【摘要】：目的:芳香化酶抑制劑(aromatese inhibitor,AI)作為絕經(jīng)后乳腺癌患者輔助內(nèi)分泌治療中的一線用藥,其療效確切,耐受性良好,在乳腺癌治療中得到廣泛應(yīng)用。然而,芳香化酶抑制劑的長期使用所帶來的副反應(yīng)不可忽視,尤其芳香化酶抑制劑引起的相關(guān)肌肉骨關(guān)節(jié)癥狀,嚴(yán)重影響患者的日常生活和工作,往往成為更換治療藥物甚至停止藥物治療的重要原因。臨床上芳香化酶抑制劑相關(guān)肌肉骨關(guān)節(jié)癥狀(aromatase inhibitor-associated musculoskeletal symptoms,AIMSS)的治療無統(tǒng)一標(biāo)準(zhǔn),主要通過補(bǔ)鈣、止痛劑、糖皮質(zhì)激素以及中醫(yī)藥治療等方法來緩解癥狀,治療療效各不相同。中醫(yī)藥治療在防治西藥的副作用方面有著獨(dú)特的療效,具有補(bǔ)益肝腎、強(qiáng)筋健骨、化瘀通絡(luò)作用的補(bǔ)腎強(qiáng)筋膠囊也許能緩解AIMSS。本研究采用隨機(jī)對照實(shí)驗(yàn)方法,通過記錄分析受試者在兩種不同治療方法中治療前后相關(guān)指標(biāo)的變化,以評估補(bǔ)腎強(qiáng)筋膠囊治療AIMSS的臨床療效,探索有效改善AIMSS的防治手段。方法:本研究納入廣東省第二中醫(yī)院乳腺科以第三代AI為輔助內(nèi)分泌治療的乳腺癌患者73例,采用隨機(jī)數(shù)字表法隨機(jī)分為對照組和實(shí)驗(yàn)組。對照組予口服鈣爾奇D 1#qd,共服用6個月;實(shí)驗(yàn)組予口服鈣爾奇D 1#qd+補(bǔ)腎強(qiáng)筋膠囊2#tid,共服用6個月。在治療前測定簡明疼痛量表(Brief Pain Inventory,BPI)、SF-36 健康測量量表(Short Form 36-Item Health Survey,SF-36),骨密度(bone mineral density,BMD),并測定血常規(guī)、肝腎功能、E2等安全性指標(biāo);治療后3月測定BPI、SF-36,并測定血常規(guī)、肝腎功能、E2等安全性指標(biāo);治療后6月測定BPI、SF-36、BMD,并測定血常規(guī)、肝腎功能、E2等安全性指標(biāo)。采用SPSS21.0統(tǒng)計軟件建立數(shù)據(jù)庫以及分析數(shù)據(jù)。計量資料采用均數(shù)士標(biāo)準(zhǔn)差表示。主要采用t檢驗(yàn),若不滿足正態(tài)分布或方差齊性,則采用秩和檢驗(yàn);若多個樣本比較,則采用方差分析;以百分率表示的數(shù)據(jù),采用卡方(x2)檢驗(yàn);關(guān)聯(lián)性分析采用pearson相關(guān)性分析。結(jié)果:本研究結(jié)果顯示:與對照組相比,實(shí)驗(yàn)組的最劇烈痛、最輕微痛、平均痛、當(dāng)時痛在治療前后的總體均值均具有顯著性差異。對照組內(nèi),治療3月后與治療前相比,最劇烈痛、最輕微痛、平均痛、當(dāng)時痛的總體均值具有顯著性差異。治療6月后與治療前相比,最劇烈痛、最輕微痛、平均痛、當(dāng)時痛的總體均值具有顯著性差異。實(shí)驗(yàn)組內(nèi),治療3月后與治療前相比,最劇烈痛、最輕微痛、平均痛、當(dāng)時痛的總體均值具有顯著性差異。治療6月后與治療前相比,最劇烈痛、最輕微痛、平均痛、當(dāng)時痛的總體均值具有顯著性差異。與對照組相比,實(shí)驗(yàn)組的生理機(jī)能(PF)、生理職能(RP)、軀體疼痛(BP)、一般健康狀況(GH)、精力(VT)、社會功能(SF)、情感職能(RE)、精神健康(MH)在治療前后的總體均值具有顯著性差異。對照組內(nèi),治療3月后與治療前相比,PF、RP、BP、GH、SF、MH的總體均值具有顯著性差異。VT、RE的總體均值無顯著性差異。治療6月后與治療前相比,PF、RP、BP、GH、SF、RE的總體均值具有顯著性差異。VT、MH的總體均值無顯著性差異。實(shí)驗(yàn)組內(nèi),治療3月后與治療前相比,PF、RP、BP、GH、VT、SF、RE、MH的總體均值均具有顯著性差異。治療6月后與治療前相比,PF、RP、BP、GH、VT、SF、RE、MH的總體均值均具有顯著性差異。實(shí)驗(yàn)組在治療后與治療前相比,骨密度升高,但無統(tǒng)計學(xué)意義。對照組在治療后與治療前相比,骨密度較前下降。治療前后測定的安全性指標(biāo)均無異常,患者雌激素水平仍處于絕經(jīng)后狀態(tài)。結(jié)論:補(bǔ)腎強(qiáng)筋膠囊治療AIMSS的療效主要體現(xiàn)在疼痛評分和生活質(zhì)量評分等指標(biāo)上,而骨密度具有輕微的提升,但無顯著性差異。補(bǔ)腎強(qiáng)筋膠囊在改善患者疼痛癥狀以及提高患者生活質(zhì)量方面具有明顯的效果,且無不良反應(yīng),雌激素保持在安全水平,不影響乳腺癌的整體治療。補(bǔ)腎強(qiáng)筋膠囊能有效地治療乳癌AIMSS,方便可行,值得進(jìn)一步在臨床實(shí)踐中應(yīng)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.
【學(xué)位授予單位】：廣州中醫(yī)藥大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2017
【分類號】：R273

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