1.Analysis of medical disputes related to drug-induced cross-allergy and study on prescripition review strategy
Wei LI ; Chengliang ZHANG ; Pinpin XUE ; Jinfeng DU ; Dong LIU
Chinese Journal of Pharmacoepidemiology 2024;33(1):2-8
Objective To analyze the rules and characteristics of cross-allergy cases related to drug-related medical disputes,and to provide reference for the formulation of cross-allergy prescription review strategy.Methods The judgments of cross-allergy related medical damage liability disputes recorded in the legal document database of Beijing Yingke Law Firm and the Chinese Judgment Document Network database from August 2010 to June 2023 were analyzed,the causes of relevant disputes were summarized and analyzed,and more comprehensive response measures were formulated.Results A total of 65 judgments were retrieved,and seven judgments were included.The main drugs causing cross allergy were antibiotics(penicillins,cephalosporins and sulfonamides).Seven cases of medical disputes,all of which were ruled by the court that the medical party had medical errors due to cross-allergies,and had to bear 30%to 80%of the compensation liability.The main reasons for the punishment were that the doctor did not pay enough attention to the patient's past history of allergy and chose unreasonable drugs.Conclusion Medical institutions can reduce the risk of cross-allergy by means of information technology,and play the role of pharmacists in prescription review and pharmaceutical care.Physicians should pay attention to the patient's past history,earnly inquire,strengthen medication education and monitoring,reduce the threat of adverse reactions to the patient's life safety and related drug disputes,and protect the legitimate rights and interests of both doctors and patients.
2.The relationship between heart rate variability, severity, and prognosis in patients with acute cerebral infarction
Chengliang GUO ; Cuiyun ZHANG ; Jie LI ; Rui YAO ; Ling CHEN ; Yue HU
Journal of Chinese Physician 2024;26(9):1369-1373
Objective:To explore the relationship between heart rate variability, severity, and prognosis in patients with acute cerebral infarction (ACI).Methods:A prospective study was conducted on 80 patients with acute cerebral infarction (ACI) admitted to Qinhuangdao Workers′ Hospital from February 2021 to March 2023. The severity of ACI patients was evaluated based on their National Institutes of Health Stroke Scale (NIHSS) scores, and they were divided into mild group (26 cases, NIHSS scores 0-15), moderate group (32 cases, NIHSS scores 16-30), and severe group (22 cases, NIHSS scores 31-45); And 30 healthy individuals who underwent physical examinations during the same period were selected as the control group. The improved Rankin Scale (MRS) was used to evaluate the prognosis of patients, who were divided into a good prognosis group (59 cases) and a poor prognosis group (21 cases) based on the scoring results. All patients underwent dynamic electrocardiogram examination, and the heart rate variability parameters of each group were compared [standard deviation of R-R interval for all sinus beats at 24 hours (SDNN), mean standard deviation of R-R interval for 5 consecutive minutes at 24 hours (SDNN Index), standard deviation of R-R interval mean every 5 minutes (SDANN), root mean square of all adjacent R-R interval differences (rMSSD), and the proportion of adjacent NN interval differences greater than 50 ms (PNN50%)]. The predictive value of heart rate variability parameters on the severity and prognosis of ACI patients was analyzed using receiver operating characteristic (ROC) curves. Logistic regression analysis was used to identify the risk factors for the severity and prognosis of ACI patients.Results:The SDNN, SDANN, SDNN Index, rMSSD, and PNN50% of the mild, moderate, and severe groups were significantly lower than those of the control group ( F=59.382, 11.859, 12.376, 11.699, 47.703, all P<0.01), and the severe group was less than the moderate group and less than the mild group (all P<0.05). The SDNN, SDANN, SDNN Index, rMSSD, and PNN50% in the poor prognosis group were lower than those in the good prognosis group ( t=4.536, 4.181, 5.091, 4.384, 2.851, all P<0.01). The results of logistic regression analysis showed that heart rate variability parameter was an independent influencing factor for the severity and poor prognosis of ACI patients (all P<0.01). The area under the curve for the combined diagnosis of the severity of ACI patients using SDNN, SDANN, SDNN Index, rMSSD, and PNN50% was 0.950, and the area under the curve for the combined prediction of ACI patients′ prognosis was 0.970. Conclusions:The heart rate variability parameter is an independent influencing factor on the severity and prognosis of ACI patients, and its predictive power for the severity and prognosis of ACI patients is high. It can be used as an effective indicator for evaluating the severity and prognosis of ACI patients.
