1.Clinical comprehensive evaluation of recombinant Mycobacterium tuberculosis fusion protein
Xiaofeng NI ; Sha DIAO ; Siyi HE ; Xuefeng JIAO ; Xiao CHENG ; Zhe CHEN ; Zheng LIU ; Linan ZENG ; Deying KANG ; Bin WU ; Chaomin WAN ; Binwu YING ; Hui ZHANG ; Rongsheng ZHAO ; Liyan MIAO ; Zhuo WANG ; Xiaoyu LI ; Maobai LIU ; Benzhi CAI ; Feng QIU ; Feng SUN ; Naihui CHU ; Minggui LIN ; Wei SHA ; Lingli ZHANG
China Pharmacy 2023;34(4):391-396
OBJECTIVE To evaluate the effectiveness, safety, economy, innovation, suitability and accessibility of recombinant Mycobacterium tuberculosis fusion protein (EC), and to provide evidence for selecting skin detection methods for tuberculosis infection diagnosis and auxiliary diagnosis of tuberculosis. METHODS The effectiveness and safety of EC compared with purified protein derivative of tuberculin (TB-PPD) were analyzed by the method of systematic review. Cost minimization analysis, cost-effectiveness analysis and cost-utility analysis were used to evaluate the short-term economy of EC compared with TB-PPD, and cost-utility analysis was used to evaluate the long-term economy. The evaluation dimensions of innovation, suitability and accessibility were determined by systematic review and improved Delphi expert consultation, and the comprehensive score of EC and TB-PPD in each dimension were calculated by the weight of each indicator. RESULTS The scores of effectiveness, safety, economy, innovation and suitability of EC were all higher than those of TB-PPD. The affordability scores of the two drugs were consistent, while the availability score of EC was lower than those of TB-PPD. After considering dimensions and index weight, the scores of effectiveness, safety, economy, innovation, suitability, accessibility and the comprehensive score of EC were all higher than those of TB-PPD. CONCLUSIONS Compared with TB-PPD, EC performs better in all dimensions of effectiveness, safety, economy, innovation, suitability and accessibility. However, it is worth noting that EC should further improve its availability in the dimension of accessibility.
2.Clinical treatment outcomes and their changes in extremely preterm twins: a multicenter retrospective study in Guangdong Province, China.
Bi-Jun SHI ; Ying LI ; Fan WU ; Zhou-Shan FENG ; Qi-Liang CUI ; Chuan-Zhong YANG ; Xiao-Tong YE ; Yi-Heng DAI ; Wei-Yi LIANG ; Xiu-Zhen YE ; Jing MO ; Lu DING ; Ben-Qing WU ; Hong-Xiang CHEN ; Chi-Wang LI ; Zhe ZHANG ; Xiao RONG ; Wei SHEN ; Wei-Min HUANG ; Bing-Yan YANG ; Jun-Feng LYU ; Hui-Wen HUANG ; Le-Ying HUO ; Hong-Ping RAO ; Wen-Kang YAN ; Xue-Jun REN ; Yong YANG ; Fang-Fang WANG ; Dong LIU ; Shi-Guang DIAO ; Xiao-Yan LIU ; Qiong MENG ; Yu WANG ; Bin WANG ; Li-Juan ZHANG ; Yu-Ge HUANG ; Dang AO ; Wei-Zhong LI ; Jie-Ling CHEN ; Yan-Ling CHEN ; Wei LI ; Zhi-Feng CHEN ; Yue-Qin DING ; Xiao-Yu LI ; Yue-Fang HUANG ; Ni-Yang LIN ; Yang-Fan CAI ; Sha-Sha HAN ; Ya JIN ; Guo-Sheng LIU ; Zhong-He WAN ; Yi BAN ; Bo BAI ; Guang-Hong LI ; Yue-Xiu YAN
Chinese Journal of Contemporary Pediatrics 2022;24(1):33-40
OBJECTIVES:
To investigate the clinical treatment outcomes and the changes of the outcomes over time in extremely preterm twins in Guangdong Province, China.
METHODS:
A retrospective analysis was performed for 269 pairs of extremely preterm twins with a gestational age of <28 weeks who were admitted to the department of neonatology in 26 grade A tertiary hospitals in Guangdong Province from January 2008 to December 2017. According to the admission time, they were divided into two groups: 2008-2012 and 2013-2017. Besides, each pair of twins was divided into the heavier infant and the lighter infant subgroups according to birth weight. The perinatal data of mothers and hospitalization data of neonates were collected. The survival rate of twins and the incidence rate of complications were compared between the 2008-2012 and 2013-2017 groups.
