苍附导痰汤治疗痰湿阻滞型多囊卵巢综合征的临床研究
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摘要
目的
本临床研究采用随机对照的方法,评估苍附导痰汤对痰湿阻滞型多囊卵巢综合症患者的疗效和安全性。
方法
选取自2008年3月至2009年3月到仁心堂中医诊所就诊的病人符合西医多囊卵巢综合症诊断标准和中医痰湿阻滞辨证标准的患者60例。采用随机对照试验方法,将合格受试者以1：1的比例分配至试验组、安慰剂组,每组各30例。均为门诊病人。试验组采用口服中药苍附导痰汤(成份：茯苓20克,法半夏12克,陈皮6克,苍术10克,香附子12克,枳壳15克,神曲15克,制南星9克,党参20克,补骨脂15克,淫羊藿10克,当归15克)结合耳穴贴压(内分泌、子宫、脾)治疗。安慰剂组采用安慰剂颗粒(淀粉赋形剂)结合耳穴贴压(内分泌、子宫、脾)治疗。苍附导痰汤按照每日剂量制成GMP科学中药制剂,一日份9g以0号胶囊分10粒装,早晚各服5粒。安慰剂淀粉赋形剂,服用方法数量同试验组,要求与苍附导痰汤两药物的外形、颜色、包装、服法基本一致。每组服药3月。耳穴贴压：使用王不留行籽贴压耳穴,选准耳穴,75%酒精常规消毒耳穴皮肤,然后用0.5cm×0.5cm胶布将王不留行籽固定于耳穴上,使稍有压痛感,并嘱患者每天按压5次,每次2-3min,双耳交替贴压,治疗每3天1次。操作方法：两组均从月经前三天开始服药,连续服用10天,连服三个月经周期。三个月为一个疗程,观察三个疗程,疗程结束后作疗效判定。
用EPIDATA3.1软件建立数据库,用SPSS17.0软件进行统计分析。计量资料用均数±标准差((?)±S)表示,计数资料用构成比(%)表示。计量资料组间比较采用t检验(方差不齐采用t’检验或秩和检验),自身前后比较用配对t检验或Wilcoxon配对秩和检验。分类资料组间比较采用χ2检验,等级资料组间比较采用Wilcoxon秩和检验。统计图形的制作采用软件Graph Pad Prism 4.03完成。
结果
本研究共有合格受试者60例。试验组30例,安慰剂组30例,均为门诊病人。西医诊断为多囊卵巢综合征,中医辨证属于痰湿阻滞证。
治疗前两组治疗前年龄、体重指数、病程、病情程度、月经情况、临床症状、基础体温等比较,差异均无统计学意义(P＜0.05)。提示影响两组预后的主要因素具有均衡性和可比性。研究结果如下：
1.试验组和安慰剂组疾病综合疗效：试验组痊愈率为23.3%,显效率为53.3%,有效率为10.0%,总有效率为86.67%；安慰剂组痊愈率为0.0%,显效率为13.3%,有效率为60.0%,总有效率为73.33%。两组疾病综合疗效比较,差异有统计学意义(z=4.26,P=0.00)。试验组总有效率(86.7%)高于安慰剂组(73.3%)。
2.试验组和安慰剂组中医证候总疗效：试验组痊愈率为36.6%,显效率为43.3%,有效率为13.3%,总有效率为93.4%；安慰剂组痊愈率为20.0%,显效率为36.67%,有效率为20.0%,总有效率为86.7%。两组中医证候总疗效比较,差异有统计学意义(z=2.09,P=0.03)。试验组中医证候总有效率(93.4%)高于安慰剂组(86.7%)。
3.试验组和安慰剂组临床症状改善情况：治疗后,试验组月经异常、胸腹痞满、神疲嗜睡、面目虚浮的消失率分别为86.7%、90.5%、82.6%、75.0%,安慰剂组消失率均低于50%,两组比较,差异有统计学意义(P＜0.05)。试验组治疗前多毛6例,治疗后消失4例,消失率为66.7%；安慰剂组治疗前多毛4例,治疗后无消失,但两组消失率比较,差异无统计学意义(P＞0.05)。试验组治疗前痤疮8例,治疗后消失5例,消失率62.5%；安慰剂组治疗前6例,治疗后消失1例,消失率16.7%,两组比较,差异无统计学意义(P＞0.05)。由此表明苍附导痰汤可以有效缓解痰湿型多囊卵巢综合征的临床症状。尤其是在改善月经周期,减轻中医临床症状方面,对多毛、痤疮也有一定的疗效。
4.经过治疗,试验组血FSH, LH, E2、P、PRL, T和LH/FSH均比治疗前降低,治疗后均比治疗前降低,两组治疗前后组内比较差异均有统计学意义(P＜0.05)。苍附导痰汤能够调节患者的激素分泌。
5.试验组治疗后患者卵巢体积缩小。说明苍附导痰汤可缩小卵巢体积,改善卵巢多囊性改变状态。
6.整个试验过程中未发现任何实验室指标异常变化,也未发现任何不良反应。
结论
苍附导痰汤治疗痰湿阻滞型多囊卵巢综合征具有显著疗效,相对较对照组能明显减轻患者的临床症状,有效调节患者的激素水平,缩小卵巢体积,改善卵巢多囊性改变状态。作用机制可能通过作用于下丘脑——垂体——卵巢轴,使该轴的调节紊乱恢复正常,患者恢复正常排卵。且毒副反应少,值得临床广泛推广。
Purpose
Using a randomized controlled experiment, the safety and curative effect of taking cang fu dao tan tang concoction was observed in the treatment of polycystic ovary syndrome (PCOS) as a result of phlegm stagnation.
Method
During the period of March 2008 to March 2009 at the Renxin Tang TCM clinic, 60 patients with PCOS due to phlegm stagnation were qualified to participate in the experiment. They were randomly divided into treatment and placebo groups with a one to one ratio. The patients in the treatment group were treated with cang fu dao tan wan concoction, which is composed of the following: 20g fuling,12g fabanxia,6g chenpi, 10g cangzhu,12g xiangfu,15g zhike,15g shenqu,9g zhinanxing,20g dangshen,15 pohuzhi, 10g yinyanghuo, and 15g danggui. They were also treated with auricular acupuncture at the points: endocrine, uterus, and spleen. Under GMP guidelines, the concoction was prepared into powdered form. A daily dosage of 9g was put into 10 model no. 0 capsules to be taken twice a day,5 capsules in the morning and 5 at night. It was required that the placebo had the same shape, color, packaging, as well as the given dosage as the cang fu dao tan wan capsules. The course of herbal intake was 3 months, auricular acupuncture was given daily. Method:The patients in both groups began taking the prescription 3 days before menses for 10 days, and were required to continue for 3 menstrual cycles, which equal to one course of treatment. The patients were observed for 3 courses and curative effects were analyzed.
