| Background:Inflammatory Bowel Disease (IBD) is a group of non- specific chronic, inflammatory disease of the gastrointestinal tract, including Ulcerative Colitis (UC) and Crohn’s disease (CD); are the two primary types of IBD. The two diseases share many clinical, patho genetic, and epidemiological characteristic, suggesting that underlying causes may be similar and both share same drugs in their management. While the etiology has remained unknown, several areas of possible importance, such as genetic, infectious, immunologic and inflammatory factors may play the role. The incidence and prevalence rates for Asian population; affecting IBD are much lower in comparison. But more recent data; however, have shown significantly higher rates in Asians, may be due to westernization of lifestyle, including changes in dietary habits and environmental changes and industrialization. The last few decades have seen a gradual increase in the number of drugs available for the use in the treatment of IBD. Among them; Immunomodulator therapy; which includes Azathioprine and 6-Mercaptopurine remains the mainstay of therapy for the maintenance of a steroid-free remission in patients with IBD. The aim of this study is to evaluate the efficacy and safety in the patients with IBD treated with Azathioprine and follow up in our clinic at the interval of 3mnths,6mnths,1 year and 2 year consecutatively and also assessing its adverse-effect. Hospitalization accounts for 50%-60% of total medical costs and economic burden of patients in relapse is 3-9 times higher for patients in remission. On the other hand; we try to evaluate that the use of AZA reduce resource consumption, including hospitalization, surgery, diagnostic endoscopic procedure and out-patient visits and presenting the possibility of using AZA might prove to be a cost-effective option.Part 1 Evaluation of Efficacy and Safety of Low-dose Azathioprine Therapy for the Induction of Remission in Steroid-dependent Inflammatory Bowel Disease (IBD) patients.Objective:The aim of our study is to evaluate the efficacy and safety in the patients with IBD treated with Azathioprine and follow up in our clinic at the interval of 3months, 6months,l year and 2 years consecutively and is also assessing its adverse-effectMaterials and Method:After collecting 80 patients with active IBD treated with AZA, including 60 UC patients and 20 CD patients from Kunming Medical University 1st Affiliated Hospital from December 2012-December 2014 and analyzing data by using prospective study for its efficacy and safety profile.Results:1) Total 80 patients with active IBD were collected for this research, including 60 UC patients and 20 CD patients.2) There are 60 UC patients, age ranges from 19-72 years, male/female:37/29, AZA doses ranges from 1-2 mg/kg/day. Among those,46 cases were completely investigated, 14 cases were failed to follow-up.3) There are 20 CD patients, age ranges from 15-53 years, male/female:16/4, AZA doses ranges from 1-2mg/kg/Day. Among them 18 cases were completely investigated till 96weeks and 2 cases were withdrawal with their own reasons.4) Among those investigated, most of them do not experience any adverse effect. Those who have side effect have adverse reaction like:flu-like symptoms; rashes, arthralgia; GI symptoms, Urinary Tract Infection (UTI) but only some of them had severe reaction like myelosuppresion and liver injury.5) At 12,24,48 and 96weeks, the efficacy rate of AZA treating UC patients were 78.9%,96.0%,5.3%and 84.8%. The clinical remission rates were 4.0%,8.0%,15.2%and 26.1%. Finally the rate of relapse was 22.0%,4.0%,34.7% and 15.2%. Also, the rate of mucosal healing at 48 and 96 weeks was 56.5% and 76.1%.6) At 12,24,48,96 weeks, the rate of efficacy for CD were 80%,77.8%,72.2%, 83.3%. The remission rate was 70%,55.6%,27.8%,38.9%. Also the rate of mucosal healing at 48 and 96 weeks was 72.2%and 88.9%.7) In UC patients; at 12 weeks, after using AZA,ESR and WBC counting were lower than before, so there is statistically difference than before(P<0.05); whereas CRP shows no difference(P>0.05). While evaluating truelove and witts grading index showed a drastic difference (P<0.05).8) At 24 weeks, while evaluating the efficacy after using AZA, ESR, CRP, WBC and also true love and witt grading showed a marked differences(P<0.05).9) At 48 weeks, during comparing the efficacy after using AZA, the whole parameters like ESR, CRP,WBC, Truelove and witt index, Mayo score and also Mayo endoscopic subscore, showed a significant improvement and all the parameters were significantly lower than those receiving before AZA therapy (P<0.05).10) At 96 weeks, all the evaluation index like ESR,CRP,WBC, Truelove and witt index, Mayo score and Mayo endoscopic subscore shows a statistically significant difference (P<0.05); comparing than those before receiving AZA therapy.11) In CD, at 12 weeks; while evaluating efficacy after using AZA, the parameters like ESR, CRP, WBC, HCT, HBI shows the significant improvement while index like Hb and Degree of severity in endoscopy does not change (P> 0.05).12) At 24 weeks, ESR, CRP, HCT and HBI shows a drastic improvement (P<0.05), while other parameters like Hb, WBC, and endoscopy degree does not showed any changes (P>0.05).13) At 48 weeks, all the parameters like ESR, WBC, CRP, Hb, HCT, HBI, Degree of severity and as well as endoscopic evaluation showed a significant improvement than at week 24 (P<0.05), comparing patients after receiving AZA treatment.14) AT 96 weeks, continuing all the parameters like ESR, CRP, Hb, WBC, HCT,HBI, Degree of grading at endoscopy and endoscopic evaluation were significantly better outcome than those before using AZA (P<0.05).15) While evaluating about safety concern after using AZA, total 28 cases had adverse reaction including 22 UC patients and 6 CD patients; while most of the adverse reaction were mild.Conclusion:This Research