桂枝茯苓丸合海藻甘草（十八反）水蛭等治疗子宫肌瘤的研究
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摘要
目的
本研究主要通过随机对照的研究方法,对桂枝茯苓丸合海藻甘草(十八反)水蛭等治疗子宫肌瘤的的临床疗效和安全性进行客观的疗效评价。
方法
按照西医子宫肌瘤诊断标准,以及中医证型辨证标准,在台湾台南市高堂中医联合诊所门诊收集病例,纳入年龄在20-50岁之间的患者60例,随机分为两组,每组各30例,治疗组(自拟桂枝茯苓合十八反与虫类药等中药复方),对照组(桂枝茯苓胶囊),从非经期开始给药,每日三剂,三个月为一疗程。采用中医证候量化评分,并结合指标检查结果对两种方法治疗子宫肌瘤进行临床观察。
治疗组：非经期予自拟桂枝茯苓合海藻甘草水蛭等中药复方治疗30例。每日3次,饭后,温水服用。(庄松荣药厂科学中药,3个月/1人份,单位：克。桂枝茯苓丸15×30×2×3=2700,三棱1×30×3=90,威灵仙1×30×3=90,莪术1×30×3=90,楮实子1×30×3=90,水蛭1×30×3=90,海藻1×30×3=90,甘草1×30×3=90)
对照组：非经期予桂枝茯苓胶囊(庄松荣药厂)治疗30例。每日3次,早、中、晚各一次口服,饭后,温水服用。
结果
经过治疗后,治疗组与对照组的中医证候疗效总有效率分别为90.0%和83.33%,两组间中医证候总疗效等级分布差异有统计学意义(P<0.05)。两组中医证候疗效比较,差异有显著性意义,治疗组疗效优于对照组。
治疗后两组中医证候分值比较,治疗组优于对照组。分值差值比较,治疗组优于对照组。
两组治疗后子宫情况、月经量情况、腹痛情况改善程度比较,差异无显著性意义(P>O.05)。说明两组的治疗方法对以上证候的疗效相当。
治疗组与对照组的血清FSH水平分别由治疗前6.53±2.43和5.39±2.20下降到治疗后的2.13±0.85和3.55±0.71,两组治疗后组间差异和组内前后比较差异均有统计学意义(P<0.05)。
治疗组与对照组的血清LH水平分别由治疗前44.58±11.57和50.78±13.24下降到治疗后的23.23±7.48和33.37±9.33,两组治疗后组间和组内前后比较差异有统计学意义(P<0.05),组间前后差值比较差异无统计学意义(P>0.05)。
治疗组与对照组的血清E2水平分别由治疗前161.2±20.85和152.4±22.11升高到治疗后的297.5±59.3和271.4±60.2,两组治疗后组间差异和组间差值差异均无统计学意义(P>0.05),组内前后比较差异有统计学意义(P<0.05)。
治疗组与对照组的血清PRL水平分别由治疗前13.54±4.79和14.77±5.27下降到治疗后的9.01±4.26和12.88±5.57,两组治疗后组间差异和组内前后比较差异均有统计学意义(P<0.05)。
治疗组与对照组的t检测值分别由治疗前6.09±3.54和6.69±2.68下降到治疗后的3.21±1.08和3.54±0.56,两组治疗后组间差异和组内前后比较差异均无统计学意义(P>0.05)。
治疗组与对照组的P检测值分别由治疗前16.5±9.3和15.3±10.3下降到治疗后的13.6±11.3和12.1±7.1,两组治疗后组间差异和组内前后比较差异均无统计学意义(P>0.05)。
两组治疗后头晕目眩症状及体征等消失率比较,差异有显著性意义(P>0.05)。手足心热、少气懒言、神疲乏力、食欲减退等症状及体征等消失率比较,差异无显著性意义(P>0.05)。
安全性检测表明,治疗前血、尿、大便常规、肝肾功能、心电图正常者,治疗后未见异常改变,表明该药临床应用安全。
结论
1.桂枝茯苓合海藻甘草及水蛭等(十八反结合虫类药物)治疗子宫肌瘤,在改善中医证候方面,疗效优于桂枝茯苓胶囊。且未发现不良反应。说明海藻配甘草是安全的。
2.十八反结合虫类药物治疗比桂枝茯苓胶囊更有效降低子宫肌瘤患者血清FSH、LH、PRL水平。
Objective
This randomized controlled clinical trial intends to discuss the clinical efficacy and safety on the treatment of hysteromyoma with Ramulus Cinnamomi and Poria Cocos Pills together with seaweed and liquorice (18 antagonisms) and leeches.
