• Tidak ada hasil yang ditemukan

Penilaian Skoring RA

BAB 6. KESIMPULAN DAN SARAN

6.1 Kesimpulan

Pada penelitian kami dijumpai penurunan persen skor rinitis alergi sebelum

diterapi dan sesudah diterapi dengan cetirizin atau loratadin tetapi secara

statisitik tidak dijumpai perbedaan yang signifikan skor rinitis alergi antara

terapi cetirizin dan loratadin yang dievaluasi pada hari ke-3, ke-7 dan ke-14.

Kami juga menilai efek samping dari kedua obat pada hari ke-3, ke-7 dan ke-

14 ternyata secara statistik dijumpai perbedaan yang signifikan efek samping

sakit kepala dan jantung berdebar dengan loratadin.

6.2 Saran

Uji cukit merupakan pemeriksaan yang paling peka untuk reaksi yang

diperantarai oleh IgE dengan pemeriksaan ini alergen penyebab akan dapat

diketahui. Dalam penelitian ini diagnosis rinitis alergi ditegakkan hanya

berdasarkan anamnesis, pemeriksaan THT rutin tanpa pemeriksaan tes kulit

BAB 7. RINGKASAN

Telah dilakukan penelitian secara uji klinis acak tersamar ganda yang

bertujuan membandingkan efikasi loratadin dengan cetirizin pada anak

penderita rinitis alergi. Penelitian dilakukan di SMP Alwasliyah dan SMP

Univa di kota Medan Propinsi Sumatera Utara, dilakukan mulai Oktober

sampai November 2009. Penelitian berlangsung selama 2 minggu. Dari 475

siswa yang diperiksa terdapat penderita rinitis alergi sebanyak 150 orang.

Sampel didapat 100 siswa yang memenuhi kriteria inklusi yaitu anak sekolah

usia 13-16 tahun yang menderita rinitis alergi dan didukung pemeriksaan

hidung dengan alat spekulum untuk menilai anatomi hidung dan mendukung

rinitis alergi, adanya riwayat atopi dalam keluarga dan orang tua mengisi

informed consent.

Sampel dipilih secara acak dengan randomisasi sederhana

menggunakan tabel random. Terdiri dari dua kelompok yaitu 50 anak

mendapat terapi cetirizin 10 mg dan 50 anak mendapat terapi loratadin 10

mg. Gejala klinis di evaluasi pada hari ke-3,-7 dan hari ke-14. Sebelum

pemberian terapi didapatkan jumlah anak penderita rinitis alergi dengan skor

berat pada kelompok cetirizin 29 siswa (58%) dan kelompok loratadin 34

(68%), penderita rinitis alergi dengan skor sedang pada kelompok cetirizin

Pada evaluasi hari ke-14, didapatkan jumlah anak yang tidak

mengalami keluhan lebih banyak pada kedua kelompok terapi, 43 anak

(86%) pada kelompok cetirizin dan 37 anak (74%) pada kelompok loratadin.

Akan tetapi tidak didapatkan perbedaan yang bermakna secara statistik (P = 0.057). Pada studi ini didapatkan efek samping yang lebih besar pada anak

yang diberi terapi loratadin pada hari ketiga dan hari ketujuh dibandingkan

pada kelompok cetirizin (P < 0.05).

Sebagai kesimpulan tidak ada perbedaan efikasi yang bermakna

Summary

A randomized clinical trials research has been done to compare cetirizine and

loratadine efficacy on children suffer from allergic rhinitis. The research are

done in Alwasliyah Junior High School and Univa Junior High School in city of

Medan, North Sumatera, started since October until November 2009. This

study are been held in two weeks time. One hundred fifty were allergic rhinitis

from a total of 475 students. One hundred sample are taken using diagnosed

with which is students aged between 13 until 16 years who suffered from

allergic rhinitis and supported by nose examination with speculum to evaluate

nose anatomy and diagnose with allergic rhinitis, familial atopic history and

parents who are willing to sign the informed consent.

