【摘要】：目的:評(píng)價(jià)中藥復(fù)方芪芎種子湯治療特發(fā)性弱精子癥(脾腎兩虛兼血瘀證)的有效性和安全性。方法:1.研究設(shè)計(jì):隨機(jī)、對照的臨床試驗(yàn)。2.研究對象:2015年1月～2016年8月在中國中醫(yī)科學(xué)院西苑醫(yī)院男科門診就診的符合入選標(biāo)準(zhǔn)的特發(fā)性弱精子癥患者66例。入選患者按1:1隨機(jī)(SAS軟件產(chǎn)生隨機(jī)編碼)分為試驗(yàn)組(33例)和對照組(33例)。3.治療方法:試驗(yàn)組給予芪芎種子湯(藥物組成:炙黃芪20g、仙靈脾10g、熟地15g、山藥10g、山萸肉10g、川芎10g、菟絲子10g、枸杞子15g、雞血藤10g、懷牛膝10g、砂仁6g、黃連3g;口服,每日一劑,每日2次,每次150ml。對照組給予左卡尼汀口服液,口服,每日2次,每次1g(1支)。兩組患者均用藥12周,隨訪4周。4.觀察指標(biāo)及觀察時(shí)間:一般人口學(xué)資料;主要療效指標(biāo):①精子參數(shù)(包括精子密度、PR級(jí)精子、PR+NP級(jí)精子、精液量);次要療效指標(biāo):①受孕率;②中醫(yī)證候評(píng)分(記錄就診前后證候評(píng)分)。安全性指標(biāo):血常規(guī)、尿常規(guī)、肝功能(ALT、AST)以及腎功能(BUN,Cr)檢查,用藥前后各檢查一次。結(jié)果:1.剔除脫落情況本研究共入組66例患者,研究期間有5例脫落,總脫落率為7.58%;其中試驗(yàn)組2例,對照組3例。5例脫落病例只有第一次訪視記錄,無治療后記錄,故不進(jìn)入療效分析。上述脫落病例均從FAS數(shù)據(jù)集中剔除,PPS數(shù)據(jù)集病例即為FAS數(shù)據(jù)集病例(兩者一致),均為61例,故以下有效性分析中只做FAS數(shù)據(jù)集的分析,PPS數(shù)據(jù)集結(jié)果與FAS數(shù)據(jù)集相同。安全性數(shù)據(jù)集共66例病例。2.基線資料2.1年齡試驗(yàn)組31例患者中,年齡最小者25歲,最大40歲,平均年齡31.19±4.36歲;對照組30例,年齡最小者24歲,最大39歲,平均年齡32.03士3.10歲,兩組經(jīng)獨(dú)立樣本t檢驗(yàn):t=-0.86,P=0.390.05。兩組年齡分布具有可比性,無顯著統(tǒng)計(jì)學(xué)差異。2.2病程試驗(yàn)組病程最長者36月,最短者12月,平均18.32±12.05月;對照組病程最長者42月,最短者12月,平均14.63±3.26月;兩組經(jīng)獨(dú)立樣本t檢驗(yàn):t=1.62,P=0.110.05。兩組年齡分布統(tǒng)計(jì)學(xué)無顯著性差異,具有可比性。2.3教育程度試驗(yàn)組中,小學(xué)、初中、高中、大專及以上學(xué)歷的人數(shù)是1、3、9、18;在對照組中人數(shù)分別為:0、1、10、19;兩組患者所受教育程度無統(tǒng)計(jì)學(xué)差異,具有可比性。2.4精液量試驗(yàn)組與對照組在治療前的精液量分別為2.60±0.30ml和2.56±0.33ml;兩組進(jìn)行差異性檢驗(yàn),t=-0.45,P=0.650.05,結(jié)果無統(tǒng)計(jì)學(xué)差異,兩組具有可比性。2.5精子密度試驗(yàn)組與對照組精子密度(×106/L)在治療前進(jìn)行了比較,分別為36.35±18.14、34.68± 14.71,結(jié)果顯示無統(tǒng)計(jì)學(xué)差異,具有可比性(t=0.40,P=0.690.05)。2.6 PR級(jí)精子試驗(yàn)組與對照組在治療前的PR級(jí)精子(%)分別是9.47±6.23、9.25±5.21;統(tǒng)計(jì)量t=0.40,P=0.690.05,統(tǒng)計(jì)未見明顯差異,具有可比性。2.7 PR+NP級(jí)精子試驗(yàn)組與對照組的PR+NP級(jí)精子(%)基線值分別為18.42±8.72與21.05±8.45,統(tǒng)計(jì)量t=-1.19,P=0.240.05,結(jié)果顯示無統(tǒng)計(jì)學(xué)差異,兩組具有可比性。2.8中醫(yī)證候評(píng)分試驗(yàn)組與對照組在治療前的中醫(yī)證候評(píng)分分別是16.77±4.18、14.80±4.54,兩組進(jìn)行了統(tǒng)計(jì)學(xué)差異性檢驗(yàn),結(jié)果顯示無統(tǒng)計(jì)學(xué)差異(t=-1.77,P=0.080.05)。3.臨床療效情況3.1精液量在治療4周、8周、12周后,兩組的精液量組內(nèi)比較無統(tǒng)計(jì)學(xué)差異(P0.05),組間比較無差異(P0.05)。3.2精子密度試驗(yàn)組和對照組兩組在治療4周、8周、12周后,精子密度組內(nèi)比較無統(tǒng)計(jì)學(xué)差異(P0.05),組間比較無差異(P0.05)。3.3 PR級(jí)精子組內(nèi)比較,在提高PR級(jí)精子(%)方面,試驗(yàn)組在治療第4周時(shí),PR級(jí)精子為12.17±6.13,與治療前9.47±6.23相比提高沒有統(tǒng)計(jì)學(xué)差異(P0.05);治療8周、12周時(shí),PR級(jí)精子分別為15.98±8.01、22.71 ±9.00,與治療前有統(tǒng)計(jì)學(xué)差異(P0.05)。對照組在治療4周、8周、12周分別為9.95±7.37、12.15±6.64、14.13±8.83;在治療8周、12周后,PR級(jí)精子與基線值比較提高有統(tǒng)計(jì)學(xué)差異(P0.05)。組間比較,試驗(yàn)組PR級(jí)精子治療后第4周、第8周提高與對照組比較無統(tǒng)計(jì)學(xué)差異(P0.05),在治療12周時(shí),試驗(yàn)組PR級(jí)精子方面提高優(yōu)于對照組(P0.05)。3.4 PR+NP級(jí)精子組內(nèi)比較,試驗(yàn)組、對照組在0周、4周、8周、12周,PR+NP級(jí)精子(%)分別為 18.42±8.72、23.83± 10.65、29.29± 12.20、38.71 土 14.06,以及 21.05±8.45、21.22±11.98、27.13±11.55、26.17土15.40。組內(nèi)比較,治療4周時(shí),試驗(yàn)組與對照組兩組患者精液PR+NP級(jí)精子提高無統(tǒng)計(jì)學(xué)差異(P0.05);在治療8周、12周時(shí),PR+NP級(jí)精子與治療前相比有統(tǒng)計(jì)學(xué)差異(P0.05)。組間比較,在治療第4周、第8周時(shí),兩組PR+NP級(jí)精子提高無統(tǒng)計(jì)學(xué)差異(P0.05);在治療12周后,兩組PR+NP精子提高存在差異(P0.05),試驗(yàn)組提高顯著。3.5受孕率治療期間,兩組受試者的配偶受孕情況進(jìn)行比較,試驗(yàn)組患者在各個(gè)時(shí)段的配偶受孕率與對照組進(jìn)行比較,差異均無統(tǒng)計(jì)學(xué)差異(P0.05)。3.6中醫(yī)證候評(píng)分試驗(yàn)組在治療4周、8周、12周時(shí),中醫(yī)證候評(píng)分為12.30±3.30、9.63±2.72、7.10±2.28;經(jīng)配對t檢驗(yàn),與治療前(16.77±4.18)相比,中醫(yī)證候評(píng)分降低有統(tǒng)計(jì)學(xué)差異(P0.05),并隨著治療時(shí)間延長,分值降低趨勢更為明顯。對照組在0周、4周、8周、12周中醫(yī)證候評(píng)分分別為14.80±4.54、13.86±3.50、12.99±2.71、13.40±2.27,評(píng)分改變無統(tǒng)計(jì)學(xué)差異(P0.05)。4.安全性評(píng)價(jià)本研究共發(fā)生3例不良事件,其中試驗(yàn)組2例,對照組1例;3例患者未行干預(yù),不適自行緩解:經(jīng)分析與本研究藥物無關(guān)。給藥前后血常規(guī)、尿常規(guī)、肝功能(ALT、AST)以及腎功能(BUN,Cr)實(shí)驗(yàn)室檢查,異常結(jié)果分析均無臨床意義。結(jié)論:1.芪芎種子湯治療8周、12周后,明顯提高特發(fā)性弱精子癥患者的PR級(jí)精子和PR+NP級(jí)精子;2.治療12周后,芪芎種子湯在提高PR級(jí)精子和PR+NP級(jí)精子方面優(yōu)于左卡尼汀口服液;3.芪芎種子湯治療4周后,患者中醫(yī)證候評(píng)分降低,并且隨著治療時(shí)間延長,證候評(píng)分降低趨勢更為明顯。4.芪芎種子湯未見明顯的毒副作用,安全有效。
