Objective To observe the clinical efficacy and safety of Yishen Gukang Recipe（ 益肾骨康方） combined with oxycodone hydrochloride sustained-release tablets in the treatment of patients with moderate to severe cancer pain with kidney deficiency and blood stasis syndrome. Methods A randomized

controlled

double-blind study was conducted. Totally 100 patients who met the inclusion criteria were randomized into the treatment group and the control group

with 50 cases in each. Both groups received oxycodone hydrochloride sustained-release tablets 10 mg

oral administration once every 12 hours; in the second week

the treatment group was given oxycodone hydrochloride sustained-release tablets with Yishen Gukang Recipe

and the control group was given oxycodone hydrochloride sustained-release tablets with Chinese medicine placebo

one dose per day for 7 consecutive days. The numeric rating scale（ NRS）

the times of breakthrough pain

and the dose of oxycodone hydrochloride sustained-release tablets before and 1 and 2 week after treatment were observed in both groups. The clinical efficacy was determined after 1 and2 weeks of treatment

and the adverse events were observed during the treatment. Results After 2 weeks of treatment

the total effective rate was 94. 00%

and the markedly effective rate was 70. 00% in the treatment group. And the control group was 88. 00% and 40. 00% respectively. The treatment group was superior to the control group（ P <0. 01）. After 2 weeks of treatment

the NRS score and the dose of oxycodone hydrochloride sustained-release tablets were lower than those of the control group（ P < 0. 05）. After 2 weeks of treatment

the times of breakthrough pains decreased after 1 week of treatment（ P < 0. 01）. The incidence of adverse events in the treatment group was less than that in the control group（ P < 0. 05）. Conclusion Yishen Gukang Recipe combined with oxycodone hydrochloride sustained-release tablets can alleviate the pain of patients with moderate to severe cancerous pain with kidney deficiency and blood stasis syndrome

reduce the dosage of opioids

and have fewer adverse reactions.