RESULTS:
Compared with the 2008-2012 group, the 2013-2017 group (both the heavier infant and lighter infant subgroups) had lower incidence rates of severe asphyxia and smaller head circumference at birth (P<0.05). The mortality rates of both of the twins, the heavier infant of the twins, and the lighter infant of the twins were lower in the 2013-2017 group compared with the 2008-2012 group (P<0.05). Compared with the 2008-2012 group, the 2013-2017 group (both the heavier infant and lighter infant subgroups) had lower incidence rates of pulmonary hemorrhage, patent ductus arteriosus (PDA), periventricular-intraventricular hemorrhage (P-IVH), and neonatal respiratory distress syndrome (NRDS) and a higher incidence rate of bronchopulmonary dysplasia (P<0.05).
CONCLUSIONS
There is a significant increase in the survival rate over time in extremely preterm twins with a gestational age of <28 weeks in the 26 grade A tertiary hospitals in Guangdong Province. The incidences of severe asphyxia, pulmonary hemorrhage, PDA, P-IVH, and NRDS decrease in both the heavier and lighter infants of the twins, but the incidence of bronchopulmonary dysplasia increases. With the improvement of diagnosis and treatment, the multidisciplinary collaboration between different fields of fetal medicine including prenatal diagnosis, obstetrics, and neonatology is needed in the future to jointly develop management strategies for twin pregnancy.
Bronchopulmonary Dysplasia/epidemiology*
;
Female
;
Gestational Age
;
Humans
;
Infant
;
Infant, Extremely Premature
;
Infant, Newborn
;
Pregnancy
;
Respiratory Distress Syndrome, Newborn/epidemiology*
;
Retrospective Studies
;
Treatment Outcome
3. Menopausal symptoms and quality of life of hormone receptor positive breast cancer patients at different endocrine therapy time
Xu LI ; Hao WANG ; Hongping XU ; Sha DIAO ; Yangwen ZHOU ; Fang YI ; Hui LI ; Jiachang LI ; Yu HAO ; Jiayuan LI
Chinese Journal of Oncology 2020;42(1):55-60
Objective:
To explore the menopausal symptoms and quality of life of hormone receptor positive (HR+ ) breast cancer patients at different endocrine therapy time.
Methods:
The HR+ breast cancer patients who were pathologically confirmed from 2011 to 2017 in the Sichuan Cancer Hospital were divided into three groups according to endocrine therapy time (<12 months, 12~36 months, >36 months) and analyzed by a cross-sectional study. The Menopausal symptoms and quality of life of these patients were measured using the modified Kupperman scale and the functional assessment of cancer therapy-breast cancer (FACT-B) scale. The differences of menopausal symptoms among different time groups and drug groups were analyzed by Chi-square test. The differences of quality of life and the effects of menopausal symptoms on quality of life were tested by covariance and multiple linear regression analyses.
