1.Efficacy comparison of Sweet versus Ivor-Lewis esophagectomy in the treatment of middle-lower esophageal squamous cell carcinoma.
Xiaodong YANG ; Cheng ZHAN ; Fenghao SUN ; Li CHEN ; Mengkun SHI ; Wei JIANG ; Qun WANG
Chinese Journal of Gastrointestinal Surgery 2016;19(9):979-984
OBJECTIVETo compare the short-term efficacy and long-term survival between Sweet and Ivor-Lewis esophagectomy for patients with middle-lower esophageal squamous cell carcinoma.
METHODSClinicopathologic data of 1 308 patients with middle-lower esophageal squamous cell carcinoma undergoing Sweet or Ivor-Lewis procedures in our department from January 2007 to December 2014 were retrospectively analyzed, including 1 021 patients of Sweet operation (Sweet group) and 287 patients of Ivor-Lewis operation(Ivor-lewis group). Lymph node clearance, lymphatic metastasis, postoperative complication morbidity and long-term survival were compared between the two groups.
RESULTSThere were no significant differences in baseline data between the two groups(all P>0.05). There were more lymph nodes resected during the Ivor-Lewis procedure compared with the Sweet procedure (20.8 vs.19.3, P=0.030). Compared with Ivor-Lewis group, the incidence of wound infection in Sweet group was significantly lower[(3.2%(33/1 021) vs. 8.0%(23/287), P=0.000]. Sweet group had a significantly lower rate of delayed gastric emptying[1.9%(19/1 021) vs. 5.2%(15/287), P=0.002] and significantly shorter hospital stay (14.7 days vs. 17.2 days, P=0.029). With respect to other postoperative complications, such as pulmonary complications, cardiac events, anastomotic leakage, vocal cord palsy, chylothorax and pyothorax, the differences between the two groups were not statistically significant. The 5-year survival rate was not significantly different between the two group (54.0% vs. 56.9%, P=0.873). Stratified analysis based on TNM staging showed that no significant difference of 5-year survival rate was found between the two groups in stageI( and stageIII( patients (P>0.05), while the 5-year survival rate of stageII( patients in Sweet group was significantly lower than that in Ivor-Lewis group (56.4%% vs. 70.4%, P=0.039).
CONCLUSIONSFor patients with middle-lower esophageal squamous cell carcinoma, Sweet procedure has certain superiority regarding the incidence of wound infection and delayed gastric emptying compared with the Ivor-Lewis procedure. Ivor-Lewis esophagectomy can harvest more lymph nodes. The 5-year survival rate of these two procedures is similar. Sweet procedure is still valuable in clinical practice, especially for stageI( and stageIII( patients, while it requires thorough considerations for stageII( patients.
Anastomotic Leak ; Antineoplastic Protocols ; Carcinoma, Squamous Cell ; mortality ; surgery ; Esophageal Neoplasms ; mortality ; surgery ; Esophagectomy ; adverse effects ; methods ; Gastroparesis ; etiology ; Humans ; Incidence ; Length of Stay ; Lymph Node Excision ; statistics & numerical data ; Lymph Nodes ; Lymphatic Metastasis ; Neoplasm Staging ; statistics & numerical data ; Postoperative Complications ; etiology ; Recovery of Function ; Retrospective Studies ; Surgical Wound Infection ; etiology ; Survival Rate ; Treatment Outcome
2.Research on the impact of the adjustment of National Reimbursement Drug List on drug use of rare disease in hospitals
Hongbin YI ; Fenghao SHI ; Liping KUAI ; Hua XING
China Pharmacy 2022;33(24):2952-2956
OBJECTIVE To explore the impact of the adjustment of the national reimbursement drug list on rare disease drugs in hospitals, and to provide reference for improving the drug security of patients with rare diseases in China.METHODS The monthly procurement data of rare disease drugs from 789 medical institutions that continuously reported data from January 2016 to December 2018 were extracted from the Chinese Medicine Economic Information. The single-group interrupted time series model was used to compare drug varieties, procurement amount, average defined daily cost (DDDc) and defined daily doses (DDDs) of rare disease drugs before and after the adjustment of national reimbursement drug list. RESULTS In 2017, a total of 9 rare disease drugs were newly included in the national reimbursement drug list, including pirfenidone, carbidopa/levodopa, riluzole, ropinirole, droxidopa, ezetimibe, everolimus, coagulation factor Ⅸ human recombinant and coagulation factor Ⅶa human recombinant. After the adjustment of the national reimbursement drug list, the average DDDc of 9 rare disease drugs was significantly decreased, the upward trend of DDDs and the procurement amount was significantly increased (P<0.001). CONCLUSIONS The number of newly included rare disease drugs in national reimbursement drug list keeps increasing, the coverage of medical security keeps expanding, the price of rare disease drugs is significantly decreased, the economic burden of patients is further decreased, and the consumption of rare disease drugs is significantly increased, benefiting more patients with rare diseases; but at the same time, it also increases the procurement amount of rare disease drugs in hospitals. National medical security departments need to fully consider how to balance the affordability of medical insurance funds with the demand for rare disease drug coverage.
