Clinical effectiveness and safety of gemifloxacin versus cefpodoxime in acute exacerbation of chronic bronchitis: A randomized, controlled trial

Objective:

Acute exacerbation of chronic bronchitis (AECB) is a commonly encountered problem and those suspected to be due to bacterial infections require antibiotic therapy. This randomized, controlled trial was designed to evaluate the effectiveness and safety of gemifloxacin, a new fluoroquinolone, versus cefpodoxime, an oral third-generation cephalosporin, for the treatment of mild to moderately severe cases of AECB.

Materials and Methods:

Adult subjects diagnosed with chronic bronchitis with clinical symptoms suggestive of an Anthonisen type II acute exacerbation (any two of the following criteria – increased dyspnea, cough, sputum purulence) were eligible and those fulfilling the subject selection criteria were randomized to receive either gemifloxacin 320 mg once daily or cefpodoxime 200 mg twice daily orally for 7 days. The primary outcome measure was clinical success rate at day 14 visit and the secondary outcome measures were changes in Clinical Global impression (CGI) scales and incidence of adverse events (AEs). Fifty-two subjects were enrolled: 26 in gemifloxacin group and 24 in the other and 2 were lost to follow-up.

Results:

The clinical success rates were comparable (84.6% in gemifloxacin group versus 83.3% in cefpodoxime group) and no statistically significant difference was observed between the groups. AEs were mild, self-limiting and few (two in gemifloxacin and three in cefpodoxime arm) and tolerability was also good.

Conclusion:

The results of this randomized, single-blind trial demonstrated that a 7-day course of gemifloxacin is therapeutically comparable to cefpodoxime in terms of both clinical effectiveness and safety for the treatment of type II Anthonisen category AECB patients.     

文拉法辛缓释剂和帕罗西汀治疗抑郁症随机对照研究

目的:比较文拉法辛缓释剂和帕罗西汀治疗抑郁症的疗效及安全性。方法:80例住院抑郁症病人随机分为文拉法辛组和帕罗西汀组,疗程8 wk,用汉密尔顿抑郁量表(HAMD),临床疗效总体评定量表(CGI)和不良反应症状量表(TESS)在基线及治疗后wk 1、2、4、8末进行评定。结果:治疗1 wk文拉法辛组HAMD评分与帕罗西汀组比较有显著差异(P<0.05),治疗8 wk末2组减分值分别为14±s 4和14±4,2组治疗前后比较差异均有非常显著意义(P<0.01),但2组间比较差异无显著意义(P>0.05)。文拉法辛组不良反应发生率为20%,帕罗西汀组为20%,2组间比较差异无显著意义(P>0.05)。结论:文拉法辛与帕罗西汀对抑郁症病人的疗效相当,而文拉法辛缓释剂起效快于帕罗西汀,2药不良反应有所不同,但均较轻,安全性好。     

依那西普治疗活动性类风湿关节炎的安全性和有效性

目的：研究注射用重组人Ⅱ型肿瘤坏死因子受体：抗体融合蛋白（依那西普，etanercept，rhTNF：Fc）对活动性类风湿关节炎（RA）患者的疗效及安全性。方法：本研究为标签开放研究。30例活动期RA患者随机分为试验组和对照组，每组15例。试验组在每周口服甲氨蝶呤（MTX）10～15mg基础上联合应用依那西普，每周皮下注射2次，每次25mg。对照组口服相同剂量的MTX。疗程均12周。疗效采用美国风湿病学会（ACR）核心标准评定。结果：治疗6周后，试验组和对照组的ACR20比例分别为42．8％和21．4％（P〈0．001），ACR50缓解比例为14．3％和0％（P〈0．001）。治疗12周后，试验组和对照组的ACR20比例分别为71．4％和50．0％（P=0．003），ACR50缓解比例为42．9％和0％（P〈0．001）。试验组主要不良反应是注射部位局部反应。结论：MTX联用依那西普比单用MTX治疗RA起效快、疗效肯定、安全性好。     