Methods
According to the Western Medicine diagnosis criteria of hysteromyoma and the TCM syndrome differentiation standards,60 cases of age between 20 and 50 years old are collected in Gaotang TCM Joint Clinics in Tainan City, Taiwan. They are randomly divided into two groups with each group 30 cases. The Treatment Group adopts the Chinese Medicine compounds including ramulus cinnamomi, poria cocos,18 antagonisms and insect drugs. The Control Group takes the Ramulus Cinnamomi and Poria Cocos Capsules. The administration starts from the non-menstruation period with 3 doses daily for three months which consist one period of treatment. Adopt the quantitative scoring of Chinese Medicine syndromes and conduct the clinical observation on the hysteromyoma treatment with two therapies, with the index examination results taken into consideration.
The Treatment Group:30 cases were treated with the Chinese Medicine compounds including ramulus cinnamomi, poria cocos, seaweed, liquorice and leeches, etc. from the non-menstruation period. Take 3 times a day after meal with warm water (Science Chinese Medicine products from Chuang Songzong Pharmaceutical Co., Ltd.,3 months/1 person, unit:grams. Ramulus Cinnamomi and Poria Cocos Pill 15×30×2×3= 2700, rhizoma sparganii:1×30×3 = 90, Chinese Clematis Root:1×30×3= 90, zedoaria:1×30×3=90, paper mulberry fruit:1×30×3= 90, leeches:1×30×3= 90, seaweed:1×30×3= 90, liquorice:1×30×3= 90).
The Control Group:30 cases were treated with Ramulus Cinnamomi and Poria Cocos Capsules (Chuang Songzong Pharmaceutical Co., Ltd.) from the non-menstruation period. Orally intake for 3 times a day after meals in the morning, noon and evening with warm water. Results
After treatment, the TCM syndrome total effective rates of the Treatment Group and Control Group are respectively 90.0% and 83.33% whose interclass grade distributional difference has statistical significance (P< 0.05). Comparing the TCM syndrome curative effect, the author finds the difference has significance and the curative effect of the Treatment Group is superior to that of the Control Group.
After treatment, comparing the TCM syndrome scores, the author finds the Treatment Group is superior to the Control Group. The Treatment Group is superior to the Control Group in D-value comparison.
No statistically significant difference (P> 0.05) is found in the improvement degree comparison of uterine, menstrual volume and abdominal pain conditions, which indicate two groups'treatment methods have equivalent effect for the syndromes mentioned.
The Treatment Group and Control Group's serum FSH levels decrease from 6.53±2.43 and 5.39±2.20 before treatment to 2.13±0.85 and 3.55±0.71 after treatment respectively. The interclass difference after treatment and the in-class AP difference have statistical significance (P< 0.05).
The Treatment Group and Control Group's serum LH levels respectively decrease from 44.58±11.57 and 50.78±13.24 before treatment to 23.23±7.48 and 33.37±9.33 after treatment. The interclass difference and in-class AP differences after treatment have statistical significance (P< 0.05). The interclass AP D-value comparison has statistical significance (P> 0.05).
