1.Guidelines for the management of therapeutic drug monitoring
Zhengxiang LI ; Liyan MIAO ; Rong DUAN ; Xiaocong ZUO ; Xianglin ZHANG ; Zhuo WANG ; Miao YAN ; Lingli ZHANG ; Rongsheng ZHAO ; Suodi ZHAI ; Guobiao GAO ; Jinhui TIAN
China Pharmacy 2026;37(11):1381-1392
OBJECTIVE To further standardize the technical operations and management processes throughout therapeutic drug monitoring (TDM), clarify the clinical value of TDM implementation, improve the scientific validity and reliability of monitoring results, and provide a solid reference basis for the formulation and optimization of clinical individualized precision dosing regimens. METHODS The Guidelines for the Management of Therapeutic Drug Monitoring were formulated in accordance with the latest definition of guidelines by the Institute of Medicine of the National Academies and the standard guideline development methodology of the World Health Organization, and in compliance with the requirements of the appraisal of guidelines for research and evaluation. A modified Delphi method was adopted to establish the research question system; evidence-based medicine research methods were applied to systematically search multiple databases to screen the latest and most comprehensive evidence. Evidence was graded and evaluated based on the evidence grading system of the Chinese Evidence-Based Medicine Center, and the grading criteria for recommendation strength from the Oxford Centre for Evidence-Based Medicine were used to determine the recommendation strength. The recommendation opinions were formed through multidisciplinary expert consensus. RESULTS The Guidelines for the Management of Therapeutic Drug Monitoring cover four core modules, including TDM application indications, technical procedures, result interpretation and clinical application, and quality control, involving 18 primary research questions, 34 secondary research questions, and yield 82 recommendations. CONCLUSIONS The guidelines systematically standardize the key technical links and management requirements of the whole TDM process, provide scientific and operable standardized tools, help improve the standardization level of TDM work, promote the translation of monitoring results into clinical decision-making, and provide strong support for precision personalized medicine and ensuring the safety and rationality of medication use.
2.Effect of anlotinib on immune function of second-line targeted drug-resistant advanced lung adenocarcinoma with epidermal growth factor receptor mutation
Guobiao YANG ; Feiyan YANG ; Congcong ZHANG
Chinese Journal of Postgraduates of Medicine 2025;48(6):555-558
Objective:To investigate the value of anlotinib combined with radiotherapy in second-line targeted drug-resistant advanced lung adenocarcinoma with epidermal growth factor receptor(EGFR) mutation.Methods:A total of 150 patients with advanced lung adenocarcinoma with EGFR mutation who were resistant to second-line targeted therapy and admitted to the Affiliated Hospital of Shaoxing University from July 2021 to July 2023 were prospectively selected as the study objects, and they were divided into the control group and the study group by random number table method, with 75 cases in each group. The control group received radiotherapy, and the study group received anrotinib combined radiotherapy. The recent clinical effects, tumor indexes, cellular immune indexes and the occurrence of adverse reactions were compared between the two groups.Results:After treatment, the objective response rate (ORR) and disease control rate (DCR) in the study group were higher than those in the control group: 53.33%(40/75) vs. 34.67%(26/75), 86.67%(65/75) vs. 64.00%(48/75), there were statistical differences ( χ2 = 5.30, 10.37, P<0.05). After treatment, the levels of VEGF, cytokeratin 21-1 fragment (CYFRA21-1) and carcinoembryonic antigen (CEA) in the study group were lower than those in the control group: (472.93 ± 45.71) ng/L vs. (510.26 ± 50.49) ng/L, (4.82 ± 1.13) μg/L vs. (5.25 ± 1.34) μg/L, (5.65 ± 1.24) μg/L vs. (6.17 ± 1.42) μg/L, there were statistical differences ( P<0.05). After treatment, the levels of CD 3+, CD 4+ and CD 4+/CD 8+ in the study group were higher than those in the control group, and the level of CD 8+ was lower than that in the control group: 0.532 ± 0.044 vs. 0.508 ± 0.041, 0.321 ± 0.030 vs. 0.305 ± 0.027, 1.02 ± 0.19 vs. 0.93 ± 0.16, 0.303 ± 0.040 vs. 0.320 ± 0.044, there were statistical differences ( P<0.05). There was no significant difference in the occurrence of adverse reactions between the two groups ( P>0.05). Conclusions:Anlotinib combined with radiotherapy can enhance the clinical efficacy of second-line targeted drug resistant advanced lung adenocarcinoma with EGFR mutation, improve tumor indexes, promote the recovery of immune function, without significantly increasing adverse reactions.
