安非他酮缓释片治疗抑郁症72例的随机双盲双模拟多中心临床研究

目的:评价安非他酮缓释片治疗抑郁症的有效性和安全性。方法:采用随机双盲双模拟多中心平行对照研究。氟西汀为对照药。试验组和对照组各入组72例,完成6wk治疗的病人共125例,其中试验组61例,对照组64例。试验组用安非他酮缓释片300mg·d-1,对照组用氟西汀20mg·d-1。结果:治疗6wk后,试验组和对照组HAMD的减分值分别为(12±s6)分和(12±6)分,2组的有效率分别为74%和62%,2组相比差异均无统计学意义(P>0.05)。试验组总不良反应发生率为53%,对照组为54%,2组相比差异无统计学意义(P>0.05)。结论:安非他酮缓释片是一种安全、有效的抗抑郁新药。     

盐酸安非他酮缓释片治疗抑郁症的随机、双盲、平行对照的多中心临床研究

目的评价盐酸安非他酮缓释片治疗抑郁症的有效性和安全性,以及治疗该症伴随焦虑的疗效。方法共收集抑郁症患者211例,安非他酮组(治疗组)107例,氟西汀组(对比组)104例。采用多中心、随机、双盲双模拟、阳性药平行对照,剂量固定的研究。受试者分别口服安非他酮片300mg/d或氟西汀片20mg/d,疗程6周。结果治疗6周后,安非他酮组和氟西汀组的HAMD总分减分值分别为(11.75±6.66)、(11.91±5.43)(P=0.843);有效率分别为69.2%、74.0%(P=0.432);疾病严重度和总的进步评分(CGI)相比,P=0.295,0.245;治疗该症伴焦虑的HAMA总分减分评价疗效分别为(8.71±6.15)(、8.75±5.57),P=0.952。以上结果提示各项指标的对比均无统计学差异。不良反应为主要为口干、头昏、恶心。结论盐酸安非他酮缓释片治疗抑郁症和/(或)伴随焦虑的疗效和安全性与盐酸氟西汀相似,认为其可作为一种安全有效的新型抗抑郁药物。     

盐酸安非他酮缓释片治疗焦虑症的临床观察

目的观察盐酸安非他酮缓释片用于焦虑症临床治疗的疗效及不良反应,探讨安非他酮作为新型抗焦虑药物的应用价值。方法选取59例焦虑症患者,按照分段随机法分为安非他酮组(治疗组)30例及氟西汀组(对照组)29例,两组患者分别口服安非他酮片300mg/d及氟西汀片20mg/d,疗程均为6周。分别于治疗前后采用汉密尔顿焦虑量表(HAMA)及临床总体印象量表(CGI)评价两组疗效,并进行统计学分析及安全性分析。结果疗程结束后,治疗组及对照组的临床有效率分别为66.7%、65.6%(P>0.05),HAMA减分值分别为(8.80±5.59)、(8.79±5.31)(P>0.05),临床总体印象降低值分别为(2.60±0.86)、(2.93±1.03)(P>0.05),不良事件发生率分别为63.3%,48.3%(P>0.05),未发生严重不良事件,各项指标差异均无统计学意义。结论盐酸安非他酮用于焦虑症的治疗具有与氟西汀相近的疗效及安全性,可作为一种新型抗焦虑药物用于临床治疗。     

盐酸安非他酮与盐酸氟西汀治疗抑郁症的临床研究

目的比较安非他酮与氟西汀对抑郁症的疗效和安全性。方法将125例抑郁症患者随机分为两组,研究组口服安非他酮治疗,对照组口服氟西汀治疗,均6周一个疗程。研究组63例,男30例,女33例;平均年龄(38.8±12.4)岁,平均病程(15.5±4.9)个月,予安非他酮300～450mg/d,po,tid。对照组62例,男28例,女34例;平均年龄(35.9±11.1)岁,平均病程(14.9±8.6)个月,予氟西汀20～40mg/d,po,qd。结果对抑郁症的治疗,安非他酮组显效率71%,氟西汀组为74%,两组间疗效比较无显著性差异(P>0.05);对伴随焦虑症状的治疗,安非他酮组显效率48%,氟西汀组显效率45%,两组比较无显著性差异(P>0.05)。两组不良反应发生率均较低,且程度较轻微。结论安非他酮与帕罗西汀治疗抑郁症总体疗效相当,能有效治疗抑郁及伴随焦虑症状,且安全性高。     

