Self-reported adverse drug effects and associated factors among H. pylori infected patients on standard triple therapy: Prospective follow up study
Autoři:
Endalew Gebeyehu aff001; Desalegn Nigatu aff002; Ephrem Engidawork aff003
Působiště autorů:
Department of Pharmacology, School of Health Sciences, College of Medicine and Health Sciences, Bahir Dar University, Bahir Dar, Ethiopia
aff001; Department of Internal Medicine, School of Medicine, College of Medicine and Health Sciences, Bahir Dar University, Bahir Dar, Ethiopia
aff002; Department of Pharmacology and Clinical Pharmacy, School of Pharmacy, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia
aff003
Vyšlo v časopise:
PLoS ONE 14(11)
Kategorie:
Research Article
doi:
https://doi.org/10.1371/journal.pone.0225585
Souhrn
Background
One of the most common reasons for poor medication adherence and associated treatment failure of triple therapy is adverse drug effect (ADEs) of medications.
Objective
Assessment of ADEs and associated factors during H. pylori eradication therapy.
Method
Consented H. pylori positive adult outpatients on standard triple therapy (proton pump inhibitor, amoxicillin and clarithromycin) were involved in this facility based follow up study from May 2016 to April 2018 at Bahir Dar city in Ethiopia. Pre-developed questionnaire and formats were used to collect sociodemographic, medical information, and patient practice data before, during, and after therapy. Bivariate and backward stepwise multivariate logistic regression was used to analyze data. P-value < 0.05 at 95%CI was considered as significant.
Result
A total of 421 patients were involved in the study. Almost 80% of the patients were urban residents. Mean (±SD) age and body weight of patients were 30.63 (± 10.74) years and 56.79 (± 10.17) kg, respectively. ADE was reported from 26.1% of the patients and of all the reported ADEs, more than 85% was manifested with gastrointestinal symptoms which include gastrointestinal discomfort(39.1%), nausea (13.6%), constipation(12.7%), diarrhea(12.9%) and anorexia(10%). Determinants of self-reported ADEs among patients in the present study were body mass index above 25 (AOR: 2.55; 95%CI (1.21–5.38), p = 0.014), duration of acid-pepsin disorder more than 3weeks (AOR: 3.57; 95%CI (1.63–7.81), p = 0.001), pain feeling during long interval between meals (AOR: 2.14; 95%CI (1.19–3.84), p = 0.011), and residence in urban area (AOR: 1.95; 95% CI (1.04–3.67), p = 0.038).
Conclusion
Significant proportion of patients reported ADEs which commonly manifested with gastrointestinal symptoms. Consideration of patients’ body mass index, duration of the disorder, period of the day when patients feel pain, and patients’ area of residence could help to reduce ADEs experienced during H. pylori eradication therapy.
Klíčová slova:
Adverse reactions – Alcohol consumption – Antibiotic resistance – Body Mass Index – Helicobacter pylori – Pain sensation – Patients – Urban areas
Zdroje
1. Kouitcheu Mabeku LB, Noundjeu Ngamga ML, Leundji H (2018) Potential risk factors and prevalence of Helicobacter pylori infection among adult patients with dyspepsia symptoms in Cameroon. BMC Infect Dis 18: 278. doi: 10.1186/s12879-018-3146-1 29907086
2. Labigne A, de Reuse H (1996) Determinants of Helicobacter pylori pathogenicity. Infect Agents Dis 5: 191–202. 8884364
3. McColl KE (2010) Clinical practice. Helicobacter pylori infection. N Engl J Med 362: 1597–1604. doi: 10.1056/NEJMcp1001110 20427808
4. Suerbaum S, Michetti P (2002) Helicobacter pylori infection. N Engl J Med 347: 1175–1186. doi: 10.1056/NEJMra020542 12374879
5. Vakil N (1998) Treatment of Helicobacter pylori infection. Am J Ther 5: 197–201. doi: 10.1097/00045391-199805000-00011 10099059
6. Bardhan KD (1996) Triple therapy as a cure for Helicobacter pylori infection. Eur J Gastroenterol Hepatol 8 Suppl 1: S27–30.
