1.“Textbook Outcome” and Influencing Factors in Patients with Pancreatic Ductal Adenocarcinoma Following Laparoscopic Pancreaticoduodenectomy: A Retrospective Cohort Study
Yakai YANG ; Shuai XU ; Chunhong ZHAO ; Yukun CAO ; Guangsheng YU ; Jun LIU
Cancer Research on Prevention and Treatment 2025;52(10):827-833
Objective To investigate the short- and long-term prognoses and the risk factors affecting “textbook outcome” (TO) after laparoscopic pancreaticoduodenectomy (LPD) for pancreatic ductal adenocarcinoma (PDAC). Methods The clinical and follow-up data of patients diagnosed with PDAC and treated with LPD from January 2019 to December 2022 were retrospectively analyzed. The prognosis was compared between TO and non-TO groups, and univariate and multivariate logistic regression analyses were used to identify independent prognostic factors for TO. Results A total of 284 patients were enrolled in this study, including 185 cases in the TO group and 99 cases in the non-TO group. The 1-, 3- and 5-year overall survival (OS) rates of the TO and non-TO groups with PDAC were 87.3% vs. 85.9%, 52.5% vs. 38.4%, and 18.0% vs. 4.5%, respectively (P=0.020); the recurrence-free survival (RFS) rates were 74.1% vs. 65.7%, 27.1% vs. 21.0%, and 10.0% vs. 0%, respectively (P=0.042). Multivariate logistic regression analysis showed that operation time >360 min (OR=0.561, 95%CI: 0.321-0.979, P=0.042), intraoperative blood loss >400 ml (OR=0.392, 95%CI: 0.175-0.879, P=0.023), hard or tough texture of pancreas (OR=2.240, 95%CI: 1.247-4.022, P=0.007), and main pancreatic duct diameter >3 mm (OR=1.931, 95%CI: 1.126-3.312, P=0.017) were independent prognostic factors for TO. Conclusion After the learning curve, more than 60% of patients with PDAC can achieve TO after LPD. The chances of achieving TO are significantly reduced when the operation time >360 min, the intraoperative blood loss >400 ml, the texture of pancreas was soft, and the diameter of the main pancreatic duct >3 mm.
2.Combination of AAV-delivered tumor suppressor PTEN with anti-PD-1 loaded depot gel for enhanced antitumor immunity.
Yongshun ZHANG ; Lan YANG ; Yangsen OU ; Rui HU ; Guangsheng DU ; Shuang LUO ; Fuhua WU ; Hairui WANG ; Zhiqiang XIE ; Yu ZHANG ; Chunting HE ; Cheng MA ; Tao GONG ; Ling ZHANG ; Zhirong ZHANG ; Xun SUN
Acta Pharmaceutica Sinica B 2024;14(1):350-364
Recent clinical studies have shown that mutation of phosphatase and tensin homolog deleted on chromosome 10 (PTEN) gene in cancer cells may be associated with immunosuppressive tumor microenvironment (TME) and poor response to immune checkpoint blockade (ICB) therapy. Therefore, efficiently restoring PTEN gene expression in cancer cells is critical to improving the responding rate to ICB therapy. Here, we screened an adeno-associated virus (AAV) capsid for efficient PTEN gene delivery into B16F10 tumor cells. We demonstrated that intratumorally injected AAV6-PTEN successfully restored the tumor cell PTEN gene expression and effectively inhibited tumor progression by inducing tumor cell immunogenic cell death (ICD) and increasing immune cell infiltration. Moreover, we developed an anti-PD-1 loaded phospholipid-based phase separation gel (PPSG), which formed an in situ depot and sustainably release anti-PD-1 drugs within 42 days in vivo. In order to effectively inhibit the recurrence of melanoma, we further applied a triple therapy based on AAV6-PTEN, PPSG@anti-PD-1 and CpG, and showed that this triple therapy strategy enhanced the synergistic antitumor immune effect and also induced robust immune memory, which completely rejected tumor recurrence. We anticipate that this triple therapy could be used as a new tumor combination therapy with stronger immune activation capacity and tumor inhibition efficacy.
