国产氨磺必利与丙咪嗪治疗迟滞性抑郁症的临床对照研究

目的探讨国产氨磺必利治疗迟滞性抑郁症的疗效和安全性。方法将162例迟滞性抑郁患者随机分为观察组(国产氨磺必利)和对照组(丙咪嗪),治疗12周后对疗效、不良反应发生率、治疗依从性及随访1年复发率等数据进行组间比较及统计学分析。结果观察组研究对象的痊愈率和总有效率分别为39.0%和91.4%与对照组的38.3%和88.9%进行组间比较,观察组具有一定优势,但差异无统计学意义(P>0.05);随访1年复发率的比较中,观察组优于对照组,且差异有统计学意义(P<0.05);观察组研究对象的不良发应率为14.8%,低于对照组的23.5%,且差异有统计学意义(P<0.05);在治疗依从性的比较中,观察组显著高于对照组,且差异有统计学意义(P<0.05)。结论国产氨磺必利在迟滞性抑郁症的治疗中具有疗效显著,安全性高,复发率低,治疗依从性高等优势,具有重要的临床价值,适于临床推广使用。     

Weight gain and antipsychotics: a drug safety review

Introduction: Second-generation antipsychotics (SGAs) are widely used in several psychiatric disease entities and exert to a different extent a risk for antipsychotic-induced weight gain (AIWG). As AIWG is associated with an increase in metabolic syndrome or cardiovascular events, knowledge of these risks is crucial for further monitoring and the initiation of counteractive measures.

Areas covered: We searched PubMed and Web of Sciences for randomized-controlled trials and naturalistic observational studies published between 2010 and 2014 with sample sizes exceeding 100, including all marketed SGAs apart from zotepine, and providing data on weight increase. We also summarized relevant systematic reviews and meta-analyses of head-to-head comparisons.

Expert opinion: Recently published data still support the hierarchical ranking of SGAs already proposed in previous reviews ranking clozapine and olanzapine as having the highest risk, followed by amisulpride, asenapine, iloperidone, paliperidone, quetiapine, risperidone and sertindole in the middle, and aripiprazole, lurasidone and ziprasidone with the lowest risk. Number needed to harm varied considerably in our meta-analysis. Younger patients and patients with a lower baseline body mass index are most vulnerable. The greatest amount of weight gain occurs within the first weeks of treatment. AIWG occurs in all diagnostic groups and is also common in treatment with first-generation antipsychotics; therefore, awareness of this adverse event is essential for anyone prescribing antipsychotics.     

氨磺必利与奥氮平治疗女性精神分裂症对照研究

目的：探讨氨磺必利与奥氮平治疗女性精神分裂症的临床疗效和安全性。方法将50例女性精神分裂症患者随机分为两组,研究组口服氨磺必利治疗,对照组口服奥氮平治疗,观察6周。于治疗前后采用阳性与阴性症状量表评定临床疗效,副反应量表评定不良反应。结果治疗2周末起两组阳性与阴性症状量表总分及各因子分均较治疗前呈持续性下降（ P＜0.05或0.01）,治疗6周末研究组显效率59.1％、有效率81.8％,对照组分别为65.2％、86.9％,两组比较差异无显著性（P＞0．05）。两组总体不良反应发生率比较差异无显著性（P＞0．05）,但不良反应表现形式有所不同。结论氨磺必利治疗女性精神分裂症疗效显著且与奥氮平相当,安全性高,依从性好。     

Amisulpride versus moclobemide in treatment of clozapine-induced hypersalivation

Abstract

Objectives. Previous publications demonstrated substitute benzamides as effective agents in treatment of clozapine-induced sialorrhea (CIS). The aim of this study was to compare efficacy of amisulpride and moclobemide (both from the substitute benzamide group) in controlling, or at least minimizing, CIS. Methods. The study was designed as a 6-week, two-center, fixed-dose, comparison study of 400 mg/day of amisulpride versus 300 mg/day of moclobemide as an adjunctive treatment in 53 schizophrenia and schizoaffective disorder patients (diagnosed according to DSM-IV) suffering from CIS. The patients were treated with each medication during 2 weeks, followed by a washout period of 2 weeks. Primary outcome measures included the reduction in the five-point Nocturnal Hypersalivation Rating Scale (NHRS). Secondary outcomes included the Positive and Negative Syndrome Scale (PANSS), Manic State Assessment Scale, and Extrapyramidal Symptom Rating Scale (ESRS). Results. Both amisulpride and moclobemide were very effective in reducing CIS. Almost 74% of patients treated with amisulpride and 83% of patients treated with moclobemide showed some level of improvement on NHRS. Only in one patient treated with amisulpride, CIS worsened. Conclusions. Both medications were safe and effective as treatment of CIS. Although moclobemide exceeded amisulpride in antisalivation activity, treatment of CIS with amisulpride leads to improvement in psychotic symptoms.     

