1.Guide on Methodological Standards in Pharmacoepidemiology(2nd edition)and their series interpretation(9):research report standards and results visualization
Jingru CHENG ; Ruina CHEN ; Jiarui LI ; Shaowen TANG ; Feng SUN ; Siyan ZHAN
Chinese Journal of Pharmacoepidemiology 2025;34(9):1004-1016
Standardized research reporting is crucial for the translation of pharmacoepidemiology research findings,and visual reporting can significantly enhance the clarity,understandability,and transparency of research results.Based on the Guide on Methodological Standards in Pharmacoepidemiology(2nd edition),this article systematically explains the key points for writing each component of a research report(including title,abstract,introduction,research methods,research results,discussion and conclusions,acknowledgments,conflict of interest statement,and references).This article also summarizes recognized international and domestic standards for pharmacoepidemiology research reporting,providing a reference for researchers.Furthermore,real-world cases will be used to demonstrate common forms of visualized reports and their interpretation methods.Finally,it further explores strategies for communicating research results.This study aims to provide pharmacoepidemiology researchers with detailed guidance on visually presenting research results and writing high-quality research reports,thereby enhancing the integrity and impact of their research.
2.Guide on Methodological Standards in Pharmacoepidemiology(2nd edition)and their series interpretation(9):research report standards and results visualization
Jingru CHENG ; Ruina CHEN ; Jiarui LI ; Shaowen TANG ; Feng SUN ; Siyan ZHAN
Chinese Journal of Pharmacoepidemiology 2025;34(9):1004-1016
Standardized research reporting is crucial for the translation of pharmacoepidemiology research findings,and visual reporting can significantly enhance the clarity,understandability,and transparency of research results.Based on the Guide on Methodological Standards in Pharmacoepidemiology(2nd edition),this article systematically explains the key points for writing each component of a research report(including title,abstract,introduction,research methods,research results,discussion and conclusions,acknowledgments,conflict of interest statement,and references).This article also summarizes recognized international and domestic standards for pharmacoepidemiology research reporting,providing a reference for researchers.Furthermore,real-world cases will be used to demonstrate common forms of visualized reports and their interpretation methods.Finally,it further explores strategies for communicating research results.This study aims to provide pharmacoepidemiology researchers with detailed guidance on visually presenting research results and writing high-quality research reports,thereby enhancing the integrity and impact of their research.
3.Cohort study on correlation between serum TTF-1,PAX-8 and thyroid dysfunction after breast cancer post-operative radiation therapy
Gang CHEN ; Shunkang ZHANG ; Shaowen GUO ; Yue LU ; Liyun SUN ; Lei SHEN ; Cheng WANG
China Oncology 2024;34(12):1100-1107
Background and purpose:Thyroid dysfunction can frequently be discovered in breast cancer patients during long-term follow-up after receiving post-operative radiation therapy(PORT).This study aimed to compare serum levels of thyroid transcription factors(TTFs)TTF-1 and paired box 8(PAX-8)before and after PORT in breast cancer patients,combined with the results of serological thyroid indicators tests,and to analyze the relationship between the changes in serum levels of these two kinds of TTFs and thyroid dysfunction after breast cancer PORT.Methods:Female breast cancer patients without thyroid disease records who received PORT in Department of Radiation Oncology,Shanghai Ninth People's Hospital Huangpu Branch,Shanghai Jiao Tong University School of Medicine from Jan.2022 to Jun.2022 were prospectively selected,and were divided into two groups according to being with or without supraclavicular radiation field.All the patients had given informed consent before joining the study.The study design was approved by the ethic committee of our hospital(Ethic Approval No.2021-KY-2).Serum levels of TTF-1 and PAX-8,serological thyroid