The"promising zone"is a method used to analyze interim data from adaptive design clinical trials in an unblinded state.It allows for the adjustment of sample size based on interim results to enhance the trial's probability of success or minimize investment in unnecessary sample size.Mehta and Pocock proposed rules for increasing sample size based on interim analysis results using the concept of the"promising zone"(MP design).Furthermore,combination of the MP design with group sequential design can set up early stopping boundaries in trials,allowing for a reduction in sample size under favorable or unfavorable zone.The combination test(CT)design further optimizes the framework of the"promising zone",by considering sample size and conditional power in combination to achieve the highest conditional power with the smallest sample size.This review summarizes the principles of the"promising zone",introduces the method of determining the"promising zone"and re-estimating sample size,and further illustrates the feasibility of this method in clinical trials with a practical case.

Objective:To design two kinds of intensity modulated radiotherapy (IMRT) plans with different radiation field distributions,and to compare the dose differences of that at the dose of target region and organs at risk (OAR) for middle and lower esophageal cancer,so as to provide a reference for the design of IMRT plan. Methods:The data of 17 patients with middle and lower esophageal cancer who received IMRT at Shangluo Central Hospital from November 2022 to May 2023 were retrospectively analyzed. IMRT plans with different radiation fields for Plan 1 and Plan 2 were designed for each patient. The angles of radiation field for Plan 1 were 0°,80°,120°,160° and 200°,and those for Plan 2 were 30°,130°,180°,230° and 330°,respectively. The prescribed dose to the planning target volume (PTV) was 60 Gy/30 F. The differences in dosimetric parameters between the two plans were compared. Results:There were no statistically significant differences in the dose parameters of 2％,98％,50％ target dose (D2％,D98％,D50％),homogeneity index (HI),conformity index (CI) and monitor unit between the two groups (P>0.05). There were no significant differences in V5 of dual lungs,the mean dose (Dmean) of heart,and the maximum dose (Dmax) of spinal-cord between two groups (P>0.05). The volume percentage (V10,V20,V30) of dual lungs received radiation doses of 10,20 and 30 Gy,and the mean dose (Vmean) of lung in the Plan1 group reduced respectively 7.44％,21.16％,10.09％ and 5.31％ than those in the Plan2 group,and the differences of them were statistically significant (t=-5.845,-7.729,-2.247,-3.960,P<0.05). Heart V10 and V20 in the Plan1 group decreased respectively by 7.23％ and 5.78％,with statistical significance (t=-4.376,-3.523,P<0.01),while V30 and V40 of Plan 1 increased respectively by 2.7％ and 4.92％,without statistical significance (P>0.05). There was no significant difference in heart Dmean between the Plan1 group and the Plan2 group (P>0.05). Conclusion:Both two methods of distribution field can meet the clinical requirements,and Plan1 has more advantages in protecting organs at risk under the premise of meeting the requirements of target region.

The"promising zone"is a method used to analyze interim data from adaptive design clinical trials in an unblinded state.It allows for the adjustment of sample size based on interim results to enhance the trial's probability of success or minimize investment in unnecessary sample size.Mehta and Pocock proposed rules for increasing sample size based on interim analysis results using the concept of the"promising zone"(MP design).Furthermore,combination of the MP design with group sequential design can set up early stopping boundaries in trials,allowing for a reduction in sample size under favorable or unfavorable zone.The combination test(CT)design further optimizes the framework of the"promising zone",by considering sample size and conditional power in combination to achieve the highest conditional power with the smallest sample size.This review summarizes the principles of the"promising zone",introduces the method of determining the"promising zone"and re-estimating sample size,and further illustrates the feasibility of this method in clinical trials with a practical case.

Objective:To design two kinds of intensity modulated radiotherapy (IMRT) plans with different radiation field distributions,and to compare the dose differences of that at the dose of target region and organs at risk (OAR) for middle and lower esophageal cancer,so as to provide a reference for the design of IMRT plan. Methods:The data of 17 patients with middle and lower esophageal cancer who received IMRT at Shangluo Central Hospital from November 2022 to May 2023 were retrospectively analyzed. IMRT plans with different radiation fields for Plan 1 and Plan 2 were designed for each patient. The angles of radiation field for Plan 1 were 0°,80°,120°,160° and 200°,and those for Plan 2 were 30°,130°,180°,230° and 330°,respectively. The prescribed dose to the planning target volume (PTV) was 60 Gy/30 F. The differences in dosimetric parameters between the two plans were compared. Results:There were no statistically significant differences in the dose parameters of 2％,98％,50％ target dose (D2％,D98％,D50％),homogeneity index (HI),conformity index (CI) and monitor unit between the two groups (P>0.05). There were no significant differences in V5 of dual lungs,the mean dose (Dmean) of heart,and the maximum dose (Dmax) of spinal-cord between two groups (P>0.05). The volume percentage (V10,V20,V30) of dual lungs received radiation doses of 10,20 and 30 Gy,and the mean dose (Vmean) of lung in the Plan1 group reduced respectively 7.44％,21.16％,10.09％ and 5.31％ than those in the Plan2 group,and the differences of them were statistically significant (t=-5.845,-7.729,-2.247,-3.960,P<0.05). Heart V10 and V20 in the Plan1 group decreased respectively by 7.23％ and 5.78％,with statistical significance (t=-4.376,-3.523,P<0.01),while V30 and V40 of Plan 1 increased respectively by 2.7％ and 4.92％,without statistical significance (P>0.05). There was no significant difference in heart Dmean between the Plan1 group and the Plan2 group (P>0.05). Conclusion:Both two methods of distribution field can meet the clinical requirements,and Plan1 has more advantages in protecting organs at risk under the premise of meeting the requirements of target region.

