BACKGROUND There is no standard therapy for second-line treatment of gemcitabine-refractory pancreatic cancer patients with poor performance status.A combination of chemotherapy drugs 5-fluorouracil(5-FU),leucovorin,i...BACKGROUND There is no standard therapy for second-line treatment of gemcitabine-refractory pancreatic cancer patients with poor performance status.A combination of chemotherapy drugs 5-fluorouracil(5-FU),leucovorin,irinotecan,and oxaliplatin(FOLFIRINOX)or 5-fluorouracil/leucovorin plus nanoliposomal irinotecan can be considered as second-line treatment for such patients;however,due to toxicity,none of the regimens are recommended for patients with poor performance.Capecitabine or S-1 has relatively low toxicity and can be considered a treatment option for gemcitabine-refractory pancreatic cancer.AIM To investigate the efficacy and toxicity of oral chemotherapy as second-line treatment in patients with pancreatic cancer.METHODS Patients who had progressive disease after first-line gemcitabine-based chemotherapy were retrospectively analyzed between January 2011 and December 2018.They were treated with capecitabine or S-1 as the second-line treatment.Capecitabine was administered as a 2500 mg/m2 divided dose on days 1-14,followed by a 1-wk rest.S-1 was taken orally based on the patient’s body surface area for 28 d,followed by 2-wk of rest.Progression-free survival and overall survival were used to compare efficacy of capecitabine and S-1.RESULTS Of the 81 patients,41 were treated with capecitabine and 40 with S-1.The median time to treatment failure in both groups was 1.5 mo(P=0.425).The objective response rate was similar in the two groups:9.8%with capecitabine and 2.5%with S-1(P=0.359).Median progression-free survival was longer in the S-1 group than in the capecitabine group(S-12.7 mo,capecitabine 2.0 mo,P=0.003).There was no significant difference in the median overall survival between the capecitabine and S-1 groups(4.3 mo vs 5.0 mo,P=0.092).Grade 3 or 4 hand-foot syndrome was significantly more common in the capecitabine group than in the S-1 group(14.6%vs 0%,P=0.026).CONCLUSION Capecitabine or S-1 can be used as a second-line treatment for patients with advanced pancreatic cancer with poor performance status after progression to a gemcitabine-based regimen.展开更多
Advanced gastric cancer(a GC), not amenable to curative surgery, is still a burdensome illness tormenting afflicted patients and their healthcare providers. Whereas combination chemotherapy has been shown to improve s...Advanced gastric cancer(a GC), not amenable to curative surgery, is still a burdensome illness tormenting afflicted patients and their healthcare providers. Whereas combination chemotherapy has been shown to improve survival and tumor related symptoms in the frontline setting, second-line therapy(SLT) is subject to much debate in the scientific community, mainly because of the debilitating effects of GC, which would impede the administration of cytotoxic therapy. Recent data has provided sufficient evidence for the safe use of SLT in patients with an adequate performance status. Taxanes, Irinotecan and even some Fluoropyrimidine analogs were found to provide a survival advantage in this subset of patients. Most importantly, quality of life measures were also improved through the use of adequate therapy. Even more pertinent were the findings involving antiangiogenic agents, which would add measurable improvements without significantly jeopardizing the patients' well-being. Further lines of therapy are cause for much more debate nowadays, but specific targeted agents have shown considerable promise in this context. We herein review noteworthy published data involving the use of additional lines of the therapy after failure of standard frontline therapies in patients with a GC.展开更多
