依托芬那酯凝胶联合替扎尼定治疗潜在胃肠道风险的急性颈肩腰部疼痛疗效及安全性研究

目的观察非甾体抗炎药依托芬那酯凝胶联合中枢性肌松药替扎尼定对治疗有潜在胃肠道风险的急性痉挛性颈肩腰痛的疗效和安全性。方法 2012年3月-5月共诊断急性痉挛性颈肩痛及腰痛患者375例,依据排除标准排除33例,根据分组标准将有潜在胃肠道疾病风险者设为试验组(A组,n=63),明确无胃肠道疾病史者按照年龄、性别和疼痛部位与试验组进行配伍设为阳性对照组(B组,n=63)和安慰剂对照组(C组,n=63),未分组144例不纳入统计。试验组服用替扎尼定2 mg,2次/d,同时外用依托芬那酯凝胶5～10 cm均匀涂抹患处,3次/d;对照组服用替扎尼定2 mg,2次/d,同时口服塞来昔布0.2 g,2次/d;安慰剂对照组服用替扎尼定2 mg,2次/d,同时安慰剂1粒,2次/d。观察药物疗效和不良反应。结果 A组随访57例,平均起效时间为(2.17±0.99)d,总有效44例(77.2%),胃肠道不良反应2例(3.5%);B组随访54例,平均起效时间为(1.78±0.96)d,总有效45例(83.3%),胃肠道不良反应发生3例(5.5%);C组随访55例,平均起效时间(4.10±1.63)d,总有效35例(63.6%),胃肠道不良反应发生2例(3.6%)。结论依托芬那酯凝胶和口服非甾体抗炎药疗效和起效时间相当,胃肠道耐受性较好,联合用药效果优于单独使用肌松药。对于有潜在胃肠道风险的痉挛性颈肩腰背痛患者可选择外用非甾体抗炎药联合中枢性肌松药的治疗方案,以获得更好的疗效以及较高耐受性。     

甲氨蝶呤联合双氯芬酸治疗骨性关节炎60例疗效分析

目的:探讨甲氨蝶呤联合双氯芬酸治疗骨性关节炎的疗效.方法:将120例骨性关节炎患者随机分为治疗组和对照组各60例,治疗组采用口服双氯芬酸与甲氨蝶呤治疗,双氯芬酸用法为每日75 mg,甲氨蝶呤用法为每周10 mg.对照组单用双氯芬酸治疗,用法同治疗组.2组疗程均为1个月.疗程结束后比较2组的疗效及不良反应的发生率.结果:治疗组总有效率为95%,不良反应的发生率30%,对照组相应为77%、27%,治疗组总有效率高于对照组(P<0.05),2组不良反应的发生率比较差异无统计学意义(P＞0.05).结论:甲氨蝶呤联合双氯芬酸治疗骨性关节炎疗效好,不良反应轻微,可供临床酌情应用.     

"清痹方"合双氯芬酸钠联合治疗类风湿性关节炎临床观察

目的：观察中药“清痹方”合双氯芬酸钠联合治疗类风湿性关节炎的疗效和不良反应。方法：60例患者随机分为治疗组和对照组。两组均维持常规的甲氨喋呤7.5mg，每周1次治疗，对照组服用双氯芬酸钠25mg，每日3次；治疗组除服用双氯芬酸钠25mg，每日3次外，加服“清痹方”，每日2剂。观察治疗后的临床疗效。实验室检查和不良反应。结果：对照组总有效率为76.7%。治疗组为86.7%。不良反应对照组发生7例。治疗组发生2例。结论：“清痹方”合双氯芬酸钠联合治疗类风湿性关节炎疗效佳。不良反应少。     

对乙酰氨基酚与非甾体抗炎药治疗骨关节炎的疗效和安全性的观察

目的：比较对乙酰氨基酚、双氯芬酸钠、美洛昔康和布洛芬治疗骨关节炎的疗效和安全性。方法：采用多中心、随机、对照研究方法。每组30例。其中对乙酰氨基酚组口服1300mg，bid；双氯芬酸钠组口服25mg，tid；美洛昔康组口服7．5mg，qd；布洛芬组口服300mg，bid，共观察4周。结果：对乙酰氨基酚组的有效率为73．33％，双氯芬酸钠组为76．67％，美洛昔康组为76．67％，布洛芬组为70．00％，各组有效率无显著差异；4组患者的SF-36生活质量评分部分项目治疗前后有显著差异。各组不良反应发生率无显著差异，但实验室检查显示肝功能均有不同程度影响，以3种非甾体抗炎药尤为显著。结论：经4种药物治疗，骨关节炎患者的症状和生活质量均有改善，但4种药物对肝功能有一定的影响，临床长期运用要注意安全。     