indicators[triiodothyronine(T3),tetraiodothyronine(T4),free triiodothyronine(FT3),free tetraiodothyronine(FT4),thyroid stimulating hormone(TSH)and thyroid peroxidase antibody(TPO-Ab)]were recorded before PORT,at the end of PORT,6,12 and 24 months after the end of PORT,respectively.The Strengthening the Reporting of Observational Studies in Epidemiology(STROBE)checklist was followed for this study.Results:Eighty patients were enrolled in this study(40 in each group).A total of 19 patients who had hypothyroidism were divided in two groups,15 in supraclavicular field group(SC group)and 4 in non-supraclavicular field group(NSC group),respectively(P=0.004).Levels of TTF-1[5.70(5.11,7.13)vs 6.68(5.15,7.57),P=0.296]and PAX-8(5.26±1.01 vs 5.66±1.37,P=0.149)did not show statistically significant deference between two groups before PORT.In SC group,levels of TTF-1 and PAX-8 gradually rose in 12 months after the end of PORT.In NCS group,levels of TTF-1 and PAX-8 did not change significantly during 24 months after the end of PORT.Test results of serum TTF-1 between two groups were statistically different at 6 months[6.99(4.73,13.94)vs 5.79(5.01,6.28),P=0.049],12 months[7.65(5.02,17.85)vs 5.43(4.52,6.22),P=0.005]after the end of PORT,while test results of serum PAX-8 between two groups were statistically different at 12 months[6.79(4.86,14.30)vs 5.81(4.70,7.25),P=0.042]after the end of PORT.The median values of TTF-1 and PAX-8 test results at 12 months after the end of PORT in SC group which were both significantly higher compared with NSC group were selected as the referent thresholds.Patients in SC group whose test results were higher than referent thresholds were defined as TTF-1/PAX-8 elevating subgroups,and patients whose test results under the threshold defined as TTF-1/PAX-8 normal subgroups.The incidences of hypothyroidism were higher in elevation subgroups than in normal subgroups(65.0%vs 10.0%,60.0%vs 15.0%,respectively,P=0.001,P=0.008,respectively).Positive correlations were observed between the elevation of TTF-1/PAX-8 at 12 months after the end of PORT and hypothyroidism after breast cancer supraclavicular field radiation(OR=9.702,3.930,and P=0.020,0.046,respectively)according to multivariate analysis.Conclusion:Thyroid dysfunction after breast cancer PORT was mainly manifested with hypothyroidism;supraclavicular field radiation may significantly increase the incidence of hypothyroidism;serum levels of TTF-1 and PAX-8 elevated obviously in breast cancer PORT patients who had hypothyroidism after receiving supraclavicular field radiation.
4.Cohort study on correlation between serum TTF-1,PAX-8 and thyroid dysfunction after breast cancer post-operative radiation therapy
Gang CHEN ; Shunkang ZHANG ; Shaowen GUO ; Yue LU ; Liyun SUN ; Lei SHEN ; Cheng WANG
China Oncology 2024;34(12):1100-1107
Background and purpose:Thyroid dysfunction can frequently be discovered in breast cancer patients during long-term follow-up after receiving post-operative radiation therapy(PORT).This study aimed to compare serum levels of thyroid transcription factors(TTFs)TTF-1 and paired box 8(PAX-8)before and after PORT in breast cancer patients,combined with the results of serological thyroid indicators tests,and to analyze the relationship between the changes in serum levels of these two kinds of TTFs and thyroid dysfunction after breast cancer PORT.Methods:Female breast cancer patients without thyroid disease records who received PORT in Department of Radiation Oncology,Shanghai Ninth People's Hospital Huangpu Branch,Shanghai Jiao Tong University School of Medicine from Jan.2022 to Jun.2022 were prospectively selected,and were divided into two groups according to being with or without supraclavicular radiation field.All the patients had given informed consent before joining the study.The study design was approved by the ethic committee of our hospital(Ethic Approval No.2021-KY-2).Serum levels of TTF-1 and PAX-8,serological thyroid indicators[triiodothyronine(T3),tetraiodothyronine(T4),free triiodothyronine(FT3),free tetraiodothyronine(FT4),thyroid stimulating hormone(TSH)and thyroid peroxidase antibody(TPO-Ab)]were recorded before PORT,at the end of PORT,6,12 and 24 months after the end of PORT,respectively.The Strengthening the Reporting of Observational Studies in