3.Analysis of factors associated with nonalcoholic steatohepatitis in children with obesity
Lin YANG ; Yan LIN ; Guangsheng WU
Chinese Journal of Health Management 2022;16(11):776-780
Objective:To investigate the related factors of nonalcoholic steatohepatitis in children with obesity.Methods:A retrospective analysis was performed on 91 children with obesity who visited the Pediatric Obesity Clinic in the Affiliated Hospital of Hangzhou Normal University from July 2020 to January 2021. The 91 children with obesity were divided into two groups: with or without nonalcoholic steatohepatitis. Age, gender, body mass index, blood 25 hydroxyvitamin D3, fasting blood glucose, total cholesterol, triglyceride, low density lipoprotein, fasting insulin, control attenuation parameter and liver hardness value of in the 2 groups were recorded. Univariate analysis of the clinical data of the two groups was performed, and the clinical data with statistically significant differences between the two groups were included in binary logistic regression analysis to explore the related factors of nonalcoholic steatohepatitis in children with obesity. And then the receiver operating characteristic curve (ROC curve) was drawn on the relevant factors.Results:The children with obesity received treatment at the age of 6 years 1 month to 14 years 11 months, the male to female ratio was 1.33∶1. And 13 children (14.3%) were diagnosed with non-alcoholic steatohepatitis, of 46 nonalcoholic fatty liver disease, 9 were male and 4 were female. Univariate analysis showed that there were significant differences in gender, age, fasting insulin, control attenuation parameter and liver hardness value between the two groups (all P<0.05). Binary logistic regression analysis showed that control attenuation parameter ( OR=1.022, 95% CI: 1.001-1.041) and liver hardness value ( OR=1.689, 95% CI: 1.077-2.648) were the related factors of nonalcoholic steatohepatitis in children with obesity (both P<0.05). The area under the curve (AUC) values of control attenuation parameter and liver hardness value for predicting nonalcoholic steatohepatitis in children with obesity was 0.840 (95% CI: 0.748-0.931) and 0.794 (95% CI: 0.672-0.915), respectively. Conclusion:Control attenuation parameter and liver hardness value are correlated with nonalcoholic steatohepatitis in children with obesity with certain diagnostic value.
4.Comparison of the effects between low-level assisted ventilation and T-piece method on respiratory mechanics during weaning of mechanically ventilated patients
Shiya WANG ; Zhenjie JIANG ; Baozhu ZHANG ; Guangsheng LU ; Zhimin WANG ; Zhimin LIN ; Qiang CHEN ; Chun YANG ; Qingwen SUN ; Honglian RUAN ; Yuanda XU
Chinese Critical Care Medicine 2021;33(6):697-701
Objective:To compare the difference of low-level assisted ventilation and T-piece method on respiratory mechanics of patients with invasive mechanical ventilation during spontaneous breathing trial (SBT) within 3 days before extubation.Methods:A retrospective observational study was conducted. Twenty-five patients with difficulty in weaning or delayed weaning from invasive mechanical ventilation who were admitted to department of critical care medicine of the First Affiliated Hospital of Guangzhou Medical University from December 2018 to June 2020, and were in stable condition and entered the weaning stage after more than 72 hours of invasive mechanical ventilation were studied. A total of 119 cases of respiratory mechanical indexes were collected, which were divided into the low-level assisted ventilation group and the T-piece group according to the ventilator method and parameters used during the data collection. The different ventilation modes related respiratory mechanics indexes