ABSTRAK
Nama : Yenny Rachmawati
Program studi : Dermatologi dan Venereologi
Judul : Perbandingan Efektivitas serta Keamanan antara Krim Pelembap Niasinamid 4% dan Virgin Coconut Oil 30% untuk Pencegahan Sekunder Dermatitis Tangan Akibat Kerja pada Perawat Intensive Care Unit : Uji Klinis Acak Tersamar Ganda
Latar belakang: Dermatitis tangan akibat kerja (DTAK) sering terjadi pada perawat Intensive Care Unit (ICU) terutama pada individu yang rentan akibat pajanan iritan berupa hand rub alcohol dan aktivitas cuci tangan berulang. Penggunaan pelembap adalah salah satu rekomendasi untuk perawatan kulit pada DTAK. Niasinamid memiliki efek antiinflamasi dan dapat memperbaiki fungsi sawar kulit. Vigin coconut oil (VCO) kaya akan kandungan lipid dan asam laurat, serta memiliki efek oklusif. Sampai saat ini belum ada panduan dan referensi jenis pelembap untuk pencegahan sekunder pada DTAK.
Tujuan: Mengetahui perbandingan efektivitas serta keamanan antara krim pelembap niasinamid 4% dan VCO 30% untuk pencegahan sekunder dermatitis tangan akibat kerja pada perawat ICU.
Metode: Penelitian ini merupakan uji klinis acak tersamar ganda terhadap perawat ICU dengan DTAK pada bulan September hingga Oktober 2019. Pasien yang memenuhi kriteria penerimaan dan bersedia mengikuti penelitian, mendapat niasinamid 4% atau VCO 30% sesuai dengan randomisasi blok. Pengolesan pelembap dilakukan dua kali sehari selama 28 hari. Perbaikan klinis dinilai dengan parameter skor Hand Eczema Scoring Index (HECSI) dan penilaian sawar kulit dinilai dengan transepidermal water loss (TEWL) serta hidrasi kulit dengan skin capasitance (SCap) pada hari ke-14 dan hari ke-28. Keamanan dinilai berdasarkan efek samping selama penelitian.
Hasil: Didapatkan 46 SP pada masing-masing kelompok niasinamid 4% dan VCO 30%. Terdapat penurunan skor HECSI pada kedua kelompok perlakuan di hari ke-14 dan hari ke-28. Median skor HECSI di kelompok niasinamid 4% dan VCO 30% pada hari ke-14 yaitu 6,5 dan 6 (p 0,160), serta pada hari ke-28 yaitu 4 dan 3 (p 0,046). Pada hari ke-28, perbedaan skor HECSI kedua kelompok secara statistik bermakna, namun secara klinis tidak bermakna. Terdapat penurunan nilai TEWL pada kedua kelompok perlakuan di hari ke-14 dan hari ke-28 dibandingkan baseline, namun pada area palmar di kelompok niasinamid 4% terdapat sedikit peningkatan nilai TEWL pada hari ke-28. Terdapat peningkatan nilai SCap pada kedua kelompok perlakuan di hari ke-14 dan hari ke-28 dibandingkan baseline. Kedua pelembap dapat ditoleransi dengan baik dengan efek samping minimal.
Kesimpulan: Niasinamid dan VCO efektif memperbaiki klinis DTAK pada perawat ICU, walaupun tidak terdapat perbedaan bermakna antara krim pelembap niasinamid 4% dengan VCO 30% untuk pencegahan sekunder dermatitis tangan akibat kerja pada perawat ICU
Kata kunci: dermatitis tangan akibat kerja, efektivitas, keamanan, pelembap, niasinamid 4%, VCO 30%
ABSTRACT
Name : Yenny Rachmawati
Study Program : Dermatologi dan Venereologi
Title : Comparison of the Effectiveness and Safety between Moisturizing Cream Containing Niacinamide 4% and Virgin Coconut Oil 30% for Secondary Prevention of Occupational Hand Dermatitis in Intensive Care Unit Nurses: a Double Blind Randomized Clinical Trial
Background: Occupational hand dermatitis (OHD) often occurs in intensive care unit (ICU) nurses, especially in individuals who are vulnerable due to irritant exposure e.g. hand rub alcohol and repeated hand washing activities. The use of moisturizer is one of the recommendations for skin care in OHD. Niacinamide which has anti-inflammatory effects and can improve the skin sawar function. Virgin coconut oil (VCO) is rich in lipids and lauric acid, and has an occlusive effect. Until now there are no guidelines and reference types of moisturizers for secondary prevention in OHD.
Objective: To assess the difference of effectiveness and safety between moisturizing cream containing niacinamide 4% and VCO 30% for secondary prevention of occupational hand dermatitis in ICU nurses
Methods: A double blind randomized controled trial was performed in ICU nurses with OHD during September–October 2019. Patients who fulfilled inclusion criteria and willing to be involved in the study were allocated to niacinamide 4% or VCO 30% based on block randomization. Moisturizer were applied twice daily for 28 days. Measurement of Hand Eczema Scoring Index (HECSI) scores were conducted to evaluate the clinical improvement . Measurement of transepidermal water loss (TEWL) were conducted to evaluate the barrier skin and skin capacitance (SCap) values were conducted to evaluate skin hydration on 14th and 28th day. Safety were assessed based on side effects during research.