文拉法辛联合艾司西酞普兰治疗老年焦虑症的临床效果及安全性研究

目的 探讨文拉法辛联合艾司西酞普兰治疗老年焦虑症的临床疗效及安全性。方法 选取2015年5月-2018年5月青海省第三人民医院收治的120例老年焦虑症患者,根据其入院顺序随机分为两组,每组各60例,对照组患者给予艾司西酞普兰治疗,初始剂量5 mg/d,后根据患者病情进行调整,剂量控制在10~20 mg/d,每日1次;观察组患者给予文拉法辛联合艾司西酞普兰治疗,初始剂量75 mg/d,后根据患者病情进行调整,最高用量控制在200 mg/d,每日1次。连续治疗1个月。比较两组的治疗效果、汉密尔顿焦虑量表（HAMA）评分及不良反应发生率。结果 观察组治疗总有效率为95.00%,显著高于对照组的81.67%（P<0.05）。治疗后两组HAMA评分均显著低于治疗前（P<0.05）,且观察组显著低于对照组（P<0.05）。两组治疗期间口干、恶心呕吐、便秘、头晕等不良反应发生率无显著差异。结论 文拉法辛联合艾司西酞普兰治疗老年焦虑症的疗效显著,可有效缓解患者焦虑症状,且安全性较好。     

A pilot controlled trial of bupropion XL versus escitalopram in generalized anxiety disorder

To compare the efficacy and safety of bupropion XL (150 to 300 mg/day) with the selective serotonin reuptake inhibitor escitalopram (10 to 20 mg/day) in outpatients diagnosed with generalized anxiety disorder (GAD). Methods: Twenty-four participants with GAD between 18 and 64 years enrolled in a 12-week, double-blind, randomized trial. The primary efficacy measures were the Clinical Global Impression of Improvement (CGI-I) and the Hamilton Anxiety Rating Scale (HARS). Results: Bupropion XL demonstrated comparable anxiolytic efficacy to escitalopram in outpatients with GAD. Both treatments were well-tolerated. Conclusion: Findings from this pilot project suggest that bupropion XL may be useful in treating GAD. These preliminary results warrant further research to explore the use of bupropion XL in the treatment of GAD.     

Paliperidone ER versus risperidone for neurocognitive function in patients with schizophrenia: a randomized, open-label, controlled trial

This study aims to determine the effectiveness of paliperidone extended release (ER) on cognitive function in patients with schizophrenia in comparison with risperidone. This was a 12-week, randomized, open-label study on schizophrenia patients who were receiving risperidone. The patients were randomized to a risperidone-continuation group or a paliperidone-switch group. The primary outcome measure was neurocognitive function, which was measured using a computerized battery. Secondary efficacy measures included the Positive and Negative Syndrome Scale, Social and Occupational Functioning Scale, and Calgary Depression Scale for Schizophrenia. In total, 58 patients participated in this trial. Improvements in recall after an interference phase in the verbal learning test were significantly greater in the paliperidone-switch than in the risperidone-continuation group. No significant differences in changes were observed in the other six neurocognitive domains measured. Improvements in the Social and Occupational Functioning Scale were significantly greater in the paliperidone ER-switch group than in the risperidone-continuation group. In other efficacy outcome measures, no significant differences were observed between the two drugs. Paliperidone ER had a side-effect profile similar to that of risperidone, including metabolic problems and prolactin-related adverse events. In conclusion, switching from risperidone to paliperidone ER may lead to additional cognitive and social functional improvements.     

A randomized,double-blind,placebo-controlled study of escitalopram in patients with social anxiety disorder in Japan

Objective This randomized, double-blind placebo-controlled study compared the efficacy and tolerability of escitalopram (10 and 20?mg/day) in Japanese patients with social anxiety disorder (SAD).

