Hasil Pencarian  ::  Simpan CSV :: Kembali

Abstrak :
ABSTRAK
Latar belakang: Fundic gland polyp (FGP) merupakan salah satu polip gaster yang sering ditemukan pada saat endoskopi. Penggunaan proton pump inhibitor (PPI) jangka panjang dianggap berpengaruh terhadap perkembangan FGP. Hipergastrinemia/hiperplasia sel G dan hiperplasia sel ECL dapat terjadi pada penggunaan PPI jangka panjang. Efek trofik dari hiperplasia sel G ini yang kemudian menyebabkan proliferasi sel parietal hingga berkembang menjadi FGP, bahkan dapat menyebabkan terjadinya tumor karsinoid pada tikus. Untuk mengkonfirmasi adanya sel G dilakukan pulasan imunohistokimia gastrin. Penelitian ini bertujuan untuk mengetahui adanya hiperplasia sel G ditinjau dari ekspresi gastrin pada mukosa antrum kasus-kasus FGP yang dihubungkan dengan riwayat penggunaan PPI. Bahan dan cara kerja: Penelitian ini menggunakan desain potong lintang. Sampel terdiri atas 40 kasus FGP yang terbagi menjadi 25 kasus dengan riwayat penggunaan PPI jangka panjang dan 15 kasus dengan riwayat penggunaan PPI jangka pendek di RSCM dari tahun 2016-2017. Dilakukan pulasan gastrin untuk menilai sel G pada mukosa antrum. Kondisi hiperplasia sel G dinilai melalui ekspresi gastrin apabila terdapat lebih dari 40 sel terpulas positif dalam 10 kelenjar antrum. Hasil: Didapatkan 13 kasus dengan hiperplasia sel G dan 27 kasus tanpa hiperplasia. Sebelas dari 13 kasus dengan hiperplasia sel G memiliki riwayat penggunaan PPI jangka panjang, sedangkan 2 kasus dengan penggunaan PPI jangka pendek. Uji Fisher's exact menunjukkan perbedaan bermakna antara hiperplasia sel G pada penggunaan PPI jangka panjang dan pendek dengan nilai p<0,05. Simpulan: Secara statistik terdapat perbedaan bermakna antara hiperplasia sel G pada FGP dengan riwayat penggunaan PPI jangka panjang dan pendek.

---

ABSTRACT
Background: Fundic gland polyps is one of gastric polyps often found at endoscopy. Long-term proton pump inhibitors (PPIs) use is considered to influence the development of FGP. Hypergastrinemia/G cell hyperplasia and ECL cell hyperplasia can occur in long-term PPI use. This trophic effect of G cell hyperplasia causes proliferation of parietal cells that then develop into FGP, and can even cause carcinoid tumors in mice. To confirm the presence of G cells, we can use gastrin immunohistochemistry. This study aims to determine the presence of G cell hyperplasia based on gastrin expression in mucosa of FGP associated with a history of PPI use. Method: This study uses a cross-sectional design. Samples consisted of 40 cases of FGP which were divided into 25 cases with long-term use of PPI and 15 cases with short-term use of PPI at RSCM from 2016-2017. We performed gastrin staining to assess G cells in the antrum mucosa. Hyperplasia of G cells is considered if there were more than 40 cells with positive staining to gastrin in 10 antrum glands. Result: There were 13 cases with G cell hyperplasia and 27 cases without hyperplasia. Eleven of 13 cases with G cell hyperplasia had a history of long-term PPI use, while 2 cases with short-term PPI use. The Fisher's exact test showed a significant difference between G cell hyperplasia in the use of short and long-term PPIs with p value <0.05. Conclusion: Statistically there are significant difference between G cell hyperplasia in FGP with a history of long and short term PPI use.

