文拉法辛与三环类抗抑郁药治疗抑郁症痊愈率的循证医学研究

目的　比较文拉法辛与三环抗抑郁药治疗抑郁症临床痊愈率的差异。方法　应用循证医学的Me-ta分析,采用固定效应模型(fixed effects model,FEM)法对符合标准的16项对照研究文献进行评价。结果　文拉法辛与三环抗抑郁药治疗抑郁症的临床痊愈率不同,差异有显著性(χ2=4.773,df=1,P<0.05);综合的ORs=1.36,95%CI为1.04~1.78。提示文拉法辛治疗抑郁症的临床痊愈率是三环抗抑郁药的 1.36倍。结论　治疗抑郁症,文拉法辛比三环抗抑郁药有更可靠的临床痊愈率。     

文拉法辛与帕罗西汀治疗抑郁症对照研究

目的 比较文拉法辛与帕罗西汀治疗抑郁症的临床疗效和安全性。方法 对48例抑郁症患者随机分为文拉法辛组与帕罗西汀组，治疗6周。治疗前后用汉密尔顿抑郁量表（HAMD）、汉密尔顿焦虑量表（HAMA）和副反应量表（TESS）评定疗效和不良反应。结果 文拉法辛组有效率87．5％，帕罗西汀组有效率83．3％。两组疗效相仿。但在治疗2周末时，文拉法辛组HAMD减分率下降明显（P〈0．05），两组不良反应均较轻微。结论 文拉法辛和帕罗西汀抗抑郁疗效肯定，不良反应轻。     

文拉法辛与米氮平治疗抑郁症的对照研究

目的 评价文拉法辛与米氮平治疗抑郁症的疗效及安全性.方法 将76例抑郁症患者随机分为两组,分别给予文拉法辛和米氮平治疗,疗程8周.用汉密尔顿抑郁量表(HAMD)评定临床疗效,副反应量表(TESS)评定不良反应.结果 文法拉辛显效率76.3%,有效率92.1%,米氮平组为73.7%,89.5%,两组疗效相仿.在治疗2周末时,文法拉辛组减分多于米氮平,差异有显著性.两组不良反应均轻微.结论 文拉法辛和米氮平抗抑郁疗效肯定,不良反应轻.     

国产万拉法新治疗肠易激综合征的初步临床研究

目的 观察国产新药万拉法新对肠易激综合征（IBS）及其伴随的焦虑和抑郁症状的临床治疗效果。方法 选择48例IBS患者,随机分为治疗组和对照组,分别服用万拉法新及硝苯地平进行为期4周的治疗,通过对IBS各项症状的改善率和总体改善率评定观察治疗效果。同时采用Zung编制的抑郁自评量表和焦虑自评量表进行评分观察治疗前后抑郁和焦虑的改善程度。结果 万拉法新对IBS的治疗总体改善率为80％,对照组为52．17％（P＜0．05）。万拉法新治疗前后焦虑和抑郁的改善程度经检验均有统计学意义（P＜0．01）。结论 单独应用万拉法新对IBS的总体治疗效果优于硝苯地平组,对改善伴随的焦虑和抑郁症状有明显的疗效。     

文拉法辛治疗持续性躯体形式疼痛障碍35例

目的：观察文拉法辛治疗持续性躯体形式疼痛障碍的疗效。方法： 将持续性躯体形式疼痛障碍初诊患者70例随机分为治疗组和对照组各35例，两组分别给予文拉法辛和阿米替林，均以25 mg，po，bid，根据病情渐增至50 mg，po，tid。分别在治疗后第4天和第1，2，4周评定疗效。结果：治疗组和对照组完全缓解分别为9，8例，明显缓解分别为13，10例，轻度缓解分别为8，10例，无效分别为5，7例；有效率分别为85.71%，80.00%；两组间差异无显著性(P＞0.05)。但治疗组口干、便秘、视物模糊、心动过速、嗜睡等不良反应明显比对照组少(P＜0.01)。结论： 文拉法辛对持续性躯体形式疼痛障碍疗效好，不良反应小，安全性高。     

In vivo studies of effects of antidepressants on parotid salivary secretion in the rat

Tricyclic antidepressants (TCA) are well-known xerogenic drugs, while antidepressants such as selective serotonin reuptake inhibitors (SSRI) are considered less xerogenic. The antimuscarinic effect of the TCAs has been considered to be the principal mechanism causing a dry mouth. Although the muscarinic receptor is commonly targeted by xerogenic pharmaceuticals, the salivation reflex arc may be affected at other levels as well. We currently wondered whether or not antidepressants exert an inhibition of the salivary reflex not only at the glandular level but at a central level as well. In this study, the effects of a TCA (clomipramine), a SSRI (citalopram) and a serotonin-noradrenaline reuptake inhibitor (SNRI; venlafaxine) were examined on reflex- (0.5 M citric acid applied on the tongue) and methacholine-evoked salivary secretion. While all three compounds inhibited citric acid-evoked secretion (−40 to −60% at 5 mg/kg i.v. of the antidepressants), only clomipramine inhibited methacholine-evoked secretion (−30% at 5 mg/kg i.v.). On the contrary, both citalopram and venlafaxine increased the methacholine-evoked secretion (+44 to 49%). This was particularly obvious for the salivary protein output (>200%). In the presence of α- and β-adrenoceptor antagonists, the citalopram- and venlafaxine-induced increases were reduced. Thus, antidepressants irrespective of type may exert xerogenic effects by inhibiting the salivary reflex in the central nervous system. However, while TCAs may also hamper the secretory response by antimuscarinic effects, the SSRI and the SNRI groups of pharmaceuticals seem to lack this additional xerogenic mechanism indicating a better therapeutic profile and better opportunities for pharmacological treatment of drug-induced xerostomia.     