3.Pharmacoeconomic evaluation of glucagon-like peptide-1 receptor agonist combined with metformin in the treatment of type 2 diabetes mellitus
Tian YU ; Shaohua LIU ; Anhua WEI ; Jieru GUO ; Chengliang ZHANG ; Dong LIU ; Zhelong LIU
Chinese Journal of Pharmacoepidemiology 2024;33(4):388-401
Objective To evaluate the economic value of using glucagon-like peptide-1 receptor agonist(GLP-1RA)in combination with metformin for the treatment of type 2 diabetes mellitus(T2DM).Methods Based on 7 randomized controlled clinical trials(RCTs),Markov model was built to simulate the dynamic changes of metformin alone or combined with GLP-1RA in the treatment of T2DM patients without or with complications and death from the perspective of China's health system.Quality-adjusted life years(QALYs)was used as a health output indicator and 3 times China's per capita gross domestic product(GDP)in 2023 was set as the willingness-to-pay(WTP)threshold.The cycle was at the rate of 1 year and a total of 20 years cohort simulation in Markov model was applied to obtain long-term cost and effect of each treatment strategy.The incremental cost-utility ratio(ICUR)was analyzed as the primary evaluation indicator and the sensitivity of cost,utility and discount was performed to test the stability of the results.Results Compared with metformin alone,the ICUR of GLP-1RA including liraglutide,dulaglutide,exenatide,loxenatide,semaglutide combined with metformin were all below the WTP threshold,and the increased cost was acceptable.Extending the simulation time to 30 years or 50 years had no effect on results.The results of probability sensitivity analysis showed that the cost effect of semaglutide 0.5 mg combined with metformin had the highest probability of a cost-utility advantage of 99.7%among all the treatment strategies when WTP threshold was 3 times China's per capita GDP in 2023(268 074 yuan).Conclusion GLP-1RA,including liraglutide,dulaglutide,exenatide,lixisenatide,and semaglutide,at the regular recommended dose combined with metformin,would present higher cost-utility compared to metformin monotherapy.
4.Efficacy and safety of glucagon-like peptide 1 receptor agonists in the treatment of overweight or obese patients with type 2 diabetes:a Meta-analysis
Tian YU ; Shaohua LIU ; Anhua WEI ; Jieru GUO ; Chengliang ZHANG ; Dong LIU ; Zhelong LIU
Chinese Journal of Pharmacoepidemiology 2024;33(5):519-538
Objective To evaluate the efficacy and safety of glucagon-like peptide 1 receptor agonists(GLP-1RA)in type 2 diabetes mellitus(T2DM)patients with overweight or obese.Methods PubMed,Embase,Cochrane Library,Ovid,ClinicalTrial.gov,SinoMed,CNKI,WanFang Data and VIP databases were electronically searched to collect randomized controlled trials(RCTs)on the efficacy of GLP-1RA in the treatment of T2DM patients with overweight or obese from January 1,2005 to November 1,2023.Two researchers independently screened the literature,extracted data and evaluated the risk of bias of the included studies.R software was then used for meta-analysis.The level of evidence was assessed by using the GRADE system.Results A total of 71 RCTs were included,including 29 476 patients.The results of Meta-analysis showed that compared with other hypoglycemic drugs,GLP-1RA showed superior effects in improving HbAlc status(WMD=-0.55,95%CI-0.65 to-0.45,P<0.001)and weight