Abstrak :
Penghambat pompa proton merupakan golongan obat yang telah banyak digunakan untuk mengobati penyakit-penyakit terkait gastrointestinal. Obat golongan PPI aman dan dapat ditoleransi dengan baik bila digunakan dengan tepat, namun peningkatan penyalahgunaan obat golongan PPI dapat berakibat pada terjadinya luaran terapi yang tidak diharapkan. Evaluasi terhadap penggunaan obat golongan ini perlu dilakukan untuk mengetahui apakah obat golongan PPI digunakan sebagaimana mestinya. Penelitian ini bertujuan untuk mengevaluasi penggunaan obat golongan PPI dan menilai kerasionalan penggunaannya yang dilakukan secara deskriptif analitik observasional dengan pengambilan data secara retrospektif menggunakan data resep dan rekam medik. Sampel merupakan data pasien di Instalasi Rawat Jalan RSPAD Gatot Soebroto periode Juli 2015 - Desember 2015 yang menerima obat golongan PPI. Analisis dilakukan terhadap 400 jenis terapi obat dari 192 pasien. Aspek kerasionalan penggunaan obat golongan PPI dilihat dari lima aspek ketepatan, yaitu tepat penilaian kondisi pasien, tepat indikasi penyakit, tepat regimen dosis, tepat lama pemberian, dan tepat pemilihan obat. Sebanyak 100% terapi obat golongan PPI masuk ke dalam kategori tepat penilaian kondisi pasien, 79% tepat indikasi penyakit, 79% tepat regimen dosis, 79% tepat lama pemberian, dan 83,75% tepat obat. ......Proton Pump Inhibitor are drugs that have been widely used to treat gastrointestinal related disorders. PPI is safe and well tolerated when used appropriately, but an increased in drug abuse can lead to unwanted outcome therapy. Evaluation of drug using Proton Pump Inhibitor is necessary to know whether PPI used properly. This study aimed to evaluate the use of PPIs and assess the rationalization of its use with observational analitical descriptive with retrospective methode using prescription data and medical records. Samples were data from outpatient at Gatot Subroto Army Hospital in the period of July 2015 - December 2015 that receive PPI. The analysis conducted from 400 therapy (192 patients). Aspects of the rational use of drugs known as PPI seen by five aspects of precision, appropriate condition of patients, appropriate indication, appropriate dosage, appropriate for the duration of PPI use, and appropriate for right medication. Data showed 100% appropriate condition of patients, 79,00% appropriate indication, 79,00% appropriate dosage, 79,00% appropriate for the duration of PPI use, and 83,75% appropriate for right medication.

Abstrak :
Latar belakang: Refluks laringofaring LPR merupakan penyakit komorbid laringomalasia terbanyak, sehingga tata laksana laringomalasia mencakup penanganan LPR. Tujuan: Mengetahui karakteristik pasien, hubungan keteraturan berobat, dosis penghambat pompa proton PPI , dan faktor lain yang memengaruhi perbaikan klinis laringomalasia. Metode: Penelitian kohort retrospektif berdasarkan rekam medis. Subjek penelitian dipilih secara total sampling. Hasil: Total subjek adalah 95 rekam medis. Usia median pasien 3 bulan. Mayoritas pasien adalah lelaki, lahir cukup bulan, berat lahir cukup. Pada awal diagnosis, sebagian besar berstatus gizi baik, tidak gagal tumbuh, mengalami laringomalasia tipe 1, berderajat klinis sedang, skor gejala laringomalasia positif LSS , mengalami gejala refluks, tanpa pipa nasogastrik, tidak teratur berobat, dan mendapat PPI ge;1,0mg/kg/hari. Penyakit penyerta yang terbanyak adalah kelainan neurologi dan yang terjarang adalah penyakit refluks. Pasien yang berobat teratur mengalami perbaikan status gizi p=0,020 , derajat laringomalasia p=0,043 , nilai LSS p=0,002 , gejala refluks. ......Background Laryngopharyngeal refluks LPR is laryngomalacia rsquo s most common comorbidity. Laryngomalacia management includes LPR treatment. Aim To describe the characteristics of patients, relationships of compliance, proton pump inhibitor PPI dosage, and other factors that contribute to clinical improvements. Methods Cohort retrospective study based on medical records. Subjects is recruited by total sampling. Results Total subject consists of 95 medical records. Median age is 3 months, majority are boys, born aterm, normal birth weight. Most patients are well nourished, thrive well, experienced type 1 laryngomalacia, moderate degree, positive laryngomalacia symptom score LSS , experienced reflux symptoms, did not require feeding tube, poor compliance to medication, and prescribed PPI ge 1,0mg kg day. The most common recorded comorbidity is neurologic abnormality, while the most infrequent is reflux. Good compliance is related to improvements of nutritional status p 0,020 , degree p 0,043 , LSS p 0,002 , reflux symptom p

