1.Analysis on quality value transmitting of substance benchmark of Houpo Wenzhong Decoction.
Qing ZHANG ; Ju-Yuan LUO ; Wen-Jun HU ; Ruo-Nan SHEN ; Xue-Chun LIU ; Yue-Ying ZHAO ; Xing-Yue HUANG ; Chang-Hai WANG ; Ze-Kang ZHANG ; Yang LU ; Ning HAN ; Wen-Yan ZHOU
China Journal of Chinese Materia Medica 2021;46(4):810-819
By preparing 15 batches of lyophilized powder samples of substance benchmark in Houpo Wenzhong Decoction,the fingerprint,index component content and extract rate were determined,and the characteristic peaks,the range of similarity with the reference map,the content range and transfer rate range of magnolol,hesperidin,glycyrrhizic acid and pinocembrin,the extract rate range and the change range were clarified. The results showed that the similarity between the fingerprint of substance benchmark and the reference map R generated from the 15 batches of substance benchmark samples was higher than 0. 90. The assignment of the characteristic peaks in the full prescription's fingerprint of the herbs except Poria cocos was clarified. Nineteen characteristic peaks were assigned,and 12 characteristic peaks were assigned by the reference substance,of which 4 were from Magnolia ocinalis Cortex,5 from Exocarpium Citri Rubrum,2 from Radix aucklandiae,3 from Glycyrrhiza Radix et Rhizoma,4 from Semen Alpiniae Katsumadai,and one from Rhizoma Zingiberis and Zingiber officinale Roscoe. The index component content range and transfer rate range were 0. 80%-1. 14% and 20. 25%-39. 61% for hesperidin,0. 49%-0. 79% and 23. 09%-33. 87%for glycyrrhizic acid,0. 03%-0. 07% and 3. 55%-10. 09% for pinocembrin,0. 15%-0. 38% and 8. 08%-24. 35% for magnolol. The extract rate range and the change range were22. 60%-25. 57% and 12. 67%-23. 68% respectively. In this study,we introduced the concepts of index component content,fingerprint,extract rate,explored the transfer relation of quality value transmitting of substance benchmark in Houpo Wenzhong Decoction,and initially established the quality standard of Houpo Wenzhong Decoction,all of which would provide ideas for the development and research of similar prescriptions.
Benchmarking
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Chromatography, High Pressure Liquid
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Drugs, Chinese Herbal
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Glycyrrhiza
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Quality Control
2.Standard Operating Procedures for Chinese Medicine Data Monitoring Committees of Clinical Studies.
Jun LIU ; Nian WANG ; Hai-Xia DANG ; Bing-Wei CHEN ; Li ZHANG ; Chong ZOU ; Cheng-Liang ZHONG ; Ju-Kai HUANG ; Qiong LIU ; Ya-Nan YU ; Meng JIANG ; Wei-Xiong LIANG ; Qi-Guang CHEN ; Yong-Yan WANG ; Chun-Ti SHEN ; Zhong WANG
Chinese journal of integrative medicine 2021;27(7):483-489
Although there is guidance from different regulatory agencies, there are opportunities to bring greater consistency and stronger applicability to address the practical issues of establishing and operating a data monitoring committee (DMC) for clinical studies of Chinese medicine. We names it as a Chinese Medicine Data Monitoring Committee (CMDMC). A panel composed of clinical and statistical experts shared their experience and thoughts on the important aspects of CMDMCs. Subsequently, a community standard on CMDMCs (T/CACM 1323-2019) was issued by the China Association of Chinese Medicine on September 12, 2019. This paper summarizes the key content of this standard to help the sponsors of clinical studies establish and operate CMDMCs, which will further develop the scientific integrity and quality of clinical studies.
3.Therapy-related chronic myelomonocytic leukemia secondary to acute promyelocytic leukemia in remission for 15 years: one case report.
Yun Ju MA ; Wen hong SHEN ; Xiao Wen TANG ; Hai Ping DAI ; Hong Jie SHEN ; Ting Ting TAO ; Dan Dan LIU ; Li YAO ; Xia Ming ZHU ; De Pei WU
Chinese Journal of Hematology 2018;39(8):628-628
4.Seroepidemiology of Syphilis Infection among 2 Million Reproductive-age Women in Rural China: A Population-based, Cross-sectional Study.
Kai-Ju LIAO ; Shi-Kun ZHANG ; Min LIU ; Qiao-Mei WANG ; Jue LIU ; Hai-Ping SHEN ; Yi-Ping ZHANG
Chinese Medical Journal 2017;130(18):2198-2204
Background:Quantifying syphilis prevalence is important for planning interventions and advocating for resources on syphilis. However, data on large sample studies regarding the prevalence of syphilis among reproductive-age women in rural China were not available for analysis. The aim of the study was to determine the prevalence, epidemiological characteristics, and related factors of syphilis infection among reproductive-age women in rural China.
