Clinical comprehensive evaluation of Naoxintong Capsules in treatment of cerebral infarction with Qi deficiency and blood stasis syndrome and coronary heart disease angina pectoris / 中国中药杂志

Through investigating the current research on the effect of Naoxintong Capsules in the treatment of cerebral infarction with Qi deficiency and blood stasis syndrome and coronary heart disease angina pectoris, this study conducted a clinical comprehensive evaluation in "6+1" dimensions [safety, effectiveness, economy, innovation, suitability, accessibility, and characteristics of traditional Chinese medicine(TCM)], so as to highlight the advantages and clinical value of Naoxintong Capsules. By combining qualitative and quantitative methods, we used the multi-criteria decision analysis(MCDA) model to measure each dimension, and the results thereby were divided into four grades of A, B, C, and D in high-to-low order. Through literature review and evaluation, the adverse effects of Naoxintong Capsules are mainly caused by the gastrointestinal system. Since the safety risk is controllable based on current research, the safety evaluation is grade B. The effectiveness of Naoxintong Capsules combined with conventional western medicine in the treatment of cerebral infarction with Qi deficiency and blood stasis syndrome and coronary heart disease angina pectoris is evaluated as grade A, as compared with conventional therapy alone. The economy of Naoxintong Capsules, compared with Tongxinluo Capsules, is assessed as grade B. According to literature reports, Naoxintong Capsules exhibits outstanding clinical innovation in optimizing the current anti-platelet therapy strategy for patients with coronary heart disease after percutaneous coronary intervention(PCI), and the innovation is class A. Given the capsule formulation is convenient for storage and transportation, and its usage is easy for patients to grasp and accept, the suitability is grade B. The accessibility is grade A considering the price level, availability, and affordability, and the characteristics of TCM are evaluated as grade A from the perspectives of theoretical characteristics and human experience. The results of the comprehensive drug evaluation showed that the clinical value of Naoxintong Capsules is class A for treating cerebral infarction with Qi deficiency and blood stasis syndrome and coronary heart disease angina pectoris. According to the Guidelines for the Management of Comprehensive Clinical Evaluation of Drugs(trial 2021 version) issued by the National Health Commission, relevant policy results for basic clinical drug management can be formulated directly by procedure.

Report standards for clinical comprehensive evaluation of Chinese patent medicine / 中国中药杂志

The clinical comprehensive evaluation of drugs is an important basis for the return of clinical value, decision-making of medical and health authorities, and allocation of medical resources. In July 2021, the National Health Commission issued the Guidelines for the Management of Clinical Comprehensive Evaluation of Drugs(trial version 2021), which required the evaluation to be implemented from the six dimensions(safety, effectiveness, economy, innovation, suitability, and accessibility), and made detailed arrangements for the clinical comprehensive evaluation of drugs. As Chinese patent medicine differs from chemical medicines in terms of effective components and action modes, the clinical comprehensive evaluation of Chinese patent medicine should highlight the characteristics and advantages of traditional Chinese medicine(TCM) on the basis of general requirements of comprehensive clinical evaluation of drugs. At present, in the clinical comprehensive evaluation of Chinese patent medicine, unified report standards have not yet been generated, resulting in the uneven quality of existing reports. To standardize the clinical comprehensive evaluation report of Chinese patent medicine and improve its quality, the editorial team, based on the relevant policy documents of clinical comprehensive evaluation of drugs, formulated the clinical comprehensive evaluation report standards for Chinese patent medicine in combination with the previous practice and expert opinions. The report standards, containing seven sections with 15 items determined, focus on data source, evaluation content, evidence synthesis, quality control, and evaluation results supported with detailed interpretations to help researchers better understand and apply the report standards for clinical comprehensive evaluation of Chinese patent medicine, improve the report quality, and provide references for the decision-making by the national medical management authorities.

