1.Constructing core outcome set for clinical research on traditional Chinese medicine treatment of post-stroke aphasia.
Ya-Nan MA ; Min-Jie XU ; Yu-Ai YANG ; Jian CHEN ; Qiao-Sheng REN ; Ying LI ; Jing-Ling CHANG
China Journal of Chinese Materia Medica 2025;50(1):238-253
According to the principle and current domestic and international construction processes of core outcome set(COS) and the characteristics of post-stroke aphasia, this study built COS with evidence-based support for traditional Chinese medicine(TCM) treatment of post-stroke aphasia. Firstly, a comprehensive review was conducted on the articles about the TCM treatment of post-stroke aphasia that were published in the four major Chinese databases, three major English databases, and three clinical registration centers over the past five years. The articles were analyzed and summarized, on the basis of which the main part of the COS for clinical research on the TCM treatment of post-stroke aphasia was formed. Secondly, clinical doctors and related nursing personnel were interviewed, and important outcome indicators in the clinical diagnosis and treatment process were supplemented to form a pool of core outcome indicators. Two rounds of Delphi surveys were carried out to score the importance of the core outcome indicators in the pool. Finally, a consensus meeting of experts was held to establish the COS for clinical research on the TCM treatment of post-stroke aphasia. The final COS included a total of 268 studies [236 randomized controlled trials(RCTs), 21 Meta-analysis, and 11 clinical registration protocols] and 20 open questionnaire survey results. After two rounds of Delphi surveys, a total of 14 outcome indicators and their corresponding measurement tools were included in the expert consensus meeting. The final expert consensus meeting determined the COS for post-stroke aphasia, which included 9 indicator domains and 12 outcome indicators.
Humans
;
Aphasia/therapy*
;
Stroke/complications*
;
Medicine, Chinese Traditional
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Drugs, Chinese Herbal/therapeutic use*
;
Treatment Outcome
2.Analysis of risk factors of mortality in infants and toddlers with moderate to severe pediatric acute respiratory distress syndrome.
Bo Liang FANG ; Feng XU ; Guo Ping LU ; Xiao Xu REN ; Yu Cai ZHANG ; You Peng JIN ; Ying WANG ; Chun Feng LIU ; Yi Bing CHENG ; Qiao Zhi YANG ; Shu Fang XIAO ; Yi Yu YANG ; Xi Min HUO ; Zhi Xian LEI ; Hong Xing DANG ; Shuang LIU ; Zhi Yuan WU ; Ke Chun LI ; Su Yun QIAN ; Jian Sheng ZENG
Chinese Journal of Pediatrics 2023;61(3):216-221
Objective: To identify the risk factors in mortality of pediatric acute respiratory distress syndrome (PARDS) in pediatric intensive care unit (PICU). Methods: Second analysis of the data collected in the "efficacy of pulmonary surfactant (PS) in the treatment of children with moderate to severe PARDS" program. Retrospective case summary of the risk factors of mortality of children with moderate to severe PARDS who admitted in 14 participating tertiary PICU between December 2016 to December 2021. Differences in general condition, underlying diseases, oxygenation index, and mechanical ventilation were compared after the group was divided by survival at PICU discharge. When comparing between groups, the Mann-Whitney U test was used for measurement data, and the chi-square test was used for counting data. Receiver Operating Characteristic (ROC) curves were used to assess the accuracy of oxygen index (OI) in predicting mortality. Multivariate Logistic regression analysis was used to identify the risk factors for mortality. Results: Among 101 children with moderate to severe PARDS, 63 (62.4%) were males, 38 (37.6%) were females, aged (12±8) months. There were 23 cases in the non-survival group and 78 cases in the survival group. The combined rates of underlying diseases (52.2% (12/23) vs. 29.5% (23/78), χ2=4.04, P=0.045) and immune deficiency (30.4% (7/23) vs. 11.5% (9/78), χ2=4.76, P=0.029) in non-survival patients were significantly higher than those in survival patients, while the use of pulmonary surfactant (PS) was significantly lower (8.7% (2/23) vs. 41.0% (32/78), χ2=8.31, P=0.004). No significant differences existed in age, sex, pediatric critical illness score, etiology of PARDS, mechanical ventilation mode and fluid balance within 72 h (all P>0.05). OI on the first day (11.9(8.3, 17.1) vs.15.5(11.7, 23.0)), the second day (10.1(7.6, 16.6) vs.14.8(9.3, 26.2)) and the third day (9.2(6.6, 16.6) vs. 