1.Case Reports of Adverse Drug Reactions Induced by Tislelizumab in A Hospital and the Literature Review
Xiaojian WANG ; Zhe LI ; Ye XU ; Chen PAN ; Xiangli CUI
Herald of Medicine 2023;42(12):1873-1878
Objective To investigate the characteristics of adverse drug reactions(ADRs)induced by tislelizumab and to provide reference for clinic drug safety.Methods The ADR of tislelizumab in Beijing Friendship Hospital Affiliated to Capital Medical Univeristy from July 2021 to December 2022 were retrospectively analyzed.The case reports of ADR induced by tislelizumab from January 2019 to December 2022 in PubMed,ScienceDirect,Embase,Wanfang,VIP databases were searched.Age,sex,original diseases,adverse reaction time,clinical manifestation,treatment measures and clinical outcome were analyzed.Results A total of 30 patients including 8 cases in hospital and 22 cases in literature were collected.Among these patients,male accounted for 83.33%(25/30),and the highest proportion was from patients over 60 years old(21 patients,70.00%).Most ADRs occurred in 1-2 dose cycles of medication,mainly including skin toxicity in 8 patients,digestive disease in 6 patients and kidney injury in 4 patients.After the symptomatic treatment,29 patients improved and 1 patient died.Conclusion During the medication with tislelizumab,ADRs of skin,gastrointestinal tract and renal should be vigilant,and the changes of relevant indicators should be closely monitored.
2.Clinical analysis of prostate targeted biopsy guided by multiparametric magnetic resonance imaging and 68Ga-PSMA PET/CT image fusion
Guowen LIN ; Bo DAI ; Dingwei YE ; Chang LIU ; Yao ZHU ; Xiaojian QIN ; Hongkai WANG
Chinese Journal of Urology 2022;43(7):484-489
Objective:To explore clinical value of prostate target biopsy guided by multiparametric magnetic resonance imaging (mpMRI) and 68Ga-labeled prostate specific membrane antigen ligand imaging positron emission tomography/X-ray computed tomography ( 68Ga-PSMA PET/CT) image fusion. Methods:The data of 50 patients admitted to Fudan University Shanghai Cancer Center from January 2021 to February 2022 who underwent mpMRI and 68Ga-PSMA PET/CT to guide prostate biopsy were retrospectively analyzed. The median age was 70 (63-79) years, the median serum tPSA value was 8.1 (6.8-83.0) ng/ml, and the prostate volume was 45.5 (30-80) ml. 36 cases were positive by mpMRI, including PI-RADS score 3 in 5 cases, 4 score in 19 cases, 5 score in 12 cases. 32 cases were positive by 68Ga-PSMA PET/CT examination, of which 30 cases were double positive and the fusion of both imaging techniques was positive, referred to as PET/CT-MRI. The patient's mpMRI and 68Ga-PSMA PET/CT images were imported into the MIM fusion software, and the outline of the prostate and the target area were outlined respectively. When PET/CT and MRI double positive cases were biopsied, the two images were alternately fused, calibrated and locked with the real-time prostate ultrasound interface(PET/CT-MRI). Single-positive cases were guided by positive images to complete targeted biopsy, and 12-needle systematic biopsies were completed after targeted biopsy and double-negative cases. The advantages of targeted biopsy and systematic biopsy was evaluated, and the diagnostic performance (sensitivity, specificity, positive predictive value, and negative predictive value) was analyzed. Results:Among the 50 biopsy patients in this group, 31 (62%) had prostate cancer, of which 22 (44%) were CsPCa. There was no significant difference in the detection rate of prostate cancer between targeted biopsy and systematic biopsy [78.9% (30/38) and 62.0% (31/50), P=0.088], and there was no significant difference in the detection rate of CsPCa [57.9% (22/38) and 40.0% (20/50), P=0.096]. The positive rate of the biopsy needles number was significantly different [86.3% (69/80) and 19.0% (114/ 600), P<0.001]. The detection rates of prostate cancer in mpMRI positive, PET/CT positive and PET/CT-MRI positive cases were 83.3% (30/36), 90.6% (29/32) and 96.6% (29/30) respectively, the detection rates of CsPCa were 61.1% (22/36), 68.8% (22/32) and 73.3% (22/30) respectively.The sensitivity, specificity, positive predictive value and negative predictive value of mpMRI in the diagnosis of prostate cancer were 96.8%(30/31), 68.4%(13/19), 83.3%(30/36)and 92.9%(13/14), respectively.Those values in 68Ga-PSMA PET/CT were 93.5%(29/31), 84.2%(16/19), 90.6%(29/32)and 88.9%(16/18), respectively.Those values in PET/CT-MRI were 93.8%(29/31), 94.7%(18/19), 96.7%(29/30)and 90.0%(18/20), respectively. The above four indicators of mpMRI diagnosis of CsPCa were 100.0%(22/22), 50.0%(14/28), 61.1%(22/36)and 100.0%(14/14), respectively.Those indicators in 68Ga-PSMA PET/CT were 100.0%(22/22), 64.3%(18/28), 68.8%(22/32)and 100.0%(18/18), respectively.Those indicators in PET/CT-MRI was 100.0%(22/22), 71.4%(20/28), 73.2%(22/30)and 100.0%(20/20), respectively. The detection efficiency of PET/CT-MRI was better than that of mpMRI (Kappa value was 0.737, P=0.031). Conclusions:PET/CT-MRI image fusion-guided targeted prostate biopsy can effectively improve the detection efficiency of prostate cancer and clinically significant prostate cancer, and increase the positive rate.
