目的 本文旨在对全流程的生物安全管理问题进行梳理,为未来出现的大规模核酸筛查提供参考。方法 我们参考技术规范及其他医疗机构的实践总结,结合自身实际经验,梳理了核酸采集场所、个人防护、标本采集转运检测流程共3个方面的生物安全管理需注意的问题及解决措施。严格要求采样队伍按标准要求执行,以达到保质保量完成筛查任务的目的。结果 新冠核酸筛查期间我院共外派采集标本361 841人次。标本零污染零丢失,未发生一例生物安全事件,圆满完成采样任务。结论 大规模新冠核酸筛查是查清疫情源头、抑制疫情蔓延的重要手段。为了保证全流程的生物安全,应做好充足准备,严格落实各项生物安全措施。

Objective This article aims to sort out the problems in the whole process of biosafety management and provide reference for large-scale nucleic acid screening in the future. Methods We refer to the technical guidelines and the practice of other medical institutions, combined with our practical experience, summarized the problems and solutions needing attention in biosafety management in three aspects: nucleic acid sampling place, personal protection and the process from sample collection to detection. The sampling team was strictly required to implement the standard requirements, so as to complete the screening task with quality and quantity. Results A total of 361 841 samples were collected during SARS-CoV-2 nucleic acid screening. No samples were contaminated or lost, and no biosafety accident occurred. The sampling task were successfully completed. Conclusion Large-scale SARS-CoV-2 nucleic acid screening is an important method to find out the source of the epidemic and curb the spread of the SARS-CoV-2 pandemic. In order to ensure the biosafety of the whole process, sufficient preparations should be made and biosafety measures should be strictly implemented.

目的 系统评价胰岛素联用α-葡萄糖苷酶抑制剂(AGIs)治疗成人1型糖尿病(T1DM)的疗效和安全性。方法 检索中英文数据库,纳入关于胰岛素联用AGIs治疗成人T1DM患者的随机或非随机对照试验。使用Review Manager 5.3软件进行Meta分析。结果 共纳入10项研究,616例患者。与安慰剂或空白对照相比,在有效性方面,胰岛素联合AGIs可改善成人T1DM患者的糖化血红蛋白;降低平均血糖、空腹血糖和餐后2小时血糖;改善血糖波动情况,包括平均血糖波动幅度和最大血糖波动幅度(均P<0.05)。在安全性方面,AGIs增加总不良反应发生的风险(P<0.05),其中主要是胃肠道不适,但未增加低血糖的发生率和发生次数(均P>0.05)。胰岛素联合AGIs减少了每日胰岛素总剂量(P<0.05),但对体重、甘油三酯和高密度脂蛋白胆固醇无显著影响(均P>0.05)。结论 胰岛素联合AGIs可降低成人T1DM患者的糖化血红蛋白,改善血糖水平和血糖波动情况。AGIs不会增加低血糖的风险,但需重视其不良反应,特别是胃肠道不良反应。

Objective To systematically evaluate the efficacy and safety of adding alpha-glucosidase inhibitors (AGIs) to insulin therapy in adult patients with type 1 diabetes (T1DM). Methods Articles about randomized or non-randomized controlled trials of insulin combined with AGIs in adult patients with T1DM were retrieved from Chinese and English database. Meta-analyses were performed by using Review Manager 5.3. Results A total of 616 patients were included from 10 clinical trials. Compared with adding placebo or nothing, in terms of efficacy, the addition of AGIs resulted in decreased HbA1c, mean blood glucose, fasting plasma blood glucose and 2-hour postprandial blood glucose levels (all P<0.05). And this scheme improved the glucose variability including mean amplitude of glycemic excursions and the largest amplitude of glycemic excursions (P<0.05, respectively). As to safety, AGIs increased the risk of total adverse reactions (P<0.05), most of them were gastrointestinal complaints, while the occurrence and the frequency of hypoglycemia were similar (P>0.05, respectively). This scheme could also lead to the reduced total daily insulin dose (P<0.05) but had no significant effect on body weight, triglyceride or cholesterol concentration (P>0.05, respectively). Conclusions The addition of AGIs to insulin therapy in adult patients with T1DM may reduce HbA1c and improve the glucose levels and glucose variability. But total adverse effects especially the gastrointestinal complaints should also be considered in the use of AGIs although it does not increase the risk of hypoglycemia.