Abstrak :
[ABSTRAK
Latar Belakang : Sindrom frailty berkaitan dengan angka morbiditas dan kematian yang lebih tinggi, sehingga dipakai sebagai prediktor kesehatan pada orang usia lanjut (usila). Polifarmasi sebagai salah satu faktor risiko sindrom frailty, dapat berkaitan dengan obat PPI yang sering diberikan pada usila, atas indikasi adanya keluhan gangguan saluran cerna bagian atas. Sampai saat ini belum ada penelitian yang mempelajari hubungan PPI jangka panjang dan sindrom frailty pada usila. Penelitian ini diharapkan dapat memberikan data mengenai penggunaan PPI jangka panjang (≥ 6 bulan) terhadap risiko sindrom frailty pada usila.

Metode : Desain studi kasus kontrol dengan kriteria inklusi subjek penelitian 60 tahun ke atas dan berstatus kognitif baik. Kriteria ekslusi adalah data yg tidak lengkap atau terdapat kontraindikasi PPI. Kasus adalah usila terdiagnosis Frailty menurut FI-40 item dan kontrol adalah usila yang tidak frailty berdasarkan instrumen yang sama. Pengambilan data primer termasuk status frailty telah dilakukan bulan Maret-Juni 2013 oleh Seto E dan Sumantri S. Pengambilan data sekunder yang digunakan pada penelitian ini dilakukan pada bulan Oktober- November 2014 dari data primer tersebut, ditambah dengan data dari rekam medis poliklinik Geriatri dan poliklinik diabetes RS Cipto Mangunkusumo.

Hasil : Didapatkan 225 subjek (75 kasus:150 kontrol), 59,6% berjenis kelamin perempuan (rerata usia 72,14 tahun; simpang baku ± 6,4 tathun) dan 47,1% berpendidikan tinggi. Subjek yang berpendidikan rendah, berstatus cerai mati, berstatus nutrisi lebih buruk, tidak mandiri, memerlukan caregiver, hidup tidak berkecukupan dan kondisi kesehatan yang lebih buruk lebih banyak didapatkan pada kelompok frailty dibandingkan kelompok yang tidak frail. Proporsi pengguna PPI Jangka Panjang sebesar 40,9%. Penggunaan PPI jangka panjang meningkatkan risiko sindrom frailty (Crude OR 2,15; IK 95% 1,22-3,78; p<0,007) dengan adjusted OR 1,83 (IK 1,0-3,36) terhadap variabel nutrisi dan merokok.

Kesimpulan : Penggunaan PPI jangka panjang (≥ 6 bulan) secara independen meningkatkan salah satu risiko sindrom frailty pada usila.

---

ABSTRACT
Background: Frailty syndrome as being used as the newest elderly health predictor, associated with higher morbidity and mortality. PPI are often used in elderly due to presence of upper gastrointestinal complaints, and related with polypharmacy as one of the risk factor for frailty syndrome. No study has studied the relationship of long term PPI and frailty syndrome in elderly. The objective of the study is to find whether long term use of PPI (≥ 6 months) would increase the risk of frailty syndrome in the elderly.

