神曲消食口服液联合乳酸菌素治疗小儿功能性消化不良的临床研究

目的 探讨神曲消食口服液联合乳酸菌素片治疗小儿功能性消化不良的临床疗效。方法 选取2022年4月—2023年6月北京市大兴区人民医院收治的104例功能性消化不良患儿,采用随机数表法将患儿分为对照组（52例）和治疗组（52例）。对照组嚼服乳酸菌素片,患儿＜5岁,0.4 g/次;患儿≥5岁,0.8 g/次,3次/d。治疗组在对照组治疗基础上口服神曲消食口服液,患儿＜5岁,5 mL/次;患儿≥5岁,10 mL/次,3次/d。两组均连续治疗2周。观察两组的临床疗效和中医症状改善时间,比较两组治疗前后功能性消化不良生存质量量表（FDDQL）评分及血清胃动素、神经肽Y水平。结果 治疗后,治疗组总有效率为96.15%,显著高于对照组的84.62%（P＜0.05）。治疗后,治疗组食少纳呆、脘腹痞闷、脘腹胀痛的改善时间均显著短于对照组（P＜0.05）。治疗后,两组FDDQL评分均高于治疗前（P＜0.05）;且治疗组的FDDQL评分高于对照组（P＜0.05）。治疗后,两组胃动素、神经肽Y水平均高于治疗前（P＜0.05）;且治疗后,治疗组胃动素、神经肽Y水平高于对照组（P＜0.05）。结论 神曲消食口服液联合乳酸菌素片治疗小儿功能性消化不良具有较好的治疗效果,可改善患儿的中医症状、生活质量及消化功能,并增加患儿食欲,且无明显不良反应。     

甘露特钠联合多奈哌齐治疗阿尔茨海默病的临床研究

目的 探讨甘露特钠联合多奈哌齐治疗阿尔茨海默病的临床疗效。方法 选取2020年3月—2021年11月在常熟市第二人民医院治疗的82例阿尔茨海默病患者,按照随机数字表法分为对照组（41例）和治疗组（41例）。对照组每日睡前口服盐酸多奈哌齐片,5 mg/次,持续治疗4周后调整剂量,最大剂量10 mg/d。治疗组在对照组基础上口服甘露特纳胶囊,450 mg/次,2次/d。两组患者持续治疗3个月。观察两组患者临床疗效,比较治疗前后两组患者日常生活能力量表（ADL）、简易智力状态检查量表（MMSE）和阿尔茨海默病评定量表–认知量表（ADAS-cog）评分,及血清肠道菌群代谢标志物短链脂肪酸（SCFA）、γ-氨基丁酸（GABA）和苯丙氨酸（Phe）水平。结果 治疗后,治疗组总有效率明显高于对照组（92.68% vs 75.61%,P＜0.05）。治疗后,两组患者ADL评分、MMSE评分均高于治疗前,ADAS-cog评分低于治疗前（P＜0.05）,治疗组患者ADL、MMSE和ADAS-cog评分明显好于对照组（P＜0.05）。治疗后,两组患者血清SCFA和GABA水平高于治疗前,Phe低于治疗前（P＜0.05）,治疗组患者血清SCFA、GABA和Phe水平明显好于对照组（P＜0.05）。结论 甘露特钠联合多奈哌齐可提高阿尔茨海默病患者日常生活能力及智力水平,调节肠道菌群代谢标志物平衡,且其安全性较高。     

静灵口服液联合阿立哌唑治疗儿童注意缺陷多动障碍的临床研究

目的 探讨静灵口服液联合阿立哌唑片治疗儿童注意缺陷多动障碍的临床疗效。方法 选取2022年1月-2022年12月秦皇岛市第一医院收治的60例注意缺陷多动障碍患儿,经随机数字表法分为对照组和治疗组,每组各30例。对照组晚上口服阿立哌唑片,初始剂量1片/次,1次/d,用药2周后可以根据患儿的实际疗效和耐受情况逐渐增加药物剂量,最大剂量不超过3片/d。治疗组在对照组基础上口服静灵口服液,1支/次,2次/d。两组患儿均治疗8周。比较两组的治疗效果、症状情况、多动障碍、注意力、血清指标。结果 治疗组总有效率(93.33%)显著高于对照组总有效率(73.33%)(P<0.05)。治疗后,两组患儿注意力缺陷多动障碍评定量表(SNAP-IV)评分、Conners父母症状问卷评分和数字划消试验失误率均显著降低,血清催乳素(PRL)、中枢神经特异蛋白(S100β)、25-羟维生素D水平均显著升高(P<0.05),且治疗组各指标的变化明显优于对照组(P<0.05)。结论 静灵口服液联合阿立哌唑片治疗儿童注意缺陷多动障碍的临床效果显著,可以有效改善患儿的临床症状,提高注意力,调节血清因子。     

