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DAFTAR PUSTAKA

Aamir, M., Khan, J.A., Shakeel, F., Shareef, R., dan Shah, N., 2018. Drug
utilization in neonatal setting of Pakistan: focus on unlicensed and off
label drug prescribing. BMC Pediatrics, 18:242-250 .
Agrawal, R.P., Goswami, J., Jain, S., dan Kochar, D.K., 2009. Management of
diabetic neuropathy by sodium valproate and glyceryl trinitrate spray: A
prospective double-blind randomized placebo-controlled study. Diabetes
Research and Clinical Practice, 83: 371–378.
Ambrósio, A.F., Soares-Da-Silva, P., Carvalho, C.M., dan Carvalho, A.P., 2002.
Mechanisms of action of carbamazepine and its derivatives, oxcarbazepine,
BIA 2-093, and BIA 2-024. Neurochemical Research, 27: 121–130.
Andayani, T. M., 2013, Farmakoekonomi, Prinsip dan Metodologi, Bursa Ilmu,
Yogyakarta
Arora, M., Agarwal, A., Baidya, D., dan Khanna, P., 2011. Pregabalin in acute
and chronic pain. Journal of Anaesthesiology Clinical Pharmacology, 27:
307-314.
Athanasakis, K., Petrakis, I., Karampli, E., Vitsou, E., Lyras, L., dan Kyriopoulos,
J., 2013. Pregabalin versus gabapentin in the management of peripheral
neuropathic pain associated with post-herpetic neuralgia and diabetic
neuropathy: a cost effectiveness analysis for the Greek healthcare setting.
BMC neurology, 13: 56-63.
Baron, R., Binder, A., dan Wasner, G., 2010. Neuropathic pain: diagnosis,
pathophysiological mechanisms, and treatment. The Lancet Neurology, 9:
807–819.
Basbaum, A.I., Bautista, D.M., Scherrer, G., dan Julius, D., 2009. Cellular and
Molecular Mechanisms of Pain. Cell, 139: 267–284.
Bashir, A.H., Abdullahi, A., Abba, M.A., dan Mukhtar, N.B., 2017. Central
Poststroke Pain: Its Profile among Stroke Survivors in Kano, Nigeria.
Behavioural Neurology, 2017.
Berlin, R.K., Butler, P.M., dan Perloff, M.D., 2015. Gabapentin Therapy in
Psychiatric Disorders: A Systematic Review. The Primary Care
Companion for CNS Disorders, 17(5):1-28 .
Birse, F., Derry, S., dan Moore, R.A., 2012. Phenytoin for neuropathic pain and
fibromyalgia in adults, dalam: The Cochrane Collaboration (Ed.),
Cochrane Database of Systematic Reviews. John Wiley & Sons, Ltd,
Chichester, UK.
Bockbrader, H.N., Wesche, D., Miller, R., Chapel, S., Janiczek, N., dan Burger, P.,
2010. A Comparison of the Pharmacokinetics and Pharmacodynamics of
Pregabalin and Gabapentin: Clinical Pharmacokinetics, 49: 661–669.

131
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Bootman, J.L., Townsend, R.J., dan McGhan, W.F., 2005, Principles of