7. Malfertheiner P, Megraud F, O'Morain C, Hungin AP, Jones R, Axon A, et al. (2002) Current concepts in the management of Helicobacter pylori infection—the Maastricht 2–2000 Consensus Report. Aliment Pharmacol Ther 16: 167–180.
8. Howden CW, Hunt RH (1998) Guidelines for the management of Helicobacter pylori infection. Ad Hoc Committee on Practice Parameters of the American College of Gastroenterology. Am J Gastroenterol 93: 2330–2338. doi: 10.1111/j.1572-0241.1998.00684.x 9860388
9. Malfertheiner P, Megraud F, O'Morain C, Bazzoli F, El-Omar E, Graham D, et al. (2007) Current concepts in the management of Helicobacter pylori infection: the Maastricht III Consensus Report. Gut 56: 772–781. doi: 10.1136/gut.2006.101634 17170018
10. Abbasinazari M, Sahraee Z, Mirahmadi M (2013) The Patients' Adherence and Adverse Drug Reactions (ADRs) which are Caused by Helicobacter pylori Eradication Regimens. J Clin Diagn Res 7: 462–466. doi: 10.7860/JCDR/2013/4673.2799 23634397
11. Alomar MJ (2014) Factors affecting the development of adverse drug reactions (Review article). Saudi Pharm J 22: 83–94. doi: 10.1016/j.jsps.2013.02.003 24648818
12. Graham DY, Lew GM, Malaty HM, Evans DG, Evans DJ Jr., Klein PD, et al. (1992) Factors influencing the eradication of Helicobacter pylori with triple therapy. Gastroenterology 102: 493–496. doi: 10.1016/0016-5085(92)90095-g 1732120
13. Al-Eidan FA, McElnay JC, Scott MG, McConnell JB (2002) Management of Helicobacter pylori eradication—the influence of structured counselling and follow-up. Br J Clin Pharmacol 53: 163–171. doi: 10.1046/j.0306-5251.2001.01531.x 11851640
14. Bazzoli F, Zagari M, Pozzato P, Varoli O, Fossi S, Ricciardiello L, et al. (1998) Evaluation of short-term low-dose triple therapy for the eradication of Helicobacter pylori by factorial design in a randomized, double-blind, controlled study. Aliment Pharmacol Ther 12: 439–445. doi: 10.1046/j.1365-2036.1998.00330.x 9663723
15. Dore MP, Bibbo S (2019) Role of Probiotics in Helicobacter pylori Eradication: Lessons from a Study of Lactobacillus reuteri Strains DSM 17938 and ATCC PTA 6475 (Gastrus(R)) and a Proton-Pump Inhibitor. 2019: 3409820.
16. Liu Q, Qi D, Kang J, Jin Y, Liu W, Gao W, et al. (2015) Efficacy of real-time PCR-based detection of Helicobacter pylori infection and genotypic resistance-guided quadruple therapy as the first-line treatment for functional dyspepsia with Helicobacter pylori infection. Eur J Gastroenterol Hepatol 27: 221–225. doi: 10.1097/MEG.0000000000000186 25629566
17. Lu M, Yu S, Deng J, Yan Q, Yang C, Xia G, et al. (2016) Efficacy of Probiotic Supplementation Therapy for Helicobacter pylori Eradication: A Meta-Analysis of Randomized Controlled Trials. PLoS One 11: e0163743. doi: 10.1371/journal.pone.0163743 27723762
18. Park CS, Lee SM, Park CH, Koh HR, Jun CH, Park SY, et al. (2014) Pretreatment antimicrobial susceptibility-guided vs. clarithromycin-based triple therapy for Helicobacter pylori eradication in a region with high rates of multiple drug resistance. Am J Gastroenterol 109: 1595–1602. doi: 10.1038/ajg.2014.222 25091062
19. Tepes B, O'Connor A, Gisbert JP, O'Morain C (2012) Treatment of Helicobacter pylori infection 2012. Helicobacter 17 Suppl 1: 36–42.
