1.Evaluation on efficacy of trastuzumab combined with neoadj uvant chemotherapy in Her-2 positive breast cancer patients and analysis of influencing factors of prognosis
Wanting SHAO ; Tong FU ; Panpan WU ; Di WU ; Sijie LI ; Chao ZHENG ; Zhimin FAN
Journal of Jilin University(Medicine Edition) 2016;42(2):351-357
Objective:To assess the efficacy of trastuzumab combined with neoadjuvant chemotherapy in the treatment of human epidermal growth factor receptor-2 (Her-2)positive breast cancer patients,and to explore its influencing factors of prognosis of breast cancer.Methods:The clinical materials of 112 Her-2 positive breast cancer patients were collected and they were divided into combined treatment group (trastuzumab + neoadj uvant chemotherapy)and single chemotherapy group (without trastuzumab ). SPSS 1 9.0 software was employed to calculate and analyze their clinical characteristics.The survival rate and prognosis were analyzed by Kaplan-Meier method,Log-rank test, and Cox regression. Results:Among the 112 Her-2 positive breast cancer patients, 23 cases were treated with trastuzumab,89 cases were treated without trastuzumab.The disease-free survival (DFS)in combined treatment group and single chemotherapy group had significant difference (P=0.012).And there was no significant difference of overall survival (OS)between two groups (P=0.064).The HR negative group had 18 (32.7%)patients with 5-level of Miller and Payne (MP)classification which was higher than HR positive group (5/46,10.9%)(P=0.009).In univariate analysis,the tumor size,node status at diagnosis and node status after operation were the influencing factors of DFS in the Her-2 positive breast cancer patients;the tumor size,node status at diagnosis,MP classification and node status after operation were the influencing factors of OS in the Her-2 positive breast cancer patients.The result of multivariate analysis indicated that the tumor size, node status at diagnosis,and with or without radiotherapy were the independent influencing factors of DFS and OS in the Her-2 positive breast cancer patients. Conclusion:The breast lesions in the Her-2 positive breast cancer patients with negative HR are relieved after treated with trastuzumab combined with neoadjuvant chemotherapy. The combination of trastuzumab and neoadj uvant chemotherapy can significantly improve the DFS and has a positive influence in the prognosis of Her-2 positive breast cancer patients.
2.The short-term efficacy of left-sided three-port total laparoscopic distal gastrectomy: a pros-pective study
Qinchuan YANG ; Haikun ZHOU ; Chao YUE ; Di TANG ; Weidong WANG ; Ruiqi GAO ; Zhenchang MO ; Panpan JI ; Zhiyu GUO ; Changming ZHANG ; Yannian WANG ; Juan YU ; Xiangxiang GAO ; Pengfei YU ; Jiangpeng WEI ; Xiaohua LI ; Gang JI
Chinese Journal of Digestive Surgery 2023;22(9):1120-1128
Objective:To investigate the short-term efficacy of left-sided three-port total laparoscopic distal gastrectomy (TPTLDG).Methods:The prospective randomized controlled study was conducted. The 68 patients undergoing laparoscopic distal gastrectomy in the First Affiliated Hospital of Air Force Medical University from March 2022 to March 2023 were collected. All patients were randomly assigned to the TPTLDG group with a double number, and to the five-port laparoscopic distal gastrectomy (FPLDG) group with a single number, respectively. Observation indicators: (1) grouping situations of the enrolled patients; (2) comparison of perioperative condition; (3) comparison of complications during postoperative 30 days; (4) comparison of pathological examination. Measure-ment data with normal distribution were represented as Mean± SD, and comparison between groups was conducted using the independent sample t test. Measurement data with skewed distribution were represented as M( Q1, Q3), and comparison between groups was conducted using the Mann-Whitney U test. Count data were described as absolute numbers, and comparison between groups was conducted using the chi-square test or continuous correction chi-square test. Comparison of ordinal data was analyzed using the non‐parameter rank sum test. Results:(1) Grouping situations of the enrolled