Zhang Qixin, Zeng Liling, Chen Xiuyan, Zhou Yuexiang, Gong Baoying, Li Haijun, Guo Jianwen
Brain Center, The Guangdong Provincial Hospital of Chinese Medicine, The Second Teaching Hospital of Guangzhou University of Chinese Medicine, China.
Evid Based Complement Alternat Med. 2018 Aug 26;2018:3120179. doi: 10.1155/2018/3120179. eCollection 2018.
Hypertensive intracerebral haemorrhage (HICH), which is characterized by rapid change, high morbidity, and mortality, is extremely dangerous. Both medical and surgical treatments lack definitive evidence and remain controversial. A prospective RCT that we have conducted has shown that the usage of the herbal medicine ICH-012 within 6 h of the event may increase the risk of haematoma enlargement and gastrointestinal bleeding. However, the volume of haematoma remains stable after 6 h. Thus, we will increase the time window to the period from 6 to 72 h after onset to evaluate the safety and efficacy of ICH-012 treating ICH (ClinicalTrial.gov ID: NCT03354026).
METHODS/DESIGN: The CRRICHTrial-II study, a prospective, double-blinded, controlled, multicentre RCT, includes three groups: A, B, and C. Group A patients were treated with 8 herbal medicines (with 2 herbal medicines of Hirudo and Tabanus as well as 6 other combined herbal medicines of Group B) and Group C were placebo. Patients should meet all the inclusion criteria: age between 18 and 80 and diagnosis of HICH by brain CT scan between 6 and 72 h from the onset. The CT scan will be taken at four critical time points: baseline, between 6 and 72h, 24h after onset, and between 10 and 14 days after onset. The drug intervention lasts 10 days, and there is a follow-up visit taken after 90 days. The haematoma enlargement after 24 h onset as demonstrated by CT is the primary outcome.
A large amount of data from high-quality RCTs is needed for the extensive clinical application of herbal medicine. The CRRICHTrial-II will evaluate the safety and effectiveness of ICH-012 in a safer time window between 6 and 72 h and investigate the possible mechanisms of action and direction of herbal medicine in the haematoma growth after HICH. ClinicalTrial.gov, ID: NCT03354026, is registered on 23rd Nov. 2017.
高血压性脑出血（HICH）病情变化迅速，发病率和死亡率高，极其危险。药物治疗和手术治疗均缺乏确凿证据，仍存在争议。我们进行的一项前瞻性随机对照试验表明，在发病6小时内使用中药ICH - 012可能会增加血肿扩大和胃肠道出血的风险。然而，6小时后血肿体积保持稳定。因此，我们将时间窗延长至发病后6至72小时，以评估ICH - 012治疗脑出血的安全性和有效性（ClinicalTrial.gov标识符：NCT03354026）。
方法/设计：CRRICHTrial - II研究是一项前瞻性、双盲、对照、多中心随机对照试验，包括A、B、C三组。A组患者接受8种中药治疗（其中包括水蛭和虻虫两种中药以及B组的其他6种联合中药），C组为安慰剂组。患者应符合所有纳入标准：年龄在18至80岁之间，发病后6至72小时内经脑部CT扫描诊断为HICH。CT扫描将在四个关键时间点进行：基线、发病后6至72小时、发病后24小时以及发病后10至14天。药物干预持续10天，90天后进行随访。CT显示发病后24小时血肿扩大情况为主要观察指标。
中药的广泛临床应用需要大量来自高质量随机对照试验的数据。CRRICHTrial - II将在6至72小时这一更安全的时间窗内评估ICH - 012的安全性和有效性，并研究中药在HICH后血肿生长过程中可能的作用机制和方向。ClinicalTrial.gov标识符：NCT03354026于2017年11月23日注册。