Results:
The average score of menopausal symptom of 167 patients was 14.5±7.6 and the prevalence rate was 87.4% (146/167). Among all of the menopausal symptoms, the prevalence rate of insomnia was the highest (73.7%, 123/167). Besides insomnia and excitement, hot flashes was more prevalent in selective estrogen receptor modulator (SERM) users (64.8%, 79/122) , while osteoarthritis was more prevalent in aromatase inhibitor (AI) users (62.2%, 28/45). The total score of FACT-B of Patients was 104.5±15.5, and the compliance rate was up to 89.8% (150/167). However, the condition of each dimension was different, the compliance rates of social/ family and functional dimension were lowest, which were 73.0% (122/167) and 50.9% (85/167), respectively. The menopausal symptoms of patients at different time groups were 15.0±1.3, 14.0±6.9, 14.5±7.4, respectively, and the total score of FACT-B of patients at different time groups were 102.7±17.8, 105.0±12.9, 105.6±16.7, respectively, without significant differences (both
4.Screening and evaluation of sunscreen cosmetics for sensitive facial skin
Jing LYU ; Qingchun DIAO ; Haiyan TANG ; Yang JIANG ; Jinyu ZHU ; Shuqin DENG ; Sha WANG
Chinese Journal of Dermatology 2020;53(8):623-628
Objective:To screen and evaluate sunscreen cosmetics for sensitive facial skin.Methods:From June to August in 2019, 40 subjects with positive lactic acid sting test were recruited from the staff of Chongqing Traditional Chinese Medicine Hospital, and subjected to human skin closed patch testing with 4 kinds of sunscreen cosmetics for sensitive skin (marked as products Ⅰ, Ⅱ, Ⅲ, Ⅳ respectively) separately. Then, the 40 subjects were equally divided into 2 groups to apply 2 sunscreen products with relatively higher safety (according to the above closed patch testing results) on the face respectively. Erythema, edema and desquamation were evaluated at baseline, 2 and 4 weeks after application of the 2 products, and non-invasive measurement methods were used to detect transepidermal water loss (TEWL) , stratum corneum hydration, skin melanin content and skin sebum content. In additon, the 2 products were applied on the back of the subjects separately, and an ultraviolet solar simulator was used to determine the sun protection factor (SPF, n = 12) and protection factor of UVA (PFA, n = 11) . Measurement data were compared using paired t test and one-way analysis of variance, and nonparametric data were compared using Wilcoxon signed rank test. Results:Patch testing showed that only 1 subject developed a grade 1 reaction to the sunscreen product Ⅲ, no subjects showed positive reactions to the product Ⅳ, and the safety of products Ⅲ and Ⅳ was higher than that of the other 2 products. Subjective safety evaluation revealed that the degree of erythema after 4-week application of products Ⅲ and Ⅳ was significantly lower than that before application (Wilcoxon signed rank test, Z = 4.73, 4.82 respectively, both P < 0.05) . Objective efficacy evaluation revealed that the TEWL, stratum corneum hydration and skin melanin content significantly differed among different time points (baseline, after 2- and 4-week application of products Ⅲ and Ⅳ, all P < 0.05); after 4-week application of products Ⅲ and Ⅳ, the TEWL (30.05 ± 1.47, 30.37 ± 1.28 respectively) and skin melanin content (112.58 ± 7.34, 103.47 ± 5.48 respectively) were significantly lower than those before application (all P < 0.05) , and the stratum corneum hydration (62.35 ± 2.67, 63.72 ± 2.54 respectively) was significantly higher than that before application (both P < 0.05) . At week 4, the skin melanin content was significantly lower in the product Ⅳ group (103.47 ± 5.48) than in the product Ⅲ group (112.58 ± 7.34, t = 8.45, P < 0.05) . The SPF and PFA values of the product Ⅳ (51.8 ± 2.9, 10.1 ± 1.2 respectively) were both significantly higher than those of the product Ⅲ (31.5 ± 2.6, 7.4 ± 0.7, t = 15.34, 24.66, respectively, both P < 0.05) . Conclusion:Comprehensive application of closed patch testing, long-term application test and sun protection index determination can be used to screen and evaluate the safety and efficacy of sunscreen cosmetics for sensitive facial skin.