Methods: A case control study includes subjects 60 years and above with good cognitive status. All subject with history of hypersensitivity of PPI is excluded. Elderly diagnosed as frailty based in FI-40 item is defined as cases, while individuals that are not frailty are classified as the control. Primary data (included frailty status) was collected on March-June 2013 by Seto E and Sumantri S, et al. Secondary data used in the current study was gathered on October-November 2014, from the primary data above and from the medical record taken from geriatric and diabetic outpatient clinics Cipto Mangunkusumo Hospital.

Result: There were 225 subjects collected (75 cases : 150 controls), 59,6% were female (mean age 72,14 years old, SD ± 6,4 years) and 47,1% with higher education. Lower education, divorced, poor nutrition, dependent, needed caregiver, economicaly insufficient, more comorbidity and poor health condition are seen in frailty group.The proportion of long term PPI use were 40,9%. Long term PPI medication increase the risk of frailty syndrome (Crude OR 2,154; CI 95% 1,225-3,778; p<0,007) with adjusted OR 1,83 (CI 95% 1,02-3,37) after adjusting to nutrition and smoking variables.

Conclusion: Long term use of PPI significantly increase the risk of frailty syndrome compared to the non-users.;Background: Frailty syndrome as being used as the newest elderly health predictor, associated with higher morbidity and mortality. PPI are often used in elderly due to presence of upper gastrointestinal complaints, and related with polypharmacy as one of the risk factor for frailty syndrome. No study has studied the relationship of long term PPI and frailty syndrome in elderly. The objective of the study is to find whether long term use of PPI (≥ 6 months) would increase the risk of frailty syndrome in the elderly. Methods: A case control study includes subjects 60 years and above with good cognitive status. All subject with history of hypersensitivity of PPI is excluded. Elderly diagnosed as frailty based in FI-40 item is defined as cases, while individuals that are not frailty are classified as the control. Primary data (included frailty status) was collected on March-June 2013 by Seto E and Sumantri S, et al. Secondary data used in the current study was gathered on October-November 2014, from the primary data above and from the medical record taken from geriatric and diabetic outpatient clinics Cipto Mangunkusumo Hospital. Result: There were 225 subjects collected (75 cases : 150 controls), 59,6% were female (mean age 72,14 years old, SD ± 6,4 years) and 47,1% with higher education. Lower education, divorced, poor nutrition, dependent, needed caregiver, economicaly insufficient, more comorbidity and poor health condition are seen in frailty group.The proportion of long term PPI use were 40,9%. Long term PPI medication increase the risk of frailty syndrome (Crude OR 2,154; CI 95% 1,225-3,778; p<0,007) with adjusted OR 1,83 (CI 95% 1,02-3,37) after adjusting to nutrition and smoking variables. Conclusion: Long term use of PPI significantly increase the risk of frailty syndrome compared to the non-users., Background: Frailty syndrome as being used as the newest elderly health predictor, associated with higher morbidity and mortality. PPI are often used in elderly due to presence of upper gastrointestinal complaints, and related with polypharmacy as one of the risk factor for frailty syndrome. No study has studied the relationship of long term PPI and frailty syndrome in elderly. The objective of the study is to find whether long term use of PPI (≥ 6 months) would increase the risk of frailty syndrome in the elderly. Methods: A case control study includes subjects 60 years and above with good cognitive status. All subject with history of hypersensitivity of PPI is excluded. Elderly diagnosed as frailty based in FI-40 item is defined as cases, while individuals that are not frailty are classified as the control. Primary data (included frailty status) was collected on March-June 2013 by Seto E and Sumantri S, et al. Secondary data used in the current study was gathered on October-November 2014, from the primary data above and from the medical record taken from geriatric and diabetic outpatient clinics Cipto Mangunkusumo Hospital. Result: There were 225 subjects collected (75 cases : 150 controls), 59,6% were female (mean age 72,14 years old, SD ± 6,4 years) and 47,1% with higher education. Lower education, divorced, poor nutrition, dependent, needed caregiver, economicaly insufficient, more comorbidity and poor health condition are seen in frailty group.The proportion of long term PPI use were 40,9%. Long term PPI medication increase the risk of frailty syndrome (Crude OR 2,154; CI 95% 1,225-3,778; p<0,007) with adjusted OR 1,83 (CI 95% 1,02-3,37) after adjusting to nutrition and smoking variables. Conclusion: Long term use of PPI significantly increase the risk of frailty syndrome compared to the non-users.]

