Evaluation Of Efficacy And Safety Of Xuebijing Injection In The Treatment Of Sepsis

Objective:In this study,the functional modules of the evaluation scheme of Chinese Hospital Pharmacovigilance System(CHPS)were applied to obtain the real world data of the subjects that met the inclusion criteria of this study.The real world data were analyzed to evaluate the efficacy and safety of Xuebijing in the treatment of sepsis in the real world,so as to provide Xuebijing can become the first-line drug for the treatment of sepsis patients,and provides a paradigm for the academic research on TCM injection and other drugs in the real world.Methods:The inclusion criteria of this study were established by using the functional modules of the evaluation scheme of Chinese Hospital Pharmacovigilance System(CHPS).Electronic diagnosis and treatment data of 133 inpatients in a grade A hospital in Guangzhou who met the diagnostic criteria and inclusion criteria of this study from January 2018 to June 2019 were collected.Patients were divided into Xuebijing group and routine group according to drug use by case-control analysis.Among them,the changes of general indicators,organ function indicators and coagulation function results before and after medication were used as efficacy evaluation indexes,and the incidence of adverse reactions and deterioration rate of clinical indicators were used as safety evaluation indexes.Statistical software SPSS26.0 was used for statistical analysis of the data,and the baseline data of the two groups were described and compared.χ~2test(expressed as%)was used for counting data,and T test(expressed as x±s)was used for measurement data.P<0.05 was considered to be statistically significant.Results:1.Comparison between the two groups before grouping.There was no statistical significance in the distribution between Xuebijing group and routine group(P>0.05);there were no significant differences in vital signs before medication between two groups(P>0.05).Data comparison of important test items before medication in two groups had no statistical significance.2.Comparison of prognosis effect between the two groups.(1)Among 133 patients with sepsis,there were 33 cases of complications,3.including 14 cases in the Xuebijing group and 19 cases in the routine group.Chi-square test showed no significant difference in the occurrence of complications between the two groups(P>0.05),but the proportion of complications in the Xuebijing group was slightly lower than that in the routine group.(2)The average length of hospital stay in Xuebijing group was 12 days less than that in the routine group,and independent sample T test showed that the difference in hospital stay between the two groups was statistically significant(P<0.01).(3)In the Xuebijing group and the routine group,the in-hospital mortality was 3%and 6.02%,and the automatic discharge rate was 19.55%and 36.09%,respectively.Chi-square test showed that the clinical outcomes of the two groups were significantly different(χ~2=8.87,P<0.01),and the prognosis of Xuebijing group was significantly better than that of the routine group(χ~2=8.86,P<0.01).4.Changes in observation indexes of patients in the two groups(1)Respiratory function indexes and general inflammatory indexes:CRP and Lac in the routine group were lower than those at admission after3 days and 7 days of routine treatment,and PCT was also lower than that at admission after 7 days of routine treatment,with statistical significance(P<0.05).PCT in Xuebijing group decreased after treatment for 3d and 7d(2)compared with before treatment,and the difference was statistically significant(P<0.01).There were no significant differences in respiratory function indexes and general inflammatory indexes between the Xuebijing group and the routine group at 3d and 7d,but the test values of other indicators in the Xuebijing group were lower than those in the routine group,except that the test values of PA-a DO2 were higher at 7d,which were within the normal reference value range or closer to the normal reference value.(3)Changes in coagulation indexes:TT of two groups before and after treatment was within the normal range,the difference was statistically significant(P<0.05).In the comparison of PT and APTT in the two groups of patients treated for 3d and 7d,the indexes of PT and APTT in Xuebijing group were improved more significantly than those in the routine group(P<0.05),and the coagulation indexes of routine group did not return to normal after 7d of APTT treatment.The Fib of both groups did not return to normal after 7 days of treatment,but the Fib index of Xuebijing group was slightly higher than the normal reference value.(4)Changes in organ function indexes:CK-MB in the routine group decreased after 7 days of routine treatment compared with admission,with statistical significance(P<0.05);After 7 days of treatment,CR and(5)CK-MB in Xuebijing group decreased compared with those before treatment,and the difference was statistically significant(P<0.01).After 7 days of treatment,the changes of BUN and CR levels in Xuebijing group were lower than those in routine group,the differences were statistically significant(P<0.05),indicating that the improvement of liver function indexes in Xuebijing group was more significant.There was no significant difference in other indexes between the Xuebijing group and the conventional group at the same time after 3 days and 7 days of treatment,but compared with the routine group,the index test values of the Xuebijing group were more within or close to the normal reference value.4.Adverse reactions:A total of 26 cases of adverse reactions occurred in the two groups of sepsis patients during the study period,and 13 cases occurred in the conventional treatment group,with an incidence of 17.57%.There were 13 cases of adr in Xuebijing group,and the incidence of adr was 22.03%.5.Comparison of abnormal rates of laboratory indicators:Chi-square test was used to calculate the comparison of abnormal values of laboratory test indexes between Xuebijing group and routinet group after 7 days of treatment.The results showed that the abnormal rate of APPT in Xuebijing group was significantly lower than routinet group(P<0.05),and there was no significant difference in the abnormal values of other important safety indexes(P>0.05).Conclusion:1.Efficacy evaluation:On the basis of routine treatment,Xuebijing injection in the treatment of patients with sepsis,can better to suppress the inflammatory reaction,improve the function of the body’s blood coagulation state and reduce the injury of heart,kidney and other major organs function,and there is important clinical value to improve the prognosis of patients with sepsis.2.Safety evaluation.:Compared with the conventional treatment group,the incidence of xuebijing group was higher,but the abnormal rate of important safety indicators in xuebijing group was lower than that in the conventional treatment group or had no significant difference with the conventional treatment group.Therefore,the monitoring of Xuebijing injection should be strengthened in clinical application to reduce or avoid the recurrence of adverse reactions and ensure drug safety.