1.Evaluation of CARIFS Score and Negative Antigen Conversion Rate of Qingxuan Daozhi Formula in Treatment of Influenza in Children (Heat Accumulation in Lung and Stomach Syndrome):A Multi-center Randomized Controlled Clinical Study
Jing WANG ; Liqun WU ; Tiegang LIU ; Yongning CAO ; Jing QIU ; Jing LI ; Huaqing TAN ; Ying ZHANG ; Xulei GOU ; Jia WANG ; Jing LI ; Haipeng CHEN ; Xueying QIN ; Yuanshuo TIAN ; Yang WANG ; Chen BAI ; Zhendong WANG ; Qianqian LI ; He YU ; Xueyan MA ; Fei DONG ; Lin JIANG ; Yingqi XU ; Jianping LIU ; Xiaohong GU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(13):188-196
ObjectiveThis paper aims to observe the syndrome improvement and negative antigen conversion rate of Qingxuan Daozhi formula in the treatment of influenza in children (heat accumulation in the lung and stomach syndrome). MethodsThrough a multi-center randomized controlled methodology design,confirmed influenza cases were collected from October 2022 to April 2023 in the pediatrics department of eight hospitals,such as Dongfang Hospital of Beijing University of Chinese Medicine. A total of 180 children with influenza and heat accumulation in the lung and stomach syndrome conforming to the standard were recruited through the clinic. The sick children meeting the inclusion criteria were randomly divided into groups by a block-randomized method. The children in the experimental group were treated with Qingxuan Daozhi formula for five days,and those in the control group were treated with Oseltamivir Phosphate Granules for five days. The primary efficacy indicator was the negative conversion rate of influenza antigen detection. Secondary efficacy indicators were the Canadian acute respiratory illness and flu scale (CARIFS) and the incidence of complications,severe cases, and critical cases. Follow-up observation was conducted on the day of enrollment,48 hours after medication,72 hours after medication, and (6+1) d after medication. ResultsOne hundred and eighty participants were randomly assigned to the experimental group (90 cases) or the control group (90 cases). All participants were followed up during the study. Comparison of influenza antigen detection results in the primary efficacy indicators showed that the average time of negative influenza antigen conversion in the experimental group was (5.29±1.25) d,and that in the control group was (5.40±1.68) d,without a statistically significant difference. After five days of intervention,52 cases in the experimental group and 51 cases in the control group converted to negative,without a statistically significant difference. CARIFS score results in the secondary efficacy indicators showed that during 72 hours after intervention,there were statistically significant differences between the experimental group and the control group in three dimensions, including headache,muscle soreness, and the need for extra care (P<0.05). On the (6+1) days after the intervention,the differences in both the experimental group and the control group were statistically significant in 10 dimensions, including sore throat,bad sleep,uncomfortable feeling,poor spirit and fatigue,crying more than usual,the need for extra care,symptom,function,influence on parents,and total score (P<0.05). The comparison results within the group in the dimensional scores of symptom, function, and influence on parents,as well as the CARIFS total score showed that with the delay of follow-up time,scores of both groups decreased significantly,with a statistically significant difference (P<0.01). Inter-group comparison results showed that the mean score of the experimental group was higher than that of the control group at the time of enrollment. With the progress of intervention,the score of the experimental group was significantly decreased compared with that of the control group. At the end of follow-up,the mean score of the experimental group was lower than that of the control group,with no statistically significant difference. In terms of the incidence of complications,severe cases, and critical cases, there were no complications,severe cases, and critical cases in the two groups,without a statistically significant difference. ConclusionThe symptom improvement effect and negative antigen conversion rate of Qingxuan Daozhi formula in the treatment of influenza in children (heat accumulation in the lung and stomach syndrome) are not inferior to Oseltamivir Phosphate granules, and children's acceptance is better. It can be more widely used in clinical treatment of influenza in children (heat accumulation in the lung and stomach syndrome).
2.LIU Zhibin's experience in treatment of subjective tinnitus with acupuncture based on the "kidney-bone-brain" axis.