[Abstract]:Objective: To evaluate the efficacy and safety of Qixiong Seed Decoction in the treatment of idiopathic asthenospermia (spleen and kidney deficiency and blood stasis syndrome). Sixty-six patients with spermatozoosis were randomly divided into experimental group (33 cases) and control group (33 cases) according to the 1:1 random code generated by SAS software. 3. Treatment methods: The experimental group was given Qixiong seed decoction (drug composition: fried Astragalus membranaceus 20g, immortal spleen 10g, cooked land 15g, yam 10g, cornel meat 10g, Ligusticum chuanxiong 10g, dodder 10g, wolfberry 15g, chicken blood rattan 10g, Huaixiong 10g, sand Ren 6g, Huanglian 3g; oral, one dose daily, twice a day, 150 ml each time. The control group was given levocarnitine oral liquid, twice a day, 1 g (1 branch). Both groups were treated for 12 weeks, followed up for 4 weeks. 4. Observation indicators and observation time: general demographic data; main efficacy indicators: 1. Sperm parameters (including sperm density, PR grade sperm, PR + NP grade sperm, PR + NP grade sperm, etc.). Secondary efficacy indicators: 1. Pregnancy rate; 2. TCM syndrome score (recorded before and after treatment score). Safety indicators: blood routine, urine routine, liver function (ALT, AST) and kidney function (BUN, Cr) examination before and after medication, each examination. Results: 1. Excluding the abscission of 66 patients in this study, there were 5 cases of abscission, total abscission. The shedding rate was 7.58%. There were 2 cases in the experimental group and 3.5 cases in the control group with only the first visit record, and there was no record after treatment, so we did not enter the curative effect analysis. In the 2.1-year-old trial group, 31 patients were the youngest 25 years old, the oldest 40 years old, with an average age of 31.19 + 4.36 years; in the control group, 30 patients were the youngest 24 years old, the oldest 39 years old, with an average age of 32.03 Shi 3.10 years. The two groups were tested by independent sample t test: t = - 0. There was no significant difference in age distribution between the two groups. 2.2 The longest course of disease was 36 months, the shortest was 12 months, the average was 18.32 + 12.05 months; the longest was 42 months, the shortest was 12 months, the average was 14.63 + 3.26 months; the independent sample t test showed that t = 1.62, P = 0.110.05. There was no significant difference in age distribution between the two groups. There was no significant difference in educational level between the two groups. 2.4 The semen volume of the experimental group and the control group before treatment were 2.60 + 0.30, respectively. Ml and 2.56 + 0.33 ml; the difference between the two groups was tested, t = - 0.45, P = 0.650.05, the results showed no statistical difference, the two groups had comparability. 2.5 Sperm density test group and control group sperm density (*106/L) before treatment were 36.35 + 18.14, 34.68 + 14.71, the results showed no statistical difference, with comparability (t = 0.40, P = 0.690.05). The baseline values of PR + NP sperm (%) in the 2.6 PR + NP sperm test group and the control group were 18.42 + 8.72 and 21.05 + 8.45 respectively, and the statistical values t = - 1.19, P =0.240.05, respectively. Results showed that there was no statistical difference between the two groups. 