知柏地黄丸加减治疗月经先期肾虚血热型的临床观察
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摘要
目的：
本研究拟探讨知柏地黄丸加减治疗月经先期的临床疗效和安全性,为临床应用提供科学依据。
方法：
2010年1月至2011年12月到台湾康程中医诊所就诊的90例月经先期患者,中医辨证为肾虚血热型,西医诊断为：月经不调(月经频发)。随机将90例患者分成2组,知柏地黄丸加减治疗组(45例)和两地汤对照组(45例),疗程均为3个月经周期。从患者月经周期,量、色、质及主要症状体征方面评价临床疗效,从血液分析、尿液分析、大便常规、肝、肾功能、心电图等方面评价其安全性。
给药方法：治疗组给予口服知柏地黄丸(采用台湾科学中药产品,粉剂),每日2次,每次20g,冲服,月经期间暂停服药。3个月经周期为1个疗程。月经先期时有兼证,常虚热实热皆有,阴虚阳盛并存等等。并按月经周期不同时期随证加味治疗。对照组：方药予两地汤(采用台湾科学中药产品,粉剂),药物组成(基本方)：生地,玄参,麦冬,白芍,地骨皮,阿胶。每日2次,每次20g,冲服,加减同治疗组。月经期间暂停服药。3个月经周期为1疗程。治疗期间两组均不得使用其他有治疗月经先期作用的药物。
两组治疗1个疗程后进行疗效及安全性评定,两组在治疗前后患者症状改善情况采用计分法进行评分,同时记录各参数的分值。
统计方法：临床资料用Epi Data3.01软件进行统计分析。等级资料用两样本比较Wilcoxon秩和检验(校正),分类资料用χ2矿检验,两样本均数比较用t检验或Wilcoxon秩和检验,治疗前后比较用配对t检验或Wilcoxon配对秩和检验。统计分析采用SPSS17.0统计软件完成,统计图形采用Graphd Prism4.03绘制。
结果：
本研究共有合格受试者90例,知柏地黄丸加减为治疗组(45例)和两地汤为对照组(45例),疗程均为3个月经周期。治疗组近期临床痊愈率为46.67%,显效率为24.44%,有效率为20.0%,总有效率为91.20%；对照组近期临床痊愈率为35.56%,显效率为33.33%,有效率为17.78%,总有效率为86.7%。两组总疗效比较,差异有统计学意义(P<0.05)。
安全性指标检测结果示：,治疗前后患者的血液分析、尿液分析、大便常规、肝、肾功能、心电图未见明显改变,提示该药临床应用安全可靠,无明显毒副作用。
用药3个月经周期后治疗组和对照组的基础体温均出现双相趋势,但治疗组的改善程度明显大于对照组,差异有显著性意义(P<0.05),治疗后两组的临床证候均出现不同程度改善,两组的记录分值均下降,差异有统计学意义,(P<0.05)。
结论：
知柏地黄丸加减治疗月经先期肾虚血热型疗效确切,且安全无毒副作用,为临床应用及推广提供科学理论依据,但其作用机制尚需进一步探讨。
Objective
The study intends to explore the clinical efficacy and safety of Pill of Anemarrhena, Phellodendron and Rehmannia in the treatment of preceeded menorrhea and provide scientific basis for its clinical application.
Methods
The research objects are90patients of preceeded menorrhea receiving treatment from Taiwan Kangcheng TCM Clinic from January2010to December2011. They are classified as kidney deficiency and blood heat in TCM syndrome differentiation and irregular menstruation (polymenorrhea) in Western Medicine.90cases are randomly divided into two groups:Group of Modified Pill of Anemarrhena, Phellodendron and Rehmannia (45cases) and Liangdi Decoction Control Group (45cases). The treatment courses are both3menstruation cycles for two groups. Evaluate the clinical curative effect from patients'menstruation cycles, menstruation volume, color, quality and other major symptoms and body signs. Evaluate its safety from the analysis of blood, urine, stool, liver and kidney function and cardiogram, etc.
