目的 无菌冷喷剂为我国首个批准的该类型无菌型医疗器械，研制过程对冷媒和阀门促动器进行了优化，并对生产工艺进行创新，实现了产品的无菌化。针对浅表组织具有局部即刻镇痛的作用。我们于2023年12月—2024年6月开展了无菌冷喷剂在减轻初次献血和献浆者静脉穿刺疼痛、以及由此引起紧张恐惧情绪的有效性和安全性观察。方法 采用开放、随机对照、多中心方法，针对首次无偿献血者480例、血浆捐赠者2296例分别在血站和浆站进行了无菌冷喷剂减轻疼痛、降低捐赠者紧张恐惧情绪试验；献血者被随机分为观察组（n=240）与对照组(n=240)，同样，血捐赠浆者分为观察组（n=1146）、对照组（n=1150）；观察组在静脉穿剌前予以无菌冷喷剂进行疼痛干预，在穿刺部位喷用无菌冷喷剂4-10秒，对照组按常规进行操作，各组进行了视觉模拟量表（VAS）和献血者焦虑量表（BDAS）问卷调查。针对初次献血者还进行献血意愿电话回访；针对初次献浆者进行了满意度电话回访调查。结果 各组在性别、学历、年龄、身高、体重、BMI均无显著差异；献血者观察组疼痛评分：2.75±1.85，焦虑评分：14.97±2.39，对照组疼痛评分：3.85±1.72，焦虑评分：16.76±2.62；血浆捐赠者观察组疼痛评分2.67±1.87，焦虑评分：15.13±2.20，对照组疼痛评分：4.02±1.88，焦虑评分：16.90±2.67；两组之间的差异均具有统计学意义 (P< 0.001)。献血意愿电话回访，观察组愿意再次献血比例为72.1%，高于对照组的48.0%（P< 0.01)；血浆捐赠者对疼痛管理满意度电话回访，观察组满意度86.31%，高于对照组的61.05%（P< 0.01）。结论 给初次献血者或献浆捐赠者，在静脉穿刺时使用无菌冷喷剂干预，可降低其疼痛感、缓解其焦虑状态，有利于提高捐赠者再次捐赠的意愿。

Objective Sterile cold spray is the first approved sterile medical device of this type in China. During its development, optimizations were made to the refrigerant and valve actuator, and innovations were introduced to the manufacturing process, achieving product sterilization. The spray offers a localized, immediate analgesic effect for superficial tissues. From December 2023 to June 2024, we conducted an observation study on the effectiveness and safety of sterile cold spray in alleviating venipuncture pain and the associated nervousness and fear in first-time blood and plasma donors. Methods Using an open, randomized controlled, multi-center approach, a trial of sterile cold spray to reduce pain and donor nervousness and fear was carried out on 480 first-time non-remunerated blood donors and 2,296 plasma donors at the blood and plasma stations, respectively; the donors were randomly divided into an observation group (n=240) and a control group (n=240), and similarly, the plasma donors were divided into an observation group (n=1146), a control group (n=1150), and a control group (n=1150), and the plasma donors were divided into an observation group (n=1146), and a control group (n=1150). , control group (n=1150); the observation group was given a sterile cold spray for pain intervention before venipuncture by spraying a sterile cold spray at the puncture site for 4-10 seconds and the control group was operated as usual and each group was administered the Visual Analogue Scale (VAS) and Blood Donor Anxiety Scale (BDAS) questionnaires. A telephone callback survey on blood donation intention was also conducted for first-time donors; a telephone callback survey on satisfaction was conducted for first-time plasma donors. Results There were no significant differences between the groups in terms of gender, education, age, height, weight, and BMI; pain scores in the blood donor observation group: 2.75±1.85, and anxiety scores: 14.97±2.39, and pain scores in the control group: 3.85±1.72, and anxiety scores: 16.76±2.62; and pain scores in the plasma donor observation group: 2.67±1.87, and anxiety scales: 15.13±2.20, pain score in the control group: 4.02±1.88, anxiety score: 16.90±2.67; the differences between the two groups were statistically significant (P< 0.001). In the telephone interview on willingness to donate blood, the proportion of the observation group willing to donate blood again was 72.1%, higher than that of the control group, which was 48.0% (P< 0.01); and in the telephone interview on plasma donors' satisfaction with pain management, the observation group was satisfied with 86.31%, higher than that of the control group, which was 61.05% (P< 0.01). Conclusion For first-time blood donors or plasma donors, the use of aseptic cold spray intervention during venipuncture can reduce their pain, relieve their anxiety, and help increase their willingness to donate again.