经前期综合征辨证论治在现代医学药物治疗中的意义
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摘要
目的：现代医学治疗经前期综合征(Premenstrual Syndrome，PMS)，西药一线药物治疗PMS不分亚型、对抑郁症状改善明显、不良反应多，针对这一问题，依据前期导师将PMS分为肝气逆证、肝气郁证(简称“PMS两证”)，本项研究应用盐酸氟西汀治疗PMS两证，推测该药对PMS肝气郁证疗效显著，旨在证明这一推测，选用一种西药(盐酸氟西汀)治疗PMS的两种中医证型，这将说明中医辨证论治有优势，而现代医学虽有亚型诊断但无亚型用药是临床治疗中亟待解决的问题。
方法：用《PMS现况调查表》和《症状严重程度每日记录表》(Daily Record Of Severity Of Problems，DRSP)筛选出PMS轻、中、重度患者共76例(中度以上患者药物干预)，《MS肝气逆证症状患者自评表》筛选出PMS肝气逆证中度以上患者20例，《PMS肝气郁证症状患者自评表》筛选出PMS肝气郁证中度以上患者20例，肝气逆证组、肝气郁证组均给予盐酸氟西汀胶囊，每次20mg，每日1次，各组均于经前14天开始服用到下次月经来潮为止，连续服药2个月经周期，1个月经周期为1个疗程，观察时间为两个疗程；患者整个疗程分别填写《DRSP》、《PMS肝气逆证症状患者自评表《DRSP》、《PMS肝气郁证症状患者自评表》；观测指标为：PMS治疗前后症状变化(症状积分)，治疗前后5-羟色胺(5-HT)含量变化；统计学处理：统计软件包采用SPSS 11.5录入数据并统计，计量资料采用均数加减标准差((?)±S)表示，自身前后比较采用配对t检验，组间比较采用独立样本t检验或秩和检验，计数资料采用X~2检验，对患者治疗后的评定进行X~2检验，对患者治疗前后的积分进行t检验。
结果：临床疗效判定，氟西汀治疗PMS总有效率为68.75％。治疗后，肝气逆证组：通过DRSP症状积分，肝气逆证组总有效率为41.67％，烦躁易怒症状，肝气逆证组总有效率16.67％，自觉郁闷症状，肝气逆证组总有效率83.33％。通过《PMS肝气逆证症状患者自评表》症状积分，PMS肝气逆证患者症状改善的有小腹胀痛、乳房胀痛、抑郁寡欢(发火后)、疲乏、浮肿、理家热情降低、注意力不集中；治疗后，肝气郁证组：通过DRSP症状积分，肝气郁证组总有效率为85％，烦躁易怒症状，肝气郁证组总有效率10％，自觉郁闷症状，肝气郁证组总有效率95％。通过《PMS肝气郁证症状患者自评表》症状积分，PMS肝气郁证患者症状改善的有情绪低落、胸胁不舒、善太息、头痛、乳房胀痛、少腹胀满、食欲不振、失眠多梦、嗜睡、浮肿、理家热情降低；通过对比治疗前后DRSP总积分，情绪类、躯体类、社会事件类症状积分，盐酸氟西汀治疗PMS肝气郁证组疗效优于肝气逆证组；治疗后比治疗前5—HT含量：肝气逆证组降低，有统计学差异(P＜0.05)。肝气郁证组有升高趋势，但差异无统计学意义(P＞0.05)。
结论：临床研究表明，治疗PMS—线西药盐酸氟西汀用于治疗PMS肝气逆证疗效欠佳(总有效率低于50％)，PMS肝气郁证疗效显著(总有效率高于80％)，从而论证了我们得推测盐酸氟西汀治疗PMS肝气郁证疗效显著；中医辨证论治治疗PMS优于现代医学应用一线西药不分型治疗PMS，且西药的不良反应对患者影响明显，证明在治疗PMS两证中，中医辨证论治优于现代医学的群体化治疗；通过对PMS两证同时给予西药的研究，证明中医辨证论治有优势，而现代医学虽有亚型诊断但无亚型用药是临床治疗中亟待解决的问题。
Objective: The western modern medical treatment is able to clinically differentiate subtypes of the premenstrual syndrome (PMS). Although the first-line drug therapy in the modern western medicine offers effective anti-depression treatment, hitherto there is none subtype-specific drug therapy available for PMS. Moreover, these drug treatments produce various adverse reactions. Our former systemic study of the PMS rooted in the theory of traditional Chinese medicine found that PMS were clinically classified into two subtypes according their symptoms, namely, Liver-qi sthenic symptom complex, and Liver-qi negative symptom complex. The study also found that it was favorable to offer individualized drug therapy according to the subtype of PMS. Therefore, we hypothesized that efficacy of the drug therapy for PMS differs in the two subtypes by using first-line drug treatment. To test the hypothesis, we investigated the effectiveness of the treatment using fluoxetine hydrochloride for the two subtypes of PMS. This study attempt to provide the evidence that indicates the advantages of the traditional Chinese medicine for individualized treatment for PMS over the western medical drug therapy. While it is acknowledged that the modern medicine is capable to differentiate the subtype of PMS in diagnostic, but it offers no differentiated treatments. We argue that it is of importance to find specific drug treatment for the different subtypes of PMS for the future study.
