Akut Renal Kolik Ağrısı Olan Türk Hastalarda Kısa Süreli Metamizol Sodyum ile Diklofenak Sodyum tedavilerinin karşılaştırılması; Bir Çift Kör, Gözlemsel Çalışma

Amaç: Renal kolik ağrısı, acil servis başvurularının en sık nedenlerinden biridir. Metamizol sodyum ve diklofenak, ilaçların bulunduğu ülkelerde en yaygın kullanılan narkotik olmayan ilaçlardır. Bu çalışmanın amacı, Ankara’daki acil servislerde akut renal kolik ağrısının tedavisinde metamizol sodyum ve diklofenak’ın etkinliğini ve güvenliğini karşılaştırmaktır.Yöntem: Renal kolik ağrısı olan 88 hasta intramüsküler metamizol sodyum 1 g n=48 veya diklofenak sodyum 75 mg n=40 ile tedavi edildi. Ağrı şiddeti, ilaç uygulanmadan önce başlangıç düzeyi ve uygulandıktan 30, 60, 90 ve 120 dakika sonra, Görsel Analog Skala 0100 mm ve 5-Nokta Sözel Derecelendirme Ölçeği ile ölçüldü. Bulgular: Her iki tedavi grubu da yaş, cinsiyet ve başlangıçtaki ağrı şiddeti yönlerinden analiz edildiğinde homojendi. Her iki tedavi de iyi tolere edildi ve gözlenen yan etkilerin hiçbiri ciddi değildi. Metamizol sodyum grubunda beş, diklofenak grubunda ise üç hasta ek tedaviye ihtiyaç duydu. Ölçülen tüm zaman noktaları için gruplar arasındaki ortalama ağrı şiddeti farkı anlamlı değildi. Her iki ilaç için de hekim ve hasta değerlendirmeleri arasında anlamlı fark yoktu. Sonuç: Sonuçlarımız akut renal kolik tedavisinde i.m. 1 g metamizol sodyumun, iki saatlik gözlem dönemi için i.m. 75 mg diklofenak sodyum kadar etkili olduğunu göstermektedir

Anahtar Kelimeler:

Renal kolik, metamizol sodyum, diklofenak sodyum

Short-Term Use Of Metamizole Sodium Versus Diclofenac Sodium In Acute Renal Colic Pain In Turkish Patients; A Double-Blind, Observational Study

Objective: Renal colic pain is one of the most frequent reasons for emergency department visits. Metamizole sodium and diclofenac are the most common used non-narcotic drugs in available countries. The objective of this study was to compare the effectiveness and safety of metamizole sodium and diclofenac in treatment of acute renal colic pain in emergency room services in Ankara, Turkey.Methods: Eighty-eight patients with renal colic were treated intramuscularly i.m. with metamizole sodium 1 g n=48 or diclofenac sodium 75 mg n=40 . Pain intensity was measured by using visual analogue scale 0-100 mm and 5-point verbal score before baseline and after 30, 60, 90 and 120 minutes of i.m. drug administration.Results: Both of the treatment groups were homogeneous when analyzed by age, sex and baseline pain intensity. Both treatments were well tolerated and none of the observed side effects were serious. Five patients in the metamizole sodium and three patients in the diclofenac group needed extra treatment. The average pain intensity difference between groups for all time points measured was not significantly different. There was no significant difference in physician and patient evaluations for both drugs. Sonuç: Sonuçlarımız akut renal kolik tedavisinde i.m. 1 g metamizol sodyumun, iki saatlik gözlem dönemi için i.m. 75 mg diklofenak sodyum kadar etkili olduğunu göstermektedir

Keywords:

