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1.
Chinese Journal of Digestion ; (12): 379-384, 2021.
Article in Chinese | WPRIM | ID: wpr-912196

ABSTRACT

Objective:To observe the clinical efficacy of endoscopic submucosal dissection (ESD) in the treatment of superficial esophageal cancer (SEC), and to explore the application value of ESD in the treatment of SEC.Methods:From January 2016 to December 2019, at The First Affiliated Hospital With Nanjing Medical University, the clinical data of 368 patients with SEC and receiving ESD treatment were retrospectively analyzed, induding the general condition, the circumferential proportion of lesions, effectiveness of ESD treatment (en bloc resection rate, complete resection rate, curative resection rate, operation time and resected lesion area), incidence of complications and follow-up. 368 patients were divided into stenosis group (94 cases) and non-stenosis group (274 cases) according to the occurrence of esophageal stenosis after ESD. The circumferential proportion of lesions, operation time and resected lesion area were compared between stenosis group and non-stenosis group, and the independent risk factors of esophageal stenosis after ESD were analyzed. Independent sample t test, chi-square test and binary logistic regression analysis were used for statistical analysis. Results:Among 368 patients, 270(73.4%) were male and 98 (26.6%) were female; the age was (64.4±7.6) years old. The circumferential proportion of lesions of 231 cases (62.8%) was <1/2 circle, 49 cases (13.3%) was 1/2 to <2/3 circle, and 88 cases (23.9%) was ≥2/3 circle. The en bloc resection rate of the lesion was 98.6%(363/368), the complete resection rate and curative resection rate were both 97.8% (360/368). The operation time was (89.4±47.9) min. The area of resected lesion was (12.5±8.9) cm 2. The incidence of perforation during operation, delayed bleeding and stenosis was 0.3% (1/368), 0.5% (2/368) and 25.5% (94/368), respectively. The followed-up period was 8 to 53 months, and the median follow-up period was 25 months. During the follow-up period, no recurrence or new lesion was found, and no lymph node or distant metastasis occurred. The circumferential proportion of lesions of 38 cases (40.4%) of stenosis group and 193 cases (70.4%) of non-stenosis group was <1/2 circle, respectively, the circumferential proportion of lesions of 9 cases (9.6%) and 40 cases (14.6%) was 1/2 to <2/3 circle, respectively, the circumferential proportion of lesions of 47 cases (50.0%) and 41 cases (15.0%) was ≥2/3 circle, respectively, and the difference was statistically significant ( χ2=47.30, P<0.01). The operation time of stenosis group was longer than that of non-stenosis group, the resected lesion area was larger than that of non-stenosis group ((126.1±56.3) min vs. (76.8±37.2) min, (17.5±10.7) cm 2 vs. (10.8±7.4) cm 2), and the differences were statistically significant ( t=9.57 and 5.41, both P<0.01). The results of binary logistic regression analysis showed that circumferential proportion of lesions ≥2/3 circle, operation time and the resected lesion area were independent risk factors for the occurrence of esophageal stenosis after ESD (odds ratio=0.253, 1.018 and 1.041, 95% confidence interval 0.116 to 0.551, 1.011 to 1.025, 1.007 to 1.076, all P<0.05). Conclusions:ESD is a safe and effective way to treat SEC, with low local recurrence rate and few complications, which is worthy of further clinical promotion.

2.
Article in Chinese | WPRIM | ID: wpr-911653

ABSTRACT

Objective:To summarize the experience and skills of ex-vivo ureteroscopy that performed on deceased donor kidneys with gifted lithiasis on bench prior to transplantation.Methods:From January 2018 to December 2019, a total of 7 death donors in Capital Medical University Beijing Friendship Hospital were found to have donor gifted lithiasis during pre-donation evaluation, and all of them underwent ureteroscope laser lithotripsy on bench before transplantation. We retrospectively analysied the demographic information of donors, stone size, location, operative complications and stone clearance rate of the total 7 donor kidneys. The mean age of donors was (49.6±6.8) years. The 7 gifted lithiasis consisted of 6 cases of simple pyelolithiasis and 1 case of upper ureteral calculi.Results:The mean diameter of the stones was (1.2±0.5)cm (0.4~2.1 cm). The 5 cases of pyelolithiasis and 1 case of ureteral calculi were examined with semi-rigid ureteroscopy and then underwent holmium laser lithotripsy. The other 1 case had not found the stone during the bench operation. The mean lithotripsy time was (23.0±6.1)min, and all donor kidneys underwent hypothermic machine perfusion after lithotripsy. The initial resistance index (RI) of donor kidney with gifted lithiasis was higher than the other side of the same donor ( P<0.05), but there was no statistical difference in end-point RI between the both sides. None of the 7 recipients had severe hematuria after operation and their renal function recovered well. CT scan at 1 month after the operation showed the clearance of stone was satisfied in all 7 recipients. Conclusions:Bench surgery is a minimally invasive method for donor gifted lithiasis management, and it is relatively safe and effective. For most cases, the semi-rigid ureteroscopy can handle it well, but the long-term effect still needs to be further evaluated.