Sample are choosen randomly using simple randomized from a

random table. Sample are divided into two groups, fifty of there were given

cetirizine 10 mg whereas another 50 were given loratadine 10 mg. Clinical

sign was evaluated on day 3,7 and day 14. Before the therapy are given 29

sample (58%) from cetirizine therapy group only 21 sample (42%) from

loratadine therapy group were diagnosed with severe allergic instead. Fourty

two persen cetirizine group were put under moderate score while 32% from

On the 14-day of evaluation there are more children with complaint in

this two group therapy, fourty three childrens (86%) in cetirizine group and 37

children (74%) in loratadine group. But there are no significant difference

statictically (P = 0.057). In this study, there are greater side effect when treated children with loratadine on day-3 and day-7 than treated with cetirizine

group (P < 0.05). For conclusion, there are no significant differente effication between cetirizine and loratadine in decreasing allergic rhinitis symptoms.

Daftar Pustaka

1. Strachan D, Sibbald B, Weiland Sl. Worldwide variations in prevalence of symptoms of allergic rhinoconjunctivitis in children: The International study of Asthma and Allergies in Childhood (ISAAC). Pediatr Allergy Immunol. 1997; 8:161-76

2. Lundback B. Epidemiology of rhinitis and asthma. Clin Exp Allergy. 1998;2:3-10

3. Melitzer EO. Evaluation of the optimal oral antihistamine for patients with allergic rhinitis. Mayo Clin Proc. 2005; 80(9):1170-6

4. Kar Hui Ng, Chong D, Wong CK, Ong HT, Lee CH, lee BW, et al. Central nervous system side effects of first and second generation antihistamines in school children with perennial allergic rhinitis: Randomized, double blind, placebo-controlled comparative study. Pediatrics. 2004;113:116-21

5. Heir B, Ortis G, Williams DM. The role of nonprescription antihistamines in the treatment of allergic rhinitis. Am pharmacists assoc. 2007;1:1-20

6. Motala C. Antihistamines in allergic disease. Curr Allergy & Clin Immun. 2009;22:71-4

7. Simons FER. Advances in H1- antihistamines. N Engl J Med. 2004; 351:2203-17

8. Pousti A, Malihi G, Bakharian, Abdullah Z. The comparative effects of four antihistamines isolated rat atria. IJPT. 2002

9. Bender BG, Berning S, Dudden R, Milgrom H., Tran ZV. Sedation and performance impairment of diphenhydramine and second-generation antihistamines; a meta analysis. J Allergy Clin Immunol. 2003;111 Suppl 4:770-6

10. Du Buske LM. Pharmacokinetics/pharmacodynamics and psychomotor performance aspects of antihistamine therapies. Clin Appl Immunol. 2001;1:277-89

11. Roongapinum S, Wajajamreon S, Fooanant S. Comparative efficacy of wheal and flare suppression among various non sedating antihistamines and the pharmacologic insights to their efficacy. J Med Assoc Thai. 2004;87:551-6

12. Davila I, Sastre J, Bartra J, Cuvillo A, Jauregui L, Montoro J, et al. Effect of antihistamines upon the cardiovascular system. J Investig Allergy Clin Immunol. 2006;16:13-23

13. Munasir Z, Rakun MW. Rinitis alergi. Dalam: Akib AAP, Munasir Z, Kurniati N, penyunting. Buku ajar alergi-imunologi anak. Jakarta: Ikatan Dokter Anak Indonesia, 2007. h. 246-52

14. Jack D, McCue MD. Safety of antihistamines in the treatment of allergic rhinitis in elderly patients. Arch Fam Med.1996;5:464-8