5.Clinical characteristics of 512 cases of cosmetics-related skin adverse reactions and analysis of allergenic components of cosmetics
Yang JIANG ; Yuyi WANG ; Shuqin DENG ; Sha WANG ; Qingchun DIAO ; Jinyu ZHU ; Chunzhu NING ; Jing LYU
Chinese Journal of Dermatology 2020;53(11):895-899
Objective:To analyze clinical characteristics of cosmetics-related adverse reactions and main allergenic components of cosmetics, to provide guidance for cosmetics-related adverse reaction monitoring, and to provide an objective basis for risk assessment.Methods:A total of 512 patients with suspected cosmetic adverse reactions were collected from the outpatient clinic of Chongqing Traditional Chinese Medicine Hospital from March 2018 to October 2019, including 14 males and 498 females. A uniform cosmetic adverse reaction report card was filled in, and medical history of patients and related information about the used cosmetics were recorded; 103 patients (3 males and 100 females) were subjected to patch test with their own cosmetics or cosmetic ingredients, and 48- and 72-hour patch test results were combined for comprehensive determination and analysis.Results:Among the 512 cases of suspected cosmetic adverse reactions, contact dermatitis (495 cases, 96.7%) was the most common manifestation. Cosmetic adverse reactions mainly manifested as erythema (501 cases, 97.9%), papules (313, 61.1%), edema (249, 48.6%), and scaling (166, 32.4%) ; main symptoms included itching (480, 93.8%), burning sensation (359, 70.1%), and tense sensation (297, 58.0%). Patch test with cosmetic ingredients showed positive reactions in 71 of 103 cases, and thimerosal was the allergen mostly liable to cause adverse reactions (31 cases, 30.1%), followed by sodium dodecyl sulfate (29 cases, 28.2%), Peru balsam (17 cases, 16.5%), bronopol (12 cases, 11.7%) and triethanoamine (10 cases, 9.7%). The cosmetic allergens were divided into 14 categories, and the top 4 categories with high positive patch test rates were emulsifiers (54 cases, 45.8%), preservatives (47 cases, 39.8%), fragrances (17 cases, 14.4%) and surfactants (10 cases, 8.5%). Positive patch test reactions were observed in 2 males and 69 females, and there was no significant difference in the positive rate between males and females (2/3 vs. 69/100, χ2 = 0.01, P > 0.05) ; there was also no significant difference in the positive rate among the groups aged 18 - 29 years (34%), 30 - 49 years (34%) and 50 - 70 years (32.4%; χ2 = 0.693, P > 0.05) . Conclusions:Contact dermatitis is the most common adverse reaction to cosmetics. Among the diverse allergenic components of cosmetics, thimerosal is the allergen that is mostly liable to cause adverse reactions, followed by sodium dodecyl sulfate, Peru balsam, bronopol and triethanoamine.
6. Association of plasma leptin levels and soluble leptin receptor with breast cancer
Fang YI ; Sha DIAO ; Xuelian YUAN ; Jiayuan LI
Chinese Journal of Preventive Medicine 2018;52(3):253-259
Objective:
To explore the association between plasma leptin (LEP) levels, soluble leptin receptor(SLR), free leptin index and breast cancer.
Methods:
245 new female cases of primary breast cancer confirmed by histopathology examination were sequentially recruited into the study. A total of 245 age-matched healthy women were enrolled as controls during the same period. A standardized questionnaire was used to collect the demographic information of the subjects. Blood samples were collected and the levels of LEP and SLR in plasma were measured by enzyme linked immunosorbent assay. The differences of LEP, SLR and FLI expression between control and cases group, as well as different breast cancer subtypes and TNM stages were compared using
7. Applying decision trees to establish risk rating model of breast cancer incidence based on non-genetic factors among Southwest China females
Qin LI ; Sha DIAO ; Hui LI ; Hua HE ; Jiayuan LI
Chinese Journal of Oncology 2018;40(11):872-877
Objective:
To estimate incident probability and establish risk rating model of breast cancer incidence under different combinations of non-genetic factors among Southwest China females, applying the decision trees.
Methods:
From 2014 to 2015, a total of 783 cases, which were pathologically diagnosed as primary breast cancer, were sequentially collected from West China Hospital of Sichuan University, Sichuan Cancer Hospital and Sichuan Province People′s Hospital. 3, 879(excluding 36 samples with missing data) controls were randomly selected and matched by area of residence and age. Classification and regression tree (CART) algorithm was applied to construct breast cancer risk rating model according to non-genetic factors. 5 test sets were randomly selected for model validation.
Results:
BI-RADS classes, menopausal status, age, history of benign breast disease, menarche age, age of first delivery and number of live births were identified as risk factors and included in the risk rating model of breast cancer incidence. Among these factors, BI-RADS classes, menopausal status and age were the most important. The risk rating model developed were vitrificated by 5 test sets, and the average sensitivity, positive predictive value, accuracy were 95.60%, 92.26%, 97.93%, respectively.
Conclusions
Breast cancer risk rating model constructed by decision trees was valid and reliable. The model could be used as the basic tool of breast cancer risk assessment among Southwest China females.
8.Target value of parathyroid hormone in hemodialysis patients
Zongli DIAO ; Wang GUO ; Sha LIU ; Wenhu LIU
Chinese Journal of General Practitioners 2017;16(6):474-477
The target value of intact parathyroid hormone (iPTH) in main international guidelines is not consistent completely.Furthermore,the evidence levels of clinical studies these guidelines based on are generally low and most of them are based on observational studies.Some studies even showed that there was no association between iPTH level and clinical outcomes.This review focuses on the following three points for reassessing iPTH target value: comparison of iPTH target value in main international guidelines,the difference of iPTH target value in large clinical studies and reasons for the difference.