3.Effect of anlotinib on immune function of second-line targeted drug-resistant advanced lung adenocarcinoma with epidermal growth factor receptor mutation
Guobiao YANG ; Feiyan YANG ; Congcong ZHANG
Chinese Journal of Postgraduates of Medicine 2025;48(6):555-558
Objective:To investigate the value of anlotinib combined with radiotherapy in second-line targeted drug-resistant advanced lung adenocarcinoma with epidermal growth factor receptor(EGFR) mutation.Methods:A total of 150 patients with advanced lung adenocarcinoma with EGFR mutation who were resistant to second-line targeted therapy and admitted to the Affiliated Hospital of Shaoxing University from July 2021 to July 2023 were prospectively selected as the study objects, and they were divided into the control group and the study group by random number table method, with 75 cases in each group. The control group received radiotherapy, and the study group received anrotinib combined radiotherapy. The recent clinical effects, tumor indexes, cellular immune indexes and the occurrence of adverse reactions were compared between the two groups.Results:After treatment, the objective response rate (ORR) and disease control rate (DCR) in the study group were higher than those in the control group: 53.33%(40/75) vs. 34.67%(26/75), 86.67%(65/75) vs. 64.00%(48/75), there were statistical differences ( χ2 = 5.30, 10.37, P<0.05). After treatment, the levels of VEGF, cytokeratin 21-1 fragment (CYFRA21-1) and carcinoembryonic antigen (CEA) in the study group were lower than those in the control group: (472.93 ± 45.71) ng/L vs. (510.26 ± 50.49) ng/L, (4.82 ± 1.13) μg/L vs. (5.25 ± 1.34) μg/L, (5.65 ± 1.24) μg/L vs. (6.17 ± 1.42) μg/L, there were statistical differences ( P<0.05). After treatment, the levels of CD 3+, CD 4+ and CD 4+/CD 8+ in the study group were higher than those in the control group, and the level of CD 8+ was lower than that in the control group: 0.532 ± 0.044 vs. 0.508 ± 0.041, 0.321 ± 0.030 vs. 0.305 ± 0.027, 1.02 ± 0.19 vs. 0.93 ± 0.16, 0.303 ± 0.040 vs. 0.320 ± 0.044, there were statistical differences ( P<0.05). There was no significant difference in the occurrence of adverse reactions between the two groups ( P>0.05). Conclusions:Anlotinib combined with radiotherapy can enhance the clinical efficacy of second-line targeted drug resistant advanced lung adenocarcinoma with EGFR mutation, improve tumor indexes, promote the recovery of immune function, without significantly increasing adverse reactions.