16.7(11.2, 31.4)) after PARDS identified were all higher in non-survival group compared to survival group (Z=-2.70, -2.52, -3.79 respectively, all P<0.05), and the improvement of OI in non-survival group was worse (0.03(-0.32, 0.31) vs. 0.32(-0.02, 0.56), Z=-2.49, P=0.013). ROC curve analysis showed that the OI on the thind day was more appropriate in predicting in-hospital mortality (area under the curve= 0.76, standard error 0.05,95%CI 0.65-0.87,P<0.001). When OI was set at 11.1, the sensitivity was 78.3% (95%CI 58.1%-90.3%), and the specificity was 60.3% (95%CI 49.2%-70.4%). Multivariate Logistic regression analysis showed that after adjusting for age, sex, pediatric critical illness score and fluid load within 72 h, no use of PS (OR=11.26, 95%CI 2.19-57.95, P=0.004), OI value on the third day (OR=7.93, 95%CI 1.51-41.69, P=0.014), and companied with immunodeficiency (OR=4.72, 95%CI 1.17-19.02, P=0.029) were independent risk factors for mortality in children with PARDS. Conclusions: The mortality of patients with moderate to severe PARDS is high, and immunodeficiency, no use of PS and OI on the third day after PARDS identified are the independent risk factors related to mortality. The OI on the third day after PARDS identified could be used to predict mortality.
Female
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Male
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Humans
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Child, Preschool
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Infant
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Child
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Critical Illness
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Pulmonary Surfactants/therapeutic use*
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Retrospective Studies
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Risk Factors
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Respiratory Distress Syndrome/therapy*
3.Formulation of expert consensus on clinical application of external ethnic medicine: taking Baimai Ointment as an example.
Ying-Jie GUAN ; Xiao-Qiao REN ; Hong-Sheng ZHAN ; Zhi-Xiu SHEN ; Kai-Lie LIU ; Wen-Jing CHANG ; Yun LI ; Wei CHEN
China Journal of Chinese Materia Medica 2023;48(3):847-852
The concept of ethnic medicine is divided into a broad sense and a narrow sense. The broad concept refers to the traditional medicine of the Chinese nation, and the narrow concept refers to the traditional medicine of Chinese ethnic minorities. The external medicine is one of the main forms of ethnic medicine, and it is also the important content of ethnic medicine for external use, which is widely used in clinical practice. As the theory of ethnic medicine is unique, the application methods have certain characteristics, which are the key technical parts of clinical practice. However, the existing traditional Chinese medicine consensus formulation me-thods cannot meet the needs of the consensus formulation of the external ethnic medicine. Therefore, the methods suitable for expert consensus on external ethnic medicine are required. This article took Expert opinion on clinical application of Baimai Ointment as an exa-mple, and explorde a reasonable, effective, multi-dimensional, and multi-stage method to formulate expert consensus on the external ethnic medicine. In this research, three-dimensional sources of information, including ancient classics, clinical research evidence, and expert application experiences, were systematically and scientifically collected. After organization and analysis, the information was formed into comprehensive evidence. In a formal consensus meeting, part of the recommendations reached consensus. As to the issues that did not reach agreement, in-depth interviews were used to explore the reasons for the differences and resolve the disagreements. Finally, unanimous recommendations were reached. There are common problems during the formulation process of Expert opinion on clinical application of Baimai Ointment. This study is expected to provide references for the formulation of expert consensus on other external ethnic medicine.
Humans
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Biological Products
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Consensus
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Drugs, Chinese Herbal
4.Efficacy and safety of Shenyankangfu Tablet, a Chinese patent medicine, for primary glomerulonephritis: A multicenter randomized controlled trial.
