定经汤合二至丸加减治疗肝郁肾虚型月经后期的临床研究
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摘要
目的：
本课题主要研究定经汤合二至丸加减治疗肝郁肾虚型月经后期的疗效情况,并对其治疗的安全性进行客观评价,为临床应用提供科学依据。
方法：
研究对象为2011年里1月至11月期间,在台湾高雄市仁大中医门诊的肝郁肾虚型月经后期病人(均为门诊病人)。研究以按随机对照的方法,严格控制可变因素,对入选者随机地分为治疗组与对照组,每组30例。对照组：治则为调肝补肾,养血调经。给予逍遥丸治疗。逍遥丸药物组成：组成：柴胡、当归、白芍、白术(炒)、茯苓、炙甘草、薄荷。服用方法：采用逍遥丸(庄松荣制药厂,卫署药制字第030877号),9克/次,一天三次,服用一周后复诊,三个月为一个疗程,停药后再追踪3个月。治疗组治则为调补肝肾,养血调经,采用定经汤合二至丸加减治疗。定经汤由熟地、当归、白芍、柴胡、茯苓、山药、菟丝子、荆芥穗八味药构成,二至丸由女贞子、墨旱莲二味药组成。兼有气血虚弱者,加党参、黄芪；兼有痰湿阻滞者,加砂仁白术；兼有虚寒者加香附、肉桂。6克/次,一天三次,服用一周后复诊,三个月为一个疗程,停药后再追踪3个月。治疗前和治疗结束后所有入组的患者都应该按要求详细填写观察表,并且在治疗结束后作出疗效的评定。
统计方法：分类资料用X2检验,等级资料用两样本比较Wilcoxon秩和检验(校正),两样本均数比较用t检验或Wilcoxon秩和检验,自身前后比较用配对t检验或Wilcoxon配对秩和检验。
结果：
本研究入组合格患者共有60例：治疗组与对照组各30例。治疗前两组患者的年龄构成、病程、月经初潮时间、中医症状、基础体温、血清性激素FSH(促卵泡成熟素)、LH(促黄体生成素)、E2(雌二醇)、T(睾酮)等方面,均无显著性统计学差异。两组具有可比性。
治疗一个疗程后,治疗组能显著降低中医症状评分(P<0.05),并且在治疗后停药3个月的症状评分降低幅度仍然显著优于对照组(P<0.05)。从中医证候总疗效来看,逍遥丸对照组的总有效率为50%,而定经汤加二至丸治疗组的总有效率为86.66%。治疗组疗效优于对照组。从基础体温的改善情况来看,对照组治疗一个疗程后,有效率为40.00%。治疗组有效率为73.33%,治疗组对于基础体温的改善情况显著优于对照组。对照组与治疗组都能显著降低FSH,显著升高E2。并且对照组与治疗组的改变幅度两两比较,FSH、E2有显著性差异(P<0.05)。治疗组显著优于对照组。
经过治疗并停药三个月后,两组中医证候总疗效比较,差异有统计学意义。对照组的总有效率为63.33%,治疗组的总有效率为90%。治疗组疗效优于对照组。对于基础体温的改善情况,对照组治疗一个疗程后,有效率为50.00%。治疗组有效率为76.66%,治疗组显著优于对照组(P<0.05)。FSH在经过两种方法治疗后,自身前后比较,显著降低(P<0.05)。E2在经过两种方法治疗后,显著升高(P<0.05)。对照组与治疗组治疗后的改变幅度两两比较,FSH、E2、LH、PRL、T没有显著性差异。
结论：
1.定经汤合二至丸加减治疗肝郁肾虚型月经后期具有良好的临床疗效,能显著降低中医症状评分。既可调整月经周期,改善基础体温,并提高雌激素水平,降低过高的FSH水平。
2.停药后3个月,使用定经汤合二至丸加减的治疗组仍具有较稳定的疗效。对于降低中医症状评分以及中医证候的总疗效显著优于对照组(P<0.05)。
Objective
This research was aim to study the effect of Dingjingtang and Erzhiwan in treating menstruation, and evaluate the safety of the treatment for providing scientific basis in clinical application.
