1.Comparison the effect of Shengxuening tablets and ferrous succinate in treating pregnancy with anemia
Feng ZHANG ; Fuqun ZHOU ; Weidong WEI
Chinese Journal of Biochemical Pharmaceutics 2017;37(2):68-71
Objective To compare the clinical efficacy and safety of anemia during pregnancy of Shengxuening tablets and ferrous succinate treatment for clinical treatment in patients with anemia .Methods 212 cases of pregnancy in early pregnancy patients with anemia from March 2015 to February 2016 in our hospital,numbered according to the order of treatment, were randomly divided the patients into group A and group B,106 cases in each group,group A with Shengxuening tablets treatment, group B with ferrous succinate tablets treatment,two groups of patients were treated with the same program of diet guidance,all patients were treated for three months.Each patient was followed up to the end of delivery, and the two groups of patients before and after pregnancy treatment to the end of pregnancy anemia and pregnancy outcomes were compared.Comparison of two groups of patients before and after treatment for one,two and three months of hemoglobin (Hb) level,red blood cell count (RBC),serum ferritin (SF),total iron binding rate (TIBC) changes;finishing treatment of the two groups during the three follow-up of Hb, RBC, SF TIBC, which returned to normal levels at the time and, after three months of treatment and evaluate the clinical efficacy of the two groups were collected and compared during the treatment of adverse drug reactions of two groups were compared.Results After treatment for one,two and three months, levels of Hb,RBC and SF in two groups of patients were significantly higher than those before treatment,TIBC was lower than that before treatment (P<0.05);After treatment for one and two months,RBC,SF and Hb in group B were significantly higher than those in group A,TIBC lower than group A(P <0.05);After treatment for three months,the levels of Hb, RBC, SF and TIBC in two groups were back to normal,and there was no significant difference between the two groups.Hb, RBC,SF,TIBC index recovery time of group B was significantly shorter than the group A (P<0.05).After treatment for three months,there was no significant difference in clinical efficacy between two groups.The adverse drug reaction rate was significantly higher in the group B than in the group A during the treatment period (P<0.05).The end of the treatment to the end of pregnancy, five cases of group A were again the parallel treatment of anemia, 11 cases of group B were again anemia and pregnancy outcome in patients with treatment ,the adverse pregnancy rate in group A was higher than that of group B, the difference was statistically significant (P<0.05).Conclusion Shengxuening tablets and succinate iron treatment of early pregnancy anemia have advantages and disadvantages,clinical can consider the combined treatment of anemia in pregnancy,improve the clinical efficacy and safety.
2.The evaluation of alpha-fetoprotein response on efficacy and prognosis in targeted therapy combined with immunotherapy for intermediate-to-advanced hepatocellular carcinoma: a multicenter clinical study
Kongying LIN ; Qingjing CHEN ; Luobin GUO ; Yun YANG ; Yufeng CHEN ; Jianxi ZHANG ; Fuqun WEI ; Hui ZHANG ; Zhiqing CHENG ; Yuntong LI ; Congren WANG ; Yabin JIANG ; Kecan LIN ; Weiping ZHOU ; Yongyi ZENG
Chinese Journal of Digestive Surgery 2024;23(2):248-256
Objective:To investigate the evaluation efficacy and predictive prognostic value of alpha-fetoprotein (AFP) response in tyrosine kinase inhibitors (TKIs) in combination with PD-1 inhibitors (α-PD-1) for intermediate-to-advanced hepatocellular carcinoma (HCC).Methods:The retrospective cohort study was conducted. The clinicopathological data of 205 patients with intermediate-to-advanced HCC who were admitted to 9 medical centers, including Mengchao Hepatobiliary Hospital of Fujian Medical University et al, from March 2020 to July 2022 were collected. There were 178 males and 27 females, aged (52±12)years. Based on AFP response at 6-8 weeks after treatment, patients were divided into the AFP response group (AFP level decreased by ≥50% compared to baseline) and the AFP