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中医周期疗法治疗月经后期的临床研究
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摘要
目的
     本课题主要研究中医周期疗法治疗月经后期的疗效情况,并对其治疗的安全性进行客观评价。
     方法
     研究对象为2011年里1月至11月期间,在台湾佑倡中医诊所就诊的月经后期延期的病人(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,对入组者简单随机地分为治疗组与对照组,每组45例。对照组:单纯中药治疗,治则为调肝补肾,养血调经。以逍遥散为基础方加减。药物组成:柴胡10克、当归10克、白芍10克、白术10克、茯苓10克、菟丝子12克、续断12克、女贞子10克、香附10克、薄荷5克、炙甘草5克。随证用药:兼有气血虚弱者加黄芪、党参;兼痰湿阻滞者加半夏、陈皮、苍术;兼虚寒者加肉桂、淫羊霍。上药水煎服,每日一剂,早晚各一次,从月经周期第五天开始用药,至月经来潮为一个疗程。治疗组:除服上述中药外需配合周期治疗,周期疗法如下:1号方用于经后期(左归丸合四物汤加减);2号方用于排卵期,即由五子衍宗汤加减而成;3号方用于经前期,拟方为二仙汤合八珍汤加减);月经期间则用4号方,由生化汤加减拟方而来。服药方法为早晚各服一次,一日一剂,水煎服。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。共治疗、观察三个疗程。
     结果:
     本研究入组合格患者共有90例:治疗组与对照组各45例。两组年龄构成比较,无统计学差异(χ2检验,P>0.05);平均年龄构成比较,无统计学差异(t检验,P>0.05)。提示两组患者年龄具有可比性。治疗组病程最短5个月,最长6年;对照组病程最短4个月,最长5年,两组患者病程比较,无统计学差异。两组患者的月经初潮时间比较,无统计学差异。两组病情经Wilcoxon秩和检验,无统计差异。两组中医症状总积分相比较,统计无差别。两组在治疗前月经错后、月经量少、经色紫黯有块、月经质稀色淡、经期腰酸腹痛等中医症状比较,差异无显著差异性,有可比性。两组患者治疗前的基础体温比较,无统计学差异。两组治疗前血清性激素FSH(促卵泡成熟素)、LH(促黄体生成素)、E2(雌二醇)、T(睾酮)检测情况比较,治疗前血清性激素FSH (mIU/ml)、LH (mIU/ml)、PRL (ng/ml)、E2(ng/ml)、T(nmol/L)两组比较,差异无统计学意义。两组治疗前有45例进行了妇科检查,未发现有合并其他的疾病。
     经过可比性比较后,两组患者的主要症状、病程、年龄、基础体温、妇科检查、病情、血清性激素等方面,均无显著性统计学差异。两组具有可比性。
     两组患者的中医证候总疗效比较显示有统计学差异(等级资料的秩和检验,P<0.05)。治疗组疗效优于对照组。两组患者治疗后的基础体温改善情况相比较,有统计学的差异(P<0.05)。其中,治疗组有14人BBT恢复正常,复常率75.0%,对照组有10人BBT恢复正常,复常率60.0%。两组复常率比较,经卡方检验,差异有统计学意义(P<0.05)。两组治疗前后血清性激素FSH(促卵泡成熟素)、LH(促黄体生成素)、PRL(泌乳素)、E2(雌二醇)、T(睾酮)检测改变情况,两组治疗前比较,差异无统计学意义;两组组内比较,治疗前、后血清性激素有统计学差异;而治疗后比较,差异无统计学意义。两组治疗后的安全性,与治疗前比较没有显著性差异。两组治疗疗期均未出现不良反应。
     结论
     中医周期疗法治疗月经后期的临床疗效显著,能有效治疗月经后期,改善卵巢功能,两组治疗后血清FSH(促卵泡成熟素)显著下降,E2(雌二醇)水平提高,治疗组有14人BBT恢复正常,复常率75.0%,对照组有10人BBT恢复正常,复常率60.0%。两组复常率比较,差异有统计学意义(P<0.05)。中医周期疗法具有良好的调经及整体调节作用,治疗组疗效优于对照组,临床应用安全,有推广价值。
Objective
     This randomized controlled clinical trial intends to discuss the clinical effect of Traditional Chinese Medicine cyclic therapy (CT for short) on treating Menstruation delay, and provide scientific basic for the clinical application of it.
