1.Quantitative textual analysis of policies about the national oral health based on the policy tools
Xuenan LIU ; Biyu PAN ; Chunxiao WANG
Chinese Journal of Stomatology 2025;60(7):749-756
Objective:To explore the characteristics of oral health policies at national government level, thus providing evidence for the ongoing refinement and enhancement of these policies.Methods:This study took the relevant texts reflecting the national government-level oral public health as the research objects, and searched the policy texts on Wanfang Data Knowledge Service Platform and government department websites since 1978. The contents of the policy texts were coded, classified and statistically analyzed. The literature research method, content analysis method and text analysis method were adopted as research tools. From the perspective of policy tools, an analysis framework of X dimension (policy tool dimension) and Y dimension (oral health strategic goal dimension) was constructed to conduct quantitative analysis of the relevant texts of oral public health.Results:A total of 195 policy texts were included in the analysis. From the perspective of the document type, published time and issuing department, notification documents [89.74% (175/195)], documents published at the fourth stage [47.69% (93/195)], documents published by National Health Commission of the People′s Republic of China [72.31% (141/195)] accounted for the highest proportion. From the perspective of the X and Y dimension, environment-based policy tools [71.18% (247/347)], as well as oral health promotion and oral disease prevention [40.47% (155/383)] accounted for the highest proportion respectively.Conclusions:Since 1978, the number of oral public health policies issued in China has shown an upward trend, reflecting the strengthening of the coordinated role of various departments, the inclusion of oral health work in the important policies of government health and hygiene, and taking into account the Chinese characteristics of local areas. With the strategic goals of WHO as a reference, it shows that China′s policies in terms of health workforce, oral health information system and oral health research agenda are relatively insufficient. The structure of X and Y policy tools in China is unbalanced and needs to be improved.
2.Quantitative textual analysis of policies about the national oral health based on the policy tools
Xuenan LIU ; Biyu PAN ; Chunxiao WANG
Chinese Journal of Stomatology 2025;60(7):749-756
Objective:To explore the characteristics of oral health policies at national government level, thus providing evidence for the ongoing refinement and enhancement of these policies.Methods:This study took the relevant texts reflecting the national government-level oral public health as the research objects, and searched the policy texts on Wanfang Data Knowledge Service Platform and government department websites since 1978. The contents of the policy texts were coded, classified and statistically analyzed. The literature research method, content analysis method and text analysis method were adopted as research tools. From the perspective of policy tools, an analysis framework of X dimension (policy tool dimension) and Y dimension (oral health strategic goal dimension) was constructed to conduct quantitative analysis of the relevant texts of oral public health.Results:A total of 195 policy texts were included in the analysis. From the perspective of the document type, published time and issuing department, notification documents [89.74% (175/195)], documents published at the fourth stage [47.69% (93/195)], documents published by National Health Commission of the People′s Republic of China [72.31% (141/195)] accounted for the highest proportion. From the perspective of the X and Y dimension, environment-based policy tools [71.18% (247/347)], as well as oral health promotion and oral disease prevention [40.47% (155/383)] accounted for the highest proportion respectively.Conclusions:Since 1978, the number of oral public health policies issued in China has shown an upward trend, reflecting the strengthening of the coordinated role of various departments, the inclusion of oral health work in the important policies of government health and hygiene, and taking into account the Chinese characteristics of local areas. With the strategic goals of WHO as a reference, it shows that China′s policies in terms of health workforce, oral health information system and oral health research agenda are relatively insufficient. The structure of X and Y policy tools in China is unbalanced and needs to be improved.