Research design and methods Patients aged 18–64 years with a primary diagnosis of DSM-IV-TR defined SAD, a Liebowitz Social Anxiety Scale Japanese version (LSAS-J) total score ≥60 and a Clinical Global Impression–Severity (CGI-S) score ≥4 at baseline were randomly assigned (1:1:1) to placebo, escitalopram 10?mg or escitalopram 20?mg. The primary endpoint was change from baseline to Week 12 in the LSAS-J total score for both escitalopram 10?mg and 20?mg versus placebo (ANCOVA, FAS, LOCF), using a hierarchical testing procedure. Pre-specified secondary endpoints included LSAS-J sensitivity analyses.

Clinical trial registration This study has the www.japic.or.jp identifier: JapicCTI-121842.

Results For the primary efficacy endpoint, the difference from placebo in the LSAS-J was ?3.9 (p?=?0.089) for escitalopram 10?mg. Since the superiority of escitalopram 10?mg over placebo was not confirmed, an analysis without multiplicity adjustment was made, which showed a difference for escitalopram 20?mg versus placebo of ?9.8 (p?<?0.001). In pre-specified sensitivity analyses, the difference versus placebo was ?4.9 (p?=?0.035) (ANCOVA, FAS, OC) and ?5.0 (p?=?0.028) (MMRM, FAS) (escitalopram 10?mg) and ?10.1 (p?<?0.001) (ANCOVA, FAS, OC) and ?10.6 (p?<?0.001) (MMRM, FAS) (escitalopram 20?mg). Common adverse events (incidence ≥5% and significantly different from placebo) were somnolence, nausea and ejaculation disorder.

Conclusion Escitalopram was efficacious, safe and well tolerated by patients with SAD in Japan. Study limitations are discussed including patient characteristics.     

Effects of escitalopram on stress-related relapses in women with multiple sclerosis: An open-label,randomized, controlled,one-year follow-up study

A growing body of evidence supports the association between Stressful Life Events (SLEs) and increased risk for relapse in Multiple Sclerosis (MS). In this open-label, randomized, controlled, one-year prospective study we investigated the effects of escitalopram on stress-related relapses in 48 women with relapsing–remitting MS. Patients were randomly assigned either to receive escitalopram 10 mg/day (e-group, N = 24) or to continue with treatment as usual, as a control group (c-group, N = 24). SLEs were documented weekly in self-report diaries and were classified afterwards as short- or long-term depending on their psychological impact as this was subjectively felt by the patient. The cumulative risk for relapse was 2.9 times higher for controls than for escitalopram-treated patients (95% CI = 1.7–5.1, p < 0.001) and it was influenced only by long-term SLEs. In the e-group only 3 or more long-term SLEs were associated with a significant increase of the risk of a relapse during the following 4 weeks, and this risk was 4 times lower compared to the c-group. Our study shows preliminary evidence that escitalopram may constitute an effective and well-tolerated treatment option for the prevention of stress-related relapses in women with MS.     

The effectiveness and safety of adjunctive aripiprazole in Taiwanese patients with antidepressant-refractory major depressive disorder: a prospective, open-label trial

There is currently no published clinical trial on the safety and effectiveness of aripiprazole in Taiwanese patients with treatment-refractory major depressive disorder. We were interested in determining the applicability of current recommended doses of aripiprazole as an adjunct to antidepressant therapy in this population. We conducted a prospective, open-label nonrandomized, 4-week flexibly dosed (2.5-5 mg/d) trial with aripiprazole augmentation in 9 Taiwanese patients who had a history of nonresponse to at least 2 adequate courses of antidepressant therapy with different types of antidepressants. The primary end point for clinical effectiveness was mean change in the 17-item Hamilton Rating Scale for Depression at the end of the 4-week trial. Secondary end points for clinical effectiveness included mean change in Beck Depression Inventory and Beck Anxiety Inventory scores. The Systematic Assessment of Treatment Emergent Events-General Inquiry was used to assess adverse effects. All patients completed the trial and responded to treatment; the remission rate was 77.8%. The mean daily dose of adjunctive aripiprazole was 4.2 mg. Common treatment-emergent adverse events included insomnia and sedation (33.3%) and akathisia (22.2%). We found high effectiveness despite a lower mean daily dose of adjunctive aripiprazole (4.2 mg) when compared with previously reported findings; however, we also observed a higher frequency of treatment-emergent adverse effects. Additional studies are required to ascertain whether there are ethnic differences in the pharmacokinetics and/or pharmacodynamics of aripiprazole in treatment-refractory depression.     