demonstrates as well as with other published data, that AZA therapy is efficacious in patients with CD/UC, but the drug is especially valuable in long-term treatment. Careful follow-up and regular blood monitoring is mandatory, but the data and results available in our research appear to be reassuring and should be considered as a safe drug.PART 2:Analyzing the Cost-effectiveness of Azathioprine Therapy for the Induction of Remission in Steroid-dependent Inflammatory Bowel Disease (IBD) patients.Objective:To evaluate the use of AZA reduces resource consumption, including hospitalization, diagnostic endoscopic procedure and out-patient visits and presenting the possibility of using AZA might prove to be a cost-effective option. Hospitalization accounts for 50% -60% of total medical costs and economic burden of patients in relapse is 3-9 times higher for patients in remission.Material and Method:80 active IBD patients with and without using AZA from Kunming Medical University 1st Affiliated Hospital from December 2012-December 2014 by using prospective study for cost-effectiveness.Results:1. While evaluating the rate of relapse among 20 CD patients who use AZA (Group 1) has 5 relapse patients and 15 no-relapse patients; whereas in no-AZA group (Group 2),10 relapse and 10 no-relapse patients. After using chi-squared test, as the total number seems same; we concluded that by using AZA, there is no difference in relapse rate (p= 0.102).2. The patients in group 1 expenses around 1333.69 ± 258.39yuan; while in group 2 expenses around 2167.12 ±468.625 yuan, it shows group 1 patients save more money than group 2, who were spending more on different types test fees (p=0.00).3. As group 1 (AZA) spend 587.81 ± 220.93yuan, compared to group 2(no-AZA) spend 4281±1733.074 yuan on various drug expenses; concluding group 1 spend less buying drugs (p= 0.00).4. Analyzing total hospitalization costs, group 1 spend 48317.25652±25934; while group 2 spend 30854.0543±27049, suggesting group 1 patients tend to spend less money (p=0.931).5. Here group 1 showed, around 17.7±14.291 days and group 2 showed 22.4+-15.292 days of hospital stay during 2 years of our study, concluding by using AZA; there might be reduced number of hospital stay (p=0.322).6. Evaluating group 1 versus group 2, which spend 93.8 ±81.271 yuan versus 117.1 ±104.415 yuan respectively; suggesting group 1 spend less money on traffic expenses (p= 0.436).7. While evaluating total cost of work; group 1 loose 2772.6±2645.835 yuan and group 2 loose 3575.3±2782.233 yuan; concluding AZA group less money on working time (p= 0.356).8. Finally evaluating total overall costs between group 1, which spend 4849.93 ± 28232 yuan and group 2, which spend around 33658±31901 yuan, this result suggest that there might be little difference in overall total cost between AZA and no-AZA group; however it does signify that there might be a impact on saving money who used AZA (p= 0.00).9. While comparing the rate of relapse between AZA (Group 1) and no-AZA (Group 2); we found that AZA group has 39 relapse and 21 no-发relapse patients, while no-AZA group has 59 relapse and only 10 relapse patients, concluding using AZA showed a significant drop in relapse rate in Group 1 (p= 0.007).10. Analyzing the patients in group 1, which spend around 2194±240.42 yuan, while group 2 spend 2705.74 ±923.67 yuan, concluding AZA group spend less and save more (p= 0.00).11. Comparing about spending on drug fees, here in our study, group 1 spend 737.20 ±326.64 yuan and group 2 spend 7887.13±1471.08 yuan, which clearly shows that patients using AZA will spent less money while buying drug for IBD patients (p= 0.00).12. During hospitalization, group 1 spend around 24001 ±2277.57 yuan and group 2 spend 27981±1586.13 yuan, although there is not vast amount difference in hospitalization costs between AZA and no- AZA groups, but there was less spending money in group 1 (P=0.00).13. As here group 1 stayed in hospital around 28.23±19.53 days, while group 2 stayed around 31.94±17.55 days, suggesting AZA group will spend less days in hospital (p=0.247).14. Traffic expenses, which is also important factor among IBD patients affecting economic situation, that’s why, while evaluating, group 1 spend around 125.72±107.94 yuan, followed by group 2 which spend 187.72±148.28 yuan. This result suggest that AZA group will spend less on traffic expenses than no- AZA group (p=0.009).15. Total charge for loss of working hour, group 1 loose around 3575.3±239.19 yuan, while group 2 loose 3962.23±2515.72 yuan. Although there might be not much differences in loss of working time between two groups, however, AZA group will have little advantage in loss of working time (p=0.448).16. Finally evaluating total costs between AZA and no- AZA group, we concluded, group 1 spend 30404±2316.58 yuan, while group 2; which spent 33067±865.65 yuan, proving there is a major impact on total overall costs in IBD patients which will choose AZA as their drug of choice (p= 0.00).Conclusion:This drug Azathioprine has the potential of improving medical and economic outcomes by reducing total costs from frequent hospitalization, expensive drug costs, as well as maintain IBD patients to the better employment. After collecting data and analyzing, this study concluded that using Azathioprine as a drug of choice in IBD patients; has many advantages in a various factors, which are minimum drug and procedure costs, improving opportunity in employment and as well as in overall drug cost.This study was supported by National Natural Science Foundation of China (81260074, 81160055) Confederative Special Foundation of Science & Technology Department of Yunnan Province and Kunming Medical College (2011FB183,2007C0010R); Medical academic leader of Yunnan Provincial Bureau of Health (D-201215); Social development of science and technology projects of Yunnan Province (2013CA021)... |
PDF Full Text Request