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Recently, several novel therapeutic drugs (NTDs) were found to have therapeutic potential in treating chronic heart failure (CHF). This network meta-analysis aimed to compare and rank different NTDs in patients with CHF. We searched Medline/PubMed, Embase and Cochrane Library of Clinical Trials database through February 9, 2021, for RCTs comparing the NTDs with standard of care (SOC) in adult patients with CHF. Trials of angiotensin receptor-neprilysin inhibitor (ARNI), sodium-glucose transporter 2 (SGLT2) inhibitors, ivabradine, non-steroidal mineralcorticoid receptor antagonists (MRA), soluble guanylate cyclase (SGC) stimulators and cardiac myosin activators (CMA) were included. We performed a Bayesian network meta-analysis to indirectly compare the mortality, HF hospitalization and adverse events of the NTDs. Thirty-three studies enrolling 63614 patients were included in this analysis. The results showed none of the NTDs was associated with a significant superiority in reducing all-cause mortality, composite outcome of cardiovascular mortality or HF hospitalization and HF hospitalization alone. For cardiovascular mortality alone, ARNI was superior to ivabradine and CMA, while SGLT2 inhibitors were superior to CMA. For adverse events, SGLT2 inhibitors were associated with a lower risk of serious adverse events than ivabradine and CMA. ARNI and SGLT2 inhibitors were recommended as better choices in reducing CV mortality, while SGLT2 inhibitors performed better regarding serious adverse event.

According to the notice on revision of the instructions for traditional Chinese medicine injections(TCMIs) issued by the National Medical Products Administration(NMPA) from January 2006 to May 2020, the revised contents in the instructions for 29 varieties involved in the notice were sorted out, and the existing problems in the instructions for TCMIs were analyzed, so as to provide the basis for dynamic revision of the instructions. It was found that the revised items of instructions for 29 varieties all involved adverse reactions, contraindications and precautions, and warnings were added for 82.76% of 29 TCMIs preparations, indicating that all the revised contents were related to safety issues. In addition, 33.33% of the drugs risks mentioned in the precautions were not indicated in the adverse reactions; 82.76% instructions did not indicate drug interactions; 17.24% instructions lacked medication notes for special populations; 48.28% instructions did not indicate traditional Chinese medicine(TCM) syndromes of the main disease; 44.83% instructions did not indicate the type and stage of indication; and 86.21% instructions did not indicate the course of treatment. It could be concluded that the instructions for TCMIs have known risks of drugs that are not fully reflected in adverse reactions and the effective information is not comprehensive. The risk control measures proposed in the precautions need to have aftereffect evaluation and there is a lack of drug interactions and medications for special populations. As an important part of the full life-cycle management of drugs, the revision of instructions for TCMIs should be continuously improved to provide the basis for safe and reasonable application of TCMIs. Based on the above problems, it is proposed that the marketing license holder as the main body of the revision of instructions should actively carry out post-marketing basic and clinical research in accordance with the characteristics of TCM, combine the updated research with the guidance of TCM theory and improve the revision level of instructions for TCMIs to provide the basis for post-marketing evaluation.