A randomized,controlled, dose-ranging trial of sertindole in patients with schizophrenia

Sertindole is a novel antipsychotic agent with high selectivity for the mesolimbic dopaminergic pathway and nanomolar affinities for dopamine D₂, serotonin 5-HT₂, and norepinephrine NE₁ receptors. This 40-day randomized, placebo-controlled, dose-ranging multicenter study was designed to assess the effect of sertindole on previously neuroleptic-responsive, hospitalized schizophrenic patients (n=205). Sertindole doses began at 4 mg/day and were increased to 8, 12, or 20 mg/day, depending on randomization. Efficacy measures included the Positive and Negative Syndrome Scale (PANSS), Brief Psychiatric Rating Scale (BPRS), and Clinical Global Impression (CGI). Extrapyramidal symptoms (EPS) were assessed by movement rating scales, EPS-related adverse events, and use of anti-EPS medications. A dose-related improvement was observed for PANSS, BPRS, and CGI, with statistically significant mean differences (P<0.05) between placebo and 20-mg/day sertindole (decreases from baseline of –5.8 versus –16.9 for PANSS, –4.8 versus –10.4 for BPRS, respectively). The differences in CGI final improvement score between placebo and 20-mg/day sertindole were 3.8 versus 2.9, respectively. EPS-related events were comparable in the placebo and sertindole groups. In conclusion, sertindole 20 mg/day was effective, well tolerated, and not associated with significant motor system abnormalities.This study was presented as a podium presentation at the 23rd Annual Meeting of the American College of Neuropsychopharmacology, Honolulu, Hawaii, December 13–17, 1993. Members of the Sertindole Study Group are listed under Acknowledgements     

唑尼沙胺添加治疗耐药性癫痫部分性发作的临床疗效和安全性评价

目的 观察在耐药性癫痫部分性发作治疗中,唑尼沙胺作为添加治疗的临床疗效和安全性,探讨唑尼沙胺在耐药性癫痫中的治疗作用.方法 采用随机双盲、安慰剂对照、前瞻性研究方法.耐药性部分性癫痫45例,随机进入试验组与对照组,分别服用唑尼沙胺或安慰剂,观察病人的发作情况及不良反应.结果 试验组有效率17%(4例),显效率17%(4例),完全控制率17%(4例);对照组有效率14%(3例),显效率9%(2例),完全控制率0%(0例);2组比较有显著差异(P＜0.05).试验组不良反应率(75%)高于对照组(50%),但2组比较无显著差异(P＞0.05).结论 唑尼沙胺作为耐药性癫痫的添加治疗,疗效好,且不良反应轻而少.     

Treating depression and substance use: a randomized controlled trial

Few integrated substance use and depression treatments have been developed for delivery in outpatient substance abuse treatment settings. To meet the call for more "transportable" interventions, we conducted a pilot study to test a group cognitive-behavioral therapy (CBT) for depression and substance use that was designed for delivery by outpatient substance abuse treatment counselors. Seventy-three outpatient clients were randomized to usual care enhanced with group CBT or usual care alone and assessed at three time points (baseline and 3 and 6 months postbaseline). Our results demonstrated that the treatment was acceptable and feasible for delivery by substance abuse treatment staff despite challenges with recruiting clients. Both depressive symptoms and substance use were reduced by the intervention but were not significantly different from the control group. These results suggest that further research is warranted to enhance the effectiveness of treatment for co-occurring disorders in these settings.     

