补肾强筋胶囊治疗乳腺癌AIMSS的临床研究

发布时间：2018-08-31 09:04

【摘要】：目的:芳香化酶抑制剂(aromatese inhibitor,AI)作为绝经后乳腺癌患者辅助内分泌治疗中的一线用药,其疗效确切,耐受性良好,在乳腺癌治疗中得到广泛应用。然而,芳香化酶抑制剂的长期使用所带来的副反应不可忽视,尤其芳香化酶抑制剂引起的相关肌肉骨关节症状,严重影响患者的日常生活和工作,往往成为更换治疗药物甚至停止药物治疗的重要原因。临床上芳香化酶抑制剂相关肌肉骨关节症状(aromatase inhibitor-associated musculoskeletal symptoms,AIMSS)的治疗无统一标准,主要通过补钙、止痛剂、糖皮质激素以及中医药治疗等方法来缓解症状,治疗疗效各不相同。中医药治疗在防治西药的副作用方面有着独特的疗效,具有补益肝肾、强筋健骨、化瘀通络作用的补肾强筋胶囊也许能缓解AIMSS。本研究采用随机对照实验方法,通过记录分析受试者在两种不同治疗方法中治疗前后相关指标的变化,以评估补肾强筋胶囊治疗AIMSS的临床疗效,探索有效改善AIMSS的防治手段。方法:本研究纳入广东省第二中医院乳腺科以第三代AI为辅助内分泌治疗的乳腺癌患者73例,采用随机数字表法随机分为对照组和实验组。对照组予口服钙尔奇D 1#qd,共服用6个月;实验组予口服钙尔奇D 1#qd+补肾强筋胶囊2#tid,共服用6个月。在治疗前测定简明疼痛量表(Brief Pain Inventory,BPI)、SF-36 健康测量量表(Short Form 36-Item Health Survey,SF-36),骨密度(bone mineral density,BMD),并测定血常规、肝肾功能、E2等安全性指标;治疗后3月测定BPI、SF-36,并测定血常规、肝肾功能、E2等安全性指标;治疗后6月测定BPI、SF-36、BMD,并测定血常规、肝肾功能、E2等安全性指标。采用SPSS21.0统计软件建立数据库以及分析数据。计量资料采用均数士标准差表示。主要采用t检验,若不满足正态分布或方差齐性,则采用秩和检验;若多个样本比较,则采用方差分析;以百分率表示的数据,采用卡方(x2)检验;关联性分析采用pearson相关性分析。结果:本研究结果显示:与对照组相比,实验组的最剧烈痛、最轻微痛、平均痛、当时痛在治疗前后的总体均值均具有显著性差异。对照组内,治疗3月后与治疗前相比,最剧烈痛、最轻微痛、平均痛、当时痛的总体均值具有显著性差异。治疗6月后与治疗前相比,最剧烈痛、最轻微痛、平均痛、当时痛的总体均值具有显著性差异。实验组内,治疗3月后与治疗前相比,最剧烈痛、最轻微痛、平均痛、当时痛的总体均值具有显著性差异。治疗6月后与治疗前相比,最剧烈痛、最轻微痛、平均痛、当时痛的总体均值具有显著性差异。与对照组相比,实验组的生理机能(PF)、生理职能(RP)、躯体疼痛(BP)、一般健康状况(GH)、精力(VT)、社会功能(SF)、情感职能(RE)、精神健康(MH)在治疗前后的总体均值具有显著性差异。对照组内,治疗3月后与治疗前相比,PF、RP、BP、GH、SF、MH的总体均值具有显著性差异。VT、RE的总体均值无显著性差异。治疗6月后与治疗前相比,PF、RP、BP、GH、SF、RE的总体均值具有显著性差异。VT、MH的总体均值无显著性差异。实验组内,治疗3月后与治疗前相比,PF、RP、BP、GH、VT、SF、RE、MH的总体均值均具有显著性差异。治疗6月后与治疗前相比,PF、RP、BP、GH、VT、SF、RE、MH的总体均值均具有显著性差异。实验组在治疗后与治疗前相比,骨密度升高,但无统计学意义。对照组在治疗后与治疗前相比,骨密度较前下降。治疗前后测定的安全性指标均无异常,患者雌激素水平仍处于绝经后状态。结论:补肾强筋胶囊治疗AIMSS的疗效主要体现在疼痛评分和生活质量评分等指标上,而骨密度具有轻微的提升,但无显著性差异。补肾强筋胶囊在改善患者疼痛症状以及提高患者生活质量方面具有明显的效果,且无不良反应,雌激素保持在安全水平,不影响乳腺癌的整体治疗。补肾强筋胶囊能有效地治疗乳癌AIMSS,方便可行,值得进一步在临床实践中应用。
[Abstract]:AIM: Aromatase inhibitor (AI), as a first-line adjuvant endocrine therapy for postmenopausal breast cancer, has been widely used in the treatment of breast cancer because of its definite efficacy and good tolerance. There is no uniform standard for the treatment of aromatase inhibitor-associated musculoskeletal symptoms (AIMSS). Chinese medicine treatment has a unique effect on the prevention and treatment of side effects of Western medicine. It has the effect of tonifying liver and kidney, strengthening tendons and bones, removing blood stasis and dredging collaterals. This study used randomized pairs. According to the experimental method, the changes of related indexes before and after treatment were recorded and analyzed in order to evaluate the clinical efficacy of Bushen Qiangjin capsule in the treatment of AIMSS and explore the effective means to improve the prevention and treatment of AIMSS. 