Analysis of adverse reactions of Xianling Gubao preparation based on real world SRS data / 中国中药杂志

From January 1, 2004 to July 21, 2016 a total of 2 796 cases of adverse drug reaction/adverse event(ADR/AE) after the use of Xianling Gubao Capsules/Tablets were reported by National Adverse Drug Reaction Monitoring Center. The following results were obtained by analyzing the reports of 2 796 cases of adverse drug reactions/adverse drug events after the use of Xianling Gubao Capsules/Tablets. A total of 75 patients, accounting for 2.68% of the total ADR/AE time, had severe ADR/AE events. Among them, 30 patients were aged 65 and above, accounting for 40.00% of the total number of severe ADR/AE patients. All the patients with ADR/AE were aged 45-64 years, which totaled 1 346 cases and took up 48.14% of the total patients with ADR/AE. All of ADR/AE cases and severe ADR/AE cases were orally given Xianling Gubao Capsules/Tablets. Females accounted for 52.50% and 76.00%, respectively, and the proportion of females was significantly higher than that of males. Among patients with a medical history of ADR/AE, severe ADR/AE was higher than the average, accounting for about 1.33%. The proportion of cases orally given 1-3 tablets of Xianling Gubao Capsules/Tablets in all ADR/AE cases and severe ADR/AE cases was 95.32% and 96.00%, which conformed to the usage in the package insert. All ADR/AE cases and severe ADR/AE cases orally given Xianling Gubao Capsules/Tablets twice daily occupied the highest proportions, or 77.00% and 61.00%, respectively. The proportion of severe ADR/AE cases orally given Xianling Gubao Capsules/Tablets was slightly higher than that of all ADR/AE cases in the medication frequency, which didn't conform to the usage in the package insert. All the symptoms of ADR/AE orally given Xianling Gubao Capsules showed many manifestations, and the top 10 symptoms were nausea, rash, itching, stomach dysfunction, vomiting, abdominal pain, dizziness, diarrhea, anaphylaxis, and reflux heartburn. The symptoms of severe ADR/AE after oral administration of Xianling Gubao Capsules were varied, and the top 10 symptoms were abnormal liver function, rash, suffocation, itching, dizziness, vomiting, anaphylaxis, abdominal pain, weakness, and convulsions. Abnormal liver function accounted for 44.12%. All of ADR/AE cases occurred within 2 days after oral administration of Xianling Gubao Capsules/Tablets, accounting for 54.26%. Severe ADR/AE occurred within 2 days after the use of Xianling Gubao Capsules/Tablets, accounting for 25.34%. The proportion of ADR/AE cases occurring within 15 days after oral administration of Xianling Gubao Capsules/Tablets increased again(57.33%). The overall trend contained two peaks.

Common clinical medical combinations with Shenfu injection based on 25 704 electronic medical records / 中国中药杂志

Shenfu injection is a common clinical medicine. To explore the common clinical medical combinations with Shenfu injection the real world, 25 704 patients who used Shenfu injection were selected from the hospital information system (HIS) database established by Clinical and Basic Research Institute for Traditional Chinese Medicine of China Academy of Chinese Medical Sciences. The association rules were applied in a correlation analysis on common medical combinations with Shenfu injection in the patients. According to the findings, when Shenfu injection was combined with a single medicine in clinic, the ratio of using Omeprazole, Lidocaine or Furosemide were respectively 22.19%, 20.32%, 19.61%; when Shenfu injection was combined with two medicines, the top three medical combinations were respectively midazolam + omeprazole (11.01%), lidocaine + omeprazole (10.8%) and propofol + midazolam (10.76%); when Shenfu injection was combined with three medicines, the top three medical combinations were respectively propofol + fentany + midazolam (8.83%), remifentanil + propofol + midazolam (8.77% ) and propofol + midazolam + omeprazole (8.77%). According to the further analysis, the combination of Shenfu injection and Propofol + Fentany + Midazolam may reduce the incidence of hypotension and bradycardia during anesthesia, accelerate recovery after anesthesia and relieve the synergistic effect after anesthesia. The combination of Shenfu injection and furosemide may show the synergistic effect in treating the acute left ventricular failure by reducing the returned blood volume and increasing the myocardial contractile force and vitality. The combination of Shenfu injection and Omeprazole may play the synergistic effect in shortening the digestive tract ulcer healing time, reducing the ulcer recurrence and preventing hemorrhagic shock and stress ulcer caused by shock in treating ulcer hemorrhage.