3.Key prevention and control measures and events of iodine deficiency disorders in Hainan Province from 2011 to 2023 and their impact on monitoring results
Hongying WU ; Biyu PAN ; Shizhu MENG ; Xingren WANG ; Yan CHEN
Chinese Journal of Endemiology 2024;43(9):736-741
Objective:To analyze the monitoring results of iodine deficiency disorders (IDD) in Hainan Province from 2011 to 2023, key prevention and control measures taken during this period, and the impact of related events on the monitoring results.Methods:From 2011 to 2023, a systematic sampling method was used to divide 21 cities (districts, counties) in Hainan Province into 5 districts based on east, west, south, north, and center each year. One township (street) was selected from each district, and 40 children aged 8 - 10 (non boarding students) and 20 pregnant women were selected from each township (street) for determination of iodine level of their household salt and urine samples. Based on the monitoring results, the impact of key events such as the pre reduction (2011), post reduction (implementation of new iodized salt standard, 2012 - 2023), salt industry system reform (2017), and the two-year campaign for endemic disease prevention and control (2019, 2000), on the salt iodine coverage rate and qualified iodized salt consumption rate, the urinary iodine level and its distribution in children and pregnant women were analyzed in Hainan Province. B-ultrasound was used to detect the situation of thyroid enlargement was analyzed.Results:(1) In 2011, the median iodine level in edible salt of residents in Hainan Province was 32.1 mg/kg. It was 30.8 mg/kg after the implementation of the new standard in 2012. In 2013, the salt iodine level of residents had significantly decreased to 25.9 mg/kg, with 24.5, 24.2, and 23.8 mg/kg in 2017, 2019, and 2020, respectively. The differences of median salt iodine levels between different years were statistically significant ( H = 29.01, P < 0.001). The coverage rate of iodized salt among residents in Hainan Province from 2011 to 2023 was 98.08% (80 727/82 308), and the difference between different years was statistically significant (χ 2 = 9.51, P = 0.023). The consumption rate of qualified iodized salt was 95.65% (78 738/82 308), and the difference between different years was statistically significant (χ 2 = 21.80, P < 0.001). (2) The median urinary iodine level of children from 2011 to 2023 was 177.5 μg/L, with a median of 204.2 μg/L in 2011. After the implementation of the new standard, the median urinary iodine level of children was 194.9 μg/L in 2012. In 2013, the median urinary iodine level in children decreased to 167.8 μg/L, and had remained within the range of 100 - < 200 μg/L thereafter. In 2017, 2019, and 2020, the median urinary iodine levels were 170.4, 172.8, and 186.3 μg/L, respectively. There was no statistically significant difference in different years ( H = 1.67, P = 0.061). The proportion of children with urinary iodine < 100 μg/L from 2011 to 2023 was 16.29% (8 740/53 634), and the proportion of children with urinary iodine between 100 and < 200 μg/L was 43.96% (23 575/53 634). The differences between different years were statistically significant (χ 2 = 21.50, 23.40, P < 0.001). The childhood goiter rate from 2011 to 2023 was 0.19% (101/53 634). (3) The median urinary iodine level of pregnant women was 153 μg/L in 2011, it was 154.7 μg/L in 2012 after the implementation of the new standard, and it had remained within the range of 100 - < 150 μg/L since then. The median urinary iodine level of pregnant women was 126.2 μg/L in 2013. The median urinary iodine level in 2017, 2019 and 2020 were 123.5, 133.8, and 135.4 μg/L, respectively. There was a statistically significant difference in the median urinary iodine levels of pregnant women between different years ( H = 92.10, P < 0.001). From 2011 to 2023, the proportion of pregnant women with a median urinary iodine level < 150 μg/L was the highest (55.75%, 14 761/26 477). Conclusion:From 2011 to 2023, although the monitoring results of iodine deficiency disorders in children and pregnant women in Hainan Province have fluctuated, they are still in a state of continuous elimination of IDD.