Abstrak :
ABSTRAK
Latar belakang: Laringomalasia merupakan kondisi kelemahan struktur supraglotis saat inspirasi sehingga menyebabkan sumbatan jalan nafas atas dan menimbulkan gejala stridor inspirasi. Stridor semakin memburuk pada posisi terlentang. Penyakit penyerta laringomalasia umumnya adalah refluks laringofaring (RLF) yaitu 25-68%. RLF adalah pergerakan isi lambung secara retrograd menuju laring-faring, menimbulkan gejala dan tanda klinis yang bervariasi. Pemberian omeperazol dapat memperbaiki gejala regurgitasi dan stridor serta memperpendek durasi perjalanan alamiah laringomalasia

Tujuan: Mengetahui efektifitas omeperazol pada bayi dan anak dengan laringomalasia, mengetahui prevalensi RLF pada laringomalasia, ada tidaknya RLF berdasar nilai reflux finding score (RFS) menurut Belafsky dan mengetahui berat ringan gejala laringomalasia berdasar nilai laryngomalacia symptom score (LSS).

Metode: Uji controlled trials pada 65 subyek laringomalasia, dibagi kedalam kelompok 42 subyek yang mendapat omeperazol 2 x 2 mg/kg/bb dan 23 subyek yang mendapat plasebo selama 3 bulan Hasil : Kelompok omeperazol dengan gejala berat 58,8% mengalami perbaikan dibanding kelompok plasebo 66,7% dengan nilai p = 0,716. Kelompok omeperazol dengan RLF positif 58,3% mengalami perbaikan dibanding kelompok plasebo 75% dengan nilai p = 1.0

Simpulan : Prevalensi RLF positif sebesar 24,6% dan gejala berat sebesar 44,6%. Efektifitas pemberian omeperazol selama 3 bulan belum terbukti efektif dibanding plasebo berdasarkan perbaikan nilai LSS, RFS dan status gizi. Namun hasil tersebut hanya berlaku sebagai kesimpulan penelitian pendahuluan karena tidak optimalnya besar sampel dan randomisasi subyek. Perlu penelitian lanjutan untuk membuktikan efektifitas omeperazol pada perbaikan skor LSS, skor RFS dan status gizi bayi dan anak dengan laringomalasia

---

ABSTRACT
Background: laryngomalacia is condition of floopy supraglottis stucture in respiratory that trigger obstruction the upper airway and it causes symptom stridor inspiratory. Stridor can get worse in face up position. In general, the comorbidity of laryngomalacia is laryngopharyngeal reflux (LPR) about 25-68%. LPR is the movement of gaster retrogradely toward laryngopharyngeal and it triggers various symptom and clinical sign. The giving of omeperazole can improve the symptom of regurgitation and stridor and shorten the duration of natural disease of laryngomalacia

Objective: Knowing the effectivity of giving omeperazole to the babies and children with laryngomalacia, knowing the prevalance of LPR to the laryngomalacia, knowing the positibility of LPR based on the value of reflux finding score (RFS) according to Belafsky and knowing severity of symptom laryngomalacia based on the value of laryngomalacia symptom score (LSS).