Methods:Data were obtained from a nationwide, population-based, cross-sectional study under the National Free Preconception Health Examination Project which covered all the 31 provinces in Mainland China. Women intending to get pregnant within the next 6 months were enrolled between January 1, 2010, and December 31, 2012. Sociodemographic, gynecological and obstetric characteristics, and other relevant information were obtained through face-to-face interviews. Treponema pallidum particle agglutination assay test was used to detect positive samples of syphilis. Univariate and multivariate logistic regressions were performed to assess the associations between syphilis seropositivity and related factors.
Results:The overall seroprevalence of syphilis (SPS) among the 2,044,126 women who received syphilis screening test during 2010-2012 was 0.37% (95% confidence interval [CI]: 0.36-0.37%). The SPS appeared 0.24% (95% CI: 0.23-0.26%) and 0.66% (95% CI: 0.59-0.72%) in women at 21-24 and 40-44 years of age, respectively, showing an increase of SPS, parallel with age, and the difference was significant. SPS was significantly higher in ethnic minorities than that in Han nationality (0.58% vs. 0.35%, respectively, odds ratio [OR] = 1.41, 95% CI: 1.30-1.53) and higher in workers than that in farmers (0.45% vs. 0.36%, respectively, OR = 1.27, 95% CI: 1.14-1.41). Women with primary school or below level had a higher SPS as compared to those with college or above educational level (0.61% vs. 0.32%, respectively, OR = 2.49, 95% CI: 2.14-2.89), and the increase reversely correlated with the levels of education. Women whose spouses were syphilis seropositive had significant greater risk (OR = 48.26, 95% CI: 44.38-52.48) as compared those whose spouses were seronegative. Women who reported having had a history of sexually transmitted infections were more likely to be tested positive for serological syphilis (OR = 27.17, 95% CI: 20.44-36.11) as compared to those without.
Conclusions:High SPS is seen among reproductive-age women in rural China that calls for targeted interventions on syphilis prevention and control in this target population, with emphasis on those who are 35 years of age and above, less educated, being minor ethnicity, workers, and living in the western regions of China.
5.Therapeutic Efficacy of VICP+L-ASP/TKI on Adult Patients with B-ALL.
Ming-Fang SHEN ; Ju-Ying WEI ; Wen-Juan YU ; Jing-Han WANG ; Hong-Yan TONG ; Hai-Tao MENG ; Wen-Yuan MAI ; Wen-Bin QIAN ; Jie JIN
Journal of Experimental Hematology 2016;24(6):1730-1736
OBJECTIVETo evaluate the therapeutic efficacy of VICP+L-ASP/TKI on adult patients with B-ALL and to explore the influence factors.
METHODSForty-one adult B-ALL patients treated with VICP+L-ASP/TKI from August 2008 to June 2014 were following-up. The complete remission(CR) rate, toxicity, overall survival(OS) and event free survival(EFS) after induction treatment were analyzed, the therapeutic outcome of patients between different risk stratification subgroups was compared, the influence of standardized consolidatory and maintaining treatment as well as allogeneic hematopoietic stem cell transplantation(allo-HSCT) on survival time was analyzed.
RESULTSThe early death not occurred in 41 patients with B-ALL including 37 cases with CR; the CR rate of 1 course treatment was 90.2%. The follow-up time lasted to March 17, 2015, the median follow-up time was 25(9-79) months; the 1 year OS rate was 75.3%, the EFS rate was 58.3%. Analysis of risk factors showed that the initial WBC count over 30×10/L, LDH over 250 U/L and minimal residual disease(MRD) over 10after treatment were poor prognostic factors. After remission, the standardized consolidatory treatment or allo-HSCT according to the "2012 China adult ALL diagnosis and treatment expert consensus" could improve long-term survival, 3 years OS rate was 73.8% and 61.5% respectively, 3 years EFS were 63.5% and 65.7% respectively. The main toxic and side effects were hematologic reactions, the hematologic adverse reaction of IV grade was observed in 97.6%(40/41) during induction treatment.
CONCLUSIONInduction chemotherapy based on VICP+L-ASP/TKI and standardized consolidatory after remission according to the "2012 China adult acute lymphoblastic leukemia diagnosis and treatment expert consensus" can improve the therapeutic efficacy. The allo-HSCT should be actively performed for B-ALL paients with high risk(elevated initial WBC count and LDH level); at some time, the regularly monitoring MRD and adjusting therapeutic protocol according to monitoring result can promote the prognosis of adult B-ALL patients.