4.Efficacy and safety of Shugan Jieyu capsule combined with mosapride in the treatment of functional dyspepsia: a multicenter, randomized, double-blind, placebo-controlled trial
Ping XU ; Biyu WU ; Bin ZHAO ; Weiwu SHI ; Xuefeng ZHANG ; Shujun LIU ; Lina MENG ; Caihua WANG ; Rongyuan QIU ; Jie WU ; Xuanping XIA ; Xiujuan YAN ; Shengliang CHEN
Chinese Journal of Digestion 2024;44(10):671-678
Objective:To evaluate the efficacy and safety of mosapride citrate dispersible tablet (MP) combined with Shugan Jieyu capsule (SGJY) in the treatment of functional dyspepsia (FD).Methods:From April 2018 to January 2019, FD patients from 10 hospitals including Renji Hospital, Shanghai Jiaotong University School of Medicine, Luohe Hospital of Traditional Chinese Medicine, the Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Handan Hospital of Traditional Chinese Medicine and Nanshi Hospital of Nanyang were selected for a randomized, double-blind, placebo-controlled trial. The patient health questionnaire-9 (PHQ-9) and generalized anxiety disorder-7 (GAD-7) were used to assess depression and anxiety in FD patients, respectively. According to the random number table method, 200 FD patients who met the inclusion criteria were randomly divided into SGJY+ MP group and placebo+ MP group, with 100 patients in each group, and all the patients were given oral MP. The patients of the SGJY+ MP group and the placebo+ MP group were given oral SGJY or placebo on the basis of MP, respectively. The patients of both groups were treated continuously for 6 weeks. Total FD symptom scores, PHQ-9 and GAD-7 scores, as well as efficiency and safety were evaluated after treatment. Independent samples t-test and chi-square test were used for statistical analysis. Results:A total of 193 patients were included into the full analysis set with 94 cases in the SGJY+ MP group and 99 cases in the placebo+ MP group. A total of 183 patients completed the 6-week trial, including 89 cases in the SGJY+ MP group and 94 cases in the placebo+ MP group. A total of 198 patients were included in the safety analysis set, including 99 cases in the SGJY+ MP group and 99 cases in the placebo+ MP group.After treatment, the total FD symptom scores of the SGJY+ MP group and the placebo+ MP group were both lower than those of baseline before treatment (3.71±3.06 vs. 11.79±5.18 and 4.17±3.69 vs. 11.19±5.05), and the differences were both statistically significant ( t=-24.87 and -23.27, both P<0.001). The efficacy of the SGJY+ MP group was higher than that of the placebo+ MP group (86.5%, 77/89 vs. 74.5%, 70/94), and the difference was statistically significant ( χ2=4.69, P=0.030). The efficacy of patients with moderate-to-severe anxiety and depression in the SGJY+ MP group was both higher than that of patients in the placebo+ MP group (10/10 vs. 3/7, 85.0%, 17/20 vs. 8/14), and the differences were statistically significant ( χ2=5.66 and 5.33, P=0.017 and 0.010). The efficacy of patients with postprandial distress syndrome (PDS) subtype in the SGJY+ MP group was higher than that of patients in the placebo+ MP group (93.0%, 53/57 vs. 76.5%, 39/51), and the difference was statistically significant (χ 2=5.82, P=0.016). The PHQ-9 scores of patients with depression in both SGJY+ MP and placebo+ MP groups were lower than those at baseline before treatment (3.63±2.76 vs. 7.87±2.24 and 3.35±2.51 vs. 7.63±2.25), and the differences were statistically significant ( t=-14.88 and -15.87, both P<0.001). There was no significant difference in proportion of depressed patients with a ≥50% reduction in PHQ-9 scores from baseline value between the SGJY+ MP group and the placebo+ MP group (60.2%, 50/83 vs. 62.8%, 54/86; χ2=0.05, P=0.825). The GAD-7 scores of anxious patients both the SGJY+ MP group and the placebo+ MP group were lower than the baseline value before treatment (3.27±2.57 vs. 7.09±2.08 and 3.86±2.49 vs. 6.84±1.66), and the differences were statistically significant ( t=-13.30 and -11.47, both P<0.001). The proportion of anxious patients with a ≥50% reduction in GAD-7 scores from baseline in the SGJY+ MP group was higher than that of the placebo+ MP group (54.4%, 43/79 vs. 36.5%, 27/74), and the difference was statistically significant ( χ2=4.53, P=0.033). There were no serious adverse events in both the SGJY+ MP group and the placebo+ MP group during the treatment. There were no significant differences in the incidence of adverse events and adverse reactions during the treatment between the SGJY+ MP group and the placebo+ MP group (7.1%, 7/99 vs. 5.1%, 5/99, and 3.0%, 3/99 vs. 3.0%, 3/99, respectively; both P>0.05). Conclusion:SGTY can safely and effectively improve the efficacy of the prokinetic drugs in the treatment of FD symptoms, especially in FD patients with PDS subtype or with moderate-to-severe anxiety and with depression.