Jie WU ; Shu-Wei DUAN ; Hong-Tao YANG ; Yue-Yi DENG ; Wei LI ; Ya-Ni HE ; Zhao-Hui NI ; Yong-Li ZHAN ; Shan LIN ; Zhi-Yong GUO ; Jun ZHU ; Jing-Ai FANG ; Xu-Sheng LIU ; Li-Hua WANG ; Rong WANG ; Nian-Song WANG ; Xiao-Hong CHENG ; Li-Qun HE ; Ping LUO ; Shi-Ren SUN ; Ji-Feng SUN ; Ai-Ping YIN ; Geng-Ru JIANG ; Hong-Yu CHEN ; Wen-Hu LIU ; Hong-Li LIN ; Meng LIANG ; Lu MA ; Ming CHEN ; Li-Qun SONG ; Jian CHEN ; Qing ZHU ; Chang-Ying XING ; Yun LI ; Ji-Ning GAO ; Rong-Shan LI ; Ying LI ; Hao ZHANG ; Ying LU ; Qiao-Ling ZHOU ; Jun-Zhou FU ; Qiang HE ; Guang-Yan CAI ; Xiang-Mei CHEN
Journal of Integrative Medicine 2021;19(2):111-119
BACKGROUND:
Shenyankangfu Tablet (SYKFT) is a Chinese patent medicine that has been used widely to decrease proteinuria and the progression of chronic kidney disease.
OBJECTIVE:
This trial compared the efficacy and safety of SYKFT, for the control of proteinuria in primary glomerulonephritis patients, against the standard drug, losartan potassium.
DESIGN, SETTING, PARTICIPANTS AND INTERVENTION:
This was a multicenter, double-blind, randomized, controlled clinical trial. Primary glomerulonephritis patients, aged 18-70 years, with blood pressure ≤ 140/90 mmHg, estimated glomerular filtration rate (eGFR) ≥ 45 mL/min per 1.73 m
MAIN OUTCOME MEASURES:
The primary outcome was change in the 24-hour proteinuria level, after 48 weeks of treatment.
RESULTS:
A total of 735 participants were enrolled. The percent decline of urine protein quantification in the SYKFT group after 48 weeks was 8.78% ± 2.56% (P = 0.006) more than that in the losartan 50 mg group, which was 0.51% ± 2.54% (P = 1.000) less than that in the losartan 100 mg group. Compared with the losartan potassium 50 mg group, the SYKFT plus losartan potassium 50 mg group had a 13.39% ± 2.49% (P < 0.001) greater reduction in urine protein level. Compared with the losartan potassium 100 mg group, the SYKFT plus losartan potassium 100 mg group had a 9.77% ± 2.52% (P = 0.001) greater reduction in urine protein. With a superiority threshold of 15%, neither was statistically significant. eGFR, serum creatinine and serum albumin from the baseline did not change statistically significant. The average change in TCM syndrome score between the patients who took SYKFT (-3.00 [-6.00, -2.00]) and who did not take SYKFT (-2.00 [-5.00, 0]) was statistically significant (P = 0.003). No obvious adverse reactions were observed in any group.
CONCLUSION:
SYKFT decreased the proteinuria and improved the TCM syndrome scores of primary glomerulonephritis patients, with no change in the rate of decrease in the eGFR. SYKFT plus losartan potassium therapy decreased proteinuria more than losartan potassium therapy alone.
TRIAL REGISTRATION NUMBER
NCT02063100 on ClinicalTrials.gov.
5. Analysis on protein expression of ferritin light chain in alveolar macrophages of patients with occupational silicosis
Jie-jie QIAO ; Lu ZHANG ; Ke HAN ; Huan WANG ; Sheng-qiang DU ; Dong-xu REN ; Yu-qing JIN ; Xin XU ; Fu-hai SHEN
China Occupational Medicine 2021;48(05):519-522
OBJECTIVE: To observe the protein expression of ferritin light chain(FTL) in alveolar macrophages(AM) of patients with occupational silicosis(hereinafter referred to as silicosis). METHODS: The male patients with silicosis at stage Ⅰ, Ⅱ, and Ⅲ were separately selected as the silicosis groupⅠ, Ⅱ, and Ⅲ using judgment sampling method, with 15 patients in each group. Meanwhile, 15 male silicon dust workers with small lung shadows but not diagnosed as silicosis were selected as the control group. Bronchoalveolar lavage fluid was collected from the four groups, and AM was separated and purified, and protein was extracted after lysis of the AM. Western blotting was used to detect the relative expression of FTL protein in the AM. RESULTS: The relative expression of FTL protein in AM of silicosis groupⅠ, Ⅱ, and Ⅲ was lower than that in the control group(all P<0.05). The relative expression of FTL protein in AM decreased with the increase of silicosis stage(P<0.05).CONCLUSION: The expression of FTL protein in AM was down-regulated in patients with silicosis in a dose-response manner. It is speculated that FTL may have a negative regulatory effect in the progress of silicosis fibrosis.