Yunru WU ; Zhibin LIU ; Weixing FENG ; Weigang WANG ; Enzhao FAN ; Yanbin YAN
Chinese Acupuncture & Moxibustion 2025;45(6):808-812
This paper introduces Professor LIU Zhibin 's clinical experience in the treatment of subjective tinnitus with acupuncture based on the "kidney-bone-brain" axis. Professor LIU proposes that the disease is most closely related to the kidney and brain. The lesion is located in the brain, and the pathogenesis is kidney essence deficiency, marrow sea loss, and ear orifice dystrophy. The "kidney-bone-brain" shows close correlation in physiological function, pathological changes and treatment. According to the "kidney-bone-brain" axis, Professor LIU proposes that the treatment of subjective tinnitus should be tonifying kidney qi, tonifying essence and filling marrow, and the principle of local acupoint selection, touching bone acupuncture, matching distal acupoints and proximal acupoints, tonifying kidney and benefiting brain should be adopted. The acupoints of Tinggong (SI19) and Yifeng (TE17) are selected to be treated with touching bone acupuncture, combined with Taixi (KI3), Shenshu (BL23), Baihui (GV20) and Shenting (GV24), so as to achieve common benefit of kidney, bone and brain, and multi-angle treatment.
Humans
;
Acupuncture Therapy/history*
;
Tinnitus/physiopathology*
;
Acupuncture Points
;
Kidney/physiopathology*
;
Brain/physiopathology*
;
Bone and Bones/physiopathology*
;
Female
;
Male
;
Adult
;
Middle Aged
3.Practice of establishing a"6+1"homogenization management system for outpatient services:a case study of a tertiary general hospital in Guangdong province
Xuan ZHONG ; Xiaowen MAI ; Minyi WANG ; Zhimin HE ; Qichang WU ; Simiao WANG ; Hao WANG ; Xun ZENG ; Ming ZHAO ; Dayue LIU
Modern Hospital 2025;25(4):534-536,540
This study aims to innovate a homogeneous outpatient service management system across multiple hospital campuses to enhance service quality.Based on the practical experience of a tertiary general hospital in Guangdong Province and in accordance with the"Interim Regulations on Outpatient Quality Management in Healthcare Institutions,"we constructed a"6+1"homogeneous outpatient service management system.This system includes:① a multi-stakeholder co-governance outpa-tient management system,②a vertical and cross-hierarchical management network,③ a democratic-centralized clinical coordina-tion strategy,④ a guidance-encouragement performance evaluation standard,⑤a collaborative dynamic supervision mechanism,⑥a spiral retrospective evaluation and improvement method,and ⑦ an integrated outpatient diagnosis and treatment system.Af-ter over two years of implementation,the hospital's outpatient volume has grown by an average of over 15%annually,patient waiting time after appointment has been reduced to 20 minutes,and patient satisfaction in the tertiary public hospital performance evaluation achieved full marks.The electronic medical record system functionality reached Level 6,significantly improving healthcare service efficiency and quality while enhancing homogeneous management across campuses.
4.Practice of establishing a"6+1"homogenization management system for outpatient services:a case study of a tertiary general hospital in Guangdong province
Xuan ZHONG ; Xiaowen MAI ; Minyi WANG ; Zhimin HE ; Qichang WU ; Simiao WANG ; Hao WANG ; Xun ZENG ; Ming ZHAO ; Dayue LIU
Modern Hospital 2025;25(4):534-536,540
This study aims to innovate a homogeneous outpatient service management system across multiple hospital campuses to enhance service quality.Based on the practical experience of a tertiary general hospital in Guangdong Province and in accordance with the"Interim Regulations on Outpatient Quality Management in Healthcare Institutions,"we constructed a"6+1"homogeneous outpatient service management system.This system includes:① a multi-stakeholder co-governance outpa-tient management system,②a vertical and cross-hierarchical management network,③ a democratic-centralized clinical coordina-tion strategy,④ a guidance-encouragement performance evaluation standard,⑤a collaborative dynamic supervision mechanism,⑥a spiral retrospective evaluation and improvement method,and ⑦ an integrated outpatient diagnosis and treatment system.Af-ter over two years of implementation,the hospital's outpatient volume has grown by an average of over 15%annually,patient waiting time after appointment has been reduced to 20 minutes,and patient satisfaction in the tertiary public hospital performance evaluation achieved full marks.The electronic medical record system functionality reached Level 6,significantly improving healthcare service efficiency and quality while enhancing homogeneous management across campuses.