5.Efficacy and safety of Shugan Jieyu capsule combined with mosapride in the treatment of functional dyspepsia: a multicenter, randomized, double-blind, placebo-controlled trial
Ping XU ; Biyu WU ; Bin ZHAO ; Weiwu SHI ; Xuefeng ZHANG ; Shujun LIU ; Lina MENG ; Caihua WANG ; Rongyuan QIU ; Jie WU ; Xuanping XIA ; Xiujuan YAN ; Shengliang CHEN
Chinese Journal of Digestion 2024;44(10):671-678
Objective:To evaluate the efficacy and safety of mosapride citrate dispersible tablet (MP) combined with Shugan Jieyu capsule (SGJY) in the treatment of functional dyspepsia (FD).Methods:From April 2018 to January 2019, FD patients from 10 hospitals including Renji Hospital, Shanghai Jiaotong University School of Medicine, Luohe Hospital of Traditional Chinese Medicine, the Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Handan Hospital of Traditional Chinese Medicine and Nanshi Hospital of Nanyang were selected for a randomized, double-blind, placebo-controlled trial. The patient health questionnaire-9 (PHQ-9) and generalized anxiety disorder-7 (GAD-7) were used to assess depression and anxiety in FD patients, respectively. According to the random number table method, 200 FD patients who met the inclusion criteria were randomly divided into SGJY+ MP group and placebo+ MP group, with 100 patients in each group, and all the patients were given oral MP. The patients of the SGJY+ MP group and the placebo+ MP group were given oral SGJY or placebo on the basis of MP, respectively. The patients of both groups were treated continuously for 6 weeks. Total FD symptom scores, PHQ-9 and GAD-7 scores, as well as efficiency and safety were evaluated after treatment. Independent samples t-test and chi-square test were used for statistical analysis. Results:A total of 193 patients were included into the full analysis set with 94 cases in the SGJY+ MP group and 99 cases in the placebo+ MP group. A total of 183 patients completed the 6-week trial, including 89 cases in the SGJY+ MP group and 94 cases in the placebo+ MP group. A total of 198 patients were included in the safety analysis set, including 99 cases in the SGJY+ MP group and 99 cases in the placebo+ MP group.After treatment, the total FD symptom scores of the SGJY+ MP group and the placebo+ MP group were both lower than those of baseline before treatment (3.71±3.06 vs. 11.79±5.18 and 4.17±3.69 vs. 11.19±5.05), and the differences were both statistically significant ( t=-24.87 and -23.27, both P<0.001). The efficacy of the SGJY+ MP group was higher than that of the placebo+ MP group (86.5%, 77/89 vs. 74.5%, 70/94), and the difference was statistically significant ( χ2=4.69, P=0.030). The efficacy of patients with moderate-to-severe anxiety and depression in the SGJY+ MP group was both higher than that of patients in the placebo+ MP group (10/10 vs. 3/7, 85.0%, 17/20 vs. 8/14), and the differences were statistically significant ( χ2=5.66 and 5.33, P=0.017 and 0.010). The efficacy of patients with postprandial distress syndrome (PDS) subtype in the SGJY+ MP group was higher than that of patients in the placebo+ MP group (93.0%, 53/57 vs. 76.5%, 39/51), and the difference was statistically significant (χ 2=5.82, P=0.016). The PHQ-9 scores of patients with depression in both SGJY+ MP and placebo+ MP groups were lower than those at baseline before treatment (3.63±2.76 vs. 7.87±2.24 and 3.35±2.51 vs. 7.63±2.25), and the differences were statistically significant ( t=-14.88 and -15.87, both P<0.001). There was no significant difference in proportion of depressed patients with a ≥50% reduction in PHQ-9 scores from baseline value between the SGJY+ MP group and the placebo+ MP group (60.2%, 50/83 vs. 62.8%, 54/86; χ2=0.05, P=0.825). The GAD-7 scores of anxious patients both the SGJY+ MP group and the placebo+ MP group were lower than the baseline value before treatment (3.27±2.57 vs. 7.09±2.08 and 3.86±2.49 vs. 6.84±1.66), and the differences were statistically significant ( t=-13.30 and -11.47, both P<0.001). The proportion of anxious patients with a ≥50% reduction in GAD-7 scores from baseline in the SGJY+ MP group was higher than that of the placebo+ MP group (54.4%, 43/79 vs. 36.5%, 27/74), and the difference was statistically significant ( χ2=4.53, P=0.033). There were no serious adverse events in both the SGJY+ MP group and the placebo+ MP group during the treatment. There were no significant differences in the incidence of adverse events and adverse reactions during the treatment between the SGJY+ MP group and the placebo+ MP group (7.1%, 7/99 vs. 5.1%, 5/99, and 3.0%, 3/99 vs. 3.0%, 3/99, respectively; both P>0.05). Conclusion:SGTY can safely and effectively improve the efficacy of the prokinetic drugs in the treatment of FD symptoms, especially in FD patients with PDS subtype or with moderate-to-severe anxiety and with depression.
