Department of Pharmacology, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India.
Pain Med. 2012 Mar;13(3):466-71. doi: 10.1111/j.1526-4637.2011.01314.x. Epub 2012 Feb 1.
To evaluate the analgesic efficacy and safety of intramuscular drotaverine hydrochloride vs diclofenac sodium in treatment of acute renal colic.
We conducted a randomized, single-blind study comparing single intramuscular doses of drotaverine hydrochloride (80 mg) vs diclofenac sodium (75 mg) on 100 patients (50 in each arm) presenting to the emergency department (ED) with renal colic. Subjects with inadequate pain relief at 30 minutes received rescue intramuscular tramadol (100 mg). Pain intensity was recorded using a visual analog scale (VAS), which is the primary outcome measure of this study, before drug administration and 30 and 60 minutes afterwards. The drug effectiveness was defined as ≥50% decrease in pain intensity 60 minutes after intramuscular administration, without exacerbation during the following 2 hours. The need for rescue medication and the presence of adverse effects were considered as secondary outcome of the study.
VAS decreased significantly (P < 0.001) with both drotaverine (52.4%) and diclofenac (49%) at 30 minutes. Reduction of VAS at 60 minutes was 61.3% with drotaverine in comparison to 60.4% with diclofenac. Forty-five patients (90%) in the drotaverine group and 44 (88%) in the diclofenac group found the therapy effective. The need for rescue medication was in five patients of the drotaverine group and six patients in the diclofenac group. There was no significant difference in safety profile in the study groups.
The efficacy and safety of drotaverine as analgesic in renal colic is noninferior to diclofenac and may be used as an alternative or add-on therapy to currently available options.
评估盐酸丁咯地尔与双氯芬酸钠肌内注射治疗急性肾绞痛的镇痛效果和安全性。
我们进行了一项随机、单盲研究，比较了 100 例（每组 50 例）急诊就诊的肾绞痛患者单次肌内注射盐酸丁咯地尔（80mg）与双氯芬酸钠（75mg）的效果。30 分钟后疼痛缓解不足的患者接受肌内注射曲马多（100mg）补救治疗。在给药前、给药后 30 分钟和 60 分钟使用视觉模拟评分（VAS）记录疼痛强度，这是本研究的主要结局指标。肌内注射后 60 分钟，疼痛强度下降≥50%且在随后的 2 小时内无加重定义为药物有效。补救用药的需要和不良反应的发生被认为是研究的次要结局。
丁咯地尔（52.4%）和双氯芬酸钠（49%）在 30 分钟时均显著降低 VAS（P<0.001）。丁咯地尔组 VAS 在 60 分钟时的下降率为 61.3%，而双氯芬酸钠组为 60.4%。丁咯地尔组 45 例（90%）和双氯芬酸钠组 44 例（88%）患者认为治疗有效。丁咯地尔组有 5 例患者需要补救用药，双氯芬酸钠组有 6 例。两组安全性特征无显著差异。
丁咯地尔作为肾绞痛的镇痛剂，其疗效和安全性不劣于双氯芬酸钠，可作为现有治疗选择的替代或附加治疗。
