1.Mining and analysis of adverse drug event signals of cinacalcet and etelcalcetide
Hongli WANG ; Guizun ZHONG ; Dongxuan LI ; Zhengze SHEN
China Pharmacy 2024;35(8):986-990
OBJECTIVE To explore and analyze the adverse drug event (ADE) signals of cinacalcet and etelcalcetide, to provide a reference for safe drug use in the clinic. METHODS ADE reports related to cinacalcet and etelcalcetide were extracted from the FDA Adverse Event Reporting System from January 1st, 2004 to June 30th, 2023 using the OpenVigil online tool. The Bayesian confidence propagation neural network method was adopted to detect the signals of ADE from the key organ systems. The signals were encoded according to the preferred term in the ADE terminology set of the Medical Dictionary for Regulatory Activities (26.0 edition). RESULTS A total 41 709 and 1 710 ADE reports were extracted, and 29 and 45 safety signals were detected in key systems for cinacalcet and etelcalcetide, respectively; 20 and 36 positive signals were not included in the drug instructions. Hypocalcemia/decreased serum calcium, abnormal blood parathyroid hormone (PTH)/increased or decreased serum PTH were common ADEs of the two drugs, which were detected in the study. Among the signals not included in the drug instructions, new moderate and strong signals were detected, such as cinacalcet-induced calcification defense (metabolic and nutritional diseases), bone starvation syndrome and high conversion bone diseases (musculoskeletal and connective tissue diseases) as well as etelcalcetide-induced sudden death, necrosis and treatment of non-responders (general disorders, administration site), unstable angina pectoris, myocardial ischemia (cardiac diseases), intestinal perforation, gastric antrum vasodilation and gastric ulcer (gastrointestinal diseases). CONCLUSIONS In the clinical application of the two drugs, apart from the common ADEs such as hypocalcemia and abnormal blood PTH, the surveillance of some new potential ADEs should also be carried out, such as bone starvation syndrome, calcification defense, ventricular disease and other cinacalcet-induced ADEs, sudden death, myocardial ischemia, unstable angina pectoris, intestinal perforation, gastric ulcer and other etecalcetide-induced ADEs. If new ADEs appear, clinic should promptly assess the benefits and risks, and update the treatment plan and pharmacological monitoring plan to ensure the safety of patient medication.
2.Gut microbiota: a new insight into neurological diseases.
Lanxiang LIU ; Haiyang WANG ; Xueyi CHEN ; Peng XIE
Chinese Medical Journal 2023;136(11):1261-1277
In the last decade, it has become increasingly recognized that a balanced gut microbiota plays an important role in maintaining the health of the host. Numerous clinical and preclinical studies have shown that changes in gut microbiota composition are associated with a variety of neurological diseases, e.g., Parkinson's disease, Alzheimer's disease, and myasthenia gravis. However, the underlying molecular mechanisms are complex and remain unclear. Behavioral phenotypes can be transmitted from humans to animals through gut microbiota transplantation, indicating that the gut microbiota may be an important regulator of neurological diseases. However, further research is required to determine whether animal-based findings can be extended to humans and to elucidate the relevant potential mechanisms by which the gut microbiota regulates neurological diseases. Such investigations may aid in the development of new microbiota-based strategies for diagnosis and treatment and improve the clinical management of neurological disorders. In this review, we describe the dysbiosis of gut microbiota and the corresponding mechanisms in common neurological diseases, and discuss the potential roles that the intestinal microbiome may play in the diagnosis and treatment of neurological disorders.
