1.Evaluation of risks of skin sparing breast conserving surgery for early stage breast cancer
Xiaohui HUANG ; Lin CHEN ; Huaiyin SHI
Medical Journal of Chinese People's Liberation Army 1982;0(03):-
Objective To evaluate the oncologic risks of skin sparing breast conserving surgery for carcinoma of breast at early stage.Methods Serial sections of skin overlying the tumor were done for pathological examination in 50 cases of early stage breast cancer after skin sparing breast conserving operation.Results In 50 cases of breast conserving surgery,the extent of skin removal was 0.5-1.0cm in 21 cases,1.0-1.5cm in 25 cases,and 1.5-2.0cm in 4cases.Skin involvement was found in one patient with stage Ⅱ breast cancer,and the rate of skin involvement was 2%.Skin involvement was closely related with the changes in skin overlying the tumor,but not with the tumor size,pathologic types or axillary lymph node metastasis.Conclusion The rate of skin involvement in early stage breast cancer is rare,therefore if there are no abnormal clinical manifestations in the skin,skin sparing breast conserving surgery is safe.
2.Clinicopathological features of chronic inflammatory mass lesion of the pancreas
Yuehua WANG ; Zhiqiang HUANG ; Ningxin ZHOU ; Jiahong DONG ; Huaiyin SHI ; Shaohong ZHAO
Chinese Journal of General Surgery 1994;0(05):-
Objective To study the clinicopathological features of chronic inflammatory mass lesion of the pancreas.Methods The clinical data of 37 patients with focal chronic inflammatory mass lesion of the pancreas were retrospectively studied.Seventeen cases congruent with the standard clinical diagnostic of chronic pancreatitis were separated into group A;and Whipple procedure was carried out in two cases,resection of the body and tail of the pancreas in 2 cases,local resection in one case,and choledochojejunostomy in 12 cases.Those without the stander clnical features of Group A but with the features of pancreatic tumor were separated into Group B;and Whipple procedure was carried out in 4 cases,choledochojejunostomy in 16 cases.Results In group A,except for the local mass lesion,sclerosis of the whole pancreas was found in 88.2% of cases.Pathological examination showed proliferation of fibrous tissue with associated inflammation,as well as acinar atrophy,remnant islet cells,and ductular dilatation and focal calcification.While in Group B,only a local mass lesion of the pancreas was found in 19 cases.The pathological features were characterized histologically by proliferation of fibrous tissue with associated moderate or marked inflammation.No pancreatic carcinoma was found during 1 to 12 years follow-up of 33 cases.Conclusions Chronic inflammatory mass lesion of the pancreas showed the clinicopathological features of pseudotumoral pancreatitis.Internal drainage by choledochojejunostomy is suggested as its effective management.
3.A CCCG-HB-2016 regimen in the treatment of hepatoblastoma in children
Wenfang TANG ; Yi QING ; Xianbo SHEN ; Xiangling HE ; Huaiyin HUANG ; Chengguang ZHU ; Keke CHEN ; Xin TIAN ; Runying ZOU ; Chuang PENG ; Zhihong CHEN ; Zhiqun MAO ; Kang ZHAO
Chinese Journal of General Surgery 2021;36(5):332-336
Objective:To evaluate the clinical efficacy of multi-disciplinary single center's CCCG-HB-2016 regimen in the treatment of hepatoblastoma (HB) in children.Methods:Clinical data of 36 HB patients treated with CCCG-HB-2016 program from Aug 2016 to March 2020 were analyzed.Results:These 36 patients included 20 boys and 16 girls. The serum AFP was all higher than 2 792 ng/ml,there was a correlation between AFP and tumor risk stratification ( H=14.973, P<0.05). Twenty eight cases (77.78%) were epithelial type and 8 cases (22.22%) were mixed epithelial mesenchymal type.All children were treated by tumor resection combined with chemotherapy, and there was a correlation between tumor risk stratification and surgical resection of liver lobe ( H=8.847, P<0.05). The probability of bone marrow suppression in the low-risk group was 58.33% (35/60),that in the intermediate-risk group was 73.49% (61/83) and in the high-risk group was 80.23% (69/86).All 36 cases were followed up to March 31, 2020,with an average follow-up of 21.9 months and the median survival was 22.5 months.The overall survival rate (OS) and event-free survival rate (EFS) were 97.2% and 83.3% respectively. Conclusions:The multidisciplinary CCCG-HB-2016 regimen was with a high success rate and along with a high incidence of bone marrow suppression.
