1.Comprehensive Clinical Evaluation of Xueshuantong for Injection(Lyophilized) in Treatment of Acute Cerebral Infarction
Xuming ZHANG ; Hongjiao GENG ; Yi LIU ; Xin CUI ; Yanming XIE
Chinese Journal of Experimental Traditional Medical Formulae 2023;29(15):131-141
ObjectiveTo systematically review the existing studies on Xueshuantong for injection(lyophilized) in the treatment of acute cerebral infarction(ACI), and to clarify the clinical value of Xueshuantong for injection(lyophilized) through comprehensive clinical evaluation, so as to promote clinical rational drug use and relevant policy transformation. MethodEvidence of Xueshuantong for injection(lyophilized) in terms of safety, effectiveness, economy, innovation, suitability, accessibility, traditional Chinese medicine(TCM) characteristics(6+1 dimensions) and information service was comprehensively collected. Evidence-based medicine, questionnaire survey, health technology assessment, pharmacoeconomic evaluation and other research methods were used, and the multi-criteria decision analysis model was used to measure each dimension, in order to comprehensively evaluate the clinical value of Xueshuantong for injection(lyophilized). ResultSpontaneous reporting system, Meta-analysis of adverse reactions, and active safety monitoring study showed that the main adverse reactions of Xueshuantong for injection(lyophilized) were rash, pruritus, chest tightness, headache, dizziness and other general adverse reactions, the incidence of serious adverse reactions was judged to be rare, the known risk was small, the evidence was sufficient, and the safety evaluation was grade A. The results of Meta-analysis showed that Xueshuantong for injection(lyophilized) combined with conventional treatment for ACI was superior to conventional treatment in terms of improving neurological deficit score, improving daily activity score and clinical efficacy, and the effectiveness evaluation was grade B. The results of pharmacoeconomic evaluation showed that Xueshuantong for injection(lyophilized) combined with conventional treatment was relatively economic compared with conventional treatment alone, with the total clinical effective rate as the effect parameter, but the incremental effect was not significant, the economic evaluation was grade B. In addition to ACI and unstable angina of coronary heart disease, the drug also had good clinical efficacy in central retinal vein occlusion, and had a wider range of indications and awarded 16 patents, and its innovation evaluation was grade B. The suitability of medical personnel and patients was good without special technical and management requirements, and the suitability was evaluated as grade B. Xueshuantong for injection(lyophilized) had reasonable price, good affordability, certain prescription restrictions and general availability, the accessibility evaluation was grade B. Since the drug is an injection of effective parts of TCM, no grade evaluation of its TCM characteristics is conducted. The legal and non-legal information evaluation results of Xueshuantong for injection(lyophilized) showed that all the information was complete and in accordance with the requirements of national standards. Based on the grade scores of the 6 dimensions, the clinical comprehensive evaluation of Xueshuantong for injection(lyophilized) in the treatment of ACI was calculated as category B by CSC 2.0. ConclusionThe clinical value of Xueshuantong for injection(lyophilized) is good, and it is suggested that it can be directly translated into relevant policy outcomes for basic clinical medication management.
2.Herbal Textual Research, Quality Evaluation and Phase Analysis of Ophicalcitum
Jianxiong WEI ; Mingyang YUAN ; Hongjiao CUI ; Yan CAO ; Guohua ZHENG ; Juan LI
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(21):185-193
By reviewing the historical materia medica, medical books and modern literature, this paper has systematically sorted out and verified the name, origin, quality and other aspects of Ophicalcitum. After herbal textual research, it is shown that before the Qing dynasty, the mineral medicine was mostly recorded in the name of Huarushi, but now it is called Huaruishi, and there is another mixed name Baiyunshi. The light white spots described in the historical materia medica are consistent with the characteristics of marble with sparkling star-like luster, combined with the color like sulfur, color are green, black spots and other serpentine features, it is deduced that it is serpentine marble, consistent with the present-day Ophicalcitum, and Ophicalcitum in the Song dynasty has a high content of serpentine. The main producing areas are Henan, Shaanxi, Shanxi and Sichuan, Jiangsu, Zhejiang, Hebei and other places are also available. Successive generations of materia medica on the quality evaluation of Ophicalcitum is less, the modern to neat and firm in the texture, sandwiched with yellow-green mottled for the best. Ophicalcitum is acidic, astringent and neutral in nature, belonging to the liver meridian, with the efficacy of treatment of gold sores and blood flow, internal leakage of cataracts, dropping afterbirth, now describing its efficacy as removing blood stasis and stopping bleeding. In ancient times, the earliest processing method was burning, followed by calcination by sulphur, calcination, quenching with vinegar and other methods. In modern times, it has been simplified to open calcination, processing with vinegar and the addition of water quenching. The gravimetric method and ethylenediaminetetraacetic acid titration were used to detect the contents of CO32- and CaCO3 in Ophicalcitum, respectively, and it was found that the gap in CaCO3 content among commercially available products was wide, and the content of CaCO3 in sample S13 and sample S18 was the same, but their compositions were different, and according to the contents of CO32- and CaCO3, the dolomite and calcite contents could be calculated, of which the higher the calcite content the more obvious the sparkling star-like luster. Raman spectroscopy and X-ray diffraction(XRD) were used to detect the physical phase composition of the powder of the samples, and Raman spectroscopy was used for the rapid non-destructive testing of the striped part, which showed that Ophicalcitum was mainly composed of dolomite, calcite, serpentine, olivine and pyroxene, with serpentine dominanting the striped part. In summary, the 2020 edition of Chinese Pharmacopoeia stipulates that the content of CaCO3 in Ophicalcitum is not less than 40%, which is difficult to control its quality, and it is suggested to increase the detection of CO32- content. This study can provide a scientific basis for the traceability of Ophicalcitum and better guide the clinical medication and rational utilization of resources.