AIM: To compare the efficacy of 14- and 7-d bismuthbased quadruple therapies as second-line eradication treatment for Helicobacter pylori(H.pylori) infection.METHODS: Between 2004 and 2014,the medical records of 790 p...AIM: To compare the efficacy of 14- and 7-d bismuthbased quadruple therapies as second-line eradication treatment for Helicobacter pylori(H.pylori) infection.METHODS: Between 2004 and 2014,the medical records of 790 patients who had experienced failure of first-line proton pump inhibitor(PPI)-based eradication therapy and were then treated with bismuth-based quadruple therapy were retrospectively reviewed.Those who received bismuth-based quadruple therapy [PPI,bismuth,metronidazole,and tetracycline(PBMT)] for either 7 d or 14 d were assigned to a PBMT-7 group(n = 543) or a PBMT-14 group(n = 247),respectively.The eradication rates for both groups were determined by intention-to-treat(ITT) and per-protocol(PP) analyses.ITT analysis compared the treatment groups as originally allocated while the PP analysis including only those patients who had completed the treatment as originally allocated.Successful eradication therapy for H.pylori infection was defined as a negative 13C-urea breath test 4 wk after the end of eradication treatment.RESULTS: The overall ITT eradication rate was 69.1%(546/790).Final ITT eradication rates were 67.4%(366/543; 95%CI: 63.1%-71.7%) in the PBMT-7 group and 72.8%(180/247; 95%CI: 67.4%-78.2%) in the PBMT-14 group(P = 0.028).The overall PP eradication rate was 80.0%(546/682),and the final PP eradication rates were 78.2%(366/468; 95%CI: 72.1%-84.0%) in the PBMT-7 group and 84.1%(180/214; 95%CI: 76.8%-90.8%) in the PBMT-14 group(P = 0.009).The H.pylori eradication rates in the PBMT-14 group weresignificantly higher than in the PBMT-7 group according to both ITT(P = 0.028) and PP analysis(P = 0.009).Compliance was similar in both groups(PBMT-7 group: 97.9%; PBMT-14 group: 96.4%).Adverse event rates were 10.7%(51/478) and 17.1%(38/222) in the PBMT-7 and PBMT-14 groups,respectively(P = 0.487).CONCLUSION: The 14-d bismuth-based quadruple therapy is a significantly more effective second-line eradication treatment for H.pylori infection than the 7-d alternative.展开更多
AIM: To evaluate the efficacy of the 14-d moxifloxacinbased triple therapy for the second-line eradication of Helicobacter pylori(H. pylori) infection.METHODS: Between 2011 and 2013, we conducted a retrospective revie...AIM: To evaluate the efficacy of the 14-d moxifloxacinbased triple therapy for the second-line eradication of Helicobacter pylori(H. pylori) infection.METHODS: Between 2011 and 2013, we conducted a retrospective review of the medical records of 160 patients who had experienced failure of their first-line proton pump inhibitor-based eradication therapy and subsequently received the moxifloxacin-based triple therapy as a second-line eradication treatment regimen. The patients who were treated with the moxifloxacinbased triple therapy(oral 20 mg rabeprazole b.i.d., 1000 mg amoxicillin b.i.d., and 400 mg moxifloxacin q.d.) for 7 d were assigned to the RAM-7 group(n = 79) while those who took them for 14 days were assigned to RAM-14 group(n = 81). The eradication rates for both groups were determined by intentionto-treat(ITT) and per-protocol(PP) analyses. ITT analysis compared the treatment groups as originally allocated while the PP analysis including only those patients who had completed the treatment as originally allocated. Successful eradication therapy for H. pylori infection was defined as the documentation of a negative 13C-urea breath test 4 wk after the end of the eradication treatment.RESULTS: The overall ITT eradication rate was 76.2%(122/160). The final ITT eradication rates were 70.8%(56/79; 95%CI: 63.3%-77.1%) in the RAM-7 group and 81.4%(66/81; 95%CI: 74.6%-88.3%) in the RAM-14 group(P = 0.034). The overall PP eradication rate was 84.1%(122/145), and the final PP eradication rates were 77.7%(56/72; 95%CI: 70.2%-85.3%) in the RAM-7 group and 90.4%(66/73; 95%CI: 82.8%-98.1%) in the RAM-14 group(P = 0.017). The H. pylori-eradication rates in the RAM-14 group were significantly higher compared with that of the RAM-7 group according to both the ITT(P = 0.034) and the PP analyses(P = 0.017). Both groups exhibited good treatment compliance(RAM-7/RAM-14 group: 100%/100%). The adverse event rates were19.4%(14/72)and 20.5%(15/73)in the RAM-7 and RAM-14 groups,respectively(P=0.441).Adverse events occurred in 14 of the 72 patients(19.4)in the RAM-7 group and in 15 of the 73 patients(20.5)in the RAM-14 group.No statistically significant differences(P=0.441)were observed.CONCLUSION:The 14-d moxifloxacin-based triple therapy is a significantly more effective secondline eradication treatment as compared to the 7-d alternative for H.pylori infection in South Korea.展开更多