20. Graham DY, Shiotani A (2008) New concepts of resistance in the treatment of Helicobacter pylori infections. Nat Clin Pract Gastroenterol Hepatol 5: 321–331. doi: 10.1038/ncpgasthep1138 18446147
21. B P, AS, Quereshi JM, JJ E (2017) Current Status of H. pylori Infection Treatment. Journal of Applied Pharmaceutical Science 7.
22. Kwok A, Lam T, Katelaris P, Leong RW (2008) Helicobacter pylori eradication therapy: indications, efficacy and safety. Expert Opin Drug Saf 7: 271–281. doi: 10.1517/14740338.7.3.271 18462185
23. Shakya Shrestha S, Bhandari M, Thapa SR, Shrestha R, Poudyal R, Purbey B, et al. (2016) Medication Adherence Pattern and Factors affecting Adherence in Helicobacter Pylori Eradication Therapy. Kathmandu Univ Med J (KUMJ) 14: 58–64.
24. Abuhammour A, Dajani A, Nounou M, Zakaria M (2016) Standard triple therapy versus sequential therapy for eradication of Helicobacter pylori in treatment naive and retreat patients. Arab J Gastroenterol 17: 131–136. doi: 10.1016/j.ajg.2016.07.001 27665525
25. Gebeyehu E, Nigatu D, Engidawork E (2019) Helicobacter pylori eradication rate of standard triple therapy and factors affecting eradication rate at Bahir Dar city administration, Northwest Ethiopia: A prospective follow up study. 14: e0217645.
26. Shimoyama T (2013) Stool antigen tests for the management of Helicobacter pylori infection. World J Gastroenterol 19: 8188–8191. doi: 10.3748/wjg.v19.i45.8188 24363508
27. Sperandei S (2014) Understanding logistic regression analysis. Biochem Med (Zagreb) 24: 12–18.
28. Jaka H, Mueller A, Kasang C, Mshana SE (2019) Predictors of triple therapy treatment failure among H. pylori infected patients attending at a tertiary hospital in Northwest Tanzania: a prospective study. BMC Infect Dis 19: 447. doi: 10.1186/s12879-019-4085-1 31113384
29. Ksiądzyna D, Szandruk M, Szeląg A (2012) Treatment prospects of Helicobacter pylori infection. Gastroenterology Review 2: 70–77.
30. Lee M, Kemp JA, Canning A, Egan C, Tataronis G, Farraye FA (1999) A randomized controlled trial of an enhanced patient compliance program for Helicobacter pylori therapy. Arch Intern Med 159: 2312–2316. doi: 10.1001/archinte.159.19.2312 10547171
31. Zhou YQ, Xu L, Wang BF, Fan XM, Wu JY, Wang CY, et al. (2012) Modified Sequential Therapy Regimen versus Conventional Triple Therapy for Helicobacter Pylori Eradication in Duodenal Ulcer Patients in China: A Multicenter Clinical Comparative Study. Gastroenterol Res Pract 2012: 405425. doi: 10.1155/2012/405425 22550478
32. Arkkila PE, Seppala K, Kosunen TU, Sipponen P, Makinen J, Rautelin H, et al. (2005) Helicobacter pylori eradication as the sole treatment for gastric and duodenal ulcers. Eur J Gastroenterol Hepatol 17: 93–101. doi: 10.1097/00042737-200501000-00018 15647648
33. Chen YI, Fallone CA (2015) A 14-day course of triple therapy is superior to a 10-day course for the eradication of Helicobacter pylori: A Canadian study conducted in a 'real world' setting. Can J Gastroenterol Hepatol 29: e7–10. doi: 10.1155/2015/659390 26301332
34. Hori K, Takagawa T, Hida N, Nakamura S (2017) Safety of One-Week, First-Line, Standard Triple Therapy for Helicobacter Pylori Eradication in a Japanese Population. Curr Drug Saf.
