The efficacy of Rhinos® SR on nasal resistance and nasal symptoms in patients with perennial allergic rhinitis : a randomized, double-blind, placebo-controlled study

Broj cestovnih vozila povećava se svakoga dana, a sukladno tome povećava se i potrošnja pogonskih goriva. Poznato je kako je izgaranje pogonskih goriva jedan od glavnih uzročnika efekta staklenika te općenito onečišćenja okoliša. Razvojem cestovnih vozila su se postupno razvijale i ideje o ekološkoj svijesti te sukladno tome i ideje o upotrebi ekološki prihvatljivijih pogona i pogonskih goriva. Glavna svrha ovog završnog rada je kroz analizu i usporedbu utjecaja na okoliš konvencionalnih i alternativnih goriva za pogon vozila prikazati prednosti i nedostatke svih goriva. Pomoću podataka iz prakse te rezultata računa za emisije CO2 svakog goriva pojedinačno, načinjen je redoslijed najviše, odnosno najmanje pogodnih pogona i pogonskih goriva za korištenje u svrhu očuvanja okoliša.The number of road vehicles increases daily in accordance with the enhancement of the fuel consumption. It is clear that the fuel combustion represents one of the main causes for the greenhouse effect and environmental pollution generally. Development of road vehicles induced the growth of ecological consciousness ideas and also the ideas for using ecologically acceptable drives and fuels. The main objective of this final assignment is to present the positive and negative sides of conventional and alternative fuels through analysis and comparison of each one individually. With the information about CO2 emissions from literature and from results of task computing, it is created order from the least favourable to the most favourable drive and fuel with the aim of environmental protection

UJI KLINIK OBAT TRADISIONAL

Obat tradisional sebenarnya tidak memerlukan uji klinik untuk persetujuan pemasaran selama klaim obat tersebut hanya untuk mengobati gejala. Namun untuk dikemas dan diproduksi oleh industri, perlu bukti klinis bahwa obat itu bermanfaat, sehingga si pemakai yakin bahwa klaim itu benar.Uji klinik jenis ini merupakan explanatory study, yaitu dirancang dengan ketat, mengikutsertakan penderita dengan penyakit yang jelas dan batas-batas yang tegas, memenuhi perhitungan jumlah sampel, pengukuran parameter yang obyektif, dan jika tidak berlawanan dengan hak azasi manusia diharuskan menggunakan kelompok kontrol plasebo. Jika penelitian dengan plasebo sudah pernah dan tuntas membuktikan efektivitas obatnya, maka dalam studi berikutnya tidak perlu lagi memakai kontrol plasebo

Dosing schedule of second generation sulfonylureas in the treatment of non-insulin dependent diabetes should be revised (A commentary)

[no abstract available

Safety and tolerability of fluvastatin XL in the treatment of hyper-cholesterolemia : a postmarketing surveillance conducted in Indonesia

<p>Fluvastatin XL 80 mg tablet has been marketed in Indonesia since December 2002. This post-marketing surveillance (PMS) was conducted between May 2004 and April 2005 involving 98 general physicians to observe the safety and tolerability of fluvastatin XL 80 mg once daily at bedtime for 8 weeks in the treatment of outpatients with hypercholesterolemia. The efficacy of the drug in lowering LDL-cholesterol and other lipid parameters was also observed in daily clinical practice in this PMS. A total of 740 patients were eligible for safety analyses. There were 32 patients (4.32%) with 39 adverse events that were considered related to fluvastatin XL therapy. The most common adverse reactions were dizziness (2.03%), nausea (1.22%), and myalgia (0.68%). No serious adverse event (SAE) was found in this PMS, and no patient discontinued due to adverse event. According to physician’s global evaluation, the safety and tolerability of treatment was good in 91.9% of patients. For efficacy analyses, only 566 patients were eligible. At week 8, fluvastatin XL caused decreases in LDL-cholesterol (LDL-C), total cholesterol (TC) and triglyceride (TG) levels by 28.6%, 30.2% and 24.5%, respectively, and an increase in HDL-cholesterol (HDL-C) by 14.3%. In 74 patients with baseline TG &gt; 300 mg/dL, the decrease in TG was 38.1% and the increase in HDL-C was 18.1%. Reduction in LDL-C of &gt; 40% occurred in 19.6% of the patients. In conclusion, treatment with fluvastatin XL 80 mg once daily for 8 weeks in this PMS was shown to be safe and well tolerated, and also effective in reducing LDL-C, TC and TG, and raising HDL-C in daily clinical practice.<em><strong> (Med J Indones 2008; 17:88-95)</strong></em></p><p><strong>Keywords:</strong> <em>post-marketing surveillance (PMS), fluvastatin XL, hypercholesterolemia</em></p

The efficacy of Rhinos® SR on nasal resistance and nasal symptoms in patients with perennial allergic rhinitis : a randomized, double-blind, placebo-controlled study

