舍曲林联合普瑞巴林治疗老年带状疱疹后神经痛镇痛疗效的研究

目的评价舍曲林联合普瑞巴林治疗老年带状疱疹后神经痛的临床疗效。方法 60例老年带状疱疹后神经痛患者随机分为对照组(n=32)和试验组(n=28)。对照组用普瑞巴林150 mg·d-1,试验组在对照组基础上加用舍曲林50mg·d-1,2组均常规营养神经药物治疗及物理治疗。治疗前、治疗后4周用视觉模拟评分(VAS)评估患者的疼痛强度变化,中文版简明健康测量量表(SF-36)评定生活质量的变化。结果 2组治疗后疼痛强度均较治疗前显著降低(P<0.05),试验组疼痛缓解显著高于对照组(P<0.05)。试验组在6个领域的生活质量较对照组明显改善(P<0.05)。2组不良反应发生率差异无统计学意义。结论舍曲林联合普瑞巴林能提高老年带状疱疹后神经痛的疗效。     

丁丙诺菲透皮贴联合普瑞巴林治疗老年带状疱疹后神经痛的临床观察

目的观察丁丙诺菲透皮贴联合普瑞巴林治疗老年带状疱疹后神经痛的临床效果。方法 60例老年带状疱疹后神经痛患者随机分为试验组和对照组。试验组:丁丙诺菲透皮贴联合普瑞巴林;对照组:单独应用口服普瑞巴林。治疗8周后记录两组患者用药前、用药后2周、4周、8周的疼痛评分(visual analogue scale,VAS)、睡眠评分、普瑞巴林日剂量及不良反应发生率。结果两组患者治疗后VAS评分明显低于治疗前(P<0.01),治疗后4周及8周试验组VAS评分明显低于对照组(P<0.05);用药治疗后两组患者睡眠质量明显改善(P<0.05);联合应用丁丙诺菲透皮贴后可明显减少试验组普瑞巴林的用量(P<0.05);联合应用丁丙诺菲透皮贴可以显著减少普瑞巴林相关不良反应头晕、嗜睡的发生率(P<0.05)。结论丁丙诺菲透皮贴联合普瑞巴林对老年带状疱疹后神经痛患者的临床效果优于单独应用普瑞巴林,不良反应较小。     

普瑞巴林治疗带状疱疹后神经痛的临床疗效观察

目的观察普瑞巴林治疗带状疱疹后神经痛的临床疗效和安全性。方法带状疱疹后神经痛患者80例,采用随机对照,分为治疗组和对照组,治疗组(n=40)给予普瑞巴林口服150 mg.d-1,对照组(n=40)给予卡马西平600 mg.d-1,观察时间为4周。采用视觉模拟评分(VAS)评估治疗前及治疗后1、2、3、4周疼痛程度,采用中国版生活质量量表(SF-36)对两组患者治疗前和治疗后4周生活质量情况进行评定,同时观察治疗期间McGill疼痛问卷简表(SF.MPQ)分值的改变、持续睡眠时间及不良反应。结果经过4周的治疗,治疗组较对照组疼痛程度明显减轻(P0.05),睡眠和生活质量改善情况优于对照组(P0.05),且不良反应相对较少(P0.05)。结论普瑞巴林可明显减轻带状疱疹后神经痛患者疼痛,改善生活质量。     

普瑞巴林与卡马西平分别联合甲钴胺分散片治疗带状疱疹后神经痛的疗效分析

目的观察普瑞巴林与卡马西平分别联合甲钴胺分散片治疗带状疱疹后神经痛的疗效及不良反应的对比分析。方法将60例带状疱疹后神经痛的患者分为普瑞巴林组(30例)和卡马西平组(30例):采用视觉模拟量表(VAS)评估本治疗患者用药前和用药后1周、2周、4周时疼痛情况及观察其伴随症状。结果普瑞巴林组治疗带状疱疹后神经痛优于卡马西平组(P<0.05)。结论普瑞巴林较卡马西平更能快速、强效的缓解并缩短带状疱疹后神经痛的持续时间,延长睡眠时间,降低不良反应发生率。     

加巴喷丁胶囊联合普瑞巴林治疗老年带状疱疹后神经痛的临床研究

目的:探讨加巴喷丁胶囊联合普瑞巴林治疗老年带状疱疹后神经痛的临床效果.方法:在医院2015年6月～2016年10月诊治的老年带状疱疹后神经痛患者中抽取78例,以随机抽签方式分组,治疗组(n=39)应用加巴喷丁胶囊联合普瑞巴林治疗,对照组(n=39)单纯采取加巴喷丁胶囊治疗,就治疗效果以及治疗前后疼痛程度变化进行统计学分析.结果:①治疗前,治疗组、对照组的VAS疼痛评分无显著差异(P>0.05);治疗后,治疗组VAS疼痛评分低于对照组(P<0.01);②治疗组治疗总有效率是97.44％,高于对照组的79.49％(P<0.05).结论:加巴喷丁胶囊联合普瑞巴林治疗老年带状疱疹后神经痛的临床效果确切,可有效减轻疼痛感,有借鉴意义.     