73 patients with adenocarcinoma were randomly divided into control group and experimental group by random number table method.The control group was given Calcium Digest 1 # QD orally for 6 months.The experimental group was given Calcium Digest 1 # QD + Bushen Qiangjin Capsule 2 # TID orally for 6 months.Brief Pain Inventory (BPI) and SF-36 Health Measurement Scale (Short For Pain Inventory, BPI) were measured before treatment. M 36-Item Health Survey, SF-36, bone mineral density (BMD), blood routine, liver and kidney function, E2 and other safety indicators were measured; BPI, SF-36, blood routine, liver and kidney function, E2 and other safety indicators were measured 3 months after treatment; BPI, SF-36, BMD were measured 6 months after treatment, and blood routine, liver and kidney function, E2 and other safety indicators were measured. 1.0 statistical software to establish a database and analysis of data.Measurement data is expressed by means of the standard deviation of the mean number.Mainly used t test, if it does not meet the normal distribution or homogeneity of variance, then used rank sum test; if more than one sample is compared, then used analysis of variance; the data expressed in percentage, using chi-square (x2) test; correlation analysis using Pearson test; Result: Compared with the control group, the experimental group had the most severe pain, the slightest pain, the average pain, and the total mean pain before and after treatment had significant difference. In the experimental group, after treatment for 3 months, compared with before treatment, the most severe pain, the slightest pain, the average pain, the total average pain was significantly different. Compared with the control group, the experimental group had significant differences in the overall mean of physical function (PF), physiological function (RP), body pain (BP), general health status (GH), energy (VT), social function (SF), emotional function (RE), and mental health (MH) before and after treatment. There was no significant difference in the mean values of PF, RP, BP, GH, SF and MH. There was no significant difference in the mean values of VT, RE and PF, RP, BP, GH, SF, RE after 6 months of treatment. After 6 months of treatment, the total mean values of PF, RP, BP, GH, VT, SF, RE, MH were significantly different from those before treatment. After treatment, the bone mineral density of the experimental group was higher than that before treatment, but there was no significant difference. Conclusion: The therapeutic effect of Bushen Qiangjin Capsule on AIMSS is mainly reflected in pain score and quality of life score, while bone mineral density is slightly increased, but there is no significant difference. High quality of life in patients with obvious effect, and no adverse reactions, estrogen to maintain a safe level, does not affect the overall treatment of breast cancer.
【学位授予单位】：广州中医药大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R273

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