Administration method:Patients in the Treatment Group orally take Pill of Anemarrhena, Phellodendron and Rehmannia (Taiwan scientific TCM products) twice a day with20g each time. Take it after mixing with water. Stop administration during menstruation.3menstruation cycles make1treatment course. Accompanying symptoms and signs may occur during preceeded menorrhea, therefore asthenic fever and sthenic fever, yin deficiency and yang predominance often coexist. Medicine may be modified at different periods of menstruation cycles. The Control Group:Take Liangdi Decoction (Taiwan scientific medicine products, powder). Basic prescription for the medicine: rehmannia dried rhizome, figwort root, ophiopogonis tuber, white peony root, lycium bark, medicinal glue. Take twice a day with20g each time. Take after mixing with water. Its modification is the same as the Treatment Group. Stop administration during menstruation.3menstruation cycles make1treatment course. No other drugs for preceeded menorrhea treatment are allowed to use in both groups during treatment.
Conduct efficacy and safety evaluation after1treatment course for two groups. Scoring is adopted for evaluation. At the same time record the value of each parameter.
Statistical method:Use Epi Data3.01software to process the clinical material. The ranked data is processed with Wilcoxon rank sum test (correction), the classified material with%test, two samples'average with t test or Wilcoxon rank sum test, AP comparison with t test or Wilcoxon pairing rank sum test. The analysis is conducted with SPSS17.0software. The statistical graph is made by Graphd Prism4.03software.
Results
The study has90qualified subjects,45cases in the Treatment Group (Modified Pill of Anemarrhena, Phellodendron and Rehmannia Group) and45in the Control Group (Liangdi Decoction Group). The treatment courses of two groups both consist of three menstrual cycles. For the Treatment Group, the recent clinical cure rate is46.58%, the excellence rate is24.38%, the effective rate is20.0%and the total effective rate is91.20%; for the Control Group, the recent clinical cure rate is35.47%, the excellence rate is33.33%, the effective rate is17.7%and the total effective rate is86.7%. The comparison of two groups'total curative effect shows significant difference (P＜0.05)
Safety test indicates that the analysis of blood, urine, stool, kidney and liver function, electrocardiogram shows no abnormal changes before and after treatment which indicates the safety for clinical application and no obvious toxic side effects.
Administering drugs for3menstruation cycles, the author finds BBT double-phase tendency appears in both the2groups. However, the improvement in the Treatment Group is significantly greater than that of the Control Group and there's statistically significant difference (P<0.05). After treatment, two groups'clinical syndromes are improved at certain degrees. The score records decrease in both groups and the difference is statistically significant (P<0.05).
Conelus ion
Using the modified Pill of Anemarrhena, Phellodendron and Rehmannia to treat the preceeded menorrhea in the type of kidney deficiency and blood heat has exact curative effect. It's safe and atoxic. This provides theoretical basis for its clinical application and promotion. However, its functioning mechanism still needs to be furthur investigated.
