| Objective:According to the methods of clinical scientific research,by observing the clinical efficacy of different doses of Peony-Glycyrrhiza Decoction in the treatment of risperidone-induced hyperprolactinemia,we observed the changes of prolactin level and the improvement of Traditional Chinese Medicine(TCM)symptoms before and after treatment,to assess whether it was safe and reliable,hoping for further study of Peony-Glycyrrhiza Decoction in the treatment of risperidone-induced by hyperprolactinemia mechanism to provide clinical basis,and broaden the new ideas of TCM prevention-research for antipsychotic-drugs-induced adverse reactions.Methods:According the clinical diagnostic criteria,through the screening of hospitalized patient in line with ICD-10 mental and behavioral disorders classification of schizophrenia diagnostic criteria in the Second People’s Hospital of Hunan Province during February 2016 to February2017,collected hyperprolactinemia(serum PRL> 29.2ng/ml)patients who were caused by Risperidone treatment in 1 to 2 weeks,and in line with TCM clinical dialectical with fire derived from stagnation of liver-QI type,in patients with TCM and Western medicine clinical data.Inclusion of age 18~45(Including 18 and 45 years-old),a total of 120 female patients,according to the principle of randomization,they were divided into four groups,as followed(white peony 90 g,Licorice 30g)group,(white peony 60 g,Licorice 20g)group,(white peony 30 g,Licorice 10g)group,no Chinese medicine intervention group,30 cases in each group.Peony-Glycyrrhiza Decoction treatment group in the treatment of risperidone plus Peony-Glycyrrhiza Decoction,1 day,decoction 100 ml,early morning and evening warm service in 2 times;The blank control group was treated with risperidone only.Short-term observation time was 6 weeks,long-term observation time was 12 weeks.The clinical efficacy and safety of hyperprolactinemia were evaluated by serum prolactin,TCM syndrome quantification score and related laboratory test.Results:(1)In 6 weeks observation(n=107),the total effective rate of TCM symptoms in the high-dose,medium-dose and low dose group and the control group were 88.9%,78.57%,48.15% and 40.00%.There was significant difference between the high-dose group and the low-dose group,the difference between the high-dose group and the control group was statistically significant(P<0.01).High-dose and middle-dose groups were significantly better than those without Chinese medicine intervention group,while the high-dose group was superior to the low-dose group.(2)In 12 weeks follow-up observation(n=86),the total effective TCM symptoms in the high-dose,medium-dose and low dose group and the control group were 96.00%,80.00%,57.89% and 47.06%.Compared with the control group,there was significant difference between the high-dose group and the low-dose group,the difference was statistically significant(P<0.01).High-dose and middle-dose groups were significantly better than control group,while the high-dose group was superior to the low-dose group.(3)In 6w observation(n =107),four groups of prolactin values were compared within the group,SG 93 group at 6w-end compared with baseline,2w-end,4w-end(P<0.001),4w-end compared with 2w-end(P<0.05),and there were significant difference between them(P<0.05),but the difference was not significant between 4w-end and 6w-end(P>0.05).There was no significant difference between the SG31 group and the control group at 6w-end and 2w-end and4w-end(P>0.05),but significantly higher than the baseline level at 4w-end(P<0.05).Comparison between groups,there was significant difference between the SG93 group and the control group at 4w-end and 6w-end(P<0.01),but there was no significant difference between the baseline and 2w-end(P>0.05).There was significant difference between the SG62 and the control group at 2w-end and 6w-end(P<0.05),but it had no significant difference between them at baseline and 4w-end(P>0.05).There was no significant difference between the SG31 and control group,at baseline and 2w-end,4w-end and 6w-end,the difference was not statistically significant(P> 0.05).(4)In 12 w observation(n=107),four groups of prolactin values were compared within the group,SG 93 group at 12w-end compared with baseline,2w-end,4w-end(P<0.001),6w-end compared with baseline,2w-end,4w-end(P<0.05),4w-end compared with baseline,2w-end(P<0.05),and there were significant difference between them.There was significant difference between the SG62 group and the control group at 12w-end and 2w-end and 4w-end(P<0.05),6w-end compared with 2w-end,4w-end(P<0.01),4w-end compared with 2w-end(P<0.05),and there were significant difference between them.There was no significant difference between the SG31 group and the control group at 12w-end and baseline and 6w-end(P<0.05),6w-end compared with 2w-end,4w-end(P>0.05),4w-end compared with baseline and 2w-end(P>0.05),and there were no significant difference between them.Comparison between groups,there was significant difference between the SG93 group and the control group at 12w-end and 6w-end(P<0.01),but there was no significant difference at the baseline,2w-end and 4w-end(P>0.05).There was significant difference between the SG62 and the control group at 12w-end and6w-end(P<0.05),but it had no significant difference between them at baseline and 2w-end,4w-end(P>0.05).There was no significant difference between the SG31 and control group,at baseline,2w-end,4w-end and 6w-end,the difference was not statistically significant(P>0.05).(5)In 6 weeks observation,13 cases came off,completed 107 cases(89.17%),83 cases(77.57%)patients with hyperprolactinemia-related symptoms,the incidence of each group was no significant difference(P>0.05),but the middle-dose and high-dose group effective remission rate was significantly higher than the low-dose group and control group(P<0.05).There were 34cases(71.67%)and 83 cases(96.51%)of patients with hyperprolactinemia.The low-dose,middle-dose and high-dose groups were significantly lower than those in the control group(P<0.05).The low-dose group was also superior to the control group(P<0.05),but still the best in the high-dose group(P<0.001).(6)There were no significant differences in adverse drug reactions between the four groups at 6w-end(P>0.05).The long-term observation showed that the incidence of the control group was significantly higher than that of the other three groups at the end of the 12 th week(P<0.05).(7)Both the 6 weeks(n=107)and 12 weeks(n=86)observation,course of treatment observed that no Chinese medicine intervention group and Peony-Glycyrrhiza Decoction group low-dose intervention group were higher than the high-dose group(P<0.05).The middle-dose and high-dose intervention group showed less shedding rate and better therapeutic compliance.Conclusions:1.In this study,the use of different doses(low-dose,middle-dose and high-dose)Peony-Glycyrrhiza Decoction treatment for hyperprolactinemia caused by risperidone,symptoms of Chinese medicine were better than the control group,effectively improve the high prolactin,the symptoms of hyperlipidemia were optimal for high dose groups.2.In this study,both the 6 weeks(n=107)and 12 weeks(n=86)observation,treatment sample comparison,the high-dose and middle dose group of Peony-Glycyrrhiza Decoction in reducing serum prolactin levels was significantly better than low-dose group and control group,and the high-dose group was the best.3.Peony-Glycyrrhiza Decoction,the use for treatment of hyperprolactinemia was safe and reliable,it did not affect the patient’s psychotic symptoms,and no serious adverse reactions.Which may also improve the other adverse reactions caused by risperidone,improve patient compliance. |
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