目的 比较甲苯磺酸瑞马唑仑和丙泊酚在超声胃镜检查中的有效性和安全性。方法 采用随机对照的研究方法,选择接受超声胃镜病人60例,分为观察组(29例)和对照组(31例)。观察组采用甲苯磺酸瑞马唑仑麻醉,对照组采用丙泊酚。观察麻醉过程中不同时点的血流动力学指标、改良警觉/镇静(MOAA/S)评分各时刻的变化、苏醒及离室时间、围术期不良事件。结果 观察组的血流动力学影响更小;观察组可进入足够的镇静深度,而对照组的镇静程度更深;2组起效时间相似,且迅速苏醒而离室,但在苏醒及离室时间方面观察组稍短;不良事件对照组高于观察组。结论 甲苯磺酸瑞马唑仑应用于无痛超声胃镜检查,其对血流动力学影响小,能产生足够的镇静深度,能使患者迅速苏醒,且不良事件发生率低,总体有效性和安全性优于丙泊酚。

Objective To compare the efficacy and safety of remimazolam tosilate and propofol in painless ultrasonic gastroscopy. Methods In a randomized, single-blind controlled study, 60 patients undergoing ultrasonic gastroscopy were selected and divided into observation group (31 cases) and control group (29 cases). Observation group was anesthetized with remimazolam tosilate, while control group was anesthetized with propofol. Two groups' hemodynamic index, perioperative adverse events, changes of MOAA/S score, awakening and departure time were observed at different time points during anesthesia. Results The observation group had less changes on hemodynamics. The observation group had enough depth of sedation, while the control group had a deeper degree of sedation. The onset time of the two groups was similar and both awoke quickly and left, but the awakening time and leaving time in the observation group were slightly shorter. Adverse events in the control group were more than those in the observation group. Conclusions Remimazolam tosilate for painless ultrasonic gastroscopy had little effect on hemodynamics, which can generate enough depth of sedation, and make patients wake up quickly. In addition, the incidence of its adverse events was low, and the overall effectiveness and safety were superior to those of propofol.

目的 探讨重组人干扰素α2b喷雾剂治疗儿童流行性感冒的疗效及安全性。方法 选取我院2017年1月—2020年2月所收治的80例儿童流行性感冒患者,按1:1随机分为实验组及对照组,每组患儿40例,对照组患者给予奥司他韦治疗,实验组患者在对照组治疗基础上联合重组人干扰素α2b喷雾剂治疗,对比2组患者的疗效及安全性。结果 实验组患儿咽痛症状消失时间(2.01±0.23)d、体温恢复正常时间(2.18±0.30)d、咳嗽症状消失时间(1.68±0.52)d、治疗时间(5.41±0.36)d均短于对照组(t=26.001、9.766、19.277、28.089,P＜0.05);实验组患儿治疗有效率95.0%高于对照组治疗有效率(χ²=4.114,P＜0.05);实验组患儿的不良反应发生率低于对照组(χ²=4.021,P＜0.05)。结论 重组人干扰素α2b喷雾剂治疗儿童流行性感冒的方案可获取较为理想的治疗效果,保证患儿用药安全性,尽快缓解患儿的临床症状,促使患儿病情康复,促进患儿健康生长,该治疗方案可在临床中推广应用。

