1.Preparation of Dexzopiclone Orally Disintegrating Tablets and Formulation Optimization
Hui LI ; Hongmei LUO ; Qingqing TIAN ; Shuanghua CHEN ; Wenhan TANG ; Yuxiang WAN
China Pharmacy 2018;29(1):46-49
OBJECTIVE:To prepare Dexzopiclone orally disintegrating tablets (DODT),and to optimize its formulation.METHODS:Direct powder compression method was used to prepare DODT.Using repose angle of material,disintegration time and taste evaluation as indexes,single factor test was used to screen the types or amount of bulking agent,disintegrating agent,glidant and flavoring agent;using disintegration time as index,orthogonal experiment was applied to optimize the proportion of bulking agent,the amount of disintegrating agent,glidant and flavoring agent.Then the hardness and main component contents of DODT prepared by optimal formulation were determined.RESULTS:The optimal formulation was as follows as the ratio of mannitol-MCC 1 ∶ 4,the amount of disintegrating agent PVPP was 15%,the amount of glidant magnesium stearate was 1.0%,the amount of flavoring agent stevia was 3.0%.Three batches of prepared DODT were smooth in surface and good in taste;their disintegration time were(26.7 ± 1.2),(26.7 ± 0.6),(27.6 ± 0.9)s,hardness were (3.59 ± 0.19),(3.49 ± 0.18),(3.27 ± 0.16) kg,and contents were (99.47 ± 0.15) %,(99.53 ± 0.05)%,(99.46 ± 0.20) %,respectively (all RSDs≤0.87%,n=3).CONCLUSIONS:Prepared DODT are all in line with the quality requirements of orally disintegrating tablets.
2.A prospective follow-up study on thea ssociation between serum level of C-reactive protein and risk of digestive system cancers in Chinese women
Gang WANG ; Liying CAO ; Shuohua CHEN ; Shuanghua XIE ; Xiaoshuang FENG ; Zhangyan LYU ; Lanwei GUO ; Fang LI ; Kai SU ; Sheng CHANG ; Jiansong REN ; Min DAI ; Ni LI ; Shouling WU ; Jie HE
Chinese Journal of Oncology 2016;38(11):876-880
Ob jective It has been reported by some prospective studies that C-reactive protein (CRP ) is associated with cancer risk .However, the correlation between CRP and digestive system cancers has not been evaluated in Chinese females .We conducted a large population-based cohort study to investigate whether elevated level of CRP in serum is associated with an increased risk of digestive system cancers in Chinese women.Metho ds From the Chinese Kailuan Female Cohort , 19,437 women were enrolled in this study in July 2006, and all of the subjects were followed up through 2014.At the baseline investigation , the serum levels of high-sensitivity CRP ( hsCRP ) were tested for all subjects , and demographic information and risk factor data were collected .Multivariable Cox proportional hazards regression model was used to calculate the hazard ratios ( HR ) and 95%confidence intervals ( 95%CI ) for the baseline levels of hsCRP after adjusting for age, marital status, smoking, drinking, body mass index ( BMI), diabetes and physical activity, and risk of digestive system tumors (including colorectal cancer, stomach cancer, pancreas cancer, liver and gallbladder cancer, and other cancers).Results By Dec 31, 2014, a total of 100 incident cancer cases were observed , including 47 colorectal cancers , 17 stomach cancers , and altogether 29 pancreas , liver and gallbladder cancers .All the subjects investigated were divided into three groups according to the level of hsCRP (<1 mg/L, 1-3 mg/L and >3 mg/L) .The 8-year cumulative incidence of digestive system cancers were 405/100 000, 520/100 000 and 787/100 000 in these 3 groups, respectively (Log rank test χ2=8.37, P=0.015 ) .Compared to those with lower hsCRP levels (<1 mg/L ) , the women with higher hsCRP (>3 mg/L) had a significantly increased risk of pancreas , liver and gallbladder cancers ( HR =2.70, 95%CI =1.06-6.91;Ptrend=0.036).Conclusions Elevated levels of hsCRP at baseline may be associated with increased risk of certain digestive system cancers .
