注射液(CPCGI)治疗脑卒中。本研究缘于本地区低剂量CPCGI使用的高发生率。然而,没有研究证实低于标准剂量的CPCGI的有效性。因此,本研究的目的是为临床选择不同剂量的治疗方法提供参考。我们收集缺血性脑卒中患者,将其分为低剂量组:A组= 4 mL, B组= 6 mL,标准剂量组:C组= 10 mL。采用改良Rankin量表(mRS)评分、美国国立卫生研究院卒中量表(NIHSS)评分和Barthel指数(BI)评分,分别于治疗前、治疗后14天和90天进行。在90天内,计算主要结局,包括残疾程度、神经恢复和日常生活活动。所有数据在治疗前后及组间进行比较。各组NIHSS、mRS和BI评分在第14天和第90天均有所改善。B、C组在第14天和第90天较A组改善。B组与C组间差异无统计学意义。90 d时,各组在残疾程度、神经功能恢复情况、日常生活能力等方面存在差异。两组均未发生药物相关不良反应。虽然4或6 mL CPCGI有一定的神经保护作用,但标准剂量10 mL CPCGI对减轻残疾程度和提高日常生活能力的效果最好。
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