Pharmacoeconomics. 3rd Ed. Havard Whitney Books Company,
Cincinnati.
Breivik, H., Borchgrevink, P.C., Allen, S.M., Rosseland, L.A., Romundstad, L.,
Breivik Hals, E.K., dkk., 2008. Assessment of pain. British Journal of
Anaesthesia, 101: 17–24.
Cellini, S.R. dan Kee, J.E., 2010. Cost-effectiveness and cost-benefit analysis.
Handbook of practical program evaluation,21: 493-530 .
Chen, H., Deshpande, A.D., Jiang, R., dan Martin, B.C., 2005. An
epidemiological investigation of off-label anticonvulsant drug use in the
Georgia Medicaid population. Pharmacoepidemiology and Drug Safety,
14: 629–638.
Chen, H., Reeves, J.H., Fincham, J.E., Kennedy, W.K., dan Martin, B.C., 2006.
Off-Label Use of Antidepressant, Anticonvulsant, and Antipsychotic
Medications Among Georgia Medicaid Enrollees in 2001. The Journal of
Clinical Psychiatry, 67: 1,478-982.
Choonara, I. dan Conroy, S., 2002. Unlicensed and off-label drug use in children:
implications for safety. - PubMed - NCBI. Drug Safety, 25: 1–5.
Clarke, H., Kay, J., Orser, B.A., Gollish, J., Mitsakakis, N., dan Katz, J., 2010.
Gabapentin Does Not Reduce Preoperative Anxiety When Given Prior to
Total Hip Arthroplasty. Pain Medicine, 11: 966–971.
Cross, A.L. dan Sherman, A. l, 2017. Pregabalin, dalam: StatPearls. StatPearls
Publishing, Treasure Island (FL).
Dahlan, M.S, 2010. Besar Sampel dan Cara Pengambilan Sampel. Seri 2. Salemba
Medika, Jakarta.
Danés, I., Agustí, A., Vallano, A., Alerany, C., Martínez, J., Bosch, J.A., dkk.,
2014. Outcomes of off-label drug uses in hospitals: a multicentric
prospective study. European Journal of Clinical Pharmacology, 70: 1385–
1393.
Dasgupta, A., 2012. Therapeutic Drug Monitoring: Newer Drugs and Biomarkers.
Academic Press.
Davis, L.L., Bartolucci, A., dan Petty, F., 2005. Divalproex in the treatment of
bipolar depression: a placebo-controlled study. Journal of Affective
Disorders, 85: 259–266.
Defrin, R., Eli, I., dan Pud, D., 2011. Interactions Among Sex, Ethnicity, Religion,
and Gender Role Expectations of Pain. Gender Medicine, 8: 172–183.
Defrin, R., Shramm, L., dan Eli, I., 2009. Gender role expectations of pain is
associated with pain tolerance limit but not with pain threshold: Pain, 145:
230–236.

132
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BANGUNAWATI RAHAJENG, Prof. Dr. Zullies Ikawati.,Apt; Dr. Tri Murti Andayani., SpFRS., Apt; Prof.dr Iwan Dwipra
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Dworkin, R.H., Turk, D.C., Wyrwich, K.W., Beaton, D., Cleeland, C.S., Farrar,
J.T., dkk., 2008. Interpreting the Clinical Importance of Treatment
Outcomes in Chronic Pain Clinical Trials: IMMPACT Recommendations.
The Journal of Pain, 9: 105–121.
Ebell, M.H., Siwek, J., Weiss, B.D., Woolf, S.H., Susman, J., Ewigman, B., dkk.,
2004. Strength of Recommendation Taxonomy (SORT): A Patient-
Centered Approach to Grading Evidence in the Medical Literature. The
Journal of the American Board of Family Medicine, 17: 59–67.
Ferreira, L. de A., Ibiapina, C. da C., Machado, M.G.P., dan Fagundes, E.D.T.,
2012. High prevalence of off-label and unlicensed drug prescribing in a
Brazilian intensive care unit. Revista da Associação Médica Brasileira
(English Edition), 58: 82–87.
Finnerup, N.B. dan Jensen, T.S., 2007. Clinical use of pregabalin in the
management of central neuropathic pain. Neuropsychiatric disease and
treatment, 3: 885-891.
Franco, V., Canevini, M.P., Capovilla, G., De Sarro, G., Galimberti, C.A., Gatti,
G., dkk., 2014. Off-Label Prescribing of Antiepileptic Drugs in
Pharmacoresistant Epilepsy: A Cross-Sectional Drug Utilization Study of
Tertiary Care Centers in Italy. CNS Drugs, 28: 939–949.
Gazarian, M., 2007. 'Off ‐ Label Use Of Medicines In The Paediatric Poulation:
Recommendations For Assesing Appropriateness'. NSW, 2031, Sydney,
Australia.
Ghaemi, S.N., Gilmer, W.S., Goldberg, J.F., Zablotsky, B., Kemp, D.E., Kelley,
M.E., dkk., 2007. Divalproex in the treatment of acute bipolar depression:
A preliminary double-blind, randomized, placebo-controlled pilot study.
Journal of Clinical Psychiatry, 68: 1840–1844.
Gill, D., Derry, S., Wiffen, P.J., dan Moore, R.A., 2011. Valproic acid and sodium
valproate for neuropathic pain and fibromyalgia in adults, dalam: The
Cochrane Collaboration (Ed.), Cochrane Database of Systematic Reviews.
John Wiley & Sons, Ltd, Chichester, UK.
Gilron, I., Wajsbrot, D., Therrien, F., dan Lemay, J., 2011. Pregabalin for
peripheral neuropathic pain: a multicenter, enriched enrollment
randomized withdrawal placebo-controlled trial. The Clinical Journal of
Pain, 27: 185–193.
Gilron, I., Watson, C.P.N., Cahill, C.M., dan Moulin, D.E., 2006. Neuropathic
pain: a practical guide for the clinician. Canadian Medical Association
Journal, 175: 265–275.
Gloth, F.M., 2001. Pain management in older adults: prevention and treatment.
Journal of the American Geriatrics Society, 49: 188–199.
Gómez-Pérez, F.J., Choza, R., Ríos, J.M., Reza, A., Huerta, E., Aguilar, C.A.,
dkk., 1996. Nortriptyline-fluphenazine vs. carbamazepine in the