盐酸安非他酮缓释片治疗抑郁症的Ⅱ期临床研究

目的 评价盐酸安非他酮缓释片治疗轻中度抑郁症的临床疗效和安全性。方法 对符合《CCMD》勘抑郁症诊断标准的66例抑郁症患者进行盐酸安非他酮缓释片和氟西汀的对照研究，其中盐酸安非他酮缓释片组34例（300mg／d），氟西汀组32例（20mg／d），共治疗6周。采用汉密尔顿抑郁量表（HAMD），汉密尔顿焦虑量表（HAMA），临床总体评定量表（CGI）评定临床疗效，副反应量表（Tess）评定不良反应。结果经6w治疗后，盐酸安非他酮缓释片治疗总有效率为76．47％，氟西汀组为75．00％，两组比较。差异无显著性（P〉0．05）。两组的HAMD，HAMA评分治疗前后相比较差异有高度显著性（P〈0．01）。不良反应分析，两组药物不良反应的发生率无显著性差异（P〉0．05），常见的不良反应有恶心、口干、头昏、失眠、出汗、食欲减退、便秘等。结论 盐酸安非他酮缓释片治疗抑郁症安全有效。     

盐酸安非他酮缓释片治疗抑郁症的临床试验

目的:评价国产盐酸安非他酮缓释片治疗抑郁症的有效性和安全性。方法:采用随机、双盲、双模拟、阳性药平行对照研究。48例抑郁症患者随机分为试验组24例与对照组24例,分别口服盐酸安非他酮缓释片300mg·d~(-1)或氟西汀20mg·d~(-1),疗程42d,观察汉密尔顿抑郁量表与临床总体印象量表总分变化及药物不良反应等。结果:两组汉密尔顿抑郁量表评分在治疗结束时较基线均显著减少(P＜0．01);试验组与对照组有效率分别为86．4%与73．9%,差异无显著性(P＞0．05)。试验组常见的不良反应为:恶心呕吐、头昏、口干、食欲减退。结论:盐酸安非他酮缓释片治疗抑郁症安全而有效。     

国产安非他酮缓释片治疗抑郁症的Ⅱ期临床研究

目的:评价安非他酮治疗抑郁症的疗效和安全性。方法:采用随机、双盲、多中心、平行对照研究。共入组抑郁症患者237例,其中试验组119例,对照组118例,分别口服安非他酮150～450 mg·d-1,氟西汀10～30 mg·d-1。疗程均为6周。用汉密尔顿抑郁量表(HAMD)和临床总体印象量表(CGI)评定疗效,药物不良反应量表(TESS)评定安全性。结果:治疗6周后两组患者HAMD评分较基线均显著降低(P<0．05),总有效率安非他酮组70．69％,氟西汀组74．14％。组间差异无显著性(P>0．05)。不良反应发生率安非他酮组41．4％,氟西汀组44．8％,组间差异无显著性(P>0．05)。结论:安非他酮治疗抑郁症安全有效。     

安非他酮与艾司西酞普兰治疗老年期抑郁症的临床疗效及安全性

目的比较安非他酮缓释片与艾司西酞普兰治疗老年期抑郁症的效果及安全性。方法选取2012年4月至2014年11月就诊的97例老年抑郁症患者。分为安非他酮组49例和艾司西酞普兰组48例,分别口服安非他酮缓释片与艾司西酞普兰治疗8周。采用汉密尔顿抑郁量表(HAMD)评定临床疗效,采用大体评定量表(GAS)评定总体功能情况,采用不良反应量表(TESS)评估治疗的安全性。结果安非他酮组43例,艾司西酞普兰组44例完成本研究。与治疗前比较,治疗8周后2组HAMD评分均较治疗前降低(P<0.01),GAS评分均较治疗前增加(P<0.01)。组间比较,治疗8周后2组患者HAMD评分及GAS评分差异均无统计学意义(P>0.05)。安非他酮组显效率(HAMD减分率≥50)为60%,艾司西酞普兰组显效率为59%,差异无统计学意义(P>0.05)。2组患者不良反应发生率差异无统计学意义(P>0.05)。结论安非他酮缓释片与艾司西酞普兰治疗老年期抑郁症均安全有效,2种药物的治疗效果及安全性基本相当。     