酮替芬治疗小儿咳嗽变异性哮喘疗效观察

将符合诊断为小儿咳嗽变异性哮喘急性期的患儿随机分为观察组和对照组各30例,两组均采用抗生素加舒喘灵作为基础治疗,观察组在此基础上加用酮替芬:﹤6岁0.25～0.5mg,bid,﹥6岁0.5～1mg,bid,观察临床疗效。结果观察组总有效率达96.7%,对照组总有效率76.7%。酮替芬在治疗小儿咳嗽变异性哮喘中的作用明显,费用少,服用方便,不良反应少,使用安全。     

腹腔灌注顺铂联合替吉奥治疗胃肠道肿瘤合并腹腔积液25例效果观察

目的:探讨腹腔灌注顺铂联合替吉奥治疗胃肠道肿瘤合并腹腔积液患者的临床效果。方法:对25例胃肠道肿瘤合并腹腔积液患者采用中心静脉导管行腹腔留置,引流腹水后给予顺铂60 mg/m2行腹腔化疗同时口服替吉奥胶囊40～60 mg/m2,早晚各1次,连续14 d为1个周期,7 d后进行下个周期,共2个周期。结果:本组25例患者中,胃癌治疗总有效率80%,结直肠癌治疗总有效率70%;主要不良反应:恶心、呕吐发生率68%,白细胞下降发生率64%,贫血发生率24%,腹痛发生率24%,口腔黏膜炎发生率16%,多为Ⅰ～Ⅱ度不良反应。结论:腹腔灌注顺铂联合替吉奥治疗胃肠道肿瘤合并腹腔积液,临床效果明显,患者发生不良反应轻,可明显提高生活质量。     

替扎尼定治疗三叉神经痛的临床观察

目的:评价盐酸替扎尼定治疗三叉神经痛的临床疗效及安全性.方法:45例三叉神经痛患者分为替扎尼定组(A组)、卡马西平组(B组).在治疗前、治疗后第7、14、28天对患者的疼痛频率、疼痛程度进行评定,并观察其总体有效性、耐受性和安全性.结果:替扎尼定组治疗前后比较均有显著差异(P＜0.05),替扎尼定组和卡马西平组两组间疗效有显著差异,替扎尼定组的起效时间较卡马西平组慢,但不良反应少,耐受性好.结论:替扎尼定对于三叉神经痛的治疗是一种有效的药物.     

替扎尼定联合尼美舒利治疗纤维织炎的临床疗效

目的观察盐酸替扎尼定治疗腰背肌纤维织炎的临床疗效。方法2011年8月-2013年1月门诊就诊腰背肌纤维织炎患者,共166例,随机分为对照组与试验组,每组各83例。实际完成试验者145例,其中试验组74例,对照组78例。对照组采用尼美舒利进行治疗,试验组采用尼美舒利与盐酸替扎尼定联合治疗,治疗周期均为2周。分别对治疗前与治疗后心理测评（采用症状自评量表检测）、视觉疼痛模拟和日常生活能力进行测评,并进行组间比较,观察其疗效,治疗期间随访平均为3个月。结果治疗后与治疗前比较,各组均有所改善,且组间比较,试验组疗效优于对照组,试验组胃肠道疾病发生情况少于对照组。结论盐酸替扎尼定联合尼美舒利治疗腰背肌纤维织炎具有较好的临床疗效,且盐酸替扎尼定对胃肠道功能起到一定的保护作用。     

