| Abstract: | 研究目的：急性缺血性腦中風目前的最有效的治療為發作4.5小時內施打血栓溶解劑及6小時內做血栓拔除術，其他神經保護藥物的臨床證據力仍不足。piracetam是目前台灣衛生福利部食品藥物管理署核准可使用在急性腦中風，包括缺血性及出血性腦中風。但對急性中風的效益仍缺乏新的證據，在此探討piracetam對急性缺血性中風神經障礙之效益。
研究方法及資料：資料來源在單一區域教學醫院中風登錄系統做回溯性分析，符合的患者有1351位，894未使用piracetam，457位有使用piracetam，神經科醫師使用針劑piracetam於剛入住急性缺血性腦中風的患者；將符合健保急性缺血性腦中風住院者，出入院有使用美國國家衛生研究院量表紀錄的患者，紀錄住院期間量表分數改變，入院量表分數減出院量表分數，差異超過4分為改善。將缺血性腦中風的分類(依TOAST分類)、性別、年齡、高血壓、血脂異常、糖尿病、身體質量指數、抽菸、及使用針劑piracetam，做單一因素分析及多重因素分析，以釐清臨床上急性缺血性腦中風改善的因素及piracetam 使用的效益；另外將piracetam 跟各變項做分群分析，看在哪一類族群效益較好。
研究結果：單一因素分析中，有顯著改善勝算比依次為心因性中風（勝算比：4.19, p<0.001）、體重過輕（勝算比：3.37, p<0.001）、心房陣顫（勝算比：3.14, p<0.001）、大血管阻塞（勝算比：2.81, p<0.001）、年紀大於75歲（勝算比：1.88, p<0.001）、戒菸（勝算比：1.73, p=0.039）、使用piracetam（勝算比：1.69, p=0.005）；多重因素分析後，對中風量表分數有顯著改善勝算比依次為心房陣顫（勝算比：3.92, p<0.001）、大血管阻塞（勝算比：2.68, p<0.001）、體重過輕（勝算比：3.05, p=0.003）、戒菸（勝算比：2.29, p<0.001）、抽菸（勝算比：1.81, p=0.026）、使用piracetam（勝算比：1.73, p=0.005）；在piracetam和其他變數分層分析發現年齡大於75歲（勝算比：1.86, p=0.025）、男性（勝算比：1.94, p=0.007）、體重正常（勝算比：1.99, p=0.016）跟肥胖（勝算比：9.21, p=0.035）、戒菸（勝算比：3.36, p=0.033）、有高血壓（勝算比：1.93, p=0.004）及血脂異常（勝算比：1.83, p=0.013）、以及無糖尿病者（勝算比：1.84, p=0.018），使用piracetam得到的好處較多，而缺血性腦中風分型對使用piracetam無差異。
結論與建議：雖然使用piracetam有增加改善的勝算比，但在缺血性腦風分型的大血管阻塞及心房陣顫、體重過輕、男性及戒菸的族群改善的勝算比使用piracetam更明顯，要證實piracetam對缺血性腦中風的效益仍需更多資料分析。在年齡大於75歲、男性、正常體重及肥胖者、戒菸者、合併高血壓或血脂異常、無糖尿病者使用piracetam似乎可以得到較多的好處。
Objective: Current effective treatment for acute ischemic stroke are intravenous thrombolytic therapy within 4.5 hours of onset and intra-arterial thrombectomy within 6 hours. There are no conclusive evidence supporting the use of various drugs claiming neuroprotective effects. Piracetam is approved by the Taiwan Food and Drug Administration for use in acute stroke, including hemorrhagic and ischemic stroke. But there is no new evidence supporting its treatment efficacy. Therefore, in the current environment with a better treatment standard, there is room for discussion of the effect of piracetam in ischemic stroke patients’ neurological impairment.
Methods and Materials: This retrospective study obtained patient information from the stroke registration database of single regional teaching hospital. A total of 1351 ischemic stroke cases are included in the study, 457 received piracetam treatment and 894 did not. This study includes patients admitted with the diagnosis of acute ischemic stroke who received National Institutes of Health Stroke Scale evaluation. In the analysis of the change in NIHSS score, a decrease >4 is considered improvement. Univariate and multivariate analysis of ischemic stroke classification (based on TOAST classification), gender, age, hypertension, dyslipidemia, diabetes mellitus, body mass index, smoking history and use of intravenous piracetam is performed to determine the effect of the drug in acute ischemic stroke patients and potentially favorable factors. Subgroup analysis of piracetam with other factors was also done.
Results: Univariate analysis showed the following factors have odds ratio in favor of improvement in NIHSS score: embolic ischemic stroke (OR: 4.19, p<0.001), underweight (OR: 3.37, p<0.001), atrial fibrillation (OR: 3.14, p<0.001), large vessel disease (OR: 2.81, p<0.001), age >75 years old (OR: 1.88, p<0.001), previous smoker (OR: 1.73, p=0.039), use of piracetam (OR: 1.69, p=0.005). Multivariate analysis showed the following factors have odds ratio in favor of improvement in NIHSS score: atrial fibrillation (OR: 3.92, p<0.001), underweight (OR: 3.05, p=0.003), large vessel disease (OR: 2.68, p<0.001), previous smoker (OR: 2.29, p=0.009), current smoker (OR: 1.81, p=0.026), use of piracetam (OR: 1.73, p=0.005). Further analysis of the use of piracetam and other variables showed age >75 years old (OR: 1.86, p=0.025), male (OR: 1.94, p=0.007), normal weight (OR: 1.99, p=0.016) or obese (OR: 9.21, p=0.035), previous smoker (OR: 3.36, p=0.033), history of hypertension (OR: 1.93, p=0.004), dyslipidemia (OR: 1.83, p=0.013) and no history of diabetes mellitus (OR: 1.84, p=0.018), have beneficial results with piracetam treatment. The different strokes classifications showed no obvious favorable odds ratio in improvement after treatment with piracetam subgroup analysis.
Conclusion and Suggestion: Even though the use of piracetam show increased possibility of improvement. Large vessel disease and embolic stroke in TOAST classification, underweight, male, and previous smoker also present with odds ratio in favor of improvement in ischemic stroke neurological impairment. Further data is necessary for analysis to prove piracetam effect in acute ischemic stroke. In this study, elderly patients (age >75 years old), male, normal weight or obese, previous smoker, with history of hypertension or dyslipidemia, and no history of diabetes mellitus, have beneficial results with piracetam treatment. |
