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"Summary:Critical appraisal is now accepted as central to the development of rational health care and evidence-based medicine, by applying it to questions of aetiology, clinical therapy, and health care management. The reader will learn how to assess the strengths and weaknesses of new studies, and how to conduct their own studies"

"ABSTRAKA PILOT STUDY : EFEKTIVITAS KAPSUL EKSTRAK RUMPUT MUTIARA HEDYOTIS CORYMBOSA L. LAMK. TERHADAP PASIEN OSTEOARTHRITIS USIA LANJUT Nita Sari Wijaya1, Anton Bahtiar1, Katrin11 Faculty of Pharmacy, Universitas Indonesia, Kampus UI Depok 16424Email : anton.bahtiar@gmail.com, yenlinita@gmail.com ABSTRAK Ekstrak Rumput Mutiara Hedyotis corymbosa mengandung senyawa polifenol dan flavonoid secara preklinis terbukti memiliki aktivitas untuk mengobati osteoarthritis dan arthritis reumatik dengan bantuan model hewan. Penelitian ini bertujuan untuk mengevaluasi keamanan dan efektivitas ekstrak rumput mutiara pada penderita osteoarthritis usia lanjut. Penelitian ini merupakan uji klinis fase 2, dengan metode double blind randomized control trial, telah disetujui oleh komite etik Fakultas Kedokteran Universitas Indonesiadengan subyek yang memenuhi kriteria seperti berusia lebih dari 50 tahun, memiliki tanda dan gejala osteoarthritis, tidak memiliki gangguan fungsi hati dan ginjal, serta tidak memiliki penyakit berat lainnya. Kapsul Ekstrak Rumput Mutiara diberikan satu kali sehari selama 8 minggu dan diberikan natrium diklofenak 50 mg dua kali sehari bila dirasakan nyeri dan dilakukan evaluasi sebelum dan sesudah terapi melalui pemeriksaan laboratorium dan roentgen, dan dilakukan pengawasan selama satu minggu serta evaluasi selama dua minggu menggunakan skala WOMAC dan VAS, serta penilaian efek yang timbul selama pemberian terapi. Subyek penelitian berusia 59.65 7.11 tahun dan pemberian kapsul ekstrak rumput mutiara tidak mempengaruhi fungsi ginjal maupun hati dalam pemakaian selama 8 minggu dan pemberian kapsul ekstrak rumput mutiara menurunkan nyeri yang dialami oleh peserta yang dinilai menggunakan skala VAS, WOMAC, dan pengurangan konsumsi diklofenak, dimana secara statistik, di dapatkan hasil bahwa pemberian ekstrak rumput mutiara berbeda signifikan saat sebelum dan sesudah pemberian p

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ABSTRACT A PILOT STUDY EFFECTIVENESS OF PEARL GRASS EXTRACT CAPSULES HEDYOTIS CORYMBOSA L. LAMK. ON GERIATRIC PATIENTS WITH OSTEOARTHRITIS Nita Sari Wijaya1, Anton Bahtiar1, Katrin11 Faculty of Pharmacy, Universitas Indonesia, Kampus UI Depok 16424Email anton.bahtiar gmail.com, yenlinita gmail.com ABSTRACT Pearl Grass Hedyotis corymbosa , contain a lot of flavonoid and polyphenol compounds that can be used to cure inflammatory diseases. On preclinical trial, pearl grass have been proven can cure osteoarthritis and rheumatoid arthritis on animals model. This study is to evaluate effectiveness of pearl grass extract on elderly patients with osteoarthritis. This is was clinical trial second phase, with double blind randomized control trial methods, and have been approved by ethics committee from Faculty of Medicine University of Indonesia with inclusion criteria, patients more than 50 years old, with sign and symptoms of osteoarthritis, doesn rsquo t have liver and renal insufficiently, and doesn rsquo t have another severe diseases and patients also already signed the informed consents before join this study. Capsules contains pearl grass extract and placebo have been given once daily everyday for 8 weeks and the participants also given sodium diclofenac 50 mg twice daily as emergency relief. Laboratory evaluation have been provided and x ray evaluation also have been provided before and after treatment to assess the improvement of the diseases. We also evaluated participants every weeks and assessed every two weeks with WOMAC and VAS scale, and effect that occurred in this treatment. Results of this study is, pearl grass extract was safe to consumed based on liver and renal function. Pearl grass extract effective to reduce pain using VAS and WOMAC scale p"

