经前安片治疗经前期综合征（肝郁气滞证）的临床观察
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摘要
经前期综合征(premenstrual syndrome,PMS),是一组反复发生在经前,影响妇女日常生活和工作,涉及躯体和精神(情感、行为)两方面的症候群。中医古籍中无此病名,有关论述散见于“经行诸症”中。现代中医妇科学将其归属于“月经前后诸症”范畴。
本文分两部分:第一部分为文献综述,总结了历代医家对“经行诸症”的认识,并回顾了近10年来经前期综合征的研究进展,其中重点回顾了现代医学对其病因病机的研究进展以及中医药治疗的研究进展。第二部分为临床观察,观察经前安片治疗经前期综合征(肝郁气滞证)的临床疗效,为经前安片的临床应用提供科学依据。
本临床观察共选择门诊确诊为经前期综合征(肝郁气滞证)的患者87例,采用随机分组、双盲双模拟对照的方法,分为经前安片治疗组66例,逍遥丸对照组21例,于经前14天开始服药,服至月经来潮即停药,3个月经周期为一个疗程。
结果表明:(1)经前安片治疗组愈显率68.18%,总有效率100%;逍遥丸对照组愈显率52.38%,总有效率100%。两组临床疗效经统计学分析无显著性差异(P>0.05),提示经前安片与逍遥丸疗效相同,是治疗经前期综合征(肝郁气滞证)的有效药物;(2)两组病例中医单项症状疗效比较均无显著性差异(P>0.05),治疗组中医单项症状评分在治疗前后有极显著性差异(P<0.01),提示经前安片能有效治疗烦躁易怒、抑郁悲伤、胸胁胀痛、小腹胀痛、乳房胀痛、头痛及肢体肿胀等临床症状与体征,且疗效与逍遥丸相同;(3)两组87例病例经治后黄体期血中雌二醇水平、孕激素水平及雌孕激素比例较疗前均无显著性差异(P>0.05),而催乳素水平较疗前下降,有显著性差异(P<0.05),提示催乳素水平升高可能是经前期综合征(肝郁气滞证)的病因之一,而经前安片有调整催乳素水平的趋势。
Objective:To evaluate the efficacy and safety of Jingqianan tablet of treating premenstrual syndrome (PMS) in clinical trail, and to supply scientific evidences for the clinical usage of Jingqianan tablet. Methods:Random, double blind and double simulation and control method was adopted in this study. 87 cases of patients of PMS which had been diagnosed in our outpatient clinic were chosen and divided into the treatment group (Jingqianan tablet, n=66), and the control group (Xiaoyao pill, n=21). Both groups started about 14 days before menstrual period and ended until menses. A course contained three menstrual cycles. To observe the changes of clinical symptoms, sexual hormones and safety between the two groups and to compare each group between pretreatment and post-treatment. Results:(l)For 87 cases with the method, clinical cure rate and notable curative effect rate of the treatment group were 68.18%, the total rate of curative effect was 100%; there were no significant difference compared with the control group(P>0.05). (2)The treatment group could obviously ameliorate the correlate clinical symptoms (P<0.01), but there were no significant difference compared with the control group (P>0.05). (3)There were no significant difference between pretreatment and post-treatment in the level of E2, P, E2/P of the total 87 cases (P>0.05), but there was significant difference in the level of PRL (P<0.05). This showed Jingqianan tablet could regulate the level of PRL. (4) The toxic and adverse drug reaction was not observed. Conclusion:Jingqianan tablet is effective and safe in treatment of the liver qi invasion of PMS.
本文分两部分:第一部分为文献综述,总结了历代医家对“经行诸症”的认识,并回顾了近10年来经前期综合征的研究进展,其中重点回顾了现代医学对其病因病机的研究进展以及中医药治疗的研究进展。第二部分为临床观察,观察经前安片治疗经前期综合征(肝郁气滞证)的临床疗效,为经前安片的临床应用提供科学依据。
本临床观察共选择门诊确诊为经前期综合征(肝郁气滞证)的患者87例,采用随机分组、双盲双模拟对照的方法,分为经前安片治疗组66例,逍遥丸对照组21例,于经前14天开始服药,服至月经来潮即停药,3个月经周期为一个疗程。
结果表明:(1)经前安片治疗组愈显率68.18%,总有效率100%;逍遥丸对照组愈显率52.38%,总有效率100%。两组临床疗效经统计学分析无显著性差异(P>0.05),提示经前安片与逍遥丸疗效相同,是治疗经前期综合征(肝郁气滞证)的有效药物;(2)两组病例中医单项症状疗效比较均无显著性差异(P>0.05),治疗组中医单项症状评分在治疗前后有极显著性差异(P<0.01),提示经前安片能有效治疗烦躁易怒、抑郁悲伤、胸胁胀痛、小腹胀痛、乳房胀痛、头痛及肢体肿胀等临床症状与体征,且疗效与逍遥丸相同;(3)两组87例病例经治后黄体期血中雌二醇水平、孕激素水平及雌孕激素比例较疗前均无显著性差异(P>0.05),而催乳素水平较疗前下降,有显著性差异(P<0.05),提示催乳素水平升高可能是经前期综合征(肝郁气滞证)的病因之一,而经前安片有调整催乳素水平的趋势。
Objective:To evaluate the efficacy and safety of Jingqianan tablet of treating premenstrual syndrome (PMS) in clinical trail, and to supply scientific evidences for the clinical usage of Jingqianan tablet. Methods:Random, double blind and double simulation and control method was adopted in this study. 87 cases of patients of PMS which had been diagnosed in our outpatient clinic were chosen and divided into the treatment group (Jingqianan tablet, n=66), and the control group (Xiaoyao pill, n=21). Both groups started about 14 days before menstrual period and ended until menses. A course contained three menstrual cycles. To observe the changes of clinical symptoms, sexual hormones and safety between the two groups and to compare each group between pretreatment and post-treatment. Results:(l)For 87 cases with the method, clinical cure rate and notable curative effect rate of the treatment group were 68.18%, the total rate of curative effect was 100%; there were no significant difference compared with the control group(P>0.05). (2)The treatment group could obviously ameliorate the correlate clinical symptoms (P<0.01), but there were no significant difference compared with the control group (P>0.05). (3)There were no significant difference between pretreatment and post-treatment in the level of E2, P, E2/P of the total 87 cases (P>0.05), but there was significant difference in the level of PRL (P<0.05). This showed Jingqianan tablet could regulate the level of PRL. (4) The toxic and adverse drug reaction was not observed. Conclusion:Jingqianan tablet is effective and safe in treatment of the liver qi invasion of PMS.
引文
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