4.Chinese expert consensus on the diagnosis and treatment of traumatic supraorbital fissure syndrome (version 2024)
Junyu WANG ; Hai JIN ; Danfeng ZHANG ; Rutong YU ; Mingkun YU ; Yijie MA ; Yue MA ; Ning WANG ; Chunhong WANG ; Chunhui WANG ; Qing WANG ; Xinyu WANG ; Xinjun WANG ; Hengli TIAN ; Xinhua TIAN ; Yijun BAO ; Hua FENG ; Wa DA ; Liquan LYU ; Haijun REN ; Jinfang LIU ; Guodong LIU ; Chunhui LIU ; Junwen GUAN ; Rongcai JIANG ; Yiming LI ; Lihong LI ; Zhenxing LI ; Jinglian LI ; Jun YANG ; Chaohua YANG ; Xiao BU ; Xuehai WU ; Li BIE ; Binghui QIU ; Yongming ZHANG ; Qingjiu ZHANG ; Bo ZHANG ; Xiangtong ZHANG ; Rongbin CHEN ; Chao LIN ; Hu JIN ; Weiming ZHENG ; Mingliang ZHAO ; Liang ZHAO ; Rong HU ; Jixin DUAN ; Jiemin YAO ; Hechun XIA ; Ye GU ; Tao QIAN ; Suokai QIAN ; Tao XU ; Guoyi GAO ; Xiaoping TANG ; Qibing HUANG ; Rong FU ; Jun KANG ; Guobiao LIANG ; Kaiwei HAN ; Zhenmin HAN ; Shuo HAN ; Jun PU ; Lijun HENG ; Junji WEI ; Lijun HOU
Chinese Journal of Trauma 2024;40(5):385-396
Traumatic supraorbital fissure syndrome (TSOFS) is a symptom complex caused by nerve entrapment in the supraorbital fissure after skull base trauma. If the compressed cranial nerve in the supraorbital fissure is not decompressed surgically, ptosis, diplopia and eye movement disorder may exist for a long time and seriously affect the patients′ quality of life. Since its overall incidence is not high, it is not familiarized with the majority of neurosurgeons and some TSOFS may be complicated with skull base vascular injury. If the supraorbital fissure surgery is performed without treatment of vascular injury, it may cause massive hemorrhage, and disability and even life-threatening in severe cases. At present, there is no consensus or guideline on the diagnosis and treatment of TSOFS that can be referred to both domestically and internationally. To improve the understanding of TSOFS among clinical physicians and establish standardized diagnosis and treatment plans, the Skull Base Trauma Group of the Neurorepair Professional Committee of the Chinese Medical Doctor Association, Neurotrauma Group of the Neurosurgery Branch of the Chinese Medical Association, Neurotrauma Group of the Traumatology Branch of the Chinese Medical Association, and Editorial Committee of Chinese Journal of Trauma organized relevant experts to formulate Chinese expert consensus on the diagnosis and treatment of traumatic supraorbital fissure syndrome ( version 2024) based on evidence of evidence-based medicine and clinical experience of diagnosis and treatment. This consensus puts forward 12 recommendations on the diagnosis, classification, treatment, efficacy evaluation and follow-up of TSOFS, aiming to provide references for neurosurgeons from hospitals of all levels to standardize the diagnosis and treatment of TSOFS.
5.Solitary renal duplication with misaligned malrotation of upper and lower moieties complicated by complete staghorn stones in the lower moiety: a case report
Hui ZHOU ; Shulian CHEN ; Guangjie LI ; Neng ZHANG ; Guobiao LIANG ; Xu LUO
Chinese Journal of Urology 2022;43(5):387-388
Solitary kidney, renal duplication and malrotation are rare congenital renal malformations in urology department, and probably contributed to some complications such as obstruction, hydronephrosis, infection, stones. In this case report, we firstly presented a male patient with rarely multiple renal malformations, including solitary kidney, renal duplication, misaligned malrotation of upper and lower moieties, and accompanied by complete staghorn stones and hydronephrosis, who was treated with open pyelolithotomy under general anesthesia. After the operation, obstruction, hydronephrosis, and infection were relieved.
