【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(zhǎng)期使用所帶來(lái)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(wú)統(tǒng)一標(biāo)準(zhǔn),主要通過(guò)補(bǔ)鈣、止痛劑、糖皮質(zhì)激素以及中醫(yī)藥治療等方法來(lái)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(duì)照實(shí)驗(yàn)方法,通過(guò)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(píng)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(duì)照組和實(shí)驗(yàn)組。對(duì)照組予口服鈣爾奇D 1#qd,共服用6個(gè)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(gè)月。在治療前測(cè)定簡(jiǎn)明疼痛量表(Brief Pain Inventory,BPI)、SF-36 健康測(cè)量量表(Short Form 36-Item Health Survey,SF-36),骨密度(bone mineral density,BMD),并測(cè)定血常規(guī)、肝腎功能、E2等安全性指標(biāo);治療后3月測(cè)定BPI、SF-36,并測(cè)定血常規(guī)、肝腎功能、E2等安全性指標(biāo);治療后6月測(cè)定BPI、SF-36、BMD,并測(cè)定血常規(guī)、肝腎功能、E2等安全性指標(biāo)。采用SPSS21.0統(tǒng)計(jì)軟件建立數(shù)據(jù)庫(kù)以及分析數(shù)據(jù)。計(jì)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(gè)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(duì)照組相比,實(shí)驗(yàn)組的最劇烈痛、最輕微痛、平均痛、當(dāng)時(shí)痛在治療前后的總體均值均具有顯著性差異。對(duì)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(shí)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(shí)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(shí)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(shí)痛的總體均值具有顯著性差異。與對(duì)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(huì)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(duì)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(wú)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(wú)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(wú)統(tǒng)計(jì)學(xué)意義。對(duì)照組在治療后與治療前相比,骨密度較前下降。治療前后測(cè)定的安全性指標(biāo)均無(wú)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(píng)分和生活質(zhì)量評(píng)分等指標(biāo)上,而骨密度具有輕微的提升,但無(wú)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(wú)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(jí)別】：碩士
【學(xué)位授予年份】：2017
【分類(lèi)號(hào)】：R273

【參考文獻(xiàn)】

相關(guān)期刊論文 前10條

1 徐兵河;張頻;;絕經(jīng)后早期乳腺癌芳香化酶抑制劑治療相關(guān)的骨安全管理中國(guó)專(zhuān)家共識(shí)[J];中華腫瘤雜志;2015年07期

2 陳萬(wàn)青;鄭榮壽;;中國(guó)女性乳腺癌發(fā)病死亡和生存狀況[J];中國(guó)腫瘤臨床;2015年13期

3 馮晗;周宏灝;歐陽(yáng)冬生;;杜仲的化學(xué)成分及藥理作用研究進(jìn)展[J];中國(guó)臨床藥理學(xué)與治療學(xué);2015年06期

4 王俊玲;黃思敏;梁?jiǎn)?魏秋實(shí);譚新;鄧偉民;;雌激素的來(lái)源及其在骨代謝中的作用[J];中國(guó)骨質(zhì)疏松雜志;2015年06期

5 史磊;張?zhí)戾a;杜聰穎;苑如;王聰聰;李峰;;中藥全蝎活性成分、藥理作用及臨床應(yīng)用研究進(jìn)展[J];遼寧中醫(yī)藥大學(xué)學(xué)報(bào);2015年04期

6 錢(qián)茜;;骨碎補(bǔ)化學(xué)成分和藥理作用研究進(jìn)展[J];中國(guó)生化藥物雜志;2015年03期

7 張智海;劉忠厚;李娜;張萌萌;黃琪仁;馬遠(yuǎn)征;王亮;劉勇;劉新宇;朱鈞;藍(lán)旭;李士春;楊鴻兵;喻恒峰;湯光宇;張偉;姚偉武;李紹林;彭俊紅;周晟;周勁松;;中國(guó)人骨質(zhì)疏松癥診斷標(biāo)準(zhǔn)專(zhuān)家共識(shí)(第三稿·2014版)[J];中國(guó)骨質(zhì)疏松雜志;2014年09期

8 高萬(wàn)露;汪小海;;視覺(jué)模擬疼痛評(píng)分研究的進(jìn)展[J];醫(yī)學(xué)研究雜志;2013年12期

9 劉文剛;許學(xué)猛;趙傳喜;謝國(guó)平;吳淮;魏凌峰;魯海;;單側(cè)椎體成形術(shù)配合補(bǔ)腎強(qiáng)筋膠囊治療老年胸腰椎壓縮性骨折臨床研究[J];中醫(yī)學(xué)報(bào);2013年10期

10 施航;;中西醫(yī)結(jié)合緩解乳腺癌口服阿那曲唑引起骨關(guān)節(jié)、肌肉痛24例[J];中國(guó)中醫(yī)藥科技;2012年06期

，

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