摘要
[目的]子宫肌瘤是妇科常见的良性肿瘤,西医多采用手术治疗,但手术给患者身体、精神及经济上都造成了一定的负担,于是子宫肌瘤的保守治疗越来越受到关注。米非司酮是经实验及临床证明治疗子宫肌瘤疗效确切的药物,但有一定副作用。米非司酮的使用剂量从高到低各家报道不一。用量大时疗效好,但副作用大；用量小副作用小,但疗效较差。中成药橘荔散结片从整体入手,以调理气血阴阳为法,既往的研究证实不但可以确实有效的缩小肌瘤瘤体,更鲜有不良反应,但远期疗效尚待研究。为此,我们研究橘荔散结片与小剂量的米非司酮联合使用治疗子宫肌瘤的疗效,以期疗效更高,副作用更小,远期疗效佳,为子宫肌瘤患者带来福音。
[方法]选择符合纳入标准的45例子宫肌瘤患者,随机分成三组：
中西医结合组15例：橘荔散结片,口服,每次4片,每日3次；米非司酮5mg/片,口服,每次1片,每周服2次,橘荔散结片经期停止服用,米非司酮月经周期第一天开始服用,连服3个月为1个疗程；
中药组15例：单用橘荔散结片,口服,每次4片,每日3次,经期停止服用,3个月为一疗程；
西药组15例：单用米非司酮,米非司酮5mg／片,口服,每次1片,每周服2次,月经周期第一天开始服用,连服3个月为1个疗程。
治疗前后分别行盆腔B超检查测量肌瘤的三维径线,计算肌瘤体积大小,并复查血常规(服用米非司酮者监测肝肾功能)。停药后随访3个月,复查盆腔B超及血红蛋白量。所得数据的统计工作均应用SPSS13.0统计软件进行统计。
[结果]三组患者治疗前在年龄、肌瘤体积、血红蛋白量等方面比较均无显著性差异(P>0.05),具有可比性。
(1)中药组15例中12例有效,有效率80%；西药组15例中11例有效,有效率73%；中西医结合组15例均有效,有效率100%。三组治疗前后肌瘤体积、血红蛋白量经比较差异均有显著性,中西医结合组缩小子宫肌瘤及提高血红蛋白量的疗效明显优于中药组与西药组。
(2)用药过程中,中药组患者无明显不适感；西药组有2例患者服药早期出现轻度恶心,继续用药后症状自然消失,3例患者体重稍有增加；中西医结合组有1例患者出现体重稍有增加。中西医结合组与西药组的30例患者在治疗期间均出现不同程度的月经减少,其中7例出现月经停止来潮；5例患者出现轻微转氨酶一过性升高,继续服药后消失。
(3)用药1个疗程后停药,随访3个月,共随访43例(随访率96%),7例月经停止来潮的患者在停药25天—30天内月经恢复；中西医结合组与西药组的30例患者肝肾功能检查均未见明显异常。其中中药组肌瘤体积10例较治疗后缩小,4例无明显变化,14例患者血红蛋白量无明显变化或稍有有上升；西药组9例肌瘤体积较治疗后缩小,2例恢复服药前水平,3例较前增大,此3例患者均不需手术治疗,2例患者血红蛋白量稍有下降,但仍高于服药前水平,其余12例患者血红蛋白量无明显变化或稍有上升：中西医结合组13例肌瘤体积较治疗后缩小,2例无变化,15例患者血红蛋白量无明显变化或稍有上升。中西医结合组及中药组远期疗效较西药组更佳。
[结论]口服橘荔散结片(每日3次,每次4片)联合小剂量米非司酮(5mg／片,每次1片,每周服2次)治疗子宫肌瘤效果好,副反应小,远期疗效满意。
Uterine myoma is a kind of gynecologic common benign tumor. Western medicine is used to surgical treatment for patients. But the operations bring certain burden to the patients's physiology, mentality and economy. More and more people pay attention to the cure with medicine of uterine myoma. Mifepristone which has been proved by experiment and clinic is a really effective drug for uterine myomas. But it has some side effects. The quantity of Mifepristone is not positive in clinical reports. Is there a dosage that not only can reach the same levle in reducing myoma just as the dosage uesd in clinical reports(12.5mg/d), but also make fewer side effects? Julisanjie tablet which treat uterine myoma from the whole of human body can regulate Qi, Xue, Yin and Yang. The past studies have proved Julisanjie tablet can reduce volume effectively, and it has little side effects. We establish this research which is to observe the curative effect of Julisanjie tablet combined small doses mifepristone whether can do better than single mifepristone or single Julisanjie tablet in treating uterine myoma in the clinical. Whether Julisanjie tablet combined small doses mifepristone not only can reduce the side effects caused by mifepristone influences alone but also have a better long-term follow-up.