3.A prospective follow-up study on thea ssociation between serum level of C-reactive protein and risk of digestive system cancers in Chinese women
Gang WANG ; Liying CAO ; Shuohua CHEN ; Shuanghua XIE ; Xiaoshuang FENG ; Zhangyan LYU ; Lanwei GUO ; Fang LI ; Kai SU ; Sheng CHANG ; Jiansong REN ; Min DAI ; Ni LI ; Shouling WU ; Jie HE
Chinese Journal of Oncology 2016;38(11):876-880
Ob jective It has been reported by some prospective studies that C-reactive protein (CRP ) is associated with cancer risk .However, the correlation between CRP and digestive system cancers has not been evaluated in Chinese females .We conducted a large population-based cohort study to investigate whether elevated level of CRP in serum is associated with an increased risk of digestive system cancers in Chinese women.Metho ds From the Chinese Kailuan Female Cohort , 19,437 women were enrolled in this study in July 2006, and all of the subjects were followed up through 2014.At the baseline investigation , the serum levels of high-sensitivity CRP ( hsCRP ) were tested for all subjects , and demographic information and risk factor data were collected .Multivariable Cox proportional hazards regression model was used to calculate the hazard ratios ( HR ) and 95%confidence intervals ( 95%CI ) for the baseline levels of hsCRP after adjusting for age, marital status, smoking, drinking, body mass index ( BMI), diabetes and physical activity, and risk of digestive system tumors (including colorectal cancer, stomach cancer, pancreas cancer, liver and gallbladder cancer, and other cancers).Results By Dec 31, 2014, a total of 100 incident cancer cases were observed , including 47 colorectal cancers , 17 stomach cancers , and altogether 29 pancreas , liver and gallbladder cancers .All the subjects investigated were divided into three groups according to the level of hsCRP (<1 mg/L, 1-3 mg/L and >3 mg/L) .The 8-year cumulative incidence of digestive system cancers were 405/100 000, 520/100 000 and 787/100 000 in these 3 groups, respectively (Log rank test χ2=8.37, P=0.015 ) .Compared to those with lower hsCRP levels (<1 mg/L ) , the women with higher hsCRP (>3 mg/L) had a significantly increased risk of pancreas , liver and gallbladder cancers ( HR =2.70, 95%CI =1.06-6.91;Ptrend=0.036).Conclusions Elevated levels of hsCRP at baseline may be associated with increased risk of certain digestive system cancers .
4.Prospective cohort study on the relationship between smoking cessation and cancer risk in males.
Hongzhao ZHANG ; Jiansong REN ; Ni LI ; Gang WANG ; Lanwei GUO ; Shuohua CHEN ; Shuanghua XIE ; Shouling WU ; Jingbo ZHAO ; Min DAI
Chinese Journal of Preventive Medicine 2016;50(1):67-72
OBJECTIVETo investigate the effect of smoking cessation on the risk of cancer among male subjects.
METHODSParticipants of this study were derived from the workers in Kailuan Group who took the health check-up examination in its 11 affiliated hospitals. The check-up examinations were given biennially based on uniformed standard. From May 2006 to December 2011, health examinations were given for 3 rounds and a total of 104 809 male workers involved. The date of being enrolled in this study was defined as that of taking first check-up, and the date of end-of-observation was defined as that of cancer diagnosis, death or end of follow-up.
INCLUSION CRITERIAage ≥18 while being enrolled in this study, and there was no information missing in the questionnaire for age (or date of birth), smoking status, the age of starting smoking, the age of quitting smoking, and smoking amount. The information of smoking status was collected by questionnaires, and the information of newly-diagnosed cancer cases was obtained by follow-up. After adjusted for age, education background, drinking habits, working environment and BMI, multi-variate Cox proportional hazard regression models were used to analyze the association between smoking cessation and cancer risk (all sites of cancers, smoking-related cancers, and lung cancer) by calculating the values of HR (hazard ratio) and 95% CI (confidence interval).