3.
Chinese Journal of Urology ; (12): 954-957, 2021.
Article in Chinese | WPRIM | ID: wpr-911161

ABSTRACT

Gleason grading system is a critical factor for assessing the risk, making treatment decision and evaluating prognosis for patients with prostate cancer. However, it has been reported that concordance rates of Gleason score between biopsy pathology and radical prostatectomy specimen were only39%-63%, whilst postsurgical upgrade and downgrade rates were 30%-55% and 7%-20% respectively. This situation brings difficulties in performing clinical practice. This literature aimed to review relevant and updated studies in literature to summarize the concordance rate and independent predictive factors of Gleason score change from following several aspects: patient clinical characteristics, biopsy-related factors, accuracy of pathologic assignment and interpretation of pathology reports. This review also investigated how the factors influenced the Gleason score change and clinical decision-making. There were many factors influencing the Gleason score change which were roughly consistent with risk factors of prostate cancer, however, some factors were controversial. In order to provide precise evaluation of risk stratification and optimal individualized treatment, it is essential to consider the risk factors which are correlated with Gleason score change.

4.
Chinese Journal of Urology ; (12): 414-422, 2021.
Article in Chinese | WPRIM | ID: wpr-911043

ABSTRACT

Objective:To assess the efficacy and safety of 100 units of botulinum toxin A (BTX-A) intradetrusor injection in patients with overactive bladder.Methods:From April 2016 to December 2018, 17 tertiary hospitals were selected to participate in this prospective, multicenter, randomized, double-blind, placebo-controlled study. Two phases of study were conducted: the primary phase and the extended phase. This study enrolled patients aged 18 to 75 years who had been inadequately managed by anticholinergic therapy (insufficient efficacy or intolerable side effects) and had spontaneous voiding with overactive bladder. Exclusion criteria included patients with severe cardiac, renal and hepatic disorders, patients with previous botulinum toxin treatment for 6 months or allergic to BTX-A, patients with urinary tract infections, patients with urinary stones, urinary tract tumors, diabetes mellitus, and bleeding tendency. Eligible patients were randomly assigned to BTX-A group and placebo control group in a ratio of 2∶1. Two groups of patients received 20 intradetrusor injections of BTX-A 100U or placebo at the depth of the submucosal muscle layer respectively under cystoscope, including 5 injections at the base of the bladder, 3 injections to the bladder triangle, 5 injections each to the left and right walls and 2 injections to the top, sparing the bladder neck. As a placebo control group, patients received same volume of placebo containing no BTX-A and only adjuvant freeze-dried preparations for injection with the same method. A combination of gelatin, sucrose, and dextran served as adjuvants. Average micturition times per 24 hours, urinary incontinence (UI) episodes per day, average micturition volume per day, OAB symptom score(OABSS), and quality of life (QOL) score were recorded at baseline and the 2nd, 6th and 12th week after treatment. The primary efficacy endpoint was the change from baseline in the average micturition times per 24 hours at the 6th week after treatment. The secondary efficacy endpoints included the change from baseline in the average micturition times per 24 hours at 2nd and 12th week, as well as the change from baseline in the OABSS, QOL score, average frequency of urgency and UI episodes per day, urgency score, average micturition volume per day at 2nd, 6th and 12th week after treatment. Patients were followed for 12 weeks to assess adverse events (AEs). After assessed at week 12, if the micturition times has decreased less than 50% compared to baseline and the patient is willing to receive retreatment, then patients could enter the extended trial phase. In that phase, patients in both groups were injected with 100 units BTX-A from 12th week onwards and then followed up the same indicators for 12 weeks.Results:216 patients were enrolled in this trial (144 cases in the BTX-A group and 72 cases in the placebo control group). Baseline characteristics such as age (47.75±14.20 in the BTX-A group and 46.39±15.55 in the control group), sex (25 male/117 female in the BTX-A group and 10/61 in the control group), and disease duration (0.51 years in the BTX-A group and 0.60 years in the control group) were balanced between the two groups( P>0.05). A marked reduction from baseline in average micturition times per 24 hours was observed in all treatment groups at the 6th week and the reduction of the two groups was statistically different ( P<0.001 and P=0.008 respectively). Compared with the baseline, the average micturition times per 24 hours at the 6th week decreased from baseline by 2.40(0.70, 4.60)times for the BTX-A group and 0.70(-1.00, 3.30) times for the placebo control group respectively, and the difference between the two groups was considered to be statistically significant ( P=0.003). The change rates of average micturition times per 24 hours from baseline at the 6th week of the two groups were (16±22)% and (8±25)% respectively, and the difference between the two groups was statistically significant ( P=0.014). Compared with the baseline, the average micturition times per 24 hours at 2nd and 12th week decreased by 2.00(0.00, 4.00)and 3.30(0.60, 5.03)for the BTX-A group, 1.00(-1.00, 3.00)and 1.70(-1.45, 3.85)for the placebo control group respectively. The difference between two groups was considered to be statistically significant ( P=0.038 and P=0.012); the changes of average urgency times per day for the BTX-A group and the control group at the 2nd, 6th and 12th week were 2.00(0.00, 4.30)and 2.40(0.30, 5.00), 3.00(0.30, 5.70)and 0.70(-1.30, 2.70), 0.70(-1.30, 3.00) and 1.35(-1.15, 3.50), respectively. There were significant differences between two groups at the 2nd, 6th and 12th week, ( P=0.010, P=0.003 and P=0.025, respectively). The OABSS of the BTX-A group and the control group at the 6th week decreased by 1.00(0.00, 4.00)and 0.50(-1.00, 2.00) compared with the baseline, and the difference between the two groups was statistically significant ( P=0.003). 47 cases of BTX-A group and 34 cases of placebo control group entered the extended trial phase, and 40 and 28 cases completed the extended trial phase, respectively. The average micturition volume per 24 hours changed by -16.60(-41.60, -0.60)ml and -6.40(-22.40, 13.30)ml, (-35.67±54.41)ml and(-1.76±48.69)ml, (-36.14±41.51)ml and (-9.28±44.59)ml, (-35.85±43.35)ml and(-10.41±40.29)ml for two groups at the 12th, 14th, 18th and 24th week, and the difference between two groups was statistically significant at each follow-up time ( P=0.01, 0.006, 0.012 and 0.016, respectively). There was no significant difference in other parameters( P>0.05). However, adverse reactions after intradetrusor injection included increased residual urine volume (27 in the BTX-A group and 3 in the control group), dysuria (21 in the BTX-A group and 6 in the control group), urinary infection (19 in the BTX-A group and 6 in the control group), bladder neck obstruction (3 in the BTX-A group and 0 in the control group), hematuria (3 in the BTX-A group and 1 in the control group), elevated alanine aminotransferase (3 in the BTX-A group and 0 in the control group), etc. During the follow-up period, there was no significant difference in the other adverse events between two groups except the increase of residual urine volume( P<0.05). In the primary trial phase, among the 27 cases with increased residual urine volume in BTA group, only 1 case (3.70%) with PVR more than 300 ml; the PVR of 3 patients in the placebo group was less than 100 ml. The increase of residual urine volume caused by the injection could be improved or disappeared with the passage of time. Conclusions:Intradetrusor injection of Chinese BTX-A improved the average micturition times per 24 hours, the average daily urgent micturition times, OABSS, and average micturition volume per time, and reduced the adverse effects in patients with overactive bladder.Chinese BTX-A at dose of 100U demonstrated durable efficacy and safety in the management of overactive bladder.