Method
The60cases objects was collected from January2011to November in Taiwan, Kaohsiung Municipal Renda TCM clinic late menstruation patients whom meet the inclusion criteria according to the principle of randomly divided into2groups. According to the method of random control, strict control of variable factors, the participants were randomly divided into treatment group and control group,30cases each group. Control group:treatment for regulating the liver and kidney, nourishing menstruation. The control group was treated with Xiaoyao Pill.
Xiaoyao Pill drug composition:Caihu, Danggui, Baishao, Baizhu(fried), Fulin, Gancao and Bohe. Directions:use of Xiaoyao Pill (Jiuzhitang Ltd. Co., the country medicine accurate Z20013060),9g/time, three times a day, take one week after operation, three months for a course of treatment, and3months of follow-up after stopping drug. The treatment group was cured for nourishing liver and kidney, nourishing menstruation, the decoction for the treatment of the decoction mixed Ding Jing Tang and Erzhiwan. Ding Jing Tang was composed of Shudi, Danggui, Baishao, Caihu, Fulin, Shanyao, Tusizi, Jinjiesui. Erzhiwan was composed of Nvzhenzi and Mohanlian. With qi and blood deficiency was added Dangshen and Huangqi; with phlegm stagnation was added Sharen and Baizhu; with deficiency-cold was added Xiangfu and Rougui. Take one week after operation, three months for a course of treatment, and3months of follow-up after stopping drug. Before and after treatment in all patients should be according to the requirements detailed in the observation table, evaluation and make the effect after the end of treatment.
Statistical methods:classification of data with χ2test, ranked data for two samples Wilcoxon test (calibration), two samples were compared using t test or Wilcoxon test, the t test for comparison or Wilcoxon paired rank sum test.
Result
There were60cases in the group of eligible patients:the treatment group and the control group of30cases. Before treatment, two groups of patients with age, menarche, duration time of TCM symptoms, basic body temperature, serum sex hormone FSH (follicle stimulating hormone), LH (luteinizing hormone), E2(estradiol), T (testosterone), there were no statistical significant difference. The two groups were comparable.
After a course of treatment, the treatment group can significantly reduce the clinical symptoms score (P<0.05), and3months after treatment stopped in the symptom score reducing rate is still better than those of the control group (P<0.05). And the total curative effect of TCM syndrome, Xiaoyao Pill and control group in the total efficiency was50%, and the treatment group total effectiveness is86.66%. The treatment group curative effect surpasses the control group. From the improvement of the basal body temperature, the control group after a course of treatment,40%efficiency. The treatment group was73.33%, the treatment group with the basal body temperature was significantly better than the control group. The control group and the treatment group had significantly decreased FSH, increased E2. And the comparison of two two changes of group and the treatment group, there were significant differences in FSH, E2(P<0.05). The treatment group was significantly better than the control group.
After stopping the treatment after three months, compared with two groups of total curative effect of TCM syndrome, there was significant difference. The control group in the total efficiency of63.33%, the total effective rate in treatment group was90%. The treatment group curative effect surpasses the control group. To improve the situation of the basal body temperature, the control group after a course of treatment,50%efficiency. Effective rate of treatment group76.66%, treatment group was significantly better than the control group (P<0.05). FSH after the two treatment, the comparison, decreased significantly (P<0.05). E2after the two treatment, increased significantly (P<0.05). Comparison between the two two changes of group and the treatment group after treatment, FSH, E2, LH, PRL, T had no significant difference.
Conclusion
Dingjingtang and Erzhiwan in treating menstruation has significantly clinical efficacy, after treatment, the treatment group can improve TCM syndrome score and can significantly reduce the symptoms of Chinese medicine. The two groups after treatment the serum FSH (follicle stimulating hormone) decreased significantly, E2(estradiol) level, and the treatment group for the basal body temperature regulation is better than that of control group. Three months after discontinuation of treatment effect, TCM syndrome score group can, and effectively improve the basal body temperature. Dingjingtang and Erzhiwan in treating late menstruation had significant therapeutic effect, and the effect is lasting, after treatment condition is not easily repeatedly. So the Dingjingtang and Erzhiwan in treating menstruation had clinical value.
