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OBJECTIVE To evaluat e the cost-effectiveness of Keluoxin capsule combi ned with chemical medicine in the treatment of diabetic kidney disease （DKD）from the perspective of the whole society. METHODS Six-state Markov model with 1 year cycle and 40 years time horizon was constructed by means of secondary literature review ，medical record analysis of sample hospital and clinical expert consultation. The cost-effectiveness of Keluoxin capsule combined with chemical medicine versus chemical medicine alone for DKD was evaluated by taking the quality-adjusted life year （QALY）as the output index ，setting the discount rate as 5％，and taking one time domestic gross domestic product （GDP）per capita in 2020 of China as the judgement threshold of incremental cost-effectiveness ratio （ICER）. RESULTS Within 40 years，Keluoxin capsule combined with chemical medicine group spent 8 644.09 yuan per capita more than chemical medicine alone group ，and gained more 0.143 QALYs；ICER was 60 460.25 yuan/QALY，which was less than one times GDP per capita of China in 2020（72 447 yuan）. The results of sensitivity analysis showed that the annual days of using Keluoxin capsule ，the health utility value of DKD at early stage had a great influence on the results of cost-effectiveness analysis. The results of probabilistic sensitivity analysis suggested that the basic analysis results of this study were robust. CONCLUSIONS At the current price level ，Keluoxin capsule combined with chemical medicine is more cost-effective to treat DKD than chemical medicine alone. The dosage of Keluoxin capsule and health utility value should be paid attention in specific decision- bjmu.edu.cn making scenarios.
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Objective To assess the clinical effect and safety evaluation of Keluoxin capsule in the treatment of the patients with early diabetic nephropathy. Methods One hundred and forty-nine patients with early diabetic nephropathy were randomly divided into the treatment group and control group, 74 in each group. The control group was treated with Keluoxin placebo capsules (2 g every time, 2 times a day, oral) and Irbesartan (150 mg every time, once a day, oral) simultaneously; and thetreatment group was treated with Keluoxin capsules (2 g every time, 2 times a day, oral) and Irbesartan (150 mg every time, once a day, oral) simultaneously. Both groups were treated for 24 weeks. The clinical curative effect, the changes of blood sugar levels, TG, TC, LDL-C, HDL-C, BUN, Scr, 24 hUTP and 24 hUAE were assessed and compared, and the treatment safety of Keluoxin capsule was assessed. Results Compared with the control group, the markedly effective rate and total effective rate of treatment group increased significantly (χ2=9.208, P0.05). There was no adverse event between two groups. Conclusions The clinical effect of Keluoxin capsule can benefit the patients with early diabetic nephropathy.