6.Does Early Postsurgical Temozolomide Plus Concomitant Radiochemotherapy Regimen Have Any Benefit in Newly-diagnosed Glioblastoma Patients? A Multi-center, Randomized, Parallel, Open-label, Phase II Clinical Trial.
Ying MAO ; Yu YAO ; Li-Wei ZHANG ; Yi-Cheng LU ; Zhong-Ping CHEN ; Jian-Min ZHANG ; Song-Tao QI ; Chao YOU ; Ren-Zhi WANG ; Shu-Yuan YANG ; Xiang ZHANG ; Ji-Sheng WANG ; Ju-Xiang CHEN ; Qun-Ying YANG ; Hong SHEN ; Zhi-Yong LI ; Xiang WANG ; Wen-Bin MA ; Xue-Jun YANG ; Hai-Ning ZHEN ; Liang-Fu ZHOU
Chinese Medical Journal 2015;128(20):2751-2758
BACKGROUNDThe radiochemotherapy regimen concomitantly employing temozolomide (TMZ) chemotherapy and radiotherapy (RT) 4 weeks after surgery, followed by 6 cycles of TMZ is a common treatment for glioblastoma (GBM). However, its median overall survival (OS) is only 14.6 months. This study was to explore the effectiveness and safety of early TMZ chemotherapy between surgery and chemoradiotherapy plus the standard concomitant radiochemotherapy regimen.
METHODSA randomized, parallel group, open-label study of 99 newly diagnosed GBM patients was conducted at 10 independent Chinese neurosurgical departments from June 2008 to June 2012. Patients were treated with concomitant radiochemotherapy regimen plus early postsurgical temozolomide (early TMZ group) or standard concomitant radiochemotherapy regimen (control group). Overall response was assessed based on objective tumor assessments, administration of corticosteroid and neurological status test. Hematological, biochemical, laboratory, adverse event (AE), and neurological condition were measured for 24 months of follow-up. The primary efficacy endpoint of this study was overall survival (OS). The secondary endpoint was progression free survival (PFS).
RESULTSThe median OS time in the early TMZ group was 17.6 months, compared with 13.2 months in the control group (log-rank test P = 0.021). In addition, the OS rate in the early TMZ group was higher at 6, 12, and 18 months than in the control group, respectively (P < 0.05). The median PFS time was 8.7 months in the early TMZ group and 10.4 months in the control group (log-rank test P = 0.695). AEs occurred in 29 (55.8%) and 31(73.8%) patients respectively in early and control groups, including nausea (15.4% vs. 33.3%), vomiting (7.7% vs. 28.6%), fever (7.7% vs. 11.9%), and headache (3.8% vs. 23.8%). Only 30.8% and 33.3% were drug-related, respectively.
CONCLUSIONSAddition of TMZ chemotherapy in the early break of the standard concomitant radiochemotherapy regimen was well tolerated and significantly improved the OS of the GBM patients, compared with standard concomitant radiochemotherapy regimen. However, a larger randomized trial is warranted to verify these results.
Adult ; Aged ; Antineoplastic Agents, Alkylating ; therapeutic use ; Chemoradiotherapy ; methods ; Dacarbazine ; analogs & derivatives ; therapeutic use ; Glioblastoma ; drug therapy ; radiotherapy ; Humans ; Middle Aged ; Treatment Outcome ; Young Adult
7.Expression of EIIIA+ fibronectin in incised wound of rat's skin.
Meng HE ; Hai ZHAO ; Yi-wen SHEN ; Ai-min XUE ; Long CHEN ; Yun-ju GU ; Zi-qin ZHAO
Journal of Forensic Medicine 2014;30(6):409-412
OBJECTIVE:
To explore the relationship between the expression of EIIIA+ fibronectin in incised wound of rat's skin and injury time.
METHODS:
The wounding model was established by cutting the dorsal skin of 48 adult SD rats. The rats were sacrificed at the pre-set injury time as immediately, 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, and 8 h. The skin samples were taken at the margin of wound. The expression of the EIIIA? fibronectin was detected by immunohistochemistry and Western blotting and the relationship be- tween its expression and injury time was observed. Results The expression of EIIIA+ fibronectin was not observed immediately. The basal cell of skin began to show positive expression 0.5 h after injury. With the extension of injury time, positive staining became stronger. The value of relative optical density was gradually increased with prolonged injury time by the Western blotting analysis.
CONCLUSION
The expression of EIIIA+ fibronectin could be used for estimation of injury time in the early stage of skin injury.
