芪芎种子汤治疗特发性弱精子症的有效性及安全性临床研究
发布时间：2018-08-18 07:47
【摘要】：目的:评价中药复方芪芎种子汤治疗特发性弱精子症(脾肾两虚兼血瘀证)的有效性和安全性。方法:1.研究设计:随机、对照的临床试验。2.研究对象:2015年1月～2016年8月在中国中医科学院西苑医院男科门诊就诊的符合入选标准的特发性弱精子症患者66例。入选患者按1:1随机(SAS软件产生随机编码)分为试验组(33例)和对照组(33例)。3.治疗方法:试验组给予芪芎种子汤(药物组成:炙黄芪20g、仙灵脾10g、熟地15g、山药10g、山萸肉10g、川芎10g、菟丝子10g、枸杞子15g、鸡血藤10g、怀牛膝10g、砂仁6g、黄连3g;口服,每日一剂,每日2次,每次150ml。对照组给予左卡尼汀口服液,口服,每日2次,每次1g(1支)。两组患者均用药12周,随访4周。4.观察指标及观察时间:一般人口学资料;主要疗效指标:①精子参数(包括精子密度、PR级精子、PR+NP级精子、精液量);次要疗效指标:①受孕率;②中医证候评分(记录就诊前后证候评分)。安全性指标:血常规、尿常规、肝功能(ALT、AST)以及肾功能(BUN,Cr)检查,用药前后各检查一次。结果:1.剔除脱落情况本研究共入组66例患者,研究期间有5例脱落,总脱落率为7.58%;其中试验组2例,对照组3例。5例脱落病例只有第一次访视记录,无治疗后记录,故不进入疗效分析。上述脱落病例均从FAS数据集中剔除,PPS数据集病例即为FAS数据集病例(两者一致),均为61例,故以下有效性分析中只做FAS数据集的分析,PPS数据集结果与FAS数据集相同。安全性数据集共66例病例。2.基线资料2.1年龄试验组31例患者中,年龄最小者25岁,最大40岁,平均年龄31.19±4.36岁;对照组30例,年龄最小者24岁,最大39岁,平均年龄32.03士3.10岁,两组经独立样本t检验:t=-0.86,P=0.390.05。两组年龄分布具有可比性,无显著统计学差异。2.2病程试验组病程最长者36月,最短者12月,平均18.32±12.05月;对照组病程最长者42月,最短者12月,平均14.63±3.26月;两组经独立样本t检验:t=1.62,P=0.110.05。两组年龄分布统计学无显著性差异,具有可比性。2.3教育程度试验组中,小学、初中、高中、大专及以上学历的人数是1、3、9、18;在对照组中人数分别为:0、1、10、19;两组患者所受教育程度无统计学差异,具有可比性。2.4精液量试验组与对照组在治疗前的精液量分别为2.60±0.30ml和2.56±0.33ml;两组进行差异性检验,t=-0.45,P=0.650.05,结果无统计学差异,两组具有可比性。2.5精子密度试验组与对照组精子密度(×106/L)在治疗前进行了比较,分别为36.35±18.14、34.68± 14.71,结果显示无统计学差异,具有可比性(t=0.40,P=0.690.05)。2.6 PR级精子试验组与对照组在治疗前的PR级精子(%)分别是9.47±6.23、9.25±5.21;统计量t=0.40,P=0.690.05,统计未见明显差异,具有可比性。2.7 PR+NP级精子试验组与对照组的PR+NP级精子(%)基线值分别为18.42±8.72与21.05±8.45,统计量t=-1.19,P=0.240.05,结果显示无统计学差异,两组具有可比性。2.8中医证候评分试验组与对照组在治疗前的中医证候评分分别是16.77±4.18、14.80±4.54,两组进行了统计学差异性检验,结果显示无统计学差异(t=-1.77,P=0.080.05)。3.临床疗效情况3.1精液量在治疗4周、8周、12周后,两组的精液量组内比较无统计学差异(P0.05),组间比较无差异(P0.05)。3.2精子密度试验组和对照组两组在治疗4周、8周、12周后,精子密度组内比较无统计学差异(P0.05),组间比较无差异(P0.05)。3.3 PR级精子组内比较,在提高PR级精子(%)方面,试验组在治疗第4周时,PR级精子为12.17±6.13,与治疗前9.47±6.23相比提高没有统计学差异(P0.05);治疗8周、12周时,PR级精子分别为15.98±8.01、22.71 ±9.00,与治疗前有统计学差异(P0.05)。对照组在治疗4周、8周、12周分别为9.95±7.37、12.15±6.64、14.13±8.83;在治疗8周、12周后,PR级精子与基线值比较提高有统计学差异(P0.05)。组间比较,试验组PR级精子治疗后第4周、第8周提高与对照组比较无统计学差异(P0.05),在治疗12周时,试验组PR级精子方面提高优于对照组(P0.05)。3.4 PR+NP级精子组内比较,试验组、对照组在0周、4周、8周、12周,PR+NP级精子(%)分别为 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。组内比较,治疗4周时,试验组与对照组两组患者精液PR+NP级精子提高无统计学差异(P0.05);在治疗8周、12周时,PR+NP级精子与治疗前相比有统计学差异(P0.05)。组间比较,在治疗第4周、第8周时,两组PR+NP级精子提高无统计学差异(P0.05);在治疗12周后,两组PR+NP精子提高存在差异(P0.05),试验组提高显著。3.5受孕率治疗期间,两组受试者的配偶受孕情况进行比较,试验组患者在各个时段的配偶受孕率与对照组进行比较,差异均无统计学差异(P0.05)。3.6中医证候评分试验组在治疗4周、8周、12周时,中医证候评分为12.30±3.30、9.63±2.72、7.10±2.28;经配对t检验,与治疗前(16.77±4.18)相比,中医证候评分降低有统计学差异(P0.05),并随着治疗时间延长,分值降低趋势更为明显。对照组在0周、4周、8周、12周中医证候评分分别为14.80±4.54、13.86±3.50、12.99±2.71、13.40±2.27,评分改变无统计学差异(P0.05)。4.安全性评价本研究共发生3例不良事件,其中试验组2例,对照组1例;3例患者未行干预,不适自行缓解:经分析与本研究药物无关。给药前后血常规、尿常规、肝功能(ALT、AST)以及肾功能(BUN,Cr)实验室检查,异常结果分析均无临床意义。结论:1.芪芎种子汤治疗8周、12周后,明显提高特发性弱精子症患者的PR级精子和PR+NP级精子;2.治疗12周后,芪芎种子汤在提高PR级精子和PR+NP级精子方面优于左卡尼汀口服液;3.芪芎种子汤治疗4周后,患者中医证候评分降低,并且随着治疗时间延长,证候评分降低趋势更为明显。4.芪芎种子汤未见明显的毒副作用,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.
【学位授予单位】：中国中医科学院
【学位级别】：博士
【学位授予年份】：2017
【分类号】：R277.5
本文编号：2188811
[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.
【学位授予单位】：中国中医科学院
【学位级别】：博士
【学位授予年份】：2017
【分类号】：R277.5
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