6.Analysis of the effect of stent-assisted embolization for low-grade subarachnoid hemorrhage caused by V4 segment dissecting aneurysm of vertebral artery
Fangyu YANG ; Jiaming LIU ; Xu GAO ; Haifeng ZHANG ; Yushu DONG ; Jun LIU ; Minghao ZHOU ; Guobiao LIANG
Chinese Journal of Surgery 2021;59(8):691-696
Objective:To investigate the efficacy and safety of different stents assisted embolization in the treatment of subarachnoid hemorrhage(SAH) caused by V4 dissecting aneurysm of vertebral artery.Methods:The clinical data of 39 patients with spontaneous SAH V4 dissecting aneurysm treated at the Department of Neurosurgery, the Northern Theater General Hospital from January 2016 to June 2019 were analyzed retrospectively.There were 21 males and 18 females, aged (48±17) years(range:35 to 68 years).There were 24 cases of HUNT-HESS grade Ⅰ and 15 cases of grade Ⅱ.Among them, 20 cases were treated with single stent-assisted embolization, 9 cases with multi-stent-assisted embolization, 9 cases with semi-dense mesh-assisted embolization, and 1 case with dense-mesh stent-assisted embolization.The perioperative and postoperative complications, postoperative recurrence were collected.Results:Intraoperative complications included 2 cases of aneurysm rupture and 2 cases of acute thrombosis.All aneurysms were densely packed according to the angiography performed immediately after operation.Postoperative complications included 3 cases of long-term responsible vascular ischemia(modified Rankin score<2). The patients were followed up for 15.1 months(range: 12 to 29 months). At the last follow-up, aneurysms recurrence occured in 10 cases, the recurrence rate was 25.6%(10/39). There were 6 cases of recurrence and 2 cases of complications in 20 cases with single stent-assisted embolization, 3 cases of recurrence and 4 cases of complications in 9 cases with multi-stent-assisted embolization, 1 case of recurrence and 1 case of complications in 9 cases with semi-dense mesh stent.Conclusion:Endovascular treatment is feasible for patients with vertebral artery dissecting aneurysm, and the appropriate surgical method should be selected according to the vascular structure and the location of the aneurysm.
7.Analysis of the effect of stent-assisted embolization for low-grade subarachnoid hemorrhage caused by V4 segment dissecting aneurysm of vertebral artery
Fangyu YANG ; Jiaming LIU ; Xu GAO ; Haifeng ZHANG ; Yushu DONG ; Jun LIU ; Minghao ZHOU ; Guobiao LIANG
Chinese Journal of Surgery 2021;59(8):691-696
Objective:To investigate the efficacy and safety of different stents assisted embolization in the treatment of subarachnoid hemorrhage(SAH) caused by V4 dissecting aneurysm of vertebral artery.Methods:The clinical data of 39 patients with spontaneous SAH V4 dissecting aneurysm treated at the Department of Neurosurgery, the Northern Theater General Hospital from January 2016 to June 2019 were analyzed retrospectively.There were 21 males and 18 females, aged (48±17) years(range:35 to 68 years).There were 24 cases of HUNT-HESS grade Ⅰ and 15 cases of grade Ⅱ.Among them, 20 cases were treated with single stent-assisted embolization, 9 cases with multi-stent-assisted embolization, 9 cases with semi-dense mesh-assisted embolization, and 1 case with dense-mesh stent-assisted embolization.The perioperative and postoperative complications, postoperative recurrence were collected.Results:Intraoperative complications included 2 cases of aneurysm rupture and 2 cases of acute thrombosis.All aneurysms were densely packed according to the angiography performed immediately after operation.Postoperative complications included 3 cases of long-term responsible vascular ischemia(modified Rankin score<2). The patients were followed up for 15.1 months(range: 12 to 29 months). At the last follow-up, aneurysms recurrence occured in 10 cases, the recurrence rate was 25.6%(10/39). There were 6 cases of recurrence and 2 cases of complications in 20 cases with single stent-assisted embolization, 3 cases of recurrence and 4 cases of complications in 9 cases with multi-stent-assisted embolization, 1 case of recurrence and 1 case of complications in 9 cases with semi-dense mesh stent.Conclusion:Endovascular treatment is feasible for patients with vertebral artery dissecting aneurysm, and the appropriate surgical method should be selected according to the vascular structure and the location of the aneurysm.
