ABSTRACT
Objective To evaluate an effective and feasible quantitative evaluation table of traditional Chinese medicine (TCM) syndrome differentiation, and to observe the effect of combination of TCM syndrome differentiation and standard bundle therapy in patients with septic shock. Methods A prospective randomized controlled trial was conducted. The septic shock patients with acute deficiency syndrome admitted to department of critical care medicine of Ruijin Hospital, Shanghai Jiao Tong University School of Medicine from January 1st, 2016 to December 31st, 2017 were enrolled. The patients were randomly divided into control group and Shenfu group. The patients in both groups received early application of standardized bundle therapy; those in Shenfu group received 60 mL Shenfu injection infusion in addition for 7 days. The TCM syndrome score was evaluated by classification and scoring method of TCM symptoms. The circulation and tissue perfusion, severity of disease, organ function, inflammation response, adjuvant treatment and 28-day mortality were compared between the two groups. Results A total of 50 patients with septic shock were enrolled in the analysis, 25 in control group and 25 in Shenfu group. The markedly effective rate of TCM symptoms score in Shenfu group was significantly higher than that in control group [60.0% (15/25) vs. 16.0% (4/25), P < 0.01]. There was no significant difference in all parameters before treatment between the two groups. After treatment, the observation indexes of both groups were improved. Compared with control group, the mean arterial pressure (MAP) in Shenfu group increased more significantly [mmHg (1 mmHg = 0.133 kPa): 13.0 (2.5, 28.5) vs. 6.0 (0, 13.5)], the lactate (Lac) and procalcitonin (PCT) decreased more significantly [Lac (mmol/L): 0.8 (0.1, 3.7) vs. 0.5 (-0.6, 1.7), PCT (μg/L): 2.0 (0.7, 32.3) vs. 0 (-1.8, 3.8)], activated partial thromboplastin time (APTT) was shortened more significantly [s: 8.5 (0, 12.9) vs. 0 (-7.2, 10.0)], and interleukins (IL-2 receptor and IL-6) levels decreased more significantly [IL-2 receptor (ng/L):1 031.0 (533.0, 1 840.0) vs. 525.5 (186.0, 1 166.8), IL-6 (ng/L): 153.1 (21.4, 406.8) vs. 35.1 (16.3, 110.1)] with significant differences (all P < 0.05). There was no significant difference in the use time of vasoactive drugs, duration of mechanical ventilation, severity of the disease or 28-day mortality between the two groups. However, the use time of vasoactive drugs in Shenfu group was shorter than that in control group (days: 5.48±4.81 vs. 8.28±7.83), and the 28-day mortality was decreased [8.0% (2/25) vs. 20.0% (5/25)]. Conclusions TCM syndrome score is helpful to evaluate the effect of TCM syndrome differentiation and treatment, and it is effective and feasible in clinical application. Septic shock patients treated with TCM syndrome differentiation and treatment combined with standard bundle therapy were significantly improved in circulation, tissue perfusion, coagulation function and inflammation reaction.
ABSTRACT
Objective To explore the efficacy ofTiaogan-Bushen-Xiaoji recipe (TGBSXJ Recipe) on overall survival and progression free survival (PFS) in patients with advanced breast cancer.Methods A total of 105 patients with advanced breast cancer, who received the first-line treatment, were divided into two groups, 56 cases in the control group and 49 in the experimental group. The control group received standard therapy according to guidelines, including chemotherapy, targeted therapy, endocrine therapy and treatment of bisphosphonates.The experimental group received the treatment of TGBSXJ Recipe besides the standard therapy. The overall survival (OS), progression-free survival (PFS) and Karnofsky (KPS) of the patients in two groups were observed and compared. The treatment ended with the sighs of the observation ending, the second progress for the disease or death.Results The overall survival of the experimental group was significantly higher than that of the control group [OS: 58.2(50.7-65.8)/monthsvs. 43.8(30.6-51.6)/months,P=0.040]. The PFS of the experimental group was significantly higher than the control group [PFS: 30.7(23.8-37.7)/monthsvs. 15.2(11.3-19.1)/months,P=0.001]. The KPS of the experimental group was significantly higher than the control group (88.6 ± 10.0vs. 80.5 ± 19.0,t=2.654). The PFS of the triple negative breast cancer (TNBC) in the experimental group was significantly higher than control group [(25.1(12.1-38.0)/monthsvs. 9.9(4.7-15.0)/months,P=0.038].Conclusions The TGBSXJ recipe could extend the OS and PFS and improve the life quality of the patients with advanced breast cancer. In this study, no severe adverse effects had been found in the experimental group.