1.Comparative study on efficacy and safety of generic and original pemetrexed in patients with non-small cell lung cancer
Jun YANG ; Yafei SHI ; Shuya QI ; Wei CHEN ; Guohui LI
Adverse Drug Reactions Journal 2021;23(9):468-473
Objective:To compare the efficacy and safety between the generic pemetrexed produced by Sichuan Huiyu Pharmaceutical Co., LTD and the original pemetrexed produced by Eli Lilly Nederland B.V. in the treatment for patients with non-small cell lung cancer (NSCLC).Methods:The subjects were patients who received generic and original pemetrexed from March 2019 to December 2019 in Cancer Hospital of Chinese Academy of Medical Sciences. Demographic characteristics (age, gender, past history, etc.), treatment-related information (NSCLC stage, treatment regimen, underlying diseases, etc.), occurrence of adverse events, and efficacy evaluation in patients were collected. Patients were divided into the generic group and the original group, and the general situation, clinical use of pemetrexed, and adverse events in patients in the 2 groups were compared. After propensity score matching for 7 variables such as gender, age, body weight, body surface area, Eastern Cooperative Oncology Group (ECOG) score, tumor stage, and standardized chemotherapy dose, the efficacy and safety in patients between the 2 groups after 2 cycles of treatment with generic and original pemetrexed were compared.Results:A total of 182 patients were enrolled in the study, including 85 patients in the generic group and 97 patients in the original group. The differences in age, gender, ECOG score, body weight and body surface area, and underlying chronic diseases between the 2 groups were not statistically significant (all P>0.05). The patients with advanced stage Ⅲ and Ⅳ cancer in the generic group were significantly more than those in the original group [92%(78/85) vs. 79% (77/97), P=0.032]. The proportion of palliative chemotherapy and maintenance chemotherapy in the generic group was higher than that in the original group ( P<0.001). The difference in median dosage between the generic group and the original group was statistically significant [900 (800, 1 000) mg/m 2vs. 800 (800, 900) mg/m 2, P=0.019]. The difference in chemotherapy cycles between the 2 groups was statistically significant [5 (4, 10) vs. 4 (2, 4), P<0.001]. The overall incidence of adverse events and the incidences of bone marrow toxicity and liver toxicity in the generic group were higher than those in the original group ( P=0.018, P=0.037, P=0.018). After propensity score matching, there were 38 patients in both groups, and the differences in the objective response rate, disease control rate and the incidence of adverse events between the 2 groups were not statistically significant [26% (10/38) vs. 32%(12/38), P=0.723; 89% (34/38) vs. 96% (36/38), P=0.674; 47% (18/38) vs. 24%(9/38), P=0.055]. Conclusion:After propensity score matching, the difference in the efficacy and safety between the generic and the original pemetrexed was not significant.
2.Comparative study on efficacy and safety of generic and original pemetrexed in patients with non-small cell lung cancer
Jun YANG ; Yafei SHI ; Shuya QI ; Wei CHEN ; Guohui LI
Adverse Drug Reactions Journal 2021;23(9):468-473
Objective:To compare the efficacy and safety between the generic pemetrexed produced by Sichuan Huiyu Pharmaceutical Co., LTD and the original pemetrexed produced by Eli Lilly Nederland B.V. in the treatment for patients with non-small cell lung cancer (NSCLC).Methods:The subjects were patients who received generic and original pemetrexed from March 2019 to December 2019 in Cancer Hospital of Chinese Academy of Medical Sciences. Demographic characteristics (age, gender, past history, etc.), treatment-related information (NSCLC stage, treatment regimen, underlying diseases, etc.), occurrence of adverse events, and efficacy evaluation in patients were collected. Patients were divided into the generic group and the original group, and the general situation, clinical use of pemetrexed, and adverse events in patients in the 2 groups were compared. After propensity score matching for 7 variables such as gender, age, body weight, body surface area, Eastern Cooperative Oncology Group (ECOG) score, tumor stage, and standardized chemotherapy dose, the efficacy and safety in patients between the 2 groups after 2 cycles of treatment with generic and original pemetrexed were compared.Results:A total of 182 patients were enrolled in the study, including 85 patients in the generic group and 97 patients in the original group. The differences in age, gender, ECOG score, body weight and body surface area, and underlying chronic diseases between the 2 groups were not statistically significant (all P>0.05). The patients with advanced stage Ⅲ and Ⅳ cancer in the generic group were significantly more than those in the original group [92%(78/85) vs. 79% (77/97), P=0.032]. The proportion of palliative chemotherapy and maintenance chemotherapy in the generic group was higher than that in the original group ( P<0.001). The difference in median dosage between the generic group and the original group was statistically significant [900 (800, 1 000) mg/m 2vs. 800 (800, 900) mg/m 2, P=0.019]. The difference in chemotherapy cycles between the 2 groups was statistically significant [5 (4, 10) vs. 4 (2, 4), P<0.001]. The overall incidence of adverse events and the incidences of bone marrow toxicity and liver toxicity in the generic group were higher than those in the original group ( P=0.018, P=0.037, P=0.018). After propensity score matching, there were 38 patients in both groups, and the differences in the objective response rate, disease control rate and the incidence of adverse events between the 2 groups were not statistically significant [26% (10/38) vs. 32%(12/38), P=0.723; 89% (34/38) vs. 96% (36/38), P=0.674; 47% (18/38) vs. 24%(9/38), P=0.055]. Conclusion:After propensity score matching, the difference in the efficacy and safety between the generic and the original pemetrexed was not significant.