Renal colic, metamizole sodium, diclofenac sodium,

PDF

___

Edwards JE, Meseguer F, Faura C, Moore RA, McQuay HJ. Single dose dipyrone for acute renal colic pain. Cochrane Database Syst Rev. 2002; (4):CD003867.
Giovannetti M, Machado MA, Borrelli Jşnior M, Ikejiri CI, Alonso N, Branco PD. Tissue necrosis: a side effect of sodium diclofenac: report of cases and discussion of the physiopathology. Rev Hosp Clin Fac Med Sao Paulo. 1993;48(1):39-42.
Cagliyan CE, Balli M, Tekin K, Turkmen S, Tanboga HI. Kounis syndrome triggered by diclofenac sodium injection which leads to myocardial infarction and cardiac arrest. Journal of Cardiology Cases.2013;8(1):e17-e19.
Singh R, Bansal D, Baduni N, Vajifdar H. Anaphylactic reaction to intravenous diclofenac. Indian J Crit Care Med 2011;15:37-9. Neki N, Sharma R, Gupta S, Gupta H, Manie T. Case Report_Anaphylactic Reaction to Intramuscular Diclofenac. Case Reports from the Tropics. 2013;1(1): e2.
Colak S, Gunes H, Afacan MA, Kandis H, Erdogan MO, Ayranci M, Saritas A. Anaphylaxis after intramuscular injection of diclofenac sodium. Am J Emerg Med. 2014 Jul;32(7):815.e1-2. doi: 10.1016/j.ajem.2013.12.049.
Godara S., Srivastava R., Vashist M., & Godara R. Lornoxicam versus diclofenac sodium in acute renal colic: a prospective randomized trial. International Journal of Basic & Clinical Pharmacology. 2017;2(2):193-198.
Shams-Vahdati S, Robaei N, Habibollah P, Jafari- Rouhi A , Mohammadi S, et al. Paracetamol vs. Intravenous Morphine Plus Diclofenac in Renal Colic Pain: A Randomized Clinical Trial, Nephro- Urol Mon. 2018;10(4):e77193. doi: 10.5812/ numonthly.77193.
Pathan SA, Mitra B, Cameron PA. A Systematic review and meta-analysis comparing the efficacy of nonsteroidal anti-inflammatory drugs, opioids, and paracetamol in the treatment of acute renal colic. Eur Urol. 2018 ;73(4):583-595. doi: 10.1016/j. eururo.2017.11.001.
Garcća-Alonso Dr. F. Comparative study of the efficacy of dipyrone, diclofenac sodium and pethidine in acute renal colic. European Journal of Clinical Pharmacology 40 (2004): 543-6.
Kötter T, da Costa BR, Fässler M, Blozik E, Linde K, Jüni P, et al. Metamizole-Associated. Adverse events: A systematic review and metaAnalysis. PLoS ONE. 2015;10(4): e0122918. doi:10.1371/ journal.pone.0122918.
Miralles R, Cami J, Gutierrez J, Torne J, Garces JM, Badenas JM. Diclofenac versus dipyrone in acute renal colic: a double-blind controlled trial. Eur J Clin Pharmacol. 1987; 33(5):527-8.
Marthak KV, Gokarn AM, Rao AV, Sane SP, Mahanta RK, Sheth RD, Chavda KD, Rane BS, Vaidya AB. A multi-centre comparative study of diclofenac sodium and a dipyrone/spasmolytic combination, and a single-centre comparative study of diclofenac sodium and pethidine in renal colic patients in India. Curr Med Res Opin. 1991; 12(6):366-73.
Collaborative Group of the Spanish Society of Clinical Pharmacology. Comparative study of the efficacy of dipyrone, diclofenac sodium and pethidine in acute renal colic. Eur J Clin Pharmacol. 1991; 40(6):543-6.
EMuriel-Villoria C, Zungri-Telo E, Diaz-Curiel M, Fernandez-Guerrero M, Moreno J, Puerta J, Ortiz P. Comparison of the onset and duration of the analgesic effect of dipyrone, 1 or 2 g, by the intramuscular or intravenous route, in acute renal colic. Eur J Clin Pharmacol. 1995; 48(2):103-7.
Muriel C, Ortiz P. Efficacy of two different intramuscular doses of dipyrone in acute renal colic. Cooperative Study Group. Methods Find Exp Clin Pharmacol. 1993; 15(7):465-9.
Sanahuja J, Corbera G, Garau J, Pla R, Carmen Carre M. Intramuscular diclofenac sodium versus intravenous Baralgin in the treatment of renal colic. DICP. 1990; 24(4):361-4.
Burroughs VJ, Maxey RW, Levy RA. Racial and ethnic differences in response to medicines: towards individualized pharmaceutical treatment. J Natl Med Assoc. 2002; 94(10 Suppl):1-26.
Babaoglu MO, Yasar U, Sandberg M, Eliasson E, Dahl ML, Kayaalp SO, Bozkurt A. CYP2C9 genetic variants and losartan oxidation in a Turkish population. Eur J Clin Pharmacol. 2004; 60(5):337-42.
Tulunay FC, Ergün H, Gülmez SE, Özbenli T, Özmenoğlu M, Boz C, Erdemoglu AK, Varlıkbaş A, Göksan B, İnan L. The efficacy and safety of dipyrone (Novalgin®) tablets in the treatment of acute migraine attacks: A double-blind, cross- over, randomized, placebo-controlled multi-center study. Funct Neurol 2004, 19(3):197-202.
Saray A, Buyukkocak U, Cinel I, Tellioglu AT, Oral U. Diclofenac and metamizol in postoperative analgesia in plastic surgery. Acta Chir Plast. 2001; 43(3):71-6.
Koçyiğit ID, Gülmez SE, Kaya M, Ergün H, Mocan A, Tulunay FC. Efficacy & safety of preemptive Celecoxib, Rofecoxib or dipyrone treatment in third molar surgery: A preliminary report. Clin Exp Pharmacol Physiol. 2004; 31 Suppl 1: A67.
Zwergel U, Felgner J, Rombach H, Zwergel T. Current conservative treatment of renal colic: value of prostaglandin synthesis inhibitors Schmerz. 1998; 12(2):112-7.
Lloret J, Munoz J, Monmany J, Puig X, Bonastre M, Brau J, Sola J, Domingo P, Jane F. Treatment of renal colic with dipyrone. Curr Ther Res. 1987; 42(6):1119-1128.
Ergun H, Ayhan IH, Tulunay FC. Pharmacological characterization of metamizol-induced relaxation in phenylephrine-precontracted rabbit thoracic aorta smooth muscle. Gen Pharmacol. 1999; 33(3):237-41.
Levy M, Zylber-Katz E, Rosenkranz B. Clinical pharmacokinetics of dipyrone and its metabolites. Clin Pharmacokinet. 1995; 28(3):216-34.
Kurowski M. Pharmacokinetics and biological availability of diclofenac preparations following intramuscular injection of 75 mg and oral administration of 150 mg of active drug. Z Rheumatol. 1988; 47(1):37-42.
Andrade SE, Martinez C, Walker AM. Comparative safety evaluation of non-narcotic analgesics. J Clin Epidemiol. 1998; 51(12):1357-65.