1.Therapeutic efficacy analysis of sintilimab combined with paclitaxel and docetaxel for advanced non-small cell lung cancer
Xiaoyong WEI ; Xiaofeng LI ; Wanting SHI ; Jiale DU
Cancer Research and Clinic 2024;36(1):6-10
Objective:To investigate the efficacy of sintilimab combined with paclitaxel and docetaxel in the treatment of advanced non-small cell lung cancer (NSCLC).Methods:Prospective cohort study was performed. A total of 90 patients with advanced NSCLC receiving second-line treatment in Baotou Cancer Hospital from October 2019 to October 2022 were prospectively selected. All patients were divided into the study group (sintilimab combined with paclitaxel and docetaxel as second-line treatment, 45 cases) and the control group (paclitaxel or docetaxel alone, 45 cases) according to random number table method. The short-term efficacy, serum cytokine levels, quality of life and T-cell subsets of the two groups were compared. The survival of patients within 6 months was followed up. Kaplan-Meier method was used to analyze the overall survival (OS) of both groups, and log-rank test was used to make comparison among groups.Results:There were 25 males (55.56%) in the study group with the age of (63±5) years and 28 males (62.22%) in the control group with the age of (65±6) years. There were no statistically significant differences in the gender, age, Eastern Cooperative Oncology Group scores, the body mass (all P>0.05). The total effective rate was 88.89% (40/45) in the study group and 71.11% (32/45) in the control group, and the difference was statistically significant ( χ2 = 4.44, P = 0.035). The levels of serum vascular endothelial growth factor (VEGF) and carbohydrate antigen 125 (CA125) of both groups after treatment were lower than those before treatment (all P<0.001); the levels of VEGF and CA125 in the study group after treatment were lower than those in the control group [VEGF: (223±15) pg/ml vs. (289±15) pg/ml, t=20.82, P<0.001;CA125: (23±6) ng/ml vs. (75±4) ng/ml, t=51.28, P<0.001].Quality of life scale score, Karnofsky score of both groups after treatment were higher than those before treatment (all P<0.05); quality of life scale score and Karnofsky score in the study group after treatment were higher than those in the control group [quality of life scale score: (63±6) scores vs. (51±5) scores, t=10.29, P<0.001; Karnofsky score: (80.5±5.7) scores vs.(78.8±3.7) scores, t=1.70, P=0.041]. T-cell subsets indicators of both groups after treatment were higher than those before treatment (all P<0.001). T-cell subsets indicators in the study group after treatment were higher than those in the control group [CD3 + cell proportion: (68±5)% vs. (65±5)%, t=2.52, P = 0.014; CD4 + cell proportion:(42.5±1.7)% vs. (36.5±3.7)%, t=9.91, P<0.001;CD4 +/CD8 +: 1.78±0.54 vs. 1.46±0.27, t=3.56, P<0.001]. There was no significant difference in the incidence of adverse reactions between the two groups [11.11% (5/45) vs. 15.55% (7/45), χ2=0.39, P=0.534]. The follow-up time was 6 months. The OS in the study group was better than that in the control group ( χ2=3.86, P = 0.044). Conclusions:Sintilimab combined with taxoid chemotherapy drugs is effective in the second-line treatment of advanced NSCLC, and it improves immune function and shows a favorable safety.