本课题主要研究定经汤合二至丸加减治疗肝郁肾虚型月经后期的疗效情况,并对其治疗的安全性进行客观评价,为临床应用提供科学依据。
方法：
研究对象为2011年里1月至11月期间,在台湾高雄市仁大中医门诊的肝郁肾虚型月经后期病人(均为门诊病人)。研究以按随机对照的方法,严格控制可变因素,对入选者随机地分为治疗组与对照组,每组30例。对照组：治则为调肝补肾,养血调经。给予逍遥丸治疗。逍遥丸药物组成：组成：柴胡、当归、白芍、白术(炒)、茯苓、炙甘草、薄荷。服用方法：采用逍遥丸(庄松荣制药厂,卫署药制字第030877号),9克/次,一天三次,服用一周后复诊,三个月为一个疗程,停药后再追踪3个月。治疗组治则为调补肝肾,养血调经,采用定经汤合二至丸加减治疗。定经汤由熟地、当归、白芍、柴胡、茯苓、山药、菟丝子、荆芥穗八味药构成,二至丸由女贞子、墨旱莲二味药组成。兼有气血虚弱者,加党参、黄芪；兼有痰湿阻滞者,加砂仁白术；兼有虚寒者加香附、肉桂。6克/次,一天三次,服用一周后复诊,三个月为一个疗程,停药后再追踪3个月。治疗前和治疗结束后所有入组的患者都应该按要求详细填写观察表,并且在治疗结束后作出疗效的评定。
统计方法：分类资料用X2检验,等级资料用两样本比较Wilcoxon秩和检验(校正),两样本均数比较用t检验或Wilcoxon秩和检验,自身前后比较用配对t检验或Wilcoxon配对秩和检验。
结果：
本研究入组合格患者共有60例：治疗组与对照组各30例。治疗前两组患者的年龄构成、病程、月经初潮时间、中医症状、基础体温、血清性激素FSH(促卵泡成熟素)、LH(促黄体生成素)、E2(雌二醇)、T(睾酮)等方面,均无显著性统计学差异。两组具有可比性。
治疗一个疗程后,治疗组能显著降低中医症状评分(P<0.05),并且在治疗后停药3个月的症状评分降低幅度仍然显著优于对照组(P<0.05)。从中医证候总疗效来看,逍遥丸对照组的总有效率为50%,而定经汤加二至丸治疗组的总有效率为86.66%。治疗组疗效优于对照组。从基础体温的改善情况来看,对照组治疗一个疗程后,有效率为40.00%。治疗组有效率为73.33%,治疗组对于基础体温的改善情况显著优于对照组。对照组与治疗组都能显著降低FSH,显著升高E2。并且对照组与治疗组的改变幅度两两比较,FSH、E2有显著性差异(P<0.05)。治疗组显著优于对照组。
经过治疗并停药三个月后,两组中医证候总疗效比较,差异有统计学意义。对照组的总有效率为63.33%,治疗组的总有效率为90%。治疗组疗效优于对照组。对于基础体温的改善情况,对照组治疗一个疗程后,有效率为50.00%。治疗组有效率为76.66%,治疗组显著优于对照组(P<0.05)。FSH在经过两种方法治疗后,自身前后比较,显著降低(P<0.05)。E2在经过两种方法治疗后,显著升高(P<0.05)。对照组与治疗组治疗后的改变幅度两两比较,FSH、E2、LH、PRL、T没有显著性差异。
结论：
1.定经汤合二至丸加减治疗肝郁肾虚型月经后期具有良好的临床疗效,能显著降低中医症状评分。既可调整月经周期,改善基础体温,并提高雌激素水平,降低过高的FSH水平。
2.停药后3个月,使用定经汤合二至丸加减的治疗组仍具有较稳定的疗效。对于降低中医症状评分以及中医证候的总疗效显著优于对照组(P<0.05)。
Objective
This research was aim to study the effect of Dingjingtang and Erzhiwan in treating menstruation, and evaluate the safety of the treatment for providing scientific basis in clinical application.
