FDA“治疗等效性评价供企业用指导原则”（草案）介绍

美国食品药品管理局（FDA）于2022年7月发布了"治疗等效性评价供企业用指导原则"（草案）。该指导原则阐明了FDA治疗等效性的标准以及治疗等效性编码系统，目的是准确评价仿制药与参比制剂的治疗等效性并通过治疗等效性代码，在"橙皮书"中迅速检索到治疗等效的仿制药。而中国目前尚无类似的指导原则，详细介绍FDA该指导原则主要内容，期望对中国加强仿制药的治疗等效性评价和加速完善和实施符合国情的治疗等效性编码系统有所帮助。     

前瞻性护理干预在急性心力衰竭患者中的应用

目的探讨前瞻性护理干预在急性心力衰竭患者中的应用效果。方法选取2018年4月—2020年5月河南省某医院收治的122例急性心力衰竭患者为研究对象,采用随机数字表法分为观察组与对照组,每组61例。对照组患者采用常规护理,观察组患者采用前瞻性护理,比较2组患者的干预效果、并发症发生情况,干预前后焦虑自评量表(SAS)、抑郁自评量表(SDS)评分及护理满意度。结果观察组患者干预总有效率为95.08%,高于对照组的75.41%,差异有统计学意义(χ²=9.385,P=0.002)。观察组患者并发症发生率为3.28%,低于对照组的18.03%,差异有统计学意义(χ²=6.974,P=0.008)。2组患者干预后SAS及SDS评分均低于干预前,且观察组低于对照组,差异均有统计学意义(P<0.05)。观察组患者护理满意度为98.36%,高于对照组的86.89%,差异有统计学意义(χ²=4.319,P=0.038)。结论前瞻性护理干预用于急性心力衰竭患者,有助于改善患者负性情绪及减少并发症的发生。     

不同手术方法治疗儿童基本型外斜视对术后侧转非共同性的影响

目的：研究不同手术方法治疗儿童基本型外斜视与术后侧转非共同性发生及矫正效果相关性。

方法：回顾性研究。选取2018-06/2020-12于我院眼科接受治疗的180例基本型外斜视患儿临床资料。根据手术方式分为单眼一退一截术组(R&R组)104例和双眼外直肌后徙术组(BLR-rec组)76例。比较两组患者一般资料、手术矫正效果，以及随访期间手术斜视度数、侧转非共同性发生情况。

结果：两组患者术后3d，1、6mo视近、视远斜视度比较均无差异(均P>0.05)。R&R组术后不同时间点正位率高于BLR-rec组(P<0.05)。R&R组较BLR-rec组发生侧转非共同性的风险更低(OR=0.524， Wald χ²=4.260， P=0.039)。两组患者术后6mo主要表现在水平直肌手术眼外展方向注视，但两组患儿视远和视近侧转非共同性发生率均无差异(均P>0.05)。

结论：R&R对于儿童基本型外斜视的矫正效果优于BLR-rec术式，可降低侧转非共同性发生情况。     

慢性泪囊炎患者应用鼻内镜下鼻腔泪囊造口术的临床效果及对安全性的影响

目的探讨慢性泪囊炎患者应用鼻内镜下鼻腔泪囊造口术的临床效果及安全性。方法选取2018年1月至2019年12月因慢性泪囊炎于本院接受治疗的46例患者为研究对象,随机分为研究组与对照组,各23例。对照组接受泪囊鼻腔造口治疗,研究组取鼻内镜下鼻腔泪囊造口术治疗,比较两组临床效果、手术指标以及并发症发生情况。结果研究组治疗总有效率高于对照组(P<0.05);研究组术中出血量少于对照组,手术及住院时间均短于对照组(P<0.05);研究组并发症总发生率低于对照组(P<0.05)。结论慢性泪囊炎患者采用鼻内镜下鼻腔泪囊造口术治疗效果显著,并发症较少,安全性较高,值得临床推广应用。     

Practical approaches to labelling terminal alkynes with deuterium

Base catalysed exchange with sodium hydroxide, calcium oxide or N,N,N,N-tetramethylguanidine in deuterium oxide is a viable procedure for the preparation of terminally deuterated alkynes for those alkynes stable to strong base. The use of silver perchlorate as a catalyst is an alternative practical option when labelling alkynes which are sensitive to base or contain functionalities which would lead to labelling elsewhere in the molecule. Labelling with this catalyst takes place smoothly at ambient temperature in a mixture of N,N-dimethylformamide and deuterium oxide.     

Preliminary study on blood coagulation and hemostatic effect and acute toxicity of Oxalis corniculata L. ethanol extract

In the present study, we aimed to observe the effects of ethanol extract of Oxalis corniculata L. on bleeding time (BT) and coagulation time (CT) and determine its acute toxicity in mice. Firstly, the ethanol extract of O. corniculata was administered to 40 mice, which were randomly divided into the normal control group, Yunnan Baiyao control group, low-dose group, and high-dose group. The low-dose (0.6 g/kg) and high-dose (1.2 g/kg) groups received ethanol extract of O. corniculata by gavage, and the BT and CT of the mice were measured by the slide method and tail clipping method, respectively. Secondly, the median lethal dose method was used with 50 mice to observe the physiological state, poisoning reaction, and death of the mice after intragastric administration. Finally, on the 14th day of the experiment, a necropsy was performed to observe any abnormality of the organs. In conclusion, in the coagulation and hemostasis tests, there were no statistical differences between the groups (P > 0.05), while there was a significant dose-response relationship, and the BT and CT were significantly shorter than those of the negative control group, which were comparable to the Yunnan Baiyao control group. Moreover, in the acute toxicity test, the median lethal dose of ethanol extract of O. corniculata was 6.0291 g/kg, with a 95% confidence interval of 5.3065–6.7829 mg/kg.