1.Effect of ligation methods of inferior mesenteric artery on preserving left colic artery in lapa-roscopic radical resection of rectal cancer: a prospective randomized controlled study
Yang LUO ; Minhao YU ; Guangyao YE ; Feng GUO ; Yifei MU ; Ming ZHONG ; Zizhen ZHANG ; Lei GU
Chinese Journal of Digestive Surgery 2025;24(6):746-753
Objective:To investigate the effect of ligation methods of inferior mesenteric artery (IMA) on preserving left colic artery (LCA) in laparoscopic radical resection of rectal cancer.Methods:The prospective randomized controlled study was conducted. The clinical data of 864 patients who underwent laparoscopic radical resection of rectal cancer at Renji Hospital of Shanghai Jiaotong University School of Medicine from January 2020 to December 2024 were selected. Patients were randomly divided into the low ligation group and high ligation group using a random number table. Patients of the low ligation group underwent laparoscopic radical resection of rectal cancer with preserving LCA by low ligation of IMA and apical lymph node dissection, and patients of the high ligation group underwent laparoscopic radical resection of rectal cancer with traditional high ligation of IMA. Observation indicators: (1) grouping of the enrolled patients; (2) intraoperative conditions; (3) postoperative pathological examination; (4) postoperative recovery. Comparison of measurement data with normal distribution between groups was conducted using the independent sample t test. Comparison of count data between groups was conducted using the chi-square test or Fisher exact probability. Comparison of ordinal data between groups was conducted using the non-parametric test. Results:(1) Grouping of the enrolled patients. A total of 864 patients with rectal cancer who underwent laparoscopic radical resection of rectal cancer were screened for eligibility, including 410 males and 454 females, aged (63±11)years. All 864 patients were randomly divided into the low ligation group and high ligation group, with 432 patients in each group. There was no significant difference in gender, age, body mass index, carcinoembryonic antigen, distance from tumor to anal margin, diabetes, hypertension, neoadjuvant radiochemotherapy, IMA subtypes and IMA length between the two groups ( P>0.05), ensuring comparability. (2) Intraoperative conditions. All patients of the two groups successfully completed surgery, with no errors in blood vessel ligation during operation or conversion to open surgery. There was a significant difference in time of IMA dissection between the low ligation group and high ligation group [(31±11)minutes vs. (28±9)minutes, t=4.39, P<0.05], and there was no significant difference in total operation time, volume of intra-operative blood loss or prophylactic stoma rate between the two groups ( P>0.05). (3) Postopera-tive pathological examination. There was a significant difference in the number of lymph node dissected between the low ligation group and high ligation group (1.8±1.4 vs. 1.5±1.4, t=2.51, P<0.05), and there was no significant difference in tumor diameter, the total number of lymph node dissected, total lymph node positive status, No.253 lymph node positive status, TNM staging between the two groups ( P>0.05). (4) Postoperative recovery. The time to postoperative first flatus and the number of anastomotic leakage of patients in the low ligation group were (74±22)hours and 16 cases, versus (78±20)hours and 31 cases in the high ligation group, respectively, showing significant differences in the above indicators between the two groups ( t=2.52, χ2=5.06, P<0.05). There was no significant difference in the time to postoperative initial liquid food intake, duration of post-operative hospital stay, duration of abdominal drainage tube indwelling, duration of anal tube indwelling, postoperative wound infection, pulmonary infection, intestinal obstruction, or urinary dysfunction between the two groups ( P>0.05). None of patients in the two groups had readmission or death during the postoperative 30 days. Conclusion:Low ligation of IMA in laparoscopic radical resection of rectal cancer can guide precise LCA preservation, which is beneficial for accelerating the recovery of intestinal function and reducing the incidence of anastomotic leakage.