133
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symptomatic treatment of diabetic neuropathy. Archives of Medical


Research, 27: 525–529.
Groleger, U., 2007. Off-label use of antipsychotics: rethinking ―off-label.‖
Psychiatria Danubina, 19: 350–353.
Harno, H., Haapaniemi, E., Putaala, J., Haanpaa, M., Makela, J.P., Kalso, E., dkk.,
2014. Central poststroke pain in young ischemic stroke survivors in the
Helsinki Young Stroke Registry. Neurology, 83: 1147–1154.
Hawker, G.A., Mian, S., Kendzerska, T., dan French, M., 2011. Measures of adult
pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for
Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill
Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short
Form-36 Bodily Pain Scale (SF. Arthritis Care & Research, 63: S240–
S252.
Henningsen, P., 2018. Management of somatic symptom disorder. Dialogues in
Clinical Neuroscience, 20: 23-31.
Horen, B., Montastruc, J.-L., dan Lapeyre-mestre, M., 2002. Adverse drug
reactions and off-label drug use in paediatric outpatients. British Journal
of Clinical Pharmacology, 54: 665–670.
Horowitz, E., Bergman, L.C., Ashkenazy, C., Moscona-Hurvitz, I., Grinvald-
Fogel, H., dan Magnezi, R., 2014. Off-Label Use of Sodium Valproate for
Schizophrenia. PLoS ONE, 9: e92573.
Ikatan Apoteker Indonesia, 2014. SK PO-001 ttg PO Standar Praktik Apoteker
Indonesia.pdf.
Javangula, H., 2012. AN OVERVIEW OF PHARMACOECONOMICS AND
OUTCOMES RESEARCH.
Jay, G.W. dan Barkin, R.L., 2014. Neuropathic pain: Etiology, pathophysiology,
mechanisms, and evaluations. Disease-a-Month, 60: 6–47.
Jensen, T.S., 2002. Anticonvulsants in neuropathic pain: rationale and clinical
evidence. European Journal of Pain, 6: 61–68.
Jia, H., Li, Q., Song, D., An, Z., Liu, Y., Ran, X., dkk., 2006. Effects of
Veniafaxine and Carbamazepine for Painful Peripheral Diabetic
Neuropathy : A Randomized , Double-blind and Double- dummy,
Controlled Multi-center Trial. Chinese Journal of Evidence Based
Medicine, 6: 321–7.
Jonsson, A.-C., Lindgren, I., Hallstrom, B., dan Lindgren, A., 2006. Prevalence
and intensity of pain after stroke: a population based study focusing on
patients’ perspectives. Journal of Neurology, Neurosurgery & Psychiatry,
77: 590–595.
Kasper, S., Herman, B., Nivoli, G., Ameringen, M.V., Petralia, A., Mandel, F.S.,
dkk., 2009. Efficacy of pregabalin and venlafaxine-XR in generalized

