1.Application of meticulous capsular dissection technique in thyroidectomy.
Yameng DONG ; Haozhan YUAN ; Hong JIANG
Journal of Clinical Otorhinolaryngology Head and Neck Surgery 2013;27(9):455-456
OBJECTIVE:
To explore the application of meticulous capsular dissection techique in thyroidectomy.
METHOD:
Forty four cases of thyroid operation in 38 patients were analyzed retrospectively. Meticulous capsular dissection in thyroidectomy could protect recurrent laryngeal nerve and parathroid gland.
RESULT:
Of all the 44 cases, no one experienced postoperatively hypocalcemia. The recurrent laryngeal nerves were found. No one suffered from laryngeal nerve injury except 1 case with postoperative horseness.
CONCLUSION
The meticulous capsular dissection techique plays a key role in ensuring the safety of thyroidectomy.
Adult
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Female
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Humans
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Male
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Middle Aged
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Recurrent Laryngeal Nerve
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surgery
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Retrospective Studies
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Thyroid Gland
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anatomy & histology
;
surgery
;
Thyroidectomy
;
methods
2.Systematic evaluation of clinical trial protocols of new drugs as a cure of chronic hepatitis B
Sha CHEN ; Lianhui ZHAO ; Shan SHAN ; Min LI ; Yameng SUN ; Jialing ZHOU ; Xiaoning WU ; Ruihua DONG ; Yuanyuan KONG ; Xiaojuan OU ; Hong MA ; Hong YOU ; Jidong JIA
Chinese Journal of Hepatology 2020;28(8):662-666
Objective:To describe the current status of registration and design characteristics of clinical trials of new drugs for curing hepatitis B through domestic and foreign websites, so as to provide references for the follow-up clinical trials of new hepatitis B drugs.Methods:A search was conducted on the US Clinical Trials Database and the Chinese Clinical Trial Registry Center. The search date was from the establishment of the database to May 26, 2020, and the registration trials of new drugs for curing hepatitis B at home and abroad were included. Two researchers independently searched and screened the literature and extracted the data.Results:A total of 106 registered clinical trials of new drugs for curing hepatitis B were included (94 English registration websites and 12 Chinese registration websites), and the number of registrations had increased year by year. Among them, the proportion of therapeutic vaccines and core protein inhibitors were the highest, accounting for 27.4% ( n = 29) and 22.6% ( n = 24), respectively. The vast majority of clinical trials ( n = 96, 90.6%) were in the early stages (Phase I and II). The subjects in phase I clinical trial were mainly healthy people and treated CHB patients, while the subjects in phase II clinical trial were mainly CHB patients who had achieved viral suppression after initial or post-treatment. The main evaluation indicators of Phase I clinical trials were the safety and tolerability of new drugs. The main evaluation indicators in about half of Phase II clinical trials were HBsAg negative conversion/quantitative decline. Overall, the number of clinical trials with the new design was small, accounting for 3.8% (4 / 106). There were relatively few trials of new drugs for curing hepatitis B on domestic registration websites, and the information provided was incomplete. Conclusion:The number of clinical trials of new hepatitis B drugs at home and abroad is increasing year by year, but most of them are in phase I and II, with few adopting new designs. In addition, the information integrity of the domestic website registration center needs to be improved.
3.Clinical trial protocols of new drugs for nonalcoholic steatohepatitis: A systematic review
Yingshuo HUANG ; Wei WEI ; Xiaofei TONG ; Yameng SUN ; Jianxiong ZHANG ; Ruihua DONG ; Jidong JIA ; Hong YOU
Journal of Clinical Hepatology 2022;38(4):798-804
Objective To describe the characteristics and registration status of clinical trials of new drugs for nonalcoholic steatohepatitis (NASH), and to provide a reference for the design and implementation of clinical trials of new drugs for NASH. Methods The U.S. Clinical Trials Database, China Clinical Trial Registry, and Center for Drug Evaluation, National Medical Products Administration, were searched for clinical trials of new drug registration and interventional studies with NASH as the indication published up to August 6, 2021, using NASH in English and Chinese characters as the keywords, and liver cirrhosis was excluded. Two researchers independently searched and screened the articles to extract relevant information. Results A total of 196 clinical trials of new drug registration or interventional studies for NASH were included, among which there were 174 trials registered abroad and 22 trials registered in China, and the number of registrations tended to increase year by year. The numbers of phase Ⅰ, phase Ⅰ/Ⅱ(including Ⅰb/Ⅱa), phase Ⅱ, phase Ⅱ/Ⅲ, and phase Ⅲ clinical trials were 45(23.0%), 8(4.1%), 112(57.1%), 4(2.0%), and 19(9.7%), respectively. The main drug types included farnesoid X receptors, fibroblast growth factors, peroxisome proliferator-activated receptor agonists, and glucagon-like peptide-1, with numbers of 16(8.16%), 14(7.14%), 11(5.61%), and 13(6.63%), respectively. The clinical trials of innovative drugs for NASH initiated by the sponsors in European and American regions accounted for the highest proportion, and there was a gradual increase in the number of clinical trials of innovative drugs in China in recent years, with a similar distribution of single-center and multicenter clinical trials. As for the trials with NASH patients as subjects, the numbers of trials with pathology, imaging, and clinical diagnosis as the main inclusion criteria were 125, 66, and 42, respectively. Phase Ⅰ clinical trials used safety, tolerability, and pharmacokinetic parameters as the main assessment indices, while phase Ⅱ and phase Ⅲ clinical trials often used safety and efficacy as the main assessment indices. The number of clinical trials for the registration of innovative drugs for NASH was relatively low but kept increasing in China, and there were fewer clinical trials of innovative traditional Chinese medicine drugs compared with innovative chemical drugs. Conclusion There is a significant increase in the registration of international clinical trials of innovative drugs for NASH, and most of these trials are in the early phases, with large differences in inclusion criteria and assessment indices, a lack of unified evaluation indices, and relatively few trials with new designs. There are fewer clinical trials of innovative drugs for NASH in China than in European and American countries, and the number of such trials is gradually increasing in China.