6.Association of Overlapped and Un-overlapped Comorbidities with COVID-19 Severity and Treatment Outcomes: A Retrospective Cohort Study from Nine Provinces in China.
Yan MA ; Dong Shan ZHU ; Ren Bo CHEN ; Nan Nan SHI ; Si Hong LIU ; Yi Pin FAN ; Gui Hui WU ; Pu Ye YANG ; Jiang Feng BAI ; Hong CHEN ; Li Ying CHEN ; Qiao FENG ; Tuan Mao GUO ; Yong HOU ; Gui Fen HU ; Xiao Mei HU ; Yun Hong HU ; Jin HUANG ; Qiu Hua HUANG ; Shao Zhen HUANG ; Liang JI ; Hai Hao JIN ; Xiao LEI ; Chun Yan LI ; Min Qing LI ; Qun Tang LI ; Xian Yong LI ; Hong De LIU ; Jin Ping LIU ; Zhang LIU ; Yu Ting MA ; Ya MAO ; Liu Fen MO ; Hui NA ; Jing Wei WANG ; Fang Li SONG ; Sheng SUN ; Dong Ting WANG ; Ming Xuan WANG ; Xiao Yan WANG ; Yin Zhen WANG ; Yu Dong WANG ; Wei WU ; Lan Ping WU ; Yan Hua XIAO ; Hai Jun XIE ; Hong Ming XU ; Shou Fang XU ; Rui Xia XUE ; Chun YANG ; Kai Jun YANG ; Sheng Li YUAN ; Gong Qi ZHANG ; Jin Bo ZHANG ; Lin Song ZHANG ; Shu Sen ZHAO ; Wan Ying ZHAO ; Kai ZHENG ; Ying Chun ZHOU ; Jun Teng ZHU ; Tian Qing ZHU ; Hua Min ZHANG ; Yan Ping WANG ; Yong Yan WANG
Biomedical and Environmental Sciences 2020;33(12):893-905
Objective:
Several COVID-19 patients have overlapping comorbidities. The independent role of each component contributing to the risk of COVID-19 is unknown, and how some non-cardiometabolic comorbidities affect the risk of COVID-19 remains unclear.
Methods:
A retrospective follow-up design was adopted. A total of 1,160 laboratory-confirmed patients were enrolled from nine provinces in China. Data on comorbidities were obtained from the patients' medical records. Multivariable logistic regression models were used to estimate the odds ratio (
Results:
Overall, 158 (13.6%) patients were diagnosed with severe illness and 32 (2.7%) had unfavorable outcomes. Hypertension (2.87, 1.30-6.32), type 2 diabetes (T2DM) (3.57, 2.32-5.49), cardiovascular disease (CVD) (3.78, 1.81-7.89), fatty liver disease (7.53, 1.96-28.96), hyperlipidemia (2.15, 1.26-3.67), other lung diseases (6.00, 3.01-11.96), and electrolyte imbalance (10.40, 3.00-26.10) were independently linked to increased odds of being severely ill. T2DM (6.07, 2.89-12.75), CVD (8.47, 6.03-11.89), and electrolyte imbalance (19.44, 11.47-32.96) were also strong predictors of unfavorable outcomes. Women with comorbidities were more likely to have severe disease on admission (5.46, 3.25-9.19), while men with comorbidities were more likely to have unfavorable treatment outcomes (6.58, 1.46-29.64) within two weeks.