"Tujuan: Mengetahui pengurangan dosis induksi propofol pada kelompok yang diberikan koinduksi ketamin 0,3 mg/kgBB dibandingkan dengan kelompok yang diberikan koinduksi midazolam 0,03 mg/kgBB.Metode: Uji Klinik Tersamar Ganda. Penelitian dilakukan di Instalasi Bedah Pusat RSCM pada hulan November sampai dengan Desember 2006, dengan jumlah sampel 46 pasien dewasa yang menjalani operasi berencana dan anestesia umum. Pasien dibagi secara acak ke dalam 2 kelompok; 23 pasien mendapatkan koinduksi ketamin 0,3 mg/kgBB dan 23 pasien Iainnya mendapatkan midazolam 0,03 mg/kgBB 2 menit sebelum induksi propofol. Induksi propofol dilakukan secara titrasi 30 mg/i0 detik. Dilakukan pencatatan dosis induksi propofol pada end point hilangnya respon verbal dan hilangnya respon terhadap jaw thrust serta respon hemodinamik 1 menit setelah induksi. Analisa statistik untuk melihat perbedaan rerata antara kedua periakuan menggunakan uji-t, sedangkan perbedaan pada dua kelompok data kategori diuji dengan uji chi-square dengan nilai signilikansi p<0,05 dengan interval kepercayaan 93%.Hasil: Terdapat perbedaan yang bermakna secara statistik antara kedua kelompok perlakuan dalarn hal pengurangan dosis induksi propofol dan penurunan tekanan darah 1 manic setelah induksi propofol. Dosis induksi propofol pada kelompok ketamin 0,3 mg/kgBB lebih sedikit dibandingkan dengan midazolam 0,03 mg/kgBB. Ketamin 0,3 mg/kgBB lebih sedikit dalam efek penurunan tekanan darah akibat induksi propofol dibandingkan dengan midazolam 0,03 mg/kgBB.

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Objective:

To observe the reduction of propofol induction dose in ketamin co induction 0,3 Mg/Kg BB compare with midazolam coinduction 0,03 mg/kgBB

Methods:

Double blinded randomized clinical trial. The study was conducted at Cipto Mangunkusuma Hospital Central-Surgery Room from November until December 2006 to 46 adult patients who went to elective surgery and general anesthesia Patients were divided randomly into two groups: The group consist of twenty-three patients give co induction ketamin 0,3 mg/kgBW The other twenty-three patients was given with 0,03 mg/kgBW of midazolam coinduction two minutes before the induction propofol. The records doses propofol induction using loss of response to verbal commands and loss. of response to jaw thrust stimulation as end point of induction. This study also observed the homodynamic response one minute after induction. T-test method was performed to identfy the mean difference between the two groups, while Chi Square method was performed to identify the frequency difference (categorical data) between the two groups. A 'p' value of <0.05 was considered statistically significant: with 95% confidence interval.

Conclusion:

There were .significant statistical differences between the two groups in a matter of reducing propofol induction doses and hemodynamic effects one minute after propofol induction. Propofol induction dose was less at ketamine group. Hemodynamic elects one minute after propofol induction, Ketamine 0,3 mg/kgBW was less in reducing blood pressure compared with midazolam 0,03 mg/kgBW."

"This is the fifth edition of a very successful textbook on clinical trials methodology, written by recognized leaders who have long and extensive experience in all areas of clinical trials. The three authors of the first four editions have been joined by two others who add great expertise. Most chapters have been revised considerably from the fourth edition. A chapter on regulatory issues has been included and the chapter on data monitoring has been split into two and expanded. Many contemporary clinical trial examples have been added. There is much new material on adverse events, adherence, issues in analysis, electronic data, data sharing, and international trials. This book is intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol. It is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of patients. The authors use numerous examples of published clinical trials to illustrate the fundamentals.The text is organized sequentially from defining the question to trial closeout. One chapter is devoted to each of the critical areas to aid the clinical trial researcher. These areas include pre-specifying the scientific questions to be tested and appropriate outcome measures, determining the organizational structure, estimating an adequate sample size, specifying the randomization procedure, implementing the intervention and visit schedules for participant evaluation, establishing an interim data and safety monitoring plan, detailing the final analysis plan, and reporting the trial results according to the pre-specified objectives."