1.Study on the Differences of Pregnancy Informs between Chinese and Foreign Informed Consent Form in Drug Clinical Trial
Nana XU ; Yao LU ; Ruifang CHEN ; Gaiyan WEN ; Guoping YANG ; Zhijun HUANG ; Yuxia XIANG ; Ying LI ; Hong YUAN ; Yan PENG
Chinese Medical Ethics 2016;29(2):293-297
Objective:To explore and discuss the differences of pregnancy contents and inform formats in in-formed consent form ( ICF) for the drug clinical trial between China and foreign countries. Methods:We collected Chinese and foreign ICFs for drug clinical trial that had been audited by the Ethics Committee of the third Xiangya Hospital for the past five years. Based on the relevant domestic and foreign law, we concluded the element stand-ards and inform formats about pregnancy inform. By analyzing the integrity of the whole elements, the inform rate of every element and the using rate of every inform format, we compared the differences of pregnancy contents and in-form formats between Chinese ICFs and foreign ICFs. Results:The total number of ICFs was 177 in this study, in-cluding 107 Chinese ICFs and 70 foreign ICFs. The integrity rate of pregnancy in Chinese ICFs was statistically lower than them in foreign ICFs (19% vs. 56%, P=0. 000). Compared with foreign ICFs, the low informed ele-ments were the study of the pregnancy risk (32% vs. 73%, P=0. 000), the pregnancy test during the following-up period (33% vs. 56%, P=0. 002) and the measurements for contraception (22% vs. 53%, P=0. 000). Conclusion:The integrity level of pregnancy content in Chinese ICFs was lower than that of the foreign ICFs. And the three elements including pregnancy risk study, pregnancy test during the following-up period and measure-ments for contraception was obviously defected. Pregnancy informing forms of informed consent in China was inferi-or to abroad.
2.Detection of exhaled nitric oxide of healthy in Nanjing.
Gaiyan LENG ; Zeqing LI ; Qiuping WANG
Journal of Clinical Otorhinolaryngology Head and Neck Surgery 2012;26(17):769-771
OBJECTIVE:
To determine the normal level of nitric oxide through mouth and nose in healthy adult people. From it the normal values were obtained to provide theory support for the prevention and cure of breathe system diseases, such as asthma, allergic rhinitis and so on.
METHOD:
One hundred and eighty two healthy nanjing adults were recruited,including 89 males and 93 females. NIOX system was used to obtain the values of exhaled NO through mouth and nose. The relativity between NO and gender, age, height, body mess index, time, ambient NO were analyzed with multiple linear regression and correlation.
RESULT:
Exhaled NO values were (17 +/- 7) ppb and correlated significantly with height and age. Regression equation: Y (FENO) = -65.784 + 0.102X1 (age) + 0.442X2 (height), P < 0.05. NNO values were (79 +/- 35) ppb.
CONCLUSION
FENO normal values and NNO normal values are easy to obtain and have good compliance and high sensitivity, which correlated with height, age, et al.
Adolescent
;
Adult
;
Aged
;
Asthma
;
diagnosis
;
Breath Tests
;
China
;
Exhalation
;
Female
;
Humans
;
Male
;
Middle Aged
;
Nitric Oxide
;
analysis
;
Reference Values
;
Rhinitis, Allergic, Perennial
;
diagnosis
;
Young Adult
3.The effect of Liuzijue qigong for patients with post-stroke dysarthria and abnormal respiratory control: A randomized and controlled trial
Yanan ZHENG ; Hongli LI ; Shanshan DING ; Gaiyan LI ; Ying ZHANG
Chinese Journal of Physical Medicine and Rehabilitation 2020;42(7):618-622
Objective:To compare the effect of combining Liuzijue qigong with basic articulation training in the treatment of patients with post-stroke dysarthria.Methods:A total of 60 stroke survivors with dysarthria were randomly divided into an observation group and a control group, each of 30. In addition to basic articulation training, the observation group practiced Liuzijue qigong for 3 weeks while the control group received conventional breathing training. Before and after the treatment, both groups were evaluated using the modified Frenchay dysarthria assessment (FDA), and in terms of maximum phonation time (MPT), maximal counting ability (MCA) and a special assessment of speech breathing.Results:After the treatment, significant improvement was observed in all of the measurements in both groups, but there was significantly greater improvement in the observation group in terms of the effectiveness of the speech breathing treatment (80%) and that group′s average MCA and FDA values compared with the control group.Conclusion:Liuzijue qigong training is superior to conventional breathing training when each is combined with basic articulation training in improving the speech breathing function and speaking ability of stroke survivors with dysarthria. It is worthy of promotion and application in clinical practice.