Objective To explore the efficacy and safety of recombinant human interferon α2b spray in the treatment of influenza in children. Methods Eighty children with influenza who were admitted to our hospital from January 2017 to February 2020 were randomly divided into experimental group and control group evenly, with 40 children in each group. Oseltamivir treatment was given to the control group, the experimental group was treated with recombinant human interferon α2b spray on the basis of oseltamivir, and the efficacy and safety of the two groups were compared. Results In the experimental group, the time for the disappearance of sore throat was (2.01±0.23) d, the time for the body temperature returned to normal was (2.18±0.30) d, the time for the cough to disappear was (1.68±0.52) d, and the treatment time was (5.41±0.36) d, which were all shorter than the control group (t=26.001, 9.766, 19.277, 28.089, P<0.05). The treatment effective rate of children in the experimental group was 95.0%, which was significantly higher than that in the control group (χ²=4.114, P<0.05); the incidence of adverse reactions in experimental group was significantly lower than that in the control group (χ²= 4.021, P<0.05). Conclusions The recombinant human interferon α2b spray for the treatment of influenza in children could obtain a more ideal therapeutic effect, ensure the safety of the children's medication, relieve the clinical symptoms as soon as possible, promote the improvement of the children's condition, and promote the healthy growth of the children. The treatment plan can be promoted and applied in clinical practice.

目的 探究宫腔镜结合避孕药治疗子宫内膜息肉的临床疗效与对其安全性的分析。方法 随机选取2016年2月—2017年12月内160例子宫内膜息肉患者,分为对照组(80例,宫腔镜治疗)和观察组(80例,宫腔镜结合屈螺酮炔雌醇片治疗),对比两组临床疗效及不良反应的差异性。结果 与对照组相比,观察组患者月经改善效果更佳,其复发率更低,差异有统计学意义(P＜0.05);在不良反应的对比中,观察组结果与对照组结果相比较,不存在较大差异(P>0.05)。结论 宫腔镜结合避孕药治疗子宫内膜息肉取得了一定的临床疗效,不良反应并不显著,可推广运用。

Objective To explore the clinical efficacy and safety of hysteroscopy combined with contraceptives in the treatment of endometrial polyps. Methods From February 2016 to December 2017, 160 patients with endometrial polyps were randomly selected and divided into control group (80 cases treated by hysteroscopy) and observation group (80 cases treated by hysteroscopy combined with drospirenone and ethinyl estradiol tablets). The differences of clinical efficacy and adverse reactions between the two groups were compared. Results Compared with the control group, the observation group had better menstruation improvement effect and lower recurrence rate. The difference was statistically significant (P<0.05). In the comparison of adverse reactions, there was no significant difference between the observation group and the control group (P>0.05). Conclusion Hysteroscopy combined with contraceptives has achieved certain clinical efficacy in the treatment of endometrial polyps, and the adverse reactions are not significant, which can be popularized and applied.

目的 探讨双靶点微创联合尼莫地平治疗丘脑出血破入脑室患者的安全性及对NIHSS评分的影响。方法 选择2017年1月—2020年1月期间本院收治的54例丘脑出血破入脑室患者作为研究资料,随机分组各27例,对照组行单纯侧脑室体外引流术治疗,观察组行立体定向下侧脑室联合丘脑血肿双靶点微创穿刺引流术治疗,均实施尼莫地平治疗,观察两组手术并发症,测定治疗不同阶段患者NIHSS评分、ADL评分、神经损伤指标、创伤应激指标变化。结果 并发症率比较,观察组7.41%低于对照组29.63%,P＜0.05;治疗后,观察组NSE、NGF、β-EP、Cor均降低,且低于对照组,P＜0.05;治疗后,观察组NIHSSL评分降低且低于对照组,ADL评分升高且高于对照组,P＜0.05。结论 针对丘脑出血破入脑室患者采取立体定向下侧脑室联合丘脑血肿双靶点微创穿刺引流术及尼莫地平治疗可进一步改善神经功能及生活质量,且手术安全性高,创伤应激恢复改善,神经损伤恢复快,并发症少,值得推广。

