健脾散结丸干预恶性肿瘤化疗后脾虚证的疗效观察

目的] 观察健脾散结丸治疗恶性肿瘤化疗后出现的脾虚证疗效及安全性。方法] 选择40例恶性肿瘤化疗后出现脾虚证的患者,症见倦怠乏力,食少纳呆,脘腹痞满,胸膈烦闷,恶心呕吐,腹胀便秘,舌淡或淡暗,苔厚,脉弦细或沉细。于化疗结束后开始口服健脾散结丸(浓缩丸),每次10 g,每日2次,共2周。2周后评价疗效,记录患者在治疗前、第3、7、10、14天时的脾虚各症状评分、舌苔、脉象的变化及评分,记录患者的卡氏评分及体质量变化的评分;在化疗结束开始服药及服药后第7、14天分别测定患者的血尿便常规、肝肾功、心电图以评价药物的安全性。结果] 恶性肿瘤化疗后出现脾虚证的患者,口服健脾散结丸后,治疗后患者的脾虚证候的总评分及脾虚各症状的评分较治疗前存在统计学差异(P<0.05);卡氏评分及体质量评分无统计学差异(P>0.05);患者的血常规治疗后较治疗前有统计学差异,受化疗影响,不作为重点参考指标;有个别患者的尿便常规及肝功能稍有变化,无统计学意义;肾功能、心电图基本无变化。结论] 健脾散结丸用于恶性肿瘤化疗后出现脾虚证候者能够明显改善症状,说明该药物能够改善患者临床症状,提高患者生存质量,临床安全性较高。该研究为进一步开发临床新药提供试验依据及参考。

Effect of Jianpi Sanjie pill on spleen deficiency syndrome after chemotherapy

Objective] To observe the efficacy and safety of Jianpi Sanjie pill for the patients with spleen deficiency syndrome after chemotherapy. Methods] Forty patients with syndromes of spleen deficiency after chemotherapy were enrolled. At the end of the chemotherapy cycle, they began to take the pills for 2 weeks. At 3rd, 7th, 10th, 14th days, the syndrome scores, tongue, pulse and some examining index, such as liver and kidney function were recorded to evaluate the toxicity of the medicine. 2 weeks later, we appreciated the whole efficacy. Results] The general scores after treatment had more significant differences in patients with the syndromes of spleen deficiency after the chemotherapy than pre-treatment (P<0.05). Conclusion] The pills may be effective for the spleen deficiency syndrome after the chemotherapy. The medicine can protect patients against the enteric side-effects of the treatment and improve the life quality. It can be helpful to recover from the chemotherapy.