Clinical centralized safety monitoring and evaluation of traditional Chinese medicine formula granules / 中国中药杂志

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.

Effect of SLC6A4 gene polymorphism on pain sensitivity in patients with lung cancer / 中华麻醉学杂志

Objective To evaluate the effect of SLC6A4 gene polymorphism on pain sensitivity in the patients with lung cancer. Methods A total of 248 patients with pulmonary malignant tumor served as lung cancer group and 104 healthy subjects in the Physical Examination Center of our hospital served as con-trol group. Patients with malignant pulmonary tumor in lung cancer group were further divided into 3 sub-groups according to pain score and the three step analgesic ladder recommended by WHO(opioids was used when visual analogue scale[VAS]score≥4 points): painless subgroup, mild pain subgroup and moder-ate-severe pain subgroup. The consumption of opioids(based on requirement for morphine)within 24 h af-ter pain relief(VAS score≤3 points)after treatment and VAS score before treatment were recorded. Ve-nous blood samples were collected, and the genotypes were analyzed by polymerase chain reaction-restric-tion fragment length polymorphism. Results There was no significant difference in genotype frequency or allele frequency at rs4795541 and rs3813034 sites between lung cancer group and control group and among the three subgroups(P>0.05). There was no significant difference in VAS score before treatment or re-quirement for morphine between patients of different genotypes and alleles(P>0.05). There was no signifi-cant difference in VAS score before treatment or requirement for morphine between lung cancer patients with medium and low expression of serotonin transporter in 5-HTT-linked polymorphic region. Conclusion SLC6A4 gene polymorphism exerts no effect on pain sensitivity in the patients with lung cancer.