Objective To investigate the safety of double target minimally invasive surgery combined with nimodipine in the treatment of patients with thalamic hemorrhage breaking into ventricle and its influence on NIHSS score. Methods From January 2017 to January 2020, 54 patients with thalamic hemorrhage ruptured into ventricles in our hospital were selected as the research data, and they were randomly divided into 27 cases in each group. The control group was treated with external drainage of lateral ventricle alone, and the observation group was treated with stereotactic double target minimally invasive puncture and drainage of hypothalamic hematoma. The changes of NIHSS score, ADL score, nerve injury index and trauma stress index in different stages of treatment were determined. Results The complication rate of the observation group was 7.41%, lower than that of the control group 29.63%, P<0.05; after treatment, NSE, NGF, β-EP, Cor in the observation group were decreased, and lower than those in the control group, P<0.05; after treatment, NIHSSL score of the observation group was decreased, lower than that of the control group, ADL score was increased and higher than that of the control group, P<0.05. Conclusion For patients with thalamic hemorrhage breaking into ventricles, stereotactic double target minimally invasive puncture drainage combined with thalamic hematoma and nimodipine treatment may further improve the neurological function and patients’ quality of life, and the operation safety is high, the recovery of traumatic stress is improved, the recovery of nerve injury is quick, and the complications are less, which is worthy of promotion.

目的 分析妊娠期糖尿病(gestational diabetes mellitus,GDM)孕妇接受胰岛素治疗对妊娠结局的影响及安全性。方法 将2018年7月—2020年7月接诊且行常规治疗的50例GDM孕妇作为对照组,将同期接诊且在对照组基础上行胰岛素治疗的50例GDM孕妇作为观察组,对组间血糖控制效果、生活质量(SF-36)、治疗效果、不良妊娠结局、不良反应展开分析。结果 (1)组间血糖指标在治疗前无明显差异(P＞0.05);治疗后,观察组血糖控制效果优于对照组(P<0.05);(2)观察组SF-36评分高于对照组,且治疗效果(96.00%)优于对照组(82.00%,P<0.05);(3)观察组出现3例不良妊娠结局(6.00%),对照组出现11例不良妊娠结局(22.00%,P<0.05);(4)观察组发生3例不良反应(6.00%),对照组发生2例不良反应(4.00%,P＞0.05)。结论 对GDM孕妇实施胰岛素治疗,可以改善孕妇血糖水平,减少不良妊娠结局,提高孕妇生活质量,安全可靠,值得推广。

Objective To analyze the effect and safety of insulin therapy on pregnancy outcome in pregnant women with gestational diabetes mellitus (GDM). Methods A total of 50 pregnant women with GDM who received conventional treatment from July 2018 to July 2020 were induded in the control group, and 50 pregnant women with GDM who received insulin treatment on the basis of the control group were induded in the observation group. Results (1) There was no significant difference in blood glucose index between two groups before treatment(P＞ 0.05); after treatment, the blood glucose control effect of the observation group was better than that of the control group(P<0.05); (2) SF-36 score of the observation group was higher than that of the control group, and the treatment effect (96.00%) was better than that of the control group (82.00%,P<0.05); (3) there were 3 cases of adverse pregnancy outcomes (6.00%) in the observation group and 11 cases (22.00%) in the control group; (4) there were 3 cases of adverse reactions (6.00%) in the observation group and 2 cases (4.00%) in the control group(P＞ 0.05). Conclusion Insulin therapy for pregnant women with GDM could improve the blood glucose level of pregnant women, reduced adverse pregnancy outcomes, improved the quality of life of pregnant women, which is safe and reliable, and is worthy of promotion.