Animals
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Fibronectins/metabolism*
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Immunohistochemistry
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Proteins/metabolism*
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Rats
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Rats, Sprague-Dawley
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Skin/metabolism*
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Staining and Labeling
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Time Factors
8.Endoscopic mucosal resection in the treatment of 2609 cases with colorectal polyps.
De-chang DENG ; Xiao-ming FANG ; Hai-hong JU ; Wen-xiao SHEN ; Hai-fei YE
Chinese Journal of Gastrointestinal Surgery 2012;15(12):1301-1303
OBJECTIVETo explore the safety and effectiveness of endoscopic mucosal resection (EMR) in the treatment of colorectal polyps.
METHODEMR was applied in the treatment of colorectal polyps.
RESULTSA total of 3578 polyps in 2609 patients were all completely resected except 2 cases and the integrated rate of samples was 99.6%. Intra- and post-operation complications occurred in 22 cases(0.8%), including 7 intraoperative bleeding, 5 postoperative bleeding, and 10 thermal burn, which were cured by symptomatic treatment. A total of 1530 (58.6%) cases were followed-up with 3-12 months and no relapse was found in former place of excision.
CONCLUSIONEMR can be applied in resection of colorectal polyps effectively and safely.
Aged ; Endoscopy, Gastrointestinal ; Humans ; Intestinal Mucosa ; surgery ; Intestinal Polyps ; surgery ; Postoperative Hemorrhage ; Recurrence
9.Impact of accountable and kindred-like nursing mode on the quality of obstetric nursing
Hong-Mei GU ; Xu-Juan XU ; Chun-Mei JU ; Mei-Yun SHEN ; Hai-Yan HUANG
Chinese Journal of Modern Nursing 2012;18(28):3396-3398
Objective To investigate the impact of accountable and kindred-like nursing and the practice of quality care.Methods 100 primiparas who gave birth three months before the accountable and kindred-like nursing were selected as the control group,while 100 primiparas who gave birth three months after accountable and kindred-like nursing were selected as the observation group.Tow groups' understanding of health education knowledge and skills,satisfaction with nursing when discharged,nomination rate of the most satisfactory nurse and compliance behavior after discharged were compared.Results In the observation group,62 cases had fully understood,28 had basically understood and 10 had not understood the health education knowledge when discharged,while in the control group the numbers were respectively 30,56 and 14.In the observation group,75 cases had fully understood,19 had basically understood and 6 had not understood the health education skills when discharged,while in the control group the numbers were respectively 28,58 and 14.The understanding of health education knowledge and skills were much better in the observation group than in the control group,and the differences were statistically significant (x2 =21.13,44.40,respectively; P <0.05).After being discharged,the compliance behaviors including pure breastfeeding,newborn massage and baby swimming of the observation group were also better than the control group (49 vs 27,58 vs 27,47 vs 18,respectively),and the differences were statistically significant (x2 =9.93,20.14,19.16,respectively; P <0.05).There were no significant differences in infant buttock nursing between two groups (P > 0.05).The satisfaction of nursing and nomination rate of the most satisfactory nurse were also much higher in the observation group (99 vs 93,82 vs 53,respectively),and the differences were statistically significant (x2 =10.86,19.17,respectively ;P < 0.05).Conclusions Accountable and kindred-like nursing can enhance the effect of health education,compliance behaviors,so as to improve the satisfaction degree of puerperants and their families with nursing service.
10.Repair of the large skin and vessel defect of upper arm with free anterolateral thigh flap.
Jin-sheng LI ; Ju-fang ZHANG ; Hai-yan SHEN ; Hong-jun WU
Chinese Journal of Plastic Surgery 2010;26(1):12-14
OBJECTIVETo explore an effective method for repairing the large skin and vessel defect of upper arm.
METHODSThe large skin defect was repaired by the free anterolateral thigh flap. The vessel defect was reconstructed with the end branch of descending branch from lateral femoral circumflex artery, or the large muscular branch through bridge-like vascular anastomosis.
RESULTSSince 2003, 5 cases were treated. All the flaps survived completely with a soft tissue texture. They were followed up for 8-24 months. The cosmetic and functional results were both satisfactory with less morbidity in the donor sites. The blood supply of the flap and the end of extremities was not affected by weather.
CONCLUSIONSAnterolateral thigh flap is very suitable for large skin and vessel defect of upper arm.
Adolescent ; Adult ; Arm Injuries ; surgery ; Dermatologic Surgical Procedures ; Female ; Humans ; Male ; Middle Aged ; Skin ; injuries ; Skin Transplantation ; methods ; Soft Tissue Injuries ; surgery ; Surgical Flaps ; Thigh ; surgery ; Young Adult

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