3.Clinicopathological characteristics and risk factors of female breast hyperplasia in different age groups
Fei WANG ; Shuohao SHEN ; Liyuan LIU ; Qi WANG ; Hongchuan JIANG ; Lisong TENG ; Zhimin FAN ; Cuizhi GENG ; Feng JIN ; Lili TANG ; Jianguo ZHANG ; Xiang WANG ; Shu WANG ; Xuening DUAN ; Lixiang YU ; Fei ZHOU ; Yujuan XIANG ; Shuya HUANG ; Chao ZHENG ; Qinye FU ; Dezong GAO ; Liang LI ; Zhongbing MA ; Qiang ZHANG ; Zhigang YU
Chinese Journal of General Surgery 2019;34(3):235-239
Objective To analyze clinicopathological characteristics and the potential risk-related factors of female breast hyperplasia in different age groups.Method From Jan 2015 to Dec 2016,patients diagnosed with breast hyperplasia in 12 hospitals were evaluated.All patients completed the self-designed questionnaires on women'health,including basic demographic information,clinic examination information,radiologic information and pathologic results.The patients were divided into a young group (< 45 years old) and an elderly group (from 45 to 75 years old).Results There were 3 684 cases of breast hyperplasia,including 2 291 cases in young group and 1 393 cases in elder group,respectively Clinically breast pain type were most commonly observed in both young and older groups (50.3% vs.42.7%,P < 0.001).While pathological research based on biopsy showed that breast adenopathy were the most common changes in both groups (67.9% vs.61.7%,P <0.001).More breast cancer cases were identified in elder group than that in young group,especially in clinically lump type patients (9.4% vs.4.2%,P < 0.001).Compared with elder group,patients in young group have different distribution characteristics regarding to fertility factors,lifestyle factors and psychology scale including anxiety and depression.Conclusion Distributions of clinicopathological characteristics and risk factors of female breast hyperplasia differ across different age groups.
4.Association between the length of CAG repeats in exon 1 of the androgen receptor gene and metabolic syndrome in Chinese men
Deyu YANG ; Jinhai TIAN ; Xin LI ; Xu ZHANG ; Jingjing YU ; Shuya LI ; Qi HUANG ; Rong MA ; Jia WANG ; Min JIANG
Journal of Xi'an Jiaotong University(Medical Sciences) 2017;38(3):431-436
Objective To study the association of the CAG repeat length polymorphism in exon 1 of the androgen receptor (AR) gene with metabolic syndrome (MS) and its components in men.Methods We used cluster sampling method to select 910 middle-and old-aged male subjects from the communities in Yinchuan and Wuzhong cities,Ningxia.Their body height,weight and blood pressure were measured;their testosterone (TT),serum lipids,fasting glucose (FBG) and fasting insulin (FINS) were assayed;and their body mass index (BMI) and free testosterone (FT) were calculated.Length of CAG repeats in exon 1 of the AR gene was determined by polymerase chain reaction (PCR) and direct sequencing method.The subjects were divided into MS group (n =304) and normal control group (n=606) according to the diagnosis standards of MS.Results No obvious difference in the frequency distribution of CAG repeats in the AR gene was found between MS group and normal control group.The systolic blood pressure in the mcn with CAG repeat number of less than 22 was significantly higher than that in those with CAG repeat number of 22 or more,but HDL-C was significantly lower than men with CAG repeat number of 22 or more.However,the two groups did not significantly differ in diastolic blood pressure,other blood lipids level,FBG,FINS,BMI,TT or FT.The men with CAG repeat number of less than 22 had a higher prevalence of hypertension than those with CAG repeat number of 22 or more,but the prevalence of MS and other components of MS in the two groups had no significant difference,Conclusion The length of CAG repeats in exon 1 of the AR gene is related to the occurrence of hypertension and the dccreased level of HDL-C,but not to the incidence of MS.The number (less than 22) of CAG repeats of the AR gene may be a genetic factor of the occurrence of hypertension and reduced level of HDL-C.
5.Association between estrogen receptor gene polymorphism and lipid metabolism in the Ningxia Hui population
Shuya LI ; Deyu YANG ; Jinhai TIAN ; Jingjing YU ; Rong MA ; Qi HUANG ; Xu ZHANG ; Jia WANG ; Min JIANG
Journal of Xi'an Jiaotong University(Medical Sciences) 2016;37(3):418-422
Objective To study the distribution of rs2234693 and rs9340799 of estrogen receptor (ER)gene and the relationship between them and lipid metabolism in the Ningxia Hui group,China.Methods We used cluster sampling method to select 5 3 3 cases of Ningxia Yinchuan communities of Hui. SNP genotyping was performed using the Sequenom MassARRAY platform.Results ① The frequencies of the distribution of each genotype of rs2234693 in Ningxia Hui population were the same as those in Chinese Han and Dai,Americans, Europeans,and Japanese (P>0.05).The distribution of each genotype of rs9340799,especially AA genotype,was different from that in Europeans (P<0 .0 5 ).② The body mass index in dyslipidemia group was significantly different from that in the control group (P<0.01).③ The risk of dyslipidemia in subjects with GG genotype of rs9340799 was 2.97 times higher than that in subjects with other genotypes (OR=2.97,P<2.97 ).After adjustment of gender,age,and body mass index (BMI),estrogen level was also 2.76 times higher (OR=2.76,P<0.05).(4)The frequency of C-G in rs2234693-rs9340799 haplotype was greater than that in the control group,but without any significant difference (P>0.05).Conclusion ER genes distribution in the Hui nationality of Ningxia is significantly different from that in other races;rs2234693 has no obvious relationship with the occurrence of dyslipidemia while GG genotype in SNP rs9340799 significantly increases the risk of lipid metabolism disorders.

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