Despite extensive clinical research in non-small cell lung cancer (NSCLC), overall survival is still poor. Racotumomab-alum is an anti-idiotypic cancer vaccine that targets NeuGcGM3 tumor associated ganglioside. The a...Despite extensive clinical research in non-small cell lung cancer (NSCLC), overall survival is still poor. Racotumomab-alum is an anti-idiotypic cancer vaccine that targets NeuGcGM3 tumor associated ganglioside. The aim of this study was to evaluate safety and efficacy of racotumomab-alum in advanced NSCLC patients with progressive disease. This expanded access program included 86 histologically confirmed NSCLC patients, 18 years or older age, with advanced disease and without therapeutic option, with ECOG performance status ≤3, adequate organ functions and signed informed consent. The primary endpoint was overall survival and toxicity was measure assessed treatment-related toxicity according CTCAEv3. The study was approved by ethical review boards of participant institutions. Racotumomab-alum treatment consisted in 5 biweekly intradermal doses (1 mg/mL) during the induction phase of treatment (2 months). The maintenance phase consisted in monthly re-immunizations until unacceptable toxicity or PS worsening. The median overall survival time of all patients treated with racotumomab-alum was 8.96 months. The survival rates at 12 and 24 months were 42.8% and 28.0%, respectively. Patients that completed the induction phase of treatment (five doses or more) reached a median OS of 12.1 months. The most common adverse events were injection site reaction, bone pain, cough and asthenia. Racotumomab-alum cancer vaccine could be considered an effective and safe treatment option as second-line therapy for advanced NSCLC. Further clinical studies should be conducted to confirm this result.展开更多
目的评价晚期非小细胞肺癌二线治疗药物帕博利珠单抗、纳武利尤单抗的经济性。方法基于医疗卫生角度,构建动态Markov模型,模拟至99%患者死亡时,产生的医疗成本和质量调整生命年(Qualityadjusted life years,QALYs)。临床参数来自临床试...目的评价晚期非小细胞肺癌二线治疗药物帕博利珠单抗、纳武利尤单抗的经济性。方法基于医疗卫生角度,构建动态Markov模型,模拟至99%患者死亡时,产生的医疗成本和质量调整生命年(Qualityadjusted life years,QALYs)。临床参数来自临床试验和间接比较。成本数据和效用值取自相关网站和已发表的文献。敏感性分析用于评估模型参数的不确定性。结果基础分析结果显示,纳武利尤单抗方案的治疗成本为278634元,获得的QALYs为0.88,帕博利珠单抗方案的治疗成本为232596元,QALYs为0.86,两者的增量成本-效果比(Incremental cost effectiveness ratio,ICER)为2301900元/QALY,均远高于支付阈值(257094元)。单因素敏感性分析显示,药品价格、无进展生存期对ICER的影响较大。结论在当前支付阈值下,纳武利尤单抗较帕博利珠单抗无经济性优势,两者的成本和QALYs值差异不大,药品价格变动极有可能逆转经济性结论。展开更多
Autoimmune hepatitis is a rare chronic inflammatory liver disease,affecting all ages,characterised by elevated transaminase and immunoglobulin G levels,positive autoantibodies,interface hepatitis at liver histology an...Autoimmune hepatitis is a rare chronic inflammatory liver disease,affecting all ages,characterised by elevated transaminase and immunoglobulin G levels,positive autoantibodies,interface hepatitis at liver histology and good response to immunosuppressive treatment. If untreated,it has a poor prognosis. The aim of this review is to summarize the evidence for standard treatment and to provide a systematic review on alternative treatments for adults and children. Standard treatment is based on steroids and azathioprine,and leads to disease remission in 80%-90% of patients. Alternative first line treatment has been attempted with budesonide or cyclosporine,but their superiority compared to standard treatment remains to be demonstrated. Second-line treatments are needed for patients not responding or intolerant to standard treatment. No randomized controlled trials have been performed for second-line options. Mycophenolate mofetil is the most widely used second-line drug,and has good efficacy particularly for patients intolerant to azathioprine,but has the major disadvantage of being teratogenic. Only few and heterogeneous data on cyclosporine,tacrolimus,everolimus and sirolimus are available. More recently,experience with the anti-tumour necrosis factoralpha infliximab and the anti-CD20 rituximab has been published,with ambivalent results; these agents may have severe side-effects and their use should be restricted to specialized centres. Clinical trials with new therapeutic options are ongoing.展开更多
