1.Efficacy and safety of CM310 in moderate-to-severe atopic dermatitis: A multicenter, randomized, double-blind, placebo-controlled phase 2b trial
Yan ZHAO ; Jianzhong ZHANG ; Bin YANG ; Jingyi LI ; Yangfeng DING ; Liming WU ; Litao ZHANG ; Jinyan WANG ; Xiaohong ZHU ; Furen ZHANG ; Xiaohua TAO ; Yumei LI ; Chunlei ZHANG ; Linfeng LI ; Jianyun LU ; Qingchun DIAO ; Qianjin LU ; Xiaoyong MAN ; Fuqiu LI ; Xiujuan XIA ; Hao CHENG ; Yingmin JIA ; Guoqing ZHAO ; Jinchun YAN ; Bo CHEN
Chinese Medical Journal 2024;137(2):200-208
Background::Atopic dermatitis (AD) affects approximately 10% of adults worldwide. CM310 is a humanized monoclonal antibody targeting interleukin-4 receptor alpha that blocks interleukin-4 and interleukin-13 signaling. This trial aimed to evaluate the efficacy and safety of CM310 in Chinese adults with moderate-to-severe AD.Methods::This multicenter, randomized, double-blind, placebo-controlled, phase 2b trial was conducted in 21 medical institutions in China from February to November 2021. Totally 120 eligible patients were enrolled and randomized (1:1:1) to receive subcutaneous injections of 300 mg CM310, 150 mg CM310, or placebo every 2 weeks for 16 weeks, followed by an 8-week follow-up period. The primary endpoint was the proportion of patients achieving ≥75% improvement in the Eczema Area and Severity Index (EASI-75) score from baseline at week 16. Safety and pharmacodynamics were also studied.Results::At week 16, the proportion of EASI-75 responders from baseline was significantly higher in the CM310 groups (70% [28/40] for high-dose and 65% [26/40] for low-dose) than that in the placebo group (20%[8/40]). The differences in EASI-75 response rate were 50% (high vs. placebo, 95% CI 31%–69%) and 45% (low vs. placebo, 95% CI 26%–64%), with both P values <0.0001. CM310 at both doses also significantly improved the EASI score, Investigator’s Global Assessment score, daily peak pruritus Numerical Rating Scale, AD-affected body surface area, and Dermatology Life Quality Index compared with placebo. CM310 treatment reduced levels of thymus and activation-regulated chemokine, total immunoglobulin E, lactate dehydrogenase, and blood eosinophils. The incidence of treatment-emergent adverse events (TEAEs) was similar among all three groups, with the most common TEAEs reported being upper respiratory tract infection, atopic dermatitis, hyperlipidemia, and hyperuricemia. No severe adverse events were deemed to be attributed to CM310. Conclusion::CM310 at 150 mg and 300 mg every 2 weeks demonstrated significant efficacy and was well-tolerated in adults with moderate-to-severe AD.Trial Registration::ClinicalTrials.gov, NCT04805411.
2.Thoughts on fund compensation of adverse events following immunization in China
Ting SU ; Zhilei ZHONG ; Dan YOU ; Litao RUAN ; Shengran YANG ; Qian LI ; Qiuyu CHEN ; Zexu YU ; Cheng LI
Shanghai Journal of Preventive Medicine 2022;34(4):382-387
After the promulgation and implementation of the Vaccine Administration Law of the People’s Republic of China, the compensation of suspected adverse reactions in China is to be reformed and innovated. There have been attempts at compensation through government finance and insurance, but there has been no precedent for a fund of vaccine-related compensation in China, which means that this could be a new method of solving disputes of compensation for vaccine-related incidences and enhancing public confidence in vaccination. It is suggested that under the current system, we can select a province as a pilot to explore the fund compensation mechanism. The fund comes from special financial allocation, special taxation of vaccine enterprises, fund investment income, charitable donation and other channels. Through a special fund management organization, the independent identification and compensation process can be realized, so as to shorten the current compensation procedure, improve the amount of compensation, ultimately protect the interests of all parties, and promote the steady development of vaccination.
3.Experiences in use of kissing pancreatojejunostomy in 267 cases of pancreatoduodenectomy
Jia WU ; Xiangdong CHENG ; Yuhua ZHANG ; Yian DU ; Zhiyuan XU ; Litao YANG ; Fang HAN
Chinese Journal of General Surgery 2022;37(5):344-347
Objective:To investigate feasibility, efficiency and safety of kissing pancreatojejunostomy after pancreatoduodenectomy.Methods:From Jan 2006 to Sep 2020, the clinical data of 267 patients undergoing pancreatoduodenectomy and kissing pancreatojejunostomy were retrospectively analyzed.Results:Grade B postoperative pancreatic fistula (POPF) occurred in 6.37%, Grade C POPF in 2.25% of patients. There was no mortality within 30 days postoperatively as to pancreatic fistula, by cut-off of pancreatic duct diameter at 3mm, there was no significant difference between two subgroups (15/140 vs. 8/127, P=0.20). also, when grouped by texture of the pancreas, no there was significant difference (20/194 vs. 3/73, P=0.11). Conclusions:Kissing pancreatojejunostomy is feasible and easy to perform. It also does not increase the POPF rate when applied to the pancreatojejunostomy with thin pancreatic duct and soft texture.