loss(WMD=-2.61,95%CI-3.25 to-1.97,P<0.001),while the effect on fasting plasm glucose was time-dependent(within 16 weeks:WMD=0.25,95%CI-0.17 to 0.66,P=0.250;16 to 52 weeks:WMD=-0.06,95%CI-0.32 to 0.20,P=0.650;over 52 to 104 weeks:WMD=-1.67,95%CI-1.91 to-1.43,P<0.001).In terms of safety,the incidence of GLP-1RA's adverse reactions was higher than other hypoglycemic drugs(RR=1.11,95%CI 1.07 to 1.15,P<0.001);the incidence of hypoglycemia was lower with GLP-1RA than with insulin(RR=0.58,95%CI 0.48 to 0.71,P<0.001)and similar to oral hypoglycemic drugs(RR=0.83,95%CI 0.58 to 1.19,P=0.310).According to the GRADE assessment,only the certainty of the evidence for the results of the incidence of hypoglycemia was moderate,and the certainty of the evidence for the other results was low.Conclusion Current evidence shows that for T2DM patients with overweight or obese,GLP-1RA especially semaglutide,was more effective in lowering blood glucose,controlling body weight and reducing the occurrence of hypoglycemia than placebo,insulin and oral hypoglycemic drugs.
5.Nomogram prediction model construction and verification for pediatric acute perforation appendicitis
Wenlong TANG ; Chengliang WAN ; Bo HAI ; Bilin XIONG ; Chenjun ZHENG ; Chuanbo ZHANG ; Chunfeng HUANG ; Qiang BAI
Chongqing Medicine 2024;53(22):3463-3468
Objective To investigate the risk factors for pediatric acute perforation appendicitis,and to construct a nomogram predictive model and conduct the verification.Methods A total of 426 children patients with appendectomy in this hospital from June 30,2020 to June 30,2022 were selected as the study subjects 340 children with acute appendicitis admitted to the hospital from 30 June 2020 to 28 February 2022 were the training set and 86 children patients with appendicitis hospitalized in this hospital from March 1,2022 to June 30,2022 conducted the external validation(verification set).The univariate and multivariate logistic regression models were employed to analyze the independent risk factors of pediatric acute perforation appendicitis.The nomograms predictive model was constructed.The receiver operating characteristic(ROC)curve and calibra-tion curve were used to evaluate the predictive efficiency of the model.The decision curve analysis(DCA)was used to evaluate the application value of the model.Results Of the 426 children,198 were perforated and 228 were not perforated.The univariate and multivariate logistic regression analyses revealed that elevated C-reac-tive protein(CRP),presence of stercorolith in appendiceal cavity,time of onset to visiting hospital ≥2 d and body temperature ≥37.3 ℃ were the independent risk factors for pediatric acute perforation appendicitis(P<0.05).The Hosmer-Lemeshow test demonstrated that the nomogram predictive model had good fitting(P=0.869),and the area under the curve(AUC)for the training and validation sets were 0.808 and 0.860 respectively,showing the good predictive ability of the model.The calibration curve closely approach the ideal diagonal.The model showed good discrimination,consistency and accuracy.The DC A revealed that the curve was far away from oblique and horizontal lines,and the model had good clinical practicability.Conclusion The constructed nomogram model of pediatric acute perforation appendicitis has good predictive ability and may help clinic to identify as early as possible.