35. Silva FM, Zaterka S, Eisig JN, Chehter EZ, Chinzon D, Laudanna AA (2001) Factors affecting Helicobacter pylori eradication using a seven-day triple therapy with a proton pump inhibitor, tinidazole and clarithromycin, in Brazilian patients with peptic ulcer. Rev Hosp Clin Fac Med Sao Paulo 56: 11–16. doi: 10.1590/s0041-87812001000100003 11378678
36. Sun WH, Ou XL, Cao DZ, Yu Q, Yu T, Hu JM, et al. (2005) Efficacy of omeprazole and amoxicillin with either clarithromycin or metronidazole on eradication of Helicobacter pylori in Chinese peptic ulcer patients. World J Gastroenterol 11: 2477–2481. doi: 10.3748/wjg.v11.i16.2477 15832421
37. Masjedizadeh A, Zaeemzadeh N, Mard SA, Vanani GS (2015) Comparing the efficacy of four different protocols for eradicating of Helicobacter pylori infection in Ahvaz, southwest Iran. Prz Gastroenterol 10: 94–99. doi: 10.5114/pg.2015.49001 26557940
38. Ramas M, Donday MG, McNicholl AG, Gisbert JP (2017) Efficacy and safety of rifaximin associated with standard triple therapy (omeprazole, clarithromycin and amoxicillin) for H. pylori eradication: A phase IV pilot clinical trial. Gastroenterol Hepatol 40: 658–662. doi: 10.1016/j.gastrohep.2017.05.017 28780968
39. Queiroz DM, Dani R, Silva LD, Santos A, Moreira LS, Rocha GA, et al. (2002) Factors associated with treatment failure of Helicobacter pylori infection in a developing country. J Clin Gastroenterol 35: 315–320. doi: 10.1097/00004836-200210000-00007 12352294
40. Lee HJ, Kim JI, Lee JS, Jun EJ, Oh JH, Cheung DY, et al. (2015) Concomitant therapy achieved the best eradication rate for Helicobacter pylori among various treatment strategies. World J Gastroenterol 21: 351–359. doi: 10.3748/wjg.v21.i1.351 25574111
41. Granstrom L, Backman L (1985) Stomach distension in extremely obese and in normal subjects. Acta Chir Scand 151: 367–370. 4036492
42. Maddox A, Horowitz M, Wishart J, Collins P (1989) Gastric and oesophageal emptying in obesity. Scand J Gastroenterol 24: 593–598. doi: 10.3109/00365528909093095 2762759
43. Fish DN, Gotfried MH, Danziger LH, Rodvold KA (1994) Penetration of clarithromycin into lung tissues from patients undergoing lung resection. Antimicrobial agents and chemotherapy 38: 876–878. doi: 10.1128/aac.38.4.876 8031063
44. Honeybourne D, Kees F, Andrews J, Baldwin D, Wise R (1994) The levels of clarithromycin and its 14-hydroxy metabolite in the lung. European Respiratory Journal 7: 1275–1280. doi: 10.1183/09031936.94.07071275 7925906
45. Abdullahi M, Annibale B, Capoccia D, Tari R, Lahner E, Osborn J, et al. (2008) The eradication of Helicobacter pylori is affected by body mass index (BMI). Obes Surg 18: 1450–1454. doi: 10.1007/s11695-008-9477-z 18443890
46. Hamrah MS, Hamrah MH, Ishii H, Suzuki S, Hamrah MH, Hamrah AE, et al. (2018) Association between Helicobacter pylori Infection and Cardiovascular Risk Factors among Patients in the Northern Part of Afghanistan: a Cross-Sectional Study in Andkhoy City. Asian Pac J Cancer Prev 19: 1035–1039. doi: 10.22034/APJCP.2018.19.4.1035 29693980
47. Pai MP, Bearden DT (2007) Antimicrobial dosing considerations in obese adult patients. Pharmacotherapy 27: 1081–1091. doi: 10.1592/phco.27.8.1081 17655508
48. Spiller RC (1999) Is there any difference in Helicobacter pylori eradication rates in patients with active peptic ulcer, inactive peptic ulcer and functional dyspepsia? Eur J Gastroenterol Hepatol 11 Suppl 2: S25–28; discussion S43-25.
