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目的:观察健脾散结丸治疗恶性肿瘤化疗后脾虚证患者的疗效及用药安全性。方法:60例恶性肿瘤化疗后出现脾虚证的患者,随机分为对照组和试验组,各30例。试验组化疗结束后开始口服健脾散结丸(浓缩丸),10g/次,Bid,共2周;对照组口服健脾益肾颗粒,10g/次,Bid,共2周。2周后评价疗效,记录2组患者在服药前后的脾虚证候评分、舌苔、脉象的变化及评分、卡氏评分及体重变化的评分;服药前后测定患者的血、尿、便常规,肝肾功能,心电图。结果:服药前2组患者具有可比性;服药后,试验组患者在倦怠乏力、食少纳呆、恶心呕吐及腹胀便秘4个证候的改善优于对照组;且2组患者疗效存在显著性差异(P<0.01)。血、尿、便常规及肝肾功能、心电图的检查证明该药无明显毒副反应。结论:健脾散结丸可改善恶性肿瘤化疗后脾虚证候患者的临床症状,提高患者生存质量,用于临床较为安全。
Objective: To observe the therapeutic effect and medication safety of Jianpi Sanjie Pill in treating patients with spleen deficiency after chemotherapy for malignant tumors. Methods: Sixty patients with spleen deficiency syndrome after chemotherapy were randomly divided into control group and experimental group, with 30 cases in each group. The experimental group began oral administration of Jianpi Sanjie Pills (concentration pills), 10g / time, Bid for 2 weeks; the control group oral Jianpi Yishen granules, 10g / time, Bid, for 2 weeks. Two weeks later, the curative effect was evaluated. The scores of spleen deficiency syndrome, tongue coating, pulse changes, score, Karnofsky score and weight change score of two groups before and after taking the medicine were recorded. Before and after taking the medicine, the blood and urine of the patients were routinely measured. Function, electrocardiogram. Results: The patients in the two groups were comparable before taking the medication. After taking the medication, the improvement of the four syndromes in the test group was better than that in the control group in fatigue, lack of food, nausea, vomiting and abdominal distension and constipation. The efficacy of the two groups was significant Difference (P <0.01). Blood, urine, then routine and liver and kidney function, ECG examination showed no obvious side effects of the drug. Conclusion: Jianpi Sanjie pill can improve the clinical symptoms of patients with spleen deficiency syndrome after chemotherapy, improve the quality of life of patients, and be safe in clinical practice.