The Treatment Group and Control Group's serum E2 levels respectively rise from 161.2±20.85 and 152.4±22.11 before treatment to 297.5±59.3 and 271.4±60.2 after treatment. The interclass difference and in-class D-value differences after treatment have no statistical significance (P> 0.05). The in-class AP comparison has statistical significance (P< 0.05).
The Treatment Group and Control Group's serum PRL levels decrease respectively from 13.54±4.79 and 14.77±5.27 before treatment to 9.01±4.26 and 12.88±5.57 after treatment. The interclass difference after treatment and in-class AP differences have statistical significance (P< 0.05).
The Treatment Group and Control Group's t values decrease respectively from 6.09±3.54 and 6.69±2.68 before treatment to 3.21±1.08 and 3.54±0.56 after treatment. The interclass difference after treatment and in-class AP differences have no statistical significance (P> 0.05).
The Treatment Group and Control Group's p values decrease respectively from 16.5±9.3 and 15.3±10.3 before treatment to 13.6±11.3 and 12.1±7.1 after treatment. The interclass difference after treatment and in-class AP differences have no statistical significance (P> 0.05).
The disappearance rates of body signs and symptoms like dizziness have significant difference (P< 0.05). The disappearance rates of body signs and symptoms like feverish palms and soles, deficient breath, fatigue and debility, decreased food appetite, etc. have no statistically significant difference (P> 0.05).
Safety test indicates those with normal blood, urine, stool, kidney function and electrocardiogram examination results before treatment have no abnormal changes which indicate that the drug can be clinically applied safely.
Conclusion
1. Ramulus Cinnamomi and Poria Cocos together with seaweed, liquorice and leeches, etc. (18 antagonisms combined with insect-drugs) have better curative effect than Ramulus Cinnamomi and Poria Cocos Capsules to treat hysteromyoma in improving the TCM syndromes. No adverse effect is found till now. It indicates that seaweed combined with liquorice is safe.
2.18 antagonisms combined with insect-drugs can reduce the serum FSH, LH and PRL levels of hysteromyoma patients more effectively than Ramulus Cinnamomi and Poria Cocos Capsules.
本研究主要通过随机对照的研究方法,对桂枝茯苓丸合海藻甘草(十八反)水蛭等治疗子宫肌瘤的的临床疗效和安全性进行客观的疗效评价。
方法
按照西医子宫肌瘤诊断标准,以及中医证型辨证标准,在台湾台南市高堂中医联合诊所门诊收集病例,纳入年龄在20-50岁之间的患者60例,随机分为两组,每组各30例,治疗组(自拟桂枝茯苓合十八反与虫类药等中药复方),对照组(桂枝茯苓胶囊),从非经期开始给药,每日三剂,三个月为一疗程。采用中医证候量化评分,并结合指标检查结果对两种方法治疗子宫肌瘤进行临床观察。
治疗组：非经期予自拟桂枝茯苓合海藻甘草水蛭等中药复方治疗30例。每日3次,饭后,温水服用。(庄松荣药厂科学中药,3个月/1人份,单位：克。桂枝茯苓丸15×30×2×3=2700,三棱1×30×3=90,威灵仙1×30×3=90,莪术1×30×3=90,楮实子1×30×3=90,水蛭1×30×3=90,海藻1×30×3=90,甘草1×30×3=90)
对照组：非经期予桂枝茯苓胶囊(庄松荣药厂)治疗30例。每日3次,早、中、晚各一次口服,饭后,温水服用。
结果