5.
Article in Chinese | WPRIM | ID: wpr-910542

ABSTRACT

Objective:To evaluate the efficacy of intensity-modulated radiation therapy (IMRT) combined with chemotherapy for treating patients with T 1-2N 1M 0 nasopharyngeal carcinoma (NPC). Methods:343 patients diagnosed with T 1-2N 1M 0 NPC in Zhejiang Cancer Hospital and Sun Yat-sen University Cancer Center from January 2008 to December 2016 were recruited in this study. All patients received IMRT and divided into the radiotherapy (RT) and chemoradiotherapy (CRT) groups. Patients in the CRT group were further assigned into the concurrent chemoradiotherapy (CCRT), induction chemotherapy+ CCRT (IC+ CCRT) and CCRT+ adjuvant chemotherapy (AC) groups. Locoregional failure-free survival (LRFFS), distant metastasis-free survival (DMFS), progression-free survival (PFS), cancer-specific survival (CSS) and overall survival (OS) were estimated by Kaplan- Meier method. Multivariate prognostic analysis was performed by Cox models. Results:The median follow-up time for surviving patients (303/343) was 91(range: 49-138) months. The 5-year OS, CSS, PFS, LRFFS, and DMFS rates in the CRT group were not superior to those of the RT group (93.7%: 93.9%, 93.7%: 93.9%, 89.0%: 87.7%, 93.8%: 92.8%, 93.8%: 91.2%, all P>0.05). No significant difference was found in treatment outcomes of patients with T 1N 1 or T 2N 1 NPC between two groups (all P>0.05). In multivariable analyses, only age was an independent prognostic factor for OS, PFS, CSS and DMFS, and negative correlation was found between them. No survival benefits were achieved in the CCRT, IC+ CCRT, CCRT+ AC and RT groups, and no significant differences were found in clinical efficacy among the three combined (all P>0.05). Conclusions:IMRT alone yields comparable clinical efficacy to CRT in treating patients with T 1-2N 1M 0 NPC. However, whether CT can be eliminated in the T 1-2N 1M 0 population still needs further confirmation by prospective, randomized and controlled clinical trials.