6.Research progress on application of eCASH concept in sedation and analgesia nursing of patients with mechanical ventilation in ICU
Jiayi WANG ; Jiwen SUN ; Wenlan ZHANG ; Biyu SHEN
Chinese Journal of Modern Nursing 2023;29(14):1939-1944
This article reviews the concept and content of eCASH concept as well as its application effect and influencing factors in sedation and analgesia nursing of patients with mechanical ventilation in ICU, so as to provide references for further implementation of the application of eCASH concept in patients with mechanical ventilation in ICU and improving patients' health outcome.
7.Discussion of the process of conducting an investigator-initiated research
Wei DAI ; Xing WEI ; Yaqin WANG ; Yangjun LIU ; Jia LIAO ; Shaohua XIE ; Bin HU ; Hongfan YU ; Yang PU ; Wei XU ; Yuqian ZHAO ; Fang LIU ; Xiaoqin LIU ; Xiang ZHUANG ; Biyu SHEN ; Shaoping WAN ; Qiang LI ; Qiuling SHI
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2023;30(02):299-304
The number of investigator initiated research (IIR) is increasing. But the recognition and management of IIR in China is still in its infancy, and there is a lack of specific and operable guidance for the implementation process. Based on our practical experiences, previous literature reports, and current policy regulations, the authors took prospective IIR as an example to summarize the implementation process of IIR into 14 steps, which are as the following: study initiation, ethical review, study registration, study filing, case report form design, database establishment, standard operating procedure making, investigator training, informed consent, data collection, data entry, data verification, data locking and data archiving.
8.Analysis of the current situation and trend of infectious disease public health emergencies in Hainan Province from 2013 to 2022
JIA Pengben ; CHEN Li ; JIANG Tao ; JIN Yuming ; WANG Xiaodan ; QIU Li ; CHEN Shaoming ; FENG Fangli ; CHEN Jingjing ; PAN Biyu ; CHEN Rui
China Tropical Medicine 2023;23(8):828-
Abstract:Objective To evaluate the basic development status of public health emergencies of infectious diseases in Hainan Province from 2013 to 2022, analyze the distribution and characteristics of these emergencies, as to provide important scientific basis for the study and formulation of economic health development planning policies, for the health security policies and infectious disease prevention and control strategies in Hainan Province. Methods The relevant statistical data of public health emergencies involving infectious diseases reported in Hainan Province from 2013 to 2022 were collected, and the status quo of these emergencies was analyzed by using descriptive data statistical analysis method. The ARIMA model was used to predict the number of public health emergencies reported by infectious diseases in Hainan Province from 2023 to 2025. Results From 2013 to 2022, a total of 482 public health emergencies were reported in Hainan Province, of which 426 were infectious disease public health emergencies, accounting for 88.38%, with a total of 8 876 cases, an incidence rate of 0.61%, and eight deaths, a case fatality rate of 0.09%. The major public health emergencies of infectious diseases were unclassified events and general events, accounting for 69.25% and 29.58%, respectively. The main diseases were novel coronavirus infection, chickenpox and hand, foot and mouth disease, accounting for 45.07%, 15.49% and 11.97%, respectively; in terms of time distribution, the number of reported incidents showed an upward trend over time, with a decline in 2021, and mainly had three peak periods, April, August and December, with a total of 220 cases reported; in terms of regional distribution, the major cities and counties reported were Haikou, Wanning and Wenchang, accounting for 27.46%, 19.25% and 9.86%, respectively; in terms of location distribution, the events mainly occurred in schools, accounting for 42.02% of the total number of incidents. The ARIMA(1, 1, 0) model was used to predict infectious disease public health emergencies, and the results showed that the forecast state would be stable from 2023 to 2025, with no obvious upward trend, that is, the fluctuation range of public health emergencies related to infectious diseases in Hainan Province would be stable in the next three years. Conclusion The number of infectious disease public health emergencies reported in Hainan Province from 2013 to 2022 has increased year by year, with a decline in 2021. Although the forecast shows that public health emergencies such as infectious diseases are relatively stable with no obvious upward trend, the prevention and control of the epidemic should not be taken lightly. Hainan Province should continue to increase the investment in monitoring public health emergencies, improve the information system of public disease prevention and control, and carry out real-time monitoring of public health emergencies of infectious diseases.