such as the esophageal pressure (Pes), the gastric pressure (Pga), the transdiaphragmatic pressure (Pdi), the maximum Pdi (Pdimax), Pdi/Pdimax ratio, the esophageal pressure-time product (PTPes), the gastric pressure-time product (PTPga), the transdiaphragmatic pressure-time product (PTPdi), the diaphragmatic electromyography (EMGdi), the maximum diaphragmatic electromyography (EMGdimax), PTPdi/PTPes ratio, Pes/Pdi ratio, the inspiratory time (Ti), the expiratory time (Te) and the total time respiratory cycle (Ttot) at the end of monitoring were recorded and compared between the two groups.Results:Compared with the T-piece group, Pes, PTPes, PTPdi/PTPes ratio, Pes/Pdi ratio and Te were higher in low-level assisted ventilation group [Pes (cmH 2O, 1 cmH 2O = 0.098 kPa): 2.84 (-1.80, 5.83) vs. -0.94 (-8.50, 2.06), PTPes (cmH 2O·s·min -1): 1.87 (-2.50, 5.93) vs. -0.95 (-9.71, 2.56), PTPdi/PTPes ratio: 0.07 (-1.74, 1.65) vs. -1.82 (-4.15, -1.25), Pes/Pdi ratio: 0.17 (-0.43, 0.64) vs. -0.47 (-0.65, -0.11), Te (s): 1.65 (1.36, 2.18) vs. 1.33 (1.05, 1.75), all P < 0.05], there were no significant differences in Pga, Pdi, Pdimax, Pdi/Pdimax ratio, PTPga, PTPdi, EMGdi, EMGdimax, Ti and Ttot between the T-piece group and the low-level assisted pressure ventilation group [Pga (cmH 2O): 6.96 (3.54,7.60) vs. 7.74 (4.37, 11.30), Pdi (cmH 2O): 9.24 (4.58, 17.31) vs. 6.18 (2.98, 11.96), Pdimax (cmH 2O): 47.20 (20.60, 52.30) vs. 29.95 (21.50, 47.20), Pdi/Pdimax ratio: 0.25 (0.01, 0.34) vs. 0.25 (0.12, 0.41), PTPga (cmH 2O·s·min -1): 7.20 (2.54, 9.97) vs. 7.97 (5.74, 13.07), PTPdi (cmH 2O·s·min -1): 12.15 (2.95, 19.86) vs. 6.87 (2.50, 12.63), EMGdi (μV): 0.05 (0.03, 0.07) vs. 0.04 (0.02, 0.06), EMGdimax (μV): 0.07 (0.05, 0.09) vs. 0.07 (0.04, 0.09), Ti (s): 1.20 (0.95, 1.33) vs. 1.07 (0.95, 1.33), Ttot (s): 2.59 (2.22, 3.09) vs. 2.77 (2.35, 3.24), all P > 0.05]. Conclusions:When mechanically ventilated patients undergo SBT, the use of T-piece method increases the work of breathing compared with low-level assisted ventilation method. Therefore, long-term use of T-piece should be avoided during SBT.
5.Anterior choroidal artery territory infarction: infarct size and its related factors
Guangsheng WANG ; Ting HU ; Jinjian YANG ; Yuanyuan TIAN ; Li HUANG ; Longxiang ZHOU ; Yuanwei WANG ; Hanpei GU ; Ying WANG
International Journal of Cerebrovascular Diseases 2020;28(5):348-354
Objective:To investigate the infarct size and its related factors in patients with anterior choroidal artery (AchA) territory infarction.Methods:From April 2016 to April 2018, consecutive patients with acute AchA territory infarction hospitalized in the Department of Neurology, the Affiliated Shuyang Hospital of Xuzhou Medical University were enrolled retrospectively. The National Institutes of Health Stroke Scale (NIHSS) was used to assess the severity of the disease at baseline, and the Diffusion-Weighted Imaging (DWI) was used to determine the side, location, size, and morphology of the infarct lesions. The patients were divided into small infarction group (<20 mm) and large infarction group (≥20 mm). Multivariate logistic regression analysis was used to determine the independent risk factors for infarct size. Results:A total of 100 consecutive patients with acute AchA territory infarction were enrolled, including 86 (86.0%) in small infarction group, 14 (14.0%) in large infarction group. Based on the NIHSS score, there were 89 patients with mild stroke, 9 with moderate stroke, and 2 with severe stroke. According to DWI, 69 patients (69.0%) had long cord-like infarcts and 31 (31.0%) had other shapes of infarcts. The baseline NIHSS score (7.0 [2.0-10.5] vs. 3.0 [2.0-4.0]; Z=2.353, P=0.019) and the proportion of patients with severe stroke (14.3% vs. 