5.Effect of electroacupuncture combined with low-frequency transcranial ultrasound stimulation on the electroencephalographic signals of rats with traumatic brain injury
Simiao GAO ; Xue HAN ; Xiaoguang WU ; Jinyu ZHENG ; Fangwen GAO ; Kuihua LI ; Yong PENG ; Lanxiang LIU
Chinese Journal of Tissue Engineering Research 2025;29(2):402-408
BACKGROUND:Traumatic brain injury is a condition in which the normal function of the brain is disrupted by a bump or impact to the head.It is necessary to find effective treatments and objective targets that can help doctors diagnose the injury status and restore the brain function of patients. OBJECTIVE:To explore the effect of electroacupuncture combined with low-frequency transcranial ultrasound stimulation on the electroencephalographic signals of rats with traumatic brain injury. METHODS:Forty 6-week-old SPF male Sprague-Dawley rats were randomly divided into five groups:sham group,model group,electroacupuncture group,low-frequency transcranial ultrasound stimulation group and combined group(electroacupuncture+low-frequency transcranial ultrasound stimulation),with eight rats in each group.Feeney weight-drop method was used to establish the animal model of traumatic brain injury.In the sham group,the bone window was only opened without impact.Interventions were started at 1 day after modeling.Electroacupuncture in the electroacupuncture group,low-frequency transcranial ultrasound stimulation in the low-frequency transcranial ultrasound stimulation group,and electroacupuncture+low-frequency transcranial ultrasound stimulation in the combined group were performed for days in total.The modified neurological severity scale score for assessing rats'neurological deficits was performed at 8 hours after modeling.The percentage of spontaneous alternation behavior in the Y-maze was measured at 7 days after modeling.Then,the electroencephalographic signals were collected and electroencephalographic data of α,β,θ,and δ waves were extracted by fast Fourier transform,and the value of oscillation amplitude and energy ratio were calculated in α,β,θ,and δ waves,as well as the Lempel-Ziv complexity and sample entropy. RESULTS AND CONCLUSION:Compared with the sham group,the modified neurological severity scale scores in the model group,electroacupuncture group,low-frequency transcranial ultrasound stimulation group and combined group were significantly increased at 8 hours after modeling(P<0.05).Compared with the sham group,the value of oscillation amplitude in δ wave and the value of δ energy ratio were significantly increased in the model group at 7 days after modeling,meanwhile the percentage of spontaneous alternation behavior in Y-maze,and the value of α/β energy ratio,Lempel-Ziv complexity,and sample entropy were significantly decreased(P<0.05).Compared with the model group,the value of oscillation amplitude in α and δ waves was significantly decreased in the combined group(P<0.05),while the value of α/β energy ratio was significantly increased(P<0.05)and the value of δ energy ratio was significantly decreased(P<0.05)in the electroacupuncture group,low-frequency transcranial ultrasound stimulation group and combined group.Compared with the electroacupuncture group and low-frequency transcranial ultrasound stimulation group,the value of δ energy ratio was significantly decreased in the combined group(P<0.05),while the percentage of spontaneous alternation behavior,the value of α/β energy ratio,the Lempel-Ziv complexity,and the sample entropy were significantly increased(P<0.05).To conclude,abnormal electroencephalographic signals can appear in rats with traumatic brain injury,while the electroacupuncture combined with low-frequency transcranial ultrasound stimulation can alleviate the abnormal electroencephalographic signals in rats,which suggests the electroencephalographic frequency domain value and nonlinear features can be used to assess the severity of traumatic brain injury.
