[Clinical comprehensive evaluation of Jiangzhi Tongluo Soft Capsules for treating hyperlipidemia (syndrome of blood stasis and Qi stagnation)].

This study provides a systematic review of existing evidence concerning the efficacy of Jiangzhi Tongluo Soft Capsules(JTSC) in treating hyperlipidemia(syndrome of blood stasis and Qi stagnation), following the Guidelines for clinical evidence and value assessment of drugs. The qualitative and quantitative methods were integrated, including questionnaire surveys, evidence-based medicine, and pharmacoeconomic evaluation. Multi-criteria decision analysis(MCDA) model was used for comprehensive assessment of the clinical evidence and value of JTSC for hyperlipidemia in "6+1" dimensions: safety, effectiveness, cost-effectiveness, innovation, suitability, accessibility, and traditional Chinese medicine(TCM) characteristics. The safety evidence was sufficient and the results of the known risk assessment indicated that JTSC was safe and had a sufficient safety profile. Meta-analysis showed that JTSC recovered patients' triglyceride levels(RR=-0.25, 95%CI[-0.41,-0.10], P=0.001). JTSC had similar efficacy to simvastatin Tablets(RR=1.11, 95%CI[0.96, 1.27], P=0.15) and Zhibituo Tablets(RR=1.07, 95%CI[0.99, 1.16], P=0.10) in restoring blood lipid levels. JTSC outperformed Xuezhikang Capsules in recovering blood lipid levels(RR=1.44, 95%CI[1.17, 1.76], P=0.000 6). According to the Grading of Recommendations Assessment, Development and Evaluation(GRADE) system, the evidence was rated as grade C, and the overall evaluation of the quality and value of the evidence indicated that the effectiveness evidence of this product was fairly sufficient. Markov economic model was established, and the results suggested that JTSC was more economical than Pushen Capsules. Considering the incremental effect and the cost of the intervention scheme, JTSC had good cost effectiveness. The innovation of JTSC was evaluated based on three primary indicators and eighteen secondary indicators, which suggested the evidence of innovation for JTSC was abundant. The information of Chinese patent medicines of JTSC was complete, and the survey results showed that the drug was suitable for clinicians, nurses, pharmacists, and patients. The comprehensive evaluation suggested that JTSC had abundant evidence of suitability. The accessibility of a drug mainly involves the price, availability, and affordability of the drug. The tender price of JTSC was 0.72 yuan/capsule, and the treatment cost after refund accounted for 0.08% of the median household disposable income of urban residents and 0.31% of the median household disposable income of rural residents. The evidence of accessibility was abundant. The TCM characteristics of JTSC were prominent. CSC v2.0 was used to calculate the comprehensive evaluation value in the "6+1" dimensions, which yielded a score of 0.69, indicating sufficient evidence for the clinical comprehensive value of this drug. According to the evaluation results of each dimension and the comprehensive evaluation score, it is believed that the clinical value evidence of JTSC in treatment of hyperlipidemia(syndrome of blood stasis and Qi stagnation) is sufficient. It is suggested that high-quality evidence-based research should be carried out on the treatment of hyperlipidemia with JTSC, and contraindications in pregnant women should be added in the section of contraindications of the product instruction.