0%; P=0.018), the infarcts in posterior part of periventricular area (85.7% vs. 57.0%; χ2=4.180, P=0.041) and medial globus pallidus (21.4% vs. 4.7%; χ2=5.206, P=0.023), and cord-like infarction (92.9% vs. 65.1%; χ2=4.332, P=0.037) in patients of the large infarction group were significantly higher than those of the small infarction group; leukocyte count (7.7±1.7×10 9/L vs. 6.6±1.8×10 9/L; t=2.214, P=0.036) and platelet count (234.5±39.5×10 9/L vs. 198.0±49.4×10 9/L; t=2.618, P=0.010) were significantly higher than those of the small infarction group; the proportion of patients with sensory impairment was significantly higher than that of the small infarction group (50.0% vs. 24.4%; χ2=3.908, P=0.048). Multivariate logistic regression analysis showed that platelet count (odds ratio 1.018, 95% confidence interval 1.000-1.621; P=0.044) and stroke severity (odds ratio 18.245, 95% confidence interval 1.534-217.052; P=0.022) were significantly and positively correlated with the infarct size. Conclusion:The related factors of the infarct size in patients with AchA territory infarction included sensory impairment, baseline NIHSS score, stroke severity, morphology and location of infarct lesions, and leukocyte and platelet counts, of which platelet count and stroke severity were independently positively correlated with the infarct size.
6.Clinicopathologic analysis of misdiagnosed extraskeletal Ewing′s sarcoma in children
Yanfei LIU ; Na ZHANG ; Juan LI ; Lu AN ; Guangsheng CHEN ; Zhe WANG ; Li YANG
Chinese Journal of Applied Clinical Pediatrics 2020;35(21):1651-1655
Objective:To investigate clinicopathological characteristics of misdiagnosed pediatric extraskeletal Ewing′s sarcoma in children, its diagnosis and differential diagnosis, and the reasons of misdiagnosis by pathologists.Methods:The clinical data of 34 cases of pediatric extraskeletal Ewing′s sarcoma diagnosed by the Department of Pathology, Xi′an Children′ Hospital and Xijing Hospital Fourth Military Medical University from January 2011 to July 2019 were retrospectively analyzed.Hematoxylin-eosin staining, immunohistochemical staining and EWSR1 fusion gene detection by fluorescence in situ hybridization (FISH) were performed on 6 primarily misdiagnosed cases.The clinical features, histological morphology, immunophenotype and molecular genetics of these 6 patients were studied. Results:The median age of 6 cases was 7 years old.There were 5 cases with slowly-growing, painless and localized masses.Four masses were located in the superficial subcutaneous fascia, and 1 was a rapidly growing soft tissue mass.Tumor cells were lobular and nest-like under low power microscopy.At high power microscopy, 2 cases were composed of small blue round cells, and 4 cases had morphological changes, including an increase in cell volume and enriched cytoplasm.Among the 4 cases with tumor morphological changes, tumor cells of 1 case had fine and smooth chromatin, tumor cells of 1 case had clear nuclei and prominent nucleoli, tumor cells of 1 case were composed of epithelioid cells, and tumor cells of 1 case were mixed spindle and epithelioid cells in large round and oval cells.The positive rates of CD 99, friend leukaemia integration-1(FLI1) and ERG were 5/6 cases, 5/6 cases and 2/6 cases, respectively.Rearrangements of EWSR1 gene were detected in all 6 cases. Conclusions:Biological characteristics including young onset age, superficial position and primary benign tumor, histological diversity and atypical immunohistochemical markers are 3 important factors contributing the misdiagnosis of extraskeletal Ewing′s sarcoma in children.The diagnosis should be made by combining the clinical features, morphology, immunohistochemical staining and EWSR1 gene detection.