健胃消食口服液联合酪酸梭菌活菌散治疗小儿功能性消化不良的临床研究

目的 探讨健胃消食口服液联合酪酸梭菌活菌散治疗小儿功能性消化不良的临床疗效。方法 选取2017年1月—2020年7月南京医科大学附属儿童医院门诊就诊的120例小儿功能性消化不良患儿,按照随机数字表法将所有患儿分为对照组和治疗组,每组各60例。对照组口服酪酸梭菌活菌散,1包/次,3次/d。治疗组在对照组治疗基础上口服健胃消食口服液,10mL/次,2次/d。两组患儿均连续治疗14d。观察两组的临床疗效,比较两组临床症状缓解时间、功能性消化不良生存质量表（FDDQL）评分、血浆胃泌素（GAS）、血浆胃动素（MTL）、血浆P物质（SP）。结果 治疗后,治疗组总有效率98.33%,显著高于对照组的85.00%（P＜0.05）。治疗后,治疗组出现腹胀、厌食、嗳气、反酸改善时间均显著短于对照组（P＜0.05）。治疗后,两组FDDQL评分均较治疗前显著升高（P＜0.05）;治疗后治疗组FDDQL评分高于对照组（P＜0.05）。治疗后,两组患儿GAS、MTL、SP水平均较治疗前显著升高（P＜0.05）;治疗后,治疗组胃肠激素指标水平显著高于对照组（P＜0.05）。结论 健胃消食口服液联合酪酸梭菌活菌散治疗小儿功能性消化不良效果确切,能有效调节患儿胃肠激素水平,更利于患儿生活质量的改善,值得借鉴。     

氟哌噻吨美利曲辛联合复方消化酶治疗功能性消化不良的疗效观察

目的 研究氟哌噻吨美利曲辛联合复方消化酶治疗功能性消化不良的临床疗效。方法 选择2016年1月—2018年1月开封市中心医院的102例功能性消化不良患者作为研究对象,采用抽签法将患者随机分为对照组和观察组,每组各51例。对照组患者在饭后30 min口服复方消化酶胶囊,2粒/次,3次/d。观察组患者在对照组的基础上分别于早晨和中午口服氟哌噻吨美利曲辛片,1片/次,2次/d。两组患者均治疗4周。观察两组患者的临床疗效,同时比较两组治疗前后的汉密尔顿焦虑量表（HAMA）、汉密尔顿抑郁量表（HAMD）和中医症候评分。结果 治疗后,观察组的总有效率为94.12%,明显高于对照组的78.43%（P<0.05）。治疗后,观察组的HAMA和HAMD评分均明显降低（P<0.05）,且观察组HAMA和HAMD评分明显低于对照组（P<0.05）。治疗后,对照组症状评分均明显降低（P<0.05）,观察组各症状评分有所降低,但明显高于对照组（P<0.05）。结论 氟哌噻吨美利曲辛联合复方消化酶能显著提高功能性消化不良的疗效,减轻抑郁、焦虑状况,缓解躯体症状,具有一定的临床推广应用价值。     