2019—2022年漯河市中心医院西城分院抗精神病药的使用情况分析

目的 分析漯河市中心医院西城分院2019—2022年抗精神病药物的用药情况,为临床合理用药提供参考。方法 采用回顾性研究方法,对漯河市中心医院西城分院2019—2022年抗精神病药物的销售金额、用药频度（DDDs）、排序比（B/A）和日均费用（DDC）进行统计分析。结果 抗精神病药物的销售金额先增长后下降,非典型抗精神病药物销售金额占比始终较高;DDDs呈逐年上涨趋势,阿立哌唑和奥氮平一直占据销售金额和DDDs的前2位;DDC值变化较大,奥氮平、氨磺必利等高价品种的DDC值下降明显,而一些低价品种DDC则略有上涨;氨磺必利、奥氮平和阿立哌唑的B/A值变动较大,2022年所有抗精神病药物B/A值均接近1。结论 该院抗精神病药的使用情况较为合理,临床治疗以疗效好、不良反应少的非典型抗精神病药为主,特别是阿立哌唑和奥氮平,使用频度最高。氨磺必利和喹硫平用药频度增幅明显。     

高效液相色谱法测定人血浆中氨磺必利的浓度

目的：建立测定人血浆中氨磺必利浓度的高效液相色谱法。方法：以Diamonsil^TM C18（150mm×4．6mm，5μm）为色谱柱，流动相为0．03mol·L^-1磷酸二氢钾（调pH6．4）-乙腈（82：18），流速为1．0mL·min^-1，柱温40℃，检测波长为275mm。以醋酸乙酯-二氯甲烷（80：20）为提取剂。结果：氨磺必利1000．0，400．0，10．0μg·L^-1 3种质量浓度平均回收率分别为97．63％，98．71％，100．29％，日内、日间差RSD均低于8％（n=5）；分析方法的最低检测浓度为10．0μg·L^-1；线性范围10．0～1000．0μg·L^-1。回归方程C=136．03 F-3．25，r=0．9996（n=9）。结论：本法灵敏、准确、简单、快速，可用于临床血药浓度监测和药动学研究。     

Amisulpride augmentation of clozapine: an open non-randomized study in patients with schizophrenia partially responsive to clozapine

OBJECTIVE: Treatment options are very limited for individuals with schizophrenia resistant to clozapine. We tested the hypothesis that amisulpride augmentation would lead to an improvement in these patients. METHOD: This was an open non-randomized study. Thirty-three patients with sub-optimal response to clozapine were commenced on amisulpride in addition to clozapine. Clinical status was evaluated at baseline, 3 and 6 months using the Positive And Negative Syndrome Scale (PANSS), Scale for the Assessment of Negative Symptoms (SANS), Global Assessment Scale (GAS), Calgary Depression Scale, Calgary Anxiety Scale and various side effect rating scales. RESULTS: Twenty-eight subjects completed 6 months treatment on clozapine and amisulpride. There was a statistically significant improvement in the mean scores for PANSS, SANS and GAS at follow-up and no significant changes in side effect ratings. CONCLUSION: Co-administration of amisulpride, in a group of patients partially or non-responsive to clozapine, may lead to a substantial improvement in positive and negative symptoms, without worsening the side effect burden.     

氨磺必利治疗首次发病的精神分裂症患者的随机对照研究

目的:比较氨磺必利及利培酮对首次发病的精神分裂症患者疗效及糖脂代谢的影响。方法:采用随机双盲法将86例首发精神分裂症患者分为研究组和对照组,每组43例;分别给予氨磺必利和利培酮治疗8周。治疗前后进行阳性和阴性症状量表(PANSS)和治疗中出现的症状量表(TESS)评分;测量体质量指数(BMI)、空腹血糖(FPG)、口服糖耐量实验2 h血糖(2h PG)、血清胰岛素(FINS)、胰岛素抵抗指数(HOMA-IR)、高密度脂蛋白(HDL)、三酰甘油(TG)、总胆固醇(TC)。结果:治疗后两组PANSS评分明显下降(P均0.05),两组间PANSS评分及临床总有效率差异无统计学意义;研究组不良反应发生率(25.6%)明显低于对照组(62.8%)(P0.05);研究组治疗前后糖脂代谢指标(BMI、FPG、2h PG、FINS、HOMA-IR、HDL、TG和TC)比较差异无统计学意义;对照组BMI、FPG、2h PG、FINS、HOMA-IR、TG和TC水平较治疗前及研究组明显增高(P0.05或P0.001)。结论:氨磺必利对首发精神分裂症患者的疗效与利培酮相似,不良反应少,短期治疗不影响患者的糖脂代谢。