普瑞巴林对带状疱疹后遗神经痛神经阻滞效果的影响

目的观察普瑞巴林对带状疱疹后遗神经痛神经阻滞效果的影响。方法将40例患者随机分为对照组(A组)和普瑞巴林组(B组),两组患者均行神经阻滞,B组加服普瑞巴林。对比观察两组患者用药前后VAS评分、睡眠质量评分(QS)和不良反应。结果与治疗前比较,两组治疗后第2周～第10周,VAS和QS显著下降(P<0.01)。普瑞巴林组治疗后疼痛VAS评分和睡眠质量评分均显著低于对照组(P<0.05)。两组不良反应的发生率没有区别。结论普瑞巴林对带状疱疹后遗神经痛的神经阻滞效果具有明显的增强作用。     

芬太尼透皮贴联合普瑞巴林治疗带状疱疹后神经痛临床观察

目的评价芬太尼透皮贴联合普瑞巴林治疗带状疱疹后神经痛的临床效果。方法 56例PHN患者随机分为实验组(A组)和对照组(B组)。A组:普瑞巴林150 mg,2次/d口服,联合应用芬太尼透皮贴4.2 mg,每72 h更换1次;B组:单独应用口服普瑞巴林150 mg,2次/d口服。两组分别治疗8周。记录两组患者用药前及用药后2、4、6、8周时的疼痛评分(VAS评分)、生活质量评分(SF-36评分)及不良反应。结果治疗前,A、B组的VAS评分为7.79±0.92、7.70±0.87,治疗2周后降至3.89±1.07、6.33±0.73(P<0.05),组间比较差异也有统计学意义(P<0.05),治疗后4、6、8周亦存在相似情况。治疗后8周,两组SF-36评分与治疗前比较,除一般健康状况和心理健康外,其余各项差异均有统计学意义;A组恶心呕吐和便秘发生率高于B组。结论芬太尼透皮贴联合普瑞巴林对PHN患者的临床效果优于单独应用普瑞巴林,不良反应较小。     

星状神经节阻滞联合普瑞巴林治疗胸背部带状疱疹病理性神经痛的临床研究

目的:观察普瑞巴林联合星状神经节阻滞治疗胸背部带状疱疹病理性神经痛的疗效和安全性。方法:120例胸背部带状疱疹病理性神经痛的患者,按入组顺序随机分为3组:A组:星状神经节阻滞治疗;B组:口服普瑞巴林治疗;C组:普瑞巴林联合星状神经节阻滞治疗。治疗中,B组和C组口服普瑞巴林,剂量为每次150 mg,bid,连续服用8周。结果:治疗后,3组的NRS评分均明显降低(P<0.05);B组和C组的NRS评分相当,组间比较无显著差异;但B组和C组的NRS评分均较A组明显降低(P<0.05)。不良反应主要是声音嘶哑、局部血肿、头晕、嗜睡和水肿。结论:普瑞巴林联合星状神经节阻滞治疗胸背部带状疱疹病理性神经痛安全有效。     

评价普瑞巴林联合曲马多治疗中重度急性带状疱疹疼痛的临床效果

目的 评价普瑞巴林与曲马多联合治疗中重度急性带状疱疹疼痛的临床效果。方法 中重度急性带状疱疹患者72例,随机分为曲马多组、普瑞巴林组和联合组,比较三组治疗效果。结果 治疗4周后,三组患者数字疼痛分级法(NRS)、匹兹堡睡眠质量指数量表(PSQI)评分均较治疗前有明显下降,联合组NRS、PSQI评分均明显低于曲马多组和普瑞巴林组(P<0.05);三组不良反应发生发生率比较差异无统计学意义(P>0.05),联合组曲马多日最大剂量明显低于曲马多组(P<0.05)。结论 普瑞巴林联合曲马多治疗中重度急性带状疱疹疼痛可有效改善患者疼痛,减少曲马多用药剂量,且具有一定的安全性,值得临床推广应用。     