6.
Article in Chinese | WPRIM | ID: wpr-910461

ABSTRACT

Surgical resection is the main radical treatment of early and mid-stage primary liver cancer (PLC), but the high postoperative recurrence rate is the main factor affecting the curative effect. With recent advancement in techniques, the efficacy and safety of radiation therapy for PLC have been widely proven. In this review, we will investigate the combination of surgery and radiation therapy, covering the topics of preoperative or postoperative radiotherapy for PLC with portal vein tumor thrombus, postoperative adjuvant radiotherapy in PLC with narrow surgical margin or microvascular invasion, stereotactic body radiation therapy as a bridge to liver transplantation, radiotherapy in conversion to resectability for intrahepatic inoperable PLC. Despite radiation therapy is one of the effective therapeutic options for PLC, there is still a compelling need for prospective, randomized, controlled phase Ⅲ trials to acquire high-levelclinical evidence for confirming the role of radiation therapy in the treatment of PLC.

7.
Article in Chinese | WPRIM | ID: wpr-910370

ABSTRACT

Objective:To explore the changes of dendritic spine morphology and structure in dentate gyrus(DG) and CA1 areas of hippocampus of young rats, so as to provide a direct morphological basis for studying the molecular mechanism of radiation cognitive impairment.Methods:21-day-old Sprague-Dawley (SD) rats were given a single dose of 10 Gy whole brain irradiation. The changes of cognitive function, dendritic spine density and morphological changes in DG and CA1 areas of hippocampus were observed 1 and 3 months after irradiation, and the expression of postsynaptic density protein (PSD95) was detected by Western blot.Results:The cognitive impairment was observed in young rats 3 months after irradiation. The density of dendritic spines in DG area of hippocampus was decreased significantly by 39.06% and 29.27% at 1 and 3 months after irradiation ( t=14.96, 12.35, P<0.05), respectively. The density of dendritic spines in the basal dendrites of hippocampal CA1 area was decreased by 33.40% ( t=10.39, P<0.05) 1 month after irradiation, but had no significant change at 3 months after irradiation. While the density of dendritic spines in the apical dendrites of CA1 region did not change significantly at 1 and 3 months after irradiation. In addition, the morphology of dendritic spines in DG and CA1 regions of hippocampus was dynamically changed after irradiation. The expression of PSD95 protein was decreased by 24.6% and 50.5% ( t=2.97, 9.27, P<0.05) at 1 and 3 months after irradiation, respectively. Conclusions:This study reported the density and morphological changes of dendritic spines in different brain regions of hippocampus of young rats after ionizing radiation, suggesting that PSD95 may participate in the occurrence of radiation-induced cognitive impairment by affecting the structure and morphology of dendritic spines and reducing synaptic plasticity.

8.
Article in Chinese | WPRIM | ID: wpr-910328

ABSTRACT

Hepatocellular carcinoma (HCC) is prone to invading portal vein system known as portal vein tumor thrombus (PVTT). PVTT is one of the main reasons for poor prognosis of HCC because of its rapid progress and lack of effective treatments, and the optimal treatment strategy remains controversial. With recent advances in techniques, the efficacy and safety of radiation therapy for PVTT has been improved. The optimization of individualized radiotherapy and multimodality treatment is the future direction of research. In this review, we will investigate the current state and future opportunities of radiation therapy and multimodality treatment for HCC with PVTT.

9.
Article in Chinese | WPRIM | ID: wpr-910314

ABSTRACT

Intestinal injury is an important toxic response during radiation therapy of pelvic tumors. With the widespread use of precision radiotherapy techniques such as intensity modulated radiation therapy (IMRT), the dose exposed to normal tissues and organs has been significantly reduced. However, the toxic response of the bowel still limits the increase of the dose to the target volume. Therefore, the protection of important organs at risk (OAR), such as the bowel, becomes more and more important while giving adequate irradiated dose to the target volume. Most current studies used loop to contour bowel. For patients who underwent IMRT, the meaningful dose-volume predictors of grade 2 acute intestinal adverse events using bowel loop (small loop + big bowel) delineation included V45 Gy < 50 cm 3,V50 Gy < 13 cm 3, and V55 Gy < 3 cm 3, and the corresponding predicators using bowel bag delineation were V40 Gy < 170 cm 3,V45 Gy < 100 cm 3, and V50 Gy < 33 cm 3.