The database was established using the EPI data 3.1 software, and statistical analysis was done via SPSS 17.0 program. Results
There was a total of 60 qualified patients in this experiment,30 in the treatment group and 30 in the placebo group. They were all from out-patients department. The diagnosis in Western medicine was PCOS, while that in TCM was phlegm stagnation.
Before treatment, the age, BMI (body mass index), course and severity of disease, menstrual condition, clinical symptoms, basal body temperature (BBT) were analyzed and found there was no significant difference (p>0.05) in the two groups. The result showed that the two groups were comparable. The experimental outcomes were as follows:
1. The curative effect in the two groups:for the treatment group, the curative rate was 23.3%, the very effective rate was 53.3%, the effective rate was 10.0%, and the total effective rate was 86.7%; as for the placebo group, the curative rate was 0.0%, the very effective rate was 13.3%, the effective rate was 60.0%, and the total effective rate was 73.3%. The group difference in the effective rate was statistically significant (z=4.26, P=0.00). The total effective rate for the treatment group (93.4%) was higher than that of the placebo group (86.7%)
2. The effectiveness in TCM syndrome after treatment were:for the treatment group, the curative rate was 36.6%, the very effective rate was 43.3%, the effective rate was 13.3%, and the total effective rate was 93.4%; for the placebo group, the curative rate was 20.0%, the very effective rate was 36.7%, the effective rate was 20.0%, and the total effective rate was 86.7%. The group difference was found to be statistically significant (z=2.09, P=0.03) The total effective rate for the treatment group (93.4%) was high than that of the placebo group (86.7%)
3. The effectiveness in clinical symptoms were:for the treatment group, the symptoms of menstrual abnormalities, chest tightness and abdominal bloatedness, energy level, and facial edema had improvement rates of 86.7%, 90.5%,82.6%, and 75.0%, respectively; for the placebo group, the improvement rate was lower than 50%. The group differences were statistically significant (p<0.05). The treatment group counted 6 patients suffering from hairiness before treatment, and 4 patients after treatment, the rate of improvement was 66.7%; the placebo group counted 4 patients suffering from hairiness before and after treatment. The group difference for hairiness was found to be statistically insignificant (p>0.05).). As for acne problem, the treatment group counted 8 patients before treatment and 5 patients after treatment, the rate of improvement was 62.5%; the placebo group counted 6 patients before treatment and 1 after treatment, the improvement rate was 16.7%. The group difference for acne showed no statistical significance (p>0.05) The use of cang fu dao tan wan in the treatment of PCOS of the phlegm stagnation syndrome is effective in relieving clinical symptoms, especially menstrual cycle and TCM syndromes, even hairiness and acne to a certain extent.