2.Effect of ligation methods of inferior mesenteric artery on preserving left colic artery in lapa-roscopic radical resection of rectal cancer: a prospective randomized controlled study
Yang LUO ; Minhao YU ; Guangyao YE ; Feng GUO ; Yifei MU ; Ming ZHONG ; Zizhen ZHANG ; Lei GU
Chinese Journal of Digestive Surgery 2025;24(6):746-753
Objective:To investigate the effect of ligation methods of inferior mesenteric artery (IMA) on preserving left colic artery (LCA) in laparoscopic radical resection of rectal cancer.Methods:The prospective randomized controlled study was conducted. The clinical data of 864 patients who underwent laparoscopic radical resection of rectal cancer at Renji Hospital of Shanghai Jiaotong University School of Medicine from January 2020 to December 2024 were selected. Patients were randomly divided into the low ligation group and high ligation group using a random number table. Patients of the low ligation group underwent laparoscopic radical resection of rectal cancer with preserving LCA by low ligation of IMA and apical lymph node dissection, and patients of the high ligation group underwent laparoscopic radical resection of rectal cancer with traditional high ligation of IMA. Observation indicators: (1) grouping of the enrolled patients; (2) intraoperative conditions; (3) postoperative pathological examination; (4) postoperative recovery. Comparison of measurement data with normal distribution between groups was conducted using the independent sample t test. Comparison of count data between groups was conducted using the chi-square test or Fisher exact probability. Comparison of ordinal data between groups was conducted using the non-parametric test. Results:(1) Grouping of the enrolled patients. A total of 864 patients with rectal cancer who underwent laparoscopic radical resection of rectal cancer were screened for eligibility, including 410 males and 454 females, aged (63±11)years. All 864 patients were randomly divided into the low ligation group and high ligation group, with 432 patients in each group. There was no significant difference in gender, age, body mass index, carcinoembryonic antigen, distance from tumor to anal margin, diabetes, hypertension, neoadjuvant radiochemotherapy, IMA subtypes and IMA length between the two groups ( P>0.05), ensuring comparability. (2) Intraoperative conditions. All patients of the two groups successfully completed surgery, with no errors in blood vessel ligation during operation or conversion to open surgery. There was a significant difference in time of IMA dissection between the low ligation group and high ligation group [(31±11)minutes vs. (28±9)minutes, t=4.39, P<0.05], and there was no significant difference in total operation time, volume of intra-operative blood loss or prophylactic stoma rate between the two groups ( P>0.05). (3) Postopera-tive pathological examination. There was a significant difference in the number of lymph node dissected between the low ligation group and high ligation group (1.8±1.4 vs. 1.5±1.4, t=2.51, P<0.05), and there was no significant difference in tumor diameter, the total number of lymph node dissected, total lymph node positive status, No.253 lymph node positive status, TNM staging between the two groups ( P>0.05). (4) Postoperative recovery. The time to postoperative first flatus and the number of anastomotic leakage of patients in the low ligation group were (74±22)hours and 16 cases, versus (78±20)hours and 31 cases in the high ligation group, respectively, showing significant differences in the above indicators between the two groups ( t=2.52, χ2=5.06, P<0.05). There was no significant difference in the time to postoperative initial liquid food intake, duration of post-operative hospital stay, duration of abdominal drainage tube indwelling, duration of anal tube indwelling, postoperative wound infection, pulmonary infection, intestinal obstruction, or urinary dysfunction between the two groups ( P>0.05). None of patients in the two groups had readmission or death during the postoperative 30 days. Conclusion:Low ligation of IMA in laparoscopic radical resection of rectal cancer can guide precise LCA preservation, which is beneficial for accelerating the recovery of intestinal function and reducing the incidence of anastomotic leakage.
3.Laparoscopic subtotal colectomy with antiperistaltic cecorectal anastomosis versus laparoscopic total colectomy with ileorectal anastomosis for slow transit constipation: a multicenter retrospective cohort study
Yang LUO ; Taotao HOU ; Yifei MU ; Chundi MIAO ; Tingyue GONG ; Jun QIN ; Dongyang WANG ; Dawei SONG ; Hao LI ; Shaolan QIN ; Rong CUI ; Tingfeng WANG ; Ming ZHONG ; Minhao YU
Chinese Journal of Gastrointestinal Surgery 2025;28(12):1426-1433
