Marthak K V, Gokarn A M, Rao A V, Sane S P, Mahanta R K, Sheth R D, Chavda K D, Rane B S, Vaidya A B
Medical Department, Ciba-Geigy Ltd., Bombay, India.
Curr Med Res Opin. 1991;12(6):366-73. doi: 10.1185/03007999109111506.
A single-blind, randomized clinical trial was carried out to compare the analgesic effectiveness in patients with renal colic of single intramuscular doses of diclofenac sodium (75 mg) versus a dipyrone (1 g)/spasmolytics combination, and diclofenac sodium (75 mg) versus pethidine (75 mg). The first study involved three centres, the second study one centre. In total, 107 patients were treated with diclofenac sodium, 85 with dipyrone/spasmolytics, and 25 with pethidine. Assessments were made during the first hour after drug administration of the degree of pain relief, the severity of pain using a visual analogue scale, and the duration of analgesia. A global assessment of treatment efficacy was made by the participating physicians at the end of the study period. Patients treated with diclofenac sodium showed an earlier onset of analgesia and a higher incidence of total pain relief compared to those treated with dipyrone/spasmolytics or pethidine. Although the mean duration of analgesia was only slightly greater in the diclofenac sodium group than in the dipyrone/spasmolytics group, a significantly longer effect was seen when diclofenac sodium was compared with pethidine (p less than 0.01). Pain severity assessments revealed that diclofenac sodium caused a significantly greater improvement in pain after 60 minutes compared to dipyrone/spasmolytics (p less than 0.05) and after 30 minutes compared to pethidine (p less than 0.05). Global efficacy assessments by the physician rated diclofenac sodium as significantly superior to dipyrone/spasmolytics (p less than 0.01) and pethidine (p less than 0.001). Moreover, diclofenac sodium was better tolerated than either of the comparative treatments. The results indicate that intramuscular diclofenac sodium is a useful alternative to the drugs commonly used in India in the treatment of renal colic.
开展了一项单盲随机临床试验，比较单次肌内注射双氯芬酸钠（75毫克）与安乃近（1克）/解痉药组合，以及双氯芬酸钠（75毫克）与哌替啶（75毫克）对肾绞痛患者的镇痛效果。第一项研究涉及三个中心，第二项研究涉及一个中心。总共107例患者接受了双氯芬酸钠治疗，85例接受了安乃近/解痉药治疗，25例接受了哌替啶治疗。在给药后的第一小时内，对疼痛缓解程度、使用视觉模拟量表评估的疼痛严重程度以及镇痛持续时间进行了评估。参与研究的医生在研究期结束时对治疗效果进行了整体评估。与接受安乃近/解痉药或哌替啶治疗的患者相比，接受双氯芬酸钠治疗的患者镇痛起效更早，完全缓解疼痛的发生率更高。虽然双氯芬酸钠组的平均镇痛持续时间仅比安乃近/解痉药组略长，但与哌替啶相比，双氯芬酸钠的作用持续时间显著更长（p<0.01）。疼痛严重程度评估显示，与安乃近/解痉药相比，双氯芬酸钠在60分钟后疼痛改善显著更大（p<0.05），与哌替啶相比，在30分钟后疼痛改善显著更大（p<0.05）。医生的整体疗效评估将双氯芬酸钠评为显著优于安乃近/解痉药（p<0.01）和哌替啶（p<0.001）。此外，双氯芬酸钠的耐受性优于两种对照治疗药物。结果表明，肌内注射双氯芬酸钠是印度治疗肾绞痛常用药物的一种有用替代药物。