7.Protective effect of insulin on myocardial ischemia-reperfusion injury in diabetic rats based on PI3K/Akt signaling pathway
Jin YANG ; Shuigen MA ; Zhaojun XU ; Zhi LIU ; Guangsheng NI
Journal of Chinese Physician 2019;21(3):364-367,372
Objective To study the effect of insulin on phosphatidylinositol 3-kinase/protein kinase B (PI3K/Akt) signaling pathway in diabetic rats with myocardial ischemia reperfusion injury.Methods Diabetic rats were induced by high-sugar and high-fat diet plus intraperitoneal injection of streptozotocin (40 mg/kg).They were randomly divided into diabetic sham group (group A),diabetes ischemic reperfusion group (group B),diabetes ischemic reperfusion insulin treatment group (group C) and diabetic ischemia reperfusion + insulin Wortmaninn (PI3K inhibitors) group (group D),10 in each group.Myocardial ischemia reperfusion model in diabetic rats:heart was exposed between the third and fourth ribs of the left chest,2 mm from the lower edge of the left atrial ear,and 5-0 sterile suture was used to ligate the anterior descending coronary artery (LAD) and the great cardiac vein for 30 min,and then the perfusion was resumed for 120 min.Wortmannin (15 μg/kg) was given through femoral vein 20 min before ligation in group D,and the same amount of normal saline was given in the other 3 groups.Insulin (2 U/kg) was injected subcutaneously in group C and D 10 min before ligation,and the same amount of normal saline was injected subcutaneously in group A and group B.Plasma creatine kinase MB (CK-MB)and troponin Ⅰ (cTnⅠ) levels were measured in arterial blood after 120 min of reperfusion,and PI3K and Akt expression in myocardial tissue were detected by Western blot.Results Compared with the group A,the plasma levels of cTnI and CK-MB increased and the expressions of PI3K and phosphorylated protein kinase B (p-Akt) in myocardium decreased in the group B (P < 0.05).After insulin treatment,the plasma cTnI [(0.89 ± 0.26) μg/L],CK-MB [(9.24 ±3.16) μg/L] in the myocardial tissue of the group C decreased,while the expression of PI3K (0.341 8 ±0.03 1) and p-Akt (0.673 1 ±0.028) in the myocardial tissue increased (P <0.05).After insulin + Wortmaninn administration,the plasma cTnI [(1.16 ±0.29) μg/L] and CK-MB [(12.57 ± 3.01) μg/L] in the group D increased,while the expression of PI3K (0.292 7 ± 0.036) and p-Akt (0.531 4 ± 0.030) in the myocardial tissue decreased,with statistically significant difference (P < 0.05).Conclusions Insulin can reduce serum CK-MB and cTnⅠ levels in diabetic rats with myocardial ischemia reperfusion injury,possibly by activating PI3K/Akt signal transduction pathway,inhibiting myocardial enzyme release,and improving myocardial ischemia reperfusion injury in diabetic rats to play a protective role in myocardial cells.