目的 探讨PAD方案治疗初发多发性骨髓瘤(MM)有效性及安全性。方法 统计54例接受PAD方案治疗的初发MM患者临床资料,采用回顾性分析方法。PAD方案:P(硼替佐米)1.3 mg/m²,第1、4、8、11天皮下注射,A(脂质体阿霉素)25～30 mg/m²,第1天静脉滴注,D(地塞米松)40 mg,第1～4 天静脉滴注或口服,每21天为1个疗程。采用IMWG疗效标准判定疗效,按NCICTCAE(第3版)标准判断不良反应。结果 ①总体疗效:平均4(2~8)个疗程后,47例(87.0%)患者获部分缓解(PR)以上疗效,其中完全缓解(CR)20例(37.0%),很好的部分缓解(VGPR)19例(35.2%),部分缓解(PR)8例(14.9%),疾病稳定(SD)5例(9.3%),病情进展率(PD)2例(3.7%)。②亚组疗效:54例患者中,35例治疗4个以上疗程,19例小于4个疗程,ORR分别为97.1%(34/35)、68.4%(13/19)(P=0.003)。按照年龄、肾功能、骨破坏数目、骨髓浆细胞比例、ALB、LDH、β2-MG、细胞遗传学、ISS分期、临床分型进行队列亚组疗效比较,结果提示亚组疗效差异无统计学意义(P＞0.05);③总体安全性:中性粒细胞减少8例(14.8%),血小板减少8例(14.8%),周围神经病变16例(29.6%),腹泻2例(3.7%),便秘2例(3.7%),带状疱疹4例(7.4%),细菌感染5例(9.3%),以上不良反应经对症治疗后症状减轻或消失。④亚组安全性:按照年龄和疗程数进行亚组比较,年龄大于60岁患者和年龄小于60岁患者总不良反应发生率和3/4级不良反应发生率分别是47.4% vs 60.0% 和15.8% vs 20.1%,(P=0.404和P=1.00);治疗4个以上疗程患者和小于4个疗程患者总不良反应发生率和3/4级不良反应发生率分别是57.9% vs 54.3%和21.2% vs 17.1%,(P=1.00和P=0.728)。结论 PAD方案治疗初发MM效果显著,缓解率和疗程数有相关性,疗效与传统的生存预后因素无关,可作为MM诱导治疗的一线方案。脂质体阿霉素心脏毒性小,替代传统蒽环类药物阿霉素,不良反应可控,耐受性良好,更适用于老年MM患者。

Objective To investigate the efficacy and safety of PAD regimen in previously untreated patients with multiple myeloma(MM). Methods We retrospectively analyzed 54 patients with newly-diagnosed MM,who were treated with PAD regimen: Bortezomib 1.3mg/m² subcutaneously on day 1,4,8,11. Liposomal doxorubicin 25～30 mg/m² intravenously on the first day. Dexamethasone 40 mg/d intravenously or orally on days 1～4. Treatment was repeated every 21 days. Response was evaluated according to the International Uniform Response Criteria for MM.Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria,version 3.0. Results ①Overall response:after median 4(2～8) courses of PAD,47patients(87.0%)responsed,including complete response (CR) in 20 (37.0%),very good partial response (VGPR) in 19 (35.2%),partial response (PR) in 8 (14.9%),stable disease (SD) in 5 (9.3%) and progressive disease (PD) in 2 (3.7%). ②Subgroups efficacy: among the 54 patients,35 patients received more than 4 therapeutic courses,and 19 patients received less than 4 courses.The ORR was 97.1% (34/35) and 68.4% (13/19) respectively (P=0.003). Subgroups efficacy were compared according to age,renal function,number of bone destruction,proportion of bone marrow plasma cells,ALB,LDH,β2-MG,cytogenetics,ISS staging and clinical classification. The results indicated that there was no statistical difference(P>0.05). ③Overall safety: adverse events included neutropenia in 8 (14.8%),thrombocytopenia in 8 (14.8%),peripheral neuropathy in 16 (29.6%),diarrhea in 2 (3.7%),constipation in 2 (3.7%),herpes zoster in 4 (7.4%) and bacterial infection in 5 (9.3%). The adverse events relieved or disappeared after symptomatic treatment. ④Subgroups safety: compared by age and courses of treatment,the incidence of overall adverse events and grade 3/4 adverse events in patients older than 60 years and ones younger than 60 were 47.4% vs 60.0% and 15.8% vs 20.1% respectively,(P=0.404,P=1.00). The incidence of overall adverse events and grade 3/4 adverse events in patients with more than 4 therapeutic courses and ones with less than 4 courses were 57.9% vs 54.3% and 21.2% vs 17.1% respectively,(P=1.00和P=0.728). Conclusion PAD regimen has really curative effect in treating patients with newly diagnosed MM. There is a correlation between remission rate and therapeutic courses. It can be used as the first selected protocol for the induction therapy of MM. Its efficacy is independent of traditional prognostic factors.Liposomal doxorubicin has almost no cardiotoxicity. Replacing traditional anthracycline doxorubicin,the adverse events are controllable and the tolerance is generally well. PAD regimen is more proper to be applied to older patients with MM.

