加味防己地黄汤治疗乳腺癌内分泌治疗后失眠的疗效观察

Effect of Modified Fangji Dihuang Decoction on Insomnia after Endocrine Therapy for Breast Cancer

目的观察加味防己地黄汤治疗乳腺癌(Breast cancer,BC)内分泌治疗后失眠的临床疗效。方法选取2020年1月—2021年2月期间广东省江门市五邑中医院收治的50例冲任失调夹痰瘀互结型BC内分泌治疗后失眠患者,随机分为对照组和治疗组,每组各25例。两组均保持原来的内分泌治疗及心理疏导,在此基础上,对照组予以阿普唑仑片治疗,治疗组予以加味防己地黄汤治疗。治疗2周后,观察两组患者临床疗效,比较两组患者治疗前后匹兹堡睡眠质量指数(Pittsburgh sleep quality index,PSQI)(包含入睡时间及睡眠的时间、效率、质量、障碍、药物及日间功能)评分、Kupperman评分、Karnofsky评分标准(Karnofsky performance status,KPS)评分及血清性激素水平[雌二醇(Estradiol,E2)、促卵泡生成素(Follicle-stimulating hormone,FSH)、促黄体生成素(Luteinizing hormone,LH)],并评估两组患者用药安全性。结果治疗后治疗组总有效率为92.00%(23/25)明显高于对照组68.00%(17/25),差异有统计学意义(P<0.05)。治疗后两组患者Kupperman评分、PSQI各项评分均低于治疗前,KPS评分均高于治疗前,差异均有统计学意义(P<0.05);且治疗组Kupperman评分、PSQI各项评分低于对照组,KPS评分高于对照组,差异均有统计学意义(P<0.05)。治疗后两组患者血清E2、FSH、LH水平比较,差异均无统计学意义(P>0.05)。两组患者治疗期间均未见明显不良反应。结论加味防己地黄汤可有效减轻BC内分泌治疗后的失眠症状及其他类更年期症状,但对性激素水平变化无显著影响。

Objective To observe the clinical efficacy of modified Fangji Dihuang Decoction in the treatment of insomnia after endocrine therapy for breast cancer(BC).Methods Fifty patients with insomnia after endocrine therapy for BC(syndrome of disharmony of thoroughfare and conception vessels combined with phlegm accumulation and blood stasis)treated in Wuyi Hospital of Traditional Chinese Medicine from January 2020 to February 2021 were randomly assigned into a control group(n=25)and a study group(n=25).Both groups received endocrine therapy and psychological counseling.On this basis,the control group was administrated with alprazolam tablets,and the study group with modified Fangji Dihuang Decoction.The clinical efficacy of the two groups was compared after two weeks of treatment.The Pittsburgh Sleep Quality Index(PSQI)score,Kupperman score,Karnofsky Performance Status(KPS)score,and serum levels of sex hormones[estradiol(E;),follicle-stimulating hormone(FSH),and luteinizing hormone(LH)]were compared between before and after treatment and between the two groups.The safety of therapies of the two groups was evaluated.Results The total effective rate of the study group was higher than that of the control group[92.00%(23/25)vs.68.00%(17/25),P<0.05].The treatments in both groups lowered the PSQI score and Kupperman score and elevated the KPS score(P<0.05).Moreover,the study group had lower PSQI score and Kupperman score and higher KPS score than the control group(P<0.05).The levels of sex hormones showed no significant differences between the two groups after treatment(P>0.05).Adverse reactions appeared in neither groups during the treatment period.Conclusion Modified Fangji Dihuang Decoction can mitigate insomnia and other menopausal symptoms after endocrine therapy for BC,while it has no significanteffect on sex hormone levels.