Zhu Haomeng, Chandra Ankush, Geng Xiaokun, Cheng Zhe, Tong Yanna, Du Huishan, Ding Yuchuan
Department of Neurology, Beijing Luhe Hospital, Capital Medical University, Beijing, China.
China-America Institute of Neuroscience, Beijing Luhe Hospital, Capital Medical University, Beijing, China.
J Neurosurg Sci. 2019 Jun;63(3):265-269. doi: 10.23736/S0390-5616.19.04665-4.
Acute ischemic stroke (AIS) is associated with significant morbidity and mortality and has a very narrow window of treatment with fibrinolytics. We investigated the safety and efficacy of combined chlorpromazine and promethazine (C+P) treatment in AIS.
A total of 64 consecutive patients diagnosed with AIS were selected and were randomly (double-blind) assigned into either the control group (standard of care [SOC] treatment) or the treatment group (SOC+C+P [12.5+12.5 mg BID or 25+25 mg BID]) which were treated for 2 weeks. The National Institutes of Health Stroke Scale (NIHSS) and Modified Rankin Scale (mRS) were computed prior to and after treatment to evaluate neurological deficits and daily functional status.
In our study, 64 patients (males=81.3%) were divided into either the control (34 patients, 83.3% males, mean age=58.8±11.7 years) or the study group (30 patients, 79.4% males, mean age=62.3±9.1 years). While the NIHSS scores were not different between the control and treatment group at admission (P>0.05), a greater proportion of the cohort in both the groups (control group low NIHSS=79.4%, high NIHSS=20.6%, P<0.01) had a lower NIHSS at admission and (treatment group low NIHSS=83.3%, high NIHSS=16.7%, P<0.01). Interestingly, while both the control and treatment group had lower NIHSS and mRS scores at 90d post treatment compared to those at baseline, there were no significant differences in those scores between the two group (P>0.05) suggesting no improved benefit with C+P. Moreover, using C+P did not lead to any serious adverse effects when compared to the treatment group.
While the addition of low dose chlorpromazine and promethazine to standard of care for acute ischemic stroke did not have any significant improvement in functional outcomes, there were no serious adverse effects. Thus, the use of chlorpromazine and promethazine in the acute ischemic stroke setting and future studies using higher doses of C+P are justified.
急性缺血性卒中(AIS)与显著的发病率和死亡率相关,且使用纤维蛋白溶解剂治疗的时间窗非常窄。我们研究了氯丙嗪和异丙嗪联合治疗(C+P)在AIS中的安全性和有效性。
共选取64例连续诊断为AIS的患者,并随机(双盲)分为对照组(标准治疗 [SOC])或治疗组(SOC+C+P [12.5+12.5 mg,每日两次或25+25 mg,每日两次]),治疗2周。在治疗前后计算美国国立卫生研究院卒中量表(NIHSS)和改良Rankin量表(mRS),以评估神经功能缺损和日常功能状态。
在我们的研究中,64例患者(男性占81.3%)被分为对照组(34例患者,男性占83.3%,平均年龄=58.8±11.7岁)或研究组(30例患者,男性占79.4%,平均年龄=62.3±9.1岁)。虽然入院时对照组和治疗组的NIHSS评分无差异(P>0.05),但两组中更大比例的队列(对照组低NIHSS=79.4%,高NIHSS=20.6%,P<0.01)入院时NIHSS较低,(治疗组低NIHSS=83.3%,高NIHSS=16.7%,P<0.01)。有趣的是,虽然与基线相比,对照组和治疗组在治疗后90天时NIHSS和mRS评分均较低,但两组之间这些评分无显著差异(P>0.05),表明C+P没有改善益处。此外,与治疗组相比,使用C+P未导致任何严重不良反应。
虽然在急性缺血性卒中的标准治疗中添加低剂量氯丙嗪和异丙嗪在功能结局方面没有任何显著改善,但也没有严重不良反应。因此,在急性缺血性卒中环境中使用氯丙嗪和异丙嗪以及未来使用更高剂量C+P的研究是合理的。