脱细胞真皮基质修复急性外伤性皮肤缺损的临床研究

目的 改善皮肤移植的功能和形态，提高急性外伤性皮肤缺损治疗的临床效果。方法 应用自制脱细胞真皮基质与自体薄皮片复合移植于23例(26次)外伤性皮肤缺损的创面上，观察其成活率和创面愈合后的质量，3例再次手术病人留取创面组织进行组织学检查。结果 复合皮移植后的皮片成活率为100!例24次；余2例2次为90％成活，植皮区光滑平整，供皮区无瘢痕增生，组织学检测提示复合皮血管化明显，胶原排列有序，表皮一真皮连接结构紧密，未见急性和慢性排异反应。结论 脱细胞真皮基质与自体薄皮片复合移植能改善外伤性皮肤缺损创面愈合的皮肤质量，优于单纯自体皮移植。     

脱细胞真皮基质修复口腔粘膜缺损的临床研究

目的：评价脱细胞异体真皮基质口腔粘膜补片治疗口腔粘膜缺损的临床效果。方法：选取口腔粘膜缺损的病例共32例。缺损部位为舌、口底及腭部，用脱细胞异体真皮基质口腔粘膜补片修复，用反包扎法固定，术后随访6个月～3年。结果：所有病例均完全成活。结论：脱细胞异体真皮修复口腔粘膜缺损，效果满意。     

脱细胞异体真皮基质与自体薄皮片复合移植修复皮肤缺损

脱细胞异体真皮基质(ADM)与自体薄皮片复合移植15例2l处修复皮肤缺损。结果显示植皮区光滑平整，瘢痕增生不明显；病理学检测提示复合皮血管化明显，胶原排列有序，表皮与真皮连接结构重建充分，未见急性免疫排斥反应。表明ADM与自体薄皮片复合移植是一种修复皮肤缺损的良好方法。     

脱细胞异种真皮基质修复口腔黏膜缺损临床研究

目的:探讨脱细胞异种真皮基质口腔修复膜修复口腔黏膜缺损的临床效果.方法:20例口腔软组织浅层缺损患者应用海奥口腔修复膜进行治疗,观察生物膜成活情况,颜色,质地及对患者的影响等.结果:完全成活17例,大部成活3例.受植床表面颜色多为粉红,质地柔软,瘢痕轻微;患者进食不受影响,未出现明显局部或全身反应.结论:脱细胞异种真皮基质口腔修复膜可作为自体皮片的替代品,口腔黏膜修复效果满意.     

改良法制备脱细胞真皮基质的实验研究

目的：检测用低含量胰蛋白酶消化加反复冻融法来制备的脱细胞异种真皮，并观察大鼠皮下移植后的结果。方法：将断层猪皮浸入0．5g／L胰蛋白酶溶液中4℃过夜消化，去除表皮和部分真皮内细胞成分，然后分别行4℃预冷，-70℃冷冻和37℃下融化，如此反复冻融3次。进行大体观察和组织学检测、细菌培养试验、细胞毒性试验。将真皮基质移植于大鼠皮下，术后2，4，6，8周行大体和组织学观察。结果：脱细胞猪真皮基质平整光滑，质地柔软，有弹性，韧性好。镜下观察基底膜存在，胶原结构完整，无细胞存在，无细菌生长，无细胞毒性。大鼠皮下移植后愈合良好，无明显炎症反应。结论：低含量胰蛋白酶消化加反复冻融法制备的脱细胞异种真皮能完全去除细胞成分，且保持胶原结构和基底膜的完整，为一种简便有效的方法。     