基于药物基因检测使用文拉法辛治疗抑郁症的临床效果

目的探讨药物基因检测下使用文拉法辛治疗抑郁症的效果和安全性,为个体化用药提供参考。方法纳入符合《国际疾病分类(第10版)》(ICD-10)抑郁发作诊断标准的66例患者为研究对象。将药物基因检测报告建议并选用文拉法辛治疗的患者分为研究组(n=32),医生与患者协商后决定使用文拉法辛治疗的患者为对照组(n=34)。于治疗前及治疗2、4、6、8周末使用汉密尔顿抑郁量表24项版(HAMD-24)评定临床疗效,于治疗前及治疗8周末使用席汉残疾量表(SDS)评定患者的社会功能,于治疗后采用副反应量表(TESS)评定不良反应发生情况。结果治疗4、6、8周末,研究组HAMD-24评分均低于对照组,差异均有统计学意义(t=2.344、4.316、5.760,P0.05或0.01);治疗8周末,研究组SDS评分低于对照组,差异有统计学意义(t=2.173,P0.05),研究组不良反应发生率低于对照组,差异有统计学意义(χ~2=5.720,P0.05)。结论基于药物基因检测使用文拉法辛治疗抑郁症,可能有助于改善患者的抑郁情绪,且安全性更好。     

Optimization and evaluation of venlafaxine hydrochloride fast dissolving oral films

Three factors, three levels (3³) full factorial design was used to develop venlafaxine HCl fast dissolving oral films (FDOFs) to optimize the concentrations of the film forming polymer; hydroxypropyl methylcellulose HPMC (X1), superdisintegrant; sodium starch glycolate SSG, (X2) and glycerol as the film plasticizer (X3). Effects of the three factors on the disintegration time (Y1), swelling index (Y2), and dissolution efficiency at 15 min; DE%15 (Y3) of the prepared FDOFs were evaluated by using statistical models. The optimized film formula was characterized in term of x-ray powder diffraction (XRPD), differential scanning calorimetry (DSC) and morphological characteristics.Disintegration time was found to increase with the increase in HPMC (X1) concentration, and the shortest disintegration time (21.67 ± 2.08 s) was observed in case of F2 formula (lowest HPMC level and highest glycerol level in absence of SSG). The highest swelling index (3.64 ± 0.59) was observed in case of film formula F1 (medium concentrations of both HPMC and glycerol and highest SSG concentration. The results also indicated that as the concentration of HPMC increased the DE%15 decreased. SSG (X2), with highest value (72.33 ± 1.71%) was recorded for in case of F12 (using 2% HPMC, 5%SSG and 1.5% glycerol). The optimized FDOF formula derived by the statistical models suggested 2% HPMC, 5% SSG, and 1% glycerol.The data obtained from DSC and XRPD revealed no interaction between drug and FDOT excipients. In addition, XRPD studies proved that the venlafaxine HCl was homogeneously dispersed in the film matrix.     

盐酸文拉法辛缓释片对42例Ⅱ型精神分裂症患者听觉P300的影响

目的：应用事件相关电位（ERP）听觉P300（即P3）评估盐酸文拉法辛缓释片对Ⅱ型精神分裂症患者认知功能的影响。方法：选取疗效已达显著进步以上的Ⅱ型精神分裂症患者42例,随机分为研究组（22例）和对照组（20例）。研究组给予盐酸文拉法辛缓释片治疗,在治疗前后对两组患者分别进行听觉ERP检查及阳性症状与阴性症状量表（PANss）评定。结果：在治疗后,研究组靶刺激P300潜伏期缩短（P〈0．05）和波幅升高（P〈0．05）,PANSS评定提示阴性因子分、反应缺乏因子分及抑郁因子分下降和激活因子分升高（P〈0．05）,与对照组比较,差异有统计学意义（P〈0．05）。对照组在治疗前后P300各项目和PANSS评分比较差异无统计学意义（P〉0．05）。结论：从ERP的P300可反映出盐酸文拉法辛缓释片能改善U型精神分裂症患者的认知功能。     

盐酸文拉法辛缓释片Beagle犬体内药动学及生物等效性研究

目的 研究盐酸文拉法辛缓释片在Beagle犬体内的药动学和生物等效性。方法 8条健康Beagle犬随机分成2组,采用双周期、双交叉、单剂量分别ig盐酸文拉法辛缓释片受试制剂或参比制剂75 mg,清洗期为1周;建立血浆中盐酸文拉法辛液相色谱-质谱联用（LC-MS/MS）检测方法,进行方法精密度、准确度、提取回收率、基质效应、稳定性方法学验证;测定给药前（0 h）及给药后2、3、4、5、6、8、10、12、14、16、24、36、48、72 h血浆中盐酸文拉法辛血药浓度,运用DAS 2.1.1软件计算其药动学参数,并评价其生物等效性。结果 LC-MS/MS方法学经验证符合检测要求,受试制剂和参比制剂主要药动学参数分别如下：T_1/2分别为（7.16±2.34）和（6.95±1.57） h、Cmax分别为（522.89±201.12）和（515.22±159.29）ng/mL、T_max分别为（10.38±1.69）和（10.50±2.07）h、AUC_0-t分别为（8 398.64±3332.86）和（8 050.71±2103.15）ng·h/mL、AUC_0-∞分别为（8 701.60±3303.29）和（8 450.01±2273.45）ng·h/mL;以参比制剂为参考,受试制剂AUC_0-∞相对生物利用度为（101.0±13.1）%。结论 盐酸文拉法辛缓释片受试制剂与参比制剂在Beagle犬体内具有生物等效性。