Randomized Clinical Trials of Traditional Chinese Medicines for Treating Ulcerative Colitis: A Scoping Review

Objective: Traditional Chinese medicines (TCMs) are efficacious against ulcerative colitis (UC). In recent years, the number of randomized clinical trials (RCTs) of TCM has increased. Thus, it is very important to summarize the basic characteristics, quality, and types of TCM interventions in published RCTs. This scoping review was performed to systematically identify and describe the current situations about RCTs of TCMs for treating UC. Hope to express the focus and specifics of nowadays research in TCM interventions in RCTs and evaluate their common disadvantages exposed to help advance in TCM researching. Materials and Methods: Ascoping review was conducted according to the PRISMA extension for scoping reviews. We searched two English databases and four Chinese databases from the date of establishment of each database to January 2020. Data from RCTs focusing on any TCM treatment for patients with UC were extracted and evaluated. Selection and characterization were performed by two independent reviewers using predefined forms. All discrepancies were resolved by consensus discussion with a third reviewer. Microsoft Excel 2010 was used to extract the following data from the included studies: (1) basic information of the included studies including research ID, article title, publication language, journal, year of publication, and funding information; (2) patient information including gender, age, disease course, disease stage, severity, sample size; and (3) information on intervention measures, types of intervention measures, drug dosage forms, and treatment courses. Results: The search identified 2225 RCTs published between 1987 and 2020. These studies covered 36 provinces in China. The time frame of the RCTs was <28 days in approximately one-third of the RCTs (647, 29.08%). Only one RCT was published in English. Nearly three-quarters of RCTs (1665, 74.83%) did not report the severity of the disease. Three types of interventions were included in the RCTs: pharmacotherapy (2028, 91.15%), nonpharmacotherapy (57, 2.56%), and a combination of the two (140, 6.29%). The administration modes of the intervention groups were evaluated. Drug therapy involved 12 types of TCM dosage forms, which were decoctions, troches, powders, capsules, granules, pills, suppositories, ointments, injections, gels, oral liquids, and substitute tea according to the frequency of use. Nondrug intervention measures involved 10 treatment options, namely, acupuncture, moxibustion, hemospasia, auricular point, acupoint catgut embedding, acupoint injection, scrapping, tuina, acupoint application, and five?tone therapy according to the frequency of use. Most studies included in this review were low in quality. This underscores the need for improvement in the quality of trial methodology in TCM RCTs.     

不同剂量蛇床子素对OPG基因敲除小鼠和去卵巢骨质疏松大鼠作用疗效的比较研究

目的 观察不同剂量蛇床子素对OPG基因敲除小鼠和去卵巢骨质疏松大鼠的影响。方法 选择3种不同剂量的蛇床子素作用于OPG基因敲除小鼠和去卵巢骨质疏松大鼠,以双能X骨密度仪检测动物全身骨密度的变化;将动物腰椎做硬组织切片,并进行骨形态计量学分析其骨小梁的变化。结果 对于OPG基因敲除小鼠,蛇床子素能提高其全身BMD,以中剂量（10mg/（kg?d））组提高最为明显,低剂量（5mg/（kg?d））次之,而高剂量（15mg/（kg?d））组效果最差。蛇床子素能提高OPG基因敲除小鼠腰椎骨小梁体积分数,增加骨小梁数目,增加骨小梁厚度,降低骨小梁分离度,其中以5mg/(kg?d)组作用最明显,其次为10mg/(kg?d)组,而15mg/(kg?d)组则效果最差;对于去卵巢骨质疏松大鼠,不同剂量的蛇床子素均能显著提高大鼠全身BMD,其中以中剂量（100mg/（kg?d））组为最佳。蛇床子素能显著提高大鼠腰椎骨小梁体积分数,以100mg/（kg?d）组最明显。显著增加大鼠腰椎骨小梁数目,以75mg/（kg?d）组最明显。蛇床子素100mg/（kg?d）组能增加大鼠腰椎骨小梁厚度。不同剂量的蛇床子素均能显著降低大鼠腰椎骨小梁分离度,其中以75mg/（kg?d）组和100mg/（kg?d）组最明显。结论 蛇床子素能促进骨形成,抑制骨吸收,从而起到抗骨质疏松的作用,其疗效与给药剂量密切相关。     

脑心同治法对老年卒中后失眠患者总体睡眠状态及失眠药物剂量的影响

目的:探讨脑心同治法对阴虚火旺型老年卒中后失眠患者总体睡眠状态及失眠药物剂量的影响。方法:选取2010年3月至2015年10月我院收治的阴虚火旺型老年卒中后失眠患者100例为研究对象,采用随机数表法分为观察组和对照组各50例,对照组给予艾司唑仑、常规西药治疗,观察组在此基础上给予黄连阿胶汤,2组均治疗1个月,对比其治疗有效率及失眠药剂量,应用匹茨堡睡眠质量指数量表(PSQI)、失眠严重程度指数(ISI)评价其睡眠状态,同时采用汉密尔顿焦虑量表(HAMA)、汉密尔顿抑郁量表(HAMD)评价2组情绪改善情况,并观察不良反应。结果:观察组治疗有效率92.00%明显高于对照组76.00%(P0.05);治疗后观察组PSQI评分(5.26±0.69)分、ISI评分(9.50±1.64)分、HAMA评分(9.87±1.59)分、HAMD评分(10.25±1.88)分较对照组低(P均0.05);观察组不良反应发生率10.00%与对照组6.00%比较无统计学意义(P0.05)。结论:脑心同治法可有效改善老年卒中后失眠患者总体睡眠状态,降低其失眠药用药剂量,且不会增加西药不良反应,值得在临床推广应用。     