Method
Choose standard 45 cases of myoma uterus, randomly divided into three groups:
15 cases of integrated traditional Chinese and western medicine group: These patients take 4 slices Julisanjie tablet 3 times a day. They also take 5mg mifepristone twice a week. Julisanjie tablet are stopped taking during the menstruation. Mifepristone is started taking on the first day of the menstrual cycle. They will continuous take these pills 3 months for one period of treatment.
There are 15 cases in the traditional Chinese medicine group:These patients take 4 slices Julisanjie tablet 3 times a day which are stopped taking during the menstruation. They will continuous take these pills 3 months for one period of treatment.
There are also 15 cases in the Western medicine group:They take 5mg mifepristone twice a week. Mifepristone is started taking on the first day of the menstrual cycle. They will continuous take these pills 3 months for one period of treatment.
All of the patients should do the pelvic B ultrasonic examination in order to measure three diameter line of uterine myomas before and after the treatment. We calculate the volume of the uterine myomas. They also check blood analysis detection(The patients who take mifepristone should be monitored the Liver and kidney function). After discontinuation of follow-up of 3 months, the patients will review pelvic B ultrasonic examination and blood analysis detection.
We use the SPSS13.0 statistical software to compile statistics the data.
Result
The three groups of patients in age, fibroid volume before treatment, and hemoglobin content, etc were no significant difference (P>0.05), so they are comparable.
(1) 12 cases were effective in Traditional Chinese medicine group, and the group's effective rate was 80%. 11 cases were effective in Western medicine group, and the group's effective rate was 73%. All cases of integrated traditional Chinese and western medicine group were equally effective, and the group's effective rate was 100%. The fibroid volume and hemoglobin content of the three groups had significant differences after treatment. The curative effect of integrated traditional Chinese and western medicine in reducing fibroid volume and increasing hemoglobin count was better than traditional Chinese medicine group and western medicine group obviously.
(2)The patients of traditional Chinese medicine group had no obvious discomfort during treatment with this medicine. Two patients of Western medicine group appeared mild nausea in early lines of medication, and the symptoms disappeared without treatment. Three patients'weight of Western medicine group increased slightly. One patient's weight increases slightly in integrated traditional Chinese and western medicine group. All patients of integrated traditional Chinese and western medicine group and Western medicine group had different degrees of menstrual decrease during the medicine treatment,7 cases in which appeared menstruation ceasing. There were 5 patients whose thransaminase rised slightly and resumed without treatment soon.
(3) There are 43 patients followed up after a period of treatment and its follow-up rate was 96%. The seven patients whose menstruation ceased resumed normal after in 25 days-30 days when drug was Withdrew. The liver and kidney function testing of all patients of integrated traditional Chinese and western medicine group and Western medicine group showed no obvious abnormalities. Ten patients'fibroid volume were reduced after treatment in the traditional Chinese medicine group, another four cases have no obvious change,14 patients'hemoglobin content had no obvious change or rised slightly. There are 9 patients' fibroid volumes smaller after the treatment in western medicine group, another 2 patients'fibroid volume had no change after the treatment.2 patients'hemoglobin content decreased slightly in western medicine group, but were still higher than the level before treatment, the others'hemoglobin content had no obvious change or rised slightly. 13 patients'fibroid volume were reduced of integrated traditional Chinese and western medicine group, another 2 cases had no obvious change, and 15 patients' hemoglobin content had no obvious change or rised slightly. The long-term outcome of integrated traditional Chinese and western medicine group and traditional Chinese group is better than western medicine group.
Conclusion
The curative effect of Julisanjie tablet(The patients take it 4 slices 3 times a day) joint small doses mifepristone (The patients take it 5mg twice a week) in treating uterine myoma is excellent, it has little side effects and satisfactory long-term outcome.
引文
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