厄洛替尼治疗吉非替尼耐药老年非小细胞肺癌脑转移的疗效

目的 观察厄洛替尼治疗吉非替尼耐药老年非小细胞肺癌(non-small cell lung cancer,NSCLC)脑转移的疗效及不良反应,评价生活质量.方法 41例老年NSCLC脑转移患者分为吉非替尼组(21例)和厄洛替尼组(服吉非替尼曾经有效耐药后改服厄洛替尼,20例).服吉非替尼250 mg/d或服厄洛替尼150 mg/d;直到疾病进展、死亡或发生不可耐受的不良反应.观察临床疗效、不良反应及评价生活质量.结果 吉非替尼组有效率14.3％(3/21)稍高于厄洛替尼组10.0％ (2/20),两组比较差异无统计学意义(P＞0.05).吉非替尼组疾病控制率38.1％(8/21)稍高于厄洛替尼组30.0％(6/20),两组比较差异无统计学意义(P＞0.05).吉非替尼组Karnofsky评分提高+稳定者57.1％(12/21)、厄洛替尼组25.0％(5/20),吉非替尼组生活质量改善高于厄洛替尼组(P＜0.05);吉非替尼组不良反应发生率低于厄洛替尼组(P＜0.05).两组2年生存率比较差异无统计学意义(P＞0.05).结论 吉非替尼及厄洛替尼均可作为治疗老年NSCLC脑转移的治疗选择,服用吉非替尼曾经有效的患者改服厄洛替尼30％病情可得到控制,但吉非替尼耐药后再服用厄洛替尼患者不良反应发生率较高.     

养正消积胶囊联合吉非替尼治疗晚期肺腺癌临床研究

目的:观察养正消积胶囊联合吉非替尼治疗晚期肺腺癌的临床疗效。方法:将63例患者随机分为治疗组(养正消积胶囊联合吉非替尼)32例与对照组(仅使用吉非替尼)31例,并在12周后对治疗组与对照组在肿瘤治疗有效率、不良反应及KPS评分方面进行统计,观察养正消积胶囊的临床疗效。结果:治疗组有效率为71.88%、获益率为90.63%,对照组有效率为35.48%、获益率为83.87%,(P均0.05);治疗组各不良反应发生的病例数均少于对照组,(P均0.05);治疗组KPS评分较对照组改善明显,(P0.05)。结论:养正消积胶囊能提高吉非替尼治疗晚期肺腺癌的临床疗效,并能在减轻不良反应、改善生活质量方面起到辅助作用。     

Double-blind evaluation of short-term analgesic efficacy of orally administered diclofenac,diclofenac plus codeine,and diclofenac plus imipramine in chronic cancer pain

A prospective double-blind randomized trial was conducted on 184 cancer patients with moderate to severe chronic pain to evaluate the analgesic efficacy and tolerability of diclofenac alone (50 mg q.i.d.) or in combination with a weak opioid (codeine 40 mg q.i.d.), or with an anti-depressant (imipramine, 10 or 25 mg t.i.d.). All demographic and clinical characteristics including cancer type, presence of bone metastases, baseline pain severity, neuropathic and nociceptive pain, and depressive state, were well balanced between the three treatment groups. The main analysis of the study was on the VAS scores at visit 2 (day 4). The mean VAS values for both associations imipramine plus diclofenac and codeine plus diclofenac were similar to the association placebo plus diclofenac. Patients on imipramine plus diclofenac and on placebo plus diclofenac were withdrawn mainly for inadequate efficacy, while patients on codeine plus diclofenac discontinued equally for inadequate efficacy or adverse events. In conclusion, in a short-term evaluation the addition of a tricyclic anti-depressant or a weak opioid to diclofenac did not provide further analgesia with respect to diclofenac administration alone.     

Tizanidine and ibuprofen in acute low-back pain: results of a double-blind multicentre study in general practice

This study reports on 105 patients with acute low-back pain given tizanidine (4 mg three times daily) plus ibuprofen (400 mg three times daily) or placebo plus ibuprofen (400 mg three times daily). Patients assessed their pain using visual analogue scales in a daily diary and the doctor assessed their condition at baseline and on days 3 and 7. Both groups were treated effectively, but earlier improvement occurred in patients given tizanidine/ibuprofen, particularly regarding pain at night and at rest. Doctors assessed the helpfulness of treatment: tizanidine/ibuprofen was significantly better than placebo/ibuprofen at day 3 (P = 0.05). Significant differences between treatments in favour of tizanidine/ibuprofen occurred in patients with moderate and severe pain at night (P less than 0.05), at rest (P less than 0.05) and those with moderate or severe sciatica (P less than 0.05). Significantly more patients given placebo/ibuprofen had gastro-intestinal side-effects compared with tizanidine/ibuprofen (P = 0.002). This supports previous work in animals showing that tizanidine mediates gastric mucosal protection against anti-inflammatory drugs. More patients given tizanidine/ibuprofen suffered drowsiness and other central nervous system effects (P = 0.025). In patients with severe acute low-back pain, however, some sedation and bed rest is advantageous. This study shows that tizanidine/ibuprofen is more effective in the treatment of moderate or severe acute low-back pain than placebo and ibuprofen alone.     