4. Preliminary efficacy analysis of Cheng's Giraffe reconstruction after proximal gastrectomy in adenocarcinoma of esophagogastric junction
Xiangdong CHENG ; Zhiyuan XU ; Yi′an DU ; Can HU ; Jianfa YU ; Litao YANG ; Ling HUANG ; Pengfei YU ; Gaiguo DAI ; Yanqiang ZHANG
Chinese Journal of Gastrointestinal Surgery 2020;23(2):158-162
Objective:
To investigate the safety and feasibility of proximal partial gastrectomy with Cheng's Giraffe esophagogastric reconstruction for the treatment of early Siewert II adenocarcinoma of esophagogastric junction (AEG).
Methods:
Indication of Cheng's Giraffe esophagogastric reconstruction: (1) Siewert II AEG or Siewert III AEG with diameter < 4 cm; (2) preoperative staging as cT1-2N0M0. A descriptive case series study was carried out. Clinical data of 34 patients with Siewert II AEG undergoing proximal partial gastrectomy and Cheng's Giraffe esophagogastric reconstruction at Department of Abdominal Surgery of Zhejiang Cancer Hospital and Department of Gastrointestinal Surgery, The First Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine from February to July 2018 were retrospectively collected and analyzed, including 14 cases in IA stage, 11 cases in IIA stage and 8 cases in IIB stage. Brief procedure of Cheng's Giraffe esophagogastric reconstruction was as follows: Firstly, 12 cm long tubular stomach was formed by longitudinal incision 4 cm away from the great curvature of the stomach. Secondly, the gastric fundus and His angle were formed. Finally, the distance from His angle to esophagal-tubular gastric anastomosis should be more than 5 cm. The reflux disease questionare (RDQ) scores, radionuclide gastric emptying scintigraphy, and 24-hour multichannel intraluminal (MII)-pH monitoring technology were used to evaluate postoperative gastric emptying and gastroesophageal reflux.
Result:
All 34 patients successfully completed proximal partial gastrectomy with Cheng's Giraffe esophagogastric reconstruction, including 13 cases by open surgery and 21 cases by laparoscopic surgery. The operation time was (144.6±39.8) minutes, the blood loss during operation was (35.4±17.2) ml. No laparoscopic case was converted to open surgery and no postoperative complication was observed. The postoperative hospital stay was (8.4±2.5) days. The postoperative RDQ score was 4.4±3.1 one month after operation, and 3.3±2.5 six months after operation. Gastric-half emptying time was (67.0±21.5) minutes, and the residual ratio was (52.2±7.7)% in 1 hour, (36.4±3.1)% in 2 hours and (28.8±3.6)% in 3 hours at postoperative 1-month. The 24-hour MII-pH monitoring at postoperative 2-month revealed the frequency of acid reflux was (12.6±7.9) times, frequency of non-acid reflux was (19.6±9.7) times, DeMeester score was 5.8±2.9.
Conclusion
Cheng's Giraffe esophagogastric reconstruction is safe and feasible in the treatment of Siewert type II AEG, and has good dynamic and anti-reflux effects.
5.The relationship between the prevalence of isolated systolic hypertension and the stages of chronic kidney disease in chronic kidney disease outpatient clinic
Haixia BU ; Litao CHENG ; Aihua ZHANG ; Tao WANG ; Yue WANG ; Minhua FAN
Chinese Journal of Nephrology 2015;31(1):19-23
Objective To investigate the relationship between the prevalence of isolated systolic hypertension (ISH) and the stages of chronic kidney disease (CKD) in chronic kidney disease outpatient clinic.Methods CKD patients of stages 1,2,3,4 and 5 were recruited (n=626).Based on office systolic pressure (SBP) and diastolic pressure (DBP),they were classified into four subtypes:normotension (< 140/90 mmHg),isolated diastolic hypertension (IDH,SBP < 140 mmHg and DBP ≥ 90 mmHg),ISH (SBP≥ 140 mmHg and DBP < 90 mmHg) and systolic-diastolic hypertension (SDH,SBP≥140 mmHg and DBP≥90 mmHg).Results The control rate of blood pressure was 86.4%,75.6%,65.3%,51.0% and 37.0% at CKD stage 1,2,3,4 and 5,respectively,which decreased with the advancement of CKD.There was a stepwise increase in the prevalence of ISH (0,9.2%,23.9%,28.6% and 37.0% at CKD stage 1,2,3,4 and 5,respectively) and SDH (4.5%,8.4%,8.0%,17.3%,21.9% at CKD stage 1,2,3,4 and 5,respectively).Logistic regression analysis showed that age,diabetes and CKD stages were independent predictors of ISH.Compared with CKD stage 1-2,CKD stage 3,4 and 5 showed 2.388,2.697 and 5.980 folds risk in developing ISH.Conclusion The prevalence of ISH increases correspondingly with the advancement of stages of CKD,which may partially contribute to the increased cardiovascular mortality during the progress of CKD.