134
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anxiety disorder: results of a double-blind, placebo-controlled 8-week


trial: International Clinical Psychopharmacology, 24: 87–96.
Kaufman, K.R., 2011. Antiepileptic drugs in the treatment of psychiatric disorders.
Epilepsy & Behavior, 21: 1–11.
Kaydok, E., Levendoglu, F., Ozerbil, M.O., dan Karahan, A.Y., 2014. Comparison
of The Efficacy of Gabapentin and Pregabalin For Neurophatic Pain In
Patients With Spinal Cord Injury : A Crossover Study. Acta Medica, 30:
1343.
Khetarpal, R., Kataria, A., Bajaj, S., Kaur, H., dan Singh, S., 2016. Gabapentin vs
pregabalin as a premedication in lower limb orthopaedics surgery under
combined spinal epidural technique. Anesthesia: Essays and Researches,
10: 262.
Kim, J.S., Bashford, G., Murphy, K.T., Martin, A., Dror, V., dan Cheung, R.,
2011. Safety and efficacy of pregabalin in patients with central post-stroke
pain: Pain, 152: 1018–1023.
Klit, H., Finnerup, N.B., dan Jensen, T.S., 2009. Central post-stroke pain: clinical
characteristics, pathophysiology, and management. The Lancet Neurology,
8: 857–868.
Klit, H.M., Finnerup, N.B., dan Jensen, T.S., 2015. Diagnosis, Prevalence
Characteristics and Treatment of Central Poststroke Pain. International
Association for the Study of Pain, 12: 1–7.
Knopf, H., Wolf, I.-K., Sarganas, G., Zhuang, W., Rascher, W., dan Neubert, A.,
2013. Off-label medicine use in children and adolescents: results of a
population-based study in Germany. BMC Public Health, 13: 631.
Kochar, D.K., Garg, P., Bumb, R.A., Kochar, S.K., Mehta, R.D., Beniwal, R.,
dkk., 2005. Divalproex sodium in the management of post-herpetic
neuralgia: a randomized double-blind placebo-controlled study. QJM, 98:
29–34.
Kochar, D.K., Rawat, N., Agrawal, R.P., Vyas, A., Beniwal, R., Kochar, S.K.,
dkk., 2004. Sodium valproate for painful diabetic neuropathy: a
randomized double-blind placebo-controlled study. QJM: An International
Journal of Medicine, 97: 33–38.
Krasowski, M.D., 2010. Therapeutic Drug Monitoring of the Newer Anti-Epilepsy
Medications. Pharmaceuticals, 3: 1909–1935.
Landmark, C.J., 2008. Antiepileptic drugs in non-epilepsy disorders. CNS drugs,
22: 27–47.
Lavigne, J.E., Heckler, C., Mathews, J.L., Palesh, O., Kirshner, J.J., Lord, R., dkk.,
2012. A randomized, controlled, double-blinded clinical trial of gabapentin
300 versus 900 mg versus placebo for anxiety symptoms in breast cancer
survivors. Breast Cancer Research and Treatment, 136: 479–486.