Animals
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Humans
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Gastrointestinal Microbiome/physiology*
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Nervous System Diseases
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Parkinson Disease
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Microbiota
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Brain
3.Comparison of different ureteral length measurement methods in the indwelling of double-J stent after ureteroscopy
Yongchuan WANG ; Yuhang BI ; Anji REN ; Xiaolu LUN ; Jing DU ; Haijun ZHOU ; Kai WANG ; Zhiyong YU ; Wenshun LIU ; Teng SHEN ; Yi SHAO
Journal of Modern Urology 2023;28(2):106-110
【Objective】 To investigate the application of different ureteral length measurement methods in the indwelling of double-J stent. 【Methods】 Clinical data of 260 patients with double-J stent indwelling after ureteroscopic surgery during Jul.2018 and Dec.2020 were prospectively analyzed. The patients were randomly divided into height calculation group, CT measurement group, KUB group and ureteroscopic measurement group. The length of ureter was calculated accordingly and the appropriate length of double-J stent was selected. KUB was performed on the first day after operation and before extubation to determine the position of double-J stent. The patients completed the ureteral stent-related symptom questionnaire (USSQ), urinary symptom score, lower urinary tract symptom (LUTS) score, pain score, hematuria score, and quality of life score before and after double-J catheter placement. 【Results】 There were no significant differences in age, gender, height, side of stent and urinary symptom score among the four groups (P>0.05). The average lengths of the ureters measured by the four methods were (21.5±1.0) cm, (21.5±1.8) cm, (23.8±1.3) cm and (21.7±1.8) cm, respectively. There were no significant differences among the height calculation group, CT measurement group and ureteroscope group, but there was significant difference between the three groups and the KUB group. The ideal ureteral stent length indwelling ratio in the ureteroscopic group was 76.9%, which was better than that in the other three groups. Postoperative indwelling time was 7-42 d (mean 29.8 d). The USSQ score of the ureteroscopic group before extubation was (14.1±1.5), which was lower than that of the other three groups (P<0.05). The ureteroscopic group was better than the other three groups in the comparison of frequency and urgency of urination, nocturia, hematuria, quality of life score, and pain score (P<0.05). 【Conclusion】 Intraoperative ureteroscopic measurement of the ureteral length is a simple and feasible method in guiding the indwelling of double-J stent to reduce ureteral stent related symptoms.
4.Medical Therapy of Hearing Impairment and Tinnitus with Chinese Medicine: An Overview.
Ying ZHANG ; Hui XIE ; Zhong-Mei HE ; Feng ZHANG ; Ling-Long LI ; Na WANG ; De-Hong MAO
Chinese journal of integrative medicine 2023;29(8):761-768
The current review gives a comprehensive overview of the recent development in Chinese medicine (CM) for treating several kinds of acquired nerve deafness and tinnitus, as well as links the traditional principle to well-established pharmacological mechanisms for future research. To date, about 24 herbal species and 40 related ingredients used in CM to treat hearing loss and tinnitus are reported for the treatment of endocochlear potential, endolymph growth, lowering toxic and provocative substance aggregation, inhibiting sensory cell death, and retaining sensory transfer. However, there are a few herbal species that can be used for medicinal purposes. Nevertheless, clinical studies have been hampered by a limited population sample, a deficiency of a suitable control research group, or contradictory results. Enhanced cochlear blood flow, antiinflammatory antioxidant, neuroprotective effects, and anti-apoptotic, as well as multi-target approach on different auditory sections of the inner ear, are all possible benefits of CM medications. There are numerous unknown natural products for aural ailment and tinnitus identified in CM that are expected to be examined in the future utilizing various aural ailment models and processes.
Humans
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Tinnitus/drug therapy*
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Medicine, Chinese Traditional
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Hearing Loss/drug therapy*
5.Chinese consensus guidelines for therapeutic drug monitoring of polymyxin B, endorsed by the Infection and Chemotherapy Committee of the Shanghai Medical Association and the Therapeutic Drug Monitoring Committee of the Chinese Pharmacological Society.
Xiaofen LIU ; Chenrong HUANG ; Phillip J BERGEN ; Jian LI ; Jingjing ZHANG ; Yijian CHEN ; Yongchuan CHEN ; Beining GUO ; Fupin HU ; Jinfang HU ; Linlin HU ; Xin LI ; Hongqiang QIU ; Hua SHAO ; Tongwen SUN ; Yu WANG ; Ping XU ; Jing YANG ; Yong YANG ; Zhenwei YU ; Bikui ZHANG ; Huaijun ZHU ; Xiaocong ZUO ; Yi ZHANG ; Liyan MIAO ; Jing ZHANG
Journal of Zhejiang University. Science. B 2023;24(2):130-142
Polymyxin B, which is a last-line antibiotic for extensively drug-resistant Gram-negative bacterial infections, became available in China in Dec. 2017. As dose adjustments are based solely on clinical experience of risk toxicity, treatment failure, and emergence of resistance, there is an urgent clinical need to perform therapeutic drug monitoring (TDM) to optimize the use of polymyxin B. It is thus necessary to standardize operating procedures to ensure the accuracy of TDM and provide evidence for their rational use. We report a consensus on TDM guidelines for polymyxin B, as endorsed by the Infection and Chemotherapy Committee of the Shanghai Medical Association and the Therapeutic Drug Monitoring Committee of the Chinese Pharmacological Society. The consensus panel was composed of clinicians, pharmacists, and microbiologists from different provinces in China and Australia who made recommendations regarding target concentrations, sample collection, reporting, and explanation of TDM results. The guidelines provide the first-ever consensus on conducting TDM of polymyxin B, and are intended to guide optimal clinical use.