     Methods
     The objects in January2011to November2011in Taiwan of traditional Chinese medicine clinics late menstruation patients. Are the clinic patients. Clinical study design using randomized controlled experiment method, the participants will be qualified to:the ratio of distribution to treatment with a control group. Each group of45patients. Looking at an object can be in hospital and clinic patients, outpatient cases shall be strictly controlled variable factors. Cases using simple random method group. Specific randomized allocation methods clinical study by researchers through the operation SAS (statistical analysis system) software that random Numbers, and made into random distribution CARDS, add the envelope seal, the envelope with the same serial number card serial number. Qualified into test cases, according to the into the order of, to open the same envelope number, according to the provisions of the envelope card group for treatment. Random number table according to the requirements to be saved. The control group therapy methods:the pure Chinese herbal medicine treatment method, the principle for liver and kidney function, raise blood to regulate the menstrual function. Based on free and unfettered scattered and party. Drug composition:radix10grams, angelica10grams, the root of herbaceous peony10grams, white atractylodes10grams, poria cocos10grams, dodder12grams, renewal12grams, broken containing10grams, sweet with10grams, mint5g, roasted liquorice5grams. Along with the card use:with blood and astragalus, dangshen hand; And phlegmy wet block adds the sprouting, dried tangerine or orange peel, cangzhu; And cold empty adds the cinnamon, with the sheep. Fry the potion take a daily agent, morning and evening each, from menstrual cycle fifth day began to use, to the menstrual cramps for a period of treatment. The treatment group:ChuFu the traditional Chinese medicine with cycle economy by the treatment, a periodic therapy as follows:(1) the1, with the late party (left to pills and four things tonga minus):cultivated land, medlar, radix morindae officinalis, every10g, BaiFang12g, yam, angelica, dogberry, danshen, poria cocos every15g, dodder30g.7agent.(2) with oviposit period2party (abital yan Pope tonga minus): cultivated land, medlar, peachseed every10g, faeries spleen, danshen every12g, raspberry, CheQianZi, each15g semen wei son.7agent.(3) in the early3party (two fairy decoction and eight Jane tonga minus):angelica, tuckahoe, danshen every15g, largehead atractylodes rhizome, JiXieTeng each30g, the sweet, faeries spleen with all12g, radix morindae officinalis,10g.7agent.(4) period with4party (biochemical tonga minus):angelica24g, river xiong, nut, every10g beef shanks, motherwort, danshen every15g, the sweet with12g, liquorice6g.7agent. Fry the potion take a daily agent, morning and evening each, a menstrual cycles for a period of treatment. During the tests, shall not use the other healing drug therapy. A menstrual cycles for a period of treatment, total view:three treatment was. Each group before and after treatment according to the requirements in to fill out the observation table, after treatment for outcome. Watch project:clinical symptoms:menstrual cycle after wrong and menstrual quantity, color, a qualitative change, fundamental temperature changes, along with the change of the symptoms, the change of the tongue veins. Adverse reaction:record the whole body and local adverse reactions. Clinical outcome:curative effect index=[(before treatment after a treatment integral points) make before treatment;*100%points. Well:after treatment, the integral reduce)95%, menstrual cycles and menstrual quantity, color, mass are back to normal, fundamental temperature is duplex, other symptoms disappeared, withdrawal of three menstrual cycle without recurrence after, or pregnancy. Powerfully:after treatment, the integral reduce)70%, menstrual cycle after wrong7to10days, the rest of the symptoms disappeared or loss. Effective:after treatment,30%more points lower, menstrual cycles>10days after wrong, but has significantly shortened, the rest of the symptom is reduced. Invalid:after treatment, the integral is reduced to before treatment of integral<30%, menstruation still wrong, no obvious shorten, other symptoms without the change. The ZhouXiaoGuo evaluation standard:well: menstrual cycle back to its original state, stopped taking the drug after three menstrual cycle without recurrence. Powerfully:menstrual cycles seven to10days after the wrong, the marking down two grades, not to reach zero. Effective: menstrual cycles>10days after the wrong, the marking down a level, not to reach zero. Invalid:menstrual cycles are still wrong, without significantly shortened, score no decline. Fundamental temperature curative effect evaluation standard:well:fundamental temperature single phase or not by typical dual phase into a duplex. Effective:fundamental temperature by a single not typical dual phase. Invalid:fundamental temperature without significantly improved determination. After the clinical research, clinical material with Epi Data3.01software in statistical analysis. In two groups of clinical treatment effect, the total clinical symptoms and signs efficacy analysis and comparison of the statistics, and finally an objective evaluation of clinical curative effect and its safety. Statistical methods: classification material with2inspection, level with two sample data comparison Wilcoxon rank and inspection (correct), two sample mean differences with more t test or Wilcoxon rank and inspection, compared with before and after their matching t test or Wilcoxon matching rank and inspection. The statistical analysis SPSS17.0statistical software, statistical graphics using Graphd Prism4.03draw.