Method: Test on controlled trials on 65 samples with laryngomalacia and is divided into 42 groups that have been given omeperazole 2x2 mg/kg/bw and 23 samples that have been given placebo for 3 month

Result: Omeperazol groups with severe symptom showed the improvement of 58,8% compared to placebo groups 66,7% with p = 0.716. Omeperazole groups with RLF positive showed the improvement of 58,3% compared to placebo groups 75 % with p = 1.0

Conclusion: The Prevalence of positive LPR based on RFS is 24,6% and with severe symptom is 44,6%. The effectivity of giving omeperazole for 3 month has not proved effective compared to placebo based on the improvement of value LSS, RFS and nutrition status. However such result is only valid for the conclusion of initial research because the size of samples were not either optimal or randomized. It is necessary to conduct research continution to prove the effectivity of giving omeperazole on the improvement of LSS score, RFS score and nutrition status of babies and children with laryngomalacia

Abstrak :
ABSTRAK
Obat penghambat pompa proton merupakan salah satu obat pengontrol asam lambung yang paling banyak diresepkan. Pemakaian jangka panjang obat penghambat pompa proton berisiko menurunkan kadar magnesium darah hipomagnesemia . Penelitian ini bertujuan untuk menilai hubungan antara penggunaan obat golongan penghambat pompa proton terhadap dan penurunan kadar magnesium darah pada pasien di RSUPN Dr. Cipto Mangunkusumo Jakarta. Desain penelitian adalah cross sectional studi komparatif dengan teknik pengambilan sampel consecutive sampling pada bulan Juni sampai Oktober 2016. Penelitian ini membandingkan kadar magnesium darah antara pasien yang menggunakan obat penghambat pompa proton lansoprazole dan omeprazole dengan pasien yang tidak menggunakan penghambat pompa proton. Jumlah sampel dalam penelitian ini adalah 184 pasien. Pengumpulan data menggunakan kuesioner dan rekam medis. Analisis statistik dilakukan dengan uji t tidak berpasangan, Mann-Whitney, dan one way ANOVA. Rata-rata kadar magnesium pasien yang menggunakan penghambat pompa proton adalah 2.08 0.21 mg/dL lebih rendah dari yang tidak menggunakan penghambat pompa proton 2.27 0.38 mg/dL dengan nilai p < 0.001 signifikan . Kadar magnesium lebih rendah secara bermakna terjadi pada pasien yang menggunakan penghambat pompa proton lebih dari satu tahun dan yang menggunakan omeprazole p < 0.05 .

---

ABSTRACT
Proton pump inhibitors is one of the controller gastric acid medication controllers most widely prescribed. The long term use of proton pump inhibitors has a risks decrease of blood magnesium levels hypomagnesemia . The purpose of this study was to determine whether and to what degree PPI use affects blood magnesium levels. The study design was a cross sectional comparative study with consecutive sampling technique on June to October 2016. This study compared blood magnesium levels among patients using proton pump inhibitors lansoprazole and omeprazole with patients not taking proton pump inhibitor. The total sample was 184 patients. Collecting data using questionnaires and medical records. Statistical analysis was performed with the unpaired t test, Mann Whitney, and one way ANOVA. The average level of magnesium patient using proton pump inhibitors is 2.08 0.21 mg dL whereas who not taking proton pump inhibitors is 2.27 0.38 mg dL with p 0.001 significant . Levels of magnesium were significantly lower in patients using proton pump inhibitors more than one year and using omeprazole p