10.
Chinese Journal of Trauma ; (12): 618-627, 2021.
Article in Chinese | WPRIM | ID: wpr-909912

ABSTRACT

Objective:To analyze the incidence and epidemiological characteristics of traumatic spinal cord injury in China in 2018.Methods:Multi-stage stratified cluster sampling was used to randomly select hospitals capable of treating patients with spinal cord injury from 3 regions,9 provinces and 27 cities in China to retrospectively investigate eligible patients with traumatic spinal cord injury admitted in 2018. National and regional incidence rates were calculated. The data of cause of injury,injury level,severity of injury,segment and type of fracture,complications,death and other data were collected by medical record questionnaire,and analyzed according to geographical region,age and gender.Results:Medical records of 4,134 patients were included in this study,with a male-to-female ratio of 2.99∶1. The incidence of traumatic spinal cord injury in China in 2018 was 50.484 / 1 million (95% CI 50.122-50.846). The highest incidence in the Eastern region was 53.791 / 1 million (95% CI 53.217-54.365). In the whole country,the main causes of injury were high falls (29.58%),as well as in the Western region (40.68%),while the main causes of injury in the Eastern and Central regions were traffic injuries (31.22%,30.10%). The main injury level was cervical spinal cord in the whole country (64.49%),and the proportion of cervical spinal cord injury in the Central region was the highest (74.68%),and the proportion of lumbosacral spinal cord injury in the Western region was the highest (32.30%). The highest proportion of degree of injury was incomplete quadriplegia (55.20%),and the distribution pattern was the same in each region. A total of 65.87% of the patients were complicated with fracture or dislocation,77.95% in the Western region and only 54.77% in the Central region. In the whole country,the head was the main combined injury (37.87%),as well as in the Eastern and Central regions,while the proportion of chest combined injury in the Western region was the highest (38.57%). A total of 32.90% of the patients were complicated with respiratory complications. There were 23 patients (0.56%) died in hospital,of which 17(73.91%) died of respiratory dysfunction. Conclusions:The Eastern region of China has a high incidence of traumatic spinal cord injury. Other epidemiological features include high fall as the main cause of injury cervical spinal cord injury as the main injury level,incomplete quadriplegia as the main degree of injury,head as the main combined injury,and respiratory complications as the main complication.

11.
Chinese Journal of Trauma ; (12): 250-260, 2021.
Article in Chinese | WPRIM | ID: wpr-909862

ABSTRACT

Objective:To establish the acute symptomatic osteoporotic thoracolumbar fracture (ASOTLF) classification system, and to examine the reliability and evaluate the effect of clinical application.Methods:A retrospective case series study was conducted to analyze the clinical data of 1 293 patients with osteoporotic thoracolumbar fracture(OTLF) admitted to Honghui Hospital from January 2016 to December 2018. There were 514 males and 779 females, aged 57-90 years [(71.4±6.3)years]. The T value of bone mass density was -5.0--2.5 SD [(-3.1±-0.4)SD]. According to the clinical symptoms a and fracture morphology, OTLF was divided into 4 types, namely type I(I occult fracture), type II(compressed fracture), type III (burst fracture) and type IV(unstable fracture). The type II was subdivided into three subtypes (type IIA, IIB, IIC), and the Type III into two subtypes (type IIIA, IIIB). of all patients, 75 patients (5.8%) were with type I, 500 (38.7%) with type II A, 134 (10.4%) with type IIB, 97 (7.5%) with type IIC, 442 (34.2%) with type IIIA, 27(2.1%) with type IIIB and 18 (1.4%) with type IV. After testing the validity of the classification, different treatment methods were utilized according to the classification, including percutaneous vertebroplasty (PVP) for Type I, PVP after postural reduction for Type II, percutaneous kyphoplasty (PKP) for Type IIIA, posterior reduction and decompression, bone graft fusion and bone cement-augmented screw fixation for Type IIIB, and posterior reduction, bone graft fusion and bone cement-augmented screw fixation for Type IV. The visual analog score (VAS), Oswestry disability index (ODI), Frankel grade of spinal cord injury, local Cobb Angle, and vertebral body angle (vertebral body angle) were recorded in all patients and in each type of patients before surgery, at 1 month after surgery and at the last follow-up. The neurological function recovery and complications were also recorded.Results:The patients were followed up for 24-43 months [(29.9±5.1)months]. A total of 3 000 assessments in two rounds were conducted by three observers. The overall κ value of inter-observer credibility was 0.83, and the overall κ value of intra-observer credibility was 0.88. The VAS and ODI of all patients were (5.8±0.7)points and 72.5±6.6 before surgery, (1.8±0.6)points and 25.0±6.3 at 1 month after surgery, and (1.5±0.6)points and 19.5±6.2 at the last follow-up, respectively (all P<0.05). The Cobb angle and vertebral body angle of all patients were (13.0±9.1)° and (8.0±4.6)° before surgery, (7.9±5.2)° and (4.6±2.9)° at 1 month after surgery, and (9.1±6.0)° and (5.8±3.0)° at the last follow-up, respectively (all P<0.05). At the last follow-up, VAS, ODI, Cobb Angle and VBA of each type of patients were significantly improved compared with those before surgery (all P<0.05). The spinal cord compression symptoms were found 1 patient with type IV and 5 patients with type IIIB preoperatively. At the last follow-up, neurological function improved from grade C to grade E in 1 patient and from grade D to grade E in 5 patients ( P<0.05). The lower limb radiation pain or numbness in 3 patients with type IV and 22 patients with type III preoperatively were fully recovered after surgical treatment at the last follow-up except for three patients. Conclusions:The ASOTLF classification is established and has high consistency and reliability. The classification-oriented treatment strategy has achieved a relatively satisfactory effect, indicating that the classification has a certain guiding significance for treatment of OTLF.