3.Efficacy and safety of radium-223 in 48 patients with bone metastatic castration resistant prostate cancer
Hongkai WANG ; Bo DAI ; Yao ZHU ; Xiaojian QIN ; Guowen LIN ; Beihe WANG ; Junlong WU ; Dingwei YE
Chinese Journal of Urology 2022;43(7):535-539
Objective:To observe the efficacy and safety of radium-223 in metastatic castration resistant prostate cancer (mCRPC) with bone metastasis.Methods:The clinical data of 48 patients with mCRPC treated with radium-223(55 kBq/kg, once every 4 weeks, planned to use for 6 cycles)from February 2021 to May 2022 were analyzed retrospectively. All patients had symptomatic bone metastasis without visceral metastasis, which the number of bone metastasis was more than one site.They were all classified as IVb stage. The average age was 70.5 (ranging 49-90) years. The median PSA was 44.70(ranging 0.15-1 864.00) ng/ml. The median ALP was 162 (ranging 43-1 589) U/L. The median time from mCRPC diagnosis to radium-223 use was 10 (ranging 3-47) months. 9, 18 and 11 patients had received first-line, second-line and third-line treatment for mCRPC before enrollment respectively, 10 patients had received at least fourth-line treatment. 38 (79.1%), 31 (64.5%), 30 (62.5%) and 7 (14.6%) patients had used abiraterone, enzalutamide, docetaxel and olaparib before enrollment. The probability of PSA level decrease >30%, ALP level decrease >30%, symptom improvement rate, median overall survival (OS), as well as the occurrence of treatment-related adverse reactions and the reasons for withdraw treatment were analyzed.Results:The median follow-up time was 8 (ranging 1-16) months. 11 patients completed all 6 courses of treatment. The median number of completed courses was 4 (ranging 1-6). 27 patients (56.2%) received radium-223 and bone protection drugs (Bisphosphate/ Denosumab). PSA decreased by >30% was recorded in 10 patients (20.8%) and ALP decreased by >30% was recorded in 25 patients (52.1%). 23 cases (47.9%) reported bone pain relief during treatment. Among the 9 patients who had received first-line of mCRPC previously, 6 cases (66%) had relief of bone pain symptoms, and 4 cases (44%) had a decrease of PSA >30%. Among the 18 patients who had previously received second-line mCRPC treatment, 11 cases (61%) had relief of bone pain symptoms, and 4 cases (22%) had a decrease of PSA >30%. Among the 21 patients who had received third-line or more mCRPC treatment in the past, 6 (28.5%) had symptom relief, and 2 (9.5%) had PSA decrease >30%. The median overall survival (OS) was not reached, and the OS was estimated to be 12.5 months using the Kaplan-Meier method. The most common hematological adverse effects were thrombocytopenia (15 cases, 31.2%; grade 3 in 6 cases and grade 4 in 0), followed by leucopenia (11 cases, 22.9%; grade 3 in 4 cases and grade 4 in 1 case) and anemia (8 cases, 16.7%; grade 3 in 3 cases and grade 4 in 0). Non-hematological adverse reactions included fever in 1 case (2.1%), constipation in 4 cases (8.3%), nausea and vomiting in 10 cases (20.8%), diarrhea in 7 cases (14.6%), dizziness in 1 case (2.1%) and fatigue in 11 cases (22.9%). Seven cases were discontinued due to intolerable adverse reactions (median 2 courses), 14 cases were discontinued due to disease progression or death (median 2 courses), and 5 cases were discontinued due to other reasons (median 1 course).Conclusions:Radium-223 has a good performance in symptom control for mCRPC patients who have previously received first-line or second-line therapy. Due to the high incidence of hematological adverse reactions, more attention should be paid to the changes of hemogram during the treatment, and timely treatment should be carried out to improve the drug tolerance of patients.