6.Clinical course, causes of worsening, and outcomes of severe ischemic stroke: A prospective multicenter cohort study.
Simiao WU ; Yanan WANG ; Ruozhen YUAN ; Meng LIU ; Xing HUA ; Linrui HUANG ; Fuqiang GUO ; Dongdong YANG ; Zuoxiao LI ; Bihua WU ; Chun WANG ; Jingfeng DUAN ; Tianjin LING ; Hao ZHANG ; Shihong ZHANG ; Bo WU ; Cairong ZHU ; Craig S ANDERSON ; Ming LIU
Chinese Medical Journal 2025;138(13):1578-1586
BACKGROUND:
Severe stroke has high rates of mortality and morbidity. This study aimed to investigate the clinical course, causes of worsening, and outcomes of severe ischemic stroke.
METHODS:
This prospective, multicenter cohort study enrolled adult patients admitted ≤30 days after ischemic stroke from nine hospitals in China between September 2017 and December 2019. Severe stroke was defined as a score of ≥15 on the National Institutes of Health Stroke Scale (NIHSS). Clinical worsening was defined as an increase of 4 in the NIHSS score from baseline. Unfavorable functional outcome was defined as a modified Rankin scale score ≥3 at 3 months and 1 year after stroke onset, respectively. We performed Logistic regression to explore baseline features and reperfusion therapies associated with clinical worsening and functional outcomes.
RESULTS:
Among 4201 patients enrolled, 854 patients (20.33%) had severe stroke on admission. Of 3347 patients without severe stroke on admission, 142 (4.24%) patients developed severe stroke in hospital. Of 854 patients with severe stroke on admission, 33.95% (290/854) experienced clinical worsening (median time from stroke onset: 43 h, Q1-Q3: 20-88 h), with brain edema (54.83% [159/290]) as the leading cause; 24.59% (210/854) of these patients died by 30 days, and 81.47% (677/831) and 78.44% (633/807) had unfavorable functional outcomes at 3 months and 1 year respectively. Reperfusion reduced the risk of worsening (adjusted odds ratio [OR]: 0.24, 95% confidence interval [CI]: 0.12-0.49, P <0.01), 30-day death (adjusted OR: 0.22, 95% CI: 0.11-0.41, P <0.01), and unfavorable functional outcomes at 3 months (adjusted OR: 0.24, 95% CI: 0.08-0.68, P <0.01) and 1 year (adjusted OR: 0.17, 95% CI: 0.06-0.50, P <0.01).
CONCLUSIONS:
Approximately one-fifth of patients with ischemic stroke had severe neurological deficits on admission. Clinical worsening mainly occurred in the first 3 to 4 days after stroke onset, with brain edema as the leading cause of worsening. Reperfusion reduced the risk of clinical worsening and improved functional outcomes.
REGISTRATION
ClinicalTrials.gov , NCT03222024.