4.Immunogenicity and safety of a severe acute respiratory syndrome coronavirus 2 inactivated vaccine in healthy adults: randomized, double-blind, and placebo-controlled phase 1 and phase 2 clinical trials.
Hong-Xing PAN ; Jian-Kai LIU ; Bao-Ying HUANG ; Gui-Fan LI ; Xian-Yun CHANG ; Ya-Fei LIU ; Wen-Ling WANG ; Kai CHU ; Jia-Lei HU ; Jing-Xin LI ; Dan-Dan ZHU ; Jing-Liang WU ; Xiao-Yu XU ; Li ZHANG ; Meng WANG ; Wen-Jie TAN ; Wei-Jin HUANG ; Feng-Cai ZHU
Chinese Medical Journal 2021;134(11):1289-1298
BACKGROUND:
The significant morbidity and mortality resulted from the infection of a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) call for urgent development of effective and safe vaccines. We report the immunogenicity and safety of an inactivated SARS-CoV-2 vaccine, KCONVAC, in healthy adults.
METHODS:
Phase 1 and phase 2 randomized, double-blind, and placebo-controlled trials of KCONVAC were conducted in healthy Chinese adults aged 18 to 59 years. The participants in the phase 1 trial were randomized to receive two doses, one each on Days 0 and 14, of either KCONVAC (5 or 10 μg/dose) or placebo. The participants in the phase 2 trial were randomized to receive either KCONVAC (at 5 or 10 μg/dose) or placebo on Days 0 and 14 (0/14 regimen) or Days 0 and 28 (0/28 regimen). In the phase 1 trial, the primary safety endpoint was the proportion of participants experiencing adverse reactions/events within 28 days following the administration of each dose. In the phase 2 trial, the primary immunogenicity endpoints were neutralization antibody seroconversion and titer and anti-receptor-binding domain immunoglobulin G seroconversion at 28 days after the second dose.
RESULTS:
In the phase 1 trial, 60 participants were enrolled and received at least one dose of 5-μg vaccine (n = 24), 10-μg vaccine (n = 24), or placebo (n = 12). In the phase 2 trial, 500 participants were enrolled and received at least one dose of 5-μg vaccine (n = 100 for 0/14 or 0/28 regimens), 10-μg vaccine (n = 100 for each regimen), or placebo (n = 50 for each regimen). In the phase 1 trial, 13 (54%), 11 (46%), and seven (7/12) participants reported at least one adverse event (AE) after receiving 5-, 10-μg vaccine, or placebo, respectively. In the phase 2 trial, 16 (16%), 19 (19%), and nine (18%) 0/14-regimen participants reported at least one AE after receiving 5-, 10-μg vaccine, or placebo, respectively. Similar AE incidences were observed in the three 0/28-regimen treatment groups. No AEs with an intensity of grade 3+ were reported, expect for one vaccine-unrelated serious AE (foot fracture) reported in the phase 1 trial. KCONVAC induced significant antibody responses; 0/28 regimen showed a higher immune responses than that did 0/14 regimen after receiving two vaccine doses.
CONCLUSIONS:
Both doses of KCONVAC are well tolerated and able to induce robust immune responses in healthy adults. These results support testing 5-μg vaccine in the 0/28 regimen in an upcoming phase 3 efficacy trial.
TRIAL REGISTRATION
http://www.chictr.org.cn/index.aspx (No. ChiCTR2000038804, http://www.chictr.org.cn/showproj.aspx?proj=62350; No. ChiCTR2000039462, http://www.chictr.org.cn/showproj.aspx?proj=63353).
Adult
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COVID-19
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COVID-19 Vaccines
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Double-Blind Method
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Humans
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SARS-CoV-2
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Vaccines, Inactivated/adverse effects*