Conclusion
Besides hypertension, diabetes, and CVD, fatty liver disease, hyperlipidemia, other lung diseases, and electrolyte imbalance were independent risk factors for COVID-19 severity and poor treatment outcome. Women with comorbidities were more likely to have severe disease, while men with comorbidities were more likely to have unfavorable treatment outcomes.
Adult
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Aged
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COVID-19/virology*
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China/epidemiology*
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Comorbidity
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Female
;
Humans
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Male
;
Middle Aged
;
Retrospective Studies
;
Severity of Illness Index
;
Treatment Outcome
7.Directing construction of CRISPR/Cas9 vector of SmPAL1 in Salvia miltiorrhiza by target efficiency detection in vitro.
Jing-Ren QIU ; Yue-Kai SU ; Zhen-Qiao SONG ; Xin-Sheng FANG ; Jing-Yu LI ; Jin ZHANG ; Jian-Hua WANG
China Journal of Chinese Materia Medica 2018;43(21):4226-4230
To construct CRISPR/Cas9 vectors for the editing of SmPAL1 in the phenylpropane metabolic pathway of Salvia miltiorrhiza, CIRSPR/Cas9 target sites of SmPAL1 were designed by online software. Its target efficiencies were detected in vitro by enzyme digestion and sequences with highly efficiency were constructed into CRISPR/Cas9 vectors. Three possible CRISPR target sequences (SmPAL1-g1, SmPAL1-g2, SmPAL1-g3) were designed and the enzyme digestion efficiencies were 53.3%, 76.6% and 10.0%. SmPAL1-g1 and SmPAL1-g2 were constructed into vector VK005-03 named as VK005-03-g1 and VK005-03-g2. The results of sequencing showed that the two CRISPR/Cas target sequences were all constructed into VK005-03. Here we first laid the foundation for the study of SmPAL1 and provided an effective strategy for the screening of sgRNA.
CRISPR-Cas Systems
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Clustered Regularly Interspaced Short Palindromic Repeats
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Metabolic Networks and Pathways
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genetics
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Salvia miltiorrhiza
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chemistry
;
genetics
8.Effect of exogenous brassinolide on morphological characters and contents of seven chemical constituents of Glycyrrhiza uralensis.
Jing QIAO ; Jun HU ; Yan-Peng LI ; Guang-Xi REN ; Yu XIANG ; Yi-Mei ZANG ; Yong LIU ; Chun-Sheng LIU
China Journal of Chinese Materia Medica 2016;41(2):197-204
The transplants of the two-year-old Glycyrrhiza uralensis were subjected to four concentration of brassinolide (BR 0.1, 0.4, 0.7, 1.0 mg•L⁻¹) in July. The morphological characters ( plant height, stem diameter, nodes number, internode length and root length , root thick, root fresh weight and root dry weight ) were measured and seven kinds of chemical constituents (glycyrrhizic acid, liquiritin, isoliquiritin, liquiritigenin, isoliquiritigenin, liquiritin apioside, isoliquiritin apioside) were determined by HPLC with the aim of increasing sinter output and improving quality of G. uralensis. Then the long-term dynamic changes of these morphological characters and chemical compositions' content were analyzed. The results showed that morphological characters of plant height, stem diameter, root length , root thick, root fresh weight and root dry weight increased remarkably with the 0.7 mg•L⁻¹ BR stimulating 2 months later,the increase rates were: 15.09%,6.15%,16.52%,8.46%,21.90%,29.41%, respectively. The content of glycyrrhizic acid, liquiritin, isoliquiritin, liquiritigenin, liquiritin apioside, isoliquiritin apioside were increased 20.16%,45.31%,53.56%,27.66%,23.54%,8.46% with the 0.7 mg•L⁻¹ BR stimulating 2 months later. The best effects were achieved in 2 months after brassinolide stimulating. The conclusions prove that morphological characters and the main chemical constituents accumulation of G. uralensis could be effected by exogenous BR stimulation in certain case.
9.Chinese Internet Searches Provide Inaccurate and Misleading Information to Epilepsy Patients.