Introduction: The key to successful elimination of tuberculosis (TB) is treatment of cases with optimum chemotherapy. Irrational anti-TB drug use over time has led to drug-resistant TB. The treatment of MDR-TB with se...Introduction: The key to successful elimination of tuberculosis (TB) is treatment of cases with optimum chemotherapy. Irrational anti-TB drug use over time has led to drug-resistant TB. The treatment of MDR-TB with second line drugs is long, complex and costly, and has a considerable rate of adverse effects. The level of ADR reporting is low in Ethiopia due to different factors. This Study conducted in a selected treated area in Addis Ababa, Ethiopia and helped the health care centers to understand the prevalence of ADR related MDR-TB and be aware of those adverse effects in order to detect them early and be prepared to take proper steps when they occur. Aim of the Study: To determine the prevalence and risk factor of adverse drug reactions associated treatments of Multidrug Resistant tuberculosis. Method: This was a cross sectional study, which was conducted between March 2012 and February 2013 at St. Peter TB specialized hospital and AHRI/ALERT. 73 MDR TB patients, who were on MDR TB treatments, enrolled to the study. Adverse Drug Reactions associated MDR TB treatments were assessed by patient history review and questionnaire. Chemistry laboratory was used to test renal function, thyroid function, liver enzyme and potassium level. Result: In 72 patients, at least two ADRs were found. The mean age of the study population (Mean ± SD) was 28 ± 8.8. In this study the most commonly found adverse drug reactions (ADRs) were: Anorexia 83.3%, Nausea and vomiting 82%, Gastritis 64%, Arteralgia 47%, Skin rash and itching 45%, Headache 29.2%, Depression 22.2% and Blurred vision 19.4%. Using binary logistic regression model older age (COR 8.71, 95% [CI] 1.06 - 71.9), alcoholism (COR 4.05, 95% [CI] 1.05 - 15.6), smoking (COR 0.24, 95% [CI] 0.06 - 0.87) and concomitant drug intake (COR 0.14, 95% [CI] 0.03 - 0.76) were independent predictors for ADRs. Conclusion: The prevalence of ADRs related MDR TB treatments is high. To minimize ADR occurrence, ADR predictors should be integrated into the clinical pathway. Monitoring of liver function, renal function, TSH and level of potassium during MDR TB treatment, helps to avoid complication caused by therapy and increase the adherence to the treatment.展开更多
文摘BACKGROUND There is no standard therapy for second-line treatment of gemcitabine-refractory pancreatic cancer patients with poor performance status.A combination of chemotherapy drugs 5-fluorouracil(5-FU),leucovorin,irinotecan,and oxaliplatin(FOLFIRINOX)or 5-fluorouracil/leucovorin plus nanoliposomal irinotecan can be considered as second-line treatment for such patients;however,due to toxicity,none of the regimens are recommended for patients with poor performance.Capecitabine or S-1 has relatively low toxicity and can be considered a treatment option for gemcitabine-refractory pancreatic cancer.AIM To investigate the efficacy and toxicity of oral chemotherapy as second-line treatment in patients with pancreatic cancer.METHODS Patients who had progressive disease after first-line gemcitabine-based chemotherapy were retrospectively analyzed between January 2011 and December 2018.They were treated with capecitabine or S-1 as the second-line treatment.Capecitabine was administered as a 2500 mg/m2 divided dose on days 1-14,followed by a 1-wk rest.S-1 was taken orally based on the patient’s body surface area for 28 d,followed by 2-wk of rest.Progression-free survival and overall survival were used to compare efficacy of capecitabine and S-1.RESULTS Of