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Topikal Olopatadine Hidroklorida dibandingkan Ketotifen fumarat


untuk alergi Konjungtivitis
Dharmistha Patel1.MD; Sarala N1.MD; Narendra Panduranga Datti2, NONA
1Departemen Farmakologi, Sri Devaraj Urs Medical College, Sri Devaraj Urs Akademi Pendidikan Tinggi dan Riset, Tamaka,
Kolar, Karnataka, India
2Departemen Ophthalmology, Sri Devaraj Urs Medical College, Sri Devaraj Urs Akademi Pendidikan Tinggi dan Riset, Tamaka,
Kolar, Karnataka, India

Abstrak
Tujuan: Alergi konjungtivitis (AC) dikaitkan dengan gatal-gatal, kemerahan, merobek, nyeri, dan
pembakaransensasi di mata. Proses inflamasi disebabkan oleh mekanisme hipersensitifdue to direct contact
with the allergen. This process triggers mast cells in the conjunctiva to activate and release mediators. The purpose
of this study was to compare topical olopatadine and ketotifen in terms of effectiveness and safety for the
management of AC.
Methods: Patients clinically diagnosed with AC were randomized into two groups of 60 patients each and received
either topical olopatadine HCl 0.1% or ketotifen fumarate 0.025%. They were followed up on the 4 th, 15th, and 30th
days to evaluate symptoms, signs, and quality of life (QOL) scoring.
Results: There were a total of 120 patients (67 men and 53 women) with a mean age of 36.35 ± 11 years.
Compared to baseline, scores of itching, tearing, redness, eyelid swelling, chemosis and papillae addition of all the
individual scores mentioned above and QOL scores reduced significantly (P = 0.001) by the 4th and 15th days of
olopatadine and ketotifen application. Compared with ketotifen, olopatadine significantly reduced itching,
tearing, hyperemia, and total AC scores by the 4th day (P = 0.001) and conjunctival papillae by the 15th day (P = 0.001).
Adverse reactions were reported in 10% and 18% of patients treated with olopatadine and ketotifen, respectively.
Conclusion: Compared to ketotifen, olopatadine provided quicker relief of symptoms, and improvedsymptoms of
AC and QOL, with fewer side effects.

Keywords: Allergic Conjunctivitis; Ketotifen Fumarate; Olopatadine Hydrochloride


J Ophthalmic Vis Res 2018; 13 (2): 119–123

INTRODUCTION burning sensation, and foreign body sensation.[1,2] These


symptoms affect academic performance and the quality of
Allergic conjunctivitis (AC) is an atopic ocular condition, life (QOL), resulting in a loss of productivity.[3] AC can
which is associated with itching, redness, tearing, pain, affect both children and adults, often coexisting with other
allergic diseases, such as asthma, atopic dermatitis, or food
Correspondence to: allergies.[4] According to the International Ocular
Sarala N, MD. Sri Devaraj Urs Medical College, Sri Devaraj Urs
Inflammation Society (IOIS), AC can be subdivided
Academy of Higher Education and Research, Tamaka, Kolar,
into seasonal allergic conjunctivitis (SAC) and perennial
Karnataka 563 102, India. E‑mail: n_sarala@rediffmail.com
AC. It also includes atopic keratoconjunctivitis, vernal

Received: 19‑04‑2017 Accepted: 09‑10‑2017 Ini adalah sebuah jurnal akses terbuka, dan artikel didistribusikan di bawah ketentuan
Creative Commons Atribusi-NonCommercial-Berbagi Serupa 4.0 License, yang
Access this article online memungkinkan orang lain untuk mencampur, tweak, dan membangun atas karya non-
komersial, selama kredit yang sesuai diberikan dan kreasi baru dilisensikan di bawah
Quick Response Code: ketentuan yang identik.
Website:
www.jovr.org Untuk kontak cetak ulang: reprints@medknow.com

Bagaimana mengutip artikel ini: Patel D, Sarala N, Datti NP.


DOI:
10.4103/jovr.jovr_85_17
Topikal olopatadine hidroklorida dibandingkan fumarate Ketotifen
untuk konjungtivitis alergi. J Kedokteran Vis Res 2018; 13: 119-23.