本研究拟探讨知柏地黄丸加减治疗月经先期的临床疗效和安全性,为临床应用提供科学依据。
方法：
2010年1月至2011年12月到台湾康程中医诊所就诊的90例月经先期患者,中医辨证为肾虚血热型,西医诊断为：月经不调(月经频发)。随机将90例患者分成2组,知柏地黄丸加减治疗组(45例)和两地汤对照组(45例),疗程均为3个月经周期。从患者月经周期,量、色、质及主要症状体征方面评价临床疗效,从血液分析、尿液分析、大便常规、肝、肾功能、心电图等方面评价其安全性。
给药方法：治疗组给予口服知柏地黄丸(采用台湾科学中药产品,粉剂),每日2次,每次20g,冲服,月经期间暂停服药。3个月经周期为1个疗程。月经先期时有兼证,常虚热实热皆有,阴虚阳盛并存等等。并按月经周期不同时期随证加味治疗。对照组：方药予两地汤(采用台湾科学中药产品,粉剂),药物组成(基本方)：生地,玄参,麦冬,白芍,地骨皮,阿胶。每日2次,每次20g,冲服,加减同治疗组。月经期间暂停服药。3个月经周期为1疗程。治疗期间两组均不得使用其他有治疗月经先期作用的药物。
两组治疗1个疗程后进行疗效及安全性评定,两组在治疗前后患者症状改善情况采用计分法进行评分,同时记录各参数的分值。
统计方法：临床资料用Epi Data3.01软件进行统计分析。等级资料用两样本比较Wilcoxon秩和检验(校正),分类资料用χ2矿检验,两样本均数比较用t检验或Wilcoxon秩和检验,治疗前后比较用配对t检验或Wilcoxon配对秩和检验。统计分析采用SPSS17.0统计软件完成,统计图形采用Graphd Prism4.03绘制。
结果：
本研究共有合格受试者90例,知柏地黄丸加减为治疗组(45例)和两地汤为对照组(45例),疗程均为3个月经周期。治疗组近期临床痊愈率为46.67%,显效率为24.44%,有效率为20.0%,总有效率为91.20%；对照组近期临床痊愈率为35.56%,显效率为33.33%,有效率为17.78%,总有效率为86.7%。两组总疗效比较,差异有统计学意义(P<0.05)。
安全性指标检测结果示：,治疗前后患者的血液分析、尿液分析、大便常规、肝、肾功能、心电图未见明显改变,提示该药临床应用安全可靠,无明显毒副作用。
用药3个月经周期后治疗组和对照组的基础体温均出现双相趋势,但治疗组的改善程度明显大于对照组,差异有显著性意义(P<0.05),治疗后两组的临床证候均出现不同程度改善,两组的记录分值均下降,差异有统计学意义,(P<0.05)。
结论：
知柏地黄丸加减治疗月经先期肾虚血热型疗效确切,且安全无毒副作用,为临床应用及推广提供科学理论依据,但其作用机制尚需进一步探讨。
Objective
The study intends to explore the clinical efficacy and safety of Pill of Anemarrhena, Phellodendron and Rehmannia in the treatment of preceeded menorrhea and provide scientific basis for its clinical application.
Methods
The research objects are90patients of preceeded menorrhea receiving treatment from Taiwan Kangcheng TCM Clinic from January2010to December2011. They are classified as kidney deficiency and blood heat in TCM syndrome differentiation and irregular menstruation (polymenorrhea) in Western Medicine.90cases are randomly divided into two groups:Group of Modified Pill of Anemarrhena, Phellodendron and Rehmannia (45cases) and Liangdi Decoction Control Group (45cases). The treatment courses are both3menstruation cycles for two groups. Evaluate the clinical curative effect from patients'menstruation cycles, menstruation volume, color, quality and other major symptoms and body signs. Evaluate its safety from the analysis of blood, urine, stool, liver and kidney function and cardiogram, etc.
Administration method:Patients in the Treatment Group orally take Pill of Anemarrhena, Phellodendron and Rehmannia (Taiwan scientific TCM products) twice a day with20g each time. Take it after mixing with water. Stop administration during menstruation.3menstruation cycles make1treatment course. Accompanying symptoms and signs may occur during preceeded menorrhea, therefore asthenic fever and sthenic fever, yin deficiency and yang predominance often coexist. Medicine may be modified at different periods of menstruation cycles. The Control Group:Take Liangdi Decoction (Taiwan scientific medicine products, powder). Basic prescription for the medicine: rehmannia dried rhizome, figwort root, ophiopogonis tuber, white peony root, lycium bark, medicinal glue. Take twice a day with20g each time. Take after mixing with water. Its modification is the same as the Treatment Group. Stop administration during menstruation.3menstruation cycles make1treatment course. No other drugs for preceeded menorrhea treatment are allowed to use in both groups during treatment.
Conduct efficacy and safety evaluation after1treatment course for two groups. Scoring is adopted for evaluation. At the same time record the value of each parameter.
Statistical method:Use Epi Data3.01software to process the clinical material. The ranked data is processed with Wilcoxon rank sum test (correction), the classified material with%test, two samples'average with t test or Wilcoxon rank sum test, AP comparison with t test or Wilcoxon pairing rank sum test. The analysis is conducted with SPSS17.0software. The statistical graph is made by Graphd Prism4.03software.