Epidemiology(STROBE)checklist was followed for this study.Results:Eighty patients were enrolled in this study(40 in each group).A total of 19 patients who had hypothyroidism were divided in two groups,15 in supraclavicular field group(SC group)and 4 in non-supraclavicular field group(NSC group),respectively(P=0.004).Levels of TTF-1[5.70(5.11,7.13)vs 6.68(5.15,7.57),P=0.296]and PAX-8(5.26±1.01 vs 5.66±1.37,P=0.149)did not show statistically significant deference between two groups before PORT.In SC group,levels of TTF-1 and PAX-8 gradually rose in 12 months after the end of PORT.In NCS group,levels of TTF-1 and PAX-8 did not change significantly during 24 months after the end of PORT.Test results of serum TTF-1 between two groups were statistically different at 6 months[6.99(4.73,13.94)vs 5.79(5.01,6.28),P=0.049],12 months[7.65(5.02,17.85)vs 5.43(4.52,6.22),P=0.005]after the end of PORT,while test results of serum PAX-8 between two groups were statistically different at 12 months[6.79(4.86,14.30)vs 5.81(4.70,7.25),P=0.042]after the end of PORT.The median values of TTF-1 and PAX-8 test results at 12 months after the end of PORT in SC group which were both significantly higher compared with NSC group were selected as the referent thresholds.Patients in SC group whose test results were higher than referent thresholds were defined as TTF-1/PAX-8 elevating subgroups,and patients whose test results under the threshold defined as TTF-1/PAX-8 normal subgroups.The incidences of hypothyroidism were higher in elevation subgroups than in normal subgroups(65.0%vs 10.0%,60.0%vs 15.0%,respectively,P=0.001,P=0.008,respectively).Positive correlations were observed between the elevation of TTF-1/PAX-8 at 12 months after the end of PORT and hypothyroidism after breast cancer supraclavicular field radiation(OR=9.702,3.930,and P=0.020,0.046,respectively)according to multivariate analysis.Conclusion:Thyroid dysfunction after breast cancer PORT was mainly manifested with hypothyroidism;supraclavicular field radiation may significantly increase the incidence of hypothyroidism;serum levels of TTF-1 and PAX-8 elevated obviously in breast cancer PORT patients who had hypothyroidism after receiving supraclavicular field radiation.
5.Analysis of the relationship between different infiltrating lymphocytes and PD-L1 expression in triple-negative breast cancer and associated survival analysis (with video)
Hao WEI ; Yunhao PAN ; Ruijie NIU ; Qian ZHAO ; Shuangshuang LI ; Shaowen GUO ; Cheng WANG
Chinese Journal of Endocrine Surgery 2023;17(5):530-534
Objective:To analyze the relationship between PD-L1 expression and the degree of infiltration of different types of TILs in triple-negative breast cancer, and the correlation with other pathological features to explore their clinical significance.Methods:Tumor tissues of 199 patients with triple-negative breast cancer in our hospital were selected, and the expression of PD-L1 and the distribution of TILs were analyzed using immunohistochemistry and counted using Image software. The relationship between CD8 +TILs, CD4 +TILs and PD-L1 expression was analyzed and compared, and survival analysis and correlation analysis between PD-L1 expression and pathological information were performed. Results:The density of CD4 + TILs ( χ2=8.75, P=0.003) and CD8 + TILs ( χ2=6.32, P=0.009) infiltration was higher in the PD-L1-positive group compared to that of the PD-L1-negative group. Among PD-L1-positive patients, patients with higher TILs infiltration compared to low infiltrating TILs could achieve longer overall survival time, and the difference was statistically significant ( P1=0.012, P2=0.023, P3=0.010). Patient PD-L1 expression was positively correlated with the number of positive lymph nodes, tumor stage, and ki-67 expression ( Pa=0.032, Pb=0.006, Pc=0.042), and was not related to age or tumor diameter ( Pd=1.031, Pe=0.672) . Conclusions:PD-L1 expression in triple negative breast cancer predicts higher infiltration of CD4 +TILs and CD8 +TILs, while higher infiltration of CD4 +TILs and CD8 +TILs predicts a relatively good survival prognosis.PD-L1 expression is associated with multiple pathological clinical factors and deserves further study to make PD-L1, TILs and other indicators better benefit triple-negative breast cancer patients.