2.Robot-assisted partial nephrectomy for totally intrarenal tumors: a single surgeon's experience
Jiazi SHI ; Chengzong LIU ; Weiping WANG ; Yi DONG ; Wanting ZANG ; Zhenjie WU ; Bing LIU ; Linhui WANG
Chinese Journal of Urology 2018;39(6):419-421
Objective To investigate the safety and efficiency of robot-assisted partial nephrectomy (RAPN) for totally intrarenal tumors (TITs).Methods Thirty-eight patients who underwent RAPN for treating TITs by one experienced surgeon were included between August 2012 and December 2017.There were 25 males and 13 females,aged 26-72 years(mean 51.6 years).Tumors of 24 cases were in right kidney,and 14 cases in left kidney.The diameter of tumor was(3.12 ± 0.92) cm,the R.E.N.A.L.score was(9.76 ± 1.00),and the Scr was (74.82 ± 20.32) μmol/L.Patients' peri-operative and oncological outcomes were analyzed.Results All the tumors were successfully resected without conversion to open surgery or radical nephrectomy.Mean operative time and ischemia time were (188.47 ± 46.75) min and (24.32 ± 7.69) min.Mean blood loss was (115.79 ± 43.66) rrd.One-week postoperative Scr was (85.97 ± 28.33) μmol/L.Postoperative hemorrhage was successfully treated by DSA or drug therapy in 3 patients.The pathological examination showed 28 clear cell renal cell carcinomas,3 chromophobe renal cell carcinomas,3 TFE-3 infusion related renal cell carcinomas,2 metanephric adenomas,1 acidophile adenoma and 2 angioleiomyolipomas.One positive surgical margin occurred in RAPN group for cystic components.No evidence of tumor progression observed during follow-up.Conclusions RAPN is safe and effective in treating TITs when performed by an experienced surgeon at a high-volume institution.Further prospective and large-scale study was warranted to evaluate the long-term outcomes.
3.Partial nephrectomy for T1b renal masses: comparison of laparoscopic and robot-assisted approach
Weiping WANG ; Zhenjie WU ; Jiazi SHI ; Yi DONG ; Xiaolong LIANG ; Yi BAO ; Jie WANG ; Hong XU ; Wanting ZANG ; Bing LIU ; Linhui WANG
Chinese Journal of Urology 2018;39(5):338-341
Objective To compare the operative-postoperative outcomes of laparoscopic and robotassisted partial nephrectomy (LPN and RAPN) for patients with T1 b renal masses.Methods A total of 169 T1 b renal mass patients receiving LPN (n =69) or RAPN (n =100) in our center between October 2009 and October 2017 were retrospectively collected.There were 46 males and 23 females in LPN group,with a mean age of (55.0 ± 11.9) years.The mean tumor size was (5.09 ± 0.76) cm,and mean R.E.N.A.L score was 6.36 ± 1.53.49 procedures (71%) were performed via a retroperitoneal approach in LPN group.There were 59 males and 41 females in RAPN group with a mean age of (52.9 ± 11.7) years.The mean tumor size was(4.95 ±0.66) cm,and mean R.E.N.A.L score was 8.17 ± 1.50.31 procedures (31%)were performed via a retroperitoneal approach in RAPN group.There was statistical significance between two groups in R.E.N.A.L score and surgery approach (P < 0.001).The group covariates were balanced through propensity score matching (PSM) using 1∶ 1 nearest neighbor matching method.After PSM,operating time,estimated blood loss,warm ischemia time,incidence of complications,hospital stay and postoperative follow-up status were compared between LPN(n =36)and RAPN(n =36)group.Results After PSM,patient distributions were closely balanced.In the LPN vs the RAPN group,there were significant different in warm ischemia time [(23.9 ± 7.3) min vs.(20.4 ± 6.7) min,P < 0.05],estimated blood loss [(136.9 ± 80.2) ml vs.(136.9 ± 80.2) ml,P < 0.05],incidence of complications (8.7% vs.1.0%,P <0.05),and hospital stay [(11.5 ±3.8)d vs.(9.8 ± 1.80)d].There was no significant differences resulted regarding operating time [(164.5 ± 64.4) min vs.(169.0 ± 42.5) min,P > 0.05],variation of estimated glomerular filtration rate from baseline [(9.97 ± 8.98)% vs.(9.27 ± 9.19)%,P > 0.05],positive surgical margin rate (1.4% vs.0,P > 0.05) and rate of recurrence or metastasis (1.4% vs.1.4%,P > 0.05) between groups.Conclusion Considering operative,functional and oncologic outcomes,both RAPN and LPN performed by an experienced surgeon were acceptable for patients with T1b renal masses.If available,robotic approach may reduce operative trauma and complications.