Results
The study has90qualified subjects,45cases in the Treatment Group (Modified Pill of Anemarrhena, Phellodendron and Rehmannia Group) and45in the Control Group (Liangdi Decoction Group). The treatment courses of two groups both consist of three menstrual cycles. For the Treatment Group, the recent clinical cure rate is46.58%, the excellence rate is24.38%, the effective rate is20.0%and the total effective rate is91.20%; for the Control Group, the recent clinical cure rate is35.47%, the excellence rate is33.33%, the effective rate is17.7%and the total effective rate is86.7%. The comparison of two groups'total curative effect shows significant difference (P＜0.05)
Safety test indicates that the analysis of blood, urine, stool, kidney and liver function, electrocardiogram shows no abnormal changes before and after treatment which indicates the safety for clinical application and no obvious toxic side effects.
Administering drugs for3menstruation cycles, the author finds BBT double-phase tendency appears in both the2groups. However, the improvement in the Treatment Group is significantly greater than that of the Control Group and there's statistically significant difference (P<0.05). After treatment, two groups'clinical syndromes are improved at certain degrees. The score records decrease in both groups and the difference is statistically significant (P<0.05).
Conelus ion
Using the modified Pill of Anemarrhena, Phellodendron and Rehmannia to treat the preceeded menorrhea in the type of kidney deficiency and blood heat has exact curative effect. It's safe and atoxic. This provides theoretical basis for its clinical application and promotion. However, its functioning mechanism still needs to be furthur investigated.
引文
[1]唐浩志,孟凡丽,赵宏庆.葆宫止血颗粒治疗月经先期及月经过多临床观察[J].中国实用医药,2008,3(2)：91.
[2]赵燕宁,王姝梅,王诗露.调经胶囊治疗月经先期的临床及药物研究[J].四川中医,2006,24(12)：73-74.
[3]陈仁华,钟兴明.辨证分型治疗月经先期124例[J].2009,5：25-27.
[4]陈宏.凉血清海汤治疗月经先期167例[J].中国中医急症,2009,18(11)：1891.
[5]韩鸿雁,陶艳玲,袁丽颖.归脾汤加减治疗少女月经先期34例[J].长春中医药大学学报,2009,25(3)：402.
[6]程慧莲,何慧,马秀兰.养血调肝汤治疗气血虚弱型月经先期36例临床疗效观察[J].四川中医,2008,26(10)：81-83.
[7]盛文贞,刘金星.加味保阴煎治疗气阴两虚型月经先期61例[J].甘肃中医,2009,22(10)：35.
[8]张晓金,杨家林,魏绍斌.清经胶囊治疗月经先期的临床研究[J].中药新药与临床药理,2004,15(1)：59-61,63.
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[2]赵燕宁,王姝梅,王诗露.调经胶囊治疗月经先期的临床及药物研究[J].四川中医,2006,24(12)：73-74.
[3]陈仁华,钟兴明.辨证分型治疗月经先期124例[J].2009,5：25-27.
[4]陈宏.凉血清海汤治疗月经先期167例[J].中国中医急症,2009,18(11)：1891.
[5]韩鸿雁,陶艳玲,袁丽颖.归脾汤加减治疗少女月经先期34例[J].长春中医药大学学报,2009,25(3)：402.
[6]程慧莲,何慧,马秀兰.养血调肝汤治疗气血虚弱型月经先期36例临床疗效观察[J].四川中医,2008,26(10)：81-83.
[7]盛文贞,刘金星.加味保阴煎治疗气阴两虚型月经先期61例[J].甘肃中医,2009,22(10)：35.
[8]张晓金,杨家林,魏绍斌.清经胶囊治疗月经先期的临床研究[J].中药新药与临床药理,2004,15(1)：59-61,63.
[9]王大增.归脾汤合奇效四物汤治疗月经失调30例[J].上海中医药杂志,2001,35(10)：37.
[10]王琪.清经散治疗月经先期月经过多临床观察50例[J].中华实用中西医杂志,2004,4(17)：2547.
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