Humans
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Anti-Bacterial Agents/therapeutic use*
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China
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Drug Monitoring/methods*
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Polymyxin B
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Practice Guidelines as Topic
6.Curative effect analysis of treating concealed penis based on the idea of flap transfer in the treatment of hypospadias
Yongchuan CAI ; Chaoyou HUANG ; Wei WANG ; Yunman TANG ; Yu LIU ; Zhiquan ZHU ; Xuejun WANG
Chinese Journal of Plastic Surgery 2023;39(6):614-620
Objective:To investigate the clinical effect of surgical treatment of concealed penis based on the idea of flap transfer in the treatment of hypospadias.Methods:Retrospectively analyzed the clinical data of children with concealed penis admitted to the Urology Department of Chengdu Second People’s Hospital and Department of Pediatric Surgery at Children’s Medical Center of Sichuan Provincial People’s Hospital, from July 2017 to July 2021. The control group used the traditional surgical method and the experimental group used a modified surgical approach based on the idea of flap transfer in the treatment of hypospadias. Short-term complications such as flap ischemia, edema, and skin dehiscence were statistically analyzed in the two groups, as well as the Boemers rating of penile appearance (good, general, poor), Vancouver scar scale (VSS) (mild, moderate, severe), overall penis shape (tower, cylindrical, inverted tower) at 6 months after surgery. Count data were analyzed using the Chi-square test.Results:298 children, aged 2.5 to 13.7 years, with a mean age of 6.4 years, were enrolled in the study. 103 children were in the control group, and 195 children were in the experimental group. All enrolled patients were operated successfully in the first stage and were discharged 3-4 days after the operation, with an average recovery time of 3-4 weeks. After a follow-up of more than 6 months, in the control group, 2 cases (1.9%) of flap ischemia and 3 cases (2.9%) of skin dehiscence occurred after surgery. Two children (1.0%) in the experimental group had skin dehiscence after surgery, and the difference in the recent complication rate between the two groups was not significant [4.9%(5/103) vs. 1.0%(2/195), P>0.05]. The proportion of Boemers rated"good"in the experimental group was higher than that in the control group [93.3% (182/195) vs. 71.8% (74/103), P<0.01]. The proportion of moderate to severe scarring assessed by VSS was lower in the experimental group than in the control group [6.2% (12/195) vs. 26.2% (27/103), P<0.01]. The proportion of the overall penis shape of the penis close to the cylindrical shape of the normal penis in the experimental group was significantly higher than that in the control group [81.5% (159/195) vs. 60.2% (62/103), P<0.01]. Conclusion:Compared with the traditional surgical method, the modified surgical approach based on the idea of flap transfer in the treatment of hypospadias attaches more importance to the overall planning of the flap and the tension distribution of the fascial layer, which can be more effective to solve the problem of insufficient coverage of the concealed penile skin and reduce postoperative scar formation. Moreover, the appearance of the external genitalia is natural and closer to normal, the surgical effect is exact, and the long-term postoperative complications are lower.