135
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Le Jeunne, C., Billon, N., Dandon, A., participants of round table N° 3 of Giens
XXVIII:, Berdaï, D., Adgibi, Y., dkk., 2013. Off-label Prescriptions: how
to Identify Them, Frame Them, Announce Them and Monitor Them in
Practice? Thérapie, 68: 233–239.
Lee, J.-H., Byon, H.-J., Choi, S., Jang, Y.-E., Kim, E.-H., Kim, J.-T., dkk., 2018.
Safety and Efficacy of Off-label and Unlicensed Medicines in Children.
Journal of Korean Medical Science, 33: 1-10.
Leijon, G. dan Boivie, J., 1989. Central post-stroke pain—a controlled trial of
amitriptyline and carbamazepine. Pain, 36: 27–36.
Lenk, C. dan Duttge, G., 2014. Ethical and legal framework and regulation for
off-label use: European perspective. Therapeutics and Clinical Risk
Management, 537.
Li, L., Liu, X., dan Herr, K., 2007. Postoperative pain intensity assessment: a
comparison of four scales in Chinese adults. Pain Medicine (Malden,
Mass.), 8: 223–234.
Liu, B., Liu, R., dan Wang, L., 2017. A meta-analysis of the preoperative use of
gabapentinoids for the treatment of acute postoperative pain following
spinal surgery: Medicine, 96: e8031.
Lydiard, R.B., 2003. The role of GABA in anxiety disorders. The Journal of
Clinical Psychiatry, 64 Suppl 3: 21–27.
Maheshwary, N., Saeed, T., Nasrullah, M., Ghafoor, A., Shahid, R., Islam, N.,
dkk., 2014. Efficacy and tolerability of carbamazepine for the treatment of
painful diabetic neuropathy in adults: a 12-week, open-label, multicenter
study. International Journal of General Medicine, 339.
Mazhar, F., Akram, S., Haider, N., Hadi, M.A., dan Sultana, J., 2018. Off-label
and unlicensed drug use in hospitalized newborns in a Saudi tertiary care
hospital: a cohort study. International Journal of Clinical Pharmacy, .
McCleane, G.J., 1999. Intravenous Infusion of Phenytoin Relieves Neuropathic
Pain: A Randomized, Double-Blinded, Placebo-Controlled, Crossover
Study. Anesth Analg, 89: 985–8.
Ménigaux, C., Adam, F., Guignard, B., Sessler, D.I., dan Chauvin, M., 2005.
Preoperative Gabapentin Decreases Anxiety and Improves Early
Functional Recovery from Knee Surgery: Anesthesia & Analgesia, 100:
1394–1399.
Minella, C., Raffaeli, W., Magnani, F., dan Sarti, 2013. Population-based study of
central post-stroke pain in Rimini district, Italy. Journal of Pain Research,
705.
Mishra, R., Tripathi, M., dan Chandola, H., 2016. Comparative clinical study of
gabapentin and pregabalin for postoperative analgesia in laparoscopic
cholecystectomy. Anesthesia: Essays and Researches, 10: 201.

136
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Monasterio, E. dan McKean, A., 2011. Off-label use of atypical antipsychotic