Objective:To compare postoperative anal function recovery between laparoscopic subtotal colectomy with antiperistaltic cecorectal anastomosis and laparoscopic total colectomy with ileorectal anastomosis for slow transit constipation.Methods:This multicenter retrospective cohort study enrolled patients meeting the following criteria: (1) severe constipation symptoms (<2 bowel movements/week), absent or insignificant defecation urge, abdominal distension, requiring laxatives to maintain bowel movements or laxatives being ineffective; (2) constipation symptoms for over 5 years, ineffective after >2 years of medical treatment, with strong desire for surgery; (3) significantly prolonged colon transit time (>72 hours) without significant gastric or small intestinal transit dysfunction; (4) no organic colonic lesions confirmed by colonoscopy and abdominal CT. Exclusion criteria: (1) patients undergoing open surgery; (2) exclusion of outlet obstruction constipation (e.g., rectocele, rectal prolapse, puborectalis spasm) by functional defecation MRI; (3) comorbid psychiatric disorders; (4) missing clinical data or loss to follow-up (postoperative follow-up <24 months). Based on these criteria, clinical and follow-up data were collected from 220 patients who underwent either laparoscopic subtotal colectomy with antiperistaltic cecorectal anastomosis (LSC group, n = 115) or laparoscopic total colectomy with ileorectal anastomosis (LTC group, n = 105) for slow transit constipation between January 2013 and December 2022. Subjective anal function (Constipation Severity Score and Wexner Fecal Incontinence Score) and objective anal function (positive rate of rectoanal inhibitory reflex [RAIR] and anorectal manometry) were observed preoperatively and at 6, 12, and 24 months postoperatively. Results:No significant differences were found in baseline characteristics between the two groups (all P >0.05). All surgeries were completed successfully without major significant complications. Subjective anal function assessment: At 24 months postoperatively, Constipation Severity Scores decreased significantly compared to preoperative scores in both groups [LSC group: (25.2±2.8) vs. (2.9±1.8), P <0.001; LTC group: (25.8±2.9) vs. (2.8±1.9), P<0.001]. No significant differences were found between the groups at 6, 12, and 24 months postoperatively (all P>0.05). Wexner Fecal Incontinence Scores at 24 months were significantly lower than those at 6 months in both groups [LSC group: (12.9±1.8) vs. (3.9±2.5), P<0.001; LTC group: (12.6±1.8) vs. (5.4±2.4), P<0.001]. Although no significant difference was found at 6 months ( P = 0.190), the LSC group had significantly lower Wexner scores than the LTC group at 12 and 24 months postoperatively (both P < 0.001). Objective anal function assessment: (1) Positive RAIR rate: Preoperative positive RAIR rates were 33.0% (38/115) in the LSC group and 25.7% (27/105) in the LTC group ( P > 0.05). At 24 months, positive rates increased significantly in both groups [LSC: 66.1% (76/115); LTC: 63.8% (67/105)] compared to preoperative rates (both P<0.001), but no significant differences were found between groups at 6, 12, and 24 months (all P>0.05). (2) Resting pressure (RP) and squeeze pressure (SP): No significant differences were found in preoperative RP and SP between groups (all P>0.05). The LSC group had significantly higher RP and SP than the LTC group at 6 and 12 months postoperatively (all P<0.05), but no significant differences were found at 24 months ( P>0.05). Conclusion:Both laparoscopic subtotal colectomy with antiperistaltic cecorectal anastomosis and laparoscopic total colectomy with ileorectal anastomosis are safe for patients with slow transit constipation. However, laparoscopic subtotal colectomy with antiperistaltic cecorectal anastomosis offers superior postoperative anal function recovery.
4.Advancements and applications in radiopharmaceutical therapy.
Shiya WANG ; Mingyi CAO ; Yifei CHEN ; Jingjing LIN ; Jiahao LI ; Xinyu WU ; Zhiyue DAI ; Yuhan PAN ; Xiao LIU ; Xian LIU ; Liang-Ting LIN ; Jianbing WU ; Ji LIU ; Qifeng ZHONG ; Zhenwei YUAN
Chinese Journal of Natural Medicines (English Ed.) 2025;23(6):641-657
Radiopharmaceuticals operate by combining radionuclides with carriers. The radiation energy emitted by radionuclides is utilized to selectively irradiate diseased tissues while minimizing damage to healthy tissues. In comparison to external beam radiation therapy, radionuclide drugs demonstrate research potential due to their biological targeting capabilities and reduced normal tissue toxicity. This article reviews the applications and research progress of radiopharmaceuticals in cancer treatment. Several key radionuclides are examined, including 223Ra, 90Y, Lutetium-177 (177Lu), 212Pb, and Actinium-225 (225Ac). It also explores the current development trends of radiopharmaceuticals, encompassing the introduction of novel radionuclides, advancements in imaging technologies, integrated diagnosis and treatment approaches, and equipment-medication combinations. We review the progress in the development of new treatments, such as neutron capture therapy, proton therapy, and heavy ion therapy. Furthermore, we examine the challenges and breakthroughs associated with the clinical translation of radiopharmaceuticals and provide recommendations for the research and development of novel radionuclide drugs.