不同方法制备猪脱细胞真皮基质及创面移植的实验研究

目的比较两种方法制备的猪脱细胞真皮基质分别与自体刃厚皮复合移植修复大鼠全层皮肤缺损的效果。方法使用DispaseⅡ／TritonX-100(中性蛋白酶／曲拉通)和高渗盐水／十二烷基硫酸钠(SDS)两种方法去除猪表皮及真皮中的细胞成分，分别得到猪脱细胞真皮基质Ⅰ和Ⅱ。63只SD大鼠背部全层皮肤缺损分别使用猪脱细胞真皮基质Ⅰ 自体刃厚皮及猪脱细胞真皮基质Ⅱ 自体刃厚皮覆盖，术后观察移植物成活率和植皮区收缩率，同时取移植物进行组织学观察，并与单纯自体刃厚皮移植相比较。结果两种方法制备的猪脱细胞真皮基质分别与自体刃厚皮复合移植的移植物成活率和植皮区收缩率差异无显著性，组织学观察显示复合皮上皮化良好，胶原纤维排列有序，基底膜结构完整。两复合皮组术后第6周移植物成活率与自体刃厚皮组比较差异均无显著性，术后第4周开始两复合皮组移植物收缩率明显降低。结论两种方法制备的异种脱细胞真皮基质与自体皮复合移植都能很好地修复全层皮肤缺损，改善创面愈合质量。     

早期应用异种脱细胞真皮基质修复小儿Ⅱ度烫伤创面的疗效观察

目的观察异种脱细胞真皮基质治疗小儿Ⅱ度烫伤创面的临床效果。方法治疗组38例早期(伤后24 h内)使用异种脱细胞真皮基质覆盖治疗,对照组44例使用传统换药的治疗方法,对比两组愈合时间、换药次数及观察愈后12个月瘢痕情况。结果治疗组浅Ⅱ度、深Ⅱ度创面平均愈合时间均短于对照组,t值分别为-3.383、-2.757,P值分别为0.001、0.010,差异有统计学意义。治疗组患儿的换药次数少于对照组,t值为-9.689,P<0.001,差异具有统计学意义。愈后12个月,治疗组7例遗留瘢痕、无明显功能障碍;对照组6例瘢痕增生。结论异种(猪)脱细胞真皮基质应用于小儿Ⅱ度烫伤能促进创面愈合、减少换药次数、有效避免瘢痕形成和挛缩畸形,适于临床推广应用。     

异种(猪)脱细胞真皮基质移植对皮肤弹性的影响

目的 比较异种(猪)脱细胞真皮基质(PADM)与自体薄厚皮、自体薄厚皮覆盖缺损创面后,与正常皮肤在黏弹性方面的差异性.方法 选用10只清洁级日本大耳白兔,每只白兔背部制作3个全层缺损创面,根据创面不同处理方式分为三组:PADM+自体薄厚皮(PADM组)、自体薄厚皮(TS组)和正常皮肤组(NS组).术后30 d时测量愈合创面挛缩率,行病理观察、离体松弛和应力应变生物力学测定.对结果进行统计学分析.结果 术后30 d,PADM组创面挛缩率低,与TS组比较差异有统计学意义(P<0.05).组织学观察见真皮基质基本完整,纤维结构致密,有少量纤维组织长入.三组生物力学关系为:NS组与TS组差异无统计学意义(P>0.05),PADM组较NS组与TS组差(P<0.05).PADM组生物力学曲线距离正常皮肤组最远,TS组与正常皮肤组最为接近.结论 与正常皮肤相比,异种(猪)脱细胞真皮基质与自体薄厚皮修复后创面弹性最差,自体薄厚皮弹性稍好.     

异体脱细胞真皮基质修复口腔颌面软组织缺损

目的评价异体脱细胞真皮基质在口腔颌面外科应用的临床效果，进一步了解脱细胞真皮基质的生物学特性。方法选择2004-01／11吉林大学口腔医学院口腔颌面部恶性肿瘤患者36例，移行沟加深黏膜缺损2例。口腔黏膜缺损面积为2cm&;#215;3cm～5cm&;#215;6cm。术中将软组织缺损处用脱细胞真皮基质行组织修补，观察创面修复的效果。术后3个月选取其中2例患者进行组织学检测。结果①所有患者口腔黏膜创面愈合良好，均未发生排异反应，口腔局部凹陷畸形及瘢痕挛缩畸形得到改善。②术后3个月组织学检查，脱细胞真皮基质处所生成的组织完全上皮化，与正常黏膜组织没有明显差异。结论异体脱细胞真皮基质可以作为口腔软组织缺损的修复材料；其植入术后3个月生物学特性稳定。     