Effect of Xingnaojing Injection in treatment of cerebral hemorrhage based on Tabu search algorithm:a real world study / 中国中药杂志

In this study, Tabu search algorithm was used to analyze the effect of Xingnaojing Injection in the treatment of cerebral hemorrhage in the real world. Through the analysis of the results, the therapies based on the pathogeny of cerebral hemorrhage were screened out: Xingnaojing Injection+hemostatic drugs for promoting blood circulation and removing stasis. Cerebral hemorrhage complicated with brain edema: combined with mannitol or mannitol+aescin. The patients with relevant complications in the acute stage of cerebral hemorrhage could select according to the indications: ①Aminocycline+Oxiracetam+Piperacillin Sodium Sulbactam Sodium+Sodium Lactate Ringer; ②Aminocycline+Oxiracetam+Nifedipine+Captopril+Metoclopramide+Cimetidine; ③Insulin+Pantoprazole+So-dium Nitroprusside. The combined therapies for patients of the stable stage with complicating diseases could select according to the indications: ① Monosialotetrahexosyl Ganglioside Sodium+Deproteinized Calf Blood Serum+Nitroglycerin+Compound Potassium Dihydrogn Phosphate; ② Edaravone+Gangliosides+Captopril+Levofloxacin+Tanreqing Injection+Aminophylline. The analysis of subgroup module of drugs for promoting blood circulation and removing blood stasis suggested that the safety of traditional Chinese medicine should be paid attention to in the treatment of cerebral hemorrhage. This study was based on the data of the real world, but with some problems, such as lack of data and confounding factors. The summarized medication plan is only for the reference of clinicians. The clinical application shall be based on the specific situation of patients and the clinical benefits and risks, and pay attention to the incompatibility.

Tabu search algorithm analysis on effect of Xingnaojing Injection in treatment of craniocerebral injury and complications in real world / 中国中药杂志

In this study, Tabu search algorithm was used to analyze the drug combination of Xingnaojing Injection in the treatment of brain injury and complications in the real world, and the clinical drug combination of Xingnaojing Injection in the treatment of brain injury and complications was selected and summarized. The combination of Xingnaojing Injection, Namefen and Citicoline were recommended in the treatment of brain injury and complications. For brain edema and nerve injury, Mannitol/Glycerol Fructose/Furosemide+Tetrahexose Monosialate Ganglioside Sodium should be recommended. For those with pulmonary infection, Xingnaojing Injection+Xiyanping+Ambroxol Hydrochloride+Tanreqing Injection should be recommended. For those with shock, Hydroxyethyl Starch+Dopamine Hydrochloride/Dobutamine Hydrochloride+Sodium Bicarbonate should be recommended. The combination reflected the characteristics of Chinese and Western medicine. The above medication regimen was only for clinicians' reference. The clinical application should be based on patients' specific conditions, clinical benefits and risks, as well as the incompatibility. On the basis of the findings, further studies can be carried out for prospective clinical efficacy evaluation and safety evaluation for a specific subgroup module.

Clinical application of Xingnaojing Injection in treatment of 11 674 cases of cerebral infarction: a real world study / 中国中药杂志

To analyzed the actual clinical application of Xingnaojing Injection in treating cerebral infarction in the real world, selected HIS(hospital information system) database of inpatients in 39 hospitals across the country, and conducted descriptive analysis and association rule analysis on the information of 11 674 patients with cerebral infarction using Xingnaojing Injection. The results showed that the average age of the patients was 69.69 years. TCM syndrome of phlegm stasis and collaterals stagnation was the most(37.56%), followed by wind-phlegm obstruction of collaterals(19.01%). Virtual syndrome accounted for 21.06%. Intravenous drip was the most important route of administration(96.50%). Iv infusion single dose of 10-20 mL(52.44%), other off-label doses accounted for a larger proportion(47.56%). Continuous use of the drug within 3 days(55.45%), 15-28 days accounted for 6.96%, >28 days accounted for 0.89%. The top 10 Western drugs used in combination mainly include antihypertensive drugs, acid-suppressing drugs to protect stomach, drugs to improve brain circulation, drugs to protect brain nerves and drugs to fight infection. The top 10 of Chinese patent medicines are mainly activating blood circulation and removing stasis, clearing heat and clearing the surface, etc. According to the analysis of association rules, three types of clinical drug use modes for the combination of Chinese and Western medicine were obtained, mainly including the first type: Xingnaojing Injection+nifedipine(nifedipine, nifedipyridine, Lixinping)+levoflo-xacin+Huayu Tongmai agent. The second category: Xingnaojing Injection+omeprazole+edaravone+Huayu Tongmai agent; The third category: Xingnaojing Injection+ganglioside and ganglioside derivatives+edaravone+Huayu Tongmai agent. The results show that Xingnaojing Injection is not a standard drug in the treatment of cerebral infarction. At the same time, the combined use of drugs is mainly recommended by the guidelines and conventional treatment drugs, reflecting the clinical application of integrated traditional Chinese and Western medicine.