Clinical trial: effectiveness of chewing-gum in accelerating capsule endoscopy transit time--a prospective randomized, controlled pilot study

Background  Capsule endoscopy (CE) fails to reach the caecum in approximately 20% of patients. Data suggest that chewing-gum, simulating sham feeding, provokes the cephalic phase of gastrointestinal (GI) motor response and may increase GI motility.
Aim  To determine whether chewing-gum increases the ability of CE reaching the caecum.
Methods  Prospective, randomized, single-blinded controlled trial. Ninety-three consecutive patients were randomized either to use chewing-gum ( n  = 47) or not ( n  = 46). All patients received the identical bowel preparation. Patients chewed one piece of gum for approximately 30 min every 2 h. Two blinded gastroenterologists examined all studies. The number of CE that reached the caecum within 8-h, gastric transit time (GTT) and small bowel transit time (SBTT) were evaluated in all patients.
Results  The CE percentage passed into the caecum was higher in the chewing-gum group compared with those in the other (83.0% vs. 71.7% respectively, P  = 0.19). Both GTT and SBTT were significantly shorter in the chewing-gum vs. control group [40.8 min (interquartile range: 21–61 min) vs. 56.1 min (interquartile range: 22–78 min) ( P  = 0.045) and 229.1 min (interquartile range: 158–282 min) vs. 266.2 min (interquartile range: 204–307 min) ( P  = 0.032) respectively]. Chewing-gum did not adversely affect CE image quality.
Conclusions  Chewing-gum significantly reduces GTT and SBTT during CE. Its use may improve the likelihood of the capsule reaching the caecum without affecting CE image quality.     

艾司西酞普兰与氟西汀治疗抑郁症对照研究

目的比较艾司西酞普兰与氟西汀治疗抑郁症的疗效和安全性。方法随机将77例符合CCMD-3抑郁发作的住院患者分为艾司西酞普兰组和氟西汀组,艾司西酞普兰组剂量10～20mg／d,氟西汀组20～40mg／d,疗程6周。疗效采取汉密尔顿抑郁量表（HAMD）和汉密尔顿焦虑量表（HAMA）评定,不良反应和安全性用TESS和实验室检查评定。结果两组总体疗效相当,艾司西酞普兰组有效率为87．2％,治愈率为48．7％,氟西汀组有效率为86．8％,治愈率4为7．4％,两组疗效比较差异无显著性。但1周末时HAMD评分及减分率两组间差异有显著性,说明艾司西酞普兰起效快;艾司西酞普兰组不良反应发生率明显少于氟西汀组,差异有统计学意义。结论艾司西酞普兰是安全、有效的抗抑郁药。     

阿戈美拉汀与艾司西酞普兰治疗抑郁症有效性与安全性的对照研究

目的：对照分析阿戈美拉汀和艾司西酞普兰治疗抑郁症的临床效果及安全性,为临床治疗提供参考。方法：选取四川省南充精神卫生中心2016年6月至2018年6月期间所收治的150例抑郁症患者作为研究对象,随机分为2组,每组75例,对照组予以艾司西酞普兰治疗,研究组予以阿戈美拉汀治疗,治疗前和每个疗程结束后通过汉密尔顿抑郁量表（HAMD）对治疗效果进行评价,并通过不良反应量表（TESS）对药物不良反应（ADR）进行评价。结果：治疗前2组HAMD评分无显著性差异（P>0.05）,治疗后2组患者HAMD评分较治疗前均有显著改善（P<0.01）;治疗2周末研究组HAMD总评分明显低于对照组（P<0.05）,治疗4周及8周末2组患者的HAMD总评分无明显差异（P>0.05）;治疗期间,实验组TESS评分显著低于对照组（P<0.05）。结论：阿戈美拉汀治疗抑郁症的总显效率与艾司西酞普兰相当,但阿戈美拉汀起效更快、不良反应少,改善睡眠障碍效果更好,是一种安全、有效的抗抑郁药。