左卡尼汀口服溶液的药品综合评价.

OBJECTIVE: To perform clinical comprehensive evaluation of L-carnitine oral solution from six dimensions of effectiveness, safety, economy, innovation, suitability and accessibility. METHODS: PubMed, Embase, the Cochrane Library, CNKI, Wanfang Data, CBM and CRDWeb were systematically retrieved( the search deadline was from database establishment to Oct. 2020). The Rapid Health Technology Assessment method was used to analyze the effectiveness, safety and economy of L-carnitine oral solution. The innovation, suitability and accessibility of drugs were analyzed by searching the professional websites of the National Medical Products Administration, Drug Evaluation Center of the National Medical Products Administration, pharmacopoeia of various countries and drug instructions. RESULTS: In terms of efficacy and safety, L-carnitine oral solution could significantly improve the levels of fasting blood glucose, triglyceride, high-density lipoprotein and insulin resistance in patients with nonalcoholic fatty liver disease, hemodialysis, type 2 diabetes mellitus, type 2 diabetes mellitus combined with dyslipidemia, hyperlipidemia, elderly and other diseases; relieve the neurogenic pain symptoms; reduce the levels of C-reactive protein, interleukin-6 and other inflammatory markers and hepatic enzymes; improve the male infertility symptoms. And the results of secondary prevention of cardiovascular disease such as all-cause death, also showed a better effect. Security data needs to be added. Economically, the drug had been included in the 2020 Chinese National Medical Insurance Catalogue, and no economic studies were available for the drug. The solution process of the drug was patented, yet there were no other innovative features. In terms of suitability, the oral solution of L-carnitine had better compliance than the injectable form. In terms of accessibility, the locations of domestic drug manufacturers included five provinces and municipalities directly under the central government, concentrated in the northeast. CONCLUSIONS: L-carnitine oral solution is effective in the treatment of diseases of several systems, including endocrine, with moderate appropriateness and accessibility, and safety and economics need to be further studied. [ABSTRACT FROM AUTHOR]