What will I receive after recruitment? 招募後我會接受什麼治療?
請點這裡查看中文版本。Please click here for Chinese version.
You will be allocated and blinded to one of two treatment arms (see table below).
| Arm 1 | Arm 2 |
|
Usual Care + Placebo administered (by mouth or nasogastric tube) once a day for five days |
Usual Care + Prednisolone (30mg) administered (by mouth or nasogastric tube) once a day for five days |
The medication we use:
| Medication | Potential side effects (including but not limited to) |
| Prednisolone - steroid with anti-inflammatory actions. | Increased risk of infection; hyperglycaemia; changes in electrolytes; a rise in blood pressure; gut effects with gastritis, ulcers and bleeding (especially in the elderly); behavioural disturbances. |
Usual Care:
Usual care for patients with suspected community-acquired acute respiratory tract infection presenting to emergency departments in Hong Kong is similar to other primary care settings in the world. For example, in Europe early treatments are highly variable and consist of paracetamol, non-steroidal anti-inflammatory drugs, low-dose corticosteroids, over the counter medicines, fluids, rest, time off school or work, and antibiotics or antivirals according to local practice IMPACT Guidelines.
Hospital clinicians are responsible for administration of the allocated treatment. The patient’s own doctors are free to modify or stop study treatment if they feel that it is in the best interests of the patient without the need for the patient to withdraw from the study. The clinician will decide on any further treatment. Antibiotics and antivirals, if indicated, will be prescribed according to Hospital Authority IMPACT guidelines. Medication will be administered on a personalised basis and according to local policy and clinician expertise.
*The English version shall prevail in case of any discrepancy or inconsistency between the English version and its Chinese translation.
招募後我會接受什麼治療?
若您同意參與此研究，您將被隨機分配到兩種治療方案之一。（請參見下表）
|
治療方案一 |
治療方案二 |
|
常規護理 + 安慰劑（口服或以鼻胃喉餵飼）每天一次，服用五天 |
常規護理 + 潑尼松龍(Prednisolone)（30mg）（口服或以鼻胃喉餵飼）每天一次，服用五天 |
潑尼松龍 (Prednisolone)是香港註冊藥物，短期且低劑量地用於炎症患者在本港是普遍而安全。藥物資料及潛在副作用已於下表列出，副作用將被密切監察。
|
藥物 |
潛在副作用（包括但不限於） |
|
潑尼松龍(Prednisolone) – 具消炎作用的類固醇 |
增加感染風險；高血糖；體內電解質變化及血壓升高；消化系統影響如：胃炎，胃潰瘍及胃出血（尤其是長者）；行為障礙 |
常規護理：
在香港，疑似社區型急性呼吸道感染患者到急診室就診的常規護理與世界其他基礎醫療機構類似。例如，在歐洲，早期治療方法差異很大，包括撲熱息痛、非類固醇消炎藥物、低劑量皮質類固醇、非處方藥物、輸液治療、休息、休假以及根據當地情況使用抗生素或抗病毒藥物。
醫院臨床醫師負責管理治療。在這項試驗中，若您的醫生判斷使用藥物的風險大於其益處，可以自由調整安排，修改或停止研究治療方案，停止使用該藥物而無需患者退出研究。如有需要，將根據醫院管理局 IMPACT 指南開立抗生素和抗病毒藥物。治療方案可能會根據本港指引而進行更改。藥物治療將根據當地政策和臨床醫生的專業知識進行個人化管理。
*此中文版本為英文版本譯本，如中、英文兩個版本有任何抵觸或不相符之處，應以英文版本為準。