Comparison of the analgesic efficacy of rofecoxib and enteric-coated diclofenac sodium in the treatment of postoperative dental pain: a randomized,placebo-controlled clinical trial

BACKGROUND: Rofecoxib is a selective cyclooxygenase-2 inhibitor indicated for the treatment of acute pain, with similar analgesic efficacy to ibuprofen and naproxen sodium. Diclofenac sodium is the most commonly prescribed nonsteroidal anti-inflammatory drug worldwide; it is effective for the treatment of pain as well as the signs and symptoms associated with the painful conditions of osteoarthritis and rheumatoid arthritis. OBJECTIVE: The aim of this study was to compare the analgesic efficacy and tolerability of a single dose of rofecoxib 50 mg, 3 doses of enteric-coated diclofenac sodium 50 mg, and placebo over 8-hour and 24-hour periods in patients with moderate to severe pain after oral surgery. METHODS: In this double-blind, placebo- and active comparator-controlled, parallel-group study, patients experiencing moderate to severe pain after the surgical extraction of > or = 2 third molars were randomized to receive a single dose of rofecoxib 50 mg, 3 doses of enteric-coated diclofenac sodium 50 mg (50 mg given every 8 hours), or placebo. Patients rated pain intensity, pain relief, and global assessments at prespecified times throughout the 24-hour period after initial dosing. Overall analgesic efficacy was determined by total pain relief over 8 hours (TOPAR8) and 24 hours (TOPAR24) and patient global assessments at 8 and 24 hours. Onset of analgesic effect was determined by using the 2-stopwatch method for confirmed perceptible pain relief. Peak analgesic effect was the maximum pain relief attained during the first 8 hours. The duration of analgesic effect was determined by median time to rescue analgesia use. RESULTS: A total of 305 patients were randomized to treatment: 121 received rofecoxib, 121 received diclofenac sodium, and 63 received placebo. The baseline demographics were similar among the groups. Overall, 61.3% experienced moderate pain and 38.7% experienced severe pain; 53.1% were female; and the mean age was 23.4 years. The overall analgesic efficacy, as assessed by TOPAR8, of a single dose of rofecoxib 50 mg was significantly greater than a single dose of enteric-coated diclofenac sodium 50 mg (20.5 vs 8.2) and placebo (20.5 vs 5.9). Patient global assessment at 8 hours was also significantly better for rofecoxib compared with enteric-coated diclofenac sodium and placebo. TOPAR24 was significantly greater for a single dose of rofecoxib 50 mg compared with 3 doses of enteric-coated diclofenac sodium 50 mg (64.1 vs 25.1) and placebo (64.1 vs 19.2). At 24 hours, the patient global assessment for rofecoxib was significantly better than that achieved with enteric-coated diclofenac sodium and placebo. The onset of analgesic effect was significantly more rapid for rofecoxib than for enteric-coated diclofenac sodium and placebo (median times: 31 minutes, >4 hours, and >4 hours, respectively). The peak analgesic effect was significantly greater for rofecoxib compared with enteric-coated diclofenac sodium (3.2 vs 1.5) and placebo (3.2 vs 1.1). The duration of analgesia was significantly longer for rofecoxib than enteric-coated diclofenac sodium (median times: >24 hours vs 1 hour and 37 minutes) and placebo (>24 hours vs 1 hour and 37 minutes). Enteric-coated diclofenac sodium was numerically greater than placebo for the key end points measuring overall efficacy (total pain relief and patient global assessment), but diclofenac sodium did not provide as much analgesic effect as expected for a drug effective for pain, osteoarthritis, and rheumatoid arthritis and did not differ significantly from placebo. Overall, both rofecoxib and enteric-coated diclofenac sodium were generally well tolerated, although the rofecoxib group had a significantly lower incidence of clinical and drug-related adverse events than the enteric-coated diclofenac sodium group. CONCLUSIONS: A single 50-mg dose of rofecoxib provided greater overall analgesic efficacy over 8 hours, more rapid onset of analgesia, greater maximum analgesic effect, and longer duration of effect than a single 50-mg dose of enteric-coated diclofenac sodium in patients with moderate to severe pain associated with oral surgery. Compared with 3 doses of enteric-coated diclofenac sodium 50 mg (50 mg every 8 hours), a single dose of rofecoxib 50 mg provided greater overall analgesic efficacy over 24 hours.     

