Research On Adverse Drug Reactions Of Anti-Tuberculosis And Its Coping Strategies

Objectives To understand the distribution characteristics and impact on tuberculosis treatment of ADRs among smear-positive TB patients in Guangxi, to assess the effectiveness and costs of hepatoprotective liver drugs to ATDH prevention, to evaluate the economic burden of ADRs, to explore the coping strategies for ADRs and provide basis to TB control program in Guangxi.Methods A total of 1117 smear-positive cases in 14 counties were selected by simple random sampling, the number of cases in each county were based on the principles of PPS and the number of initial-treated patients and re-treated patients were based on the proportion (about 5:1) of which in Guangxi. Baseline surveys, follow-up and outcome surveys were taken during the six months research. Health economics surveys were taken to ADRs cases at the time of one month after ADRs occured and at the end of the investigation. Quality control monitored the entire process. Data were double entered into Epidate 3.1 and analyaed using SPSS 17.0.Results 1. Characteristics of ADRs:①Symptoms and emergence time: The main symptoms by self-reported were nausea, vomiting (42.2%) and headache, dizziness (41.1%), which often took place at about 8 days after taken drugs. Paresthesia of finger and toe, joint pain and audio-visual anomalies occurred at about 30 days after taken drugs.②ncidence and occurrence time: The incidence of ADRs was 12.4%. Most ADRs occurred at the fist 2 months of TB treatment. ATDH took the highest incidence in all types of ADRs (3.74%), followed by gastrointestinal ADRs(3.54%), allergic ADRs (3.35%), nervous system damage (1.92%), bone and joint damage (1.05%), blood system damage (0.86%) and kidney damage (0.19%).③Distribution:The incidence of ADRs tended to increase by age. It's higher in Zhuang population (17.2%) than in Han (9.3%), higher in primary educated persons (14.8%) than in higher educated persons (10.1%)and higher in married (14.6%) than unmarried or divorced (7.0%). It was no difference in gender, BMI, occupation, income, TB types and liver disease.④Only age and nationality associated with ADRs according Logistic regression analysis, the risk of ADRs was 3.4 times higer in the age group of 60y and over years than in 14～34 age group(OR=3.406)and 2 times higher in Zhuang than Han population(OR= 2.008).⑤Impact to TB treatment: 61.2% ADRs took impact on TB treatment, including treatment interruption, termination, replacement drugs, reduce dose and change medication way, in which interruption took the highest proportion of 29%.23.7% ADRs impacted on tuberculosis prognosis, in which treatment extension took the highest propotion (91.7%). ATDH was the main type leading to treatment interruption and extension.⑥The incidence of ATDH was 3.5% in the group of taking hepatoprotective when it was 5.5% in the group not taking hepatoprotective,it showed no statistical significance (X2=0.581, P=0.446), effectivness of hepatoprotective were not so clear now.2. Health economics reserch:①The Cost effectiveness of hepatoprotective was 5530, hepatoprotective can not reduce the costs of ATDH therapy also.②ADRs economic burden: The cost of dealing with one ADRs case was 1045.6 yuan, in which 314.8 yuan was direct-medical expenditure,120.9 yuan was direct-non-medical expenditure, 609.8 yuan was indirect-expenditure; The cost for ATDH was the highest (1671.1 yuan) in all types of ADRs. It may cost about 2.195 million yuan to deal with ADRs by year in Guangxi.3. Coping strategies:①Making a correct understanding, determination and positive control to ADRs.②Anti-TB surveillance system of ADRs must be established.③High-quality anti-TB drugs.④Policy supportment.Conclusions The incidence of Guangxi ADRs was at the national average level. The main symptoms were nausea, vomiting and headache, dizziness. ADRs almost occurred in the fist 2month of TB treatment. ATDH was the most common type of ADRs and it's the main course to TB treatment interruption and extension. The effectiveness of hepatoprotective was not confirmed, and hepatoprotective could not reduce the economic burden of ATDH. ADRs cause great financial burden on families and society, so TB and ADRs control program must be improved urgently.