4.Clinical guideline for spinal reconstruction of osteoporotic thoracolumbar fracture in elderly patients (version 2022)
Tao SUI ; Jian CHEN ; Zhenfei HUANG ; Zhiyi HU ; Weihua CAI ; Lipeng YU ; Xiaojian CAO ; Wei ZHOU ; Qingqing LI ; Jin FAN ; Qian WANG ; Pengyu TANG ; Shujie ZHAO ; Lin CHEN ; Zhiming CUI ; Wenyuan DING ; Shiqing FENG ; Xinmin FENG ; Yanzheng GAO ; Baorong HE ; Jianzhong HUO ; Haijun LI ; Jun LIU ; Fei LUO ; Chao MA ; Zhijun QIAO ; Qiang WANG ; Shouguo WANG ; Xiaotao WU ; Nanwei XU ; Jinglong YAN ; Zhaoming YE ; Feng YUAN ; Jishan YUAN ; Jie ZHAO ; Xiaozhong ZHOU ; Mengyuan WU ; Yongxin REN ; Guoyong YIN
Chinese Journal of Trauma 2022;38(12):1057-1066
Osteoporotic thoracolumbar fracture in the elderly will seriously reduce their quality of life and life expectancy. For osteoporotic thoracolumbar fracture in the elderly, spinal reconstruction is necessary, which should comprehensively consider factors such as the physical condition, fracture type, clinical characteristics and osteoporosis degree. While there lacks relevant clinical norms or guidelines on selection of spinal reconstruction strategies. In order to standardize the concept of spinal reconstruction for osteoporotic thoracolumbar fracture in the elderly, based on the principles of scientificity, practicality and progressiveness, the authors formulated the Clinical guideline for spinal reconstruction of osteoporotic thoracolumbar fracture in elderly patients ( version 2022), in which suggestions based on evidence of evidence-based medicine were put forward upon 10 important issues related to the fracture classification, non-operative treatment strategies and surgical treatment strategies in spinal reconstruction after osteoporosis thoracolumbar fracture in the elderly, hoping to provide a reference for clinical treatment.
5.Clinical analysis of cryotherapy in patients with primary tumor recurrence after radical radiotherapy for prostate cancer
Guowen LIN ; Bo DAI ; Dingwei YE ; Yao ZHU ; Xiaojian QIN ; Hongkai WANG
Chinese Journal of Urology 2021;42(9):662-665
Objective:To explore the clinical value of cryoablation technology in the treatment of patients with primary tumor recurrence after radical radiotherapy for prostate cancer.Methods:The clinical data of 21 patients with prostate cancer recurrence after radical radiotherapy in the Fudan University Affiliated Cancer Hospital from August 2017 to February 2021 was retrospectively analyzed. The average age was 73.1 (57.3-85.0) years old, and the Gleason score was 6 in 5 cases, 7 in 8 cases, and ≥8 in 8 cases. The clinical stage of the first diagnosis: 13 cases of cT 2 stage; 8 cases of cT 3 stage. The baseline PSA before radiotherapy was 35.3 (6.4-78.5) ng/ml, and the lowest PSA after radiotherapy was 1.8 ng/ml. After a median follow-up of 8 (3-12) months, all patients were detected with persistently elevated PSA. Pelvic MRI and PSMA SPECT showed that the primary prostate lesion had recurred. PSA before cryoablation was 4.1 (1.8-14.4) ng/ml. Comprehensive assessment of preoperative examination showed that the patient only had a recurrence of the primary tumor, and no lymph node or distant metastasis was seen. An argon-helium cryogenic surgical treatment system was used to place 1 to 3 cryo-needles for recurring lesions, and cryoablation was performed using two cold and hot cycles. Observation indicators include prognostic indicators such as PSA, recurrence and metastasis, and the occurrence of adverse reactions. Results:Complications after cryoablation include: 2 cases of urinary retention, 1 case of urinary tract infection, and 2 cases of urination with tissue shedding. The PSA of 11 cases decreased rapidly 2 to 3 months after operation, and dropped to the lowest median value of 0.4 (0.003 to 2.8) ng/ml. After cryoablation, the median follow-up was 18 (6-51) months. Imaging examinations in 1 case showed that the prostate still had limited diffusion or increased PSMA uptake, and 4 cases had PSA progression but no recurrence or metastasis. The median recurrence time for advanced patients was 13 (4-36) months. Larger prostate volume ( P<0.001) and higher blood PSA before ablation( P=0.021) were related to biochemical recurrence. Conclusions:Prostate cryoablation could delay the progression of the primary tumor after radical radiotherapy for prostate cancer. The incidence of complications such as urinary retention and urinary tract infection is not high, and it is generally safe and controllable.
