Objective:To investigate the occurrence and characteristics of adverse reactions of Xuesaitong preparations, mine its coagulation disorders/bleeding risk signals, and provide references for its safe and rational use in clinic. Methods:The reports of adverse drug reactions (ADR) caused by Xuesaitong preparations from August 2003 to August 2023 in the database of Shandong Provincial Center of Adverse Drug Reaction Monitoring were collected. ADR were counted and classified using the system organ class (SOC) and preferred term (PT) of Medical Dictionary for Regulatory Activities 26.1. Three methods, namely the reporting odds ratio (ROR), the proportional reporting ratio (PRR), and the comprehensive standard method of the Medicines and Healthcare Products Regulatory Agency (MHRA) of the United Kingdom, were used to detect the risk signals of coagulation disorders/bleeding in using Xuesaitong preparations. Results:A total of 17 015 reports of ADR related to Xuesaitong preparations were collected, involving 9 dosage forms, in which injection dosage form accounted for 95.50% (16 250/17 015). The median age of the patients was 62 years, 44.87% of the cases were 45-64 years and 42.90% of them were 65 years and above. There were 2 217 cases of severe ADR reports, accounting for 13.03% (2 217/17 015). A total of 18 SOCs were involved, the top 3 were skin and subcutaneous tissue diseases, systemic diseases and drug administration site reactions, and neurological diseases. A total of 54 PTs were not recorded in the instructions, among which 34 were severe. Ninety-three cases about coagulation disorders/bleeding (98 times) were reported, the top 3 PTs were hematuria [24.49% (24/98)], purpura [11.22% (11/98)], and epistaxis [10.20% (10/98)]. Seven dosage forms of Xuesaitong preparations were involved, the top 3 were Xuesaitong for injection (freeze-dried) (48 cases, accounting for 51.61%), Xuesaitong injection (29 cases, accounting for 31.18%), and Xuesaitong tablets (8 cases, accounting for 8.60%). Among 93 reports of coagulation disorders/bleeding, there were 23 severe cases, accounting for 24.73%, which was significantly higher than that in other reports (12.97%), and the difference was statistically significant ( P<0.001). Sixteen PTs about coagulation disorders/bleeding were not recorded in the instructions, among which 9 were severe. The proportion of cases with onset time longer than 7 days in ADRs about coagulation disorders/bleeding was higher than that in other ADRs [22.58%(21/93) vs. 7.43%(1 258/16 922), P<0.001]. The risk signals of coagulation disorders/bleeding were mined for Xuesaitong for injection (freeze-dried), Xuesaitong injection, Xuesaitong tablets, and Xuesaitong capsules, and the risk signal density of Xuesaitong tablets was the strongest. Conclusions:The ADRs of Xuesaitong preparations involve multiple systems and organs. Among them, Xuesaitong for injection (freeze-dried), Xuesaitong injection, Xuesaitong tablets, and Xuesaitong capsules have a strong association with coagulation disorders/bleeding risks, and the proportion of severe cases is relatively high. However, the relevant risk warning information is not included in the drug instructions of some manufacturers. Medication monitoring needs to be strengthened and timely intervention should be carried out in clinic.

Objective:To investigate the occurrence and characteristics of adverse reactions of Xuesaitong preparations, mine its coagulation disorders/bleeding risk signals, and provide references for its safe and rational use in clinic. Methods:The reports of adverse drug reactions (ADR) caused by Xuesaitong preparations from August 2003 to August 2023 in the database of Shandong Provincial Center of Adverse Drug Reaction Monitoring were collected. ADR were counted and classified using the system organ class (SOC) and preferred term (PT) of Medical Dictionary for Regulatory Activities 26.1. Three methods, namely the reporting odds ratio (ROR), the proportional reporting ratio (PRR), and the comprehensive standard method of the Medicines and Healthcare Products Regulatory Agency (MHRA) of the United Kingdom, were used to detect the risk signals of coagulation disorders/bleeding in using Xuesaitong preparations. Results:A total of 17 015 reports of ADR related to Xuesaitong preparations were collected, involving 9 dosage forms, in which injection dosage form accounted for 95.50% (16 250/17 015). The median age of the patients was 62 years, 44.87% of the cases were 45-64 years and 42.90% of them were 65 years and above. There were 2 217 cases of severe ADR reports, accounting for 13.03% (2 217/17 015). A total of 18 SOCs were involved, the top 3 were skin and subcutaneous tissue diseases, systemic diseases and drug administration site reactions, and neurological diseases. A total of 54 PTs were not recorded in the instructions, among which 34 were severe. Ninety-three cases about coagulation disorders/bleeding (98 times) were reported, the top 3 PTs were hematuria [24.49% (24/98)], purpura [11.22% (11/98)], and epistaxis [10.20% (10/98)]. Seven dosage forms of Xuesaitong preparations were involved, the top 3 were Xuesaitong for injection (freeze-dried) (48 cases, accounting for 51.61%), Xuesaitong injection (29 cases, accounting for 31.18%), and Xuesaitong tablets (8 cases, accounting for 8.60%). Among 93 reports of coagulation disorders/bleeding, there were 23 severe cases, accounting for 24.73%, which was significantly higher than that in other reports (12.97%), and the difference was statistically significant ( P<0.001). Sixteen PTs about coagulation disorders/bleeding were not recorded in the instructions, among which 9 were severe. The proportion of cases with onset time longer than 7 days in ADRs about coagulation disorders/bleeding was higher than that in other ADRs [22.58%(21/93) vs. 7.43%(1 258/16 922), P<0.001]. The risk signals of coagulation disorders/bleeding were mined for Xuesaitong for injection (freeze-dried), Xuesaitong injection, Xuesaitong tablets, and Xuesaitong capsules, and the risk signal density of Xuesaitong tablets was the strongest. Conclusions:The ADRs of Xuesaitong preparations involve multiple systems and organs. Among them, Xuesaitong for injection (freeze-dried), Xuesaitong injection, Xuesaitong tablets, and Xuesaitong capsules have a strong association with coagulation disorders/bleeding risks, and the proportion of severe cases is relatively high. However, the relevant risk warning information is not included in the drug instructions of some manufacturers. Medication monitoring needs to be strengthened and timely intervention should be carried out in clinic.