Humans
;
Radiopharmaceuticals/therapeutic use*
;
Neoplasms/radiotherapy*
;
Radioisotopes/therapeutic use*
;
Animals
5.Laparoscopic subtotal colectomy with antiperistaltic cecorectal anastomosis versus laparoscopic total colectomy with ileorectal anastomosis for slow transit constipation: a multicenter retrospective cohort study
Yang LUO ; Taotao HOU ; Yifei MU ; Chundi MIAO ; Tingyue GONG ; Jun QIN ; Dongyang WANG ; Dawei SONG ; Hao LI ; Shaolan QIN ; Rong CUI ; Tingfeng WANG ; Ming ZHONG ; Minhao YU
Chinese Journal of Gastrointestinal Surgery 2025;28(12):1426-1433
Objective:To compare postoperative anal function recovery between laparoscopic subtotal colectomy with antiperistaltic cecorectal anastomosis and laparoscopic total colectomy with ileorectal anastomosis for slow transit constipation.Methods:This multicenter retrospective cohort study enrolled patients meeting the following criteria: (1) severe constipation symptoms (<2 bowel movements/week), absent or insignificant defecation urge, abdominal distension, requiring laxatives to maintain bowel movements or laxatives being ineffective; (2) constipation symptoms for over 5 years, ineffective after >2 years of medical treatment, with strong desire for surgery; (3) significantly prolonged colon transit time (>72 hours) without significant gastric or small intestinal transit dysfunction; (4) no organic colonic lesions confirmed by colonoscopy and abdominal CT. Exclusion criteria: (1) patients undergoing open surgery; (2) exclusion of outlet obstruction constipation (e.g., rectocele, rectal prolapse, puborectalis spasm) by functional defecation MRI; (3) comorbid psychiatric disorders; (4) missing clinical data or loss to follow-up (postoperative follow-up <24 months). Based on these criteria, clinical and follow-up data were collected from 220 patients who underwent either laparoscopic subtotal colectomy with antiperistaltic cecorectal anastomosis (LSC group, n = 115) or laparoscopic total colectomy with ileorectal anastomosis (LTC group, n = 105) for slow transit constipation between January 2013 and December 2022. Subjective anal function (Constipation Severity Score and Wexner Fecal Incontinence Score) and objective anal function (positive rate of rectoanal inhibitory reflex [RAIR] and anorectal manometry) were observed preoperatively and at 6, 12, and 24 months postoperatively. Results:No significant differences were found in baseline characteristics between the two groups (all P >0.05). All surgeries were completed successfully without major significant complications. Subjective anal function assessment: At 24 months postoperatively, Constipation Severity Scores decreased significantly compared to preoperative scores in both groups [LSC group: (25.2±2.8) vs. (2.9±1.8), P <0.001; LTC group: (25.8±2.9) vs. (2.8±1.9), P<0.001]. No significant differences were found between the groups at 6, 12, and 24 months postoperatively (all P>0.05). Wexner Fecal Incontinence Scores at 24 months were significantly lower than those at 6 months in both groups [LSC group: (12.9±1.8) vs. (3.9±2.5), P<0.001; LTC group: (12.6±1.8) vs. (5.4±2.4), P<0.001]. Although no significant difference was found at 6 months ( P = 0.190), the LSC group had significantly lower Wexner scores than the LTC group at 12 and 24 months postoperatively (both P < 0.001). Objective anal function assessment: (1) Positive RAIR rate: Preoperative positive RAIR rates were 33.0% (38/115) in the LSC group and 25.7% (27/105) in the LTC group ( P > 0.05). At 24 months, positive rates increased significantly in both groups [LSC: 66.1% (76/115); LTC: 63.8% (67/105)] compared to preoperative rates (both P<0.001), but no significant differences were found between groups at 6, 12, and 24 months (all P>0.05). (2) Resting pressure (RP) and squeeze pressure (SP): No significant differences were found in preoperative RP and SP between groups (all P>0.05). The LSC group had significantly higher RP and SP than the LTC group at 6 and 12 months postoperatively (all P<0.05), but no significant differences were found at 24 months ( P>0.05). Conclusion:Both laparoscopic subtotal colectomy with antiperistaltic cecorectal anastomosis and laparoscopic total colectomy with ileorectal anastomosis are safe for patients with slow transit constipation. However, laparoscopic subtotal colectomy with antiperistaltic cecorectal anastomosis offers superior postoperative anal function recovery.