7.Comparison of the short-term effects of oblique lateral approach and transforaminal approach for treating single-segment lumbar spondylolisthesis
Shengdong WANG ; Peng CHENG ; Shaowen DU ; Xiang LIU ; Kaishan YE
Journal of Xi'an Jiaotong University(Medical Sciences) 2021;42(6):802-807
【Objective】 To compare the short-term clinical effects of oblique lateral interbody fusion (OLIF) and transforaminal lumbar interbody fusion (TLIF) for treating single-segment lumbar spondylolisthesis. 【Methods】 We retrospectively analyzed the data of 68 patients with single-segment degenerative lumbar spondylolisthesis from January 2019 to February 2020. According to different surgical methods, the patients were divided into OLIF+ anterior screw fixation group (33 cases) and TLIF + posterior pedicle screw fixation group (35 cases). The operation time, intraoperative blood loss, postoperative drainage, postoperative hospital stay and complication rate were compared between the two groups of patients. The disc height (DH), lumbar lordosis (LL), fused segmental lordosis (FSL), foraminal height (FH), and spondylolisthesis angle (SA) were measured before and after surgery and during follow-up. The visual analogue scale (VAS) of waist pain and the Oswestry disability index (ODI) were used to evaluate the short-term clinical efficacy. 【Results】 The operation time, intraoperative blood loss, postoperative drainage, and postoperative hospital stay were less in OLIF group than in TLIF group (all P<0.05). There was no statistically significant difference in VAS or ODI scores between the two groups at the last follow-up after surgery (both P>0.05). The two groups had statistically significant differences in DH and FH after surgery (P<0.05), but no significant difference in postoperative LL, FSL or SA (all P>0.05). There were six (18.2%) and five (14.3%) cases of complications in OLIF group and TLIF group, respectively, with no significant difference (P>0.05). 【Conclusion】 OLIF and TLIF are equally safe and effective in treating single-segment lumbar spondylolisthesis. However, OLIF combined with anterior screw fixation has the advantages of less surgical trauma, less blood loss, shorter operation time, reduced postoperative hospital stay and shorter recovery time. Therefore, it is a more minimally invasive surgical option.
8.Efficacy and Safety of Fluorouracil Combined with Paracetamol in the Trea tment of Knee Osteoarthritis and Its Effects on Related Indexes
Shaolin REN ; Lei PENG ; Shaowen CHENG ; Cuiyun JIANG
China Pharmacy 2019;30(2):249-252
OBJECTIVE: To observe the efficacy and safety of fluorouracil combined with paracetamol in the treatment of knee osteoarthritis and its effects on related indexes. METHODS: Totally 115 patients with knee osteoarthritis admitted to our hospital from March 2015 to March 2018 were divided into control group (57 cases) and observation group (58 cases) according to medication plan. Control group was given Paracetamol tablets 0.3 g orally, 3 times a day, for consecutive 8 weeks. Observation group was additionally given intra-articular injection of Fluorouracil injection 0.075 g on the basis of control group, once a week, 4 times as a treatment course, for 2 courses in total. Clinical efficacies, VAS scores, Lysholm knee scores, Fugl-Meyer Assessment (FMA) scores, Barthel indexes, WHO QOL-BREF scores before and after treatment and the occurrence of ADR of 2 groups were observed. RESULTS: The total response rate of observation group was 94.83%, which was significantly higher than 78.95% of control group (P<0.05). Before treatment, there was no statistical significance in VAS score, Lysholm knee scores, FMA scores, Barthel index or QOL-BREF scores between 2 groups (P>0.05). After treatment, VAS scores of 2 groups were significantly lower than before treatment, and the observation group was lower than the control group; Lysholm knee scores, FMA scores, Barthel indexes and QOL-BREF scores were significantly higher than the same group before treatment, and observation group was significantly higher than control group (P<0.05). There was no statistical significance in the incidence of ADR between 2 groups (P>0.05). No severe ADR was found in 2 groups during treatment. CONCLUSIONS: Fluorouracil combined with paracetamol can significantly improve therapeutic efficacy of patients with knee osteoarthritis, and can significantly improve knee function, motor function, self-care ability and quality of life without increasing the occurrence of ADR.