Abstrak :
Proton Pump Inhibitor (PPI) merupakan salah satu golongan obat yang paling sering diresepkan di rumah sakit, termasuk Rumah Sakit Universitas Indonesia (RSUI) untuk mengatasi berbagai penyakit saluran pencernaan. Selain itu, PPI juga digunakan sebagai Stress Ulcer Prophylaxis (SUP) pada pasien rawat inap dengan faktor risiko tinggi. Meskipun obat golongan ini tergolong aman dan memiliki efikasi yang baik, penggunaan PPI dalam jangka panjang seringkali dikaitkan dengan efek samping yang tidak diinginkan dann dapat menjadi suatu masalah. Penggunaan obat golongan PPI yang banyak pada pasien rawat inap dapat menjadi masalah apabila diberikan tanpa indikasi yang tepat. Tugas khusus ini bertujuan untuk mengkaji kesesuaian indikasi pemberian obat golongan PPI di RSUI dengan literatur berdasarkan diagnosis dan terapi pasien rawat inap pada Periode Januari 2023. Tugas khusus ini dilakukan dalam tiga tahap, yaitu mengambil data sekunder yang sesuai, melajukan pengolahan dan analisis data dan kemudian membuat pembahasan dan kesimpulan. Hasil penelitian menunjukkan bahwa dari hasil random sampling dari kesuluruhan 312 data digunakan sebanyak 75 data, indikasi yang sesuai meliputi penyakit dispepsia, gastritis, GERD, sepsis, gastroenteritis, liver disease, riwayat tukak lambung dan terapi profilaksis terkait obat. Sebanyak 58 pasien atau sebesar 77,30% menunjukkan pemberian dilakukan sesuai dengan indikasi penyakit pasien dan 23,61% atau sebanyak sebanyak 17 pasien menunjukkan indikasi yang sesuai. ...... Proton Pump Inhibitor (PPI) is one of the most commonly prescribed classes of drugs in hospitals, including the University of Indonesia, to treat various gastrointestinal diseases. In addition, PPIs are also used as Stress Ulcer Prophylaxis (SUP) in hospitalized patients with high-risk factors. Although this class of drugs is classified as safe and has good efficacy, long-term use of PPIs is often associated with unwanted side effects and can be a problem. The use of many PPI drugs in hospitalized patients can be a problem if given without proper indication. This special task aims to examine the suitability of the indications for PPI drug administration at RSUI with literature based on the diagnosis and therapy of hospitalized patients in the January 2023 period. This specific task is carried out in three stages, taking the appropriate secondary data, proceeding with data processing and analysis, and then making discussions and conclusions. The results showed that from the results of a random sampling of all 312 data used as many as 75 data, appropriate indications include dyspeptic disease, gastritis, GERD, sepsis, gastroenteritis, liver disease, history of peptic ulcers, and drug-related prophylactic therapy. A total of 58 patients or 77.30%, showed that the administration was carried out according to the indication of the patient's disease, and 23.61%, or as many as 17 patients showed appropriate indications.

Abstrak :
Efek samping dari obat golongan proton pump inhibitor (PPI) pada gastrointestinal diantaranya diare dan konstipasi. Tujuan dari penelitian ini adalah untuk mengetahui persentase besarnya efek samping pada gastrointestinal berupa diare dan konstipasi serta melihat adanya hubungan antara efek samping pada gastrointestinal dengan jenis kelamin, usia, dosis PPI, dan lama pemberian PPI pada pasien rawat inap di RSPAD Gatot Soebroto periode Februari ? April 2016. Penelitian ini adalah studi deskriptif analitik. Pengambilan data dilakukan secara prospektif terhadap data sekunder dari resep, dan rekam medis pasien serta data primer melalui wawancara pasien menggunakan kuisioener yang telah diuji validitas dan reliabilitasnya. Pengambilan data dilakukan dari bulan Februari sampai April 2016 secara total sampling. Analisis kausalitas efek samping pada gastrointestinal dilakukan dengan menggunakan algoritma Naranjo. Sampel adalah pasien dengan usia ≥ 17 tahun yang menerima proton pump inhibitor dan bersedia untuk berpartisipasi dalam penelitian ini dengan menandatangani Informed Consent. Pasien yang menjadi sampel dalam penelitian ini sebanyak 58 pasien. Sebanyak 19 pasien (32,75%) mengalami efek samping berupa konstipasi dimana 16 pasien (27,58%) dengan kategori mungkin (probable), dan 3 pasien (5,17%) dengan kategori cukup mungkin (possible). Tidak ada pasien yang mengalami efek samping diare. Hasil analisis statistik dengan uji chi-square dan uji mutlak Fisher menunjukkan tidak ada hubungan antara efek samping pada gastrointestinal dengan jenis kelamin, usia, dosis PPI, dan lama pemberian PPI. ......Prevalances of crohn?s disease and ulcerative colitis in the world are still increasing. These two diseases are categorized as inflammatory bowel disease (IBD). Even there has been some theurapetic option for patient with these diseases, but surgery still the only option to treat fibrotic strictures. Tetrandrine was chosen as drug in this research because of its antifibrotic effect. This research was conducted to develop and evaluate calcium pectinate beads exploiting pH sensitive property for colon-targeted delivery of tetrandrine. Beads were prepared by ionotropic gelation method followed by enteric coating with HPMCP HP-55 or CAP. Uncoated beads were evaluated for particle size, shape, morphology, swellability, process efficiency and encapsulation efficiency. From evaluation, beads with concentration of calcium chloride 5% (formula 1) was chosen as formula for coating. First formula were more spherical in shape, not too sticky, and smaller in size when compared with beads using calcium chloride concentration 10% (formula 2) and 15% (formula 3). Encapsulation efficiency of the three formula, 65.67 ± 0.39%, 68.03 ± 0.12%, 56.28 ± 0.2% respectively. After coating process, beads were used in in vitro drug release and targeted test. The studies showed that coated calcium pectinate beads were sufficient to resist tetrandrine released in acidic medium, but was unsuccessfully in targeting colon.

