Objective To systematically evaluate the efficacy and safety of dose-dense neoadjuvant chemotherapy (ddNACT) and conventional neoadjuvant chemotherapy (cNACT) for locally advanced breast cancer (LABC). Methods PubMed, Embase, Web of Science, CNKI, Wanfang Data, and VIP databases were searched for randomized controlled trials (RCT) comparing ddNACT regimen with cNACT regimen for breast cancer. The time limit for retrieval was from establishment to March 1st, 2021. Two reviewers independently screened literatures, extracted data and assessed risk bias of included studies; then, meta-analysis was performed by using Stata 15.0 software. Results A total of 13 RCTs were included, including 3 258 patients, of which 1 625 patients received ddNACT and 1 633 patients received cNACT. The results of meta-analysis showed that the ddNACT regimen could improve the pathological complete response rate (pCR, P<0.001), objective response rate (ORR, P<0.001), and disease free survival (DFS, P=0.037) as compared with the cNACT regimen, there was no significant difference in the overall survival (OS) between the two groups (P=0.098). The incidences of grade 3 or 4 oral stomatitis (P=0.005) and neurotoxicity (P<0.001) were higher and the incidence of grade 3 or 4 neutropenia was lower (P=0.025) in the patients with ddNACT regimen, there were no significant differences in grade 3 or 4 thrombocytopenia (P=0.152), grade 3 or 4 anemia (P=0.123), chemotherapy completion rate (P=0.161) and breast conservative surgery rate (P=0.186) between the two groups. Patients with hormone receptor (HR) negative (HR–) were more likely to get pCR after neoadjuvant chemotherapy (P<0.001). ConclusionsCurrent evidence shows that the use of anthracycline/taxane-based ddNACT regimen in LABC patients can improve the pCR, ORR, and DFS as compared with cNACT regimen. The pCR after neoadjuvant chemotherapy in the patients with HR– is higher than that with HR+. Prophylactic use of granulocyte-colony stimulating factor could significantly reduce the incidence of neutropenia, and most patients are tolerant to ddNACT regimen, 2 regimens have similar chemotherapy completion rates.
目的:分析脑出血死亡时间及死因,找出脑出血不同死亡时间的主要死因,为制定脑出血不同时间的相应救治措施提供依据。方法:回顾性总结分析２１１ 例脑出血死亡病例的死亡时间、主要死因,找出不同死亡时间对应的主要死因。 结果: (１)死亡时间:≤３ 天 ９１ 例、４~７天 ５２ 例、８~１４ 天 ４２ 例、１５~２１ 天１８ 例、２２~２８ 天 ７ 例、≥ ２９ 天 １ 例。(２)死亡原因:１６９ 例死于脑疝及中枢性呼吸、循环衰竭;20例死于肺部感染;１０ 例死于消化道出血;4 例死于多器官功能衰竭;４ 例死于心脏病变(如心脏猝死、心肌梗塞、心功能衰竭);其它４例(痰窒息、肾功能衰竭、肝功能衰竭)。(３)不同死亡时间主要死亡原因:≤３ 天 ９０ 例死于脑疝及中枢性呼吸、循环衰竭,仅 １ 例死于消化道出血;４～７ 天４７ 例死于脑疝及中枢性呼吸、循环衰竭,３ 例死于肺部感染,死于心脏病变及其它各１例;８~１４ 天 ２９ 例死于脑疝及中枢性呼吸、循环衰竭,８ 例死于肺部感染,２ 例死于消化道出血,死于心脏病变、多器官功能衰竭、其它各 １ 例;１５~２１ 天 ７ 例死于肺部感染,５ 例死于消化道出血,３ 例死于脑疝及中枢性呼吸、循环衰竭,死于心脏病变、多器官功能衰竭、其它各１例;２２～２８天死于消化道出血、肺部感染各２ 例,死于心脏病变、多器官功能衰竭、其它各１ 例,已无死于脑疝及中枢性呼吸、循环衰竭者;２９ 天后死于多器官功能衰竭１ 例。结论: 脑出血死亡时间不同,其主要死亡原因不同。临床应该针对不同死亡时间的主要死因制定相应救治方案,以降低死亡率。
Objective ① To document the way in which allocation concealment is described and coded for studies included in Cochrane Reviews.②To feed back any gaps or miscodings to individual review groups.③ To suggest changes and expansions to advice on how to code and describe allocation concealment methods.Methods The coding and description of methods of allocation concealment for studies included in all 1 596 reviews on issue 1, 2003 of The Cochrane Library are being extracted.So far results are available for 10.8% (173/1 596) of reviews containing 1 844 studies, from 10 Collaborative Review Groups (CRGs).Discrepancies, and inconsistencies with the Cochrane Reviewers’ Handbook, are being documented and analysed.Results The current coding of the adequacy of allocation concealment in studies included in Cochrane reviews is not likely to be very accurate.This is due to failure to describe methods of allocation concealment (38.6% of the sample of 1 844 studies) as well as miscoding (at least an additional 9.2%).The most common method for studies coded A was some variation of envelope use (133/675-19.7% of all A codes). The most common "method" for studies coded B was method unclear or not described in the report of the study (426/665, 64% of all B codes).Conclusions Since adequate allocation concealment is so important in protecting against bias in randomised controlled trials, it needs to be accurately coded and described.We need to improve how this is done for studies included in Cochrane Reviews.Since over half the studies coded as D were likely to have been where reviewers omitted to enter a code, the default should be changed from D to "code not supplied".Structural changes to RevMan are suggested-ideally the addition of a separate new study quality assessment table with fixed headings as well as the facility to enter free text.Suggestions for improving coding in particular reviews will be fed back to CRGs in the next stages of this project.Suggestions for additions to the Cochrane Reviewers’ Handbook are also made.
