【摘要】：研究目的:通過觀察乳腺疼痛,乳腺腫塊以及中醫(yī)證侯積分的治療前后的變化借以評測十味香鹿膠囊治療乳腺增生病(肝郁兼痰凝證)的有效性及安全性。方法:選取病例為2016年07月-2017年03月黑龍江中醫(yī)藥大學(xué)附屬第一醫(yī)院外二科門診符合乳腺增生病且中醫(yī)辨證屬于肝郁兼痰凝門診患者48例,并將其隨機(jī)分為治療組(十味香鹿膠囊組)與對照組(乳康片組),每組入組患者各24例。治療組給與十味香鹿膠囊每次五粒,3次/日、口服,服藥時(shí)間為兩個(gè)月經(jīng)周期,月經(jīng)來潮時(shí)開始服藥。對照組給與乳康片3片/次,3次/日、口服,服藥時(shí)間為兩個(gè)月經(jīng)周期。觀察兩個(gè)月經(jīng)周期后各項(xiàng)觀察指標(biāo)的變化。結(jié)果:1.有效率:治療組(十味香鹿膠囊組)的總體有效率為91.70%,對照組(乳康片組)的總體有效率為87.50%,治療組(十味香鹿膠囊組)與對照組(乳康片組)在有效率上無明顯差異。2.中醫(yī)證侯積分:兩組治療前后中醫(yī)證侯積分對比有明顯差異(P0.05),治療后兩組患者積分對比無差異(P0.05),3.乳房腫塊長徑:兩組治療前后有差異(P0.05),兩組乳房腫塊治療后比較無顯著差異(P0.05).4.乳腺疼痛天數(shù):兩組治療前后比較有差異(P0.05),兩組治療后組間比較無明顯差異(P0.05)。5.乳腺疼痛積分:兩組治療前組間比較無明顯差異,治療前后組內(nèi)比較有差異(P0.05),治療后組間比較有差異(P0.05)。治療組(十味香鹿膠囊組)優(yōu)于對照組(乳康片組)。6.安全性指標(biāo):治療前后無顯著變化。結(jié)論:十味香鹿膠囊對于治療肝郁兼痰凝型乳腺增生有較好效果,在綜合療效上與中成藥乳康片組相比無顯著差異。十味香鹿膠囊能明顯的緩解乳房疼痛(療效優(yōu)于乳康片),縮短乳房疼痛時(shí)間,縮小乳腺腫塊,能明顯改善患者的中醫(yī)證侯,并且無明顯毒副作用。
[Abstract]:Objective: to evaluate the efficacy and safety of Shiwei Xianglu capsule in the treatment of hyperplasia of mammary gland (liver depression and phlegm coagulation syndrome) by observing the changes of breast pain, breast mass and TCM syndromes before and after treatment. Methods: from July 2016 to March 2017, 48 patients with liver depression and phlegm coagulation were enrolled in the outpatient department of the first affiliated Hospital of Heilongjiang University of traditional Chinese Medicine. They were randomly divided into treatment group (Shiwei Xianglu capsule group) and control group (Rukang tablet group). In the treatment group, five tablets of Shiwei Xianglu capsule were given three times a day for two menstrual cycles. The control group was given three tablets of Rukang tablets every 3 times a day for two menstrual cycles. Observe the change of observation indexes after two menstrual cycles. The result is 1: 1. The total effective rate was 91.70 in the treatment group (Shiwei Xianglu capsule group) and 87.50 in the control group (Rukang tablet group). There was no significant difference in the effective rate between the treatment group (Shiwei Xianglu capsule group) and the control group (Rukang tablet group). TCM syndromes score: the two groups before and after treatment of TCM syndromes scores were significantly different (P0.05), after treatment there was no difference between the two groups (P0.05). Breast mass length: two groups before and after treatment there was a difference (P0.05), two groups of breast masses after treatment there was no significant difference (P0.05). 4. Days of breast pain: there was significant difference between the two groups before and after treatment (P0.05), but there was no significant difference between the two groups after treatment (P0.05) .5. Breast pain score: there was no significant difference between the two groups before and after treatment, there were differences before and after treatment (P0.05). The treatment group (Shiwei Xianglu capsule group) was superior to the control group (Rukang tablet group) .6. Safety index: there was no significant change before and after treatment. Conclusion: Shiwei Xianglu capsule has good effect in treating liver depression and phlegm coagulation type hyperplasia of mammary gland. Shiwei Xianglu capsule can obviously relieve breast pain (curative effect is better than Rukang tablet), shorten the time of breast pain, reduce breast mass, can obviously improve the TCM syndrome of patients, and have no obvious side effects.
【學(xué)位授予單位】：黑龍江中醫(yī)藥大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2017
【分類號】：R269

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