经过治疗后,治疗组与对照组的中医证候疗效总有效率分别为90.0%和83.33%,两组间中医证候总疗效等级分布差异有统计学意义(P<0.05)。两组中医证候疗效比较,差异有显著性意义,治疗组疗效优于对照组。
治疗后两组中医证候分值比较,治疗组优于对照组。分值差值比较,治疗组优于对照组。
两组治疗后子宫情况、月经量情况、腹痛情况改善程度比较,差异无显著性意义(P>O.05)。说明两组的治疗方法对以上证候的疗效相当。
治疗组与对照组的血清FSH水平分别由治疗前6.53±2.43和5.39±2.20下降到治疗后的2.13±0.85和3.55±0.71,两组治疗后组间差异和组内前后比较差异均有统计学意义(P<0.05)。
治疗组与对照组的血清LH水平分别由治疗前44.58±11.57和50.78±13.24下降到治疗后的23.23±7.48和33.37±9.33,两组治疗后组间和组内前后比较差异有统计学意义(P<0.05),组间前后差值比较差异无统计学意义(P>0.05)。
治疗组与对照组的血清E2水平分别由治疗前161.2±20.85和152.4±22.11升高到治疗后的297.5±59.3和271.4±60.2,两组治疗后组间差异和组间差值差异均无统计学意义(P>0.05),组内前后比较差异有统计学意义(P<0.05)。
治疗组与对照组的血清PRL水平分别由治疗前13.54±4.79和14.77±5.27下降到治疗后的9.01±4.26和12.88±5.57,两组治疗后组间差异和组内前后比较差异均有统计学意义(P<0.05)。
治疗组与对照组的t检测值分别由治疗前6.09±3.54和6.69±2.68下降到治疗后的3.21±1.08和3.54±0.56,两组治疗后组间差异和组内前后比较差异均无统计学意义(P>0.05)。
治疗组与对照组的P检测值分别由治疗前16.5±9.3和15.3±10.3下降到治疗后的13.6±11.3和12.1±7.1,两组治疗后组间差异和组内前后比较差异均无统计学意义(P>0.05)。
两组治疗后头晕目眩症状及体征等消失率比较,差异有显著性意义(P>0.05)。手足心热、少气懒言、神疲乏力、食欲减退等症状及体征等消失率比较,差异无显著性意义(P>0.05)。
安全性检测表明,治疗前血、尿、大便常规、肝肾功能、心电图正常者,治疗后未见异常改变,表明该药临床应用安全。
结论
1.桂枝茯苓合海藻甘草及水蛭等(十八反结合虫类药物)治疗子宫肌瘤,在改善中医证候方面,疗效优于桂枝茯苓胶囊。且未发现不良反应。说明海藻配甘草是安全的。
2.十八反结合虫类药物治疗比桂枝茯苓胶囊更有效降低子宫肌瘤患者血清FSH、LH、PRL水平。
Objective
This randomized controlled clinical trial intends to discuss the clinical efficacy and safety on the treatment of hysteromyoma with Ramulus Cinnamomi and Poria Cocos Pills together with seaweed and liquorice (18 antagonisms) and leeches.
Methods
According to the Western Medicine diagnosis criteria of hysteromyoma and the TCM syndrome differentiation standards,60 cases of age between 20 and 50 years old are collected in Gaotang TCM Joint Clinics in Tainan City, Taiwan. They are randomly divided into two groups with each group 30 cases. The Treatment Group adopts the Chinese Medicine compounds including ramulus cinnamomi, poria cocos,18 antagonisms and insect drugs. The Control Group takes the Ramulus Cinnamomi and Poria Cocos Capsules. The administration starts from the non-menstruation period with 3 doses daily for three months which consist one period of treatment. Adopt the quantitative scoring of Chinese Medicine syndromes and conduct the clinical observation on the hysteromyoma treatment with two therapies, with the index examination results taken into consideration.
The Treatment Group:30 cases were treated with the Chinese Medicine compounds including ramulus cinnamomi, poria cocos, seaweed, liquorice and leeches, etc. from the non-menstruation period. Take 3 times a day after meal with warm water (Science Chinese Medicine products from Chuang Songzong Pharmaceutical Co., Ltd.,3 months/1 person, unit:grams. Ramulus Cinnamomi and Poria Cocos Pill 15×30×2×3= 2700, rhizoma sparganii:1×30×3 = 90, Chinese Clematis Root:1×30×3= 90, zedoaria:1×30×3=90, paper mulberry fruit:1×30×3= 90, leeches:1×30×3= 90, seaweed:1×30×3= 90, liquorice:1×30×3= 90).