Humans
;
Male
;
Female
;
Prospective Studies
;
Ischemic Stroke/mortality*
;
Aged
;
Middle Aged
;
Aged, 80 and over
;
Stroke
;
Brain Ischemia
7.Added value of 99Tc m-HYNIC-TOC SPECT/CT in the diagnosis and treatment of gastroenteropancreatic neuroendocrine tumors
Shuxin LIU ; Xinyu WU ; Bo LI ; Minmin TANG ; Simiao LIU ; Yuhang XUE ; Zichen DI ; Feifei HE ; Junling XU ; Yongju GAO
Chinese Journal of Nuclear Medicine and Molecular Imaging 2025;45(1):13-18
Objective:To investigate the additional value of 99Tc m-hydrazinonicotinamide (HYNIC)-Tyr3-octreotide (TOC) SPECT/CT imaging in the diagnosis and treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Methods:A total of 54 patients (28 males and 26 females, age: (52.6±11.7) years) who underwent enhanced CT (MR) and 99Tc m-HYNIC-TOC SPECT/CT in People′s Hospital of Zhengzhou University between December 2017 and June 2023 were analyzed retrospectively. Surgical pathology or biopsy was the gold standard of patients′ diagnosis (primary tumors), and comprehensive evaluation based on pathology, imaging and follow-up results was used as the diagnostic criteria of lesions. McNemar χ2 test was used to compare the diagnostic efficacy of different imaging methods. Results:Pathological results showed that 43 of the 54 patients were with GEP-NETs and 11 were with non-neuroendocrine tumors (NETs). The sensitivities of enhanced CT and enhanced MR in the diagnosis of patients with GEP-NETs were 65.1%(28/43) and 60.0%(15/25) respectively, which increased to 93.0%(40/43) and 92.0%(23/25) with the addition of 99Tc m-HYNIC-TOC imaging ( χ2 values: 8.64, 4.90, P values: 0.002, 0.021). There were 22 and 15 patients showing atypical enhancement on enhanced CT and enhanced MR respectively. The sensitivities of these two methods for GEP-NETs in patients with atypical enhancement were 54.5%(12/22) and 8/15 respectively, which increased to 95.5%(21/22) and 14/15 with the addition of 99Tc m-HYNIC-TOC imaging ( χ2 values: 5.82, 4.17, P values: 0.012, 0.031). Compared with enhanced CT, the detection rates of liver and bone metastatic lesions were improved significantly from 90.8%(158/174) and 55.2%(32/58) to 96.6%(168/174) and 87.9%(51/58) with the addition of 99Tc m-HYNIC-TOC imaging ( χ2 values: 5.79, 9.82, P values: 0.013, 0.001). Compared with enhanced MR, the detection rate of bone metastases was improved significantly from 56.0%(14/25) to 88.0%(22/25) with the addition of 99Tc m-HYNIC-TOC imaging ( χ2=4.08, P=0.039). After 99Tc m-HYNIC-TOC imaging, stages were changed in 7.0%(3/43) of patients and a greater number or extent of metastases were detected in 11.6%(5/43) of patients. 99Tc m-HYNIC-TOC imaging detected additional recurrent or metastatic lesions in 40.0%(8/20) of patients during follow-up compared to enhanced CT. Conclusion:99Tc m-HYNIC-TOC imaging can provide an added value for diagnosing GEP-NETs with atypically enhanced CT(MR), and in the detection of liver metastasis and early bone metastasis, thus helping the optimization of clinical treatment strategies.
8.Added value of 99Tc m-HYNIC-TOC SPECT/CT in the diagnosis and treatment of gastroenteropancreatic neuroendocrine tumors
Shuxin LIU ; Xinyu WU ; Bo LI ; Minmin TANG ; Simiao LIU ; Yuhang XUE ; Zichen DI ; Feifei HE ; Junling XU ; Yongju GAO
Chinese Journal of Nuclear Medicine and Molecular Imaging 2025;45(1):13-18
Objective:To investigate the additional value of 99Tc m-hydrazinonicotinamide (HYNIC)-Tyr3-octreotide (TOC) SPECT/CT imaging in the diagnosis and treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Methods:A total of 54 patients (28 males and 26 females, age: (52.6±11.7) years) who underwent enhanced CT (MR) and 99Tc m-HYNIC-TOC SPECT/CT in People′s Hospital of Zhengzhou University between December 2017 and June 2023 were analyzed retrospectively. Surgical pathology or biopsy was the gold standard of patients′ diagnosis (primary tumors), and comprehensive evaluation based on pathology, imaging and follow-up results was used as the diagnostic criteria of lesions. McNemar χ2 test was used to compare the diagnostic efficacy of different imaging methods. Results:Pathological results showed that 43 of the 54 patients were with GEP-NETs and 11 were with non-neuroendocrine tumors (NETs). The sensitivities of enhanced CT and enhanced MR in the diagnosis of patients with GEP-NETs were 65.1%(28/43) and 60.0%(15/25) respectively, which increased to 93.0%(40/43) and 92.0%(23/25) with the addition of 99Tc m-HYNIC-TOC imaging ( χ2 values: 8.64, 4.90, P values: 0.002, 0.021). There were 22 and 15 patients showing atypical enhancement on enhanced CT