高血压脑出血术后患者单病例随机对照临床试验

目的]通过对高血压脑出血(Hypertensive intracerebral hemorrhage,HICH)术后患者的中医个体化治疗,研究单病例随机对照试验在中医药临床研究中的可行性。方法]按照HICH的诊断标准纳入病例4例。合格病例采用单病例随机对照设计,每个病例研究分为3轮,每轮为2期,即治疗期和对照期,每期为4周,每1期开始前1周为洗脱期。每一轮治疗以计算机随机数字法简单随机分组,拟定随机化方案,治理怄气采用中医辨证治疗和常规基础治疗,对照期采用常规治疗和安慰剂,疗效指标为主要症状积分、血清IL-6、血肿周围脑水肿或脑梗塞的程度、神经功能缺损程度分级。逐日在固定时间记录主要症状积分。实验室治疗、影像学指标及神经功能缺损程度分级在试验前和每期试验后各记录1次。结果]4例患者中医症状积分每轮均有不同程度的改善,其中1例部分改善,3例全部改善。4例患者每轮治疗期和对照期相比,IL-6、周围脑水肿或脑梗塞的程度及神经功能缺损程度评分均有一定程度的下降,治疗期均明显好于对照期。其中,4例患者全部三轮治疗期和对照期IL-6的数据合并后,差异有统计学意义(P<0.05)。结论]单病例随机对照试验的研究方法能体现中医个性化的优势,该设计方案应用于中医药临床研究具有可行性。

Randomized Controlled Trials in Individual Pantient of Third Stage of Hypertension Intracerebral Hemorrhage

Objective]To study the feasibility and advantages of randomized controlled trials in individual patient through the TCM individual treatment for hypertension intracerebral hemorrhage. Methods ] The patients were enrolled according to the diagnosis standard of HICH. The randomized controlled design was adopted in the trial. Each phase of was 4 studied in 3 rounds, each round was divided into 2 phases, namely the treatment phase and control phase, each phase was of 4 weeks, and the first week of each phase was taken as the elution time. In each round, the randomized list was given by the computer for grouping the patients and the randomized plan was made. For the treatment phase, the Chinese medicinal decoctions based on the syndrome differentiation and the routine basic treatment were applied, whilst for the control phase, the routine basic treatment was performed. The indices of effica- cy included the scores of main symptom; IL-6, morphology index and clinical curative effect evaluation. The patient recorded the symptom score at the same time each day. Before and after each phase IL-6, morphology index and clinical curative effect evaluation were tested and recorded as well. 1Le- sults] The TCM symptom scores of these four HICH patients were improved to different degrees in three rounds. Of them, one was partially improved and three completely improved. In the comparison of each treatment and control phase of the 4 patients, IL-6, morphology index and clinical curative effect evaluation were both decreased to different degrees, the treatment phase was better than the control phase. After the date of IL-6 of all 3 rounds of the patients were summed up, it showed the statistical difference. Conclusion]The studying method of randomized controlled trials in individual patient is able to embody the advantages of TCM individual treatment,and application of this design to the clinical studies of Chinese medicine is useful and feasible.