安神补康灵方治疗恶性肿瘤相关性失眠的临床疗效观察

Curative Effect Observation of Anshen Bukangling Decoction on Patients With Cancer-related Insomnia

目的观察安神补康灵方(ASBKL)治疗恶性肿瘤相关性失眠的临床疗效和安全性。方法选取80例符合失眠诊断标准的恶性肿瘤患者,随机分为治疗组与对照组各40例。治疗组口服安神补康灵方,对照组口服艾司唑仑片。观察两组患者治疗前后中医证候积分及疗效,采用匹兹堡睡眠质量指数(PSQI)评分表在治疗前、治疗第1、2疗程末(每疗程15天)进行评分,评定临床疗效及记录不良反应。结果治疗组中医证候疗效总有效率为92.5%,对照组为77.5%,治疗组中医症候疗效优于对照组(P<0.05);两组患者PSQI评分均较治疗前下降(P<0.05),治疗后第1疗程末治疗组与对照组患者PSQI量表评分比较差异无统计学意义(P>0.05),第2疗程末对比,差异有统计学意义(P<0.05)。两组未见明显不良反应。结论安神补康灵治疗恶性肿瘤相关性失眠疗效显著,安全性高。

Objective To observe the clinical effect and adverse reactions of Anshen Bukangling decoction（ASBKL） for patients with cancer-related insomnia. Methods 80 patients with malignant tumor were randomly divided into the treatment group and the control group with 40 cases in each group. The treatment group oral sedative supplement Kang Ling, control group was treated with Estazolam Tablets. To observe the therapeutic effect of TCM syndrome score and two groups of patients before and after treatment, the Pittsburgh sleep quality index（PSQI） score before treatment, first, at the end of the 2 course（every 15 days） to score, to evaluate the clinical efficacy and adverse reactions were recorded. Results The treatment group of TCM syndrome total effective rate was 92.5%, 77.5% in the control group, the treatment group the curative effect of TCM syndrome is better than that of control group（P0.05）, two patients with PSQI were lower than that before treatment（P0.05）, after treatment at the end of the first course of treatment group and control group of patients with PSQI scores there was no statistically significant difference（P0.05）, at the end of the second course comparison, the difference was statistically significant（P0.05）. No obvious adverse reactions were found in the two groups. Conclusion Anshen Bukangling decoction is effective and safe for patients with cancer-related insomnia.