Adjunctive Aripiprazole Treatment for Risperidone-Induced Hyperprolactinemia: An 8-Week Randomized, Open-Label, Comparative Clinical Trial.
Adjunctive Aripiprazole Treatment for Risperidone-Induced Hyperprolactinemia: An 8-Week Randomized, Open-Label, Comparative Clinical Trial.
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阿立哌唑辅助治疗利培酮诱发的高催乳素血症：一项为期 8 周的随机、开放标签、比较临床试验
DOI：
10.1371/journal.pone.0139717
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发表时间：
2015
期刊：
影响因子：
3.7
通讯作者：
Lv L
中科院分区：
文献类型：
--
作者：
Zhao J;Song X;Ai X;Gu X;Huang G;Li X;Pang L;Ding M;Ding S;Lv L
目的评价阿立哌唑辅助治疗精神分裂症伴利培酮性高泌乳素血症的疗效和安全性。方法将服用稳定剂量利培酮的113例患者按1:1的比例随机分为辅助阿立哌唑治疗（10 mg/d）组（阿立哌唑组）和不辅助阿立哌唑治疗组（对照组），疗程8周。采用阳性和阴性症状量表（PANSS）测量精神分裂症症状。评分量表和安全性评估（RSESE、BARS、UKU）分别在基线和第4周和第8周进行。在基线和第2、4、6和8周测定血清催乳素水平。在基线和第4周和第8周再次测定代谢参数。结果本研究共纳入113例患者，107例患者完成研究（阿立哌唑组54例，对照组53例）。与对照组相比，阿立哌唑组panss -总分在第4周（P = 0.003）和第8周（P = 0.007）显著降低。与对照组相比，阿立哌唑组panss阴性评分在第4周（P = 0.005）和第8周也显著降低（P< 0.001）。与对照组相比，阿立哌唑组血清催乳素水平在第2周（P< 0.001）、第4周（P< 0.001）、第6周（P< 0.001）和第8周（P< 0.001）均显著降低。各组在第4周和第8周的空腹血糖、总胆固醇、甘油三酯和高密度脂蛋白的变化，除低密度脂蛋白外，均无显著差异。两组患者不良反应发生率无显著差异。结论辅助阿立哌唑治疗可降低利培酮所致高催乳素血症精神分裂症患者血清催乳素水平，改善阴性症状。试验注册chictr.org ChiCTR-IOR-15006278
Objective The present study aimed to evaluate the efficacy and safety of adjunctive aripiprazole treatment in schizophrenia patients with risperidone-induced hyperprolactinemia. Methods One hundred and thirteen patients who were receiving a stable dose of risperidone were randomly assigned to either adjunctive aripiprazole treatment (10 mg/day) (aripiprazole group) or no additional treatment (control group) at a 1:1 ratio for 8 weeks. Schizophrenia symptoms were measured using the Positive and Negative Syndrome Scale (PANSS). Rating scales and safety assessments (RSESE, BARS, UKU) were performed at baseline and at weeks 4 and 8. Serum levels of prolactin were determined at baseline and at weeks 2, 4, 6 and 8. Metabolic parameters were determined at baseline and again at weeks 4 and 8. Results One hundred and thirteen patients were enrolled in this study, and 107 patients completed the study (54 in the aripiprazole group, and 53 in the control group). PANSS-total scores in the aripiprazole group decreased significantly at week 4 (P = 0.003) and week 8 (P = 0.007) compared with the control group. PANSS-negative scores in the aripiprazole group also decreased significantly at week 4 (P = 0.005) and week 8 (P< 0.001) compared with the control group. Serum levels of prolactin in the aripiprazole group decreased significantly at week 2 (P< 0.001), week 4 (P< 0.001), week 6 (P< 0.001) and week 8 (P< 0.001) compared with the control group. There were no significant differences in changes of Fasting Plasma Glucose, Total cholesterol, Triglycerides and High Density Lipoprotein within each group at week 4 and 8 execpt low density lipoproteins. There was no significant difference in the incidence of adverse reactions between the two groups. Conclusions Adjunctive aripiprazole treatment may be beneficial in reducing serum levels of prolactin and improving negative symptoms in schizophrenia patients with risperidone-induced hyperprolactinemia. Trial Registration chictr.org ChiCTR-IOR-15006278