6.Triple-negative and Non-triple-negative Breast Cancer:A Comparison of Mammography and Ultrasonography
Hui ZHANG ; Litao SUN ; Bo GAO ; Xiaoying CHENG ; Lei ZHANG ; Shumei ZHENG
Chinese Journal of Medical Imaging 2014;(10):725-729
Purpose To compare the mammography and ultrasound imaging features of triple-negative breast cancer (TNBC) and non-triple-negative breast cancer (NTNBC), and to improve TNBC diagnosis. Materials and Methods Using immunohistochemical staining technique, 387 patients with pathologically conifrmed breast cancer were divided into TNBC group (n=54) and NTNBC group (n=333). Mammography and ultrasound ifndings as well as pathological data were retrospectively reviewed. Results TNBC was associated with higher tumor grades. There were signiifcantly more grade III inifltrating ductal carcinomas and axillary lymph node involvement in TNBC group than in NTNBC group (χ2=47.009, P<0.001;χ2=4.658, P<0.05). On mammography, TNBC most frequently presented with a mass (n=37, 69.8%) and was less associated with microcalciifcations (n=10, 18.9%). TNBC masses were mostly round or oval (n=28, 62.2%) with circumscribed margin (n=16, 35.6%). Spiculated margins were rare (n=5, 11.1%). NTNBC most frequently presented as a mass with calciifcations (n=138, 42.1%), and was more irregular in shape (n=119, 46.5%). Spiculated margins were common (n=77, 30.1%). There was statistically signiifcant difference between these two groups in mass, microcalcification, shape and margin (χ2=24.618, 19.889, 32.605 and 21.102, P<0.001). On ultrasonograhy, TNBC most frequently presented as a mass (n=52, 96.3%) with less microcalciifcations (n=5, 9.3%). TNBC masses were more frequently round or oval (n=27, 51.9%) with circumscribed margins (n=25, 48.1%). Spiculated margins were rare (n=3, 5.8%). TNBC was less likely to show attenuating posterior echoes (n=5, 9.6%);NTNBC most frequently presented as a mass (n=318, 96.1%) with microcalcifications (n=135, 40.8%). NTNBC masses were more frequently irregular in shape (n=243, 76.4%) with spiculated margins (n=76, 23.9%). NTNBC was more likely to show attenuating posterior echoes (n=78, 24.5%). There was statistically signiifcant difference between these two groups in microcalciifcation, shape, margin and posterior echo (χ2=19.006 and 18.339, P<0.001;χ2=16.170 and 8.429, P<0.05). Conclusion TNBC demonstrates round or oval mass with circumscribed margin and is less likely to show attenuating posterior echoes on mammography and ultrasound with benign imaging features. NTNBC frequently presents as irregular mass with spiculated margin, and is more associated with microcalciifcations. These imaging ifndings are useful in early diagnosis of TNBC.
7.The study of aortic stiffness in different hypertension subtypes in patients with chronic kidney disease
Haixia BU ; Litao CHENG ; Aihua ZHANG ; Tao WANG ; Yue WANG ; Minhua FAN
Chinese Journal of Nephrology 2014;30(4):254-261
Objective To investigate whether there is any difference in aortic stiffness among different hypertension subtypes in patients with chronic kidney disease.Methods Six hundred and twenty-six patients with chronic kidney disease were included in the present analysis.They were classified into four groups:normotension (n =391) with systolic blood pressure (SBP) < 140 mmHg and diastolic blood pressure (DBP) < 90 mmHg; isolated systolic hypertension (ISH,n =141) with SBP≥ 140mmHg and DBP < 90 mmHg; isolated diastolic hypertension (IDH,n =25) with SBP < 140 mmHg and DBP≥ 90 mmHg; systolic-diastolic hypertension (SDH,n =69) with SBP≥ 140 mmHg and DBP≥ 90mmHg.Aortic stiffness was assessed by pulse pressure and pulse wave velocity.Results The IDH group had lower mean age than the other groups(P < 0.01).The percentage of diabetes in the ISH group was higher than that in the other groups.The comparison of aortic stiffness showed that the ISH and SDH groups had higher aortic stiffness than the normotension and IDH groups (P < 0.01),but no significant difference in aortic stiffness was observed neither between the normotension and IDH groups nor between ISH and SDH groups.Conclusion Aortic stiffness is significantly different among different hypertension subtypes,which may be an underlying cause for the different cardiovascular mortality among the hypertension subtypes.