© 2018 Journal dari HAIphthalmic dan Vision Research| Published oleh Wolters Kluwer - Medknow 119
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Olopatadine vs Ketotifen fumarat untuk alergi Konjungtivitis; Patel et al

keratoconjunctivitis, raksasa konjungtivitis papiler, dan dari angsur obat mereka. Berikut ini tercatat pada
Kulit dan kontak-conjunctivitis, which differ in their pemeriksaan klinis. Gejala dan tanda-tanda pasien dinilai
manifestations, clinical course, and treatment.[5] menggunakan skala, dengan skor mulai dari 0 hingga 16
AC is an inflammatory disorder of the mucous tahun.[8] QOL setiap pasien adalah dinilai menggunakan
membrane that covers the sclera. It is caused by an kuesioner yang terdiri dari 15 pertanyaan, dengan skor
immunoglobulin E‑mediated immune or immediate berkisar 0-90.[9]
hypersensitivity reaction resulting from direct contact of the Penilaian gejala dan tanda-tanda mencetak dilakukan
allergen with the conjunctival surface in sensitized patients, pada 1st Kunjungan (baseline), 4th hari, dan 15thhari. Jika
which triggers mast cell activation and the release of tanda-tanda klinis bertahan, para peserta juga dievaluasi
different mediators.[6] Other mechanisms, such as pada 30th hari. The QOL kuesioner adalah diberikan pada
neurogenic and systemic immune response may also play a 1st, 4th, Dan 15thhari. Para peserta diminta untuk membawa
role.[4] buku harian mereka untuk setiap kunjungan untuk
AC can be treated by minimizing allergen contact with memeriksa kepatuhan. Perbaikan gejala dan tanda-tanda
the conjunctiva, through a series of preventive measures pasien dievaluasi. reaksi obat yang merugikan dicatat pada
(i.e., environmental control, cold compress, eye lubricants setiap kunjungan. Biaya dihitung berdasarkan jumlah yang
without preservatives, and contact lenses). Furthermore, the dibelanjakan oleh pasien untuk pemulihan lengkap AC.
symptoms triggered by the allergic inflammatory process
can be controlled by the administration of antihistamines,
mast cell stabilizers, non‑steroidal anti‑inflammatory Analisis statistik
drugs (NSAIDs), and corticosteroids. Topical olopatadine
HCl 1 mg/ml and ketotifen fumarate 250 mg/ml have mast Sampel ukuran yang diperlukan untuk mendeteksi
cell stabilizing and antihistaminic properties.[7] The current perbedaan rata-rata 0,35 dalam skor gatal pada hari 4,
study was conducted to compare the efficacy, safety dengan efek ukuran 1,2, α-kesalahan 5%,% kekuatan 80,
profile, and cost of olopatadine HCl 0.1% and ketotifen dan angka putus sekolah 10%, adalah 32 pasien dalam
fumarate setiap kelompok. Data demografi dinyatakan sebagai
0.025% for AC. In addition, the QOL of patients was mean ± standar deviasi. data kontinu dalam dan di antara
compared between the two groups. kelompok-kelompok dianalisis menggunakan berpasangan
dan tidak berpasangan t-tes, masing-masing. Skor AC
dan kualitas hidup di dalam dan antarakelompok