6.Establishment of a nomographic chart model based on CT imaging characteristics and clinical data in predicting the recurrence risk of pleomorphic adenoma of salivary gland
Li LU ; Chengliang LIU ; Chao ZUO ; Shujing YU ; Li ZHANG
China Medical Equipment 2024;21(5):54-58,63
Objective:To explore the establishment of a nomographic chart model based on computed tomography(CT)imaging characteristics and clinical data in predicting the recurrence risk of pleomorphic adenoma(PA)of salivary gland.Methods:Clinical and CT imaging data of 99 PA patients admitted to Cangzhou central hospital from November 2019 to November 2022 were retrospectively analyzed,and they were divided into recurrence group(15 cases)and non-recurrence group(84 cases)according to whether occurred recurrence.The influence factors of PA recurrence were analyzed by univariate analysis and multivariate logistic regression,and the risk prediction model was constructed.The predictive value of the model was analyzed by receiver operating characteristic(ROC)curve.Results:Multivariate Logistic regression analysis showed that the tumor site was at deep lobe,the capsule of tumor was incomplete and the surrounding tissue of tumor existed invasion were respectively independent risk factors for PA recurrence(OR=79.730,67.194,479.801,P<0.05).The area under curve(AUC)of ROC curve of the risk prediction model based on the above three indexes was 0.960,and the sensitivity and specificity were respectively 80.0%and 97.6%,which were higher than each single index in the model.There was no significant difference between this risk predictive model and actual observation value(x2=0.823,P=0.935).Conclusion:The tumor site is deep lobe,the capsule of tumor is incomplete,and the surrounding tissue of tumor exists invasion are independent risk factors of PA recurrence.The risk prediction model based on the above three indexes has higher predictive value for PA recurrence,which can provide theoretical basis for preventing PA recurrence.
7.Research advances in FLASH radiotherapy-related clinical trials
Hui LUO ; Yichen MA ; Leijie MA ; Ronghu MAO ; Hongchang LEI ; Han LIU ; Yanping ZHANG ; Meng XU ; Hong GE ; Chengliang YANG
Chinese Journal of Radiological Medicine and Protection 2024;44(10):891-895
FLASH radiotherapy (FLASH-RT) has garnered considerable attention globally in recent years. Compared to conventional radiotherapy, FLASH-RT can deliver the total radiation dose to the target volume in an extremely short time, reducing the radiation-induced damage to normal tissue while maintaining similar anti-tumor effects. FLASH-RT has been in the clinical trial stage, with several clinical research result being reported. Based on the collected global clinical research result of FLASH-RT in recent years, this study systematically reviewed FLASH-RT′s safety, radiation-related side effects, treatment efficacy, opportunities, and challenges in clinical trials.
8.The application of endoscopic tubular musculoskeletal tumor surgery in the treatment of spinal tumors
Guowen WANG ; Yan ZHANG ; Yao XU ; Chengliang ZHAO ; Xiuxin HAN ; Chao ZHANG ; Jinyan FENG ; Yongheng LIU ; Yuxiang SHEN ; Zhe FENG
Chinese Journal of Orthopaedics 2024;44(20):1339-1348
Objective:To explore the effect and safety of endoscopic tubular musculoskeletal tumor surgery (ETMS) technology in spinal tumors.Methods:Clinical data were retrospectively collected from 18 spinal tumor patients who were treated with ETMS technology at Tianjin Medical University Cancer Institute and Hospital ( n=16) or the Affiliated Hospital of Qingdao University ( n=2) from November 2022 to December 2023. The total cohort included 11 males and 7 females, with the age at 60.3±8.6 years (range of 41-76). Two cases were diagnosed with benign tumors, four patients were diagnosed with spinal hematologic malignancies while other 12 cases were patients with spinal metastases. After localization under the C-arm X-ray machine, the spinal endoscopic channel is established using dilators. Soft tissue is dissected under endoscopic guidance to create an artificial cavity. Subsequently, the saline medium relied upon by the spinal endoscopic technique is removed, and posterior decompression and tumor curettage are performed using tubular techniques. Frankel grade classification and paraplegia index were used to evaluate the improvement of postoperative function and the VAS score was performed in pain scoring. The surgical complications and tumor evaluation were observed by postoperative outpatient and telephone follow-up. Results:The ETMS technology was successfully completed in all 18 patients with the mean operation time of 240.3±80.2 min. The median of intraoperative bleeding was 200.0(172.5, 350.0) ml and the mean postoperative