15. Plaut M, Valentine MD. Allergic rhinitis.N Engl J Med. 2005;353:1934-44 16. Bousquet J, Cauwenberge VP. Allergic rhinitis and its impact on

asthma (ARIA). Allergy. 2002;57:841-55

17. Bosquet J, Khaltaev N, Cruz AA, Denburg J, Fokkens WJ, Togias A. Allergic rhinitis and its impact on asthma (ARIA) update in collaboration with the world health organization. Allergy. 2008:63;8-160 18. Lee STS, Amin MJ. Efficacy and safety of loratadine compared with astemizole

in malaysian patients with allergic rhinitis. Singapore Med J. 1994;35:591-4 19. Baratawidjaja KG. Imunologi dasar. Edisi ke-7. Jakarta: FKUI, 2006. h. 155-75 20. Scadding G. Clinical efficacy of a histamine H1-receptor antagonist :

Predicting and establishing the clinical efficacy of a histamine H. Diunduh dari : http://www.medscape.com/viewarticle

21. Sjamsudin U, Dewoto HR. Histamin dan anti alergi. Dalam: Ganiswarna GS, Setiabudy, Suyatna FD, Purwantyastuti, Nafrilda, penyunting. Farmakologi dan terapi. Edisi ke-4. Jakarta: FKUI, 1995. h. 248-61 22. Simons FER. A new classification of H1-receptor antagonists. Allergy

1995;50:7-11

23. Simons FER. Advances in H1- antihistamines. N Engl J Med. 2004;351:2203-17

24. Motala C. H1 Antihistamines in allergic disease. Curr Allergy & Clin Immunol. 2009;22:71-4

25. Skapin SD, Matijevic E. Preparation and coating of finely dispersed drugs loratadine and danazol. J of Colloid and Interface Science. 2004;272:90-8

26. Boner AL, Miglioranzi P, Richelli C, Marchesi E, Andreoli A. Efficacy and safety of loratadine suspension in the treatment of children with allergic rhinitis. Allergy. 1989;44:437-41

27. Juhlin LA. A comparison of the pharmacodynamics of H1- receptor antagonists as assessed by the induced wheal-and-flare model. Allergy Immunol.1995;50:24-30

28. Meltzer EO, Weiler JM, Widlitz MD. Comparative outdoor study of the efficacy, onset and duration of action, and safety of cetirizin, loratadin and placebo for seasonal allergic rhinitis. J Allergy Clin Immunol. 1996;97 Suppl 2 : 617-26

29. Ciprandi G, Pronzato C, Cozzani S, Tosca MA, Grimaldi L. Cetirizine reduces ICAM-1 expression on epithelial cells during nasal minimal persistent inflammation in asymptomatic children with mite allergic asthma. Int Arch Allergy Immunol. 1996;109:272-6

reduces epithelial ICAM-1 expression. Clin Exp Allergy. 1997;27:118- 23

31. ETAC Study group. Allergic factors associated with the development of asthma and the influence of cetirizine in a double-blind, randomised, placebo-controlled trial: First result of ETAC. Pediatric Allergy Immunol.1998;116-24

32. Madiyono B, Moeslichan S, Sastroasmoro S, Budiman I, Purwanto SH. Perkiraan besar sampel. Dalam : Sastroasmoro S, Ismael S. Dasar- dasar metodologi penelitian klinis. Edisi ke-3. Jakarta : Sagung Seto, 2008. h. 302–31

33. Day JH, Briscoe M, Widlitz MD. Cetirizine, loratadine or placebo in subjects with seasonal allergic rhinitis: Effects after controlled ragweed pollen challenge in an environmental exposure unit. J Allergy Clin Immunol.1998;101:638-45

34. Sienra-Monge JJ, Gazca-Aguilar A, Del Rio-Navarro B. Double blind comparison of cetirizine and loratadine in children ages 2 to 6 years with parrenial allergic rhinitis. Am J Ther. 1999;6:149-55

35. Salmun LM, Gates D, Scharf M, Greiding L, Ramon F, Heithoff K. Loratadine versus cetirizine: Assessment of somnolence and motivation during the workday. Clin Ther. 2000;22:573-82