艾地苯醌联合奥拉西坦治疗老年阿尔茨海默病的疗效观察

目的 分析艾地苯醌联合奥拉西坦治疗老年阿尔茨海默病患者的临床疗效。方法 选择2016年7月-2018年7月开滦总医院收治的老年阿尔茨海默病患者57例作为研究对象,根据治疗方法差异将患者分为对照组（30例）和观察组（27例）。对照组口服奥拉西坦胶囊,0.8 g/次,3次/d。观察组在对照组基础上口服艾地苯醌片,30 mg/次,3次/d。3个月为1疗程,两组均治疗2个疗程。观察两组患者的临床疗效,同时比较两组治疗前后的蒙特利尔认知评估量表（MoCA）评分、日常生活能力量表（ADL）评分和神经精神科量表（NPI）评分。结果 治疗后,观察组总有效率为85.19%,显著高于对照组的60.00%,两组比较具有统计学意义（P<0.05）。随着治疗时间延长,两组患者MoCA评分均显著提升（P<0.05）,但观察组MoCA评分明显高于同时期对照组（P<0.05）。随着治疗时间延长,两组患者ADL评分均显著降低（P<0.05）,但观察组ADL评分明显低于同时期对照组（P<0.05）。治疗后,观察组患者NPI评分低于治疗前（P<0.05）,且观察组治疗后NPI评分显著低于对照组（P<0.05）。结论 艾地苯醌联合奥拉西坦治疗老年阿尔茨海默病效果显著,且能有效改善患者认知及行为能力,改善精神症状,同时用药安全性较高。     

芪参益气滴丸联合非洛地平治疗冠心病心绞痛的临床研究

目的 探讨芪参益气滴丸联合非洛地平缓释片治疗冠心病心绞痛的临床疗效。方法 选取2022年6月—2023年6月皖南医学院第二附属医院收治的冠心病心绞痛患者90例,依据用药情况分为对照组（45例）和治疗组（45例）。对照组患者口服非洛地平缓释片,5 mg/次,1次/d。在对照组的基础上,治疗组口服芪参益气滴丸,1袋/次,3次/d。两组治疗14 d。观察两组患者临床疗效,比较治疗前后两组患者症状好转时间,及磷酸肌酸酶同工酶（CK-MB）、磷酸肌酸激酶（CK）、乳酸脱氢酶（LDH）水平,6 min步行距离试验量表（6MWT）、精神状态评价量表（MMSE）和全球急性冠状动脉事件注册（GRACE）评分。结果 治疗后,治疗组总有效率为93.33%,明显高于对照组（80.00%,P＜0.05）。治疗后,治疗组症状好转时间均明显早于对照组（P＜0.05）。治疗后,两组患者心肌酶中CK-MB、CK和LDH水平比治疗前明显降低（P＜0.05）,且治疗组明显低于对照组（P＜0.05）。治疗后,两组患者6MWT和MMSE评分明显升高,而GRACE评分明显降低（P＜0.05）,且治疗组6MWT、MMSE评分和GRACE评分明显好于对照组（P＜0.05）。结论 芪参益气滴丸与非洛地平缓释片协同治疗,能较好的对心绞痛症状明显改善,心肌供血能力增强,且有效改善运动耐受力、精神状态,降低预后风险。     

安脑丸联合石杉碱甲治疗脑梗死后血管性痴呆的临床研究

目的 观察安脑丸联合石杉碱甲治疗脑梗死后血管性痴呆的临床效果。方法 选取2018年1月—2019年12月广州市荔湾中心医院接收的脑梗死后血管性痴呆患者100例,根据随机数字表法将所有患者分为对照组和治疗组,每组各50例。对照组口服石杉碱甲片,0.1～0.2 mg/次,2次/d,一日量最多不超过0.45 mg。治疗组在对照组基础上口服安脑丸,3～6 g/次,2次/d。两组疗程为2个月。观察两组的临床疗效,比较两组治疗前后相关量表评分、血清学指标的变化情况。结果 治疗后,治疗组总有效率是80.00%,较对照组的62.00%显著提高（P＜0.05）。治疗后,两组痴呆简易筛查量表（BSSD）评分、简易智力状态检查量表（MMSE）评分、日常生活能力量表（ADL）评分高于治疗前（P＜0.05）,且治疗组改善优于对照组（P＜0.05）。治疗后,两组脑源性神经营养因子（BDNF）、血管内皮生长因子（VEGF）较治疗前显著升高,而同型半胱氨酸（Hcy）、内皮素-1（ET-1）、超敏C反应蛋白（hs-CRP）较治疗前显著下降（P＜0.05）,且治疗组患者改善优于对照组（P＜0.05）。结论 石杉碱甲联合安脑丸治疗脑梗死后血管性痴呆的疗效较为显著,可有效改善患者的临床症状,可调节BDNF、Hcy、VEGF、ET-1、hs-CRP等实验室指标。     