4.Liuzijue qigong for stroke survivors with dysarthria
Shanshan DING ; Gaiyan LI ; Jie WANG ; Zhijun HU ; Yan WANG ; Ying XU ; Yiwen SHE ; Qilin WU ; Hang FAN ; Changwei ZHANG ; Chaoran ZHU ; Ying ZHANG
Chinese Journal of Physical Medicine and Rehabilitation 2021;43(10):890-894
Objective:To document any improvement in the breathing control of stroke survivors with dysarthria after practicing Liuzijue qigong.Methods:A total of 157 stroke survivors with dysarthria and abnormal respiration control were randomly divided into an observation group and a control group. Both groups were given traditional breathing training and basic articulation training (including articulatory organ training and speech training). The observation group also received training in Liuzijue qigong. It requires inhaling through the nose and exhaling through the mouth while producing the speech sounds xu, he, hu, si, chui and xi. The training lasted two weeks. Both groups were then evaluated using the modified Frenchay dysarthria assessment. Maximum phonation time, maximum counting ability and volume were also recorded as secondary indexes.Results:After the 2-week intervention, significant improvement was observed in the average scores on all of the indexes, with all of the observation group′s average scores except for volume significantly better than those of the control group. The average volume scores were significantly improved, but not significantly different.Conclusion:Supplementing basic articulation training with Liuzijue qigong can improve respiratory function and the speaking ability of stroke survivors with dysarthria. It is worthy of wider clinical application.
5. Salubrinal increases the apoptosis of oral cancer cells by inhibiting radiation-induced activation of NF-Κb
Jie WANG ; Miao ZHANG ; Gaiyan LI ; Xintong LYU ; Qiao QIAO
Chinese Journal of Radiation Oncology 2020;29(2):111-114
Objective:
To explore the mechanism of the role of Salubrinal in regulating the radiation-induced apoptosis of oral cancer cells.
Methods:
Radioresistant KBR cell line was constructed (4 Gy per fraction, every 7-10 d for 4 times). The radiosensitivity of oral cancer cells after Salubrinal pretreatment was measured by colony formation assay. The expression levels of NF-κB-HIF-1α signaling pathway and apoptosis biomarker cleaved PARP in oral cancer cells were measured by Western blot. The apoptosis rate was detected by Annexin V, PI staining and flow cytometry.
Results:
Colony formation assay demonstrated that Salubrinal increased the radiosensitivity of oral cancer cells. The radiosensitization ratios of KB and KBR cells were 1.19 and 1.24. Western blot revealed that the activation of NF-κB-HIF-1α was time-dependent in the radiation-induced oral cancer cells, whereas Salubrinal inhibited the radiation-induced abnormal activation. In addition, Salubrinal increased the expression of apoptosis biomarker cleaved PARP and apoptosis index in radiation-induced oral cancer cells, whereas TNF-α, an activator of NF-κB, reversed the effect, suggesting that Salubrinal increased the apoptosis of radiation-induced oral cancer cells by suppressing the activation of NF-κB. Pretreatment of NF-κB inhibitor Bay11-7082 also increased the cell apoptosis. The expression levels of cleaved PARP of KB and KBR cell lines in the Bay11-7082+ IR group were 2.67±0.26 and 1.91±0.17, significantly higher compared with 2.1±0.16 and 1.44±0.15 in the IR group (both