4.Expert consensus on the management of auditory hallucinations in inpatients with mental illness
Yanhua QU ; Dongmei XU ; Jing SHAO ; Shan ZHANG ; Mengqian ZHANG ; Jianing GU ; Xiaolu YE ; Feifei LI ; Wei LUO ; Wanting LI ; Li WANG ; Fangzhu SHI ; Xiaoyu FENG ; Qian ZHOU ; Juan ZHAO
Chinese Journal of Practical Nursing 2024;40(14):1080-1090
Objective:To standardize the management of auditory hallucination symptoms in inpatients with mental illness and develop an expert consensus on the management of auditory hallucinations in hospitalized psychiatric patients.Methods:From March 2023 to July 2023, the Mental Health Committee of the Chinese Nursing Association focused on the key issues in the management of auditory hallucinations symptoms in inpatients with mental illness, based on clinical practice, using literature analysis combined with the work experience of mental health experts, and formed the first draft of the expert consensus on the management of auditory hallucinations in inpatients with mental illness (hereinafter referred to as the consensus). Through 3 rounds of expert consultation and 3 rounds of expert demonstration meeting, the draft was adjusted, revised, and improved.Results:37 experts were included in the Delphi expert consultation, 1 male and 36 females with 39-67(51.48 ± 6.61) years old. The positive coefficients of experts in 3 rounds of Delphi expert consultations were all 100%, and the degrees of expert authority were 0.924, 0.938 and 0.949, respectively. The average importance value of each item was higher than 4.00, the variation coefficient of each item was less than 0.25. The Kendall harmony coefficient of the experts were 0.179, 0.195 and 0.198, respectively (all P<0.05). There were 15, 12, 12 experts in the first, seeond, third rounds of expert demonstration meeting. Finally, a consensus was reached on the recommendation of 4 parts, included auditory hallucination assessment, management format, symptom management implementation, and precautions. Conclusions:The consensus covers all parts of the management of auditory hallucination symptoms in hospitalized patients with mental disorders, which is practical and scientific. It is helpful to guide mental health professionals to standardize the management of auditory hallucination symptoms, improve the quality of nursing and ensure the safety of patients.
5.Analysis of Impurities in Peptide Drug Bivalirudin Based on Three Kinds of Separation Principle Technology
Jing YIN ; Wanting WANG ; Yihong LU ; Shuqiang ZHAO ; Haiwei SHI ; Bin DI ; Minhua XUE ; Ling CAO
Chinese Journal of Modern Applied Pharmacy 2024;41(5):626-635
OBJECTIVE
To establish HPLC methods with different separation principles to analyze the relevant impurities in the APIs of bivalirudin from seven enterprises, to provide a basis for the comprehensive control of related substances of bivalirudin.
METHODS
Reversed-phase high performance liquid chromatography(RP-HPLC) was used to separate and analyze 11 kinds of impurities. Hydrophilic chromatography(HILIC)-HPLC was used to control four process impurities. Polymers were determined by size exclusion chromatography(SEC)-HPLC.
RESULTS
The established RP-HPLC could effectively separate the principal component and 11 impurities, the correction factors of 11 impurities were between 0.8−1.2, the detection concentration of bivalirudin was 0.1 μg·mL−1, and the detection limit was 0.004%. The established HILIC-HPLC could effectively separate the principal components and four process impurities, and the detection concentration of bivalirudin was 0.3 μg·mL−1, and the detection limit was 0.01%. Under SEC-HPLC conditions, the polymer and bivalirudin peaked sequentially, the resolution of the two was 2.9, the detection concentration of bivalirudin was 6 ng·mL−1, and the detection limit was 0.000 6%. Fifteen kinds of known impurities and polymers in 15 batches of samples from 7 enterprises were calculated by the self-control method of principal components, and the impurity contents from different enterprises had a certain correlation with their production processes.
CONCLUSION
The three different principles of the method have good specificity, high sensitivity, good durability, and reliable results, and can be used for quality control of substances related to bivalirudin.