6.The effect of staged thematic painting therapy on children with emotional disorders: a quasi-experimental study
Juan CHEN ; Yifei CHEN ; Hui ZHONG ; Wen HUANG ; Lei LIU ; Gengfu WANG ; Lianying XU
Chinese Journal of Practical Nursing 2024;40(1):2-7
Objective:To explore the effects of staged thematic painting therapy on positive emotions, alexithymia and self-efficacy in children with emotional disorders.Methods:This was a quasi-experimental study. By convenient sampling, 61 children with emotional disorders admitted from January 2022 to December 2022 to the Department of Child and Adolescent Psychology, Affiliated Psychological Hospital of Anhui Medical University were selected as the research objects, 31 patients admitted from January 2022 to June 2022 were listed as the control group and 30 patients admitted from July 2022 to December 2022 were listed as the observation group according to the time of admission.The control group was given routine psychiatric care, and the observation group was given staged thematic painting therapy on this basis. The intervention time was 6 weeks. The intervention effect was evaluated by Positive and Negative Affect Scale,Toronto Alexithymia Scale, and General Self-Efficacy Scale.Results:There were 15 males and 16 females in the control group, aged (14.19 ± 1.79) years old. There were 13 males and 17 females in the observation group, aged (14.47 ± 1.55) years old. The difference in baseline data between the two groups was not statistically significant ( P>0.05) and was comparable. There was no significant difference in the score of positive emotions, alexithymia and self-efficacy before intervention between the two groups (all P>0.05). After intervention, the scores of positive emotions and self-efficacy in the observation group were (43.20±7.41), (31.88 ± 5.42) points, which were higher than those in the control group (33.81 ± 6.92), (21.24 ± 5.41) points, the differences were statistically significant ( t=-6.19, -5.63, both P<0.05). After intervention, the scores of alexithymia in the observation group was (53.44 ± 4.68) points, which was lower than that in the control group (60.44 ± 5.52) points, the difference was statistically significant ( t=-8.72, P<0.05). Conclusions:Staged thematic painting therapy can effectively improve the positive emotions, self-efficacy and alexithymia level of children with emotional disorders, help the patients establish confidence to overcome the disease. It is valuable in clinical practice.
7.A multicenter, randomized controlled clinical trial of Pseudomonas aeruginosa injection for prevention of recurrent urinary tract infections
Zhen DU ; Liang CUI ; Zhan GAO ; Yi ZHI ; Gang CUI ; Peng ZHANG ; Hongfeng GUO ; Shan ZHONG ; Benkang SHI ; Yan LI ; Yong ZHANG ; Yifei XING ; Shan CHEN ; Ludong QIAO
Chinese Journal of Urology 2024;45(12):925-931
Objective:To investigate the clinical efficacy and safety of Pseudomonas aeruginosa injection in preventing reurrent urinary tract infection in women. Methods:This was a multicenter, randomized, open, positive-controlled, non-inferiority trial involving female patients with recurrent urinary tract infections (rUTIs) who were admitted to 11 medical centers in China. Inclusion criteria: ①Aged 18-70 years, with verifiable clinical data showing at least 3 episodes of acute UTIs within 1 year and at least 2 episodes within 6 months, and cured by antimicrobial therapy; ② At the time of enrollment, the patients had no obvious symptoms of urinary tract irritation, normal white blood cell count in midstream urine routine (within the normal range of laboratory standards of each unit) or ≤3HP by centrifuge microscopy, negative leucocyte esterase and nitrite, and negative urine culture; ③No abnormal urinary anatomic function (such as urinary obstruction, calculus or congenital urinary malformation) and residual urine volume ≤50 ml were detected by B-ultrasound of urinary system; ④Informed consent signed by the person or agent; ⑤Clear consciousness, able to answer questions independently, according to the requirements of the test plan to complete the research questionnaire. Exclusion criteria: ①Patients allergic to the above drugs; ②Any complex signs of urinary tract infection or pyelonephritis (manifested as low back pain, fever ≥37.3℃, systemic symptoms); ③Drugs affecting immune function were used within 7 days before randomization; ④Patients with basic diseases of urinary system such as obstruction, calculus, urinary stenosis, vesicoureteral reflux or other functional abnormalities, urine diversion, indwelling catheter or stent tube or intermittent catheterization; ⑤Combined with or existing systemic lupus erythematosus, AIDS and other diseases that can lead to systemic immune function abnormalities; ⑥Patients who are known or suspected to be pregnant, breastfeeding, or planning a pregnancy within 3 months of stopping the drug; ⑦Patients with malignant tumors and mental patients; ⑧Persons who have received any other investigational drug treatment or participated in another interventional clinical trial within 4 weeks prior to screening; ⑨Failure to comply with the trial protocol or other conditions deemed unsuitable for enrollment by the investigator. Patients were randomly divided into 2 groups. The experimental group was given Pseudomonas aeruginosa injection for 5 times, 0.5 ml for the first time, and 1 ml/ time per week for the following 4 weeks. The control group was given fosfomycin aminotriol 3g orally, once every 10 days, for 9 consecutive times. The patients were followed up for 6 to 8 months, during which urinary tract symptoms developed and routine urine tests showed abnormally elevated white blood cells, which was defined as recurrent UTIs. Urine routine, liver and kidney function, and urinary secretory immunoglobulin A(SIgA) were reviewed 0-2 days (V2) after the 5th administration of the experimental group and the 4th administration of the control group. Urine routine and urine SIgA were reviewed at (90±10) d (V3) and (180±10) d (V4) after treatment. At (270±10) d (V5) after treatment, the recurrence (re-infection caused by the same species of bacteria) or re-infection (re-infection caused by non-same species of bacteria) of the two groups were compared, and non-inferiority analysis was performed, and the non-inferiority threshold was set at 0.2. Results:From March 2021 to May 2022, a total of 152 rUTIs patients were enrolled in this study, including 80 patients in the experimental group, 71 patients in the intention-to-analysis set (ITT) and 66 patients in the protocol analysis set (PPS). In the control group, 72 cases met ITT in 69 cases and PPS in 67 cases. There were no significant differences in age, body mass index, marital status, duration of urinary tract infection, history of diabetes, history of previous major surgery, history of infection, and urinary SIgA between the two groups (all P>0.05). The recurrence rates of the experimental group and the control group at V5 time point were 44.78% (30/67) and 42.65% (29/68), respectively ( P=0.803) (ITT data set analysis results showed that the difference in recurrence rates between the two groups was 0.0213(95% CI-0.1460-0.1886, P=0.0048). PPS data set analysis showed that the difference of recurrence rate between the two groups was -0.0021(95%CI -0.1711-0.1670, P=0.0109), and the recurrence rate of the experimental group was not worse than that of the control group. At V2 time points, there were no significant differences in liver and kidney function indexes between test group and control group ( P>0.05). At V2 to V4 time points, urinary SIgA of test group and control group were 0.90 (0.37, 2.89) mg/L and 1.32 (0.34, 3.08) mg/L, 1.54 (0.44, 3.23) mg/L and 1.71 (0.27, 2.92) mg/L, 1.11 (0.65, 3.42) mg/L and 2.18 (0.43, 3.26) mg/L, there was no statistical significance ( P>0.05). The incidence of adverse events in the experimental group was 30.0% (24/80), including 14 cases of redness, pain and discomfort at the injection site, 5 cases of fever, 2 cases of allergic rash, and 1 case of urticaria, headache and constipation each. The incidence of adverse events in the control group was 5.6% (4/72), all of which were diarrhea, and the difference between the two groups was statistically significant ( P<0.01). No life-threatening serious adverse events occurred in both groups, and all adverse events were self-healing without additional intervention. Conclusions:Compared with fosfomycin aminotriol, Pseudomonas aeruginosa injection has the same clinical effect in preventing rUTI and has good safety.