安非他酮联用碳酸锂缓释片治疗双相抑郁的对照研究

目的:探讨安非他酮联用碳酸锂缓释片治疗双相抑郁的疗效及安全性。方法:进行8周开放式前瞻性随机对照研究,将78例符合《精神疾病诊断与统计手册》第4版(DSM-IV)双相抑郁诊断标准的住院患者随机分成观察组(安非他酮联用碳酸锂缓释片治疗,n=40)及对照组(单用碳酸锂缓释片治疗,n=38),分别在基线及1、2、4、8周末应用汉密尔顿抑郁量表(HAMD-17)评定疗效,同时应用Bech-Rafaelsen躁狂量表(BRMS)评定转躁情况,用治疗中出现的症状量表(TESS)及实验室检查评定不良反应。结果:8周末两组HAMD总分(8±3,8±4)与基线(24±7,25±8)相比均明显降低(P<0.01),两组间HAMD总分比较差异无统计学意义(P>0.05)。第1、2周末观察组的HAMD总分(21±7,12±5)分别低于对照组(25±8,16±6)(P<0.05)。同时观察组第2周末的有效率(30%)及治愈率(20%)亦明显高于对照组的10.5%、2.6%(P<0.05)。第4、8周末时观察组HAMD总分分别为9±4、8±3,与对照组(9±5,8±4)比较无统计学差异(P>0.05),同时第8周末两组有效率(90%vs89.5%)及治愈率(62.5%vs60.5%)比较亦无统计学差异(P>0.05)。两组间不良反应类似,研究过程中两组均无病例转躁。结论:安非他酮联用碳酸锂缓释片及单用碳酸锂缓释片治疗双相抑郁均安全有效,安非他酮联用碳酸锂缓释片治疗双相抑郁可加快起效速度,同时并不增加转躁风险。     

安非他酮缓释片戒除尼古丁依赖的多中心随机双盲对照试验

目的:评价国产安非他酮缓释片戒除尼古丁依赖的有效性及安全性。方法:多中心、随机、双盲、安慰剂平行对照研究。共入组自愿戒烟者143例,安非他酮组72例与安慰剂组71例。受试者分别口服安非他酮缓释片150～300 mg·d-1或安慰剂,疗程4 wk,观察12 wk。结果:治疗后4,12 wk安非他酮组戒烟率分别为39％,31％,高于安慰剂组(13％,9％),差异有非常显著意义(P<0．01);治疗后1 wk起安非他酮组吸烟量的减少值均大于安慰剂组,差异有非常显著意义(P<0．01)。安非他酮常见不良反应为注意力不集中、乏力、腹部不适等,其发生率高于安慰剂组,差异有显著意义(P<0．05),2组均未发生严重不良反应。结论:国产安非他酮缓释片是一种安全、有一定疗效的戒除尼古丁依赖(烟瘾)的药物。     

A prospective trial of bupropion SR augmentation of partial and non-responders to serotonergic antidepressants

Many patients fail to achieve an adequate response to a given antidepressant trial. The best-studied augmentation agents, lithium and thyroid supplementation are less commonly used. Augmenting antidepressants with bupropion has become an increasingly common strategy in the treatment of resistant depression. Several case reports and 2 open label studies suggest efficacy of this strategy. The purpose of this study is to further examine the utility of bupropion sustained release (SR) augmentation in patients with inadequate response to selective serotonin reuptake inhibitors. Patients who met DSM-IV criteria for major depression and had failed to achieve adequate response to an SSRI were considered for this study. Eligible patients were required to have a score of 16 on the 24-item Hamilton Depression Rating Scale (HDRS). Patients were treated openly for 6 weeks with bupropion SR added to their existing antidepressant. The dose range of bupropion was 150 to 300 mg per day. At each visit, patients were assessed using the Beck Depression Inventory (BDI), the Hamilton Depression Ratings Scale (HDRS), and the Clinical Global Impression (CGI). Twenty-eight patients (12 men, 16 women) entered the study. Twenty-five patients completed the six-week trial. With respect to the clinical benefit of bupropion SR augmentation, 15 out of 28, or 54% of patients, were classified as responders, showing a decrease in their HDRS or BDI scores of 50% or more between baseline and Week 6. This prospective, open-label trial supports the use of bupropion SR in the augmentation of SSRIs and venlafaxine. Placebo controlled trials should be completed to further evaluate the efficacy of this strategy.     