and enhanced MR respectively. The sensitivities of these two methods for GEP-NETs in patients with atypical enhancement were 54.5%(12/22) and 8/15 respectively, which increased to 95.5%(21/22) and 14/15 with the addition of 99Tc m-HYNIC-TOC imaging ( χ2 values: 5.82, 4.17, P values: 0.012, 0.031). Compared with enhanced CT, the detection rates of liver and bone metastatic lesions were improved significantly from 90.8%(158/174) and 55.2%(32/58) to 96.6%(168/174) and 87.9%(51/58) with the addition of 99Tc m-HYNIC-TOC imaging ( χ2 values: 5.79, 9.82, P values: 0.013, 0.001). Compared with enhanced MR, the detection rate of bone metastases was improved significantly from 56.0%(14/25) to 88.0%(22/25) with the addition of 99Tc m-HYNIC-TOC imaging ( χ2=4.08, P=0.039). After 99Tc m-HYNIC-TOC imaging, stages were changed in 7.0%(3/43) of patients and a greater number or extent of metastases were detected in 11.6%(5/43) of patients. 99Tc m-HYNIC-TOC imaging detected additional recurrent or metastatic lesions in 40.0%(8/20) of patients during follow-up compared to enhanced CT. Conclusion:99Tc m-HYNIC-TOC imaging can provide an added value for diagnosing GEP-NETs with atypically enhanced CT(MR), and in the detection of liver metastasis and early bone metastasis, thus helping the optimization of clinical treatment strategies.
9.Effects of Shengmai Decoction on postoperative recovery and the anxiety and depression in breast cancer patients
Huilong REN ; Yukun WANG ; Simiao YAO ; Kai XU ; Guokai LIU ; Chao DING
Cancer Research and Clinic 2025;37(5):366-370
Objective:To investigate the effects of Shengmai Decoction on postoperative recovery and the anxiety and depression in breast cancer patients after surgery.Methods:A prospective randomized controlled study was conducted. A total of 60 patients with breast cancer after operation in Dongzhimen Hospital, Beijing University of Chinese Medicine from October 2023 to July 2024 were selected, and all patients were divided into the Shengmai Decoction group and the control group according to the random number table method with 30 cases in each group. The Shengmai Decoction group was given the Shengmai Decoction 3 times per day (10 ml each time before meals) with continuous treatment for 7 d, and the patients in the control group drank 10 ml of water at the same time point. The scores of 40-item quality of recovery (QoR-40), traditional Chinese medicine syndrome, Pittsburgh sleep quality index (PSQI), self-rating anxiety scale (SAS), self-rating depression scale (SDS) before treatment and 7 d after treatment were compared and adverse reactions of the 2 groups were recorded.Results:All patients were female. In the Shengmai Decoction group, 17 patients (56.7%) underwent modified radical mastectomy and 13 patients (43.3%) underwent breast-conserving surgery with the age of (48±12) years; in the control group, 16 patients (53.3%) underwent modified radical mastectomy and 14 patients (46.7%) underwent breast-conserving surgery with the age of (51±12) years. There were no statistically significant differences in age, body mass index, surgery type, menopause, operation time, intraoperative blood loss and between the 2 groups (all P > 0.05). The difference in QoR-40 score before treatment between the 2 groups was not statistically significant ( P > 0.05). The emotional state score [(41.0±1.8) points vs. (38.0±2.7) points], psychological support score [(32.6±1.4) points vs. (30.3±1.5) points], and total score [(178.7±3.4) points vs. (170.1±3.9) points] of QoR-40 score in the Shengmai Decoction group were higher than those in the control group 7 d after treatment, and the differences were statistically significant ( t value was 5.21, 6.01, 9.04, all P < 0.05). The differences in the scores of traditional Chinese medicine syndrome, PSQI, SAS and SDS of both groups before treatment were not statistically significant (all P > 0.05). The scores of traditional Chinese medicine syndrome, PSQI, SAS and SDS of both groups 7 d after treatment were decreased compared with those before treatment, and the scores in the Shengmai Decoction group were lower than those in the control group, and the differences were statistically significant (all P < 0.05). The incidence of adverse reactions was 15.0% (2/30) and 10.0% (3/30) in the Shengmai Decoction group and the control group, respectively, and the difference was not statistically significant ( P > 0.05). Conclusions:Shengmai Decoction can enhance the postoperative sleep quality, improve anxiety and depression as well as the quality of postoperative recovery in patients with breast cancer.