2.8 TCM syndrome score test group and control group before treatment were 16.77 (+ 4.18), 14.80 (+ 4.54), the two groups were statistically significant test, the results showed that there was no statistical difference (t = - 1.77, P = 0.080.05). 3. Clinical efficacy of 3.1 semen volume in the treatment of 4 weeks, 8 weeks 12 weeks later, there was no significant difference in sperm volume between the two groups (P 0.05). There was no significant difference between the two groups (P 0.05). 3.2 Sperm density test group and control group in the treatment of 4 weeks, 8 weeks, 12 weeks later, there was no significant difference in sperm density between the two groups (P 0.05). 3.3 PR class sperm in the improvement of PR class sperm (%) formula. In the experimental group, at the 4th week of treatment, the PR grade sperm was 12.17 + 6.13, which had no significant difference compared with the 9.47 + 6.23 before treatment (P 0.05); at the 8th and 12th weeks of treatment, the PR grade sperm were 15.98 + 8.01, 22.71 + 9.00, respectively, which had statistical difference compared with that before treatment (P 0.05). The control group was 9.95 + 7.37, 12.15 + 6.64, 14.13 + 8.00 at the 4th, 8th and 12th weeks of treatment, respectively. 83. After 8 weeks and 12 weeks of treatment, the baseline value of PR sperm increased significantly (P 0.05). There was no significant difference between the experimental group and the control group at 4 weeks and 8 weeks after treatment (P 0.05). At 12 weeks of treatment, the improvement of PR sperm in the experimental group was superior to that in the control group (P 0.05). 3.4 PR + NP sperm group. In the experimental group, the PR + NP sperm (%) of the control group were 18.42 (+) 8.72, 23.83 (+) 10.65, 29.29 (+) 12.20, 38.71 soil 14.06, 21.05 (+) 8.45, 21.22 (+) 11.98, 27.13 (+) 11.55, 26.17 soil 15.40. There was no significant difference between the experimental group and the control group at 4 weeks of treatment (P 0.05). After 8 weeks and 12 weeks of treatment, there was a significant difference between the two groups (P 0.05). There was no significant difference between the two groups (P 0.05). After 12 weeks of treatment, there was a significant difference between the two groups (P 0.05). During the treatment period, the fertility rate of the experimental group increased significantly.3.5. Compared with the control group, there was no significant difference (P 0.05). 3.6 The score of TCM syndromes in the experimental group was 12.30 (+ 3.30), 9.63 (+ 2.72), 7.10 (+ 2.28) at 4, 8 and 12 weeks after treatment, and the score of TCM syndromes was 16.77 (+ 4.18) before treatment. Compared with the control group, the scores of TCM syndromes decreased significantly in 0, 4, 8 and 12 weeks (P 0.05). In the control group, the scores of TCM syndromes were 14.80 (+ 4.54), 13.86 (+ 3.50), 12.99 (+ 2.71) and 13.40 (+ 2.27), respectively. There was no significant difference in the scores between the two groups (P 0.05). 4. There were 2 cases of adverse events in the experimental group and 1 case in the control group, 3 cases of patients did not intervene, and they were not comfortable to relieve themselves. After 12 weeks of treatment, Qixiong Seed Decoction was superior to L-carnitine Oral Liquid in improving PR-grade sperm and PR+NP-grade sperm; 3. After 4 weeks of treatment, Qixiong Seed Decoction decreased the score of TCM syndromes, and with the extension of treatment time, the decrease trend of syndrome score was more obvious. Obvious.4. and Qi Xiong seed decoction had no obvious toxic and side effects, and it was safe and effective.
【學(xué)位授予單位】：中國中醫(yī)科學(xué)院
【學(xué)位級(jí)別】：博士
【學(xué)位授予年份】：2017
【分類號(hào)】：R277.5