ObjectiveTo evaluate the efficacy and toxicity of TEC and CEF regimen in preoperative chemotherapy for patients with breast cancer. MethodsA total of one hundred breast cancer patients undergoing preoperative chemotherapy were divided into TEC group (n=50) and CEF group (n=50) by the pairgroup method and received surgical therapy after three courses of chemotherapy. The efficacy and toxicity of preoperative chemotherapy of patients in two groups were analyzed. ResultsFour patients with stage ⅢB breast cancer quit from CEF group after two courses of treatment because of the worse satisfaction. Clinical complete remission (cCR) was 7 cases, clinic partial remission (cPR) was 34 cases, stable disease (SD) was 9 cases, therefore, the remission rate (RR) was 82.0% (41/50), and reduction rate of tumor was 64.0% (32/50) in TEC group. cCR was 2 cases, cPR was 32 cases, SD was 12 cases, thus the RR was 680% (34/50), and reduction rate of tumor was 40.0% (20/50) in CEF group. The clinical efficacy and reduction rate of tumor of patients in TEC group were significantly superior than those in CEF group (Plt;0.05). The negative conversion ratio of lymph nodes were 54.1% (20/37) and 57.1% (20/35) in TEC group and CEF group, which was not statistically different (Plt;0.05). The occurrence of hair loss and leukopenia of patients in TEC group were significantly higher than those in CEF group (Plt;0.05), while the differences in thrombocytopenia, low concentration of hemoglobin, nausea, vomiting, diarrhea, cardiac toxicity, and neurotoxicity were not significant (Pgt;0.05). ConclusionTEC regimen is better than CEF regimen in the efficacy and safety of neo-adjuant therapy for patients with breast cancer, and well tolerated.
Objective To evaluate the impact of the new performance evaluation system in H hospital on clinical rational blood use and provide a basis for optimizing medical resource management. Methods This study employed a self-controlled before-after design to evaluate the effects of a blood management reform implemented in December 2023. The reform integrated key performance indicator (KPI) assessment with objectives and key results (OKR) methodology. Key interventions included enhancing the information system, strengthening clinical blood management quality control, and promoting alternative therapeutic techniques. Clinical blood utilization data were collected for one year both before and after the reform implementation. The impact of the reform was rigorously assessed using interrupted time series analysis (ITSA). Results A total of 1 032 clinical blood transfusion records were collected from 2023 to 2024, with 977 ultimately included in the analysis. In 2024, the qualified rate of hemoglobin of patients receiving red blood cell suspension transfusions in the whole hospital increased from 67.46% to 76.38%, and the per capita consumption of red blood cell suspension decreased by 11.36% year on year. The number of blood transfusion cases in surgical departments decreased by 26.60%, and that in non-surgical specialist departments decreased by 7.53%. The multi factor model showed that the improvement of the qualified rate in non-surgical departments and the main internal medicine subgroups was statistically significant. Conclusion The new performance evaluation system significantly improves the level of rational blood use and reduces resource waste through mechanism optimization and incentive coordination, providing a reference model for blood management reform in medical institutions.