Results: There were 46 subjects in each arms of intention, the niacinamide 4% arm and in the VCO 30% arm. There were a decrease in HECSI scores in both treatment groups on 14th and 28th day. The median score of HECSI in niacinamide 4% and VCO 30% on 14th day were 6.5 and 6 (p 0.160), and on 28th day were 4 and 3 (p 0.046). On 28th day, the difference in HECSI scores of the two groups were statistically significant, but clinically not significant. There were a decrease in TEWL values in both treatment groups on 14th and 28th day compared to baseline, but there were a slight increase in TEWL values in the palmar area in the niacinamide group on 28th day. There were an increase in SCap values in both treatment groups on 14th and 28th day compared to baseline. Both moisturizers were well tolerated with minimal side effects.
Conclusion: Niacinamide 4% and VCO 30% were effective in improving clinical OHD in ICU nurses, although there were no significant difference between moisturizing cream containing niacinamide 4% and virgin coconut oil 30% for secondary prevention of occupational hand dermatitis in ICU nurses.
Keywords: occupational hand dermatitis, effectiveness, safety, moisturizer, niacinamide 4%, VCO 30%
"Latar Belakang: Perdarahan akut gastrointestinal bagian atas memiliki angka mortalitas dan morbiditas yang signifikan. Asam traneksamat telah terbukti bermanfaat dalam kasus perdarahan postoperatif dan postpartum. Namun, data mengenai efektivitas asam traneksamat untuk kasus ini masih terbatas.
Metode: Kami telah melakukan uji klinis terkontrol acak tersamar. Pasien yang memenuhi kriteria adalah dewasa (usia ≥ 18 tahun) dengan gejala hematemesis, melena, atau keduanya baik yang datang ke unit gawat darurat atau sedang dirawat di rumah sakit antara 1 Juli 2018 sampai 31 Desember 2019. Pasien secara acak dimasukan ke dua kelompok (asam traneksamat dan plasebo). Luaran utama yang diamati adalah perdarahan ulang yang didefinisikan sebagai kejadian hematemesis, melena, atau keduanya yang berkaitan dengan takikardia atau syok hipovolemik atau pengurangan hemoglobin > 2 g/dL setelah keberhasilan terapi endoskopi atau farmakologis. Perdarahan ulang ini diamati sampai 28 hari pascarandomisasi. Uji klinis ini teregistrasi di clinicaltrials.gov, NCT03540368Hasil: Terdapat 42 pasien yang masuk dalam uji klinis ini, 19 di kelompok asam traneksamat dan 23 di plasebo. Penggunaan asam traneksamat tidak berhubungan dengan penurunan kejadian perdarahan ulang (hazard ratio 1,055 [IK 95% 0,284 – 3,923]) maupun mortalitas (hazard ratio 0,960 [IK 95% 0,218 – 4,229]). Terdapatsatu kasus tromboemboli pada masing-masing kelompok. Uji klinis dihentikan lebih awal karena kemungkinan futilitas yang signifikan dan risiko kejadian tromboemboli.Kesimpulan: Tidak diperoleh perbedaan bermakna frekuensi perdarahan ulang kasus perdarahan akut saluran cerna bagian atas antara kelompok asam traneksamat dibandingkan plasebo.Background: Acute upper gastrointestinal bleeding (AUGIB) has a significant mortality and morbidity rate. Tranexamic acid has been shown to be beneficial in postoperative and postpartum hemorrhage cases. However, there are limited data exist regarding the effectiveness of tranexamic acid in AUGIB.
Method: We carried out a double-blind randomized controlled trial. Eligible patients were adults (aged ≥ 18 years) with hematemesis, melena, or both who presented to the emergency department or were hospitalized between July 1, 2018 and December 31, 2019. Patients were randomly assigned to two treatment groups (tranexamic acid or placebo). The primary endpoint was rebleeding, defined as the occurrence of hematemesis, melena, or both associated with tachycardia or hypovolemic shock or reduction in hemoglobin (> 2 g/dL) after successful endoscopic or pharmacological therapy. The occurrence of rebleeding was monitored up to 28 days after randomization. This study was registered at clinicaltrials.gov, NCT03540368Results: Forty-two patients were enrolled, 19 to the tranexamic acid and 23 to the placebo group. Tranexamic acid use was not associated with a reduction in rebleeding (hazard ratio 1.055 [95% CI 0.284 – 3.923]) or mortality (hazard ratio 0.960 [95% CI 0.218 – 4.229]). One thromboembolic event occurred in each group. Clinicaltrials were terminated early because of the significant possibility of futility, and the risk of thromboembolic events.Conclusion: No significant difference was noted in the frequency of rebleeding after AUGIB between patients treated with tranexamic acid compared with placebo."