Objective To evaluate the effect of oral tramadol controlled release tablets premedication on the efficacy of anesthesia with target-controlled infusion (TCI)of propofol and remifentanil for painless colonoscopy in elderly patients.Methods Sixty ASA Ⅰ or Ⅱ patients,aged≥ 65 yr,undergoing painless colonoscopy,were randomly divided into 2 groups ( n =30 each): control group (group C) and tramadol group(group T).In group T tramadol controlled-release tablet 100 mg was administered orally at 2 h before operation.Anesthesia was induced and maintained with TCI of propofol and remifentanil.SP,DP,HR and SpO2 were recorded before induction,at the time to reach the ileocecal valve and at the end of operation.The induction time,duration of operation,emergence time,recovery time,adverse events and the amount of propofol and remifentanil consumed were recorded.Results There was no significant difference in hemodynamics parameters,induction time,duration of operation,emergence time,recovery time,adverse events and the amount of propofol and remifentanil consumed between the two groups (P ＞ 0.05 ).Conclusion Oral tramadol controlled release tablets 100 mg premedication can be safely used in painless colonoscopy in elderly patients,however,tramadol can not enhance the efficacy of anesthesia with TCI of propofol and remifentanil.

Objective To compare the effects of different anesthesia on immunologic function during perioperative radical mastectomy in patients having undergone preoperative chemotherapy. Methods Sixty ASA Ⅰ or Ⅱ patients, aged 28-64 yr, weighing 55-70 kg, scheduled for radical mastectomy, were studied. Thirty patients received preoperative chemical therapy for 3-4 weeks were randomly divided into CP group and CS group ( n = 15 each); thirty patients received no chemical therapy were also randomly divided into NCP group and NCS group (n=15 each).Propofol at a rate of 4-6 mg·kg-1·h-1 was infused in group CP and CS and sevoflurane with the end-tidal concentration of 1.5%-2.5% inhaled in group NPC and NCS to maintain anesthesia. Peripheral venous blood samples were taken before chemical therapy, before anesthesia, immediately after operation and at 72 h after operation for determination of the levels of T lymphocyte subsets and NK cells and plasma CK19 mRNA expression (by RT-PCR). CD4+/CD8+ ratio and the micrometastatic rate of the tumor cells were calculated. Results The CD3+ , CD8+ and NK cell level were significantly lower before anesthesia, immediately after operation and at 72 h after operation than before chemical therapy ( P < 0.05). The CD8+ immediately after operation and NK cell level at 72 h after operation in group CP, and CD4+ and NK cell levels immediately and at 72 h after operation in group CS were significantly lower than those before anesthesia ( P < 0.05). CD4+ and NK cell levels immediately and at 72 h after operation were significantly lower in group CS than in group CP, and in group NCS than in group NCP (P < 0.05). The CD4+/CD8+ ratio was significantly lower immediately after operation in group CS than in group CP ( P < 0.05) .There was no significant difference in the micrometastatic rate of the tumor cells among all groups (P > 0.05). Conclusion Sevoflurane combined anesthesia has a stronger inhibitory effect on immunologic function in radical mastectomy patients with preoperative chemotherapy than propofol combined anesthesia.