丙戊酸钠缓释片与常规片剂治疗儿童癫痫的疗效比较

目的：比较丙戊酸钠缓释片与其常规片剂治疗小儿癫痫的有效性。方法：92例诊断为癫痫的儿童以随机抽样法分为缓释片组（46例）和常规片剂组（46例）,缓释片组给药剂量为25～30 mg.kg-1.d-1,常规片剂组给药剂量为20～30 mg.kg-1.d-1,32周后观察疗效。结果：经丙戊酸钠治疗后,缓释片组的总有效率（91.3%）明显高于常规片剂组（60.9%）,具有显著性差异（P〈0.05）,且缓释片组不良反应较轻。结论：丙戊酸钠缓释片治疗儿童癫痫疗效明显优于其常规片剂,且不良反应较轻。     

Bupropion: a review of its use in the management of smoking cessation

Sustained release bupropion (amfebutamone) is a non-nicotine agent that is indicated as an aid to smoking cessation. In 2 large well designed clinical trials, sustained release bupropion 300 mg/day (the recommended dose) for 7 or 9 weeks was associated with considerably and significantly higher smoking abstinence rates (continuous abstinence and 7-day point prevalence rates) than placebo during treatment and at follow-up at 6 and 12 months. Point prevalence rates at 12 months in 2 studies were 23.1 and 30.3% with bupropion, whereas values for placebo were 12.4 and 15.6%. Continuous abstinence rates at 12 months, available from 1 trial, were 18.4% with bupropion and 5.6% with placebo. Furthermore, bupropion was associated with significantly higher quitting rates than nicotine patch in a comparative study. Combination therapy with bupropion and nicotine patch provided slightly higher abstinence rates than bupropion alone, although differences were not statistically significant. The combination was superior to nicotine patch alone. Data from a preliminary report of long term bupropion treatment (52 weeks) showed that the drug was associated with significantly higher continuous abstinence rates than placebo only to 6 months. However, point prevalence abstinence rates were significantly higher with bupropion than placebo to 18 months. Bupropion 300 mg/day recipients reported nicotine withdrawal symptoms during treatment; however, the symptoms were significantly less severe with bupropion than placebo. Patients receiving bupropion 300 mg/day or bupropion in combination with nicotine patch for smoking cessation generally gained less bodyweight than placebo recipients. The benefits of bupropion for preventing weight gain persisted after the completion of long term, but not short term therapy. Bupropion was well tolerated in clinical trials, and the only adverse events that were significantly more common with bupropion than placebo were insomnia and dry mouth. Data published so far suggest that sustained release bupropion has a low potential for inducing seizures (seizure rate approximately 0.1% in patients with depression). Conclusions: Bupropion is an effective and well tolerated smoking cessation intervention. Further studies with long term follow-up will be useful in determining whether abstinence rates are maintained with bupropion. In addition, clarification of its efficacy in comparison with other therapies used for smoking cessation would help to establish its clinical value. The reduced potential for weight gain with bupropion and the ability to use bupropion in combination with nicotine replacement therapy make the drug a useful treatment option for smoking cessation.     

单硝酸异山梨酯缓释片与缓释胶囊治疗冠心病心绞痛的比较

目的 :比较单硝酸异山梨酯的缓释片与缓释胶囊治疗冠心病心绞痛的疗效。方法 :冠心病心绞痛病人 58例 ,随机分为缓释片组 30例 ,给缓释片60mg ,po ,qd ,共 4wk ;缓释胶囊组 2 8例 ,给缓释胶囊 50mg ,po ,qd ,共 4wk。结果 :缓释片组心绞痛有效率及心电图改善率分别为 93%和 57% ;缓释胶囊组依次为 93%和 61% ,组间比较差别无显著意义 (P >0 .0 5)。 2药不良反应均轻微。结论 :2种单硝酸异山梨酯缓释剂型治疗冠心病心绞痛疗效相近     