8.Relationship between clinical features and peripheral blood test indicators and curative effect in patients with acquired hemophagocytic syndrome
Yang CHEN ; Wenjing ZHANG ; Xue YAN ; Yongchao MA ; Ting ZHANG ; Lin GUI ; Lili YANG ; Jinning SHI ; Guangsheng HE
Journal of Leukemia & Lymphoma 2018;27(11):670-674
Objective To explore relationship between clinical features and peripheral blood test indicators and curative effect in adult patients with acquired hemophagocytic syndrome (HPS). Methods A total of 61 adult patients with acquired HPS who were admitted to the First Affiliated Hospital with Nanjing Medical University and the Affiliated Jiangning Hospital of Nanjing Medical University from April 2014 to March 2017 were enrolled, including 38 males and 23 females, with a median age of 48 years (17-86 years). The retrospective analyses of their clinical data and laboratory examination results were made in this study. Results There was no significant difference in the therapeutic effective rate of 61 HPS patients caused by different inducements after treatment (P =0.184). The prothrombin time (PT) before treatment was higher than that after treatment [(12.90±1.97) s vs. (12.35±1.78) s, P= 0.046]; the level of lactate dehydrogenase (LDH) before treatment was higher than that after treatment (median: 476 U/L vs. 231 U/L, P = 0.000); the level of D-dimer (D-D) before treatment was higher than that after treatment (median: 1.46 mg/L vs. 0.51 mg/L, P = 0.007); the level of aspartate aminotransferase (AST) before treatment was higher than that after treatment (median: 54.9 U/L vs. 26.0 U/L, P= 0.000); the level of serum calcium before treatment was lower than that after treatment [(2.07±0.20) mmol/L vs. (2.18±0.23) mmol/L, P = 0.043]. The peripheral blood platelet counts (Plt) in the effective group (32 cases) before treatment was higher than that in the ineffective group (29 cases) (median: 104.0×109/L vs. 63.5×109/L, P =0.007), the level of albumin (ALB) in the effective group was higher than that in the ineffective group [(35.50 ±6.17) mmol/L vs. (31.93 ±6.54) mmol/L, P = 0.033], the level of serum calcium in the effective group was higher than those in the ineffective group [(2.18±0.18) mmol/L vs. (2.08±0.20) mmol/L, P = 0.047], the level of prothrombin time (PT) in the effective group was lower than that in the ineffective group [(12.40±1.76) s vs. (13.43±2.06) s, P = 0.041], and the level of LDH in the effective group was lower than that in the ineffective group (median: 415.0 U/L vs. 593.5 U/L, P= 0.032). Conclusion The lower expressions of Plt, ALB and serum calcium, and the higher expressions of PT and LDH may indicate the poor prognosis of adult acquired HPS, and there fore these patients need to be paid attention.
9.Feasibility and preliminary technical experience of single incision plus one port laparoscopic total gastrectomy combined with π-shaped esophagojejunal anastomosis in surgical treatment of gastric cancer.
Guangsheng DU ; Enlai JIANG ; Yuan QIU ; Wensheng WANG ; Shuai WANG ; Yunbo LI ; Ke PENG ; Xiang LI ; Hua YANG ; Weidong XIAO
Chinese Journal of Gastrointestinal Surgery 2018;21(5):556-563
OBJECTIVETo explore the feasibility, safety, and preliminary technical experience of single incision plus one port laparoscopic total gastrectomy combined with π-shaped esophagojejunal anastomosis (SILT-π) in the surgical treatment of gastric cancer.
METHODSClinical data of 5 gastric cancer patients undergoing SILT-π operation at the Department of General Surgery, The Second Affiliated Hospital of the Army Medical University from August to October 2017 were retrospectively analyzed. A 2.5-3.0 cm incision around the umbilicus was made for placing the gloveport as the passage for the lens, and the instruments of the surgeon and the assistant. Another operative port was placed in the left upper quadrant with a 12-mm Trocar for the passage of the energy device, the endoscopic cutting closure, as well as the postoperative drainage tube. A D2 lymph node (LNs) dissection was regularly conducted. After the abdominal esophagus was routinely mobilized, a side-to-side esophagus-jejunum anastomosis was made through a gastric pre-pulling esophagojejunal π-shaped anastomosis. The transection was then performed with a ligation on the cardia (or esophagus above the upper margin of the tumor) using a sterilized hemp rope in order to better expose the abdominal esophagus. Throughout the course of reconstruction, the ligature rope was held by the assistant to hold down the esophagus to allow easier esophagojejunal anastomosis. A hole was then made on the posterior wall of the esophagus, between 2 cm and 3 cm above the ligature rope, and another hole was made at the anti-mesenteric border of the jejunum 40 cm distal to the Treitz ligament. A side-to-side esophagojejunal π-shaped anastomosis was performed through two holes. An entry hole was formed after the anastomosis. After checking the anastomosis, this entry hole was closed through an intestinal mesenteric hole pre-made on its opposite side. The resected esophagus and stomach, together with the afferent loop jejunum, were simultaneously transected above the level of the entry hole by a stapler from the Trocar of the left upper abdominal quadrant. After the gloveport was closed, a side-to-side jejunojejunostomy anastomosis applied with another two staples was performed between the afferent loop stump and the roux limb 30 cm below the esophagojejunal anastomosis.
