[Clinical centralized safety monitoring and evaluation of traditional Chinese medicine formula granules].

Traditional Chinese medicine(TCM) formula granules are highly praised for the advanced, convenient, and modern use of Chinese medicinal materials. The safety of TCM formula granules has long been a concern of regulatory authorities and the medical industry. A multi-center, prospective, open, non-interventional, and centralized monitoring was carried out for the patients treated with TCM formula granules in 252 medical institutions from February 5, 2020 to April 19, 2022. All the case data and the incidence of adverse drug reactions/events were recorded. This study evaluated the safety of TCM formula granules, aiming to provide a reference for the clinically use. A total of 20 547 patients were included in this study. Four adverse events were recorded, including 3 adverse drug reactions with an adverse drug reaction rate of 0.015%, all of which occurred in the digestive system. There was no serious adverse event, and no factors related to adverse drug reactions/events were identified. The incidence of adverse drug reactions/events associated with China Resources Sanjiu Medical & Pharmaceutical Co., Ltd. TCM formula granules was rare, which proved their safety in clinical use. A comprehensive data mining and objective analysis was carried out for the medicines with high frequency in TCM formula granules, the commonly used medicine pairs and combinations, and departmental medication. The drug use characteristics, prescription rules, and departmental use of TCM formula granules were summarized, which can shed light on the prescription compatibility and clinical application.

Medication Analysis of Traditional Chinese Medicine Diagnosis and Treatment Guidelines for Allergic Rhinitis Based on Clinical Efficacy Evaluation / 中国实验方剂学杂志

ObjectiveTo explore the role of efficacy evaluation methods in providing evidence for traditional Chinese medicine （TCM） clinical practice guidelines based on a demonstration study of clinical efficacy evaluation of TCM for allergic rhinitis （AR），aiming to enrich the sources of evidence for guideline development. MethodReal-world data of TCM medication for AR were collected and efficacy evaluation was carried out. SPSS 16.0 software was used to calculate the conformity of clinical syndromes，main prescriptions， and medications to the guidelines. Correlation analysis of efficacy and medications was performed according to guideline conformity to compare the differences in medications between real-world clinical applications and current guidelines. ResultA total of 198 cases were collected and the clinical medications were compared with the relevant guidelines for AR. It was found that the clinical syndrome conformity was above 70%，and in addition to the guideline syndrome，there were also syndromes in six meridians and other mixed syndromes in clinical practice. The guideline conformity of the main prescriptions used in clinical practice showed a positive correlation trend with efficacy. There were some differences between the commonly used drugs in clinical practice and those recommended by the guidelines. For example，for lung Qi deficiency and cold syndrome，drugs such as Angelicae Dahuricae Radix， Magnoliae Flos， and Schisandrae Chinensis Fructus were often used. For kidney Yang deficiency syndrome，drugs such as Atractylodis Macrocephalae Rhizoma and Ostreae Concha were often used. For spleen Qi deficiency and weakness syndrome，drugs such as Poria， Cinnamomi Ramulus， and Magnoliae Flos were used. For lung Qi deficiency and cold syndrome in children，drugs such as Chebulae Fructus， Cicadae Periostracum， Zingiberis Rhizoma， and Ginseng Radix et Rhizoma were used. For lung and spleen Qi deficiency syndrome，drugs such as Dioscoreae Rhizoma， Menthae Haplocalycis Herba， Amomi Fructus， and Zingiberis Rhizoma were used. There were also some differences in the commonly used drugs for adults and children. For example，for lung Qi deficiency and cold syndrome，adults often used Angelicae Dahuricae Radix， Magnoliae Flos， and Tribuli Fructus，while children often used Ginseng Radix et Rhizoma， Paeoniae Radix Alba， and Poria. For lung meridian hidden heat syndrome， adults often used Bupleuri Radix， Asari Radix et Rhizoma， Pinelliae Rhizoma， and Xanthii Fructus， while children often used Houttuyniae Herba， Menthae Haplocalycis Herba， Citri Reticulatae Pericarpium， and Massa Medicata Fermentata. ConclusionEffective medication regimens can be screened out based on efficacy evaluation methods，which can help supplement immediate， objective， and clinically relevant evidence of medication for the development of clinical practice guidelines in TCM from the perspective of clinical effectiveness.