正交设计筛选大黄煎剂保留灌肠治疗肝性脑病最佳方案

Orthogonal design in screening optimum scheme of retention enema with Rheum palmatum L.decoction in the treatment of hepatic encephalopathy

目的筛选大黄煎剂保留灌肠治疗肝性脑病的最佳方案,形成规范化操作,提高临床疗效及稳定性。方法选择54例肝性脑病Ⅲ级患者作为本试验的研究对象,按照插管深度(15、20、30cm)、保留时间(30、60、120min)、药液温度(36、40、45℃)、灌肠后体位(左侧卧位、平卧位、右侧卧位)4因素3水平,利用L(934)正交表安排试验,把纳入的患者分为9组,以肝性脑病患者的平均苏醒时间为观察指标,筛选出最佳的组合方案。结果大黄煎剂保留灌肠治疗肝性脑病的最佳方案为:灌肠液保留时间为120min,插管深度为30cm,保留灌肠药液温度为40℃,灌肠后右侧卧位。其中灌肠药液保留时间为影响临床疗效的最主要因素。结论应用正交设计方法能快速、高效地筛选出大黄煎剂保留灌肠治疗肝性脑病的最佳组合方案,为中医药规范化研究提供了可资借鉴的经验。

Objective To screen the optimum scheme of retention enema with Rheum palmatum L. decoction in the treatment of hepatic encephalopathy （HE） and standardize the operating procedures so as to improve clinical effect and stability. Methods Totally 54 cases of HE with grade In were selected in our study. Four factors and 3 levels including depth of intubation tube （15 cm, 20 cm, 30 cm）, retention time （30 min, 60 min, 120 min）, decoction temperature （36 ℃, 40 ℃, 45℃） and position after retention enema （left lateral decubitus, supine decubitus, right lateral decubitus） were scheduled in accordance with the L9 （34） orthogonal table, and the patients were randomly divided into 9 groups. The optimum scheme for the treatment of HE was screened according to the average palinesthesia time of the patients. Results The optimum scheme for the treatment of HE included retention enema for 120 min, incubation tube at 30 cm depth, decoction at the temperature of 40 ~C and right lateral decubitus after retention enema. The retention time was the most important factor affecting the therapeutic effect among the 4 factors. Conclusions It has been shown that the application of the orthogonal design can screen the optimum scheme of retention enema with Rheum palmatum L. decoction for the treatment of HE in a prompt and effective manner, and provide valuable experience in the standardization study of traditional Chinese medicine.