RESULTSThese five patients were all male, and aged (56.8±8.2) years with preoperative clinical stage cT2-4N0-2M0. All the 5 patients underwent SILT-π operation successfully. The average length of surgical incision was (2.9±0.2) cm. The average operation time was (396.0±36.1) minutes. The intraoperative blood loss was (140.0±66.7) ml. Postoperative pathology showed proximal and distal margins were (2.6±1.1) cm and (8.7±2.5) cm apart respectively, and the average number of retrieved lymph node was 25.8±7.2. Perioperative management was based on enhanced recovery following surgical (ERAS) principles. The average time to the first flatus was (2.6±0.5) days, and the average time to defecation was (3.6±0.5) days. The pain score on postoperative day 1 was 1-2, and the average postoperative hospital stay was (7.0±0.7) days. No perioperative complications occurred.
CONCLUSIONSSILT-π procedure is safe and feasible for patients with gastric cancer, and has positive short-term outcomes, satisfactory cosmetic abdominal incision, light postoperative abdominal pain and rapid postoperative recovery. Preliminary observations show that SILT-π procedure has good potential for clinical application in future.
Aged ; Anastomosis, Surgical ; Esophagus ; surgery ; Gastrectomy ; methods ; Humans ; Jejunum ; surgery ; Laparoscopy ; Male ; Middle Aged ; Retrospective Studies ; Stomach Neoplasms ; surgery
10.Efficacy and safety of low-dose levonorgestrel-releasing intrauterine system in Chinese women: a multicenter, single-arm, open labeled interventional trial
Cuifeng QIAN ; Guangsheng FAN ; Qinping LIAO ; Shuying WU ; Duanduan LA ; Wen DI ; Baihua DONG ; Hongwei LIU ; Liangdan TANG ; Zheng'ai XIONG ; Hanwang ZHANG ; Yali HU ; Naiming YANG ; Mulan REN ; Hong SHI ; Gaopi DENG ; Zirong HUANG
Chinese Journal of Obstetrics and Gynecology 2018;53(6):409-413
Objective To evaluate the efficacy,bleeding profile and safety of low-dose levonorgestrel-releasing intrauterine system (LNG-IUS 8) in Chinese healthy women of childbearing age.Methods A multi-center,open-label,single-arm clinical trial conducted at 16 centres in China enrolled 773 healthy women of childbearing age (mean age 31.6 years old,range 18 to 40 years old),who demanded contraception,from April 2006 to June 2013.All women placed LNG-IUS 8 for 3 years and then been followed up at 3,6,9,12,18,24,30,36 months.The efficacy variables including pregnancy rate and expulsion rate were analyzed using life table,while observing adverse events (AE) to evaluate the safety.The bleeding profile happened during the study was assessed using 90-day reference intervals (World Health Organization criteria).Results Eight pregnancies occurred among 773 women,resulting in a overall Pearl index of 0.42 per 100 women years.The 3-year cumulative pregnancy rate was 0.37 per 100 women years and the 3-year cumulative expulsion rate was 1.99 per 100 women years.The number of women with bleeding/spotting reduced and the bleeding/spotting days declined over time.Totally 219 AE were reported related to LNG-IUS 8 placements.The most common AE were vaginal bleeding (8.2%,63/773)and the ovarian cyst (6.2%,52/773).LNG-IUS 8 had an improving effect on dysmenorrhea that the percentage of women with dysmenorrhea as well as the days of dysmenorrhea decreased over time.The percentage of women satisfied or very satisfied with LNG-IUS 8 was 87.2% (622/713).Conclusion LNG-IUS 8 is highly effective and safe for Chinese healthy women of childbearing age.

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