The Control Group:30 cases were treated with Ramulus Cinnamomi and Poria Cocos Capsules (Chuang Songzong Pharmaceutical Co., Ltd.) from the non-menstruation period. Orally intake for 3 times a day after meals in the morning, noon and evening with warm water. Results
After treatment, the TCM syndrome total effective rates of the Treatment Group and Control Group are respectively 90.0% and 83.33% whose interclass grade distributional difference has statistical significance (P< 0.05). Comparing the TCM syndrome curative effect, the author finds the difference has significance and the curative effect of the Treatment Group is superior to that of the Control Group.
After treatment, comparing the TCM syndrome scores, the author finds the Treatment Group is superior to the Control Group. The Treatment Group is superior to the Control Group in D-value comparison.
No statistically significant difference (P> 0.05) is found in the improvement degree comparison of uterine, menstrual volume and abdominal pain conditions, which indicate two groups'treatment methods have equivalent effect for the syndromes mentioned.
The Treatment Group and Control Group's serum FSH levels decrease from 6.53±2.43 and 5.39±2.20 before treatment to 2.13±0.85 and 3.55±0.71 after treatment respectively. The interclass difference after treatment and the in-class AP difference have statistical significance (P< 0.05).
The Treatment Group and Control Group's serum LH levels respectively decrease from 44.58±11.57 and 50.78±13.24 before treatment to 23.23±7.48 and 33.37±9.33 after treatment. The interclass difference and in-class AP differences after treatment have statistical significance (P< 0.05). The interclass AP D-value comparison has statistical significance (P> 0.05).
The Treatment Group and Control Group's serum E2 levels respectively rise from 161.2±20.85 and 152.4±22.11 before treatment to 297.5±59.3 and 271.4±60.2 after treatment. The interclass difference and in-class D-value differences after treatment have no statistical significance (P> 0.05). The in-class AP comparison has statistical significance (P< 0.05).
The Treatment Group and Control Group's serum PRL levels decrease respectively from 13.54±4.79 and 14.77±5.27 before treatment to 9.01±4.26 and 12.88±5.57 after treatment. The interclass difference after treatment and in-class AP differences have statistical significance (P< 0.05).
The Treatment Group and Control Group's t values decrease respectively from 6.09±3.54 and 6.69±2.68 before treatment to 3.21±1.08 and 3.54±0.56 after treatment. The interclass difference after treatment and in-class AP differences have no statistical significance (P> 0.05).
The Treatment Group and Control Group's p values decrease respectively from 16.5±9.3 and 15.3±10.3 before treatment to 13.6±11.3 and 12.1±7.1 after treatment. The interclass difference after treatment and in-class AP differences have no statistical significance (P> 0.05).
The disappearance rates of body signs and symptoms like dizziness have significant difference (P< 0.05). The disappearance rates of body signs and symptoms like feverish palms and soles, deficient breath, fatigue and debility, decreased food appetite, etc. have no statistically significant difference (P> 0.05).
Safety test indicates those with normal blood, urine, stool, kidney function and electrocardiogram examination results before treatment have no abnormal changes which indicate that the drug can be clinically applied safely.
Conclusion
1. Ramulus Cinnamomi and Poria Cocos together with seaweed, liquorice and leeches, etc. (18 antagonisms combined with insect-drugs) have better curative effect than Ramulus Cinnamomi and Poria Cocos Capsules to treat hysteromyoma in improving the TCM syndromes. No adverse effect is found till now. It indicates that seaweed combined with liquorice is safe.
2.18 antagonisms combined with insect-drugs can reduce the serum FSH, LH and PRL levels of hysteromyoma patients more effectively than Ramulus Cinnamomi and Poria Cocos Capsules.
引文
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