明目蒺藜丸联合玻璃酸钠滴眼液治疗干眼症的临床研究

目的 探讨明目蒺藜丸联合玻璃酸钠滴眼液治疗干眼症的临床疗效。方法 选取2021年7月—2023年1月在中国人民解放军中部战区总医院诊治的78例干眼症患者，根据用药方案的不同将所有患者分为对照组和治疗组，每组各39例。对照组给予玻璃酸钠滴眼液，1滴/次，3次/d；治疗组在对照组治疗基础上口服明目蒺藜丸，9 g/次，2次/d。两组均治疗8周。观察两组的临床疗效和临床症状改善时间，比较两组治疗前后视功能相关生命质量量表（NEI-VFQ-25）评分、视功能损害眼病患者生存质量量表（SQOL DVI）评分、眼表疾病量表（OSDI）评分、眼表功能指标、泪液细胞因子的变化情况。结果 治疗后，治疗组的总有效率是97.44%，显著高于对照组的79.49%（P＜0.05）。治疗后，治疗组眼睛干涩感、异物感、疲劳感、畏光、灼烧感改善时间上均显著短于对照组（P＜0.05）。治疗后，两组NEI-VFQ-25评分、SQOL DVI评分均显著升高，而中国干眼问卷量表评分、OSDI量表评分均显著降低（P＜0.05）；治疗后，治疗组患者相关量表评分改善均优于对照组（P＜0.05）。治疗后，两组患者泪膜破裂时间（FBUT）、SⅠt均较治疗前显著升高，而角膜荧光素染色（FL）评分显著降低（P＜0.05）；治疗后，治疗组眼表功能指标改善均优于对照组（P＜0.05）。治疗后，两组泪液中白细胞介素-1β（IL-1β）、白细胞介素-6（IL-6）、肿瘤坏死因子-α（TNF-α）均显著降低，而溶菌酶、表皮生长因子（EGF）、乳铁蛋白（LF）均显著显著升高（P＜0.05）；治疗后，治疗组泪液细胞因子改善均优于对照组（P＜0.05）。结论 明目蒺藜丸联合玻璃酸钠滴眼液治疗干眼症可有效改善临床症状，改善眼表功能及泪液分泌，下调泪液细胞因子水平，提高生活质量，有着良好的临床应用价值。     

芍麻止痉颗粒联合氟哌啶醇治疗儿童抽动症的临床研究

目的 探讨芍麻止痉颗粒联合氟哌啶醇片治疗儿童抽动症的临床疗效。方法 选择2020年7月—2022年7月在北京航天总医院治疗的108例抽动症患儿,依据用药差别分为对照组和治疗组,每组各54例。对照组口服氟哌啶醇片,1 mg/次,3次/d;在对照组基础上,治疗组口服芍麻止痉颗粒,5 g/次,3次/d。两组患者经8周治疗。观察两组患者临床疗效,比较治疗前后两组患者症状改善时间,YGTSS、Yale-Brown、CBCL、Piers-Harris和WISC-Ⅳ量表评分,及血清5-羟色胺（5-HT）、神经元特异性醇化酶（NSE）、γ-氨基丁酸（GABA）、谷氨酸（GLU）和多巴胺（DA）水平。结果 治疗后,治疗组总有效率为98.15%,显著高于对照组（83.33%,P＜0.05）。治疗后,治疗组患儿咧嘴、耸肩、挤眼和伸脖子改善时间明显短于对照组（P＜0.05）。治疗后,两组YGTSS、Yale-Brown和CBCL量表评分明显降低,而Piers-Harris和WISC-Ⅳ量表评分均明显升高（P＜0.05）,并以治疗组改善更明显（P＜0.05）。治疗后,两组血清5-HT、NSE、GLU、DA水平明显降低,而GABA水平明显升高（P＜0.05）,且治疗组改善更明显（P＜0.05）。结论 芍麻止痉颗粒联合氟哌啶醇片治疗儿童抽动症可有效改善患儿症状,促进患儿智力发育,提高自我意识,改善机体神经递质水平。     