the 81 patients,41 were treated with capecitabine and 40 with S-1.The median time to treatment failure in both groups was 1.5 mo(P=0.425).The objective response rate was similar in the two groups:9.8%with capecitabine and 2.5%with S-1(P=0.359).Median progression-free survival was longer in the S-1 group than in the capecitabine group(S-12.7 mo,capecitabine 2.0 mo,P=0.003).There was no significant difference in the median overall survival between the capecitabine and S-1 groups(4.3 mo vs 5.0 mo,P=0.092).Grade 3 or 4 hand-foot syndrome was significantly more common in the capecitabine group than in the S-1 group(14.6%vs 0%,P=0.026).CONCLUSION Capecitabine or S-1 can be used as a second-line treatment for patients with advanced pancreatic cancer with poor performance status after progression to a gemcitabine-based regimen.
文摘Advanced gastric cancer(a GC), not amenable to curative surgery, is still a burdensome illness tormenting afflicted patients and their healthcare providers. Whereas combination chemotherapy has been shown to improve survival and tumor related symptoms in the frontline setting, second-line therapy(SLT) is subject to much debate in the scientific community, mainly because of the debilitating effects of GC, which would impede the administration of cytotoxic therapy. Recent data has provided sufficient evidence for the safe use of SLT in patients with an adequate performance status. Taxanes, Irinotecan and even some Fluoropyrimidine analogs were found to provide a survival advantage in this subset of patients. Most importantly, quality of life measures were also improved through the use of adequate therapy. Even more pertinent were the findings involving antiangiogenic agents, which would add measurable improvements without significantly jeopardizing the patients' well-being. Further lines of therapy are cause for much more debate nowadays, but specific targeted agents have shown considerable promise in this context. We herein review noteworthy published data involving the use of additional lines of the therapy after failure of standard frontline therapies in patients with a GC.
文摘AIM: To compare the efficacy of 14- and 7-d bismuthbased quadruple therapies as second-line eradication treatment for Helicobacter pylori(H.pylori) infection.METHODS: Between 2004 and 2014,the medical records of 790 patients who had experienced failure of first-line proton pump inhibitor(PPI)-based eradication therapy and were then treated with bismuth-based quadruple therapy were retrospectively reviewed.Those who received bismuth-based quadruple therapy [PPI,bismuth,metronidazole,and tetracycline(PBMT)] for either 7 d or 14 d were assigned to a PBMT-7 group(n = 543) or a PBMT-14 group(n = 247),respectively.The eradication rates for both groups were determined by intention-to-treat(ITT) and per-protocol(PP) analyses.ITT analysis compared the treatment groups as originally allocated while the PP analysis including only those patients who had completed the treatment as originally allocated.Successful eradication therapy for H.pylori infection was defined as a negative 13C-urea breath test 4 wk after the end of eradication treatment.RESULTS: The overall ITT eradication rate was 69.1%(546/790).Final ITT eradication rates were 67.4%(366/543; 95%CI: 63.1%-71.7%) in the PBMT-7 group and 72.8%(180/247; 95%CI: 67.4%-78.2%) in the PBMT-14 group(P = 0.028).The overall PP eradication rate was 80.0%(546/682),and the final PP eradication rates were 78.2%(366/468; 95%CI: 72.1%-84.0%) in the PBMT-7 group and 84.1%(180/214; 95%CI: 76.8%-90.8%) in the PBMT-14 group(P = 0.009).The H.pylori eradication rates in the PBMT-14 group weresignificantly higher than in the PBMT-7 group according to both ITT(P = 0.028) and PP analysis(P = 0.009).Compliance was similar in both groups(PBMT-7 group: 97.9%; PBMT-14 group: 96.4%).Adverse event rates were 10.7%(51/478) and 17.1%(38/222) in the PBMT-7 and PBMT-14 groups,respectively(P = 0.487).CONCLUSION: The 14-d bismuth-based quadruple therapy is a significantly more effective second-line eradication treatment for H.pylori infection than the 7-d alternative.