Methods: The patients firstly evaluated by usingand the Daily Record of Severity of Problems (DRSP) . The selected patients were grouped into gentle, moderate, and severe according the severity of their PMS syndrome. The patients with PMS at moderate, severe level normally were with moderate drug intervention) . All the patients then evaluated and subgrouped as liver-qi sthenic symptom complex and liver-qi negative symptom complex by using and . Of all the seventy six patients diagnosed as PMS, twenty were grouped into liver-qi sthenic symptom complex; and twenty were assembled as liver-qi negative symptom complex. All the patients in these two groups suffered moderate to severe PMS. From fourteen days before the menstruation, a fourteen-day of fluoxetine hydrochloride (20 mg, once daily) was given to each patient in both in liver-qi sthenic symptom complex and liver-qi negative symptom complex group. The treatment will last two cycles of menstruations and each menstruate period was considered as one complete treatment cycle. The patients were asked to fill all aforementioned evaluation forms before and after each treatment cycle. The observing indicators: PMS symptoms (symptom score) , and serotonin (5-HT) concentration.
Data analysis: All the data analysis use commercial statistical package (SPSS, USA). The paired t-test was used to examine effectiveness of before and after treatment of individual patient (mean±SD) . Independent sample t-test was used to compare the difference between two groups. For rank data, X~2 test was use to examine the effect of before and after treatment.
Results: The study showed that total efficiency of fluoxetine in the treatment for PMS was 68.75%. The effectiveness of treatment was: Liver-qi sthenic symptom complex: the total efficiency was 41.67% by using DRSP symptom score. The dysphoria irritability symptoms: the total efficiency of 16.67%; consciously depressed symptoms, the total efficiency of 83.33%. Through the symptom score, PMS patients with liver-qi sthenic symptom complex symptoms of abdominal distention and pain, breast pain, depression (after angry) , fatigue, puffiness, lower enthusiasm for house-keeping, and inattention. Liver-qi negative symptom complex: DRSP symptom score, the total efficiency of 85%, the symptoms of irritability, the total efficiency of 10%, consciously depressed symptoms, the total efficiency of 95%. Through the symptom score: depression, and chest uneasy, sighing, headache, breast pain, swell in abdomen, loss of appetite, insomnia dreams, lethargy, puffiness and low enthusiasm for house-keeping; By comparing before and after treatment DRSP total score, emotional category, body type, social events symptoms score, fluoxetine hydrochlonde treatment of PMS with depression: Serotonin levels after treatment in the Liver-qi sthenic symptom complex is significantly lower than that before treatment (P <0.05 ) . The Liver-qi negative symptom complex group had a tendency to increase, but the difference was not statistically significant ( P> 0.05) .
Conclusion : The study showed that the efficacy of treatment using fluoxetine hydrochlonde for Liver-qi sthenic symptom complex Liver-qi sthenic symptom complex is less satisfactory (total efficiency of 50%) than that for Liver-qi negative symptom complex (80% overall efficiency) . This study provided the support for the hypothesis that fluoxetine hydrochloride in the treatment of two subtype of PMS. We concluded that individualized treatment based on traditional Chinese medicine is favorable to the counterpart of modern western medicine in which drug therapy offered none subtype specific treatment. Although western modern medicine provides diagnostic differentiation, it does not offer subtype-specific drug therapy. The future study shall emphasize the need of differentiated, individual-specific treatment.