4. The lab tests showed that FSH, LG, E2, P, PRL, T and LH/GSH levels were all lower after treatment. The group differences for these lab indices after treatment was found to be statistically significant (p<0.05). The use of cang fu dao tan wan can have a corrective effect on the hormonal secretion in the patient.
5. The dimension of the polycystic ovary was found to decrease after treatment. The use of cang fu dao tan wan was effective not only in reducing ovarian volume, but also in improving the polycystic state in the ovaries.
6. The experiment did not encounter any abnormal lab test results or adverse reactions.
Conclusions
The use of cang fu dao tan wan was effective in treating PCOS of the phlegm stagnation syndrome; it can significantly improve clinical symptoms, have a regulatory role in hormonal secretion, reduce ovarian volume, and improve the polycystic state in the ovaries. The mechanism of action is probably related to the hypothalamus-pituitary-ovarian axis, recovering the axis's order resulting in normal ovulation. The use of the preparation has minimal toxicity, thus should be used more extensively in practice.
本临床研究采用随机对照的方法,评估苍附导痰汤对痰湿阻滞型多囊卵巢综合症患者的疗效和安全性。
方法
选取自2008年3月至2009年3月到仁心堂中医诊所就诊的病人符合西医多囊卵巢综合症诊断标准和中医痰湿阻滞辨证标准的患者60例。采用随机对照试验方法,将合格受试者以1：1的比例分配至试验组、安慰剂组,每组各30例。均为门诊病人。试验组采用口服中药苍附导痰汤(成份：茯苓20克,法半夏12克,陈皮6克,苍术10克,香附子12克,枳壳15克,神曲15克,制南星9克,党参20克,补骨脂15克,淫羊藿10克,当归15克)结合耳穴贴压(内分泌、子宫、脾)治疗。安慰剂组采用安慰剂颗粒(淀粉赋形剂)结合耳穴贴压(内分泌、子宫、脾)治疗。苍附导痰汤按照每日剂量制成GMP科学中药制剂,一日份9g以0号胶囊分10粒装,早晚各服5粒。安慰剂淀粉赋形剂,服用方法数量同试验组,要求与苍附导痰汤两药物的外形、颜色、包装、服法基本一致。每组服药3月。耳穴贴压：使用王不留行籽贴压耳穴,选准耳穴,75%酒精常规消毒耳穴皮肤,然后用0.5cm×0.5cm胶布将王不留行籽固定于耳穴上,使稍有压痛感,并嘱患者每天按压5次,每次2-3min,双耳交替贴压,治疗每3天1次。操作方法：两组均从月经前三天开始服药,连续服用10天,连服三个月经周期。三个月为一个疗程,观察三个疗程,疗程结束后作疗效判定。
用EPIDATA3.1软件建立数据库,用SPSS17.0软件进行统计分析。计量资料用均数±标准差((?)±S)表示,计数资料用构成比(%)表示。计量资料组间比较采用t检验(方差不齐采用t’检验或秩和检验),自身前后比较用配对t检验或Wilcoxon配对秩和检验。分类资料组间比较采用χ2检验,等级资料组间比较采用Wilcoxon秩和检验。统计图形的制作采用软件Graph Pad Prism 4.03完成。
结果
本研究共有合格受试者60例。试验组30例,安慰剂组30例,均为门诊病人。西医诊断为多囊卵巢综合征,中医辨证属于痰湿阻滞证。
治疗前两组治疗前年龄、体重指数、病程、病情程度、月经情况、临床症状、基础体温等比较,差异均无统计学意义(P＜0.05)。提示影响两组预后的主要因素具有均衡性和可比性。研究结果如下：
1.试验组和安慰剂组疾病综合疗效：试验组痊愈率为23.3%,显效率为53.3%,有效率为10.0%,总有效率为86.67%；安慰剂组痊愈率为0.0%,显效率为13.3%,有效率为60.0%,总有效率为73.33%。两组疾病综合疗效比较,差异有统计学意义(z=4.26,P=0.00)。试验组总有效率(86.7%)高于安慰剂组(73.3%)。