目的 总结GuideLiner^®延长导管在复杂经皮冠状动脉介入治疗(PCI)中的初步经验,探讨其有效性及安全性。方法 选择2015年3月—2017年3月因冠心病于广州市第一人民医院行PCI的患者13例,因复杂病变需要更强支撑力而使用GuideLiner^®延长导管完成手术,总结手术成功率、并发症以及6个月随访主要不良心脏事件的发生情况。结果 13例患者在GuideLiner^®延长导管应用下均成功完成手术。使用延长导管的目的2例手术为辅助球囊通过,7例为辅助支架通过,4例为辅助支架及球囊通过。全部患者均未发生术中及住院期间死亡、急性心肌梗死,未发生急性支架内血栓形成、目标冠脉夹层或穿孔、心包填塞等并发症,6 个月随访均无不良心脏事件发生。结论 应用延长导管可提高支撑力,有效辅助球囊和/或支架到达冠状动脉病变部位,提高手术成功率,安全性较高。

Objective To evaluate the clinical efficacy and safety of GuideLiner^® guide extension catheter during complex coronary percutaneous coronary intervention(PCI) procedures. Methods Thirteen patients with coronary heart diseases performed PCI procedures were included in this study from March 2015 to March 2017. GuideLiner^® guide extension catheters were used in these complex cases. The PCI success rate,incidence of complications and 6-month follow up data were observed. Results Benefited from the stronger support produced by GuideLiner^®, PCI success rate was 100%. The guide extension catheters were used for the delivery of balloons in 2 cases, while 7 cases for stents, and 4 cases for both balloons and stents. No death were observed during the procedure or in hospital, and there were no dissection or acute myocardial infarction. During 6 months of follow-up,there was no major adverse cardiac events (MACE). Conclusion GuideLiner^® guide extension catheter may improve procedure success rate by ensuring the delivery of balloons and stents in complex PCI.

目的 针对剖宫产术后瘢痕子宫妊娠早产进行阴道分娩方法的研究,并比较其可行性与安全性。方法 选择 2015年5月—2017年4月在来我科室采用经阴道分娩法进行分娩的瘢痕子宫妊娠早产(28～37周)患者96例为研究对象,设为观察组。同时按照随机分组法选择同时间段来我院就诊的非瘢痕子宫妊娠早产经阴道分娩的患者96例作为对照组A组,瘢痕子宫妊娠早产行剖宫产分娩的患者96例作为对照组B组。对三组患者的产妇分娩情况和新生儿出生后的情况进行比较分析。结果 观察组与对照组A在产住院天数、产程时间、出血量、新生儿窒息发生等产妇术中情况及新生儿情况的比较没有差异(P＞0. 05) 。观察组与对照组B在产后在住院天数、住院花费、出血量等方面进行比较,两组的差异有统计学意义(P＜0.05)。在发生产褥感染、进行输血的病例数、子宫切除例数、新生儿Apgar评分、新生儿并发症等新生儿情况的比较同样没有统计学差异(P＞0.05)。结论 瘢痕子宫妊娠早产患者采用经阴道分娩法进行分娩产后并发症少、新生儿出生后情况较好、母婴妊娠结局良好,是一种可行性好、安全性高的分娩手段。