小儿智力糖浆联合盐酸哌甲酯片治疗儿童注意缺陷多动障碍的疗效观察

目的探讨小儿智力糖浆联合盐酸哌甲酯片治疗儿童注意缺陷多动障碍的临床疗效。方法选择2012年1月—2014年12月重庆市开县人民医院儿科收治儿童注意缺陷多动障碍患者90例,随机分为对照组和治疗组,每组45例。对照组患者口服盐酸哌甲酯片,2片/次,1次/d。治疗组患者在对照组的治疗基础上口服小儿智力糖浆,10 m L/次,2次/d。3周为1个疗程,全部患者均治疗3个疗程。观察两组的临床疗效,同时比较两组治疗前后Conner行为评定量表各因子评分及不良反应情况。结果治疗后,对照组和治疗组总有效率分别为77.78%、88.89%,两组比较差异具有统计学意义(P0.05)。治疗后,两组患者冲动多动、多动指数、学习问题、品行问题、焦虑、身心问题评分均较较治疗前显著降低,同组治疗前后差异有统计学意义(P0.05);且治疗组治疗后各评分均显著低于对照组,两组比较差异有统计学意义(P0.05)。两组不良反应发生率比较差异无统计学意义。结论小儿智力糖浆联合盐酸哌甲酯片治疗儿童注意缺陷多动障碍,能够显著提高临床疗效,且无严重不良反应,具有一定的临床推广价值。     

Initial deficit and recovery of function after MDMA preexposure in rats

Rationale 3,4-methylenedioxymethamphetamine (MDMA) exposure was reported to result in deficits in serotonergic neurotransmission with concomitant behavioral suppression and tolerance to MDMA. Some data have also suggested that the neurochemical deficits recover over time, raising the question as to whether behavioral suppression would show a similar recovery. Objectives The possibility of recovery of behavioral deficits was examined in the present study. Rats were administered an MDMA pretreatment regimen that was shown to produce numerous serotonergic deficits and behavioral suppression 2 weeks thereafter. The full expression of MDMA-produced hyperactivity was dependent upon serotonergic integrity, therefore, the present study aimed to determine whether MDMA pretreated rats were tolerant to MDMA 2 weeks after exposure. Further, because serotonergic deficits have shown recovery over time, similar behavioral tests were conducted at a later time point to determine whether functional recovery was evident. Methods MDMA-produced hyperactivity was measured at different withdrawal periods (2 and 12 weeks) to determine initial effects and the possibility of recovery of function. Results In saline-pretreated control rats, +/−MDMA (0.0–10.0 mg/kg) produced a dose-dependent increase in locomotor activity. Rats that had received prior exposure to MDMA (4×10 mg/kg MDMA injections administered at 2 h intervals) demonstrated tolerance when the activity was measured 2 weeks after pretreatment. For these rats, there was a downward shift in the dose–effect curve for MDMA-produced hyperactivity. MDMA-produced hyperactivity in rats that were tested 12 weeks after pretreatment was, however, comparable to controls, suggesting recovery of function. Conclusion These data are consistent with the idea that high dose MDMA exposure produces neuroadaptations that exhibit recovery with extended abstinence from the drug.     

托莫西汀与哌甲酯治疗注意缺陷多动障碍患儿的疗效和安全性比较

目的:比较托莫西汀与哌甲酯治疗注意缺陷多动障碍患儿的疗效和安全性。方法:选择我院收治的注意缺陷多动障碍患儿共52例,随机分为托莫西汀组与哌甲酯组各26例,治疗结束后观察两组患儿的治疗有效率、ADHDRS-IV-Parent:Inv评分以及CPRS-R:S评分。结果:托莫西汀组与哌甲酯组的治疗有效率相近。治疗后托莫西汀组与哌甲酯组的ADHDRS-IV-Parent:Inv各项评分均明显下降,与治疗前比较差异均有统计学意义(P<0.05)。治疗后托莫西汀组与哌甲酯组CPRS-R:S评分的分数均明显下降,与治疗前比较差异均有统计学意义(P<0.05)。托莫西汀组的多动分变化值大于哌甲酯组,差异有统计学意义(P<0.05),两组患儿在治疗过程中均未发现严重的药物不良反应。结论:托莫西汀的疗效与哌甲酯相近,都具有良好的安全性,值得临床推广。     

A Postmarketing Clinical Experience Study of Metadate® CD

Summary

Objective:The objective of the study was to investigate the effectiveness and safety of Metadate® CD (methylphenidate HCl, USP) Extended Release Capsules in the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD), in actual clinical practice.

