疏肝调阴阳方改善乳腺癌术后他莫昔芬不适症状群与提高生活质量的临床研究

Shugan Tiaoyinyang Fang in Ameliorating Symptoms Caused by Tamoxifen after Breast Cancer Surgery and Improving the Quality of Life:a RCT

目的 评价疏肝调阴阳方改善他莫昔芬引起不适症状群的临床疗效.方法 将80例乳腺癌术后使用他莫昔芬内分泌治疗1a以上、伴有明显内分泌紊乱症状且卡氏评分＞60分患者,按数字编号随机分为2组.对照组予以他莫昔芬口服,10mg/次,每日2次;治疗组在同剂量口服他莫昔芬基础上,加服用疏肝调阴阳方加减口服治疗,每日1剂,早晚煎服,2个月为1个疗程.治疗结束时,采用改良kuppermann评分量表评价症状改善程度;采用KPS评分标准评价患者的生活质量;实验室检查评价用药安全.结果 治疗组在治疗后15天开始评分下降,至观察结束,P＜0.05～0.01,对照组患者的症状积分中,仅眩晕、骨关节痛、头痛及心悸症状有改善,2组比较,P＜0.05～0.01;治疗组患者卡氏评分较治疗前有明显提高（P＜0.05）,对照组治疗后KPS评分无变化（P＞0.05）,2组比较,治疗组卡氏评分较对照组有明显提高（P＜0.05）;2组血常规及肝肾功能无异常变化,治疗组甘油三酯检验数值显著低于对照组（P＜0.01）.结论 疏肝调阴阳方显著改善他莫昔芬引起的不适症状群,提高患者的生活质量,降低血脂水平,有效缓解他莫昔芬的毒副作用,临床使用安全.

OBJECTIVE To evaluate the clinical effects of Shugan Tiaoyinyang Fang on treatment of symptoms caused by oral Tamoxifen.METHODS 80 patients with breast cancer who had been treated with Tamoxifen for more than one year and had obvious endocrine disorders were randomly and equally divided into two groups,namely the treatment group of 40 cases orally taking Shugan Tiaoyinyang Fang and Tamoxifen twice a day for 60 days and the control group of 40 cases only orally taking Tamoxifen.The amended kuppermann scores were adopted to evaluate the improvement of the symptoms,KPS was adopted to evaluate patients＇ quality of life and laboratory tests were used to evaluate drug safety.RESULTS The Kuppermann scores of the treatment group degreased significantly after 15-day treatment to the end of the study （P〈0.05～0.01）,while only some of the symptoms of patients in the control group were improved,such as vertigo,joint pain,headache,palpitation （P〈0.05 ～ 0.01）.The Kuppermann scores of the treatment group degreased significantly with statistical differences after treatment compared with those before treatment （P〈0.05）,while those of the control group were not changed obviously （P 〉0.05）.The KPS scores of the treatment group improved significantly,compared with the control group （P〈0.05）.The laboratory test results showed that the blood test and hepatic and renal function test were normal for all the patients and there was a significant decrease of the triglyceride level in the treatment group （P〈0.01）.CONCLUSION Shugan Tiaoyinyang Fang can effectively ameliorate the symptoms caused by Tamoxifen improve patients＇ life quality reduce the blood lipid level and lessen the side effects of Tamoxifen in clinic.