8.Application of double liver hanging maneuver in anatomical right Hemihepatectomy
Xiangdong CHENG ; Yian DU ; Zhiyuan XU ; Ling HUANG ; Bing WANG ; Litao YANG
Chinese Journal of Hepatobiliary Surgery 2010;16(12):915-917
Objective To introduce the application of double liver hanging maneuver in anatomical right hemihepatectomy and share our own experience. Methods Twenty-four patients underwent right hemihepatectomy using double liver hanging maneuver, and the data were collected prospectively after operation. Another 49 patients underwent right hemihepatectomy using the traditional methods,serving as the control group. Results Retrohepatic tunnel was constructed in 27 patients, double liver hanging maneuver was successfully performed in 24 anatomical right hemihepatomy and failed in 3 patients due to the near proximity between the tumor and the middle line. Compared with the control group, blood loss was much less (t=3. 191 ,P<0.05), ALT and liver function recovered more quickly postoperatively and the difference in operative duration between the 2 groups was not significant (t=-1. 695,P>0. 05). There was about 1-2 cm wide space located between retrohepatic IVC and dorsal liver when the 2 tapes were tracted, and no injury in hepatic short veins and retrohepatic IVC occurred during the operation. Conclusion The double liver hanging maneuver can make anatomical right hemihepatectomy more accessible and safe.
9.Postoperative early intrahepatic recurrence and the prognosis in patients of hepatocellular carcinoma
Litao YANG ; Xinbao WANG ; Yunli ZHANG ; Yiming ZHOU ; Bing WANG ; Xiangdong CHENG ; Jianmin GUO
Chinese Journal of General Surgery 2010;25(6):466-468
Objective To investigate the predictive factors and prognosis of early intrahepatic recurrence after curative resection of hepatocellular carcinoma(HCC).Methods Clinicopathological dats of 184 HCC patients with intrahepatic recurrence after curative resection were collected.Thirteen clinicopathological factors and prognosis after recurrence were retrospectively analyzed. Results Univariate analysis showed that preoperative scrota alpha-fetoprotein(AFP)>100 ng/ml,tumour size>5 cm,venous invasion and intra-operative blood transfusion were predictive factors of early intrahepatic recurrence,and selum albumin<35 g/L was marginally predictive factor.Multivariate analysis showed that serum AFP>100 ng/ml,tumour size>5 cm and venous invasion were independent predictive factots of early intrahepatic recurrence.The survival of patients suffering from early recurrence was significantly shorter than those with late recurrence.with median survival period of 12 mos vs 18 mos(P=0.012).Conclusion Serum AFP,tumour size and venous invasion were independent predictive factors of early intrahepatic recurrence in HCC patients after radical resection of the primary tumor.Early intrahepatic recurrence implies poor prognosis.
10.Combination perioperative chemotherapy and surgery for the treatment of advanced gastric cancer
Xiangdong CHENG ; Yian DU ; Zhiyuan XU ; Ling HUANG ; Litao YANG ; Bing WANG
Chinese Journal of General Surgery 2010;25(6):463-465
Objective To investigate the feasibility and safety of designed perioperative surgical treatment for advanced gastric cancer.Method From March 2006 to Sep.2009,24 patients with advanced gastric cancer were enrolled for this study,of which 14 cases were graded as Ⅳ M0,10 as Ⅳ M1,including liver metastasis in 5 cases,peritoneal seeding in 4 and lung metastasis in 1.All patients received 2-4 cycles of chemotherapy of PCF or ECF regimen,followed by intended surgical resection and postoperative 2-3 cycles of adjuvant chemotherapy of the same regimen as used during the preoperative course.Result Seven Cases abandoned surgical therapy,a total of 17 cases completed preoperative chemotherapy,surgical resection and postoperative chemotherapy.R0 resection was achieved in 16 cases(94%).There was no perioperative mortality,and total clinical response rate was 75%,overall pathological response rate was 82%.In 59% surgical cases (10 cases) serum CEA and CA199 has returned to normal;In 71%patients tumor pathological stage degraded at the cost of Ⅲ-Ⅳ grade of neutropenia,thrombocytopenia,anemia,severe nausea and vomiting in 79%,8%,13%,and 54% cases respectively.Fever was encountered in 2 cases with grade Ⅲ-Ⅳ neutropenia.Conclusion Designed perioperative chemotherapy regimen renders advanced gastric carcinoma patients operable at the cost of acceptable complications.

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