研究背景：手术出血是临床中最常见的现象之一，安全有效地行止血是保障患者生命质量的基础，经济性的止血耗材是控制医院预算，降低成本的措施。止血材料是行止血的基础，但目前由于医院（尤其是用量较大科室如妇产科）现有准入、遴选管理暂未建立规范，导致入院品规品类众多；且临床缺乏科学合理的使用指导；未能在保障患者安全的基础上，高效率地使用，降低医院预算，给医院管理者带来较大挑战。须建立止血耗材医院的准入、遴选的评价指标体系,并进行卫生技术评估等两轮实践，实现更科学、经济地管控医用耗材。研究目的：（1）以医院角度构建止血耗材的评价指标体系，建立科学的止血耗材院内准入及遴选程序，淘汰性价比低的止血耗材；（2）对通过准入筛选后的止血耗材进行卫生技术评估，比较各类止血耗材在有效性、经济性的差异，并进行成本效果分析，最终结合临床价值，在形态品规数量管控下，科学地筛选出具有成本效果的止血耗材；便于从医院角度对耗材的全流程进行科学管理。研究方法：（1）通过德尔菲法（专家访谈与问卷法）与层次分析法建立符合妇产科手术特征的止血耗材准入、遴选评价指标体系，并科学合理地筛选出部分止血品种品规（2）真实世界研究：基于2020年-2021年医院妇产科行经腹全子宫切除术的301例住院患者的数据，按止血耗材进行分组，描述性统计不同组下的患者基线数据、有效性及医疗资源消耗性等数据，并对符合准入、遴选后的止血耗材进行成本效果分析，测算出具有成本效果的止血耗材。研究结果：（1）构建出临床价值、经济性、厂家属性三个一级评价指标也即三大维度下，包括有效性、安全性、功能性、合规性、供应性等六个二级指标，及术中止血效果、抗感染性等十一个细分三级指标为框架的止血耗材准入遴选评价指标体系；（2）并基于层次分析法，测算出止血耗材准入遴选评价指标体系各维度的权重值以及具体各止血耗材品种相对于各指标的得分。后测算出两大形态共六类止血耗材各品种总得分，进行分数排序并遴选，根据医院科室要求拟保留和淘汰的数量，最终保留纤丝/纱

Background: The evaluation system of pharmacoeconomics from the perspective of social research is relatively complete, but due to the characteristics of medical consumables such as numerous categories, large individual differentiation and fast innovation and iteration speed. At present, there is no mature health technology evaluation system. It is increasingly important to conduct health technology assessment （HB-HTA） for medical devices from the perspective of hospitals, including comprehensive consideration of hospital operation, budget, and whole process management, and to support hospital managers and clinical departments in decision-making on medical consumables access, selection, rational clinical use, and perioperative patient quality and safety. Surgical bleeding is one of the most common clinical manifestations after surgical trauma. Safe and effective hemostasis is the basis of ensuring the quality of life of patients, and economical hemostasis is a measure to control the hospital budget and reduce costs. Hemostatic materials are used to prevent bleeding during surgery. However, due to the lack of established standards for admission and selection management in hospitals （especially in departments with large consumption, such as obstetrics and gynecology）, there are many types of admission materials. And there is a lack of scientific and reasonable clinical guidance. This will lead to failure to reduce hospital budget and achieve efficient use on the basis of ensuring patient safety, which will bring great challenges to hospital managers. It is necessary to establish an evaluation index system for admission and selection of hemostatic consumables hospitals, conduct health technology evaluation, and control medical consumables scientifically and economically.Objectives: （1） To construct an evaluation index system for hemostatic consumables from the perspective of hospitals, establish a scientific admission and selection procedure for hemostatic consumables in hospitals, and eliminate the less cost-effective hemostatic consumables; （2） Health technology assessment was conducted on the hemostatic consumables after access screening, the differences in effectiveness and economy of various hemostatic consumables were compared, and the cost-effectiveness was analyzed. Finally, combined with clinical value, the hemostatic consumables with cost effectiveness were scientifically screened under the control of variety, specifications and quantity. It is convenient for hospitals to scientifically manage the whole process of hemostatic consumables.Methods: （1） The access and selection evaluation index system of hemostatic consumables in obstetrics and gynecology was established through Delphi method （expert interview and questionnaire method） and analytic hierarchy process, and some hemostatic products were scientifically and reasonably selected.（2）Real world research: Based on the data of 301 inpatients who underwent transperitoneal hysterectomy in the Department of Obstetrics and Gynecology of the hospital from 2020 to 2021, the patients were divided into groups according to the hemostatic consumables. The baseline data, effectiveness and medical resource consumption data under different groups were descriptively analyzed, and the cost-effectiveness of the hemostatic consumables after admission and selection was analyzed. Finally, the cost-effective hemostatic consumables were selected.Results: （1） Three first-level evaluation indexes of clinical value, economy and manufacturer attributes were constructed, including six secondary indicators such as effectiveness, safety, functionality, compliance and supply, and eleven third-level indicators such as surgical hemostatic effect and anti-infectivity as the selection and evaluation index system of hemostatic consumables.（2）Based on the analytic hierarchy method, the weight values of each dimension of the access selection and evaluation index system of hemostatic consumables and the scores of specific hemostatic consumables varieties relative to each index were calculated. The total scores of each variety of six types of hemostatic consumables in two major forms were calculated, and the scores were sorted and selected. According to the requirements of the hospital department, it is planned to retain and eliminate the number of hemostatic consumables, and finally retain one hemostatic consumable in filaments/gauze form and two powder forms. Due to the small quantity and total cost, nonwovens and sponge hemostatic consumables are retained. （3） After Fisher‘s accurate test, the baseline BMI index P value of patients under different groups of hemostatic consumables was 0.49, and the results were not significant, which indicated that there was no significant difference in patients at the BMI level. There were significant differences between the hemostatic consumables in the amount of bleeding, total cost, and cost of hemostatic consumables. In the cost-effect analysis of hemostatic consumables, the cost of consumables is taken as the cost item, and the amount of bleeding during surgery is used as the effect index. From the absolute value of the cost-effect ratio, the cost effect ratio of sponges is low, below 1, the cost effect is better, through the incremental cost-effect ratio, medical hemostatic sponge （XE）, gelatin sponge （JL） and filament speed yarn （QS） and instantaneous （SKSS） composite hemostatic consumables are more ideal solutions, and the department can be selected in combination with clinical practice.Conclusion: The evaluation index system for access and selection of hemostatic consumables is established by comprehensively considering the effectiveness, safety, economy and innovation. Then, the cost-effectiveness analysis based on real-world data showed that sponges were relatively more cost-effective. The establishment of an evaluation system for hemostatic consumables and the study of real-world data are conducive to improving the whole process management of medical consumables in hospitals from the perspective of health technology, reducing the overall budget and cost of hemostatic consumables in hospitals, reducing the economic burden of patients, and improving the quality and safety of patients. The HB-HTA model of hemostatic consumables is replicable and generalizable, and can be promoted vertically to multiple departments of hospitals and horizontally to other hospital departments, which can be used as a reference for hospital decision-making management, hospital management research institutions, and health commission research institutions.