12.
Article in Chinese | WPRIM | ID: wpr-873580

ABSTRACT

@#To improve the standard of quality control of tazobactam and its preparations in China, national reference standard of tazobactam impurity A was developed. After tazobactam impurity A was synthesized, its structure was validated by infrared (IR), mass spectrometry (MS) and nuclear magnetic resonance (NMR), and its content uniformity and short-term stability were measured and investigated. Then, water content and residue on ignition of impurity A were determined, and its purity was determined using high performance liquid chromatography (HPLC) with 10 mmol/L ammonium acetate solution-acetonitrile (98∶2) as the mobile phase. Mass balance method was used to determine the content of the first batch of tazobactam impurity A national standard substance. Meanwhile, nuclear magnetic quantitative method was used to calculate the content, which was mutually verified with the mass balance method. The developed reference material of tazobactam impurity A is consistent with the maximum degradation impurity in tazobactam system applicability solution and the reference material of tazobactam related substance A contained in USP41. Within the 95% confidence range, the ratio of inter- and intra-bottle variance of impurity A after separation was 0.61 (< F0.05(11,12)), proving that the uniformity was satisfying. The contents of organic impurity, water content and inorganic impurity in impurity A were 0.90%, 1.24% and 0.25%, respectively. The content of impurity A was determined to be 97.6% by mass balance method, which was basically consistent with the result of nuclear magnetic quantitative method (97.1%). Under the condition of 25 °C, the area normalized purity of impurity A was 99.1% at 0, 3, 5 and 10 days, proving that the sample was stable at room temperature for 10 days. Finally the first batch of national standard substance of tazobactam impurity A was established successfully.

13.
Article in Chinese | WPRIM | ID: wpr-885932

ABSTRACT

Objective:Study on the feature of thrombin-antithrombin complex (TAT) during traumatic brain injury and the predicting performance with adverse clinical outcomes.Methods:From January 2018 to December 2019, 147 patients with traumatic brain injury(TBI) were enrolled, including 112 males and 35 females, aged 36 (26-48) years old. The plasma levels of TAT were detected on the 0th, 1st, 3rd and 7th day after TBI attack. Kruskal-Wallis H test was used for comparison among multiple groups; Mann-Whitney U test was used for data comparison between the two groups; continuous comparison of patient data in the same group using Friedman rank test; the diagnostic performance of TAT with adverse event risk predicting was evaluated by ROC analysis; Kaplan-Meier curve was used to analyze the survival curve; the risk ratio (HR) was obtained by Cox proportional hazard regression model.Results:Among the patients groups with mild, moderate and severe phenotype, the TAT levels were gradually decreased on the 0th, 1st, 3rd and 7th day after TBI attack(χ 2 values were 95.612, 133.555, and 132.453, respectively, all P values<0.001). The TAT levels on the 0th, 1st, 3rd and 7th day in the adverse event group were higher than in the group of patients with stable condition ( U values were 959.0, 321.0, 36.0 and 1.0 respectively, all P values<0.001). In the stable condition group, the TAT levels on the 0th and 1st day in the severe group were higher than in the mild group ( U values were 0 and 1.0 respectively, both P values<0.001), while there was no statistically significant difference of TAT levels between the 3rd and 7th day in the severe group ( U values were 342.5 and 272.5, P values were 0.486 and 0.065 respectively). The TAT levels of the moderate group on 0th and 1st day were higher than those of the mild group ( U values were 0 and 280.0, respectively, both P<0.001), while there was no significant difference between the TAT levels on the 3rd and 7th day ( U values were 628.0 and 647.0, P values were 0.826 and 0.996, respectively). ROC curves analysis showed that when the TAT diagnostic thresholds were 68.75 ng/ml, 29.05 ng/ml, 17.25 ng/ml and 13.85 ng/ml on the 0th, 1st, 3rd and 7th day, the diagnostic sensitivities of predicting adverse events were 86.8%, 94.3%, 100% and 100%; while the diagnostic specificities were 71.3%, 78.7%, 91.5% and 96.8%, respectively. Survival analysis showed that the cumulative probability of adverse outcomes was significantly higher in patients above the critical value. Cox analysis showed that the HR on the 0th, 1st, 3rd and 7th day to predict adverse clinical outcomes by TAT levels were 1.818, 2.257, 3.526 and 4.813, respectively ( P value<0.001). Conclusion:There was strong relationship between the plasma TAT level and the severity of the patient′s condition, and persistent increasing with TAT level could reflect the risk of adverse events, which could be used as an effective index to comprehensively predicting the development tendency of the TBI patient′s condition.