METHODS dianalisis dengan menggunakan R-ANOVA dan uji t tidak
The study was conducted for a period of 1.5 years. The berpasangan, masing-masing. data kategori
study protocol was approved by Institutional Ethics dianalisismenggunakan Chi-square test. Statistik
Committee. Patients of either gender who were aged above signifikansi ditetapkanpada P <0,05.
8 years, clinically diagnosed with seasonal AC by an
ophthalmologist, and willing to provide written informed HASIL
consent/assent were recruited. Patients with bacterial,
chlamydial, viral, giant papillary, phlyctenular, purulent, Sebanyak 120 pasien dilibatkan dalam penelitian ini. Dari
and membranous conjunctivitis were excluded. The jumlah tersebut, 55 pasien dalam kelompok A dan 54 pasien
presence of dry eye syndrome, blepharitis, uveitis, keratitis, dalam kelompok B menyelesaikan studi [Gambar 1]. Ada 67
ocular trauma, or a history of ocular surgery performed in laki-laki dan 53 peserta perempuan. Seperti yang
the last 3 months led to patient exclusion. Other exclusion ditunjukkan pada Tabel 1, rincian demografis antara
criteria included retinal detachment, diabetic retinopathy, kelompok yang sebanding. Sebuah sejarah masa lalu dari
and progressive retinal disease; receiving either systemic or AC hadir di 42 (70%) dan 34 (57%) pasien dalam kelompok
topical corticosteroids and immunosuppressants; with the A dan B, masing-masing. Faktor-faktor yang memberatkan
use of mast cell stabilizers, NSAIDs, antihistaminics within untuk AC adalah variasi musiman (musim panas; 25 dan 16
the prior month; and a history of hypersensitivity to pasien, masing-masing) dan debu (17 dan 18 pasien,
olopatadine and ketotifen. Pregnant and lactating women masing-masing) [Gambar 2].
were also excluded. individual dasar dan skor AC Total sebanding antara
kelompok. Tak satu pun dari pasien memiliki chemosis.
Pasien secara acak ke dalam salah satu dari dua Dibandingkan dengan baseline, pasien yang menerima baik
kelompok; satu kelompok menerima dua tetes olopatadine olopatadine atau ketotifen menunjukkanpenurunan yang
HCl 0,1% (Winolap, diproduksi oleh Sun, Avesta) dua kali signifikan (P = 0,001) di kedua individu dan skor AC total,
sehari pada kedua mata, sementara yang lain dirawat dengan dengan 4th dan 15thhari [Tabel 2]. Antara-analisis kelompok
dua tetes ketotifen fumarat 0,025% (Albalon, diproduksi menunjukkan bahwa pada 4th hari, gatal-gatal, merobek,
oleh Allergan) empat kali sehari. Mereka diminta untuk hiperemia, dan jumlah AC skor, tapi tidak papila, telah
menjaga susu untuk merekam waktunya secara signifikan mengurangi dengan olopatadine (P =
0,001). Kelopak mata skor bengkak berkurang menjadi nol
dengan kedua obat pada
120 Journal dari HAIphthalmic dan Vision Research Volume 13, sayajar ngan 2, April-June 2018
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Olopatadine vs Ketotifen fumarat untuk alergi Konjungtivitis; Patel et al

