Zhang Hao, Zhang Danying, Sun Yudong, Lu Ye, Feng Jiaxuan, Zhang Lei, Song Chao, Jing Zaiping, Yu Chaoqin, Lu Qingsheng
Department of Vascular Surgery, Changhai Hospital, The Navy Military Medical University, Shanghai 200433, China.
Department of General Surgery, No. 202 Hospital of People's Liberation Army, Shenyang 110812, China.
Evid Based Complement Alternat Med. 2019 Nov 15;2019:6432953. doi: 10.1155/2019/6432953. eCollection 2019.
To explore a new treatment that can proceed from the whole, control blood pressure smoothly and coordinate the treatment of multiple factors causing blood pressure fluctuations.
We conducted a single-center, double-blinded, and randomized controlled clinical trial. 48 patients with acute Type B aortic dissection were randomly assigned into two groups: the experimental group, who received pinggan formula treatment, and the control group, who received placebo treatment. The drug was taken orally after meals three times a day. Only when the patients' blood pressure fluctuated, conventional antihypertensive drugs were given to maintain the blood pressure within the target range and the dosage was recorded to convert the DDD value. Meanwhile, the international standardized score was used to evaluate the defecation, sleep, pain, anxiety, and depression of patients in the two groups during the hospitalization.
Univariate analysis was conducted on variables that might affect the assessment results, and it was found that grouping factors had a significant impact on the outcome variables, that is, after the intervention, the mean value of DDDs used in the perioperative period in the control group was 2.19 (0.38, 4.00). (=0.0219), defecation score (2.13 (1.59, 2.67); < 0.0001), sleep score (0.95 (0.40, 1.50); =0.0014), pain score (1.77 (0.61, 2.93); =0.0045), depression score (4.04 (2.95, 5.12); and < 0.0001) were significantly higher than that of the experimental group, and the difference was statistically significant.
Pinggan formula has a clear therapeutic regulation effect on the overall hemodynamics of acute Stanford type B aortic dissection during the perioperative period and can be recommended as an auxiliary drug for conventional antihypertensive drugs at the current stage.
探索一种能从整体出发、平稳控制血压并协调治疗多种导致血压波动因素的新疗法。
我们开展了一项单中心、双盲、随机对照临床试验。48例急性B型主动脉夹层患者被随机分为两组:实验组接受平肝方治疗,对照组接受安慰剂治疗。药物餐后口服,每日3次。仅在患者血压波动时给予常规降压药物以将血压维持在目标范围内,并记录剂量以换算DDD值。同时,采用国际标准化评分评估两组患者住院期间的排便、睡眠、疼痛、焦虑和抑郁情况。
对可能影响评估结果的变量进行单因素分析,发现分组因素对结局变量有显著影响,即干预后,对照组围手术期使用的DDDs平均值为2.19(0.38,4.00)(=0.0219),排便评分(2.13(1.59,2.67);<0.0001)、睡眠评分(0.95(0.40,1.50);=0.0014)、疼痛评分(1.77(0.61,2.93);=0.0045)、抑郁评分(4.04(2.95,5.12);<0.0001)均显著高于实验组,差异有统计学意义。
平肝方对急性Stanford B型主动脉夹层围手术期的整体血流动力学有明确的治疗调节作用,现阶段可推荐作为常规降压药物的辅助用药。