普瑞巴林与加巴喷丁治疗带状疱疹后期神经痛

目的探讨在治疗带状疱疹后期神经痛(PHN)时,普瑞巴林与加巴喷丁的临床效果。方法随机选取2012年8月至2014年2月于我院接受治疗的带状疱疹后期神经痛(PHN)患者80例,随机分2组,对照组采用加巴喷丁,观察组采用普瑞巴林,2组施予相同的护理方法,比较2组患者的疼痛视觉模拟评分(VAS评分)和治疗效果。结果 2组患者病情均有明显好转(P<0.05),但2组之间没有明显差异(P>0.05),观察组的镇痛时间稍快于对照组,不良反应发生率少于对照组,临床疗效优于对照组,数据具有明显差异(P<0.05)。结论普瑞巴林在治疗PHN时,既能快速有效地达到镇痛效果,又能在一定程度上减少不良反应的发生,临床效果明显优于加巴喷丁。     

普瑞巴林联合强的松治疗带状疱疹后神经痛的疗效及安全性

目的 探讨普瑞巴林与强的松联合应用治疗带状疱疹神经痛患者的临床疗效及安全性.方法 选取2010年3月至2013年3月我院收治的带状疱疹后神经痛患者64例,按其就诊顺序均分为对照组及观察组,每组32例.对照组给予口服普瑞巴林,观察组给予普瑞巴林联合强的松治疗.比较两组的临床疗效及安全性.结果 治疗后3周,对照组疼痛发生率、疼痛程度评分、精神状况评分、不良反应发生率分别为56.25％、5.8±0.5、5.3±1.6、9.4％,观察组分别为28.12％、3.6±1.1、4.8±1.8、3.1％,两组比较,差异均具有统计学意义（P均＜ 0.05）;治疗9周后,对照组患者疼痛发生率、疼痛程度、精神状况、不良反应发生率为50.0％、2.8±0.9、3.1±0.9、12.5％,观察组为9.38％、0.9±0.06、2.3±0.6、6.25％,两组比较差异均具有统计学意义（P＜0.01或P＜0.05）.结论 普瑞巴林联合强的松治疗带状疱疹后神经痛疗效显著优于单用普瑞巴林,且不良反应发生率低于单用普瑞巴林,值得临床推广.     

普瑞巴林治疗疱疹后神经痛31例

目的:观察普瑞巴林治疗疱疹后神经痛的疗效及安全性。方法:应用普瑞巴林治疗疱疹后神经痛,疗程4周。采用视觉模拟疼痛评分(VAS)和睡眠质量评分法评估普瑞巴林治疗前后患者的疼痛程度和睡眠质量。结果:治疗后VAS评分减少,睡眠质量评分升高,与治疗前比较差异均有统计学意义(P<0.05)。不良反应共发生6例,主要表现为头昏、嗜睡和共济失调等。结论:普瑞巴林治疗疱疹后神经痛,有一定的疗效,并能改善睡眠质量,安全性较好。     

Gabapentin versus nortriptyline in post-herpetic neuralgia patients: a randomized, double-blind clinical trial--the GONIP Trial

BACKGROUND: Gabapentin and nortriptyline have not been compared in a randomized trial in post-herpetic neuralgia (PHN). The present study was, therefore, undertaken to determine their comparative efficacy and tolerability in the treatment of post-herpetic neuralgia. PATIENTS AND METHODS: The study was a randomized, double-blind, parallel-group trial of 9 weeks duration. Adult PHN patients with history of > 8 weeks of PHN pain after healing of rash, a pain intensity of at least 40 mm on a 100 mm visual analog scale at screening and at randomization, and average pain score of at least 4 on the Likert scale during the baseline week were included in the study. Gabapentin and nortriptyline were given in incremental doses at 2-weekly intervals till a maximum tolerated dose was obtained. The primary efficacy parameter was change in pain score (11-point Likert scale) from baseline to the end of the study period. RESULTS: 70 patients were available for intention-to-treat analysis. The average pain scores on the Likert scale were significantly reduced at the end of study in both the treatment groups with 47.6% and 42.8% reduction in pain scores in nortriptyline and gabapentin groups, respectively. Patients showed significant improvement in sleep scores in both the treatment groups nortriptyline (46.0%) and gabapentin (52.0%). The VAS and the SF-MPQ scores for pain were significantly reduced in both the groups. Gabapentin was, however, better tolerated as compared to nortriptyline. CONCLUSION: Gabapentin was shown to be equally efficacious but was better tolerated compared to nortriptyline and can be considered a suitable alternative for the treatment of PHN.     