Method:This was a multicenter, open-label, postmarketing study. Eligible patients were aged 6-17 with a diagnosis of ADHD and receiving either no treatment or maintenance treatment with another approved methylphenidate (MPH) product. Metadate® CD was administered once daily for 3 weeks, titrated against reported and observed symptoms. Clinical Global Impression (CGI) scores at Week 3 were used for the primary efficacy evaluation. Patient treatment satisfaction was determined by questionnaire at the final evaluation visit. Safety was assessed through adverse event reporting, laboratory tests and vital sign measurements.

Results: Overall, of the 308 patients in the Intent-To-Treat population, the majority (65%) demonstrated a positive response to Metadate® CD (defined as CGI Global Improvement rating of very much or much improved). In addition, patients previously treated with immediate-release or extended-release tablet formulations of MPH were successfully converted to Metadate® CD at a comparable dose. Most patients (87%) were very satisfied or moderately satisfied with study treatment, and among previously treated patients, 71% rated Metadate® CD as much better or better than their previous MPH treatment. Adverse events were consistent with current FDA-approved product labeling for Metadate® CD.

Conclusions: Metadate® CD is effective and well-tolerated in actual clinical use for ADHD.     

Modulation of dopamine function by glycine in the nucleus accumbens of the brain of the rat

The effects of glycine on the phasic changes in locomotor activity in the rat, caused by a persistent infusion of dopamine (DA) into the nucleus accumbens (ACB) were investigated. Dopamine (25 μg/24 hr), infused into the nucleus accumbens for 13 days, caused hyperactivity, with two peaks occurring on days 3–4 and 9–11. Glycine (12.5 or 25 μg/24 hr) infused into the nucleus accumbens on its own did not alter the locomotor activity, yet when infused at the same time as DA (25 μg/24 hr), glycine (12.5 or 25 μg/24 hr) inhibited the development of the first peak of hyperactivity induced by DA, with no effect on the second peak. A larger dose of glycine (50 μg/24 hr), infused alone, significantly increased locomotor activity, and a combination of this dose with DA (25 μg/24 hr), led to a temporal shift in the response to DA such that the first peak of hyperactivity was delayed to “fuse” with the second peak. The locomotor response to a threshold dose of DA (6.25 μg/24 hr) plus glycine (50 μg/24 hr) was no greater than could be accounted for by the hyperactivity response to glycine alone (50 μg/24 hr). Strychnine (10 μg/24 hr), infused into the nucleus accumbens, produced no alteration in locomotor activity. Similarly, when infused together with DA (25 μg/24 hr), strychnine (10 μg/24 hr) caused no significant alteration in the phasic hyperactivity induced by DA. However, strychnine (10 μg/24 hr), infused together with DA and glycine (25 and 12.5 μg/24 hr respectively), prevented the inhibition by glycine of the first peak of hyperactivity induced by DA. The results indicate that while glycine may not normally exert a tonic modulatory influence on those mechanisms in the nucleus accumbens which regulate locomotor activity, when applied exogenously glycine can partially moderate the locomotor response to DA, through an action on strychnine-sensitive receptors.     

A Phase 3 Placebo-Controlled Trial of Once-Daily 400-mg and 600-mg SPN-812 (Viloxazine Extended-Release) in Adolescents with ADHD

Objectives:Three Phase 3 trials have demonstrated the efficacy and safety of SPN-812 in pediatric subjects with ADHD. Here, we report the results of a fourth trial.Methods:Eligible adolescent subjects (N = 297) were randomized to SPN-812 (400- or 600-mg/day) or placebo. The primary efficacy endpoint was change from baseline (CFB) at end of study (EOS) in the ADHD Rating Scale-5 (ADHD-RS-5) Total score. Statistical analyses included sequential testing for multiple treatment comparisons. Key secondary endpoints included: Clinical Global Impression-Improvement (CGI-I) score at EOS and CFB at EOS in the Conners 3–Parent Short Form (Conners 3–PS) Composite T-score and Weiss Functional Impairment Rating Scale–Parent (WFIRS–P) Total average score.Results:The CFB at EOS ADHD-RS-5 Total score (least square [LS] means ± SE) for 400-mg/day, 600-mg/day SPN-812, and placebo was −18.3 ± 1.36, −16.7 ± 1.39, and –13.2 ± 1.38, respectively. The difference vs. placebo was statistically significant only for the 400-mg/day SPN-812 treatment group (600 mg/day: p = 0.0712; 400 mg/day: p = 0.0082). Neither dose could be considered superior to placebo due to the use of statistical method of sequential testing. Significant improvements were observed on a number of secondary endpoints. SPN-812 was well tolerated at both doses, with <5% discontinuation rate due to adverse events.Conclusions:Treatment with 400- but not 600-mg/day SPN-812 resulted in statistically significant improvement in the primary endpoint. The negative result seen in the 600-mg/day SPN-812 group was likely due to an unusually high placebo response. Safety data were consistent across all doses in the SPN-812 trials.     