10.Analysis of 408 cases of tigecycline-related adverse reactions
Xiao LIU ; Jingyu LIN ; Simiao ZHAO ; Bo ZHENG ; Ying ZHOU
Adverse Drug Reactions Journal 2025;27(11):674-680
Objective:To analyze the clinical characteristics of tigecycline-related adverse reactions and provide the basis for the safe and rational use of the drug.Methods:Adverse reaction reports with suspected drug as tigecycline from Beijing Adverse Drug Reaction Monitoring Center from January 1st, 2019 to June 30th, 2024 were collected. The adverse reaction reports were standardized using the preferred term (PT) and system organ class (SOC) in the Chinese updated edition (2015 version) of the World Health Organization Adverse Reaction Terminology. The patients' general condition, tigecycline use, and adverse reaction occurrence (including latency, severity, treatment, outcome, and correlation evaluation) were descriptively and statistically analyzed. Results:A total of 408 tigecycline-related adverse reaction reports were entered, including 153 females (37.5%) and 255 males (62.5%). The age was (68±21) years, ranging from 2 to 99. The main reasons for tigecycline use were infections of lung, blood flow, skin and skin soft tissue, etc. The pathogens were mainly Klebsiella pneumoniae, Acinetobacter baumanii, Escherichia coli, etc. The usage and dosage of tigecycline in most patients were in line with the instructions. Four hundred and eight adverse event reports involved 11 SOCs and 580 PTs. The top 3 SOCs were gastrointestinal diseases (195 case times, 33.62%), vascular, bleeding and coagulation diseases (183 case times, 31.55%), and hepatobiliary diseases (142 case times, 24.48%). The main clinical manifestations were nausea, vomiting, diarrhea, etc. The main laboratory abnormalities were decreased plasma fibrinogen, decreased platelet count, increased alanine aminotransferase, increased aspartate aminotransferase, and increased bilirubin. There were 27 case times of adverse reactions that were not recorded in the instructions, mainly including leukopenia, abdominal distension, fever, dysbacteriosis, etc. The latency of adverse reactions ranged from 5 min to 65 days, with a median time of 5 days. The grade of adverse reactions was general in 379 patients (92.89%) and severe in 29 patients (7.11%). The top 3 SOCs involved in 53 case times of severe adverse reactions were hepatobiliary diseases (30 case times, 56.60%), vascular, bleeding and coagulation diseases (8 case times, 15.09%), and urinary tract diseases (4 case times, 7.55%), the main clinical manifestations were elevated liver enzymes, coagulation disorders, pancreatitis, etc. After the occurrence of adverse reactions, all patients stopped tigecycline, and received symptomatic treatments such as liver protection, intravenous infusion of human fibrinogen, intravenous infusion of platelets, and antidiarrheal therapy. Among 408 patients, 66 (16.18%) were cured, 297 (72.79%) were improved, 20 (4.90%) were not improved, and 25 cases' outcome (6.13%) were unknown. The shortest time for recovery or improvement was 0.5 hour, the longest was 44 days, with a median time of 5 days. The correlation between tigecycline and adverse reactions was probable in 132 patients (32.35%), and possible in 276 patients (67.65%). Conclusions:Tigecycline-related adverse reactions involve multiple organ systems, mainly including gastrointestinal diseases, vascular, bleeding and coagulation diseases, and hepatobiliary diseases, etc. which can lead to severe adverse reactions such as acute pancreatitis and coagulation disorders. After drug withdrawal and symptomatic treatments, most patients had a good prognosis.

Result Analysis
Print
Save
E-mail