8.A multicenter, randomized controlled clinical trial of Pseudomonas aeruginosa injection for prevention of recurrent urinary tract infections
Zhen DU ; Liang CUI ; Zhan GAO ; Yi ZHI ; Gang CUI ; Peng ZHANG ; Hongfeng GUO ; Shan ZHONG ; Benkang SHI ; Yan LI ; Yong ZHANG ; Yifei XING ; Shan CHEN ; Ludong QIAO
Chinese Journal of Urology 2024;45(12):925-931
Objective:To investigate the clinical efficacy and safety of Pseudomonas aeruginosa injection in preventing reurrent urinary tract infection in women. Methods:This was a multicenter, randomized, open, positive-controlled, non-inferiority trial involving female patients with recurrent urinary tract infections (rUTIs) who were admitted to 11 medical centers in China. Inclusion criteria: ①Aged 18-70 years, with verifiable clinical data showing at least 3 episodes of acute UTIs within 1 year and at least 2 episodes within 6 months, and cured by antimicrobial therapy; ② At the time of enrollment, the patients had no obvious symptoms of urinary tract irritation, normal white blood cell count in midstream urine routine (within the normal range of laboratory standards of each unit) or ≤3HP by centrifuge microscopy, negative leucocyte esterase and nitrite, and negative urine culture; ③No abnormal urinary anatomic function (such as urinary obstruction, calculus or congenital urinary malformation) and residual urine volume ≤50 ml were detected by B-ultrasound of urinary system; ④Informed consent signed by the person or agent; ⑤Clear consciousness, able to answer questions independently, according to the requirements of the test plan to complete the research questionnaire. Exclusion criteria: ①Patients allergic to the above drugs; ②Any complex signs of urinary tract infection or pyelonephritis (manifested as low back pain, fever ≥37.3℃, systemic symptoms); ③Drugs affecting immune function were used within 7 days before randomization; ④Patients with basic diseases of urinary system such as obstruction, calculus, urinary stenosis, vesicoureteral reflux or other functional abnormalities, urine diversion, indwelling catheter or stent tube or intermittent catheterization; ⑤Combined with or existing systemic lupus erythematosus, AIDS and other diseases that can lead to systemic immune function abnormalities; ⑥Patients who are known or suspected to be pregnant, breastfeeding, or planning a pregnancy within 3 months of stopping the drug; ⑦Patients with malignant tumors and mental patients; ⑧Persons who have received any other investigational drug treatment or participated in another interventional clinical trial within 4 weeks prior to screening; ⑨Failure to comply with the trial protocol or other conditions deemed unsuitable for enrollment by the investigator. Patients were randomly divided into 2 groups. The experimental group was given Pseudomonas aeruginosa injection for 5 times, 0.5 ml for the first time, and 1 ml/ time per week for the following 4 weeks. The control group was given fosfomycin aminotriol 3g orally, once every 10 days, for 9 consecutive times. The patients were followed up for 6 to 8 months, during which urinary tract symptoms developed and routine urine tests showed abnormally elevated white blood cells, which was defined as recurrent UTIs. Urine routine, liver and kidney function, and urinary secretory immunoglobulin A(SIgA) were reviewed 0-2 days (V2) after the 5th administration of the experimental group and the 4th administration of the control group. Urine routine and urine SIgA were reviewed at (90±10) d (V3) and (180±10) d (V4) after treatment. At (270±10) d (V5) after treatment, the recurrence (re-infection caused by the same species of bacteria) or re-infection (re-infection caused by non-same species of bacteria) of the two groups were compared, and non-inferiority analysis was performed, and the non-inferiority threshold was set at 0.2. Results:From March 2021 to May 2022, a total of 152 rUTIs patients were enrolled in this study, including 80 patients in the experimental group, 71 patients in the intention-to-analysis set (ITT) and 66 patients in the protocol analysis set (PPS). In the control group, 72 cases met ITT in 69 cases and PPS in 67 cases. There were no significant differences in age, body mass index, marital status, duration of urinary tract infection, history of diabetes, history of previous major surgery, history of infection, and urinary SIgA between the two groups (all P>0.05). The recurrence rates of the experimental group and the control group at V5 time point were 44.78% (30/67) and 42.65% (29/68), respectively ( P=0.803) (ITT data set analysis results showed that the difference in recurrence rates between the two groups was 0.0213(95% CI-0.1460-0.1886, P=0.0048). PPS data set analysis showed that the difference of recurrence rate between the two groups was -0.0021(95%CI -0.1711-0.1670, P=0.0109), and the recurrence rate of the experimental group was not worse than that of the control group. At V2 time points, there were no significant differences in liver and kidney function indexes between test group and control group ( P>0.05). At V2 to V4 time points, urinary SIgA of test group and control group were 0.90 (0.37, 2.89) mg/L and 1.32 (0.34, 3.08) mg/L, 1.54 (0.44, 3.23) mg/L and 1.71 (0.27, 2.92) mg/L, 1.11 (0.65, 3.42) mg/L and 2.18 (0.43, 3.26) mg/L, there was no statistical significance ( P>0.05). The incidence of adverse events in the experimental group was 30.0% (24/80), including 14 cases of redness, pain and discomfort at the injection site, 5 cases of fever, 2 cases of allergic rash, and 1 case of urticaria, headache and constipation each. The incidence of adverse events in the control group was 5.6% (4/72), all of which were diarrhea, and the difference between the two groups was statistically significant ( P<0.01). No life-threatening serious adverse events occurred in both groups, and all adverse events were self-healing without additional intervention. Conclusions:Compared with fosfomycin aminotriol, Pseudomonas aeruginosa injection has the same clinical effect in preventing rUTI and has good safety.