Gambar 2. Persentase pasien dengan riwayat menjengkelkan


faktor.

variasi atau adanya debu. gejala okular dan tanda-tanda


termasuk gatal, merobek, hiperemia konjungtiva,
Gambar 1. Flowchart mewakili pengacakan dan ikuti-naik pasien. pembengkakan kelopak mata, chemosis, dan sensasi benda
asing,[10,11]yang, jika tidak ditangani, dapat menjadi lebih buruk.
Hal ini pada gilirannyadapat menyebabkan
Tabel 1. Data demografis
ketidaknyamanan yang akan mempengaruhi kualitas
Olopatadine ketotifen P* hidup tersebut. dibandingkanuntuk kortikosteroid, adalah
HCl (n = 60) fumarat
lebih baik bahwa kondisi ini diobati dengan stabilisator sel
(N = 60)
mast karena efek samping yang lebih sedikit.
Jenis kelamin
Dalam penelitian ini, dari 120 pasien yang secara klinis
Laki-laki (%) 38 (63,3%) 29 (48,3%) 0.098
didiagnosis dengan AC, 56% adalah laki-laki dan 44%
Wanita (%) 22 (36,7%) 31 (51,7%)
adalah perempuan. Laki-laki untuk perempuan rasio adalah
Umur (mean standar
± 36,35 ± 11,91 36,20 ± 12,70 0,947 1,2: 1. Sebuah studi yang dilakukan di Ghana menunjukkan
deviasi) bahwa persentase perempuan (61,8%) dipengaruhi dengan
HCl, hidroklorida; * Berdasarkan t-uji AC lebih tinggi.[12] Studi lain yang dilakukan di Nigeria,
termasuk 150 siswa (usia 5-15 tahun), melaporkan bahwa
4thhari [Tabel 2]. Oleh 15th hari, ada yang anak perempuan terdiri 59% dari kohort.[13] prevalensi
signifikanreduksi (P = 0,001) di gatal, merobek, papila, dan meningkat pada wanita telah dikaitkan dengan perubahan
skor total AC pada pasien yang menerima olopatadine. hormonal wanita.[12,13] dua studi lainnya, bagaimanapun,
Hiperemia dan kelopak mata bengkak skor, bagaimanapun, melaporkan bahwa 75,8% dan 63,28% dari pasien dengan
nol dengan kedua obat. konjungtivitis adalah laki-laki.[14,15]
Skor QOL dasar sebanding antara kelompok. Pasien dalam penelitian ini memiliki riwayat AC.
Meskipun persentase pasien melaporkan bahwa gejala AC
Dibandingkan dengan baseline, ada penurunan yang
diperburuk selama musim panas dan di hadapan debu lebih
signifikan dalam skor kualitas hidup oleh 4th dan 15th
tinggi diolopatadine kelompok, perbedaan itu tidak
hari in pasien yang menerima salah satu obat. Adatidak ada
signifikan. Sebuah studi oleh Palmares et al[16] showed that
perbedaan yang signifikan dalam skor pada 4th dan 15th
approximately 85% of the cohort had previous episodes of
hari antara kelompok [Tabel 3].
AC and 16% of the cohort had bronchial asthma. However,
Reaksi samping yang dilaporkan di 10% dan 18% dari
in our study, patients with bronchial asthma were excluded
pasien, dengan olopatadine dan ketotifen, masing-masing
because they were receiving medications like systemic or
[Tabel 4]. Seperti setiap pasien diperlukan satu olopatadine
inhalational steroids and mast cell stabilizers, which would
HCl vial, biaya per pasien adalah 84 rupee. Satu botol have interfered with the medications in our study. A
ketotifen fumarat adalah 57 rupee, bagaimanapun, dan sejak Nigerian study conducted in primary school children
32 pasien diperlukan dua botol, biaya untuk pasien ini reported that the disease was more common during the
adalah 114 rupee. harmattan (a dry and dusty West African trade wind) season
due to the presence of dust and pollen in the atmosphere. [12]
DISKUSI
Itching was the most common presenting complaint of
Konjungtivitis karena non-rangsangan menular termasuk the patients. Individual and total AC scores were
SAC dan abadi AC, yang mempengaruhi individu-individu comparable between the groups at baseline. Treatment with
dari semua kelompok umur, terutama anak-anak. Gejala olopatadine 0.1% significantly reduced the itching score
SAC, yang dapat mempengaruhi kedua mata, diperparah during follow‑ up and patients were completely free of the
karena musiman symptom by the 15th day. A similar finding was reported in
a study conducted in Hungary, which
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Olopatadine vs Ketotifen Fumarate for Allergic Conjunctivitis; Patel et al

Table 2. Individual and total allergic conjunctivitis scores at follow‑up visits


Symptoms Olopatadine HCl Ketotifen fumarate
and signs Mean±standard deviation P** Mean±standard deviation P**
Day 0 Day 4 Day 15 Day 0 Day 4 Day 15
Itching 3.9±0.30 1.98±0.83* 0# 0.001 3.72±0.45 2.37±0.73* 0.40±0.49# 0.001
Tearing 2.82±0.39 1.13±0.74* 0# 0.001 2.85±0.40 1.63±0.68* 0.05±0.22# 0.001
Hyperemia 2.60±0.52 0.73±0.68* 0 0.001 2.52±0.50 1.25±0.62* 0 0.001
Lid swelling 0.23±0.42 0 0 0.001 0.13±0.34 0 0 0.005
Papillae 1±0.00 0.85±0.36 0# 0.001 1.00±0.00 0.95±0.22 0.37±0.48# 0.001
Total Score 10±1.04 4.72±2.10* 0# 0.001 10.23±1.01 6.13±1.8* 0.82±0.87# 0.001
*P &#P Based on t test. *P=0.001 comparison between groups on 4 th day; #P=0.001 comparison between groups on 15th day. ** Based on RANOVA