6.Application of regional lymph node dissection in patients with metastatic castration resistant prostate cancer
Hongkai WANG ; Bo DAI ; Yao ZHU ; Guowen LIN ; Xiaojian QIN ; Dingwei YE
Chinese Journal of Urology 2021;42(9):670-674
Objective:To observe the clinical effect and safety of regional lymph node dissection in metastatic castration resistant prostate cancer(mCRPC).Methods:The clinical data of 22 patients with mCRPC who underwent regional lymph node dissection in our hospital from August 2015 to May 2021 were retrospectively analyzed. All patients had undergone radical prostatectomy and entered mCRPC, metastatic lymph nodes limited to pelvic or retroperitoneal without other metastasis were determined by PSMA-PET in 5 cases and PSMA-SPECT in 17 cases. The median time from radical surgery to mCRPC was 32 (4-96) months, and the median time from discovery of mCRPC to regional lymph node dissection was 4 (1-43) months. The median PSA before regional lymph node dissection was 4.44 (2.00-22.15) ng/ml. Image of local examination showed pelvic lymph node metastasis in 16 cases, retroperitoneal lymph node metastasis in 3 cases, pelvic together with retroperitoneal lymph node metastasis in 3 cases. Before regional lymph node dissection, 18 patients were treated with drug castration combined with first-generation antiandrogens, and 4 patients were treated with drug castration combined with abiraterone. The lymph node dissection range was determined according to the location of metastatic lymph nodes. Obturator lymph nodes and lymph node metastasis around external iliac and internal iliac vessels: the range of dissection includes fibrous adipose tissue around external iliac vein and internal iliac vein, and obturator lymph adipose tissue. Common iliac and pelvic floor lymph node metastasis: dissect lymphoid adipose tissue around common iliac vessels on the basis of the original dissection range as far as the aortic bifurcation. Retroperitoneal lymph node metastasis: remove all lymph node adipose tissue located between the bifurcation of renal artery and aorta. The PSA remission rate, PSA remission time, surgical complications and other relevant clinicopathological features were analyzed.Results:Among the 22 cases, 6 cases underwent unilateral pelvic lymph node dissection, 10 cases underwent bilateral pelvic lymph node dissection, 3 cases underwent retroperitoneal lymph node dissection, and 3 cases underwent pelvic and retroperitoneal lymph node dissection at the same time. 19 cases (86.3%) showed positive lymph nodes by pathology. An average of 9.8 (3-29) lymph nodes were dissected in each patient, with an average of 4.1 (0-12) positive lymph nodes. All 22 cases continued to use the previous anti-androgen therapy after lymph node dissection. 17 cases (77.3%) achieved PSA remission after operation, of which 9 cases developed PSA progression, and the median PSA progression time was 12 (2-36) months. Univariate analysis showed that PSA value during radical operation ( P=0.029), N stage during radical operation ( P=0.057), the number of positive lymph nodes during regional lymph node dissection ( P=0.069) and the location of lymph node metastasis during regional lymph node dissection ( P =0.005) were related to the progression time of PSA. Postoperative complications: lymphatic leakage in 7 cases; 5 cases of postoperative fever, of which 1 case was confirmed to have pelvic bacterial infection. One patient suffered from massive intra-operative bleeding due to the invasion of blood vessels by metastatic lymph nodes. After timely hemostasis during the operation, the patient returned to the ward and was discharged 6 days later. One case of intestinal obstruction, and 1 case of body surface wound infection. 6 cases of lymphatic leakage healed within 1 month after operation, and 1 case of lymphatic leakage healed within 3 months after operation. Conclusions:For mCRPC patients with lymph node metastasis which could be surgically removed, regional lymph node dissection may further delay the starting time of posterior drugs, and the complications are relatively controllable.