Rhinos® SR is a fixed combination of 5 mg loratadine and 60 mg pseudoephedrine immediate release and 60 mg pseudoephedrine sustained release. The present study was aimed to assess the efficacy of Rhinos® SR on nasal airway resistance (NAR) objectively using rhinomanometer and on nasal symptoms in patients with perennial allergic rhinitis (PAR) in a tropical country. This was a randomized, double-blind, parallel group study in 59 PAR patients who visited the ENT clinic at Dr. Soetomo General Hospital, Surabaya. Outpatients of both gender, having moderate to severe PAR for a minimal of 2 years, aged 12 years or older, with a total nasal symptom score (TNSS) > 6 and a nasal congestion score > 2, received Rhinos® SR or placebo twice daily for 7 days. The primary efficacy parameter was the decrease in the NAR values (measured by rhinomanometer on Day 1) of Rhinos® SR from those of placebo. The NAR values were calculated as the area under the curve (AUC) of NAR versus time. The secondary efficacy parameters were the percentage reduction of the clinical symptoms (nasal and nonnasal) evaluated by both the patient and the physician after 1 week use of Rhinos® SR or placebo. From 59 eligible patients, all completed this 1-week trial. For NAR values, after the baseline were considered as 100%, the AUC0-10 h were not significantly different between Rhinos® SR and placebo. However, as the pseudoephedrine reached its peak concentration, i.e. 2 hrs for the immediate release and 6 hrs for the sustained release, then AUC0-2 h and AUC0-6 h of Rhinos® SR were significantly lower compared to those of placebo. Total nasal symptom score (TNSS) evaluated by the patient (sum of the last 3 mornings) for Rhinos® SR decreased 33.0% from baseline (p < 0.001), for placebo decreased 21.9% from baseline (p = 0.002), but the decrease by Rhinos® SR was not significantly different from the decrease by placebo. TNSS evaluated by the physician, nasal congestion score (NCS) and total symptom score (TSS, total nasal and nonnasal), and even the individual symptom scores, evaluated by the patient and the physician, showed similar pattern, i.e. both Rhinos® SR and placebo decreased the symptoms significantly from baseline, and the decreases by Rhinos® SR were larger than the decreases by placebo, but the decreases by Rhinos® SR and placebo were not statistically different. No adverse event was found in this study. From the present study it was concluded that in patients with moderate to severe PAR in a tropical country, Rhinos® SR was effective in relieving nasal congestion by objective measurements of NAR. Rhinos® SR twice a day for 7 days was also effective in reducing the clinical symptoms of PAR although the reductions did not reach statistical significance compared to those by placebo, and was well tolerated. (Med J Indones 2008; 17: 114-26) Keywords: loratadine, pseudoephedrine, rhinomanometry, perennial allergic rhiniti

Comparison of the efficacy and safety of isepamicin plus metronidazole and amikacin plus metronidazole in intra-abdominal infections

Intra-abdominal infections due to penetrating wound through the abdominal wall or rupture of the gastrointestinal tract are acute conditions requiring prompt surgical intervention and the use of appropriate antimicrobial agents. Isepamicin is an effective aminoglycoside against various Gram-negative pathogens causing intra-abdominal infections. The objective of the present study is to compare the efficacy and safety of isepamicin (15 mg/kgBW IV o.d.) with amikacin (7.5 mg/kgBB b.i.d.), in conjunction with metronidazole for both drugs. An open, randomized, parallel design was applied in this trial. The subject allocation ratio for isepamicin: amikacin is 2:1. Out of 50 patients enrolled in this study, 27 fuffilled the criteria for safety and efficacy population, and 46 for intent-to-treat population. In the safety and efficacy population, the clinical success rare for isepamicin and amikacin group did not differ significantly (i.e., 95% and 100%, respectively). In the intent-to-treat population, the clinical success rates for isepamicin and amikacin group were also insignifficantly different (i.e., 97% and 100%, respectively). The rates of bacteriological elimination for isepamicin and amikacin, were 95% and 100%, respectively in the efficacy and safety population, and 90% and 93%, respectively in the intent-to-treat population. Streptococci and staphylococci were the most frequent (40%) pathogens isolated from pus, and Acinetobacter anitratus (55%) was the most common one isolated from blood. In the efficacy and safety population, the mean (± SD) length of hospital stay in the isepamicin and amikacin groups was 10.7 ± 3.9 and 11.1 ± 3.8 days, respectively, while in the intent-to-treat population, the mean (± SD) length of hospital stay in the isepamicin and amikacin groups was 10.1 ± 3.4 and 10.5 ± 3 days, respectively. In the present study, both aminoglycosides were well tolerated and there was no patient withdrawal associated with side effect. It is concluded that for intra-abdominal infections, intravenous isepamicin given once daily is as effective as intravenous amikacin given twice daily in combination with metronidazole. (Med J Indones 2001; 10: 88-94) Keywords : Isepamicin, amikacin, inta-abdominal infection