9.Current status of applying matrigel to in vitro models for cancer reseach
Yue YANG ; Lijing ZHONG ; Yifei YANG ; Gege LI ; Hongmei CUI
Tumor 2023;43(10):813-820
The components of the tumor microenvironment have a complex composition and play an important regulatory role in tumor evolution.The extracellular matrix(ECM)serves as a vital mediator in regulating cancer advancement within the TME.Incorporating ECM into tumor modeling allows for a more comprehensive simulation of the TME in vitro.As a medium for organoid growth,the matrix gel fulfills the functions of ECM.ECM is normally derived from the recombinant basement membrane of mouse sarcoma(Matrigel);however,batch-to-batch variations in Matrigel affect experiment reproducibility.To overcome such issues,researchers have designed synthetic matrix gels.This paper provides an overview of the current research in the application of matrix gels for tumor organoid modeling,offering insights for continuous optimization of organoid culture,thereby achieving more efficient and cost-effective organoid construction and advancing the translation of basic research to clinical applications.
10.Role of cold-inducible RNA-binding protein in acute renal injury in a mouse model of myocardial ischemia-reperfusion: relationship with NF-κB signaling pathway
Yuxi ZHANG ; Peng ZHONG ; Yanan LI ; Yifei WANG ; Zhongyuan XIA
Chinese Journal of Anesthesiology 2023;43(3):336-340
Objective:To evaluate the role of cold-inducible RNA-binding protein (CIRP) in acute renal injury in a mouse model of myocardial ischemia-reperfusion (I/R) and the relationship with nuclear factor kappa B (NF-κB) signaling pathway.Methods:Twenty-four SPF-grade healthy male C57BL/6 mice, aged 6-8 weeks, with body mass index of 24-28 g, were divided into 3 groups ( n=8 each) using a random number table method: sham operation group (Sham group), myocardial I/R group (I/R group) and myocardial I/R + CIRP-derived peptide C23 group (I/R+ C23 group). The model of myocardial I/R was developed by ligation of the left anterior descending coronary artery for 30 min followed by 120-min reperfusion in anesthetized animals. CIRP-derived peptide C23 8 mg/kg was intraperitoneally injected before myocardial ischemia and reperfusion in I/R+ C23 group, while Sham group was only threaded without ligation. Blood samples were collected from the right internal carotid artery at 120 min of reperfusion for determination of the serum creatine kinase isoenzymes (CK-MB), lactic dehydrogenase (LDH), creatinine (Cr) and blood urea nitrogen (BUN) concentrations. Renal tissues were obtained for examination of the pathological changes, and the tubular injury score was assessed. The expression of NF-κB, phosphorylated NF-κB (p-NF-κB), Nod-like receptor protein 3 (NLRP3), interleukin-1beta (IL-1β) and IL-18 in renal tissues was detected by Western blot. The expression of Toll-like receptor 4 (TLR4), NLRP3, IL-1β, TNF-α and IL-6 mRNA was determined by real-time polymerase chain reaction. Results:Compared with Sham group, the levels of serum CK-MB, LDH, Cr and BUN and renal tubule injury score were significantly increased, the expression of p-NF-κB, NLRP3, IL-1β and IL-18 was up-regulated, the expression of TLR4, NLRP3, IL-1β, TNF-α and IL-6 mRNA was up-regulated ( P<0.05), and the pathological injury to renal tissues was aggravated in I/R group. Compared with I/R group, the serum CK-MB, LDH, Cr, BUN and renal tubular injury score were significantly decreased, and the expression of p-NF-κB, NLRP3, IL-1β and and IL-18 was down-regulated, the expression of TLR4, NLRP3, IL-1β, TNF-α and IL-6 mRNA was down-regulated ( P<0.05), and the pathological injury to renal tissues was alleviated in I/R+ C23 group. Conclusions:CIRP is involved in the process of acute renal injury in a mouse model of myocardial I/R, which is associated with activation of NF-κB signaling pathway and promotion of inflammatory responses.

Result Analysis
Print
Save
E-mail