14.
Article in Chinese | WPRIM | ID: wpr-884596

ABSTRACT

Objective:To investigate the effect and mechanism of lysine acetyltransferase 5(KAT5) on the radio-sensitivity of anaplastic thyroid carcinoma (ATC).Methods:The expression levels of endogenous KAT5 in ATC and normal thyroid cells were detected by Western blot and qRT-PCR. The effect of KAT5 specific inhibitor NU9056 on the radio-sensitivity of human ATC cells and normal thyroid cells was evaluated by colony formation assay. TCGA database, JASPAR database, along with Western blot, microRNA sequencing, qRT-PCR and dual-luciferase reporter assay were conducted to unravel the underlying mechanism.Results:The expression of endogenous KAT5 at the protein and mRNA levels in human ATC cells was significantly higher than that in normal thyroid cells. NU9056 could significantly enhance the radiosensitivity of human ATC cells to 8505C and CAL-62, whereas showed no sensitization effect on normal thyroid cell Nthy-ori 3-1. Knockdown of KAT5 and NU9056 both down-regulated the expression level of miR-210 in the TC cells, while NU9056 decreased the expression level of transcription factor c-Myc. The putative binding sites of c-Myc in the miR-210 promoter region were predicted, and transfection of c-Myc plasmid significantly enhanced the luciferase activity of miR-210 promoter. Elevated miR-210 level was associated with worse survival of patients with thyroid carcinoma. Down-regulated expression of miR-210 decreased the TET2 mRNA level, while inhibition of miR-210 increased the TET2 mRNA level.Conclusion:The aberrantly-activated KAT5/miR-210/TET2 pathway probably causes the radioresistance of ATC, becoming a novel sensitizing target for ATC radiotherapy in clinical practice.

15.
Article in Chinese | WPRIM | ID: wpr-884588

ABSTRACT

Objective:To investigate and analyze the current status of multimodality therapy for resectable gastric cancer, aiming to provide reference for optimizing the multimodality treatment strategy for gastric cancer.Methods:Clinical data of patients diagnosed with gastric adenocarcinoma undergoing radical gastrectomy in the Second Affiliated Hospital of Soochow University were retrospectively analyzed. Clinical characteristics, preoperative medical comorbidities, pathological features, surgical and perioperative status and clinical efficacy were recorded. The gap between the diagnosis and treatment procedures and the standard guidelines was analyzed. The changes in the multimodality treatment patterns for gastric cancer were understood.Results:A total of 265 patients were included in this study. All patients were divided into two cohorts: early[2008] and late[2013] cohorts. In the early cohort, 127 patients were assigned, and 138 cases in the late cohort. In the early cohort, 67 patients (52.8%) underwent D 2 lymph node dissection, significantly less than 83 patients (60.1%) in the late cohort ( P<0.01). In the early and late cohorts, the proportion of patients with the number of lymph node dissection of ≥15 was 5.5% and 52.8%( P<0.01). The median number of lymph node dissection was increased from 6 to 16. The proportion of patients receiving neoadjuvant chemotherapy in the early and late cohorts was 2.4% and 3.6%( P=0.55). In the early cohort, the proportion of patients treated with postoperative chemotherapy and postoperative adjuvant chemoradiotherapy was 62.6% and 2.4%, significantly higher compared with 58.0% and 8.0% in the late cohort ( P=0.04). In addition, the proportion of patients receiving postoperative chemotherapy in the early cohort was 62.2%( n=79) and 58.0%( n=80) in the late cohort ( P=0.48). Conclusions:Although the level of radical gastrectomy has been continuously improved and standardized in China, which still lags behind the standard D 2 radical gastrectomy in Japan and South Korea. Adjuvant therapies including postoperative adjuvant radiotherapy can bring clinical benefits. However, the proportion of patients receiving adjuvant therapy is still low, and the multimodality therapy of gastric cancer should be widely applied.

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Article in Chinese | WPRIM | ID: wpr-884524

ABSTRACT

Objective:To evaluate whether the decrease in peripheral blood monocyte count was a potential predictor for neutropenia in patients with nasopharyngeal carcinoma and cervical cancer.Methods:The medical records of 95 patients with nasopharyngeal carcinoma and cervical carcinoma who received intensity-modulated radiation therapy (IMRT) combined with paclitaxel liposomes and platinum (TP) synchronous chemotherapy and presented with neutropenia in the Second Affiliated Hospital of Soochow University from January 2017 to December 2018 were retrospectively analyzed. Paired sample t-test was used to assess whether the number of days when the monocytes initially dropped/decreased to lowest level/eventually increased to normal value was significantly less than those of the neutrophils. In addition, the chi-square test was performed to determine the correlation between the degree of reduction in the absolute neutrophil count (ANC) and baseline absolute monocyte count (AMC). Results:The change trend of AMC was consistent with that of ANC in the two cycles of concurrent chemotherapy. The number of days when AMC initially decreased/decreased to the lowest level/finally increased to normal value was significantly less than that of ANC (4 d vs. 6 d, 4 d vs. 10 d, P<0.001; 5 d vs. 6 d, 6 d vs. 9 d, 7 d vs. 12 d, P<0.001). However, no correlation was found between the baseline level of monocytes and the degree of subsequent neutropenia [(AMC<0.4×10 9) vs.( AMC≥0.4×10 9)=32 vs. 63, P=0.172]. Conclusions:Decreased monocyte count is an important potential predictor for neutropenia and a significant indicator for guiding the next monitoring of neutrophil count and treatment with granulocyte colony-stimulating factor.