The effect of three cyclo-oxygenase inhibitors on intensity of primary dysmenorrheic pain

OBJECTIVE: To determine the effect of 3 different cyclo-oxygenase (COX) inhibitors on primary dysmenorrheic pain. METHOD: Eleven female patients self-medicated with either placebo (sugar), 25 mg of the COX-2 specific inhibitor rofecoxib, 50 mg of the nonselective COX inhibitor diclofenac potassium, or 7.5 mg of the COX-2 selective inhibitor meloxicam, over 4 menstrual cycles. Pain was assessed using the McGill Pain Questionnaire and a visual analog scale. RESULTS: The pain response index, present pain index, and visual analog scale were highly correlated as measures of intensity of pain (r=0.81 to 0.96, P<0.0001). Rofecoxib and diclofenac potassium both decreased the duration of dysmenorrheic pain compared with placebo (P<0.001) and with meloxicam (P<0.01), and were equally effective in improving pain, compared with placebo, after each capsule (P<0.001). When compared with placebo, both drugs also provided 50% or more pain relief, after each capsule (P<0.0048). Meloxicam, although superior to placebo, was not as effective as rofecoxib and diclofenac potassium in reducing pain, and when compared with placebo, was associated with providing 50% or more of pain relief only after the third and fourth capsules (P=0.016). CONCLUSIONS: Rofecoxib and diclofenac potassium, when taken in recommended doses, were equally effective in alleviating pain associated with primary dysmenorrhea.     

A multicentre placebo-controlled study in general practice to evaluate the efficacy and safety of tizanidine in acute low-back pain

Patients (112) with acute low-back pain of recent onset were recruited to this double-blind, randomized, placebo-controlled parallel group study in general practice to evaluate the efficacy and tolerability of the muscle relaxant, tizanidine. They were treated for 7 days with tizanidine (4 mg three times daily) or matching placebo. Aspirin tablets (300 mg) were taken as required as 'rescue' medication. Symptoms were assessed by the patient and doctor before treatment, and after 3 and 7 days. Patients recorded pain and aspirin consumption in a daily diary. Both treatments were effective. In patients who had taken no medication prior to entry, aspirin consumption was almost halved in the first 3 days of taking tizanidine compared with placebo (P = 0.037). Results for pain at rest, pain at night, restriction of movement and pain on movement suggest that tizanidine may give greater improvement, earlier. No serious drug-related adverse events or abnormal biochemistry or haematology were observed in either group. Drowsiness occurred in 22% of patients taking tizanidine although, in patients with severe acute low-back pain, sedation, analgesia and bed rest might be beneficial and desired. Considerably more patients given aspirin/placebo had gastro-intestinal side-effects (P = 0.018). In conclusion, tizanidine may reduce the need for analgesics and be useful in the treatment of acute low-back pain.     

Effects of the cyclooxygenase-2 specific inhibitor valdecoxib versus nonsteroidal antiinflammatory agents and placebo on cardiovascular thrombotic events in patients with arthritis

There have been concerns that the risk of cardiovascular thrombotic events may be higher with cyclooxygenase (COX)-2-specific inhibitors than nonselective nonsteroidal antiinflammatory drugs (NSAIDs). We evaluated cardiovascular event data for valdecoxib, a new COX-2-specific inhibitor in approximately 8000 patients with osteoarthritis and rheumatoid arthritis treated with this agent in randomized clinical trials. The incidence of cardiovascular thrombotic events (cardiac, cerebrovascular and peripheral vascular, or arterial thrombotic) was determined by analyzing pooled valdecoxib (10-80 mg daily), nonselective NSAID (diclofenac 75 mg bid, ibuprofen 800 mg tid, or naproxen 500 mg bid) and placebo data from 10 randomized osteoarthritis and rheumatoid arthritis trials that were 6-52 weeks in duration. The incidence rates of events were determined in all patients (n = 7934) and in users of low-dose (< or =325 mg daily) aspirin (n = 1051) and nonusers of aspirin (n = 6883). Crude and exposure-adjusted incidences of thrombotic events were similar for valdecoxib, NSAIDs, and placebo. The risk of serious thrombotic events was also similar for each valdecoxib dose. Thrombotic risk was consistently higher for users of aspirin users than nonusers of aspirin (placebo, 1.4% vs. 0%; valdecoxib, 1.7% vs. 0.2%; NSAIDs, 1.9% vs. 0.5%). The rates of events in users of aspirin were similar for all 3 treatment groups and across valdecoxib doses. Short- and intermediate-term treatment with therapeutic (10 or 20 mg daily) and supratherapeutic (40 or 80 mg daily) valdecoxib doses was not associated with an increased incidence of thrombotic events relative to nonselective NSAIDs or placebo in osteoarthritis and rheumatoid arthritis patients in controlled clinical trials.     

