1.Updates and amendments of the quality standard of nitroglycerin tablets in the Chinese Pharmacopoeia 2020
LI Ziying ; YANG Mei ; LI Weiling ; WU Liangyong ; DONG Shunling
Drug Standards of China 2024;25(1):018-024
Objective: To propose updates and amendments for the nitroglycerin tablets quality in the Chinese pharmacopoeia 2020 due to the failure of effective separation of 4 known impurities and nonseparation of free nitrate ion and excipients.
Methods: Related substances were analyzed using gradient elution by HPLC, and free nitrate ion was determined on SAX column by different HPLC method.
Results: Using the improved method to test the related substances and free nitrate ion of nitroglycerin tablets,the content of the maximum individual impurity were not more than 0.5%, the total content was not more than 2.4% and the content of free nitrate ion was not more than 6.3%.
Conclusion: The improved method is accurate and feasible. It provided a reference for the updates and amendments of the quality standard of nitroglycerin tablets in the Chinese Pharmacopoeia 2020.
2.Clinical efficacy of valsartan combined with folic acid in treatment of elderly hypertensive nephropathy
Zhiling LI ; Xinwei XU ; Ping CAI ; Hongyan LI ; Shaogang SUN ; Liangyong WU
Chinese Journal of Biochemical Pharmaceutics 2014;37(4):123-125
Objective To investigate the clinical efficacy of vallarta combined with folic acid in treatment of elderly hypertensive nephropathy.Methods 120 patients of essential hypertension with renal failure in Weifang People’s Hospital were divided into control group and observation group according to the odd and even numbers.The observation group was given vallarta and folic acid,the control group were given vallarta.4 weeks later,the effect of two groups were evaluated.Systolic and diastolic blood pressure,serum cretonne,blood urea nitrogen and 24h urinary protein were measured before and after treatment. Results The patients after treatment systolic and diastolic pressure was significantly better than control group, the difference was statistically significant(P<0.05),serum creatinine,blood urea nitrogen and 24h urine protein test results were better than control group,the difference was statistically significance(P<0.05).The total effective rate of observation group was better than control group(P<0.05),the obvious effective rate of observation group was significantly better than control group(P<0.01).Conclusion Combination of valsartan and folic acid in treatment of elderly hypertensive nephropathy has a higher total effective rate,while significantly lower blood pressure,serum creatinine,blood urea nitrogen and 24h urinary protein.
3.The factors influencing the effect of periprostatic nerve block anesthesia and the establishment of a predictive model and efficacy verification
Xiao TAN ; Xuefei DING ; Yang LUAN ; Shengming LU ; Liangyong ZHU ; Yuexing HAN ; Haopeng CHEN ; Zhong LIU ; Zhenhao WU ; Yueqi WU
Chinese Journal of Urology 2023;44(12):917-921
Objective:To investigate the factors affecting the effect of periprostatic nerve block (PNB), establish a prediction model of pain degree, and verify the prediction efficiency.Methods:The clinical data of 314 patients who underwent transperineal prostate biopsy in our hospital from June 2022 to January 2023 were retrospectively analyzed. The median age was 71 (65, 76) years, the median prostate-specific antigen (PSA) was 14.6 (10.70, 24.65) ng/ml, and the median puncture needle number was 21 (19, 23) needles, median prostate volume 45.86 (31.52, 67.96) ml, median body mass index (BMI)24.02(22.97, 25.33)kg/m 2, including 109 patients with a history of diabetes, 90 patients with a history of surgery, and 57 patients with a history of severe trauma. The patients were divided into mild pain group (1-3 points), moderate pain group (4-6 points) and severe pain group (7-10 points) according to the intraoperative visual analogue scale (VAS). According to the clinical characteristics, the factors affecting the effect of PNB were analyzed by univariate analysis and multiple ordered logistic regression method. R language was used to construct a nomogram model for predicting PNB effect, receiver operating characteristic (ROC) curve and calibration curve were drawn, and Hosmer-Lemeshow test was carried out to verify the prediction efficiency of the model. Results:The results of univariate analysis showed that 171 patients in the mild pain group had a median age of 71 (65, 75) years, a median PSA14.5 (9.6, 24.6) ng/ml, a median number of puncture needles of 20 (18, 22), and a median prostate volume of 34.94 (26.36, 45.12) ml, median BMI24.17(23.14, 25.79)kg/m 2, including 74 patients with a history of diabetes, 51 patients with a history of surgery, and 40 patients with a history of severe trauma; There were 110 patients in the moderate pain group, the median age was 71 (65, 76) years, the median PSA14.8 (11.03, 24.27) ng/ml, the median number of puncture needles was 23 (20, 24) needles, median prostatic volume 63.24 (49.14, 78.72) ml, median BMI23.91(22.58, 24.88)kg/m 2, including 26 patients with a history of diabetes, 29 patients with a history of surgery, and 10 patients with a history of severe trauma; In the severe pain group, 33 patients had a median age of 73 (67, 78) years, a median PSA14.6 (10.85, 34.80) ng/ml, and a median puncture needle number of 23 (22.5, 24) needles, median prostate volume 70.64 (61.50, 104.51) ml, median BMI24.32(23.00, 26.06)kg/m 2, including 9 patients with a history of diabetes, 10 patients with a history of surgery, and 7 patients with a history of severe trauma. The results of univariate analysis showed that the number of puncture needles ( P<0.01), prostate volume ( P<0.01), history of diabetes ( P=0.002) and history of major trauma ( P= 0.009) were the factors affecting the effect of PNB. Multiple logistic regression analysis showed that puncture needle number ( P=0.009), prostate volume ( P<0.01) and diabetes history ( P=0.041) were independent risk factors for PNB effect. The area under ROC curve (AUC) of the moderate and above pain prediction model was 0.872, P<0.01; the area under ROC curve of the severe pain prediction model was 0.817, P<0.01; the result of Hosmer-Lemeshow test of the moderate and above pain prediction model was χ2=5.001, P=0.757. The results of the severe pain prediction model were χ2=4.452 and P=0.814. The calibration curve was established, which showed that the prediction probability of pain degree was in good agreement with the actual risk. Conclusions:The number of puncture needles, prostate volume and history of diabetes are the risk factors affecting the effect of PNB. The prediction model of PNB effect based on this model can be used to predict the pain degree of patients undergoing prostate biopsy after PNB.