【參考文獻(xiàn)】

相關(guān)期刊論文 前10條

1 謝淑武;曲立娟;李國停;鐘瑞華;郭湘潔;李釗;馬阿影;桂幼倫;朱焰;;中藥提取物治療男性不育研究進(jìn)展[J];中國藥理學(xué)與毒理學(xué)雜志;2016年10期

2 陳捷;余德標(biāo);楊燕;陳麟;張冬梅;吳福春;邵斌;金星;;針灸治療男性不育癥研究進(jìn)展[J];上海針灸雜志;2016年08期

3 馬凰富;王彬;黨進(jìn);趙冰;劉洋;馬健雄;;李海松治療男性不育癥臨床思路[J];中華中醫(yī)藥雜志;2016年08期

4 羅寶生;;當(dāng)歸與川芎藥理作用研究進(jìn)展及對比[J];中國處方藥;2016年05期

5 宋春生;王福;趙家有;;男性不育癥五臟論治探析[J];中國中醫(yī)基礎(chǔ)醫(yī)學(xué)雜志;2016年03期

6 馮彥;;枸杞多糖藥理作用與臨床應(yīng)用[J];中國現(xiàn)代藥物應(yīng)用;2016年06期

7 陳立格;;枸杞子的藥理作用和臨床應(yīng)用價(jià)值分析[J];世界最新醫(yī)學(xué)信息文摘;2015年59期

8 李宏軍;;芳香化酶抑制劑在男性不育治療中的應(yīng)用[J];生殖醫(yī)學(xué)雜志;2015年07期

9 王全;周文彬;洪志明;曾楊玲;鄧靈;陳德寧;;從脾腎相關(guān)治療少弱精子癥心得[J];中國中醫(yī)基礎(chǔ)醫(yī)學(xué)雜志;2015年03期

10 姜輝;鄧春華;商學(xué)軍;吳斌;;左卡尼汀在男性不育中臨床應(yīng)用專家共識(shí)(2014版)[J];中華男科學(xué)雜志;2015年01期

相關(guān)會(huì)議論文 前1條

1 ;男性不育診斷和治療指南(征求意見稿)[A];2007年浙江省男科學(xué)學(xué)術(shù)年會(huì)論文匯編[C];2007年

，

本文編號(hào)：2188811