表皮细胞、成纤维细胞复合脱细胞真皮基质构建组织工程皮肤

目的；观察体外培养的人皮肤角朊细胞和成纤维细胞的生物学特性，复合脱细胞真皮基质构建组织工程皮肤，为进一步临床应用奠定基础。方法：分别取人皮肤角朊细胞和成纤维细胞体外培养、扩增，测定细胞生长曲线、克隆形成率和染色体倍性；将培养的角朊细胞、成纤维细胞分别接种于脱细胞真皮基质表面，体外构建组织工程皮肤，观察细胞生长增殖情况。结果：在本培养体系下人皮肤角朊细胞和成纤维细胞增殖良好，细胞染色体倍性检测结果均为二倍体细胞。脱细胞真皮基质对角朊细胞、成纤维细胞无明显毒性作用，体外复合培养细胞可生长增殖。结论：此实验方法可以获得生长状态良好的组织工程皮肤种子细胞，复合脱细胞真皮基质可成功构建组织工程皮肤     

盐酸阿那格雷胶囊治疗原发性血小板增多症的有效性和安全性——多中心、随机对照临床研究

目的 评价阿那格雷治疗原发性血小板增多症(ET)的有效性和安全性.方法 将符合WHO 2008诊断标准的ET患者随机分配到阿那格雷组和羟基脲组.阿那格雷由2mg/d始逐渐增加,最大剂量为10 mg/d,维持PLT(100～400)×109/L1个月后,逐渐减量维持.羟基脲由1 000 mg/d逐渐增加,维持PLT(100～400)×109/L1个月后,减量至10mg·kg-1·d-1维持.共观察12周.结果 17个中心共人组222例ET患者(阿那格雷组、羟基脲组分别为113、109例),198例可评价疗效(阿那格雷组、羟基脲组分别为97、101例).治疗12周,阿那格雷组血液学缓解率为87.63％(85/97),羟基脲组为88.12％(89/101),差异无统计学意义(P=0.174).阿那格雷组治疗前中位PLT为827(562～1 657)×109/L,治疗12周为400(127～1 130)×109/L,差异有统计学意义(P＜0.001).阿那格雷组治疗后PLT降低值中位数为393(-362～1 339)×109/L,羟基脲组为398(-579～1 846)×109/L,差异无统计学意义(P=0.982).阿那格雷组、羟基脲组中位起效时间分别为7(3～14)、21(14～28)d,差异有统计学意义(P=0.003).阿那格雷组不良事件发生率为65.49％(74/113),包括心悸(36.28％)、头痛(21.24％)、乏力(14.16％)和头晕(11.50％)等,均为Ⅰ～Ⅱ级.结论 盐酸阿那格雷胶囊治疗ET的血液学缓解率与羟基脲相近,不良事件发生率相似,起效时间较短,无明显血液学毒性,安全性较好.     

Cellular versus acellular matrix devices in the treatment of diabetic foot ulcers: Interim results of a comparative efficacy randomized controlled trial

Healing of diabetic foot ulcers is a major challenge. Despite adhering to optimal standard of care (SOC), less than 30% of wounds heal after 20 weeks. Advanced cellular tissue‐based products have shown better healing over SOC, albeit with great cost and modest improvement. We hypothesized no difference in healing effected by either cellular (Dermagraft), noncellular (Oasis) devices, relative to SOC in treating diabetic foot ulcer in a randomized controlled trial. The primary and secondary outcomes were the percentage of subjects that achieved complete wound closure by study endpoint (12 weeks of treatment) and study completion, respectively. During the 2‐week screening phase with SOC, subjects with 40% change in ulcer size were excluded. After randomization, 56 patients entered an active treatment phase (8 weeks) followed by a maintenance phase (4‐week SOC), with endpoint at visit 15, and 4 monthly follow‐up visits. There was equal distribution of demographic data (p>.05) and no difference in initial wound characteristics (p>.05) between all groups. No differences were observed in complete wound closure by 12 and 28 weeks of treatment, nor were there any difference in percentage area reduction from treatment weeks 1 to 12 and from treatment weeks 1 to 28 between the groups. Each of the treatment arms showed statistically significant reduction in wound area from treatment weeks 1 to 28 (p<.05). This exploratory analysis suggests that the outcomes of treatment with either Dermagraft or Oasis matrix are comparable. We have completed enrollment, and the final data analysis is underway to make definitive conclusions.     