Relief of painful diabetic peripheral neuropathy with pregabalin: a randomized, placebo-controlled trial.

This was a 6-week, randomized, double-blind, multicenter study evaluating the efficacy of pregabalin in the treatment of painful diabetic neuropathy. Two hundred forty-six men and women with painful diabetic neuropathy received pregabalin (150 or 600 mg/day by mouth) or placebo. The primary efficacy variable was mean pain score at the end of treatment. Efficacy results indicate that pregabalin 600 mg/day significantly decreased mean pain score to 4.3 (vs 5.6 for placebo, P = .0002) and increased the proportion of patients who had a > or =50% decrease from baseline pain (39% vs 15% for placebo, P = .002). Pregabalin also significantly reduced sleep interference, past week and present pain intensity, sensory and affective pain scores, and bodily pain and decreased by > or =50% the number of patients describing their pain as gnawing, sickening, fearful, and punishing-cruel. More patients receiving pregabalin 600 mg/day than placebo showed improvement, as rated on the Clinical and Patient Global Impression of Change scales, 73% vs 45% and 85% vs 47%, respectively. Pregabalin 150 mg/day was essentially no different from placebo. Dizziness was the most common side effect. These study results show pregabalin 600 mg/day to be safe and effective in reducing the pain and other associated symptoms of painful diabetic neuropathy. PERSPECTIVE: Painful diabetic peripheral neuropathy is a challenging neuropathic pain syndrome. This randomized controlled trial demonstrates that pregabalin, a new drug that interacts with the alpha2-delta protein subunit of the voltage-gated calcium channel, is an efficacious and safe treatment for the pain of this condition.     

The role of rofecoxib, a cyclooxygenase-2-specific inhibitor, for the treatment of non-cancer pain: a review.

Rofecoxib was the first specific inhibitor of cyclooxygenase-2 (COX-2) approved for the treatment of acute pain. It has been shown to provide analgesia that is significantly better than placebo and has an onset of action and efficacy similar to that of traditional nonselective nonsteroidal anti-inflammatory drugs (NSAIDs), such as naproxen and ibuprofen. In addition, the analgesic efficacy of rofecoxib has been demonstrated to be superior to that of the opioid combination of codeine 60 mg/acetaminophen 600 mg in an acute dental pain model. For the treatment of acute pain, the efficacy of rofecoxib was further demonstrated in a study of patients who had undergone orthopedic surgery. Rofecoxib has been found to be as effective as naproxen sodium and more effective than placebo in studies evaluating its use for the treatment of primary dysmenorrhea. In patients with osteoarthritis (OA) of the knee or hip, rofecoxib is superior to placebo and similar to diclofenac and ibuprofen in relieving OA pain and improving physical function. Rofecoxib has also been shown to be superior to acetaminophen and celecoxib after 6 weeks of treatment for OA. The efficacy of rofecoxib has also been demonstrated in patients with rheumatoid arthritis and low back pain. The advantages of using COX-2-specific NSAIDs include convenient once-daily dosing schedule and improved safety compared with traditional NSAIDs. Two large outcomes studies, VIGOR and CLASS, have shown that gastric mucosal ulceration occurs significantly less often in patients taking COX-2-specific inhibitors than in those treated with ibuprofen, diclofenac, or naproxen and occurs with a similar incidence to that of placebo. Absence of any effect on platelet aggregation and bleeding time further distinguishes these agents from traditional NSAIDs. Because COX-2-specific inhibitors do not have an antiplatelet effect, they cannot be used as a substitute for low-dose aspirin for cardiovascular prophylaxis. Rofecoxib is a safe and highly effective alternative to previously available NSAIDs and should be considered for the treatment of acute pain conditions in adult patients, especially those at risk for developing gastrointestinal complications. It is preferred in the perioperative setting because of its analgesic efficacy and lack of platelet effects. Because of its more favorable gastrointestinal toxicity profile compared with nonselective NSAIDs, rofecoxib is safer in patients, especially older patients, for whom chronic anti-inflammatory or analgesic therapy is indicated.     