9.Clinical trial of thymosin α 1 injection combined with entecavir capsules in the treatment of cirrhosis with decompensated liver function
Yun-Hui DIAO ; Meng XUE ; Hong-Wei FAN ; Jin-Ping SHA ; Chang-Yu SUN
The Chinese Journal of Clinical Pharmacology 2017;33(11):974-976
Objective To observe the clinical efficacy and safety of thymosin α1 injection combined with entecavir capsules in the treatment of cirrhosis with decompensated liver function.Methods Eighty patients with hepatitis B virus (HBV) e antigen (HBeAg) positive patients with decompensated liver function were randomly divided into control group (n =40 cases) and treatment group (n =40 cases).Control group was received oral entecavir 0.5 mg qd.Treatment group was given subcutaneous injection of thymosin α1 1.6 mg biw,on the basis of control group.Two groups were treated for 24 weeks.The clinical efficacy,alanine aminotransferase (ALT),aspartate aminotransferase (AST),total bilirubin,negative rates of HBV-DNA and HBeAg,adverse drug reactions were compared in two groups.Results After treatment,the total rates of treatment and control groups were 92.50% (37/40 cases) and 75.00% (30/40 cases) with significant difference (P < 0.05).After treatment,the main indexes in treatment and control groups were compared,ALT were (51.39 ± 8.17),(64.12 ± 6.24) U·L-1;AST were (33.49 ± 5.14),(40.05 ± 5.28)U · L-1;total bilirubin were (17.59 ± 1.59),(16.32 ±1.32)mmol · L-1;negative rates of HBV-DNA were 77.50%,40.00%;negative rates of HBeAg were 70.00%,32.50%;conversion rates of HBeAg/anti-HBe were 35.00%,22.50%,there were statistically significant difference (P < 0.05).Adverse drug reactions in treatment group were nausea,vomiting and dizziness,which in control group were nausea,vomiting,dizziness and allergies.The incidence of adverse drug reactions were 7.50% and 17.50% in treatment and control groups,with significant difference (P <0.05).Conclusion Thymosin α1 injection combined with entecavir capsules has a definitive clinical efficacy and safety for the treatment of HBeAg positive cirrhosis with decompensated liver function.
10.Clinical trial of docetaxel in the treatment of advanced gastric cancer
Yun-Hui DIAO ; Meng XUE ; Jin-Ping SHA ; Hong-Wei FAN ; Hai-Xia WANG
The Chinese Journal of Clinical Pharmacology 2016;32(14):1283-1285
Objective To evaluate the clinical efficacy and safety of do-cetaxel in the treatment of advanced gastric cancer .Methods Eighty-five patients with advanced gastric cancer were randomly divided into control group (n=42) and treatment group (n=43).Control group was given irinotecan hydrochloride 60 mg? m-2 , day 1 +60 mg? m-2 cisplatin, intravenous infusion, day 1.Treatment group was given 40 mg? m-2 docetaxel , intravenous infusion , day 1.Two groups were trea-ted for 4 courses with 7 d per course.The total effective rate , levels of carcinoembryonic antigen ( CEA ) and carbohydrate antigen 199 ( CA199 ) , incidence of adverse drug reactions were compared between two groups.Results After treatment, the total effective rate in treatment group was 93.02%(40/43), which was significantly higher than that in control group [69.05%(29/42), P <0.05] .After treatment, the serum levels of CEA were ( 37.61 ±5.87 ) , ( 59.73 ±6.97 )μg? L-1 and CA199 were ( 49.25 ±6.83 ) , ( 98.23 ±14.63 ) U? L-1 in the treatment and control group .And those indexes after treatment in treat-ment group were significantly lower than those in control group (P<0.05).The adverse drug reactions were based on gastrointestinal reactions and bone marrow suppression for two groups .Also, the inci-dence of adverse drug reactions was not statistically significant in the two groups ( 9.30% vs 16.67%, P >0.05 ) .Conclusion Docetaxel has a definitive clinical efficacy for the treatment of advanced gastric cancer , which was better than irinotecan hydrochloride combined with cisplatin , without increasing the incidence of adverse drug reactions .

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