注射用头孢唑肟钠治疗细菌性感染的多中心随机对照临床研究

目的评价国产注射用头孢唑肟钠治疗呼吸系统及泌尿系统细菌性感染的l临床疗效和安全性。方法采用多中心、随机、盲法、平行对照试验设计，选择呼吸系统和泌尿系统细菌性感染患者，试验组（A组）应用国产注射用头孢唑肟钠，对照组（B组）应用进口注射用头孢唑肟钠（商品名益保世灵），用法均为2．0g，静脉滴注，每12小时1次；下呼吸道感染疗程为7～14d，泌尿系统感染为5～14d。结果本研究共入选病例144例，其中下呼吸道感染和泌尿系统感染各72例。A、B两组基本临床特征差异无统计学意义，资料具有可比性。疗效分析显示．A组与B组的痊愈率分别为81．9％和63．9％，总有效率分别为98．6％和98．6％，两组差异无统计学意义（P〉0．05）。A、B两组细菌清除率分别为100％和98．4％（P〉0．05）。本研究两组不良反应发生率均较低（2．8％与2．8％，P〉0．05），未见严重不良反应。结论国产注射用头孢唑肟钠对临床常见致病菌引起的下呼吸道、泌尿系统感染，临床疗效较好而不良反应发生率低，有较高的临床应用价值。     

Efficacy and safety of Euiiyin-tang in Korean women with obesity: A randomized,double-blind,placebo-controlled,multicenter trial

BackgroundObesity is a global health problem and its incidence is on the rise. Euiiyin-tang is an herbal medicinal formula that is often used in the clinical treatment of obesity. The purpose of the present study was to evaluate the efficacy and safety of Euiiyin-tang in obesity treatment.MethodsA randomized, double-blind, placebo-controlled, multicenter trial was conducted. Participants with obesity were randomly assigned to receive Euiiyin-tang or placebo 3 times daily for 12-weeks. The primary outcome was weight reduction between the baseline and 12 weeks. The secondary outcomes included the rate of weight loss compared to baseline, and changes in body mass index, lipid profiles, and questionnaires related to the quality of life and diet. Safety factors, such as vital signs and laboratory parameters, were also measured.ResultsA total of 149 participants were randomly distributed to either the Euiiyin-tang group (n = 76) or the placebo group (n = 73). Weight reduction in the Euiiyin-tang group was significantly greater than that in the placebo group (2.50 kg in the Euiiyin-tang group vs. 0.82 kg in the placebo group). The participant response rates of ≥3% weight loss compared to baseline was 36.8 % in the Euiiyin-tang group and 17.8 % in the placebo group. Body mass index, waist circumference, and hip circumference showed a greater change in the Euiiyin-tang group than in the placebo group (1.00, 3.23, and 2.00 in the Euiiyin-tang group vs. 0.33, 1.96, and 0.86 in the placebo group). Questionnaires, lipid profiles, and safety factors did not show significant differences between groups.ConclusionThe results of this study suggest that Euiiyin-tang has beneficial effects on weight loss.Trial RegistrationClinicaltrials.gov NCT01724099     

口服国产司帕沙星片治疗急性细菌性感染多中心随机对照研究

目的评价国产司帕沙星片治疗急性细菌性感染的临床疗效与安全性.方法以国产洛美沙星片为对照药进行随机对照研究,共治疗各种细菌性感染231例,其中司帕沙星组117例、洛美沙星组114例.司帕沙星200～300mg,每日1次口服,疗程5～14d;洛美沙星300mg,每日2次口服,疗程5～14 d.结果司帕沙星组与对照组的痊愈率和有效率分别为84.62%与74.56%和94.87%与92.98%.细菌清除率分别为94.28%和92.02%.组间比较差异无显著性(P＞0.05).两组的不良反应发生率分别为7.69%和11.40%(P＞0.05),反应多呈轻度,勿需处理可自行缓解.结论司帕沙星抗菌谱广,抗菌活性强,为治疗中、轻度急性细菌性感染安全有效的口服抗菌药物.     