监测APTT指导重型肝炎患者人工肝治疗的肝素用量

目的通过血凝仪监测APTT变化探讨重型肝炎患者人工肝治疗时肝素的最佳用量.方法应用半自动血凝仪检测活化部分凝血活酶时间(APTT),对比肾透析和重型肝炎患者肝素应用后APTT的变化情况及重型肝炎患者应用不同剂量肝素后APTT的变化情况,并通过实时监测人工肝治疗时患者APTT的变化状况随时调整肝素的用量.观察管路有无凝血,皮肤黏膜、穿刺或置管部位有无渗血或出血.结果重型肝炎组应用肝素后APTT变化值明显大于肾透析组,统计学有显著性差异.大剂量肝素组重型肝炎患者肝素应用后5分钟有90.5%的患者APTT大于100秒,30分钟后仍有47.6%的患者APTT大于100秒,均显著高于小剂量肝素组.APTT比正常对照值延长40%～80%的情况下,既没有发生管路凝血,也没有加重出血倾向.结论重型肝炎患者肝素应用后凝血机制的变化更加明显,相对于肾透析而言应显著减少肝素用量.实时监测APTT的变化使之比正常对照值延长40%～80%,既可防止管路凝血又可降低出血的风险.     

胰岛素非注射制剂研究现状及展望

当前改进胰岛素治疗的关键，在于力求找到代替给患者带来痛苦和麻烦的皮下注射胰岛素的方法，即模拟生理性胰岛素分泌，恢复正常代谢环境，并由此降低糖尿病并发症的危险性。国内外有许多研究者业已扩展了许多胰岛素给药途径，包括鼻黏膜、口颊黏膜、直肠、眼、阴道内、肺、皮肤和胃肠道。我们复习了本领域的大量论文和报告，对各给药途径的进展、优点和缺点作出分析，所得出的结论是：探索各种胰岛素给药途径的视野广阔，前进道路上仍不乏困难。     

低浓度对比剂在冠状动脉 CT 血管造影中的可行性评价

【目的】评价应用低浓度对比剂在行冠状动脉CT血管造影（CTA）中的可行性。【方法】连续收集临床疑诊或确诊冠心病拟行冠状CTA,使用低浓度对比剂并采用前瞻性心电门控扫描者243例（观察组）,按体质量指数（BMI）不同分为A组（100例）、B组（112例）和C组（31例）,均使用低浓度对比剂（270mgI／mL）,另外选择使用常规扫描（高浓度对比剂370mgI／mL,扫描电压120kV）的150例（对照组）,按同样BMI分成三组进行配对比较,即A1、B1和C1组,每组各50例,比较各组辐射剂量（ED）、主动脉根部（AR）、左主干（LM）、右侧冠脉（RCA）近段CT值和标准差（SD）,计算图像的信号噪声比（SNR）和对比噪声比（CNR）;并对所有病例的冠脉图像质量按节段进行评分。【结果】相同BMI、同样的对比剂浓度组之间的辐射剂量比较均有统计学意义（P＜0．05）;A组与A1组AR的CT值、图像噪声及SNR差异具有统计学意义（P＜0．05）,两侧冠脉近段CNR差异无统计学意义（P＞0．05）;B组与B1组、C组与C1组间仅SNR差异有统计学意义（P＜0．05）;C组与C1组间可诊断率有显著差异（P＜0．05）,而A组与A1组、B组与B1组比较差异无统计学意义（P＞0．05）。【结论】应用低浓度对比剂采用低管电压扫描能够获得满足诊断的冠脉CTA图像,可降低对比剂碘注射量及辐射剂量。     

防己历代临床用量轨迹研究

目的:分析总结防己自汉代至今的临床用量变化轨迹及特点,为该药的临床合理使用提供一定的依据。方法:选取汉代至今,最具代表性的医学著作及相关文献为研究对象,建立防己历代用量数据库,分别按各历史朝代对其最大用量、最小用量、平均用量、最常用量及常用量上限、下限进行统计,并结合文献对结果进行阐释与分析。结果:防己用量在汉唐时期呈现“广剂量,宽范围”的特点。从唐末开始,由于散剂普及,防己用量也随之大幅缩减。直至明代,汤剂又开始成为中药的主要剂型,防己用量也渐次回升,但常用量范围仍较为狭窄。结论:防己的平均用量随所处朝代呈现显著变化,但对于病属风湿、水肿重症者,历代医家均有大剂量、超剂量使用者。     

不同剂量的纳络酮治疗早期高血压脑出血的临床研究

目的探究不同剂量的纳络酮治疗早期高血压脑出血的临床效果。方法回顾性分析86例早期高血压脑出血患者的临床资料,分成观察组和对照组患者各43例。在常规治疗的基础上,观察组进行大剂量纳洛酮(7 mg/d)进行治疗,对照组进行常规剂量(3 mg/d)的治疗,对比分析两组患者的脑水肿、颅内压变化和意识障碍恢复时间的情况。结果观察组患者的治疗效果较好(P<0.05)。结论与常规剂量治疗的方法相比,大剂量使用纳洛酮更有利于患者的疾病治疗情况。