2.试验组和安慰剂组中医证候总疗效：试验组痊愈率为36.6%,显效率为43.3%,有效率为13.3%,总有效率为93.4%；安慰剂组痊愈率为20.0%,显效率为36.67%,有效率为20.0%,总有效率为86.7%。两组中医证候总疗效比较,差异有统计学意义(z=2.09,P=0.03)。试验组中医证候总有效率(93.4%)高于安慰剂组(86.7%)。
3.试验组和安慰剂组临床症状改善情况：治疗后,试验组月经异常、胸腹痞满、神疲嗜睡、面目虚浮的消失率分别为86.7%、90.5%、82.6%、75.0%,安慰剂组消失率均低于50%,两组比较,差异有统计学意义(P＜0.05)。试验组治疗前多毛6例,治疗后消失4例,消失率为66.7%；安慰剂组治疗前多毛4例,治疗后无消失,但两组消失率比较,差异无统计学意义(P＞0.05)。试验组治疗前痤疮8例,治疗后消失5例,消失率62.5%；安慰剂组治疗前6例,治疗后消失1例,消失率16.7%,两组比较,差异无统计学意义(P＞0.05)。由此表明苍附导痰汤可以有效缓解痰湿型多囊卵巢综合征的临床症状。尤其是在改善月经周期,减轻中医临床症状方面,对多毛、痤疮也有一定的疗效。
4.经过治疗,试验组血FSH, LH, E2、P、PRL, T和LH/FSH均比治疗前降低,治疗后均比治疗前降低,两组治疗前后组内比较差异均有统计学意义(P＜0.05)。苍附导痰汤能够调节患者的激素分泌。
5.试验组治疗后患者卵巢体积缩小。说明苍附导痰汤可缩小卵巢体积,改善卵巢多囊性改变状态。
6.整个试验过程中未发现任何实验室指标异常变化,也未发现任何不良反应。
结论
苍附导痰汤治疗痰湿阻滞型多囊卵巢综合征具有显著疗效,相对较对照组能明显减轻患者的临床症状,有效调节患者的激素水平,缩小卵巢体积,改善卵巢多囊性改变状态。作用机制可能通过作用于下丘脑——垂体——卵巢轴,使该轴的调节紊乱恢复正常,患者恢复正常排卵。且毒副反应少,值得临床广泛推广。
Purpose
Using a randomized controlled experiment, the safety and curative effect of taking cang fu dao tan tang concoction was observed in the treatment of polycystic ovary syndrome (PCOS) as a result of phlegm stagnation.
Method
During the period of March 2008 to March 2009 at the Renxin Tang TCM clinic, 60 patients with PCOS due to phlegm stagnation were qualified to participate in the experiment. They were randomly divided into treatment and placebo groups with a one to one ratio. The patients in the treatment group were treated with cang fu dao tan wan concoction, which is composed of the following: 20g fuling,12g fabanxia,6g chenpi, 10g cangzhu,12g xiangfu,15g zhike,15g shenqu,9g zhinanxing,20g dangshen,15 pohuzhi, 10g yinyanghuo, and 15g danggui. They were also treated with auricular acupuncture at the points: endocrine, uterus, and spleen. Under GMP guidelines, the concoction was prepared into powdered form. A daily dosage of 9g was put into 10 model no. 0 capsules to be taken twice a day,5 capsules in the morning and 5 at night. It was required that the placebo had the same shape, color, packaging, as well as the given dosage as the cang fu dao tan wan capsules. The course of herbal intake was 3 months, auricular acupuncture was given daily. Method:The patients in both groups began taking the prescription 3 days before menses for 10 days, and were required to continue for 3 menstrual cycles, which equal to one course of treatment. The patients were observed for 3 courses and curative effects were analyzed.