9.Analysis of the short-term efficacy of tacrolimus in the treatment of refractory Crohn′s disease
Xitao XU ; Biyu WU ; Zhanghan DAI ; Mingming ZHU ; Tianrong WANG ; Jinlu TONG ; Zhihua RAN
Chinese Journal of Inflammatory Bowel Diseases 2022;06(2):115-121
Objective:To assess the short-term efficacy and safety of tacrolimus in patients with refractory Crohn′s disease (CD) , and analyze the influencing factors of clinical response.Methods:A single center restrospective cohort study was conducted. The clinical data of patients with refractory CD in Renji Hospital of Shanghai Jiaotong University School of Medicine from March 2014 to June 2019 were analyzed retrospectively. The patients received tacrolimus treatment for at least 3 months. Clinical response, clinical remission and relapse after tacrolimus treatment were evaluated by Crohn′s disease activity index (CDAI) . According to the existence of clinical response after 3 months of tacrolimus treatment, the patients were divided into clinical response group and non-clinical response group. The differences in clinical data between the 2 groups were assessed by univariate analysis. The variables with P<0.1 in univariate analysis and having clinical significance were further analyzed by multivariate Logistic regression to determine the independent risk factors of clinical response. The receiver operating characteristic (ROC) curve analysis was performed to evaluate the value of risk factors in predicting the clinical response of tacrolimus for the treatment of refractory CD. Results:A total of 45 patients with refractory CD were included, including 31 males and 14 females with the age of 32 (27, 39) years old. The disease duration was 61.0 (28.0, 97.5) months. The CDAI was 203 (175, 229) points before the treatment of tacrolimus while it decreased to 137 (117, 175) points after the treatment of tacrolimus for 3 months, and the difference was significant ( Z = -5.512, P<0.01) . After the treatment of tacrolimus for 3 months, 13 patients (28.9%) with clinical response were set as clinical response group and 32 (71.1%) without clinical response were set as non-clinical response group. Univariate analysis showed that the differences in gender, CDAI before the treatment of tacrolimus and neutrophil-to-lymphocyte ratio (NLR) between the clinical response group and non-clinical response group were statistically significant (all P<0.05) . Gender, CDAI before the treatment of tacrolimus and NLR were included for the multivariate Logistic regression analysis. The results showed that CDAI ( OR = 1.026, 95% CI: 1.006-1.046, P = 0.012) and NLR ( OR = 2.605, 95% CI: 1.290-5.258, P = 0.008) were the independent risk factors for predicting clinical response. The areas under ROC curve of CDAI, NLR and NLR combined with CDAI in predicting clinical response of tacrolimus in patients with refractory CD were 0.786 (95% CI : 0.648-0.924) , 0.764 (95% CI: 0.595-0.934) and 0.861 (95% CI : 0.729-0.992) , the optimal cut-off values were 189.15, 2.82 and 0.31, sensitivities were 100%, 84.6% and 84.6%, and specificities were 53.1%, 71.9% and 84.4%, respectively. Twenty-six patients continued to receive tacrolimus for 12 months, and the clinical remission rate was 73.1% (19/26) and the recurrence rate was 26.9% (7/26) . Forty-five patients were followed up for 1 year, adverse effects occurred in 6 and there was no severe adverse effects during the treatment of tacrolimus. Conclusions:Tacrolimus can be used as an immunosuppressant to induce the remission and maintenance in refractory CD patients. CDAI and NLR can be used as independent indicators to predict the clinical response of tacrolimus in the treatment of patients with refractory CD, and the combination of CDAI and NLR has higher prediction efficiency.