Comparative efficacy and safety of bupropion and placebo in the treatment of depression

This was a 4-week, three-center, double-blind, randomized, parallel, placebo-controlled evaluation of the efficacy and safety of bupropion in hospitalized depressed patients. Results from 27 placebo and 48 bupropion-treated patients were analyzed for efficacy and safety. Assessments of efficacy and safety were made at baseline and weekly during the study. Preliminary and secondary measures of efficacy included the Clinical Global Impressions for severity (CGI-S) and improvement (CGI-I) of illness, Hamilton Depression and Hamilton Anxiety Scales, and the Zung Self-Rating Scales for depression and anxiety. Assessments of safety included vital signs, electrocardiogram, clinical laboratory tests, and adverse experiences. Dosages of bupropion were 300-600 mg/day. Results showed that bupropion was significantly (P less than 0.01) more effective than placebo at termination of study on the CGI-S, CGI-I, Hamilton Depression and Hamilton Anxiety Scales. On the Zung Self-Rating Depression and Anxiety Scales, statistical trends favored bupropion at termination of study over placebo (P less than 0.10). Adverse events in the bupropion and placebo groups were minimal with notable absence of sedation and anticholinergic- and cardiovascular-related side effects. We conclude that bupropion was significantly more effective than placebo in treating depression and accompanying anxiety in depressed inpatients.     

盐酸文拉法辛缓释胶囊治疗青少年抑郁症对照研究

目的：评价盐酸文拉法辛缓释胶囊治疗抑郁症的疗效与安全性。方法：采用随机、双盲、双模拟、氟西汀平行对照研究。60例青少年抑郁症患者随机分为盐酸文拉法辛缓释胶囊组30例与氟西汀组30例,分别口服盐酸文拉法辛缓释胶囊150mg/d或氟西汀20mg/d,疗程8周。以汉密尔顿抑郁量表（HAMD）和临床疗效总评量表（CGI）为评估临床疗效的工具。结果：两组HAMD评分在治疗结束时较基线均显著减少（P〈0.01）;盐酸文拉法辛缓释胶囊组与氟西汀组有效率分别为70.0%与65.5%,差异无统计学意义（P〉0.05）。取Λ=0.1,α=0.05进行等效性检验,u=1.97,P〈0.05。盐酸文拉法辛缓释胶囊组常见的不良反应为恶心、头痛、失眠和食欲减退,发生率与氟西汀组差异无统计学意义（P〉0.05）。结论：两组药物不良反应发生率无统计学差异,盐酸文拉法辛缓释胶囊治疗青少年抑郁症和氟西汀一样有效。     

羟考酮缓释片治疗中、重度癌痛患者的临床效果

目的 研究羟考酮缓释片治疗中、重度癌痛患者的临床效果.方法 选择我院2013年6月至2014年6月收治的120例癌痛患者作为观察组,其中,中度癌痛患者59例,重度癌痛患者61例,均使用羟考酮缓释片治疗;同时选取使用硫酸吗啡缓释片进行治疗的102例中度和重度癌痛患者为对照组.以患者生活质量评分、镇痛的效果以及不良反应发生率作为指标对药物的效果进行评定.结果 观察组总有效率为89.2％,显著高于对照组的79.4％,差异具有统计学意义（P＜0.05）;中度癌痛患者其总有效率91.8％,显著高于重度癌痛患者的79.7％,差异具有统计学意义（P＜0.05）;经过治疗所有患者的生活质量评分均显著提高（P＜0.05）;与中度癌痛患者相比,重度癌痛患者生存质量评分提高更加显著（P＜0.05）;整个治疗期间所有患者均未发生不良反应.结论 羟考酮缓释片治疗中、重度癌痛患者效果较好,特别是对中度癌痛的患者镇痛效果更好,而且能够有效改善重度癌痛患者的生存质量,值得临床借鉴和进一步推广.     