patients. A total of 59 patients of gastric cancer were selected for eligibility. There were 40 males and 19 females, aged 59.00(52.00, 67.00)years. The gender (male, female), age, body mass index (BMI), Caprini score (≤2, ≥3), nutritional risk screening 2002 (<3, ≥3), Eastern Coopera-tive Oncology Group performance status (0, 1), preoperative hypersensitive C-reactive protein, preoperative IL-6, preoperative white blood cell count, preoperative albumin were 19, 11, 59.00(51.25,65.25)years, 21.92(20.93,22.73)kg/m 2, 7, 23, 24, 6, 18, 12, 0.78(0.78,1.46)mg/L, 3.07(1.50,10.56)μg/L, 6.07(4.94,7.19)×10 9/L, 44.30(40.83, 46.15) g/L in the 30 patients of TPTLDG group, versus 21, 8, 57.00(51.00, 67.00)years, 21.90(20.95, 23.35)kg/m 2, 11, 18, 24, 5, 17, 12, 1.13(0.78,11.40)mg/L, 5.56(1.88,15.12)μg/L, 5.54(4.71,6.70)×10 9/L, 43.55(40.25,44.88)g/L in the 29 patients of FPLDG group, showing no significant difference in the above indicators between the two groups ( χ2=0.557, Z=-0.444, -0.805, χ2=1.482, 0.074, 0.012, Z=-1.259, -1.262, -0.819, -1.199, P>0.05), confounding bias ensured comparability between the two groups. (2) Comparison of perioperative condition. The length of incision, time to removing drainage tube, IL-6 at postoperative day 3, cost of hospital stay were 6.65(6.48,6.93)cm, 3.00(0,3.00)days, 29.18 (13.67, 43.53)μg/L, 84 164.15(73 084.72, 96 782.14)yuan in the TPTLDG group, versus 8.00(7.50,8.35)cm, 3.00(3.00,4.00)days, 47.56(21.31,85.79)μg/L, 92 120.43(87 069.33, 113 089.74)yuan in the FPLDG group, showing significant differences in the above indicators between the two groups ( Z=-11.065, -2.141, -2.940, -2.220, P<0.05). (3) Comparison of complications during postoperative 30 days. The incidence rate of complications during postoperative 30 days was 30.00%(9/30) and 24.14%(7/29) in the TPTLDG group and FPLDG group, respectively, showing no significant difference between the two groups ( χ2=0.256, P>0.05). (4) Comparison of pathological examination. Cases with pathological N staging as 0 stage, 1 stage, 2 stage, 3 stage were 22, 2, 4, 2 in the TPTLDG group, versus 13, 7, 4, 5 in the FPLDG group, showing a significant difference between the two groups ( Z=-2.021, P<0.05). Conclusion:TPTLDG is safe and feasible for gastric cancer, with a good short-term efficacy.
3.Excavation for adverse events signals of atezolizumab
Panpan DI ; Yunfei HU ; Xiangsong MENG ; Hui QIAN ; Shuyun JIA
China Pharmacy 2022;33(24):3025-3028
OBJECTIVE To excavate the risk signals of adverse drug events (ADEs) of atezolizumab after marketing, so as to provide a reference for rational use of atezolizumab. METHODS Using the FAERS database, the ADEs of atezolizumab were collected from marketing on May 18th 2016 to Mar. 31st 2022. The ADEs risk signals were mined by reported odds ratio (ROR) and medicines and Healthcare Products Regulatory Agency method (MHRA), and then described and classified by preferred term (PT) and system organ classification (SOC) in the adverse drug reaction glossary of Medical Dictionary for Regulatory Activities (MedDRA) (23.0 edition). RESULTS A total of 16 051 ADEs reports with atezolizumab as the primary suspected drug were collected, and 401 PT were mined, involving 17 SOC. In 16 051 ADEs reports, the majority of patients were male (51.64%), with main age distribution of 19 to 64 years old and more than 65 years old. According to the number of reports, ADEs were mainly focusing on pyrexia, disease progression, interstitial lung disease, anaemia, pneumonia, etc. The involved SOC includes kidney and urinary system diseases, benign, malignant and unknown tumors (including cysts and polyps), endocrine system diseases, etc. According to the signal intensity, the new ADEs not specified in the drug instructions were macular thickening, paraneoplastic neurological syndrome, reactive perforating collagenosis, paraneoplastic dermatomyositis, anti-erythrocyte antibody positive and liver sarcoidosis. CONCLUSIONS In addition to the ADEs mentioned in the drug instructions,when using atezolizumab in clinic,attention should also be closely paid to ADEs of eyes, nervous and skin system, so as to ensure the safety of drug use in patients.