Objective:To study the dosimetry effects of differently selected values of control point(CP)in Monaco radiotherapy planning system on dynamic intensity modulated radiation therapy(dIMRT)for esophageal cancer of middle and lower segment.Methods:Thirteen patients with esophageal cancer at middle and lower segment who received dIMRT in Shangluo Central Hospital from January to June 2023 were selected.In the Monaco radiotherapy planning system,nine groups of dIMRT plans were designed for each patient according to the 9 kinds of CP limit values(10,20,30,40,50,60,70,80 and 90).There were not changes in other optimized parameters except CP parameter.The differences of the dosimetry between target region and organs at risk(OAR)included lung,heart and spinal cord were analyzed.Results:With the increase of the CP limit value,the maximum dose of the target region which was radiation dose(D2%)of 2%volume of target region,the mean dose,which was radiation dose(D50%)of 50%volume of target region,and the homogeneity index(HI)appeared a trend of gradual stability after reduction,and the radiation dose(D98%)of 98%volume of target region which was the minimum dose of target region and the conformance index(CI)appeared a trend of gradual stability after increase.There was not significant in each dose indicator of OAR(P>0.05).The variation ranges of lung at 5,10,20,30 Gy dose(V5,V10,V20 and V30)were respectively 1.13%,0.75%,0.29%and 0.19%,and the maximum deviation of mean dose(Vmean)of lung was 18.7 cGy.The variation ranges of V10,V20,V30 and V40 in the heart were respectively 2.2%,1.23%,1.39%and 1.12%,and the maximum deviation of Vmean in the heart was 63.85 cGy,and the maximum deviation of Dmax in the spinal-cord was 70.78 cGy.There were statistically significant differences in the actual CP number(CPs),execution time(DT)of plan,and ratio value of machine unit(MU)of the complexity of plan to CPs(MU/CPs)among the plans of 9 groups(F=2.857,25.145,135.467,P<0.05),respectively.Conclusion:In the dIMRT plan of esophageal cancer of middle and lower segment,the maximum CP value is set at between 40-50,which can reduce the optimization time of the plan,the number of subfields and the treatment time of patients under the premise of meeting the dose of the target region and the OAR.

Objective To investigate and analyze risk factors of re-fracture after operation of osteoporotic hip fracture.Methods Two hundred forty-seven patients receiving operation of osteoporotic hip fracture were retrospectively studied and followed up,and all patients were divided into re-fracture group (54 patients) and no-re-fracture group (193 patients).The related factors such as sex,age,body mass index (BMI),affected side,initial fracture site,operation type,perioperative blood loss,postoperative delirium,postoperative bedridden time,medical complications,Charlson comorbidity index,antiostoporosis therapy,hip function scores with Harris and functional independence measurement (FIM) scores were compared by single factor analysis and multivariate Logistic regression analysis.Results Single factor analysis and multivariate Logistic regression analysis both showed that the risk factors of re-fracture after operation of osteoporotic hip fracture included age,postoperative delirium,hypertension,diabetes mellitus,cerebrovascular disease,antiostoporosis therapy,hip function scores with Harris and FIM scores (P ＜ 0.05 or ＜ 0.01).Conclusions Risk factors of re-fracture after operation of osteoporotic hip fracture include passive factors of age,postoperative delirium and medical complications,and subjective factors of antiostoporosis therapy,hip function scores with Harris and FIM scores.Patients should receive medical treatment positively,enhance antiostoporosis therapy and rehabilitation training of hip function to prevent re-fracture.

OBJECTIVETo compare the clinical efficacy and safety among different chemotherapeutic regimens in treatment of refractory/relapsed acute myeloid leukemia (AML).

METHODSThe clinical data of 67 refractory/relapsed AML patients enrolled from September 2008 to April 2013 were collected. The differences of clinical outcome and adverse events among the patients treated with decitabine combined with DAG regimen, CAG regimen or "3+7" regimen were analyzed.

RESULTSAmong 19 patients in decitabine treatment group, 5 (26.3%) achieved complete remission (CR), 4 (21.1%) partial remission (PR), with overall response rate (ORR) of 47.4 %. Of 26 patients in CAG regimen group, 8 (30.8%) achieved CR, 1 (3.8%) PR, with ORR of 34.6%. Of 22 patients in "3+7" regimen group, 4 (18.2%) achieved CR, with ORR of 18.2%. The ORR of decitabine group was significantly higher than that of "3+7" group (P<0.05). However, no significant difference of ORR was observed among the three groups (P>0.05). It was interesting to note that in decitabine group, the marrow blast counts were lower in CR patients compared with those in non-CR patients (P<0.05), while this was not found in "3+7" group (P>0.05) and CAG regimen group (P>0.05). Adverse events in the three groups were similar, mainly including myelosuppression, pulmonary infection, nausea, vomiting and liver dysfunction, and could be well tolerated. Followed- up to September 2013, the median overall survival (OS) of decitabine group, CAG regimen group and "3+7" group after relapse was 7.5, 4 and 3 months, respectively (P>0.05), while significant difference was obtained between decitabine group and "3+7" regimen group (P<0.05).

CONCLUSIONDecitabine combined with DAG regimen is effective and well tolerated in refractory/relapsed AML patients who were unsuitable for intensive chemotherapy and hematopoietic stem cell transplantation, and the patients with low marrow blast counts are more suitable for the application of decitabine combined with DAG regimen.

Adult ; Aged ; Antineoplastic Combined Chemotherapy Protocols ; therapeutic use ; Azacitidine ; administration & dosage ; analogs & derivatives ; Female ; Humans ; Leukemia, Myeloid, Acute ; drug therapy ; Male ; Middle Aged ; Neoplasm Recurrence, Local ; Retrospective Studies ; Treatment Outcome ; Young Adult