no response group (AFP level decreased by <50% compared to baseline). Observation indicators: (1) AFP response evaluation of anti-tumor efficacy; (2) comparison of patient prognosis; (3) analysis of factors affecting patient prognosis. Measurement data with normal distrubution were represented as Mean± SD, and measurement data with skewed distribution were represented as M(range) and M( Q1, Q3). Count data were described as absolute numbers, and comparison between groups was conducted using the chi-square test. The Kaplan-Meier method was used to draw survival curve and calculate survival rate, and the Log-Rank test was used for survival analysis. The COX proportional risk model was used for univariate analysis and the COX stepwise regression model was used for multivariate analysis. Results:(1) AFP response evaluation of anti-tumor efficacy. Before treatment, all 205 patients were positive of AFP, with a baseline AFP level of 1 560(219,3 400)μg/L. All 205 patients were treated with TKIs in combination with α-PD-1, and the AFP level was 776(66,2 000)μg/L after 6 to 8 weeks of treatment. Of the 205 patients, 88 cases were classified as AFP response and 117 cases were classified as AFP no response. According to the response evaluation criteria in solid tumors version 1.1, the objective response rate (ORR) and disease control rate (DCR) were 42.05%(37/88) and 94.32%(83/88) in patients of the AFP response group and 16.24% (19/117) and 64.10% (75/117) in patients of the AFP no response group, showing significant differences between them ( χ2=16.846, 25.950, P<0.05). According to the modified response evaluation criteria in solid tumors, the ORR and DCR were 69.32% (61/88) and 94.32% (83/88) in patients of the AFP response group and 33.33% (39/117) and 64.10% (75/117) in patients of the AFP no response group, showing significant differences between them ( χ2=26.030, 25.950, P<0.05). (2) Comparison of patient prognosis. All 205 patients were followed up for 12.4(range, 2.4-34.0)months after treatment. The median progression free survival time and total survival time were 5.5 months and 17.8 months, respectively. The 1-year, 2-year progression free survival rates were 20.8% and 7.2%, and the 1-year, 2-year overall survival rates were 68.7% and 31.5%, respectively. The median progression free survival time, 1-year and 2-year progression free survival rates were 9.7 months, 39.6% and 14.2% in patients of the AFP response group and 3.7 months, 7.8% and 2.0% in patients of the AFP no response group, showing a significant difference in progression free survival between them ( χ2=43.154, P<0.05). The median overall survival time, 1-year and 2-year overall survival rates were not reached, 85.2% and 56.3% in patients of the AFP response group and 14.6 months, 56.3% and 14.5% in patients of the AFP no response group, showing a significant difference in overall survival between them ( χ2=33.899, P<0.05). (3) Analysis of factors affecting patient prognosis. Results of multivariate analysis showed that invasion of large blood vessels, extrahepatic metastasis, combined hepatic artery intervention therapy, and AFP response were independent factors influencing progression free survival in patients with intermediate-to-advanced HCC who were treated with TKIs in combination with α-PD-1 ( hazard ratio=1.474, 1.584, 0.631, 0.367, 95% confidence interval as 1.069-2.033, 1.159-2.167, 0.446-0.893, 0.261-0.516, P<0.05), and Eastern Cooperative Oncology Group score, invasion of large blood vessels, extrahepatic metastasis, and AFP response were independent factors influencing overall survival in patients with intermediate-to-advanced HCC who were treated with TKIs in combination with α-PD-1 ( hazard ratio= 1.347, 1.914, 1.673, 0.312, 95% confidence interval as 1.041-1.742, 1.293-2.833, 1.141-2.454, 0.197-0.492, P<0.05). Conclusions:AFP response at 6-8 weeks after treatment can effectively evaluate anti-tumor efficacy of TKIs in combination with α-PD-1 for intermediate-to-advanced HCC. AFP response is the independent factor influencing progression free survival and overall survival in patients with intermediate-to-advanced HCC who were treated with TKIs in combination with α-PD-1.