RESULTSTotally, 104 809 subjects were followed up for 450 639.6 person-years, including 46 013 smokers (43.90%), 51 624 never-smokers (49.26%), and 7 172 smoking quitters (6.84%). Among all these subjects, 1 323 were diagnosed as cancer cases, including 1 082 smoking-related cancers, of which 378 were lung cancer cases. The results showed that, compared with never-smokers, smokers had increased risks for all sites of cancers (HR=1.38, 95% CI: 1.20- 1.59), smoking-related cancers (HR=1.45, 95% CI: 1.24- 1.69) and lung cancer (HR=1.70, 95% CI: 1.31- 2.21). While compared with the smokers, smoking quitters had decreased risk of lung cancer (HR=0.36, 95% CI: 0.20- 0.65). For the smokers with smoking history ≥20 pack-years, HR (95% CI) of lung cancer incidence was 0.09 (0.01- 0.65). For people age ≥60 smoke quitter, HR (95% CI) of lung cancer incidence was 0.33 (0.16- 0.68). For people who quit ≥10 years, HR (95% CI) of lung cancer incidence was 0.19(0.06- 0.58).
CONCLUSIONSmoking cessation might decrease the risk of lung cancer among male smokers. The risk of lung cancer was lower among the smoking quitters with longer history of smoking, older age, and longer years of quitting smoking.
Humans ; Incidence ; Lung Neoplasms ; epidemiology ; Male ; Neoplasms ; epidemiology ; Proportional Hazards Models ; Prospective Studies ; Risk Factors ; Smoking ; adverse effects ; Smoking Cessation ; Surveys and Questionnaires
5.Status of non?steroidal anti?inflammatory drugs use in areas with a high incidence of upper gastrointestinal cancer in China: a multi?center cross?sectional survey
Shuanghua XIE ; Ru CHEN ; Deli ZHAO ; Yuqin LIU ; Changqing HAO ; Yongzhen ZHANG ; Guohui SONG ; Zhaolai HUA ; Jialin WANG ; Shuzheng LIU ; Liwei10 ZHANG ; Dantong SHAO ; Yu QIN ; Minjuan LI ; Jiachen ZHOU ; Rongshou ZHENG ; Guiqi WANG ; Wenqiang WEI
Chinese Journal of Preventive Medicine 2019;53(11):1098-1103
Objective To describe the status of non?steroidal anti?inflammatory drugs (NSAIDs) use in areas with a high incidence of upper gastrointestinal cancer in China. Methods This study was based on the National Key Research and Development Program of "National Precision Medicine Cohort of Esophageal Cancer" and "Study on Identification and Prevention of High?risk Populations of Gastrointestinal Malignancies (Esophageal cancer, Gastric cancer and Colorectal cancer)". From January 2017 to August 2018, 212 villages or communities with a high incidence of esophageal cancer or gastric cancer were selected from 12 regions in 6 provinces. A total of 35 910 residents aged between 40 and 69 years old who met the inclusion criteria and signed the informed consent were investigated and enrolled in this study. The use of NSAIDs, demographic characteristics, health?related habits, height, weight, and blood pressure were collected by the questionnaire and physical examination. The status of main NSAIDs (aspirin, acetaminophen and ibuprofen) use with the difference varying in genders, age groups and regions were analyzed by using χ2 test and Cochran?Armitage trend analysis method. Results Of 35 910 subjects, the mean age was (54.6 ± 7.1) years old and males accounted for 43.42% (15 591). The overall prevalence of NSAIDs intake was 4.56% (1 638), but it significantly varied in different provinces (P<0.001). The overall prevalence of NSAIDs intake was 4.87% (1 750) in females, which was significantly higher than that in males 4.24% (1 524) (P<0.001). The prevalence of NSAIDs intake increased with age (P for trend<0.001). As the frequency of NSAIDs intake increased, the incidence of gastrointestinal symptoms, gastrointestinal ulcers and black stools increased (P for trend<0.05 for all). Conclusion The use of NSAIDs is prevalent in some areas with a high incidence of upper gastrointestinal cancer in China. The increased use of NSAIDs may lead to more adverse effects related to the gastrointestinal tract.
