Clinical study on modified Shaoyao-Gancao Decoction and morphine sulfate sustained release tablets for the patients with cancer pain with qi and blood deficiency syndrome / 国际中医中药杂志

ABSTRACT

Objective:To evaluate the clinical effect of modified Shaoyao-Gancao Decoction combined with oral morphine sulfate sustained release tablets in the treatment of cancer pain with qi and blood deficiency. Methods:A total of 102 cancer pain patients with qi and blood deficiency from March 2017 to May 2018 were divided into two groups according to the random number table method, 51 in each group. The control group was treated with morphine sulfate sustained release tablets on the basis of conventional treatment, and the treatment group was treated with modified Shaoyao-Gancao Decoction on the basis of the control group. Both groups were treated for 4 weeks. Numerical rating scale (NRS) was used to assess the severity of cancer pain, and Karnofsky performance status (KPS) scale was used to assess the quality of life. The level of Endothelin-1 (ET-1) was measured by radioimmunoassay, The levels of 5-hydroxytryptamine (5-HT), Prostaglandin E2 (PGE2) and substance P (SP), TNF-α, IL-1β, IL-6, IL-2 were detected by ELISA, the clinical effects were evaluated, and the adverse reactions were recorded. Results:The total effective rate was 94.1% (48/51) in the treatment group and 78.4% (40/51) in the control group, the difference between two groups was statistically significant ( χ2=5.299, P=0.021). After the treatment, the NRS score (2.84 ± 1.32 vs. 4.22 ± 1.44, t=5.045) in the treatment group was significantly lower than that of the control group ( P<0.01), and the KPS score (73.13 ± 10.19 vs. 59.93 ± 8.81, t=6.998) was significantly higher than that of the control group ( P<0.01). After the treatment, serum 5-HT (0.34 ± 0.09 pg/ml vs. 0.53 ± 0.14 pg/ml, t=8.153), PGE2 (65.03 ± 15.79 pg/ml vs. 94.85 ± 20.88 pg/ml, t=8.135), ET-1 (99.96 ± 21.57 pg/ml vs. 176.78 ± 26.01 pg/ml, t=16.236), SP (60.27 ± 12.71 pg/ml vs. 65.63 ± 12.09 pg/ml, t=2.182) in the treatment group were significantly lower than those in the control group ( P<0.01 or P<0.05). Serum TNF-α, IL-1β, IL-6 level were significantly lower than that of the control group ( t value were 35.071, 12.472, 8.122, all Ps<0.01), and IL-2 level was significantly higher than that of the control group ( t=6.579, P<0.01). During the treatment, the incidence of adverse reactions was 13.7% (7/51) in the control group and 2.0% (1/51) in the treatment group. The difference between the two groups was statistically significant ( χ2=4.630, P=0.031). Conclusions:Modified Shaoyao-Gancao Decoction combined with morphine sulfate sustained release tablets can relieve the pain of cancer pain patients with qi and blood deficiency, reduce the level of inflammatory cytokines, and improve the clinical symptoms and quality of life of patients.