Characteristics of tail-tremor induced by nicotine in rats

To characterize the tail-tremor and locomotor hyperactivity induced by repeated nicotine administration, the effects of nicotinic, -adrenergic and dopaminergic blockers were investigated in rats. Daily administration of nicotine (0.5 mg/kg, s.c.) induced tail-tremor from the 4th day, which became more marked in intensity by subsequent administration. Locomotor hyperactivity was also induced by nicotine, which was enhanced by daily administration. The tail-tremor and locomotor hyperactivity induced by repeated nicotine administration were inhibited by mecamylamine (0.1–1 mg/kg, i.p.) but not by hexamethonium (0.5 and 1 mg/kg, i.p.). Clonidine (0.02 and 0.04 mg/kg, i.p.) and prazosin (0.5 and 1 mg/kg, i.p.) reduced tail-tremor more markedly than hyperactivity. However, haloperidol (0.05–0.2 mg/kg, i.p.) and chlorpromazine (1–5 mg/kg, i.p.) reduced hyperactivity more markedly than tail-tremor. These results suggest that nicotine-induced tail-tremor and hyperactivity are due to an increased susceptibility of central nicotinic receptors of nicotine followed by catecholaminergic mechanisms, and that tail-tremor may be more associated with the noradrenergic system than the dopaminergic system. Correspondence to: Y. Gomita at the above address     

沙盘游戏治疗注意缺陷多动障碍儿童的临床价值研究

目的探讨沙盘游戏对注意缺陷多动障碍(ADHD)儿童的治疗价值及临床意义。方法68例ADHD患儿,根据治疗意愿不同分为研究组与对照组,各34例。研究组进行为期12周的沙盘游戏治疗,对照组不接受沙盘游戏治疗。比较两组治疗前后Conners父母症状问卷(PSQ)评分、Achenbach儿童行为量表(CBCL)评分。结果治疗后,对照组品行问题、学习问题、心身障碍、冲动-多动、焦虑、多动指数评分与治疗前比较差异无统计学意义(P>0.05);研究组冲动-多动、焦虑、多动指数评分均低于治疗前,差异有统计学意义(P<0.05);研究组冲动-多动、多动指数评分低于对照组,差异有统计学意义(P<0.05)。治疗后,研究组CBCL总粗分(44.18±8.97)分、社交退缩(2.18±0.88)分、攻击(9.53±8.15)分、违纪(2.24±2.76)分均低于治疗前,且均低于对照组的(50.19±6.53)、(3.13±0.98)、(14.24±8.82)、(4.41±2.93)分,差异有统计学意义(P<0.05)。结论沙盘游戏治疗能改善ADHD儿童的焦虑情绪及注意缺陷、多动冲动等行为,可作为ADHD儿童综合治疗方案的非药物治疗措施。     

脑电生物反馈治疗儿童注意缺陷多动障碍疗效评价及护理指导

目的探讨脑电生物反馈治疗儿童注意缺陷多动障碍（Attention—Deficit-Hyperactivity Disorder,ADHD）疗效及护理指导。方法30例注意缺陷与多动障碍患儿脑电生物反馈治疗1个疗程共20次,采用SNAP-IV量表评价治疗效果。结果治疗后,SNAP—IV量表总分以及注意力因子、多动／冲动因子较治疗前均下降显著（P〈0．01;P〈0．05;P〈0．01）。结论脑电生物反馈治疗疗效确切,家长满意度高,对临床治疗具有一定的指导意义。