Method
The60cases objects was collected from January2011to November in Taiwan, Kaohsiung Municipal Renda TCM clinic late menstruation patients whom meet the inclusion criteria according to the principle of randomly divided into2groups. According to the method of random control, strict control of variable factors, the participants were randomly divided into treatment group and control group,30cases each group. Control group:treatment for regulating the liver and kidney, nourishing menstruation. The control group was treated with Xiaoyao Pill.
Xiaoyao Pill drug composition:Caihu, Danggui, Baishao, Baizhu(fried), Fulin, Gancao and Bohe. Directions:use of Xiaoyao Pill (Jiuzhitang Ltd. Co., the country medicine accurate Z20013060),9g/time, three times a day, take one week after operation, three months for a course of treatment, and3months of follow-up after stopping drug. The treatment group was cured for nourishing liver and kidney, nourishing menstruation, the decoction for the treatment of the decoction mixed Ding Jing Tang and Erzhiwan. Ding Jing Tang was composed of Shudi, Danggui, Baishao, Caihu, Fulin, Shanyao, Tusizi, Jinjiesui. Erzhiwan was composed of Nvzhenzi and Mohanlian. With qi and blood deficiency was added Dangshen and Huangqi; with phlegm stagnation was added Sharen and Baizhu; with deficiency-cold was added Xiangfu and Rougui. Take one week after operation, three months for a course of treatment, and3months of follow-up after stopping drug. Before and after treatment in all patients should be according to the requirements detailed in the observation table, evaluation and make the effect after the end of treatment.
Statistical methods:classification of data with χ2test, ranked data for two samples Wilcoxon test (calibration), two samples were compared using t test or Wilcoxon test, the t test for comparison or Wilcoxon paired rank sum test.
Result
There were60cases in the group of eligible patients:the treatment group and the control group of30cases. Before treatment, two groups of patients with age, menarche, duration time of TCM symptoms, basic body temperature, serum sex hormone FSH (follicle stimulating hormone), LH (luteinizing hormone), E2(estradiol), T (testosterone), there were no statistical significant difference. The two groups were comparable.
After a course of treatment, the treatment group can significantly reduce the clinical symptoms score (P<0.05), and3months after treatment stopped in the symptom score reducing rate is still better than those of the control group (P<0.05). And the total curative effect of TCM syndrome, Xiaoyao Pill and control group in the total efficiency was50%, and the treatment group total effectiveness is86.66%. The treatment group curative effect surpasses the control group. From the improvement of the basal body temperature, the control group after a course of treatment,40%efficiency. The treatment group was73.33%, the treatment group with the basal body temperature was significantly better than the control group. The control group and the treatment group had significantly decreased FSH, increased E2. And the comparison of two two changes of group and the treatment group, there were significant differences in FSH, E2(P<0.05). The treatment group was significantly better than the control group.
After stopping the treatment after three months, compared with two groups of total curative effect of TCM syndrome, there was significant difference. The control group in the total efficiency of63.33%, the total effective rate in treatment group was90%. The treatment group curative effect surpasses the control group. To improve the situation of the basal body temperature, the control group after a course of treatment,50%efficiency. Effective rate of treatment group76.66%, treatment group was significantly better than the control group (P<0.05). FSH after the two treatment, the comparison, decreased significantly (P<0.05). E2after the two treatment, increased significantly (P<0.05). Comparison between the two two changes of group and the treatment group after treatment, FSH, E2, LH, PRL, T had no significant difference.
Conclusion
Dingjingtang and Erzhiwan in treating menstruation has significantly clinical efficacy, after treatment, the treatment group can improve TCM syndrome score and can significantly reduce the symptoms of Chinese medicine. The two groups after treatment the serum FSH (follicle stimulating hormone) decreased significantly, E2(estradiol) level, and the treatment group for the basal body temperature regulation is better than that of control group. Three months after discontinuation of treatment effect, TCM syndrome score group can, and effectively improve the basal body temperature. Dingjingtang and Erzhiwan in treating late menstruation had significant therapeutic effect, and the effect is lasting, after treatment condition is not easily repeatedly. So the Dingjingtang and Erzhiwan in treating menstruation had clinical value.
引文
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