medications in Canterbury, New Zealand. NZ Med J, 124: 24–9.
Moore, R.A., Straube, S., Wiffen, P.J., Derry, S., dan McQuay, H.J., 2009.
Pregabalin for acute and chronic pain in adults, dalam: The Cochrane
Collaboration (Ed.), Cochrane Database of Systematic Reviews. John
Wiley & Sons, Ltd, Chichester, UK.
Moore, R.A., Wiffen, P.J., Derry, S., Toelle, T., dan Rice, A.S.C., 2014.
Gabapentin for chronic neuropathic pain and fibromyalgia in adults. The
Cochrane Database of Systematic Reviews, 4: CD007938.
Nemeroff, C.B., 2003. The role of GABA in the pathophysiology and treatment of
anxiety disorders. Psychopharmacology Bulletin, 37: 133–146.
O’Connor, A.B., Noyes, K., dan Holloway, R.G., 2007. A cost-effectiveness
comparison of desipramine, gabapentin, and pregabalin for treating
postherpetic neuralgia. Journal of the American Geriatrics Society, 55:
1176–1184.
Oks, M., Cleven, K.L., Healy, L., Wei, M., Narasimhan, M., Mayo, P.H., dkk.,
2018. The Safety and Utility of Phenobarbital Use for the Treatment of
Severe Alcohol Withdrawal Syndrome in the Medical Intensive Care Unit.
Journal of Intensive Care Medicine, 088506661878394.
Onouchi, K., Yokoyama, K., Yoshiyama, T., dan Koga, H., 2014. An open-label,
long-term study examining the safety and tolerability of pregabalin in
Japanese patients with central neuropathic pain. Journal of Pain Research,
439.
Onyenwenyi, A.J., 2008. 'Off-Label Prescribing of Anticonvulsant Drugs',
Desertasi, . University of Florida, Florida, United States.
Pande, A.C., Feltner, D.E., Jefferson, J.W., Davidson, J.R.T., Pollack, M., Stein,
M.B., dkk., 2004. Efficacy of the novel anxiolytic pregabalin in social
anxiety disorder: a placebo-controlled, multicenter study. Journal of
Clinical Psychopharmacology, 24: 141–149.
Pratiwi, A.A., Khairinnisa, M.A., Alfian, S.D., Priyadi, A., Pradipta, I.S., dan
Abdulah, R., 2013. Peresepan Obat-obat Off-Label pada Pasien Anak Usia
0 Hingga 2 Tahun di Apotek Kota Bandung. Jurnal Farmasi Klinik
Indonesia, 2: 39–50.
Radley, D.C., Finkelstein, S.N., dan Stafford, R.S., 2006. Off-label prescribing
among office-based physicians. Archives of Internal Medicine, 166: 1021–
1026.
Raja, M. dan Azzoni, A., 2003. Oxcarbazepine vs. valproate in the treatment of
mood and schizoaffective disorders. The International Journal of
Neuropsychopharmacology, 6: 409–414.
Reeder, C.E., 1995. Overview of pharmacoeconomics and pharmaceutical
outcomes evaluations. American journal of health-system pharmacy:

137
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AJHP: official journal of the American Society of Health-System


Pharmacists, 52: S5-8.
Rodríguez, M.J., Díaz, S., Vera-Llonch, M., Dukes, E., dan Rejas, J., 2007. Cost-
effectiveness analysis of pregabalin versus gabapentin in the management
of neuropathic pain due to diabetic polyneuropathy or post-herpetic
neuralgia. Current Medical Research and Opinion, 23: 2585–2596.
Rose, M.A. dan Kam, P.C.A., 2002. Gabapentin: pharmacology and its use in pain
management. Anaesthesia, 57: 451–462.
Sachs, J. dan Weltgesundheitsorganisation (Eds.), 2001. Macroeconomics and
Health: Investing in Health for Economic Development ; Report of the
Commission on Macroeconomics and Health. World Health Organization,
Geneva.
Sazgar, M. dan Bourgeois, B.F.D., 2005. Aggravation of Epilepsy By
Antiepileptic Drugs. Pediatric Neurology, 33: 227–234.
Schifano, F., 2014. Misuse and Abuse of Pregabalin and Gabapentin: Cause for
Concern? CNS Drugs, 28: 491–496.
Semel, D., Murphy, T.K., Zlateva, G., Cheung, R., dan Emir, B., 2010. Evaluation
of the safety and efficacy of pregabalin in older patients with neuropathic
pain: results from a pooled analysis of 11 clinical studies. BMC family
practice, 11: 85.
Shneker, B.F. dan McAuley, J.W., 2005. Pregabalin: a new neuromodulator with
broad therapeutic indications. The Annals of Pharmacotherapy, 39: 2029–
2037.
Sicras-Mainar, A., Rejas-Gutiérrez, J., Navarro-Artieda, R., dan Planas-Comes, A.,
2012. Cost analysis of adding pregabalin or gabapentin to the management
of community-treated patients with peripheral neuropathic pain: Pregabalin
and gabapentin in neuropathic pain. Journal of Evaluation in Clinical
Practice, 18: 1170–1179.
Siddall, P.J., Cousins, M.J., Otte, A., Griesing, T., Chambers, R., dan Murphy,
T.K., 2006. Pregabalin in central neuropathic CME pain associated with
spinal cord injury. Neurology, 67: 1792–800.
Singla, Chelly, J., Lionberger, D., Gimbel, J., Sanin, L., Sporn, J., dkk., 2014.
Pregabalin for the treatment of postoperative pain: results from three
controlled trials using different surgical models. Journal of Pain Research,
9.
Sjölund, K.-F., Yang, R., Lee, K.-H., dan Resnick, M., 2013. Randomized Study
of Pregabalin in Patients with Cancer-Induced Bone Pain. Pain and
Therapy, 2: 37–48.
Smith, L.A., Cornelius, V.R., Azorin, J.M., Perugi, G., Vieta, E., Young, A.H.,
dkk., 2010. Valproate for the treatment of acute bipolar depression:

138
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Systematic review and meta-analysis. Journal of Affective Disorders, 122:


1–9.
Snedecor, S., Sudharshan, L., Cappelleri, Sadosky, A., Desai, Jalundhwala, dkk.,
2013. Systematic review and comparison of pharmacologic therapies for
neuropathic pain associated with spinal cord injury. Journal of Pain
Research, 539.
Spina, E. dan Perugi, G., 2004. Antiepileptic drugs indications other than epilepsy.
Epileptic Dissorder, 6: 57–75.
Stafford, R.S., 2008. Regulating Off-Label Drug Use — Rethinking the Role of
the FDA. The New England Journal of Medicine, , 14 358: 1427–1429.
Tarride, J.-E., Gordon, A., Vera-Llonch, M., Dukes, E., dan Rousseau, C., 2006.
Cost-effectiveness of pregabalin for the management of neuropathic pain
associated with diabetic peripheral neuropathy and postherpetic neuralgia:
A Canadian perspective. Clinical Therapeutics, 28: 1922–1934.
Toth, C., 2013. Pregabalin: latest safety evidence and clinical implications for the
management of neuropathic pain. Therapeutic advances in drug safety,
2042098613505614.
Tracy Glauser, Elinor Ben-Menachem, Blaise Bourgeois, Avital Cnaan, Carlos
Guerreiro, Reetta Ka, dkk., 2013. Guidelines-epilepsia-12074-2013.pdf.
Epilepsia, 1–13.
Tran, A.R., Zito, J.M., Safer, D.J., dan Hundley, S.D., 2014. National trends in
pediatric use of anticonvulsants.
Tzellos, T.G., Toulis, K.A., Goulis, D.G., Papazisis, G., Zampeli, V.A., Vakfari,
A., dkk., 2010. Gabapentin and pregabalin in the treatment of
fibromyalgia: a systematic review and a meta-analysis. Journal of Clinical
Pharmacy and Therapeutics, 35: 639–656.
Vargas-Espinosa, M., Sanmarti-Garcia, G., Vazquez-Delgado, E., dan Gay-
Escoda, C., 2012. Antiepileptic drugs for the treatment of neuropathic
pain: A systematic review. Medicina Oral Patología Oral y Cirugia Bucal,
e786–e793.

Ventola, C.L., 2009. Off-label drug information: Regulation, distribution,


evaluation, and related controversies. Pharmacy and Therapeutics, 34:
428-449.
Vinik, A., Emir, B., Cheung, R., dan Whalen, E., 2013. Relationship Between
Pain Relief and Improvements in Patient Function/Quality of Life in
Patients With Painful Diabetic Peripheral Neuropathy or Postherpetic
Neuralgia Treated With Pregabalin. Clinical Therapeutics, 35: 612–623.
Vogenberg, F.R., 2001. Introduction to Pharmacoeconomics. McGraw-Hill, New
York; London.

139
KAJIAN RISIKO - MANFAAT PENGGUNAAN ANTIKONVULSAN SECARA OFF-LABEL PADA TERAPI
NYERI NEUROPATI
SENTRAL POST STROKE STUDI PADA PREGABALIN dan GABAPENTIN
BANGUNAWATI RAHAJENG, Prof. Dr. Zullies Ikawati.,Apt; Dr. Tri Murti Andayani., SpFRS., Apt; Prof.dr Iwan Dwipra
Universitas Gadjah Mada, 2019 | Diunduh dari http://etd.repository.ugm.ac.id/