Review of bupropion for smoking cessation

The advent of bupropion hydrochloride sustained release (Zyban) has heralded a major change in the options available for smoking cessation pharmacotherapy. Bupropion is a selective re-uptake inhibitor of dopamine and noradrenalin which prevents or reduces cravings and other features of nicotine withdrawal. Bupropion is a useful oral and non-nicotine form of pharmacotherapy for smoking cessation. For this review a total of 221 papers were reviewed plus poster presentations. This review examines in detail original clinical trials on efficacy, categorised according to whether they were acute treatment trials in healthy smokers; studies in specific populations such as people with depression, chronic obstructive pulmonary disease (COPD) or cardiovascular disease; or relapse prevention studies. Overall, these studies in varying populations comprising over four thousand subjects, showed bupropion consistently produces a positive effect on smoking cessation outcomes. The evidence highlights the major public health role that bupropion has in smoking cessation. The methodological issues of published clinical trials reporting one year outcomes were examined in detail including: completeness of follow-up; loss to follow-up; intention to treat analysis; blindness of assessment; and validation of smoking status. The review discusses contraindications, adverse effects, dose and overdose, addictive potential, and the role of bupropion in reducing cessation-related weight gain. Bupropion combined with or compared to other pharmacotherapies (nicotine patch; nortriptyline) is considered. Impressive evidence exists for the use of bupropion in smoking cessation among difficult patients who are hard-core smokers such as those with cardiovascular disease, chronic obstructive pulmonary disease (COPD) and depression. Bupropion reduces withdrawal symptoms as well as weight gain and is effective for smoking cessation for people with and without a history of depression or alcoholism. Serious side effects of bupropion use are rare. The major safety issue with bupropion is risk of seizures (estimated at approximately 0.1%) and it should not be prescribed to patients with a current seizure disorder or any history of seizures. In clinical trials of bupropion for smoking cessation no seizures were reported. Allergic reactions occur at a rate of approximately 3% and minor adverse effects are common including dry mouth and insomnia. [Richmond R, Zwar N. Review of bupropion for smoking cessation. Drug Alcohol Rev 2003;22:203 - 220]     

地尔硫缓释片治疗稳定性心绞痛的临床疗效

目的 :观察地尔硫缓释片治疗稳定性心绞痛的疗效和安全性。方法 :72例稳定性心绞痛病人随机分为 2组 ,地尔硫组 37例 ,男性 2 0例 ,女性 17例 ,年龄 5 6a±s13a ,病程 6a± 4a ,给予地尔硫缓释片 90mg ,po ,qd ;氨氯地平组 35例 ,男性19例 ,女性 16例 ,年龄 5 5a± 13a ,病程 6a± 4a ,给予氨氯地平 5mg ,poqd。 2组服药 2wk后如不能控制心绞痛发作可剂量加倍 ,疗程均 6wk。结果 :对心绞痛症状的疗效地尔硫组显效 5 1% ,有效4 1% ,无效 8% ,总有效率 92 % ;氨氯地平组显效5 1% ,有效 4 0 % ,无效 9% ,总有效率 91% (P >0 .0 5 )。对心电图的疗效地尔硫组显效 2 7% ,改善 2 4 % ,无改变 4 9% ,总有效率 5 1% ;氨氯地平组显效 2 6% ,改善 2 6% ,无改变 4 8% ,总有效率5 2 % (P >0 .0 5 )。未发生严重不良反应。结论 :地尔硫缓释片治疗稳定性心绞痛是安全、有效的。     

舍雷肽酶肠溶片黏痰溶解与祛痰疗效的多中心随机双盲对照临床研究

目的:评价国产与进口舍雷肽酶肠溶片治疗痰液黏稠、咳痰困难等症状体征的有效性和安全性。方法:用前瞻性随机双盲双模拟对照多中心试验设计,以进口舍雷肽酶肠溶片为阳性对照药。共入组140例支气管炎、肺炎、支气管哮喘、支气管扩张病人,剔除4例,进入疗效分析136例,其中试验组67例,对照组69例。国产与进口舍雷肽酶肠溶片均为每次1片,tid,饭后用温开水整片吞服。疗程均为14d。结果:治疗结束后,临床总有效率分别为试验组82％,对照组80％,2组对比差异无显著意义(P>O.05)。试验组和对照组不良反应发生率分别为3％和4％。2组比较差异无显著意义(P>0.05)。结论:国产与进口舍雷肽酶肠溶片治疗痰液黏稠均安全、有效。