加减保和丸干预乳腺癌内分泌治疗相关性血脂异常临床研究

Clinical Study of Baohe Pill in Treatment of Dyslipidemia in Endocrine Therapy of Breast Cancer

目的探讨加减保和丸联合辛伐他汀对乳腺癌患者内分泌治疗相关性血脂异常的有效性及安全性。方法选取乳腺癌内分泌治疗相关性血脂异常患者81例,采用随机数字表法将其分为治疗组(n=41)和对照组(n=40),对照组给予辛伐他汀治疗,治疗组予以加减保和丸联合辛伐他汀治疗,2组疗程均为4周。比较2组治疗前后血脂水平、中医症状评分、KPS评分、肿瘤标志物、肝肾功能及心肌酶等指标。结果治疗后,2组血脂指标TG、TC、LDL-C、APo-B均较治疗前下降(P<0.05),且治疗组明显低于对照组(P<0.05)。治疗组胸闷、肢体困倦、头晕、肢麻沉重、心悸、恶心等中医症状评分显著低于对照组(P<0.05),KPS评分显著高于对照组(P<0.05)。2组治疗前后肿瘤标志物、肝肾功能、心肌酶等指标比较,差异无统计学意义(P>0.05)。结论加减保和丸联合辛伐他汀能够改善乳腺癌内分泌治疗相关性血脂异常,降低TG、TC、LDL-C、APo-B水平,改善中医症状评分,提高KPS评分,且不影响肿瘤标志物、肝肾功能及心肌酶等指标,具有推广价值。

Objective To investigate the efficacy and safety of Baohe pill combined with simvastatin in treatment of dyslipidemia in breast cancer patients with endocrine therapy.Methods A total of 81 cases of breast cancer in endocrine therapy associated with dyslipidemia were selected.The patients were randomly divided into treatment group(n=41)and control group(n=40).The patients were treated with Baohe pill combined with simvastatin in the treatment group,while the control group was treated with simvastatin only.Both groups were treated for 4 weeks.After treatment,the changes of blood lipid,TCM symptom scores,KPS scores,tumor markers,liver and renal function indexes,myocardial enzymes were analyzed and compared.Results After 4 weeks treatment,the level of TG,TC,LDL-C,APo-B decreased in both groups(P<0.05),and the treatment group was significantly lower than the control group(P<0.05).The scores of chest tightness,limb sleepiness,dizziness,limb numbness,palpitation and nausea in the treatment group were significantly lower than those in the control group(P<0.05).The KPS scores in the treatment group were significantly higher than those in the control group(P<0.05).There was no significant difference in tumor markers,liver and kidney function indexes,myocardial enzymes before and after treatment(P>0.05).Conclusion The combination of Baohe pill and simvastatin can improve dyslipidemia in patients with breast cancer assisted endocrine therapy.It can reduce blood lipid level of TG,TC,LDL-C,APo-B,alleviate TCM syndromes and improve KPS scores.What’s more,it do not affect the level of tumor markers,liver and kidney function and myocardial enzymes,which has the value of promotion.