8.Practice and analysis of the research integrity construction at hospitals
Yun CHEN ; Zhixiong ZHONG ; Guobiao ZHANG ; Yuting GUAN ; Xiaole WANG ; Wei ZHONG
Chinese Journal of Medical Science Research Management 2021;34(5):328-331
Objective:To respond to the national requirements on the construction of research integrity, and improve the capacity building of research integrity at hospitals.Methods:Dealing with research integrity problems identified at hospital before 2018, measurements that include " policy and procedures development, standardization of the management of scientific research activities, and optimizing the scientific and technological evaluation system" were adopted to promote the construction of research integrity. Such corrective activities were monitored to summarize experiences and lessons for the continuing improvement of research integrity construction.Results:Both " heteronomy" and " self-discipline" of research integrity have been sublimated simultaneously, at the same time, a tailored research integrity management system with the characteristics of local hospitals has been established.Conclusions:Updating institutional policy and procedures, taking paper management as a priority, as well as research integrity training, these measurements played important roles in promoting the research integrity capacity building at hospitals.
9.Pseudoaneurysm caused by Pseudomonas aeruginosa infection after renal transplantation: a case report
Junjun LE ; Faliang ZHAO ; Hao LI ; Wenduo ZHANG ; Zuohui WU ; Zhouke TAN ; Xiaoyong YAN ; Guobiao LIANG
Chinese Journal of Organ Transplantation 2021;42(2):96-99
Objective:To explorethe the clinical manifestations, treatment and prognosis of anastomotic pseudoaneurysm after renal transplantation caused by infection.Methods:Clinical data of 1 recipient with pseudoaneurysm after renal transplantation due to Pseudomonas aeruginosa infection were retrospectively analysed and combined with a literature review. Results:At Month 2 post-transplantation, the recipient developed right lower abdominal pain, and contrast-enhanced ultrasound examination showed a pseudoaneurysm at the artery anastomosis. Anti-infection and anti-rejection therapy had no obvious effect, and therefore next surgical exploration was performed. A size4.0 cm×3.5cm pseudoaneurysm was found intraoperatively at the graft renal artery anastomosis.After graft was evaluated as having no preservation value, the transplanted kidney and pseudoaneurysm were resected. Bacterial culture indicated Pseudomonas aeruginosa infection.The recipient recovered well and waited for next transplantation. Conclusions:Pseudoaneurysm of transplanted kidney is a very rare complication after renal transplantation, and caused by infection of Pseudomonas aeruginosa is more rarer, It has not been reported in mainland China.This type of recipient has the characteristics of high graft inactivation rate and high mortality rate. Timely surgical resection can effectively prevent the deterioration of disease.
10.Research on application of lung water management guided by PICCO in SAP caused ARDS sequential mechanical ventilation
Kewu CHEN ; Jiayan ZHENG ; Tao ZHANG ; Guobiao GONG ; Jian LIANG
Chongqing Medicine 2018;47(6):756-759
Objective To explore the effect of lung water management guided by pulse indicator continuous cardiac output (PICCO) in noninvasive-invasive-noninvasive sequential mechanical ventilation to severe acute pancreatitis (SAP) caused acute respiratory distress syndrome (ARDS).Methods The patients with ARDS caused by SAP in the department of critical care medicine in this hospital from January 2012 to January 2015 were selected as the research subjects and divided into the treatment group (lung water management guided by PICCO) and control group(without lung water management guided by PIC CO) according to different lung water management modes.The noninvasive ventilation time,invasive ventilation time,total mechanical ventilation time,mortality rate,incidence rate of pulmonary edema,incidence rate of ventilator associated pneumonia (VAP) and ICU stay time were compared between the two groups.Results The invasive ventilation time in the treatment group was (3.54 ± 1.78)d,which was lower than (4.31 ±2.42)d in the control group(P<0.05);the occurrence rate of pulmonary edema in the treatment group was 13.64 %,which was lower than 35.42% in the control group;the VAP occurrence rate in the treatment group was 6.82 %,which was lower than 22.92% in the control group;the mortality rate was 11.36%,which was lower than 29.17% in the control group;the ICU stay time was (7.21 ± 1.13)d,which was lower than (8.19 ± 1.28)d in the control group,the differences were statistically significant(P<0.05).Conclusion The lung water management guided by PICCO in SAP caused ARDS sequential mechanical ventilation is more accurate and effective,which is related to accurate liquid management,conduces to the patient's treatment,and is worthy of popularization and application.

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