9.Study on the Effect Mechanism of Diazoxide on the Proliferation and Apoptosis of Chondrocytes with Oxidative Injury
Cuiyun JIANG ; Shaolin REN ; Chunping ZHANG ; Shaowen CHENG
China Pharmacy 2019;30(14):1890-1893
OBJECTIVE: To investigate the effect mechanism of diazoxide on the proliferation and apoptosis of chondrocytes with oxidative injury based on endoplasmic reticulum stress (ERS) pathway. METHODS: SD mice were selected for primary culture of articular chondrocytes. The 3rd generation chondrocytes were randomly divided into control group, injury model group and diazoxide group. Control group didn’t receive any treatment. The injury model group was incubated with 300 μmol/L hydrogen peroxide (H2O2) at 37 ℃ for 8 h. Diazoxide group was pretreated with 300 μmol/L diazoxide at 37 ℃ for 0.5 h,and then incubated with 300 μmol/L H2O2 for 8 h. The proliferation of chondrocytes was detected by CCK-8 assay. The apoptosis rate of chondrocytes was detected by flow cytometry. The expression of ERS-related proteins [Caspase-3, Bcl-2-associated X(Bax),C/EBP homologous protein (CHOP)] were detected by Western blotting assay. RESULTS: Compared with control group, the proliferation activity of chondrocytes in injury model group was significantly decreased, while apoptosis rate was increased significantly(P<0.05);the protein expression of Caspase-3, Bax and CHOP were increased significantly (P<0.05). Compared with injury model group, the proliferation activity of chondrocytes in diazoxide group was increased significantly, while the apoptosis rate was decreased significantly (P<0.05); the expression of above related proteins were decreased significantly (P<0.05). CONCLUSIONS: Diazoxide can improve the proliferation activity of chondrocytes with oxidative injury and inhibit their apoptosis by inhibiting ERS pathway.
10.Research of TGF-β microbubble targeting for skeletal muscle injury in rats
Jun WANG ; Shaowen CHENG ; Qingyu CHEN ; Wei YUAN ; Yunfu ZENG
Journal of Regional Anatomy and Operative Surgery 2017;26(9):630-634
Objective To explore the effect of TGF-β microbubble targeting on the treatment of skeletal muscle injury in rats.MethodsEighty SD rats of 2 months old were randomly divided into experimental group(including TGF-β microbubble),pure drug group,microbubble group(exclusive drug) and control group,20 SD rats in each group.Four groups accepted ultrasonic transmission with consistent time and frequency.The contraction stress and stress relaxation of injured gastrocnemius muscle were measured,the changes of injured gastrocnemius muscle were observed by light microscope and electron microscope.Results There was no statistically significant difference in contraction stress of gastrocnemius muscle among all groups at 1,5,9 days after injury(P>0.05).And at 14 days,the contraction stress of gastrocnemius muscle of the experimental group and the pure drug group were obviously higher than those of the rest two groups,the differences were significant(P<0.05).The difference of gastrocnemius muscle contraction stress was statistically significant between the experimental group and the pure drug group(P<0.05).For the stress relaxation of gastrocnemius muscle,the experimental group was lower than the other three groups at 1 day after injury,the differences were significant(P<0.05).Light microscopy showed the number of muscle fiber in the experimental group increased obviously at 9 days after injury.There was no scarring at 14 days after injury.Electron microscope showed mitochondria and sarcoplasmic reticulum increased in the experimental group,and the new muscle cells and satellite cells were significantly more than those of the rest three groups.Conclusion TGF-β cell targeted therapy can obviously improve the shrinkage stress of skeletal muscle in rats after injury and recover the stress decay,which can obviously promote the injury repair and regeneration of skeletal muscle,and reduce scar formation at the same time.

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