Abstrak :
ABSTRAK
Esomeprazol merupakan salah satu obat penghambat pompa proton yang efektif untuk mempertahankan pH lambung. Esomeprazol dibuat dalam bentuk tablet salut selaput sehingga termasuk obat wajib Uji Bioekivalensi menurut Peraturan Kepala Badan Pengawas Obat dan Makanan Republik Indonesia tentang Obat Wajib Uji Ekivalensi. Uji Bioekivalensi obat harus menggunakan metode bioanalisis yang tervalidasi. Penelitian ini bertujuan untuk mengembangkan metode analisis esomeprazol dalam plasma mulai dari kondisi kromatografi optimum, metode preparasi plasma optimum, hingga validasi metode analisis. Kondisi kromatografi optimum adalah kolom C-18 (Waters, SunfireTM 5 µm; 250 x 4,6 mm), suhu kolom 40 oC; fase gerak asetonitril ? dapar fosfat pH 7,6 (40 : 60 %v/v); laju alir 1,00 mL/menit; detektor photodiode array pada panjang gelombang 300 nm; dan lansoprazol sebagai baku dalam. Preparasi sampel menggunakan metode ekstraksi cair-cair dengan pelarut diklorometan lalu dikeringkan dengan gas nitrogen pada suhu 40 oC selama 30 menit; dan direkonstitusi dengan fase gerak sebanyak 100 µL. Hasil validasi terhadap metode analisis esomeprazol yang dilakukan memenuhi persyaratan validasi berdasarkan EMEA Bioanalytical Guideline tahun 2011. Metode yang diperoleh linear pada rentang konsentrasi 5,0 ? 450,0 ng/mL dengan r > 0,9997.

---

ABSTRAK
Esomeprazole is a proton pump inhibitor drug that is effective to maintain the pH of the stomach. Esomeprazole was formulated as film coated tablet that includes mandatory drug testing bioequivalence according to Regulation Head of National Agency of Drug and Food of the Republic of Indonesia about Mandatory Drug Testing equivalences. Drug bioequivalence trials should use validated bioanalytical method. This research aimed to develop analytical methods esomeprazole in human plasma from optimum chromatographic conditions, the optimum plasma preparation method, until the validation of analytical methods. The optimum chromatographic condition was obtain using C-18 column (Waters, Sunfire? 5 μm; 250 x 4.6 mm), column temperature 40 °C; mobile phase acetonitrile - phosphate buffer pH 7.6 (40: 60% v/v); a flow rate of 1.00 mL/min; photodiode array detector at a wavelength of 300 nm; and lansoprazole as internal standard. Sample preparation using liquid-liquid extraction with dichloromethane as solvent and then dried with nitrogen gas at a temperature of 40 °C for 30 minutes; and reconstituted with mobile phase of 100 mL. The results of validation fulfilled the acceptance criteria of validation method based on EMEA Bioanalytical Guideline 2011. The method was linear at concentration range of 5.0 to 450.0 ng / mL with r > 0.9997.