4.Effectiveness and safety of local anesthesia in patients with PI-RADS score 5 and ECOG score ≥2 for prostate puncture
Yuexing HAN ; Xuefei DING ; Yang LUAN ; Liangyong ZHU ; Shengming LU ; Tianbao HUANG ; Haopeng CHEN ; Xiao TAN ; Zhenhao WU ; Yueqi WU
Chinese Journal of Urology 2023;44(2):97-101
Objective:To investigate the effect of local anesthesia in patients with a PI-RADS score of 5 and ECOG score ≥2 for prostate puncture.Methods:Retrospective analysis of case data of 33 patients admitted to the Subei People's Hospital for prostate puncture from April 2020 to April 2022. Age (82.5±3.6) years. There were 18 cases with hypertensive disease, 8 cases with diabetes mellitus, and 6 cases with both diabetes mellitus and hypertensive disease. Body mass index (25.2±3.5) kg/m 2. prostate-specific antigen (PSA)(131.5±69.7) ng/ml. prostate volume (38.5±21.4) ml. all patients had a PI-RADS score of 5 on multiparametric magnetic resonance (mpMRI) and an Eastern Cooperative Oncology Group (ECOG) score ≥2. All 33 cases in this group underwent trans-perineal targeted prostate puncture using local anesthesia at the tip of the prostate. The visual analog score (VAS) and visual numeric score (VNS) were applied by the same surgeon to assess the patient's pain level and satisfaction at the time of puncture (VAS-1 and VNS-1) and 30 min after puncture (VAS-2 and VNS-2), and to record the duration of the procedure and the occurrence of postoperative complications. Results:In this group of 33 cases, the VAS-1 score was (1.9±0.3) and the VAS-2 score was (0.1±0.2); the VNS-1 score was (2.9±0.2) and the VNS-2 score was (3.9±0.1). Postoperative pathological results indicated that one of the 33 patients had a negative puncture result (pathology report indicating interstitial inflammation), while the rest of the patients had a positive puncture pathology report (puncture pathology report indicating prostate cancer), with a positive rate of 97%. One case of postoperative carnal haematuria occurred, which gradually improved after the patient was advised to drink water and take alpha-blockers. No perineal hematoma occurred, and all patients did not suffer complications such as urinary tract infection, urinary retention, azoospermia, vagal reaction, and infectious shock.Conclusion:In patients with a PI-RADS score of 5 and ECOG score ≥2, the use of single-hole local anesthesia for performing trans-perineal targeted puncture biopsy has the advantages of good paroxysmal pain and high safety.
5.Robot-assisted urinary control recovery and safety assessment of vesicoprostatic muscle reconstruction after extubation in patients undergoing radical prostatectomy for prostate cancer: a prospective randomized controlled trial
Yueqi WU ; Xuefei DING ; Yang LUAN ; Liangyong ZHU ; Xiao TAN ; Zhenhao WU
Journal of Modern Urology 2024;29(7):632-637
【Objective】 To analyze the effects of vesicoprostatic muscle (VPM) reconstruction on the early urinary control recovery and safety of patients undergoing robot-assisted radical prostatectomy (RARP). 【Methods】 A total of 128 patients who underwent RARP in our hospital during Sep.1, 2021 and Aug.31, 2023 were enrolled and divided into the non-reconstruction group (n=64) and reconstruction group (n=64) using random number table method.The reconstruction group received Montsouris + VPM reconstruction surgery, while the non-reconstructive group underwent Montsouris surgery only.Urinary control and perioperative data were collected with telephone interview, outpatient follow-up and inpatient records.The two groups were matched using overlap weighting and the Kaplan-Meier method was used to calculate urinary incontinence rates at 1, 2 and 3 months after extubation.Early urinary control (3 months after extubation), operation time, intraoperative bleeding, positive rate of incision margin, and incidence of early postoperative complications (<30 days) (Clavien-Dindo scale) were compared between the two groups. 【Results】 The recovery rate of urinary control at 1, 2 and 3 months after extubation was significantly higher in the reconstruction group than that in the non-reconstruction group (33.9% vs. 11.2%; 46.7% vs. 16.1%; 70.6% vs. 45.6%, P<0.05), but the positive rate of resection margin was lower (16.1% vs.41.7%, P<0.05).There were no significant differences in operation time, intraoperative bleeding and early postoperative complications between the two groups (P>0.05). 【Conclusion】 VPM reconstruction can improve urinary control recovery in RARP patients early after extubation without increasing the risk of surgery.