方法：用《PMS现况调查表》和《症状严重程度每日记录表》(Daily Record Of Severity Of Problems，DRSP)筛选出PMS轻、中、重度患者共76例(中度以上患者药物干预)，《MS肝气逆证症状患者自评表》筛选出PMS肝气逆证中度以上患者20例，《PMS肝气郁证症状患者自评表》筛选出PMS肝气郁证中度以上患者20例，肝气逆证组、肝气郁证组均给予盐酸氟西汀胶囊，每次20mg，每日1次，各组均于经前14天开始服用到下次月经来潮为止，连续服药2个月经周期，1个月经周期为1个疗程，观察时间为两个疗程；患者整个疗程分别填写《DRSP》、《PMS肝气逆证症状患者自评表《DRSP》、《PMS肝气郁证症状患者自评表》；观测指标为：PMS治疗前后症状变化(症状积分)，治疗前后5-羟色胺(5-HT)含量变化；统计学处理：统计软件包采用SPSS 11.5录入数据并统计，计量资料采用均数加减标准差((?)±S)表示，自身前后比较采用配对t检验，组间比较采用独立样本t检验或秩和检验，计数资料采用X~2检验，对患者治疗后的评定进行X~2检验，对患者治疗前后的积分进行t检验。
结果：临床疗效判定，氟西汀治疗PMS总有效率为68.75％。治疗后，肝气逆证组：通过DRSP症状积分，肝气逆证组总有效率为41.67％，烦躁易怒症状，肝气逆证组总有效率16.67％，自觉郁闷症状，肝气逆证组总有效率83.33％。通过《PMS肝气逆证症状患者自评表》症状积分，PMS肝气逆证患者症状改善的有小腹胀痛、乳房胀痛、抑郁寡欢(发火后)、疲乏、浮肿、理家热情降低、注意力不集中；治疗后，肝气郁证组：通过DRSP症状积分，肝气郁证组总有效率为85％，烦躁易怒症状，肝气郁证组总有效率10％，自觉郁闷症状，肝气郁证组总有效率95％。通过《PMS肝气郁证症状患者自评表》症状积分，PMS肝气郁证患者症状改善的有情绪低落、胸胁不舒、善太息、头痛、乳房胀痛、少腹胀满、食欲不振、失眠多梦、嗜睡、浮肿、理家热情降低；通过对比治疗前后DRSP总积分，情绪类、躯体类、社会事件类症状积分，盐酸氟西汀治疗PMS肝气郁证组疗效优于肝气逆证组；治疗后比治疗前5—HT含量：肝气逆证组降低，有统计学差异(P＜0.05)。肝气郁证组有升高趋势，但差异无统计学意义(P＞0.05)。
结论：临床研究表明，治疗PMS—线西药盐酸氟西汀用于治疗PMS肝气逆证疗效欠佳(总有效率低于50％)，PMS肝气郁证疗效显著(总有效率高于80％)，从而论证了我们得推测盐酸氟西汀治疗PMS肝气郁证疗效显著；中医辨证论治治疗PMS优于现代医学应用一线西药不分型治疗PMS，且西药的不良反应对患者影响明显，证明在治疗PMS两证中，中医辨证论治优于现代医学的群体化治疗；通过对PMS两证同时给予西药的研究，证明中医辨证论治有优势，而现代医学虽有亚型诊断但无亚型用药是临床治疗中亟待解决的问题。
Objective: The western modern medical treatment is able to clinically differentiate subtypes of the premenstrual syndrome (PMS). Although the first-line drug therapy in the modern western medicine offers effective anti-depression treatment, hitherto there is none subtype-specific drug therapy available for PMS. Moreover, these drug treatments produce various adverse reactions. Our former systemic study of the PMS rooted in the theory of traditional Chinese medicine found that PMS were clinically classified into two subtypes according their symptoms, namely, Liver-qi sthenic symptom complex, and Liver-qi negative symptom complex. The study also found that it was favorable to offer individualized drug therapy according to the subtype of PMS. Therefore, we hypothesized that efficacy of the drug therapy for PMS differs in the two subtypes by using first-line drug treatment. To test the hypothesis, we investigated the effectiveness of the treatment using fluoxetine hydrochloride for the two subtypes of PMS. This study attempt to provide the evidence that indicates the advantages of the traditional Chinese medicine for individualized treatment for PMS over the western medical drug therapy. While it is acknowledged that the modern medicine is capable to differentiate the subtype of PMS in diagnostic, but it offers no differentiated treatments. We argue that it is of importance to find specific drug treatment for the different subtypes of PMS for the future study.
Methods: The patients firstly evaluated by using
Data analysis: All the data analysis use commercial statistical package (SPSS, USA). The paired t-test was used to examine effectiveness of before and after treatment of individual patient (mean±SD) . Independent sample t-test was used to compare the difference between two groups. For rank data, X~2 test was use to examine the effect of before and after treatment.
Results: The study showed that total efficiency of fluoxetine in the treatment for PMS was 68.75%. The effectiveness of treatment was: Liver-qi sthenic symptom complex: the total efficiency was 41.67% by using DRSP symptom score. The dysphoria irritability symptoms: the total efficiency of 16.67%; consciously depressed symptoms, the total efficiency of 83.33%. Through the
Conclusion : The study showed that the efficacy of treatment using fluoxetine hydrochlonde for Liver-qi sthenic symptom complex Liver-qi sthenic symptom complex is less satisfactory (total efficiency of 50%) than that for Liver-qi negative symptom complex (80% overall efficiency) . This study provided the support for the hypothesis that fluoxetine hydrochloride in the treatment of two subtype of PMS. We concluded that individualized treatment based on traditional Chinese medicine is favorable to the counterpart of modern western medicine in which drug therapy offered none subtype specific treatment. Although western modern medicine provides diagnostic differentiation, it does not offer subtype-specific drug therapy. The future study shall emphasize the need of differentiated, individual-specific treatment.
引文
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