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Article in Chinese | WPRIM | ID: wpr-882578

ABSTRACT

Objective:To evaluate the clinical efficacy of self-made Liangxue-Qingfei Decoction combined with conventional western medicine in the treatment of rosacea with excessive heat in lung and stomach. Methods:312 patients with rosacea in Longfu hospital from May 2017 to May 2019 were selected and randomly divided into two groups, 156 cases in each group. The control group was treated with Doxycyclane Hyclate Tablets combined with Metronidazole Gel The study group was additionally given self-made Liangxue-Qingfei Decoction on the basis of the control group. Both groups were treated for 4 weeks. Dermatology Life Quality Index (DLQI) was evaluated . The erythema index (EI) of lesion area was measured by multi-functional skin tester. The adverse reactions during the treatment were recorded and the clinical efficacy was evaluated. Results:The total effective rate was 80.8% (126/156) in the study group and 66.7% (104/156) in the control group, with statistically significance ( χ2=8.012, P=0.005). After the treatment, the scores of physiology, psychology, family, social activities, interpersonal and occupational restrictionsin, and treatment in the study group were lower than those in the control group ( t=17.942, 15.794, 19.465, 21.586, 31.375, 27.472, P<0.001); EI (619.69 ± 71.53 vs. 822.97 ± 89.47, t=32.348) was lower than that of the control group ( P<0.01). During the treatment, the incidence of adverse reactions was 4.5% (7/156) in the control group and 5.8% (9/156) in the study group, and there was no significant difference between the two groups ( χ2=0.439, P=0.514). Conclusion:The self-made Liangxue-Qingfei Decoction combined with routine western medicine therapy can effectively improve the clinical symptoms and quality of life of rosacea patients with lung and stomach excessive heat, improve the clinical efficacy with safety.

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Article in English | WPRIM | ID: wpr-881064

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Enterovirus 71 (EV71) infection is more likely to cause hand, foot and mouth disease (HFMD) in children, which can lead to neurogenic complications and higher mortality. As a commonly used clinical medicine, Reduning injection (RDN) helps to shorten the symptoms of patients with HFMD and facilitate the early recovery of children. However, the regulatory mechanism of RDN on the HFMD immune system disorder caused by EV71 remains to be discussed. This study collected detailed treatment data of 56 children with HFMD who entered the affiliated Children's Hospital of Nanjing Medical University during 2019. Retrospective analysis of clinical data showed that the symptoms of the RDN treatment group were improved compared with the untreated group. To explore its mechanism, the relevant detection indicators were detected by flow cytometry, enzyme-linked immunosorbent assay and real-time quantitative PCR. It was found that the number and function of innate immune (ILCs) and adaptive immunity (Th1, Th2 and secreted cytokines) were reduced, suggesting that RDN plays a role by regulating cellular immunity. The in vitro differentiation inhibition test further confirmed that RDN affected Th1 differentiation by inhibiting the expression of transcription factors on the basis of Th1 cell differentiation in vitro.

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Asian Journal of Andrology ; (6): 64-68, 2021.
Article in English | WPRIM | ID: wpr-879735

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We conducted the present study to assess the correlation of the prostatic anatomical parameters, especially the ratio of peripheral zone thickness and transitional zone thickness, with clinical and uroflowmetry characteristics suggestive of benign prostate hyperplasia (BPH). A total of 468 consecutive patients with a detailed medical history were identified. All patients were evaluated by scoring subjective symptoms with the International Prostate Symptom Score (IPSS) and quality of life (QoL). The prostatic anatomical parameters were measured using transrectal ultrasonography, and postvoid residual urine and maximum flow rate (Q

20.
Article in Chinese | WPRIM | ID: wpr-908832

ABSTRACT

Objective:To explore the effect of case-based learning (CBL) based on WeChat platform in orthopedics practice teaching.Methods:A total of 101 orthopedic interns in The First Affiliated Hospital of Navy Medical University Hongkou Campus were randomly divided into two groups, with 50 interns in experimental group and 51 interns in control group. The experimental group conducted CBL based on WeChat platform for teaching, and the control group adopted traditional teaching method for teaching. At the end of the internship, the teaching effect on the interns was assessed by the "department graduation examination" and "questionnaire survey". The examination included basic theoretical knowledge and case analysis. Questionnaire survey included active preparation before class, teaching methods, class participation and discussion, interest in class and teaching effect. SPSS 17.0 was used for statistical analysis.Results:The total scores of the examinations, theoretical test and case analysis of the interns in the experimental group [(83.58±5.68) points, (49.98±3.71) points, (33.60±2.28) points, respectively] were better than those of the interns in the control group [(80.28±6.04) points, (48.20±4.12) points, (32.08±2.06) points, respectively], with statistical significance ( P < 0.05). The results of the questionnaire survey showed that the interns in the experimental group were significantly more satisfied with the teaching than those in the control group in such aspects as active preparation before class, teaching methods, class participation and discussion, class interest, class effect and satisfaction, and the differences in active preparation, participation and interest were statistically different ( P < 0.05). Conclusion:In the process of orthopedics practice teaching, the teaching method of CBL based on WeChat platform can mobilize the enthusiasm and participation of students, and can improve the clinical teaching effect of orthopedics, which is worthy of promotion and application in practice teaching.

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