Ramoshusted9195
To investigate the safety of Injection of Xuesaitong(lyophilized) in clinical "real world" application, including the types, incidence, as well as the severity and treatment measures of adverse reactions/adverse events. This will serve as a basis for hospitals and enterprises to develop risk control measures. A prospective, multi-center, and large-sample hospital centralized monitoring method was used to conduct post-marketing safety monitoring of Injection of Xuesaitong(lyophilized) in medical institutions nationwide. Paper case report forms were adopted to collect general information, medication and adverse reaction information of patients using Injection of Xuesaitong(lyophilized). Data analysis was performed by using SAS 9.1 software. The study included 79 hospitals with 30 097 patients. 199 cases of adverse events were found in patients administered with Injection of Xuesaitong(lyophilized), a total of 206 times. Among 199 cases, 40 of them showed adverse reactions, accounting for an overall incidence of 0.13% and 95%CI[0.09%,0.17%], which was an occasional grade. There were 38 cases of mild adverse reactions, accounting for 95.0%, 2 cases of moderate adverse reactions, accounting for 5.0%. Adverse reaction symptoms were relieved in six patients, accounting for 15.0% of the total number of adverse reactions, adverse reaction symptoms disappeared in 34 cases, with an overall percentage of 85.0%. The results of the study showed the adverse reactions in patients using Injection of Xuesaitong(lyophilized) were rare and mild, with a good prognosis. Therefore, clinical administration of Injection of Xuesaitong(lyophilized) is relatively safe.To investigate the extensive application of Injection of Xuesaitong(lyophilized) in clinical real world study, and provide basis for clinical guidance on rational drug use and improvement of drug instructions. A prospective, multi-center, large-sample hospital centralized monitoring method was adopted to collect the general information and medication information of all patients who received Injection of Xuesaitong(lyophilized) during the study period in the respective monitoring units. Data analysis was performed using SAS 9.1 software. This study included 79 hospitals, with 30 097 patients being recruited. The patients who met the indications for stroke and hemiplegia accounted for 31.18%, those who experienced indications of chest pain and heartache accounted for 23.15%, and patients with central retinal vein occlusion indication accounted for 0.53%. The minimum single dose of Injection of Xuesaitong(lyophilized) was 20 mg, the maximum single dose was 1 000 mg, and the average single dose was(383.31±78.10) he usage of Injection of Xuesaitong(lyophilized) basically meets the requirement of drug instructions in terms of indications, dosages, and methods of administration. this website However, it still needs to be improved in standardizing the selection of the menstruum, drip rate, course of treatment, and the combined usage of medicine.Keyin Pills is a kind of traditional Chinese medicine for the treatment of psoriasis, but it has been reported that it can cause serious liver injury. In this paper, we used the integrated evidence chain method to retrieve and reevaluate the adverse drug reaction database, CNKI literature and cases of liver injury relating to Keyin Pills in specialist hepatology hospitals. We screened out 23 cases with the causal relationship of the possible grade and above. Among them, 11 cases showed the positive causal relationship only with Keyin Pills, accounting for 47.83%, suggesting that there was objective liver injury caused by Keyin Pills. The incubation period of liver injury caused by Keyin Pills is 1-90 days, and the cumulative dosage span is 20-1 800 g. There were obvious individual diffe-rences. There was no relationship between liver injury as well as dose and course of treatment, suggesting that Keyin Pills could induce immune idiosyncratic liver injury. Furthermore, based on the liver injury model induced by immunological stress, it was confirmed that Keyin Pills could induce acute liver injury in a dose-dependent manner in rats with immunological stress. The toxic dose(14 g·kg~(-1)) of a single dose was 6.7 times of the clinical equivalent dose, and had no significant effect on the biochemical index of liver function and histopathology in normal rats. Decomposition experiments showed that Dictamnus dasycarpus in Keyin Pills is the main medicinal flavor that causes special liver injury, and the other three medicines had neither liver injury nor compatibility attenuation effect. The results suggest that clinical medication shall pay attention to the risk of liver injury caused by Keyin Pills in patients with immunological stress.To systematically evaluate the efficacy and safety of Yangwei Granules combined with conventional Western medicine for chronic gastritis. CNKI, SinoMed, WanFang, VIP, PubMed, Cochrane Library and EMbase database were electronically retrieved to collect randomized controlled trial(RCT) of Yangwei Granules combined with conventional Western medicine for chronic gastritis. Two reviewers independently screened out literatures according to the inclusion and exclusion criteria and extracted data, and evaluated the risk of bias of included studies. Meta-analysis was conducted by using RevMan 5.3 software. A total of 12 RCTs involving 1 164 patients were included. The results of Meta-analysis showed that(1) The total effective rate of Yangwei Granules combined with conventional Western medicine for chronic gastritis was better than that of conventional Western medicine group, with a statistically significant difference(RR=1.24,95%CI[1.17,1.31],P<0.000 01).(2) Compared with the conventional Western medicine group, conventional Western medicine group could increase PGⅠ(MD=6.40,95%CI[4.26,8.54],P<0.000 01) and PGR(MD=0.89,95%CI[0.71,1.07],P<0.000 01), while decrease PGⅡ(MD=-1.24,95%CI[-2.15,-0.33],P=0.007), with statistically significant differences. Current evidence showed that the clinical efficacy and Hp eradication rate of Yangwei Granules combined with conventional Western medicine in the treatment of chronic gastritis were better than those of the conventional Western medicine group alone, and could effectively improve the level of gastrointestinal hormones, vasoactive peptide and the pepsinogen level in patients with chronic atrophic gastritis, without increasing the incidence of adverse reactions. However, due to the limited quality and quantity of included studies, the above conclusions need to be confirmed by more large-scale and high-quality RCTs.