A randomized controlled feasibility trial comparing safety and effectiveness of prehospital pacing versus conventional treatment: 'PrePACE'

OBJECTIVE: To evaluate the feasibility of a prehospital randomized controlled trial comparing transcutaneous pacing (TCP) with dopamine for unstable bradycardia. METHODS: Unstable bradycardic patients who failed to respond to a fluid bolus and up to 3mg atropine were enrolled. The intervention was dopamine or TCP with crossover to dopamine if TCP failed. The primary outcome was survival to discharge or 30 days. Randomization compliance, safety, follow-up rates, primary outcome, and sample size requirements were assessed. RESULTS: Of 383 patients with unstable bradycardia, 151 (39%) failed to respond to atropine or fluid and were eligible for enrollment and 82 (55%) were correctly enrolled. Fifty-five (36%) of eligible patients could not be enrolled for practical reasons; 3 had advance directives, 32 met inclusion criteria on arrival at hospital and in 20 cases, paramedics chose not to enroll based on the circumstances of the case. The remaining 13 were missed cases; 8 were missing randomization envelopes and in 5, the paramedic forgot. Randomization compliance was 95% (78/82). Forty-two (51%) patients were randomized to TCP and seven of these crossed over to dopamine. Two cases were randomized but did not receive the intervention; either due to lack of time or loss of IV access. Three adverse events occurred in each group. Survival to discharge or 30 days in hospital was 70% (28/40) and 69% (29/42) in the dopamine and TCP groups, respectively with 100% follow up. To detect a 10% relative difference in 30 days survival between treatment arms, a sample size of 690 per group would be required. CONCLUSIONS: It is feasible to conduct a prehospital randomized controlled trial of TCP for unstable bradycardia and a definitive trial would require a multi-centre study.     

Efficacy and safety of glucocorticoids in the treatment of community-acquired pneumonia: A meta-analysis of randomized controlled trials

BACKGROUND: Community-acquired pneumonia(CAP) is pneumonia acquired infectiously from normal social contact as opposed to being acquired during hospitalization. CAP is a leading cause of illness and death. This review aims to determine the efficacy and safety of glucocorticoids in the treatment of community-acquired pneumonia(CAP).DATA SOURCES: We searched randomized controlled trials(RCTs) from Pubmed, EMBASE, Cochrane Library, Chinese Journal Full-text Database, and Chinese Biomedical Literature Database to obtain the information by using steroids, glucocorticoids, cortisol, corticosteroids, community-acquired pneumonia and CAP as key words. The quality of RCTs was evaluated. A Meta-analysis was made using Rev Man 5.0 provided by the Cochrance Collaboration.RESULTS: Seven RCTs involving 944 patients were included in the meta-analysis. The mean length of hospital stay in glucocorticoids treatment group was significantly shorter than that in standard treatment group(WMD=–1.70, 95%CI 2.01–1.39, Z=10.81, P0.00001). No statistically significant differences were found in the mortality rate(RR=0.77,95%CI 0.46–1.27, Z=1.03, P=0.30), the mean length of hospital stay in ICU(WMD=1.17, 95%CI 1.68–4.02, Z=0.81, P=0.42), the incidence of super infection(RR=1.32, 95%CI 0.66–2.63, Z=0.79, P=0.43), the incidence of hyperglycemia(RR=1.84, 95%CI 0.76–4.41, Z=1.36, P=0.17), the incidence of upper gastrointestinal bleeding(RR=1.98, 95%CI 0.37–10.59, Z=0.80, P=0.42) between the standard treatment group and the glucocorticoids treatment group.CONCLUSIONS: The use of glucocorticoids in patients with community-acquired pneumonia can significantly shorten the duration of illness and have a favorable safety profile. However, it could not reduce the overall mortality.