     Results
     The study participants were qualified to90. The treatment group in45cases; The control group in45cases; All for the clinic patients. Two groups of age composition more, the difference was not statistically significant (P>2inspection,0.05). Two groups of average age composition more, the difference was not statistically significant (P>0.05, t test). Hint two groups are comparable age. The treatment group course the shortest five months, the longest six years; The control group course the shortest4months, the longest5years. Two groups of course is, the difference was not statistically significant. Two groups of age at menarche comparison, the difference was not statistically significant. Two groups of illness after Wilcoxon rank and inspection, no statistical significance difference. Two groups of patients with symptoms of traditional Chinese medicine total score is, the difference was not statistically significant. Comparable. Two groups of patients before treatment after menstruation wrong, scanty periods, the dark purple color with piece, menstrual period of lubricious weak, thin waist sour abdominal pain and so on TCM symptoms comparison, no statistically significant difference between the difference, with comparability. The two groups before treatment situation is more fundamental temperature, the difference was not statistically significant. The two groups before treatment serum sex hormones ESH(follicle-stimulating mature grain), LH (luteinizing), E2(estradiol), T (testosterone) test the situation is more, before treatment serum sex hormones FSH (mlU/ml), LH (mlU/ml), PRL (ng/ml), E2(ng/ml), T (nmol/L) two groups of comparisons, the difference was not statistically significant. The two groups before treatment have45examples of gynecological examination, not found combined other diseases.
     The treatments two groups comparable testing results show that the two groups age, duration, illness, basic body temperature, the main symptoms of serum sex hormones, gynecology inspection comparison, there are no significant differences between the significance, indicating that the two groups of comparable.
     Two groups of traditional Chinese medical syndrome is the total curative effect, the difference was statistically significant (rank material the rank of and examine, P<0.05). The curative effect of treatment group was better than control. The two groups before and after treatment total score more symptoms, the t test, two groups before and after treatment were total score more symptoms very significant difference (P<0.01), between the two groups before treatment total score is no significant difference (P>0.05), after1.reatment, the total score more symptoms very significant difference (P<0.01). Two groups of the week is curative effect, the difference was statistically significant. The curative effect of treatment group was better than control. Two groups of menstrual wrong, menstrual quantity is little, after the dark purple color with piece, menstrual period of lubricious weak, thin waist sour abdominal pain and so on TCM symptoms is efficient, the chi-square test, the (?)reatment group the clinical symptoms improved more, the difference was statistically significant (P<0.05); The same symptoms compared between groups, the treatment group in improving after menstruation wrong, scanty periods with the symptoms such as compared with a statistically significant (P<0.05).
     The two groups after treating fundamental temperature improved (healed: fundamental temperature single phase or not by typical dual phase into a duplex, effectively:fundamental temperature by a single not typical dual phase; invalid:fundamental temperature was obviously improved. No) Comparison, two groups after treating fundamental temperature is improved, the difference was statistically significant (P<0.05). The two groups after treating fundamental temperature comparison, the difference was statistically significant (P<0.05). Among them, the group has14people BBT back to normal, after often rate%, group of10people BBT back to normal, after often rate%. Two groups of complex rate quite often, the chi-square test, the difference was statistically significant (P<0.05). Two groups before and after treatment serum sex hormones FSH (follicle-stimulating mature grain), LH (luteinizing), PRL (prolactin), E2(estradiol), T (testosterone) change detection, the two groups before treatment more, the difference was not statistically significant. The treatment group and control is in the way, a statistically significant difference were. The two groups after treating comparison, the difference was not statistically significant. Two groups after treatment three conventional, liver and kidney function, electrocardiogram safety index such as testing, the results compared with before treatment without change. Two groups of treatment cure period all did not appear adverse reaction symptoms. Conclusion
     Free and unfettered wulingsan and combination therapy menstrual cycle period of clinical curative effect is distinct, can be effectively treated the late period, and can significantly improve the clinical symptoms, his own good adjustment of the menstrual cycle and overall adjustment function, the curative effect of treatment group was better than control. Two groups of treatment cure period all did not appear adverse reaction symptoms. Clinical application security, a popular value.
     CT can treat Menstruation, delay and ameliorate the correlate symptom through its good effect of adjusting menstrual cycle and regulating the body as a wholel and it's safe in clinical application.
引文
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