49. DiMatteo MR (2004) Variations in patients' adherence to medical recommendations: a quantitative review of 50 years of research. Med Care 42: 200–209. doi: 10.1097/01.mlr.0000114908.90348.f9 15076819
50. Sousa LAO, Fonteles MMF, Monteiro MP, Mengue SS, Bertoldi AD, Pizzol T, et al. (2018) Prevalence and characteristics of adverse drug events in Brazil. Cad Saude Publica 34: e00040017. doi: 10.1590/0102-311X00040017 29617479
51. A J, SN, Mistry M, A G (2015) Evaluation of knowledge and perception toward adverse drug reactions among patients visiting tertiary-care teaching hospital. Natl J Physiol Pharm Pharmacol 5: 280–284.
52. KA K (2015) Self‐Reporting of Adverse Drug Reactions in Iraqi Hospitals: Patient’s Perspectives. Pharmacology & Pharmacy 6: 556–572.
53. Sellers EM, Holloway MR (1978) Drug kinetics and alcohol ingestion. Clin Pharmacokinet 3: 440–452. doi: 10.2165/00003088-197803060-00002 31257
54. Onder G, Landi F, Della Vedova C, Atkinson H, Pedone C, Cesari M, et al. (2002) Moderate alcohol consumption and adverse drug reactions among older adults. Pharmacoepidemiol Drug Saf 11: 385–392. doi: 10.1002/pds.721 12271880
55. Rademaker M (2001) Do women have more adverse drug reactions? Am J Clin Dermatol 2: 349–351. doi: 10.2165/00128071-200102060-00001 11770389
56. Yu Y, Chen J, Li D, Wang L, Wang W, Liu H (2016) Systematic Analysis of Adverse Event Reports for Sex Differences in Adverse Drug Events. Sci Rep 6: 24955. doi: 10.1038/srep24955 27102014
57. Fennerty MB, Kovacs TO, Krause R, Haber M, Weissfeld A, Siepman N, et al. (1998) A comparison of 10 and 14 days of lansoprazole triple therapy for eradication of Helicobacter pylori. Arch Intern Med 158: 1651–1656. doi: 10.1001/archinte.158.15.1651 9701099
58. Kim SY, Lee SW, Jung SW, Koo JS, Yim HJ, Park JJ, et al. (2008) Comparative study of Helicobacter pylori eradication rates of twice-versus four-times-daily amoxicillin administered with proton pump inhibitor and clarithromycin: a randomized study. Helicobacter 13: 282–287. doi: 10.1111/j.1523-5378.2008.00615.x 18665938
59. Liang CM, Chiu CH, Wang HM, Tai WC, Yao CC, Tsai CE, et al. (2017) First-Line Helicobacter pylori Eradication in Patients with Chronic Kidney Diseases in Taiwan. 2017: 3762194.
Článek vyšel v časopise
PLOS One
2019 Číslo 11
- S diagnostikou Parkinsonovy nemoci může nově pomoci AI nástroj pro hodnocení mrkacího reflexu
- Proč při poslechu některé muziky prostě musíme tančit?
- Je libo čepici místo mozkového implantátu?
- Chůze do schodů pomáhá prodloužit život a vyhnout se srdečním chorobám
- Pomůže v budoucnu s triáží na pohotovostech umělá inteligence?
Nejčtenější v tomto čísle
- A daily diary study on maladaptive daydreaming, mind wandering, and sleep disturbances: Examining within-person and between-persons relations
- A 3’ UTR SNP rs885863, a cis-eQTL for the circadian gene VIPR2 and lincRNA 689, is associated with opioid addiction
- A substitution mutation in a conserved domain of mammalian acetate-dependent acetyl CoA synthetase 2 results in destabilized protein and impaired HIF-2 signaling
- Molecular validation of clinical Pantoea isolates identified by MALDI-TOF
Zvyšte si kvalifikaci online z pohodlí domova
Všechny kurzy