文摘AIM: To evaluate the efficacy of the 14-d moxifloxacinbased triple therapy for the second-line eradication of Helicobacter pylori(H. pylori) infection.METHODS: Between 2011 and 2013, we conducted a retrospective review of the medical records of 160 patients who had experienced failure of their first-line proton pump inhibitor-based eradication therapy and subsequently received the moxifloxacin-based triple therapy as a second-line eradication treatment regimen. The patients who were treated with the moxifloxacinbased triple therapy(oral 20 mg rabeprazole b.i.d., 1000 mg amoxicillin b.i.d., and 400 mg moxifloxacin q.d.) for 7 d were assigned to the RAM-7 group(n = 79) while those who took them for 14 days were assigned to RAM-14 group(n = 81). The eradication rates for both groups were determined by intentionto-treat(ITT) and per-protocol(PP) analyses. ITT analysis compared the treatment groups as originally allocated while the PP analysis including only those patients who had completed the treatment as originally allocated. Successful eradication therapy for H. pylori infection was defined as the documentation of a negative 13C-urea breath test 4 wk after the end of the eradication treatment.RESULTS: The overall ITT eradication rate was 76.2%(122/160). The final ITT eradication rates were 70.8%(56/79; 95%CI: 63.3%-77.1%) in the RAM-7 group and 81.4%(66/81; 95%CI: 74.6%-88.3%) in the RAM-14 group(P = 0.034). The overall PP eradication rate was 84.1%(122/145), and the final PP eradication rates were 77.7%(56/72; 95%CI: 70.2%-85.3%) in the RAM-7 group and 90.4%(66/73; 95%CI: 82.8%-98.1%) in the RAM-14 group(P = 0.017). The H. pylori-eradication rates in the RAM-14 group were significantly higher compared with that of the RAM-7 group according to both the ITT(P = 0.034) and the PP analyses(P = 0.017). Both groups exhibited good treatment compliance(RAM-7/RAM-14 group: 100%/100%). The adverse event rates were19.4%(14/72)and 20.5%(15/73)in the RAM-7 and RAM-14 groups,respectively(P=0.441).Adverse events occurred in 14 of the 72 patients(19.4)in the RAM-7 group and in 15 of the 73 patients(20.5)in the RAM-14 group.No statistically significant differences(P=0.441)were observed.CONCLUSION:The 14-d moxifloxacin-based triple therapy is a significantly more effective secondline eradication treatment as compared to the 7-d alternative for H.pylori infection in South Korea.
文摘Despite extensive clinical research in non-small cell lung cancer (NSCLC), overall survival is still poor. Racotumomab-alum is an anti-idiotypic cancer vaccine that targets NeuGcGM3 tumor associated ganglioside. The aim of this study was to evaluate safety and efficacy of racotumomab-alum in advanced NSCLC patients with progressive disease. This expanded access program included 86 histologically confirmed NSCLC patients, 18 years or older age, with advanced disease and without therapeutic option, with ECOG performance status ≤3, adequate organ functions and signed informed consent. The primary endpoint was overall survival and toxicity was measure assessed treatment-related toxicity according CTCAEv3. The study was approved by ethical review boards of participant institutions. Racotumomab-alum treatment consisted in 5 biweekly intradermal doses (1 mg/mL) during the induction phase of treatment (2 months). The maintenance phase consisted in monthly re-immunizations until unacceptable toxicity or PS worsening. The median overall survival time of all patients treated with racotumomab-alum was 8.96 months. The survival rates at 12 and 24 months were 42.8% and 28.0%, respectively. Patients that completed the induction phase of treatment (five doses or more) reached a median OS of 12.1 months. The most common adverse events were injection site reaction, bone pain, cough and asthenia. Racotumomab-alum cancer vaccine could be considered an effective and safe treatment option as second-line therapy for advanced NSCLC. Further clinical studies should be conducted to confirm this result.
