Effect of modified Shaoyao Gancao decoction on hyperprolactinemia caused by amisulpride / 中国基层医药

ABSTRACT

Objective:To investigate the clinical efficacy and safety of modified Shaoyao Gancao decoction in the treatment of hyperprolactinemia caused by amisulpride. Methods:Ninety patients with hyperprolactinemia caused by amisulpride who received treatment in Kangci Hospital from June 2018 to October 2019 were included in this study. They were randomly divided into the placebo control, control and observation groups ( n = 30/group). The placebo control group was treated with the decoction with the taste and color (without drug ingredients) similar to that of modified Shaoyao Gancao decoction. The control group was treated with Shaoyao Gancao decoction. The observation group was treated with modified Shaoyao Gancao decoction. All patients were treated for 8 weeks. Clinical efficacy, serum prolactin level and Positive and Negative Syndrome Scale score before and after treatment, Treatment Emergent Symptom Scale score after treatment, glucose and lipid metabolism, liver and kidney function before and after treatment were compared among the three groups. Results:The effective rate in the placebo control, control and observation groups was 90.0% (27/30), 96.7% (29/30) and 100.0% (30/30), respectively, and the difference among the three groups was statistically significant (χ 2 = 7.027, P < 0.05). After treatment, serum prolactin level in the observation group [(48.2 ± 15.7) μg/L] was significantly lower than that in the control group [(52.5 ± 13.7) μg/L] and placebo control group [(57.7 ± 16.9) μg/L, t = 7.134, 7.034, both P < 0.05]. After treatment, Positive and Negative Syndrome Scale score in the observation group [(51.02 ± 3.98) points] was significantly lower than that in the control group [(54.07 ± 4.19) points] and placebo control group [(58.13 ± 4.24) points, t = 5.813, 6.317, both P < 0.05]. After treatment, Treatment Emergent Symptom Scale score in the observation group [(5.2 ± 1.3) points] was significantly higher than that in the control group [(4.9 ± 1.4) points] and placebo control group [(4.4 ± 1.2) points, t = 7.011, 7.231, both P < 0.05]. After treatment, blood glucose, low-density lipoprotein cholesterol, triglyceride, total cholesterol, alanine aminotransferase, aspartate aminotransferase levels in the observation group were significantly lower than those in the placebo control and control groups (all P < 0.05). Serum level of high-density lipoprotein cholesterol in the observation group was significantly higher than that in the placebo control and control groups (both P < 0.05). Conclusion:Modified Shaoyao Gancao decoction is highly effective in the treatment of hyperprolactinemia caused by amisulpride. It can reduce serum prolactin level and has good safety.