| 摘要: | 研究背景：休克（包括敗血性休克、低血容休克、心因性休克……等）的患者是重症醫學臨床照護之大宗。不論其最初致病可能的原因為何，如何維持患者的血行動力學，以確保各主要器官之良好血液灌流，一直是加護病房醫師在治療疾病的重要目標。在許多準則陸續發表及修訂之後，升壓劑及強心藥的選擇依舊不多。傳統在敗血病的治療準繩中，有使用低劑量類固醇以協助病人盡早脫離休克的狀態。面臨患者與疾病的多樣性，是否藉由導入傳統中醫藥的使用及配合，也能提早使病人脫離休克的狀態，更進能改善重症患者的機會和預後，為此一研究進行的動機與目標。
研究方法：採行設計良好的prospectively randomized double blind control trial。
【1】 使用藥品：四逆湯。
【2】 藥品安全：由通過GMP的中藥廠製作提煉，並提供組成、成分、及重金屬含量等相關分析報告。
【3】 研究族群：納入的條件為年紀20歲以上的成年人，因血行動力學不良而住進加護病房，接受超過1500 cc輸液後效果不佳，仍須使用升壓劑的患者為對象。進入試驗前需由病人本人或有同意權人（配偶或同居之親屬）簽署同意書(Informed Consent)，並在簽署前能充分瞭解此一臨床試驗研究的目的、方法、預期試驗的效果及利益、可能導致副作用、危險及其處理方法、其他可能之治療方法和受試者的權益等。
【4】 主要評估項目：脫離休克狀態的時間長短。
【5】 次要評估項目：加護病房死亡率、加護病房治療時間、住院死亡率、住院治療時間、給予升壓劑的劑量等。
研究結果：自2010年9月至2010年12月，共有8名受試者參與此一試驗，其中4名安慰劑組，另外四名為四逆湯組。若去除使用試驗用藥中途死亡的患者資料，開始使用試驗用藥到停用升壓劑的時間，在安慰劑組是34小時，在四逆湯組則是29.5小時。在四逆湯組似乎有縮短使用升壓劑時間的趨勢。
討論：由現有研究資料看來，四逆湯似乎有使敗血性休克的患者，提早使血行動力學穩定，以便能提早停用升壓劑之趨勢。不過由於個案數尚少，若能延續此一計畫，到達原本預期的120名受試者，將可提供有效之統計學分析，以便能適時地實際運用於臨床上。
Backgrounds: Patients with shock (including septic shock, hypovolemic shock, cardiogenic shock……etc.) are the main population which intensive care physicians will face seriously. Whether the initial exact etiology leading to the diseases is, how to maintain adequate hemodynamic status in order to keep these patients with well organs perfusion is always the main issue in the intensive care units. The choices of vasopressors or inotropic agents in the updating or revised guidelines nowadays used are still limited in the western medicine. But we all know that low dose steroid is being suggested for such patients and was considered to be beneficial to restore the hemodynamic status. For the complicacy and heterogeneity of the ICU patients, we want to find out the potential extra benefit of using traditional Chinese medicine to help the patient population. It is highly expected that concurrently using traditional Chinese medicine could help such patient population to be reversed from the shock status. This is our goal and object of this study with combination of using traditional Chinese medicine and western medicine to improve the patients’ outcome and prognosis.
Methods and Material: We use well designed prospectively randomized double blind control trial.
1. Drug of this trial: Si-Ni-Tang
2. Safety of the drugs: The drugs (Si-Ni-Tang ) of the trial was manufactured and provided by the pharmaceutical factory that meets the requirement of GMP. All the important information, including ingredients composition and heavy metal etc. are provided by the pharmaceutical factory.
3. Study population: Those patients meeting the following criteria are candidates, including: age > 20 years old and admitted to ICU, with hemodynamic instability, previously received over 1500cc fluid resuscitation and using vasopressors. Only patients themselves or their relatives signed the informed consent and well understood its contents could these patients be enrolled in the clinical trial. The informed consent document provides a summary of the clinical trial (including its method, purpose, expected outcome, potential risks and benefits, possible adverse effect and problems resolving measures, alternatives to participation, patients’ right etc.)
4. Primary outcome to be investigated: The duration from entrance of this trial to shock reversal.
5. Secondary outcome to be investigated: ICU mortality, ICU length of stay, hospital mortality, hospital length of stay, total amount of vasopressors used.
Result and Conclusion: There are totally 8 participants to be enrolled form Sep. 2010 to Dec. 2010. Four participants are in the placebo group and the other four are in the Si-Ni-Tang group. If we omitted the data of those patient expired in the treatment course, the mean value of the shock reversal time of the placebo group is 34 hours and the Si-Ni-Tang group is 29.5 hours. There seem to be a trend to shorten the time of septic status in the Si-Ni-Tang group.
Discussion: From the current obtained data, Si-Ni-Tang seems to have the effect to let patients with septic shock to be restored from shock status much earlier. However, as there is still limited amount of participants, further studies and more participants being enrolled would be needed to clarify the possible potential of this remedy to be used in treating patients in the future. We hope to go on this study to enroll the expected 120 participants. Only after reaching this point could we do adequate statistical analysis and even using it in the real clinical condition. |