6.Status of non?steroidal anti?inflammatory drugs use in areas with a high incidence of upper gastrointestinal cancer in China: a multi?center cross?sectional survey
Shuanghua XIE ; Ru CHEN ; Deli ZHAO ; Yuqin LIU ; Changqing HAO ; Yongzhen ZHANG ; Guohui SONG ; Zhaolai HUA ; Jialin WANG ; Shuzheng LIU ; Liwei10 ZHANG ; Dantong SHAO ; Yu QIN ; Minjuan LI ; Jiachen ZHOU ; Rongshou ZHENG ; Guiqi WANG ; Wenqiang WEI
Chinese Journal of Preventive Medicine 2019;53(11):1098-1103
Objective To describe the status of non?steroidal anti?inflammatory drugs (NSAIDs) use in areas with a high incidence of upper gastrointestinal cancer in China. Methods This study was based on the National Key Research and Development Program of "National Precision Medicine Cohort of Esophageal Cancer" and "Study on Identification and Prevention of High?risk Populations of Gastrointestinal Malignancies (Esophageal cancer, Gastric cancer and Colorectal cancer)". From January 2017 to August 2018, 212 villages or communities with a high incidence of esophageal cancer or gastric cancer were selected from 12 regions in 6 provinces. A total of 35 910 residents aged between 40 and 69 years old who met the inclusion criteria and signed the informed consent were investigated and enrolled in this study. The use of NSAIDs, demographic characteristics, health?related habits, height, weight, and blood pressure were collected by the questionnaire and physical examination. The status of main NSAIDs (aspirin, acetaminophen and ibuprofen) use with the difference varying in genders, age groups and regions were analyzed by using χ2 test and Cochran?Armitage trend analysis method. Results Of 35 910 subjects, the mean age was (54.6 ± 7.1) years old and males accounted for 43.42% (15 591). The overall prevalence of NSAIDs intake was 4.56% (1 638), but it significantly varied in different provinces (P<0.001). The overall prevalence of NSAIDs intake was 4.87% (1 750) in females, which was significantly higher than that in males 4.24% (1 524) (P<0.001). The prevalence of NSAIDs intake increased with age (P for trend<0.001). As the frequency of NSAIDs intake increased, the incidence of gastrointestinal symptoms, gastrointestinal ulcers and black stools increased (P for trend<0.05 for all). Conclusion The use of NSAIDs is prevalent in some areas with a high incidence of upper gastrointestinal cancer in China. The increased use of NSAIDs may lead to more adverse effects related to the gastrointestinal tract.
7. Status of non-steroidal anti-inflammatory drugs use in areas with a high incidence of upper gastrointestinal cancer in China: a multi-center cross-sectional survey
Shuanghua XIE ; Ru CHEN ; Deli ZHAO ; Yuqin LIU ; Changqing HAO ; Yongzhen ZHANG ; Guohui SONG ; Zhaolai HUA ; Jialin WANG ; Shuzheng LIU ; Liwei ZHANG ; Dantong SHAO ; Yu QIN ; Minjuan LI ; Jiachen ZHOU ; Rongshou ZHENG ; Guiqi WANG ; Wenqiang WEI
Chinese Journal of Preventive Medicine 2019;53(11):1098-1103
Objective:
To describe the status of non-steroidal anti-inflammatory drugs (NSAIDs) use in areas with a high incidence of upper gastrointestinal cancer in China.
Methods:
This study was based on the National Key Research and Development Program of "National Precision Medicine Cohort of Esophageal Cancer" and "Study on Identification and Prevention of High-risk Populations of Gastrointestinal Malignancies (Esophageal cancer, Gastric cancer and Colorectal cancer)" . From January 2017 to August 2018, 212 villages or communities with a high incidence of esophageal cancer or gastric cancer were selected from 12 regions in 6 provinces. A total of 35 910 residents aged between 40 and 69 years old who met the inclusion criteria and signed the informed consent were investigated and enrolled in this study. The use of NSAIDs, demographic characteristics, health-related habits, height, weight, and blood pressure were collected by the questionnaire and physical examination. The status of main NSAIDs (aspirin, acetaminophen and ibuprofen) use with the difference varying in genders, age groups and regions were analyzed by using χ2 test and Cochran-Armitage trend analysis method.
Results:
Of 35 910 subjects, the mean age was (54.6±7.1) years old and males accounted for 43.42% (15 591). The overall prevalence of NSAIDs intake was 4.56% (1 638), but it significantly varied in different provinces (