7.Curative effect analysis of treating concealed penis based on the idea of flap transfer in the treatment of hypospadias
Yongchuan CAI ; Chaoyou HUANG ; Wei WANG ; Yunman TANG ; Yu LIU ; Zhiquan ZHU ; Xuejun WANG
Chinese Journal of Plastic Surgery 2023;39(6):614-620
Objective:To investigate the clinical effect of surgical treatment of concealed penis based on the idea of flap transfer in the treatment of hypospadias.Methods:Retrospectively analyzed the clinical data of children with concealed penis admitted to the Urology Department of Chengdu Second People’s Hospital and Department of Pediatric Surgery at Children’s Medical Center of Sichuan Provincial People’s Hospital, from July 2017 to July 2021. The control group used the traditional surgical method and the experimental group used a modified surgical approach based on the idea of flap transfer in the treatment of hypospadias. Short-term complications such as flap ischemia, edema, and skin dehiscence were statistically analyzed in the two groups, as well as the Boemers rating of penile appearance (good, general, poor), Vancouver scar scale (VSS) (mild, moderate, severe), overall penis shape (tower, cylindrical, inverted tower) at 6 months after surgery. Count data were analyzed using the Chi-square test.Results:298 children, aged 2.5 to 13.7 years, with a mean age of 6.4 years, were enrolled in the study. 103 children were in the control group, and 195 children were in the experimental group. All enrolled patients were operated successfully in the first stage and were discharged 3-4 days after the operation, with an average recovery time of 3-4 weeks. After a follow-up of more than 6 months, in the control group, 2 cases (1.9%) of flap ischemia and 3 cases (2.9%) of skin dehiscence occurred after surgery. Two children (1.0%) in the experimental group had skin dehiscence after surgery, and the difference in the recent complication rate between the two groups was not significant [4.9%(5/103) vs. 1.0%(2/195), P>0.05]. The proportion of Boemers rated"good"in the experimental group was higher than that in the control group [93.3% (182/195) vs. 71.8% (74/103), P<0.01]. The proportion of moderate to severe scarring assessed by VSS was lower in the experimental group than in the control group [6.2% (12/195) vs. 26.2% (27/103), P<0.01]. The proportion of the overall penis shape of the penis close to the cylindrical shape of the normal penis in the experimental group was significantly higher than that in the control group [81.5% (159/195) vs. 60.2% (62/103), P<0.01]. Conclusion:Compared with the traditional surgical method, the modified surgical approach based on the idea of flap transfer in the treatment of hypospadias attaches more importance to the overall planning of the flap and the tension distribution of the fascial layer, which can be more effective to solve the problem of insufficient coverage of the concealed penile skin and reduce postoperative scar formation. Moreover, the appearance of the external genitalia is natural and closer to normal, the surgical effect is exact, and the long-term postoperative complications are lower.
8.Proportion of contextual effect of non-surgical treatments for rotator cuff injuries: a meta-analysis
Kaixin REN ; Lingcong LI ; Xiujing WANG ; Liying MA ; Zhenyu WANG
Chinese Journal of Rehabilitation Theory and Practice 2022;28(9):1039-1048
ObjectiveTo estimate the total effect size and the proportion of contextual effect (PCE) of non-surgical treatments for rotator cuff injury. MethodsRandomized controlled trial (RCT) on non-surgical treatments for rotator cuff injuries was retrieved from PubMed, Embase, Cochrane Library, Web of Science, CINAHL, CNKI, and Wanfang Data from the establishment to October, 2020. Two researchers conducted independent literature screening, data extraction and quality evaluation, and used STATA 15.0 software for meta-analyses. ResultsForty studies involving 2 976 participants were included. The total PCE of pain was 0.61 (95% CI 0.54 to 0.69). PCE of treatments from the largest to the smallest were corticosteroid injection, extracorporeal shockwave therapy, oral non-steroidal anti-inflammatory drugs (NSAIDs), manual therapy, hyaluronic acid injection therapy, platelet-rich plasma injection therapy, laser therapy, NSAIDs injection therapy, and acupuncture therapy. Total PCE for function and range of motion was 0.69 (95% CI 0.61 to 0.77) and 0.62 (95% CI 0.48 to 0.81), respectively. Blinding, studies in developed countries, and longer courses of treatment increased the PCE of pain. ConclusionUp to 61% of PCE for the non-surgical treatments for rotator cuff injuries means instable research. A higher proportion of PCE may be the cause of inconsistencies between clinical practice and clinical research conclusions.
