| ObjectiveThis research observes the clinical effect of the therapy of soothing the liver and invigorating the spleen to treat Hyperpro-lactinemia (HPRL) and observes the effect of Tiaojing Yiru Decoction on plasma PRL before and after treatment. It provides certain clinical base for selecting safer and more reliable Chinese Medicine compound for the treatment of HPRL. The author hopes it will lay foundation for the research of mechanism.MethodsProspective study is conducted according to the Chinese Medicine and Western Medicine clinical data (clinical features, etiology classification, lab examination, radiographic inspection and treatment process) of patients who comfort to the inclusion criteria of HPRL (serum PRL>25μg/L) collected between January2009to January2011in Hong Chang TCM Clinic in Taiwan.60patients aged between18to42are randomly classified into two groups with30in each group. The treatment Group patients take one dose of self-prescribed Tiaojing Yiru Decoction a day with half dose in the morning and half in the evening and are administered warm. The Control Group patients take2.5mg of Bromocriptine tablets orally once a day (continuing during menstrual period) for a month as a treatment course. Chinese Medicine Syndrome Scale in combination with index examination results is adopted to conduct clinical observation for HPRL treatment.Results1. After treatment, the TCM syndrome curative effect total effective rates of the Treatment Group and the Control Group are93.33%and76.67%respectively. Two groups'TCM syndrome total curative effect degree comparisons show significant difference (P<0.05). There's significant difference in comparing two groups'TCM syndrome curative effect and the Treatment Group is superior to the Control Group.2. After treatment, comparison of two groups'improvement situation of symptoms like infrequent menstruation, distension in the hypochondriac region, soreness and weakness of waist and knees shows no significant difference (P>0.05). This shows two groups'therapies have equivalent curative effect for the syndrome mentioned above.3. After treatment, comparison of two groups'improvement situation of symptoms like breast distending pain shows significant difference (P<0.05).4. After treatment, the intergroup difference and difference within groups before and after treatment of serum PRL level in two groups have statistical significance (P<0.05).5. The intergroup difference and difference within groups before and after treatment of serum FSH level in two groups have statistical significance (P <0.05).6. After treatment, the intergroup difference and difference within groups before and after treatment of serum LH level in two groups have statistical significance (P<0.05). There's no statistical significance in the intergroup difference before and after treatment (P>0.05)7. There's no statistical significance in the intergroup difference of serum E2level after treatment (P>0.05). The intergroup difference and difference within groups before and after treatment of serum E2level in two groups have statistical significance (P<0.05).8. There's no statistical significance in the intergroup difference of T level after treatment (P>0.05). The intergroup difference and difference within groups before and after treatment of T level in two groups have statistical significance (P<0.05).9. There's no statistical significance in the intergroup difference and difference within groups before and after treatment of P level after treatment (P>0.05)10. There's statistical significance in the intergroup difference and difference within groups before and after treatment of serum TSH level after treatment (P<0.05). There's no significance in the intergroup difference before and after treatment (P>0.05). 11. After treatment, comparing the disappearance rates of symptoms and other body signs like breast distending pain, the author finds significant difference (P<0.05). Comparing the disappearance rates of symptoms and other body signs like soreness and weakness of waists and knees, distension in the hypochondriac region, galactorrhea, irritability, etc., the author finds no significant difference (P>0.05). Safety test indicated those with normal stool, blood, urine, liver and kidney function and electrocardiogram results don't have abnormal changes after treatment which demonstrates the clinical application security.Conclusion1. In this research, the self-prescribed Tiaojing Yiru Decoction has better Chinese Medicine syndrome curative effect than Bromocriptine tablets in the treatment of HPRL.2. In this research, the self-prescribed Tiaojing Yiru Decoction has better effect in relieving breast distending pain than Bromocriptine tablets.3. In this research, the self-prescribed Tiaojing Yiru Decoction has better effect in lowering patients'PRL, FSH, LH and TSH level than Bromocriptine tablets. |