Efficacy and safety of combination therapy with 5% lidocaine medicated plaster and pregabalin in post-herpetic neuralgia and diabetic polyneuropathy

ABSTRACT

Objective: Neuropathic pain is often difficult to treat due to a complex pathophysiology. This study evaluated the efficacy, tolerability and safety of combination therapy with 5% lidocaine medicated plaster and pregabalin for neuropathic pain in patients with post-herpetic neuralgia (PHN) or painful diabetic polyneuropathy (DPN).

Methods: Patients completing 4-week monotherapy with 5% lidocaine medicated plaster or pregabalin were enrolled in an 8-week combination phase. Patients with adequate response to monotherapy (recalled average pain intensity of 4 or less on 11-point numeric rating scale in the previous 3 days [NRS-3 score]) continued their previous therapy, whereas those with insufficient response received combination therapy. Efficacy endpoints included change in NRS-3 from combination phase baseline, Patient and Clinical Global Impression of Change (PGIC/CGIC), and patient's satisfaction with treatment. Safety evaluation included adverse events (AEs), drug-related AEs (DRAEs), and withdrawal due to AEs.

Clinical trial registration: EudraCT No. 2006-003132-29.

Results: Of 229 patients in the per-protocol set (PPS: 68 PHN and 161 DPN), 71 received 5% lidocaine medicated plaster monotherapy, 57 had pregabalin added to 5% lidocaine medicated plaster, 57 pregabalin monotherapy and 44 received 5% lidocaine medicated plaster in addition to continued pregabalin treatment. There were no meaningful differences in demographic data between the treatment groups. Patients continuing on monotherapy demonstrated additional decreases in NRS-3 scores. Patients receiving combination therapy achieved clinically relevant reduction in NRS-3 values in addition to improvement achieved during the 4 weeks of monotherapy. Improvement was similar between the two combination therapy groups. Considerable improvements in patients’ treatment satisfaction were reported. Incidences of AEs were in line with previous reports for the two treatments and combination therapy was generally well tolerated.

Conclusions: In patients with PHN and painful DPN failing to respond to monotherapy, combination therapy with 5% lidocaine medicated plaster and pregabalin provides additional clinically relevant pain relief and is safe and well-tolerated.     

Pregabalin: new drug. Very similar to gabapentin

(1) The first-line treatment for partial epilepsy is carbamazepine monotherapy; gabapentin monotherapy is an alternative, given its lower risk of drug-drug interactions. (2) The standard treatment for neuropathic pain associated with diabetes or post-herpetic neuralgia is a tricyclic antidepressant, with gabapentin as an alternative. Few drugs are available in this setting, and their efficacy is often modest. (3) Pregabalin is a GABA analogue closely related to gabapentin. Both drugs are marketed by Pfizer. Pregabalin has been approved for use in two indications: refractory partial epilepsy and neuropathic pain. (4) In patients with partial epilepsy inadequately controlled by a combination of two or possibly three antiepileptics, three placebo-controlled double-blind trials lasting 12 weeks suggest that adjunctive pregabalin treatment, at a dose of 600 mg/day divided in two or three doses, at least halves the frequency of seizures in 50% of patients. Pregabalin has not been compared with other second-line antiepileptics. (5) In neuropathic pain, there are 12 double-blind placebo-controlled trials involving patients with diabetes or post-herpetic neuralgia. Depending on the trial, between one-third and one-half of patients treated with pregabalin at a dose of 600 mg/day given in two or three doses had at least a 50% reduction in their pain score. In the only trial that included a group treated with amitriptyline (75 mg/day), the latter was significantly more effective than placebo, while pregabalin was not. (6) There are no comparative trials of pregabalin after amitriptyline and gabapentin failure. (7) The adverse effects profile of pregabalin is similar to that of gabapentin, and includes mainly neuropsychological reactions (dizziness and drowsiness). (8) Pregabalin, like gabapentin, can lead to weight gain and peripheral oedema especially in elderly patients. (9) Cases of visual field restriction have been reported with pregabalin in clinical trials. Animal studies suggest a possible risk of haemangiosarcoma, although no human cases have yet been described. (10) Pregabalin, like gabapentin, is eliminated unchanged in urine, implying a limited risk of interactions involving cytochrome P450, and suggesting that the dose should be reduced in patients with even moderate renal failure (creatinine clearance below 60 ml/min). (11) In practice, pregabalin offers nothing new for patients with partial epilepsy, for whom several other antiepileptics are available. The few available treatments for neuropathic pain have limited efficacy, and pregabalin may therefore be tried when both tricyclics and gabapentin fail. However, it is in no way certain that pregabalin is effective in such patients, and comparative trials are lacking.     

