益肾骨康方联合盐酸羟考酮缓释片治疗中重度癌性躯体痛肾虚血瘀证患者随机对照双盲临床研究

Randomized Controlled Double-blind Clinical Study on Yishen Gukang Recipe(益肾骨康方) Combined with Oxycodone Hydrochloride Sustained-release Tablets in the Treatment of Moderate to Severe Cancerous Pain with Kidney Deficiency and Blood Stasis Syndrome

目的观察益肾骨康方联合盐酸羟考酮缓释片治疗中重度癌性躯体痛肾虚血瘀证患者的临床疗效及安全性。方法采用随机、对照、双盲的研究方法,将符合纳入标准的100例患者随机分为治疗组和对照组各50例,两组患者第1周给予盐酸羟考酮缓释片10 mg,每12 h口服1次;第2周治疗组给予盐酸羟考酮缓释片加益肾骨康方,对照组给予盐酸羟考酮缓释片加中药安慰剂,每日1剂,连续治疗7天。观察两组治疗前及治疗1、2周后疼痛数字评分法(NRS)评分、爆发痛次数、盐酸羟考酮缓释片用量,治疗1、2周后判定临床疗效,治疗期间观察不良事件发生情况。结果治疗2周后治疗组临床疗效总有效率为94.00%,显效率为70.00%,对照组分别为88.00%、40.00%,治疗组优于对照组(P<0.01)。治疗组治疗2周后NRS评分、盐酸羟考酮缓释片用量低于对照组(P<0.05);两组治疗2周后较本组治疗1周后爆发痛次数降低(P<0.01);治疗组不良事件发生情况少于对照组(P<0.05)。结论益肾骨康方联合盐酸羟考酮缓释片可减轻中重度癌性躯体痛肾虚血瘀证患者疼痛,减少阿片类药物用量,且不良反应少。

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.