36. Ten Eick AP, Blumer JL, Reed MD. Safety of antihistamines in children. Drug Safety. 2001;24:119-47

37. Olin BR. Drug facts and comparison. St. Louis: Facts and Comparison. 2001;698-707

38. Mann RD, Pearce GL, Dunn N, Shakir S. Sedation with” non sedating” antihistamines: four prescription-event monitoring studies in general practice. BMJ. 2000;320:1184-6

39. Woosley RI. Cardiac actions of antihistamines. Annu Rev Pharmacol Toxicol.1996;36:233-52

40. Adkinson NF Jr, Yunginger JW, Busse WW. Middleton’s Allergy: Principles and practice. Edisi ke- 6. Philadelphia, PA:Mosby. 2003 41. Kar Hui Ng, Chong D, Wong CK, Ong HT, Lee CH, lee BW, Chi shek

LP. Central nervous system side effects of first and second generation antihistamines in school children with perennial allergic rhinitis: Randomized, double blind, placebo-controlled comparative study. Pediatrics. 2004;113:116-21

42. Potter PC. Levocetirizine is effective for symptom relief including nasal congestion in adolescent and adult (PAR) sensitized to house dust mites. Journal of Asthma and Allergy. 2003;58: 893-9

43. Spector SL, NicklasRA, Chapman JA, bernstein IL, Berger WE, Moore JB,dkk. Symptom severity assessment of allergic rhinitis: Part 1. Ann Allergy Asthma Immunol. 2003;91(2):105-14

44. Allergic rhinitis and its impact on asthma (ARIA). At-a glance out patient allergic rhinitis pocket reference. 2006;1-12

45. Dreborg S, Frew A. Allergen standardization and skin tests. Allergy.1993;48:4975

46. Boot JD, Chandoesing P, de Kam ML, Mascelli MA, Das AM, Gerth van WR,dkk. Applicability and reproducibility of biomarkers for the evaluation of anti-inflammatory therapy in allergic rhinitis. J Investig Allergol Clin Immunol. 2008;18(6):433-42.

47. Weiner JM, Abramson MJ, Puy RM. Intranasal corticosteroids versus oral H1 receptor antagonists in allergic rhinitis; systemic review of randomised controlled trials. BMJ.1998;317:1624-29

48. Negrini AC, Troise C, Voltolini S, Horak F, Bachert C, Janssen M. Oral anti histamine/ decongestant treatment compared with intranasal corticosteroids in seasonal allergic Rhinitis. Clin Exp Allergy.1995;25:60-5

49. Bagnasco M, Canonica GW. Influence of H1-receptor antagonists on adhesion molecules and celullar traffic. Allergy Immunol.1995;50:17-23 50. Simons FER. Prospective, long term safety evaluation of the H1-

receptor antagonist cetirizine in very young children with atopic dermatitis. Journal Allergy Clinical Immunol.1999;104: 433-40

51. Melitzer EO. Evaluation of the optimal oral antihistamine for patients with allergic rhinitis. Mayo Clinic Proceedings. 2005; 80 (9):1170-6 52. Lehman JM, Blaiss MS. Selecting the optimal oral antihistamine for

patiens with allergic rhinitis. Drugs. 2006;66:2309-19

53. Hore I, georgalas C, Scadding G. Oral antihistamines for persistent allergic rhinitis in adults and children over 12 years old ( Protocol) . The Cochrane Collaboration.2008

54. Watanasomsiri A, Poachanukoon O, Vichyanond P. Efficacy of montelukast and loratadine as treatment for allergic rhinitis in children. Asian Pacific Journal of Allergy and Immunology. 2008;26:89-95

55. James HD, Brisco, Rafeiro M, Elizabeth, Chapman, Douglass, dkk. Comparative onset of action and symptom relief with cetirizine, loratadine, or placebo in an environmental exposure unit in subjects with seasonal allergic rhinitis: confirmation of a test system. Annals of Allergy, Asthma and Immunology. 2001;

Lampiran 1.

INFORMED CONSENT

Dokumen terkait