Table 3. Quality of life score at follow‑up visits A reduction in the individual and total AC score was
Day 0 Day 4 Day 15 P* observed at each follow‑up visit in patients receiving
ketotifen. The score reduced to zero by the 15 th day only in
Olopatadine HCl 35.73±8.55 12.90±5.17 0 0.001
46.6% of the patient cohort. Another study demonstrated
Ketotifen fumarate 32.98±7.41 12.93±5.10 0 0.001
that ketotifen 0.05% reduced itching, stinging, and tearing
P** 0.10 0.81 1.00
after 10 days in 60–80% of the patients.[23] When compared
HCl, hydrochloride; *Based on RANOVA test (Repeated measure
ANOVA). **Based on t‑test with levocabastine and placebo, ketotifen was the most
effective during the first four days in reducing itching,
hyperemia, and the tearing score [24]. Although the eyelid
Table 4. Adverse drug reactions to medications swelling score was also reduced, this was not
Headache Burning sensation statistically significant.[24] Our observation was that
in the eyes reduction in papillae score took longer with ketotifen, with
Olopatadine HCl 4 (7%) 2 (3%) only 63% of the patient cohort showing complete reduction
Ketotifen fumarate 8 (13%) 3 (5%) by the 15th day.
HCl, hydrochloride Compared to ketotifen, olopatadine significantly reduced
the itching, tearing, hyperemia and total AC scores by 4 th
included both adults and children; the itching scores reduced day, and eyelid swelling and papillae by the 15 th day. This
from 1.6 to 0 and from 2.5 to 0.2, respectively, at the end of shows that olopatadine provided quicker relief from the
14 days [17]. The study also concluded that the use of symptoms than ketotifen. Similar findings were reported
olopatadine in children was safe. [17] In a conjunctival in another study where 42.5–62.5% of patients receiving
allergen challenge human model, olopatadine 0.1% and olopatadine showed improvement of the symptoms and
0.2% were compared, with no significant difference in signs at 30 min compared to 20–27.5% receiving
the itching score between doses [18]. Additionally, a ketotifen.[25] Furthermore, by the 7th day, olopatadine
significant reduction was observed at 24 h, with both reduced symptoms by 80–87.5%, while ketotifen reduced
dosages, when compared to the placebo.[18] A study on them by 60–75%.[25] Two other studies have reported that
Japanese patients with SAC demonstrated that pretreatment olopatadine 0.1% was more effective than ketotifen.[26,27]
with olopatadine significantly reduced itching scores.
The authors attributed this finding to the mast cell QOL, the other parameter that was assessed, also
stabilizing property of the drug.[19] Olopatadine 0.1% also improved from the baseline in both groups to a similar
significantly reduced the tearing score at all follow‑up extent. A study conducted by Scoper et al[28] demonstrated
visits, when compared with sodium cromoglycate 2%.[20] that patients receiving olopatadine 0.2% had a significant
Olopatadine also significantly reduced hyperemia in improvement in the QOL. Olopatadine was also
our patient cohort. A similar result was reported by Yaylali preferred by patients in another.[29]
et al[21] when they used olopatadine and ketorolac to treat In the current study, a total of 10% and 18% of patients
SAC. reported adverse reactions with olopatadine and ketotifen,
Eyelid swelling causes a lot of discomfort to the patient. respectively, the most common of which was a headache,
Compared to cromolyn sodium 2%, olopatadine 0.1% followed by a burning sensation in the eyes. In another
reduced eyelid swelling by the 4th day of treatment.[22] study, which included 100 patients, 98% of the patients
Papillae is also a sign of AC, which was significantly receiving ketotifen reported a burning sensation in the
reduced by the 4th day of olopatadine treatment. A eyes.[29] A stinging sensation in the eyes was also observed
complete reduction in symptom and sign score was in 22.5% of patients receiving ketotifen.[25] A study
observed only in 15% of the patients by 4 th day, but by 15th monitoring adverse drug reactions (ADRs) to different
day reduction was observed in all the patients. drugs, found that

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Olopatadine vs Ketotifen Fumarate for Allergic Conjunctivitis; Patel et al

olopatadine 0.1% and ketotifen caused ADRs in 4.65% of amongst Primary school pupils in owerri urban, Nigeria. JNOA
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14. Choi H, Lee SB. Nonseasonal allergic conjunctivitis in the tropics:
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Experience in a tertiary care institution. Ocul Immunol Inflamm
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Financial Support and Sponsorship the treatment of ocular itching induced by conjunctival allergen
challenge. Curr Eye Res 2007;32:1017‑1022.
Nil. 19. Shimura M, Yasuda K, Miyazawa A, Otani T, Nakazawa T.
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Conflicts of Interest clinical symptoms of seasonal allergic conjunctivitis. AJO
2011:151;698‑702.
There are no conflicts of interest. 20. Aima U, Faruque GM, Aqmo S. A comparison of the efficacy of
olopatadine hydrochloride 0.1% ophthalmic solution and sodium
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