7.Comprehensive treatment of metastatic hormone sensitive prostate cancer: a case report and literature review
Guowen LIN ; Bo DAI ; Dingwei YE ; Yao ZHU ; Xiaojian QIN ; Hongkai WANG
Chinese Journal of Urology 2021;42(Z1):54-58
Retrospectively analyze the clinicopathological data of a patient with metastatic hormone sensitive prostate cancer, and review relevant literature. The patient was male, 68 years old. Complaints of dysuria and urgency for half a year. Blood PSA>100 ng/ml, magnetic resonance showed that the prostate was occupying space, the boundary with the seminal vesicle gland was not clear, and the pelvic cavity had multiple bone lesions. Bone scan revealed multiple bone metastases. The prostate biopsy showed adenocarcinoma, Gleason score 5+ 5. The clinical stage was T 3N 0M 1b.A palliative transurethral resection of the prostate was performed due to urination obstruction, and endocrine therapy with medical castration combined with abiraterone and prednisone. PSA was continuously controlled at <0.006 ng/ml. After half a year of treatment, the prostate-specific membrane antigen single-photon emission computerized tomography and magnetic resonance examination revealed sternal and parasternal soft tissue lesions. Local radiotherapy and continuous endocrine therapy were given. The disease was under long-term control.There are various treatment options for metastatic hormone sensitive prostate cancer. Medical castration treatment combined with abiraterone and prednisone can effectively control the disease with mild adverse reactions. Palliative transurethral resection of the prostate can improve the symptoms of urinary obstruction and may also improve the prognosis of patients.
8.Effect of band ligation or combined with tissue adhesive in the treatment of gastroesophageal varices and portal vein blood flow situational changes
Yating XU ; Jingjing WEI ; Xiaojian YE ; Dawu ZENG ; Su LIN ; Hua FAN ; Chengdang WANG ; Zehao ZHUANG
Chinese Journal of Hepatology 2021;29(5):468-471
42 cases with gastroesophageal varices were prospectively included. The groups were treated with endoscopic band ligation or combined with tissue adhesive. The results showed that the left gastric vein internal diameter, average blood flow velocity and blood flow volume after the treatment of band ligation combined with tissue adhesive were significantly lower than that of the treatment of band ligation alone, and the differences were statistically significant ( P < 0.05). Spleen and portal vein internal diameter, blood flow and average velocity, the liver and spleen size, shear wave velocity and liver function grade of the two groups after treatment did not change significantly ( P > 0.05). The effective rate of band ligation combined with tissue adhesive in the treatment of esophageal and gastric varices (66.67%, 52.38%) were higher than that of band ligation alone (42.85%, 23.81%) ( P > 0.05), and the re-bleeding rate of the latter was higher (9.52% and 19.05%, P > 0.05). Hence, it is suggested that the combined therapy is safe and more effective, and has no apparent effect on liver function and portal hypertension.
9. Chemotherapy combined with androgen-deprivation therapy in high-volume metastatic hormone sensitive prostate cancer: a short-term efficacy and safety analysis
Peihang XU ; Yijun SHEN ; Wenjun XIAO ; Guowen LIN ; Xiaojian QIN ; Yao ZHU ; Bo DAI ; Dingwei YE
Chinese Journal of Surgery 2019;57(6):418-421
Objective:
To investigate the short-term efficacy and adverse events of chemotherapy combined with androgen-deprivation therapy in high-volume metastatic hormone sensitive prostate cancer.
Methods:
From March 2015 to August 2017, 55 patients with high-volume metastatic hormone sensitive prostate cancer were enrolled at Department of Urology, Fudan University Shanghai Cancer Center receiving chemotherapy combined with androgen-deprivation therapy. The age was 65(8) years (
10.Accordion technique used in treatment of hypertrophic nonunion
Chinese Journal of Orthopaedic Trauma 2018;20(4):318-322
Objective To evaluate the therapeutic effects of the accordion technique used in external fixation for long bone hypertrophic nonunion.Methods From August 2013 to December 2015,13 patients with hypertrophic nonunion were treated by the accordion technique (distraction,compression and re-distraction) used together with an Ilizarov ring external fixator or a monolateral external fixator.They were 10 males and 3 females with an average age of 44.6 years (from 18 to 63 years).The nonunion occurred in the middle femur in 5 patients,in the femoral supracondyle in one,in the tibial diaphysis in 4,and in the distal tibia in 3.The procedure was performed with a preassembled external fixator without open surgery or bone graft.The pathological sites were gradually distracted (0.25 mm/day) from the seventh day postoperatively.In case of deformity,correction was conducted to restore the alignment.At the same rate of distraction,compression was started after the equal length was achieved and next followed by distraction.The frequency of cycle depended upon the callus observed in the X-rays.Results The mean follow-up for the 13 patients was 19 months (from 10 to 38 months) after removal of the external fixator.All the cases of hypertrophic nonunion obtained bony union after a mean duration of 7.5 months (from 5 to 13 months).No nonunion or deformity recurred during the follow-up.The complications such as pin-site infection (in 4 cases) and mild Achilles's tendon contracture (in 2 cases) were prevented or treated by careful nursing and rehabilitation.Conclusion The accordion technique together with an external fixator is a reliable and effective treatment for hypertrophic nonunion.

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