N-of-1 trials are prospective clinical randomized cross-over controlled trials with multiple rounds of trial phase alternation designed with regard to a single patient. N-of-1 trials can provide clinical decision-makers with high-level evidence of the comparison of effect of intervention measures. Recently, an international team composed of many scholars published a SPIRIT extension for N-of-1 trials list (SPENT 2019) on the BMJ, with the purposes of clarifying the content design and improving the integrity and transparency of N-of-1 trial protocols. This article showed a detailed interpretation of the 14 main extension sub-items of the SPENT 2019 list with specific cases, aiming to further standardize the publication of domestic N-of-1 trials.
ObjectiveTo compare the clinical efficacy and complications of intra-arterial chemotherapy (IAC) and intravenous chemotherapy (IVC) for unilateral advanced retinoblastoma (RB). MethodsA retrospective clinical study. From January 2020 to January 2021, 40 patients (40 eyes) unilateral group cT2 RB patients diagnosed at Baoding Children’s Hospital and Beijing Children’s Hospital were recruited in this study. There were 22 males (22 eyes) and 18 females (18 eyes). All were monocular. All the patients were assigned to two groups according to different treatment modalities they received: IVC group and IAC group. There were 26 eyes and 14 eyes, respectively. When the tumor invades the optic nerve, choroid, sclera, anterior chamber and iris, enucleation was performed. The globe salvage rate, tumor extraocular metastasis rate, solid tumor control rate, treatment-related complications and pathological high-risk factors after enucleation were observed. The globe salvage rate and solid tumor control rate were compared between the groups by chi square test. ResultsThe globe salvage rate of IAC group and IVC group were 88.5% (23/26) and 50.0% (7/14), respectively. Solid tumor control of IAC group and IVC group were 84.6% (22/26) and 42.9% (6/14), respectively. There were statistically significant differences in globe salvage rate and solid tumor control between the two groups (χ2=7.18, 7.56; P＜0.05). Compared with IVC group, IAC group had less systemic complications, mild ocular and periocular side effects. Among 26 cases in IAC group and 14 cases in IVC group, 3 and 7 cases underwent enucleation respectively. The results of pathological examination showed that there were 2 cases and 3 cases with pathological high-risk factors in the two groups, respectively. During the follow-up period, 2 cases in IAC group had extraocular metastasis, there was no extraocular metastasis in IVC group. ConclusionCompared with IVC, IAC has the advantages of high tumor control rate, high globe salvage rate, less and mild complications, however, there is still tumor recurrence.
ObjectiveTo observe the alteration of serum homocysteine (Hcy) levels of advanced non-small cell lung cancer (NSCLC) patients during gemcitabine with cis-platinum (GP) program of chemotherapy and to explore the clinical value of monitoring Hcy in evaluating chemotherapy curative effect. MethodsA total of 49 advanced NSCLC patients (including 28 squamous carcinoma and 21 adenocarcinoma) first treated between May 2012 and April 2015 were selected. The Hcy, cytokerantin-19-fragment (CYFRA21-1) and carcinoembryonic antigen (CEA) levels of the morning fasting venous blood were measured before the first and after the second cycle of chemotherapy. Combined the pathological types of NSCLC, statistical analysis was carried out on the test results. ResultsAll of the 49 patients completed two cycles of GP chemotherapy, and the chemotherapy was effective on 31 and ineffective in 18. Before the chemotherapy, the differences in the positive rates of Hcy, CYFRA21-1, and CEA were statistically significant respectively between squamous carcinoma and adenocarcinoma patients (P < 0.05). But when combined the two types, the differences of three indicators's positive rates were not significant (P > 0.05). After two cycles of GP chemotherapy, in the patients with effective chemotherapy, the Hcy, CYFRA21-1 and CEA levels were lower in both squamous carcinoma and adenocarcinoma patients compared with that before the chemotherapy; the difference in the decrease of Hcy levels in both of the two pathological types was significant (P < 0.05), while CEA levels was significant only in adenocarcinoma patients (P < 0.05) and CYFRA21-1 levels was significant only in squamous carcinoma patients (P < 0.05). Among the patients with ineffective chemotherapy, the Hcy, CYFRA21-1 and CEA levels increased compared with those before the chemotherapy; the difference in the increase of Hcy levels were significant in both of the two pathological types (P < 0.05), while CYFRA21-1 levels was significant only in squamous carcinoma patients (P < 0.05) and CEA levels was not significant in both of the two pathological types (P > 0.05). ConclusionThe effect of chemotherapy and the pathogenetic condition can be assessed by monitoring serum Hcy levels of NSCLC patients during the chemotherapy.