5% lidocaine medicated plaster versus pregabalin in post-herpetic neuralgia and diabetic polyneuropathy: an open-label,non-inferiority two-stage RCT study

ABSTRACT

Objective: To compare efficacy and safety of 5% lidocaine medicated plaster with pregabalin in patients with post-herpetic neuralgia (PHN) or painful diabetic polyneuropathy (DPN).

Study design and methods: This was a two-stage adaptive, randomized, open-label, multicentre, non-inferiority study. Data are reported from the initial 4-week comparative phase, in which adults with PHN or painful DPN received either topical 5% lidocaine medicated plaster applied to the most painful skin area or twice-daily pregabalin capsules titrated to effect according to the Summary of Product Characteristics. The primary endpoint was response rate at 4 weeks, defined as reduction averaged over the last three days from baseline of ≥2 points or an absolute value of ≤4 points on the 11-point Numerical Rating Scale (NRS-3). Secondary endpoints included 30% and 50% reductions in NRS-3 scores; change in allodynia severity rating; quality of life (QoL) parameters EQ-5D, CGIC, and PGIC; patient satisfaction with treatment; and evaluation of safety (laboratory parameters, vital signs, physical examinations, adverse events [AEs], drug-related AEs [DRAEs], and withdrawal due to AEs).

Results: Ninety-six patients with PHN and 204 with painful DPN were analysed (full analysis set, FAS). Overall, 66.4% of patients treated with the 5% lidocaine medicated plaster and 61.5% receiving pregabalin were considered responders (corresponding numbers for the per protocol set, PPS: 65.3% vs. 62.0%). In PHN more patients responded to 5% lidocaine medicated plaster treatment than to pregabalin (PPS: 62.2% vs. 46.5%), while response was comparable for patients with painful DPN (PPS: 66.7% vs 69.1%). 30% and 50% reductions in NRS-3 scores were greater with 5% lidocaine medicated plaster than with pregabalin. Both treatments reduced allodynia severity. 5% lidocaine medicated plaster showed greater improvements in QoL based on EQ-5D in both PHN and DPN. PGIC and CGIC scores indicated greater improvement for 5% lidocaine medicated plaster treated patients with PHN. Improvements were comparable between treatments in painful DPN. Fewer patients administering 5% lidocaine medicated plaster experienced AEs (safety set, SAF: 18.7% vs. 46.4%), DRAEs (5.8% vs. 41.2%) and related discontinuations compared to patients taking pregabalin.

Conclusion: 5% lidocaine medicated plaster showed better efficacy compared with pregabalin in patients with PHN. Within DPN, efficacy was comparable for both treatments. 5% lidocaine medicated plaster showed a favourable efficacy/safety profile with greater improvements in patient satisfaction and QoL compared with pregabalin for both indications, supporting its first line position in the treatment of localized neuropathic pain.     

加巴喷丁对带状疱疹后神经痛患者疼痛和生活质量的影响

目的探讨加巴喷丁对带状疱疹后遗神经痛（PHN）患者疼痛的作用及对生活质量（QOL）的影响。方法48例PHN患者随机分为2组,对照组采用传统药物治疗,治疗组采用口服加巴喷丁治疗。采用视觉模拟评分（VAS）评价患者治疗前、治疗后1周、2周和4周疼痛程度。采用生活质量SF-36表中国版对2组患者治疗前及治疗后4周生活质量进行评估比较。结果加巴喷丁组治疗后1、2和4周的VAS评分分别为3.96±1.48、3.31±1.18和2.92±1.25,明显低于对照组VAS评分（P〈0.01）。治疗后4周SF-36生活质量评分除躯体功能领域外,显著高于治疗前和对照组评分（P〈0.05）。结论加巴喷丁可明显减轻PHN患者疼痛,改善生活质量。     

米氮平联合普瑞巴林治疗带状疱疹后神经痛的疗效观察

目的研究米氮平片联合普瑞巴林治疗带状疱疹后神经痛的临床疗效和主要不良反应。方法将64例带状疱疹后神经痛患者随机分为对照组(P组)和联合组(MP组),每组32例。P组应用普瑞巴林治疗;MP组联合应用米氮平片、普瑞巴林治疗。观察比较两组患者疼痛缓解程度、疼痛缓解率、生活质量改善、药物不良反应等。结果两组患者疼痛均明显缓解,MP组的疼痛控制效果、生活质量改善及不良反应发生率明显优于对照组,两组比较差异有统计学意义(P<0.05)。结论联合应用米氮平片治疗带状疱疹后神经痛可达到更好的临床治疗效果,且安全可行。