9.Differential diagnosis and management of hemangioma at geniculate ganglion
Anying HUANG ; Yongchuan CHAI ; Lu XUE ; Hongsai CHEN ; Lingxiang HU ; Huan JIA ; Zhihua ZHANG ; Hao WU ; Zhaoyan WANG
Chinese Journal of Otorhinolaryngology Head and Neck Surgery 2022;57(7):819-826
Objective:To investigate the clinical characteristics, differential diagnosis, treatments and prognosis of facial nerve hemangioma and schwannoma at genicular ganglion, so as to provide reference for clinical diagnosis and treatments of facial nerve tumor at genicular ganglion.Methods:Clinical data of 13 patients with facial nerve tumors at genicular ganglion confirmed by postoperative pathology in the Ninth People′s Hospital affiliated to Shanghai Jiaotong University School of Medicine from March 2018 to April 2020 were retrospectively analyzed, including seven cases of hemangioma and six cases of schwannoma. There were eight males and five females. Their ages ranged from 20 to 65, with an average age of 40. The course of disease ranged from 3 to 118 months, with an average of 52 months. All the patients underwent preoperative HRCT of the temporal bone and facial nerve dynamic contrast-enhanced(DCE) MRI examinations. All the patients had detailed surgical procedures and at least one-year postoperative follow-up.Results:On HRCT of the temporal bone, (4/7) hemangioma at geniculate ganglion showed characteristic honeycomb appearance, while 6/6 schwannoma and 3/7 hemangiomas showed expansive bone changes. On DCE-MRI, geniculate ganglion hemangioma (7/7) showed characteristic "point-to-surface" enhancement, and schwannoma (6/6) showed characteristic "face-to-surface" enhancement. For five hemangioma-patients with HB-Ⅱ-Ⅳ before surgery, the facial nerve anatomy was completely preserved through transcanal endoscopic approach(TEA), and the facial nerve function improved one year after surgery (two cases of HB-I, two cases of HB-Ⅱ, and one case of HB-Ⅲ). For two patients, with preoperative facial nerve function HB-Ⅴ-Ⅵ, since their tumors was inseparable from the nerves, they were performed with facial nerve anastomosis during the surgery, and the facial nerve function was improved to HB-Ⅳ level one year after surgery. For six patients with meningioma whose facial nerve function was greater than or equal to HB-Ⅲ, based on the preoperative hearing level, the involved segments, and duration of facial paralysis, three of them were conducted surgeries through middle cranial fossa approach, one by translabyrinthine approach, and one via mastoid approach. Two patients among them with complete facial paralysis over three years preoperatively were not performed facial nerve anastomosis after total resections of the tumors, and there was no improvement in facial nerve function one year after surgery. Three patients underwent facial nerve anastomosis after total tumor resections, and their facial nerve function was HB-Ⅲ in one patient, HB-Ⅳ in two patients one year after surgery. One patient (preoperative HB-Ⅲ) had a normal hearing level preoperatively, and the tumor involved the labyrinth segment. To protect the hearing, partial tumor was resected through the middle cranial fossa approach, and facial nerve function improved to HB-Ⅱ one year after surgery.Conclusions:Temporal bone HRCT combined with DCE-MRI are useful for the differential diagnosis of hemangioma and schwannoma at geniculate ganglion and provide references for preoperative clinical decision makings. It is extremely necessary to select the appropriate surgical approach based on the patient′s hearing and involved segments. For geniculate ganglion hemangioma, early surgery can improve the possibilities of anatomical integrity of facial nerve, thereby improving facial nerve function postoperatively.TEA is a kind of surgical method worth consideration, with the characteristics of minimally invasive, favorable postoperative features, and so on. For schwannoma, one-stage functional reconstruction of the facial nerve is recommended during the resection of the tumors because of the inevitable damage to the anatomical integrity of the facial nerve.
10.Cognition and progress of de Winter electrocardiogram pattern.
Aihua WANG ; Jing XU ; Zijun CHEN
Journal of Central South University(Medical Sciences) 2021;46(4):421-425
The de Winter electrocardiogram pattern is an acute ST-segment elevation myocardial infarction equivalent, however this specific electrocardiogram change is easily ignored by clinicians. The de Winter electrocardiogram pattern in patients with acute chest pain mostly indicates sub-complete or complete occlusion of the left anterior descending or the diagonal branch. Patients with acute chest pain and such electrocardiographic finding should undergo emergency coronary angiography immediately to determine the coronary condition, and reperfusion therapy should be performed as soon as possible to reduce the incidence of adverse cardiovascular events.
Anterior Wall Myocardial Infarction
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Cognition
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Coronary Angiography
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Electrocardiography
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Humans
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ST Elevation Myocardial Infarction/diagnosis*

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