10.Analysis of the short-term efficacy of tacrolimus in the treatment of refractory Crohn′s disease
Xitao XU ; Biyu WU ; Zhanghan DAI ; Mingming ZHU ; Tianrong WANG ; Jinlu TONG ; Zhihua RAN
Chinese Journal of Inflammatory Bowel Diseases 2022;06(2):115-121
Objective:To assess the short-term efficacy and safety of tacrolimus in patients with refractory Crohn′s disease (CD) , and analyze the influencing factors of clinical response.Methods:A single center restrospective cohort study was conducted. The clinical data of patients with refractory CD in Renji Hospital of Shanghai Jiaotong University School of Medicine from March 2014 to June 2019 were analyzed retrospectively. The patients received tacrolimus treatment for at least 3 months. Clinical response, clinical remission and relapse after tacrolimus treatment were evaluated by Crohn′s disease activity index (CDAI) . According to the existence of clinical response after 3 months of tacrolimus treatment, the patients were divided into clinical response group and non-clinical response group. The differences in clinical data between the 2 groups were assessed by univariate analysis. The variables with P<0.1 in univariate analysis and having clinical significance were further analyzed by multivariate Logistic regression to determine the independent risk factors of clinical response. The receiver operating characteristic (ROC) curve analysis was performed to evaluate the value of risk factors in predicting the clinical response of tacrolimus for the treatment of refractory CD. Results:A total of 45 patients with refractory CD were included, including 31 males and 14 females with the age of 32 (27, 39) years old. The disease duration was 61.0 (28.0, 97.5) months. The CDAI was 203 (175, 229) points before the treatment of tacrolimus while it decreased to 137 (117, 175) points after the treatment of tacrolimus for 3 months, and the difference was significant ( Z = -5.512, P<0.01) . After the treatment of tacrolimus for 3 months, 13 patients (28.9%) with clinical response were set as clinical response group and 32 (71.1%) without clinical response were set as non-clinical response group. Univariate analysis showed that the differences in gender, CDAI before the treatment of tacrolimus and neutrophil-to-lymphocyte ratio (NLR) between the clinical response group and non-clinical response group were statistically significant (all P<0.05) . Gender, CDAI before the treatment of tacrolimus and NLR were included for the multivariate Logistic regression analysis. The results showed that CDAI ( OR = 1.026, 95% CI: 1.006-1.046, P = 0.012) and NLR ( OR = 2.605, 95% CI: 1.290-5.258, P = 0.008) were the independent risk factors for predicting clinical response. The areas under ROC curve of CDAI, NLR and NLR combined with CDAI in predicting clinical response of tacrolimus in patients with refractory CD were 0.786 (95% CI : 0.648-0.924) , 0.764 (95% CI: 0.595-0.934) and 0.861 (95% CI : 0.729-0.992) , the optimal cut-off values were 189.15, 2.82 and 0.31, sensitivities were 100%, 84.6% and 84.6%, and specificities were 53.1%, 71.9% and 84.4%, respectively. Twenty-six patients continued to receive tacrolimus for 12 months, and the clinical remission rate was 73.1% (19/26) and the recurrence rate was 26.9% (7/26) . Forty-five patients were followed up for 1 year, adverse effects occurred in 6 and there was no severe adverse effects during the treatment of tacrolimus. Conclusions:Tacrolimus can be used as an immunosuppressant to induce the remission and maintenance in refractory CD patients. CDAI and NLR can be used as independent indicators to predict the clinical response of tacrolimus in the treatment of patients with refractory CD, and the combination of CDAI and NLR has higher prediction efficiency.

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