The database was established using the EPI data 3.1 software, and statistical analysis was done via SPSS 17.0 program. Results
There was a total of 60 qualified patients in this experiment,30 in the treatment group and 30 in the placebo group. They were all from out-patients department. The diagnosis in Western medicine was PCOS, while that in TCM was phlegm stagnation.
Before treatment, the age, BMI (body mass index), course and severity of disease, menstrual condition, clinical symptoms, basal body temperature (BBT) were analyzed and found there was no significant difference (p>0.05) in the two groups. The result showed that the two groups were comparable. The experimental outcomes were as follows:
1. The curative effect in the two groups:for the treatment group, the curative rate was 23.3%, the very effective rate was 53.3%, the effective rate was 10.0%, and the total effective rate was 86.7%; as for the placebo group, the curative rate was 0.0%, the very effective rate was 13.3%, the effective rate was 60.0%, and the total effective rate was 73.3%. The group difference in the effective rate was statistically significant (z=4.26, P=0.00). The total effective rate for the treatment group (93.4%) was higher than that of the placebo group (86.7%)
2. The effectiveness in TCM syndrome after treatment were:for the treatment group, the curative rate was 36.6%, the very effective rate was 43.3%, the effective rate was 13.3%, and the total effective rate was 93.4%; for the placebo group, the curative rate was 20.0%, the very effective rate was 36.7%, the effective rate was 20.0%, and the total effective rate was 86.7%. The group difference was found to be statistically significant (z=2.09, P=0.03) The total effective rate for the treatment group (93.4%) was high than that of the placebo group (86.7%)
3. The effectiveness in clinical symptoms were:for the treatment group, the symptoms of menstrual abnormalities, chest tightness and abdominal bloatedness, energy level, and facial edema had improvement rates of 86.7%, 90.5%,82.6%, and 75.0%, respectively; for the placebo group, the improvement rate was lower than 50%. The group differences were statistically significant (p<0.05). The treatment group counted 6 patients suffering from hairiness before treatment, and 4 patients after treatment, the rate of improvement was 66.7%; the placebo group counted 4 patients suffering from hairiness before and after treatment. The group difference for hairiness was found to be statistically insignificant (p>0.05).). As for acne problem, the treatment group counted 8 patients before treatment and 5 patients after treatment, the rate of improvement was 62.5%; the placebo group counted 6 patients before treatment and 1 after treatment, the improvement rate was 16.7%. The group difference for acne showed no statistical significance (p>0.05) The use of cang fu dao tan wan in the treatment of PCOS of the phlegm stagnation syndrome is effective in relieving clinical symptoms, especially menstrual cycle and TCM syndromes, even hairiness and acne to a certain extent.
4. The lab tests showed that FSH, LG, E2, P, PRL, T and LH/GSH levels were all lower after treatment. The group differences for these lab indices after treatment was found to be statistically significant (p<0.05). The use of cang fu dao tan wan can have a corrective effect on the hormonal secretion in the patient.
5. The dimension of the polycystic ovary was found to decrease after treatment. The use of cang fu dao tan wan was effective not only in reducing ovarian volume, but also in improving the polycystic state in the ovaries.
6. The experiment did not encounter any abnormal lab test results or adverse reactions.
Conclusions
The use of cang fu dao tan wan was effective in treating PCOS of the phlegm stagnation syndrome; it can significantly improve clinical symptoms, have a regulatory role in hormonal secretion, reduce ovarian volume, and improve the polycystic state in the ovaries. The mechanism of action is probably related to the hypothalamus-pituitary-ovarian axis, recovering the axis's order resulting in normal ovulation. The use of the preparation has minimal toxicity, thus should be used more extensively in practice.
引文
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