文摘Autoimmune hepatitis is a rare chronic inflammatory liver disease,affecting all ages,characterised by elevated transaminase and immunoglobulin G levels,positive autoantibodies,interface hepatitis at liver histology and good response to immunosuppressive treatment. If untreated,it has a poor prognosis. The aim of this review is to summarize the evidence for standard treatment and to provide a systematic review on alternative treatments for adults and children. Standard treatment is based on steroids and azathioprine,and leads to disease remission in 80%-90% of patients. Alternative first line treatment has been attempted with budesonide or cyclosporine,but their superiority compared to standard treatment remains to be demonstrated. Second-line treatments are needed for patients not responding or intolerant to standard treatment. No randomized controlled trials have been performed for second-line options. Mycophenolate mofetil is the most widely used second-line drug,and has good efficacy particularly for patients intolerant to azathioprine,but has the major disadvantage of being teratogenic. Only few and heterogeneous data on cyclosporine,tacrolimus,everolimus and sirolimus are available. More recently,experience with the anti-tumour necrosis factoralpha infliximab and the anti-CD20 rituximab has been published,with ambivalent results; these agents may have severe side-effects and their use should be restricted to specialized centres. Clinical trials with new therapeutic options are ongoing.
文摘Introduction: The key to successful elimination of tuberculosis (TB) is treatment of cases with optimum chemotherapy. Irrational anti-TB drug use over time has led to drug-resistant TB. The treatment of MDR-TB with second line drugs is long, complex and costly, and has a considerable rate of adverse effects. The level of ADR reporting is low in Ethiopia due to different factors. This Study conducted in a selected treated area in Addis Ababa, Ethiopia and helped the health care centers to understand the prevalence of ADR related MDR-TB and be aware of those adverse effects in order to detect them early and be prepared to take proper steps when they occur. Aim of the Study: To determine the prevalence and risk factor of adverse drug reactions associated treatments of Multidrug Resistant tuberculosis. Method: This was a cross sectional study, which was conducted between March 2012 and February 2013 at St. Peter TB specialized hospital and AHRI/ALERT. 73 MDR TB patients, who were on MDR TB treatments, enrolled to the study. Adverse Drug Reactions associated MDR TB treatments were assessed by patient history review and questionnaire. Chemistry laboratory was used to test renal function, thyroid function, liver enzyme and potassium level. Result: In 72 patients, at least two ADRs were found. The mean age of the study population (Mean ± SD) was 28 ± 8.8. In this study the most commonly found adverse drug reactions (ADRs) were: Anorexia 83.3%, Nausea and vomiting 82%, Gastritis 64%, Arteralgia 47%, Skin rash and itching 45%, Headache 29.2%, Depression 22.2% and Blurred vision 19.4%. Using binary logistic regression model older age (COR 8.71, 95% [CI] 1.06 - 71.9), alcoholism (COR 4.05, 95% [CI] 1.05 - 15.6), smoking (COR 0.24, 95% [CI] 0.06 - 0.87) and concomitant drug intake (COR 0.14, 95% [CI] 0.03 - 0.76) were independent predictors for ADRs. Conclusion: The prevalence of ADRs related MDR TB treatments is high. To minimize ADR occurrence, ADR predictors should be integrated into the clinical pathway. Monitoring of liver function, renal function, TSH and level of potassium during MDR TB treatment, helps to avoid complication caused by therapy and increase the adherence to the treatment.