Comparative efficacy and safety of skeletal muscle relaxants for spasticity and musculoskeletal conditions: a systematic review

Skeletal muscle relaxants are a heterogeneous group of medications used to treat two different types of underlying conditions: spasticity from upper motor neuron syndromes and muscular pain or spasms from peripheral musculoskeletal conditions. Although widely used for these indications, there appear to be gaps in our understanding of the comparative efficacy and safety of different skeletal muscle relaxants. This systematic review summarizes and assesses the evidence for the comparative efficacy and safety of skeletal muscle relaxants for spasticity and musculoskeletal conditions. Randomized trials (for comparative efficacy and adverse events) and observational studies (for adverse events only) that included oral medications classified as skeletal muscle relaxants by the FDA were sought using electronic databases, reference lists, and pharmaceutical company submissions. Searches were performed through January 2003. The validity of each included study was assessed using a data abstraction form and predefined criteria. An overall grade was allocated for the body of evidence for each key question. A total of 101 randomized trials were included in this review. No randomized trial was rated good quality, and there was little evidence of rigorous adverse event assessment in included trials or observational studies. There is fair evidence that baclofen, tizanidine, and dantrolene are effective compared to placebo in patients with spasticity (primarily multiple sclerosis). There is fair evidence that baclofen and tizanidine are roughly equivalent for efficacy in patients with spasticity, but insufficient evidence to determine the efficacy of dantrolene compared to baclofen or tizanidine. There is fair evidence that although the overall rate of adverse effects between tizanidine and baclofen is similar, tizanidine is associated with more dry mouth and baclofen with more weakness. There is fair evidence that cyclobenzaprine, carisoprodol, orphenadrine, and tizanidine are effective compared to placebo in patients with musculoskeletal conditions (primarily acute back or neck pain). Cyclobenzaprine has been evaluated in the most clinical trials and has consistently been found to be effective. There is very limited or inconsistent data regarding the effectiveness of metaxalone, methocarbamol, chlorzoxazone, baclofen, or dantrolene compared to placebo in patients with musculoskeletal conditions. There is insufficient evidence to determine the relative efficacy or safety of cyclobenzaprine, carisoprodol, orphenadrine, tizanidine, metaxalone, methocarbamol, and chlorzoxazone. Dantrolene, and to a lesser degree chlorzoxazone, have been associated with rare serious hepatotoxicity.     

Oral ibuprofen and diclofenac in post-operative pain: a quantitative systematic review

Surveys show consistently that pain is not treated well. Improvement depends on knowing which treatments are the most effective. We used systematic review to compare the relative efficacy of two common analgesics, ibuprofen and diclofenac, in post-operative pain.Studies were identified by searching MEDLINE (1966 to Dec 1996), EMBASE (1980 to Jan 1997), the Cochrane Library (Aug 1996), Biological Abstracts (Jan 1985 to Dec 1996) and the Oxford Pain Relief Database (1950 to 1994). We sought randomised, controlled, single-dose comparisons of oral ibuprofen or diclofenac against placebo. Summed pain relief or pain intensity difference over 4–6 h was extracted and converted into dishotomous information yielding the number of patients with at least 50% pain relief. This was then used to calculate the relative benefit and the number-needed-to-treat for one patient to achieve at least 50% pain relief.Thirty-four reports compared ibuprofen and placebo (3591 patients), six compared diclofenac with placebo (840 patients), and there were two direct comparisons of diclofenac 50 mg and ibuprofen 400 mg (130 patients). In post-operative pain, the numbers-needed-to-treat for ibuprofen 200 mg were 3.3 (95% confidence interval 2.8–4.0) compared with placebo, for ibuprofen 400 mg 2.7 (2.5–3.0), for ibuprofen 600 mg 2.4 (1.9–3.3), for diclofenac 50 mg 2.3 (2.0–2.7) and for diclofenac 100 mg 1.8 (1.5–2.1). Direct comparisons of diclofenac 50 mg with ibuprofen 400 mg showed no significant difference between the two.Both drugs worked well. Choosing between them is an issue of dose, safety and cost.