drainage was 131.4±69.5 ml. The median value of postoperative hospitalization days was 6.0(4.0, 10.25) d. The paraplegia index decreased from 1.5(0, 3.0) preoperatively to 0(0, 1.25) postoperatively ( Z=-2.599, P=0.009). All the patients presented an improvement in Frankel grading after surgery except for one patient (downgrading from grade E to grade D). There was significantly difference in Frankel grading between preoperative and postoperative groups ( Z=2.812, P=0.005). The median value of preoperative VAS score was up to 5.5(4.0, 7.0) while the median value at postoperative, one month after surgery and three months after surgery were 1.5(1.0, 2.25), 1.0(0, 1.0) and 0(0, 1.0), respectively (χ 2=44.641, P<0.001). The 3-month postoperative VAS improvement rate was 91.2% (range 75%-100%). During a mean follow-up period of 7.6±6.2 months, none of the 18 patients presented surgical complications or tumor recurrence at surgical region. Only one patient died at 3.2 months after surgery until the last follow-up due to respiratory failure after lung tumor progression. The mean survival of the total cohort was up to 13.3 [95% CI (11.5, 15.0)] months. The 16 cases with spinal metastases or spinal hematological malignancies had a mean survival of 13.2 [95% CI (11.3, 15.0)] months. Conclusion:The ETMS technology presented good efficacy and safety in treatment of spinal tumors with low blood supply and with diameter less than 5cm.
9.Bispecific antibodies in cancer therapy: Target selection and regulatory requirements.
Yanze SUN ; Xinmiao YU ; Xiao WANG ; Kai YUAN ; Gefei WANG ; Lingrong HU ; Guoyu ZHANG ; Wenli PEI ; Liping WANG ; Chengliang SUN ; Peng YANG
Acta Pharmaceutica Sinica B 2023;13(9):3583-3597
In recent years, the development of bispecific antibodies (bsAbs) has been rapid, with many new structures and target combinations being created. The boom in bsAbs has led to the successive issuance of industry guidance for their development in the US and China. However, there is a high degree of similarity in target selection, which could affect the development of diversity in bsAbs. This review presents a classification of various bsAbs for cancer therapy based on structure and target selection and examines the advantages of bsAbs over monoclonal antibodies (mAbs). Through database research, we have identified the preferences of available bsAbs combinations, suggesting rational target selection options and warning of potential wastage of medical resources. We have also compared the US and Chinese guidelines for bsAbs in order to provide a reference for their development.
10.Research progress in nipple projection reconstruction based on tissue graft support.
Xiaoshan ZHANG ; Chengliang DENG
Chinese Journal of Reparative and Reconstructive Surgery 2023;37(8):1031-1036
OBJECTIVE:
To review the advances in methods for reconstructing nipple projection based on tissue graft support.
METHODS:
The literature related to nipple projection reconstruction based on tissue graft support was reviewed and summarized in terms of the advantages and disadvantages of various tissue grafts and the improved nipple projection results.
RESULTS:
Loss of nipple projection is a common cause of decreased patient's satisfaction. Reconstructing nipple projection based on tissue graft support is a more common clinical method and can be done with autologous and allogeneic tissues. Autologous tissue grafts include dermis, adipose tissue with dermis, adipose tissue, ear cartilage, rib cartilage, and contralateral nipple tissue. Autologous tissue grafts are easy to obtain and have no immune rejection, but may lead to donor area damage and prolong the surgical time for tissue collection. Allogeneic tissue grafts include acellular dermal matrix, lyophilized rib cartilage, and extracellular matrix collagen, and decellularized nipple tissue. Allogeneic tissue grafts do not cause additional donor area damage, are highly malleable, and can be designed to be utilized according to the recipient area, but the high cost often limits the development of this technique.
CONCLUSION
There is no gold standard regarding tissue graft-assisted nipple projection reconstruction techniques, and there are advantages and disadvantages to both autologous and allogeneic tissue grafts. Surgeons should choose the appropriate graft based on the actual condition of the patient.
Humans
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Adipose Tissue
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Autografts
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Costal Cartilage
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Nipples/surgery*
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Transplants

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