Jian-Ming LIU ; Ru-Xiang XU ; Yong-Sheng HU ; Lian-Kun REN ; Hui QIAO ; Hu DING ; Zhi-Liang LIU
Chinese Medical Journal 2015;128(24):3324-3328
BACKGROUNDMost patients with epilepsy want to learn as much as possible about the disease, and many have turned to the internet for information. Patients are likely to use information obtained from the internet to control their epilepsy, but little is known about the accuracy of this information. In this survey, we have assessed the feasibility and usability of internet-based interventions for the treatment of epilepsy.
METHODSData were collected from an internet search. Different search terms were used to obtain general information on epilepsy together with information about medication, types of epilepsy, treatment, women's health, and other information. The accuracy of the information was evaluated by a group of experts.
RESULTSA total of 1320 web pages were assessed. The majority were websites related to health. A large number (80.2%) of web pages contained content related to the search term. A significant number of web pages 450/1058 (42.5%) claimed to provide information from a credible source; however, only 206/1058 (19.5%) of the information was accurate and complete; 326/1058 (30.8%) was accurate but incomplete; 328/1058 (31.0%) was correct but nonstandard, and 198/1058 (18.8%) was inaccurate. The authenticity of the information was not significantly different between the two search engines (χ2 = 0.009, P = 0.924). No significant difference was observed in the information obtained from a specialist or nonspecialist source (χ2 = 7.538, P = 0.057). There was also no correlation between the quality of the information and the priority (χ2 = 6.880, P = 0.076).
CONCLUSIONSSearching for information about epilepsy on the internet is convenient, but the information provided is not reliable. Too much information is inaccurate or for advertisement purposes, and it is difficult for patients to find the useful information. Turning to the internet for medical knowledge may be harmful. Physicians should be aware that their patients may search for information on the internet and guide them to safe, reputable websites.
Chi-Square Distribution ; Epilepsy ; Humans ; Internet ; Software
10.Bioequivalence study of drospirenone and ethinylestradiol tablets in Chinese healthy volunteers
Zhou-Sheng YANG ; Xin GUO ; Zhi LIU ; Min-Su FENG ; Tao SU ; Ai-Qiao CHEN ; Hang CHENG ; Ren GUO
The Chinese Journal of Clinical Pharmacology 2015;(20):2017-2020
Objective To evaluate the bioavailability of drospirenone and ethinylestradiol tablets, and to assess its bioequivalence in Chinese healthy volunteers.Methods A two drugs, two periods, crossover trial was designed, a single oral dose of subject drug and 6 mg drospirenone-0.06 mg ethinyloestradiol was given to thirty-four healthy female volun-teers, respectively.The concentrations of drospirenone and ethinylestra-diol in plasma were determined by HPLC-MS/MS.The pharmacokine-tic parameters of drospirenone and ethinylestradiol were calculated and analyzed by WinNonlin 6.1 software.Results The main pharmacokinet-ics parameters of drospirenone in subject drug and reference drug were as follow:Cmax were (69.6 ±16.6), (71.6 ±15.9)μg? L-1, tmax were (1.6 ±0.7 ) , ( 1.5 ±0.7 ) h, AUClast were ( 845.2 ±229.1 ) , (831.3 ±217.8)μg? L-1 ? h, AUCinf were ( 968.6 ±233.3 ), (965.5 ±243.1)μg? L-1? h;t1/2 were (30.8 ±5.9) and(31.8 ±7.2) h, the relative bioavailability of subject drug were as follow: Flast was (102.4 ±14.0)%, Finf was (101.6 ±13.2)%.The main pharmacokinetics parameters of ethinyloestradiol in subject drug and reference drug were as follow: : Cmax were (139.6 ±49.7), (131.0 ± 45.1) ng? L-1, tmax were (1.6 ±0.4), (1.7 ±0.5) h, AUClast were (1256.3 ±408.3), (1205.6 ±440.7) ng? L-1? h, AUCinf were (1420.9 ±429.8), (1403.3 ±495.3)ng? L-1? h; t1/2 were (12.4 ±3.1), (13.5 ±5.6)h, the relative bioavail-ability of subject drug were as follow:Flast was (110.3 ±34.0)%, Finf was (107.2 ±31.7)%.Conclusion Subject drug and reference drug have bioequivalence.

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