4.Mining and analysis of adverse drug reaction signals of melphalan based on FAERS
Panpan DI ; Hai LIANG ; Jie WANG ; Yunfei HU ; Shuyun JIA
China Pharmacy 2023;34(12):1493-1497
OBJECTIVE To mine the adverse drug reaction (ADR) signals of melphalan, so as to provide reference for clinically safe drug use. METHODS Using OpenVigil 2.1 data platform, relative ADR reports of melphalan from the first quarter of 2004 to the second quarter of 2022 in FAERS database were collected; data mining was conducted using the reported odds ratio (ROR) method and Medicines and Healthcare Products Regulatory Agency (MHRA) method of disproportional method. ADR reports were described and classified according to the system organ class (SOC) and preferred term (PT) in Medical Dictionary for Regulatory Activities (24.0 edition). RESULTS A total of 17 046 ADR reports related to the target drug melphalan were retrieved, and the number of ADR reports showed a fluctuating upward trend; the majority of patients were male (43.28%), and were concentrated between the ages of 50-<75 (35.09%), with the main reporting country being the United States (23.97%); ADR report involved a total of 22 842 severe outcomes, mainly including hospitalization or extended hospitalization (24.45%). Totally 403 ADR signals were detected, involving 23 SOC, mainly including blood and lymphatic system diseases (801 cases, 13.77%), followed by eye organ diseases (755 cases, 12.97%) and infectious and invasive diseases (716 cases, 12.30%). The ADR signals ranked high in the number of reported cases included febrile neutropenia, diarrhea, fever and mucositis and other PT; PT such as pneumonia, sepsis, vitreous hemorrhage, chorioretinal atrophy, myelodysplastic syndrome were not recorded in drug instructions. The ADR signals with high signal strength ranking included choroidal dystrophy, chorioretinal atrophy, eyeball atrophy and other PT, and above three types of PT were not included in the drug instructions. CONCLUSIONS ADRs caused by melphalan mainly include blood and lymphatic system diseases, eye organ diseases, and infectious and invasive diseases; before using melphalan, it is necessary to evaluate the drug use of patients, and pay close attention to the patient’s blood indicators and eye toxicity reaction, so as to guarantee the safety of treatment.
5.Study on the mental health status and its influencing factors among middle school students in Yi nationality areas: a case study of Xide County, Liangshan Prefecture, Sichuan Province
Zhihong WU ; Jiayi WANG ; Hexiang BAI ; Yixian QIN ; Xiaoyu FENG ; Xing GAO ; Baofeng DI ; Chunping TAN ; Aoyi TANG ; Panpan GAO ; Bili DUAN ; Jiahe LIU ; Wei SHI
Sichuan Mental Health 2023;36(2):131-136
ObjectiveTo explore the mental health status and its influencing factors among middle school students in Xide County, Liangshan Yi Autonomous Prefecture, and to provide references for mental health interventions for local middle school students. MethodsUsing a cross-sectional study design, one junior middle school and one senior middle school in Xide County, Liangshan Prefecture, Sichuan Province, were randomly selected on September 16, 2021, and two classes per grade in each school involving 288 students were recruited. Subjects were assessed using Patients' Health Questionnaire Depression Scale-9 item (PHQ-9), Generalized Anxiety Disorder Scale-7 item (GAD-7), PTSD Checklist for DSM-5 (PCL-5), Multidimensional Scale of Perceived Social Support (MSPSS) and UCLA Loneliness Scale (ULS-3). Then the scores of above scales were compared among middle school students with different demographic characteristics, and binary Logistic regression analysis was conducted to screen the influencing factors of post-traumatic stress disorder (PTSD) symptoms. ResultsAmong the respondents, 17.71% (95% CI: 0.133~0.221), 8.68% (95% CI: 0.054~0.120), 2.78% (95% CI: 0.009~0.047) and 45.83% (95% CI: 0.400~0.516) were reported to have symptoms of depression, anxiety, PTSD and loneliness, respectively. Students in senior middle school scored lower on PCL-5 and ULS-3 than those in junior middle school [(6.46±8.91) vs. (8.87±9.42), t=2.202, P<0.05; (4.67±1.65) vs. (5.60±1.88), t=4.431, P<0.01]. Regression analysis denoted that depressive symptoms (OR=7.630, P<0.05) and anxiety symptoms (OR=3.789, P<0.01) were risk factors for PTSD symptoms among middle school students. ConclusionThe middle school students in Xide County, Liangshan Yi Autonomous Prefecture suffer a high prevalence rate of depressive symptoms and loneliness, and those in junior middle school are more likely to feel a sense of strong loneliness, furthermore, depressive symptoms and anxiety symptoms are risk factors for PTSD symptoms.