Vranken, J., Dijkgraaf, M., van der Vegt, M., Hollman, M., dan Hessen, M., 2008.
Pregabalin in patients with central neuropathic pain: a randomized,
double-blind, placebo-controlled trial of a flexible-dose regimen. -
PubMed - NCBI. Pain, 136: 150–7.
Vranken, J.H., Dijkgraaf, M.G.W., Kruis, M.R., van der Vegt, M.H., Hollmann,
M.W., dan Heesen, M., 2008. Pregabalin in patients with central
neuropathic pain: A randomized, double-blind, placebo-controlled trial of
a flexible-dose regimen: Pain, 136: 150–157.
Wallach, J.D. dan Ross, J.S., 2018. Gabapentin Approvals, Off-Label Use, and
Lessons for Postmarketing Evaluation Efforts. JAMA, 319: 776-778.
Walley, T., Haycox, A., Boland, A., dan Breckenridge, A.M., 2004.
Pharmacoeconomics.
Wandner, L.D., Scipio, C.D., Hirsh, A.T., Torres, C.A., dan Robinson, M.E., 2012.
The Perception of Pain in Others: How Gender, Race, and Age Influence
Pain Expectations. The Journal of Pain, 13: 220–227.
Wesolowicz, D., Clark, J., Boissoneault, J., dan Robinson, M., 2018. The roles of
gender and profession on gender role expectations of pain in health care
professionals. Journal of Pain Research, Volume 11: 1121–1128.
Wiffen, P.J., Derry, S., Bell, R.F., Rice, A.S., Tölle, T.R., Phillips, T., dkk., 2017.
Gabapentin for chronic neuropathic pain in adults. Cochrane Database of
Systematic Reviews, .
Wiffen, P.J., Derry, S., Moore, R.A., Aldington, D., Cole, P., Rice, A.S.C., dkk.,
2013. Antiepileptic drugs for neuropathic pain and fibromyalgia - an
overview of Cochrane reviews, dalam: The Cochrane Collaboration (Ed.),
Cochrane Database of Systematic Reviews. John Wiley & Sons, Ltd,
Chichester, UK.
Wiffen, P.J., Derry, S., Moore, R.A., dan Kalso, E.A., 2014. Carbamazepine for
chronic neuropathic pain and fibromyalgia in adults, dalam: The Cochrane
Collaboration (Ed.), Cochrane Database of Systematic Reviews. John
Wiley & Sons, Ltd, Chichester, UK.
Wiffen, P.J., Derry, S., Moore, R.A., dan McQuay, H.J., 2011. Carbamazepine for
acute and chronic pain in adults, dalam: The Cochrane Collaboration (Ed.),
Cochrane Database of Systematic Reviews. John Wiley & Sons, Ltd,
Chichester, UK.
Wittich, C.M., Burkle, C.M., dan Lanier, W.L., 2012. Ten Common Questions
(and Their Answers) About Off-label Drug Use. Mayo Clinic Proceedings,
87: 982–990.
Zaccara, G., Gangemi, P., Perucca, P., dan Specchio, L., 2011. The adverse event
profile of pregabalin: A systematic review and meta-analysis of
randomized controlled trials: Meta-Analysis of Pregabalin Adverse Effects.
Epilepsia, 52: 826–836.

140
KAJIAN RISIKO - MANFAAT PENGGUNAAN ANTIKONVULSAN SECARA OFF-LABEL PADA TERAPI
NYERI NEUROPATI
SENTRAL POST STROKE STUDI PADA PREGABALIN dan GABAPENTIN
BANGUNAWATI RAHAJENG, Prof. Dr. Zullies Ikawati.,Apt; Dr. Tri Murti Andayani., SpFRS., Apt; Prof.dr Iwan Dwipra
Universitas Gadjah Mada, 2019 | Diunduh dari http://etd.repository.ugm.ac.id/

Zaccara, G., Perucca, P., dan Gangemi, P.F., 2012. The adverse event profile of
pregabalin across different disorders: a meta-analysis. European Journal
of Clinical Pharmacology, 68: 903–912.

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