3.Cost-effectiveness analysis of nivolumab in the second-line treatment of metastatic clear cell renal cell carcinoma
Yingdan CAO ; Fenghao SHI ; Rui MENG ; Pingyu CHEN ; Zhengyang FEI ; Xueke ZHANG ; Aixia MA
China Pharmacy 2022;33(10):1233-1239
OBJECTIVE To ev aluate the economical efficiency of nivolumab versus everolimus in the second-line treatment of metastatic clear cell renal cell carcinoma. METHODS From the perspective of China ’s health system ,cost-effectiveness analysis of the two therapies was carried out by developing a three-state partitioned survival model. The clinical parameters were from the updated CheckMate 025 study,and the cost and health utility were from relevant websites and published literatures. The model adopted a 2-week cycle and a lifetime research time. The robustness of the results was verified by sensitivity analysis. The economical efficiency of two therapy schemes were evaluated in the scenario of model simulation time of 80 months and charitable drug donation scheme. RESULTS The results of basic analysis showed that compared with everolimus ,the incremental cost-effectiveness ratio (ICER)of nivolumab was 586 982.60 yuan/quality-adjusted life year (QALY),which was far higher than 3 times of China ’s per capita gross domestic product (GDP)in 2020. The results of single-factor sensitivity analysis showed that the 3 parameters that had the greatest impact on the economic evaluation results were the cost of nivolumab ,the utility value of nivolumab group and everolimus group in progressive disease state. The results of probability sensitivity analysis verified the robustness of the basic analysis results. Results of scenario analysis showed that in the first scenario analysis ,in which model simulation time lasted for 80 months,ICER of nivolumab was 417 204.52 yuan/QALY;in the second scenario analysis ,in which nivolumab charitable drug donation program for low-income people was considered ,ICER of nivolumab was 124 988.58 yuan/QALY. CONCLUSIONS Under the threshold of 1-3 times of China ’s per capita GDP in 2020,compared with everolimus ,it is not economical to use nivolumab as the second-line treatment for metastatic clear cell renal cell carcinoma ; nivolumab is economical when considering its charitable drug donation program for low-income people.
4.Cost-utility Analysis of Pembrolizumab in the Second-line Treatment of Advanced Hepatocellular Carcinoma Based on Two Models
Rui MENG ; Ting ZHOU ; Fenghao SHI ; Zijing WANG ; Mengjie LUO ; Aixia MA
China Pharmacy 2021;32(22):2761-2766
OBJECTIVE:To evaluate the econo mics of pembrolizumab in the second-line treatment of advanced hepatocellular carcinoma in China. METHODS :From the perspective of Chinese healthcare system ,a three-state PartSA model and Markov model were established ;the cost and utility for the second-line treatment of advanced hepatocellular carcinoma in China were compared between pembrolizumab and placebo. The circulation cycle of the model was 3 weeks and the study time limit was lifetime;one-way sensitivity analysis ,probability sensitivity analysis and scenario analysis were used to verify the robustness of the base-case analysis results. RESULTS :PartSA results showed that the ICER for the second-line treatment of advanced hepato- cellular carcinoma with pembrolizumab was 1 266 846.18 yuan/QALY,which is far more than 1-3 times of China ’s per capita GDP in 2020. The results of one-way sensitivity analysis showed that the three parameters that had the greatest impact on ICER were the PFS status utility of the placebo group ,the PFS status utility of the pembrolizumab group ,and the cost of pembrolizumab. The results of probability sensitivity analysis verified the robustness of the base-case analysis. The scenario analysis showed that the treatment cost of pembrolizumab had dropped significantly when the charity donation of pembrolizumab was considered. Although it was still not economical ,ICER was close to 3 times of per capita GDP of China in 2020. When WTP threshold was 1 and 3 times of China ’s per capita GDP ,the economic prices of pabolizumab (100 mg)were 4 157.67 and 5 829.24 yuan,respectively. The results of Markov model were similar to those of PartSA model. CONCLUSIONS :Under the WTP threshold of 1-3 times China ’s per capita GDP in 2020,pembrolizumab is not economical for second-line treatment of advanced hepatocellular carcinoma.