中药临床试验是中医药研究中发展较快的一个领域，临床研究协调员（CRC）在中药临床试验中有重要作用，其工作范围涉及到中药临床试验的各个方面。由于中药临床试验有着不同于西药临床试验的特点，CRC在中药临床试验中的作用也有其特殊性，对提高临床试验的安全性、科学性及试验数据的可信度方面起重要作用。
目的探讨袋形缝合术联合中药外敷治疗骶尾部藏毛窦的临床疗效。 方法应用袋形缝合术联合中药外敷治疗骶尾部藏毛窦13例。 结果13例患者全部治愈，随访1年，未见明显复发及并发症。 结论袋形缝合术联合中药外敷治疗骶尾部藏毛窦手术操作简单，治疗彻底，缩小了手术创面，愈合时间相对缩短，复发少，患者痛苦少，长期效果优良，治疗骶尾部藏毛窦安全、有效，值得临床推广应用。
ObjectiveTo assess effect of the self-made traditional Chinese medicine iontophoresis in treatment of acute lactation mastitis. MethodsTwo hundred cases of acute lactation mastitis who were treated in Langfang Maternal and Child Health-Care Hospital from Apr.to Nov.in 2012 were divided into traditional Chinese medicine group and control group by number of cases, each group enrolled 100 cases.The cases of traditional Chinese medicine group were treated with traditional Chinese medicine iontophoresis by using photoelectric ion therapeutic apparatus, and cases of control group were treated with 0.9% saline iontophoresis by using the same device.All of the 200 cases were treated with 1-3 courses (5 days per course), 2 times per day, and every time needed 30 minutes.At the same time, cases were educated the breast-feeding knowledge.Effect evaluation was performed after 1 course and 3 courses of treatment.The cases who were not cured after 3 courses needed to weaning, and needed to receive abscess incision drainage surgery.In 3 months after stopping therapy, telephone interview was performed to investigate the situation of recurrence. ResultsAfter 1 course of treatment, the effect was as follows:recovery in 89 cases, effective in 6 cases, invalid in 5 cases, and the total effective rate was 89%(89/100) in traditional Chinese medicine group; recovery in 71 cases, effective in 16 cases, invalid in 13 cases, and the total effective rate was 87%(87/100) in control group.After 3 courses of treatment, the effect was as follows:recovery in 97 cases, invalid in 3 cases, and the total effective rate was 97%(97/100) in traditional Chinese medicine group; recovery in 86 cases, invalid in 14 cases, and the total effective rate was 86%(86/100) in control group.There were 3 cases and 14 cases underwent abscess incision drainage surgery in Chinese medicine group and control group respectively.The clinical effect of Chinese medicine group were better than that of control group in 1 course (χ2=3.96, P < 0.05) and 3 courses (χ2=7.78, P < 0.01) of treatment.The recurrence rate of Chinese medicine group and control group were 5%(5/100) and 35%(35/100) respectively, and the rate of control group was higher (χ2=28.13, P < 0.01). ConclusionsCom-pared with 0.9% saline iontophoresis, the effect of traditional Chinese medicine iontophoresis in the treatment of acute lactation mastitis is better, which contribute to the breastfeeding.In addition, it is worth popularizing for that it can reduce the operation rate and recurrence rate effectively.
目的 评价中药灌肠治疗各型便秘的疗效。 方法 计算机检索CBM、VIP、CNKI及Cochrane图书馆临床对照试验数据库等，查找符合纳入标准的随机对照试验，文献检索时间均从建库截至2012年5月。并按Cochrane系统评价手册的文献质量评价办法评价纳入研究的方法学质量，而后提取相关数据用Rev Man 5.1软件进行Meta分析。 结果 最终纳入15篇随机对照试验，共1 137名受试者。结果显示：中药灌肠治疗各型便秘的效果优于口服药、肥皂水灌肠、开塞露等其他治疗，OR值及相应95%CI分别为6.6（2.61，16.69）、5.46（2.57，11.60）、6.54（2.41，17.70）。 结论 中药灌肠治疗便秘有一定疗效且相对安全。由于纳入分析的研究质量差异较大，因此有必要进行大样本、多中心、随机、双盲的对照试验，以进一步证实其临床疗效。
A total of 109 varieties of Chinese medicine injections have been approved by the State Food and Drug Administration of China, all of which have the potential to induce adverse drug reactions (ADRs). Major ADRs include systemic anaphylaxis, anaphylactic shock, acute intravascular hemolysis, hepatorenal damage, skin lesion, cardiac damage, respiratory system injury, and gastrointestinal disorders. Contributing factors of ADRs include healthcare workers’ inadequate attention to ADRs of Chinese medicine injections, complex ingredients, allergic uncertainties, and inappropriate drug use in children and the aged. To decrease ADRs resulting from Chinese medicine injections, it is essential to improve the selection of drug indications, delivery of proper dosage regimens, compliance with drug instructions, and selection of solvents for the drugs.
ObjectiveTo systematically review the research status of therapeutic drug monitoring (TDM) for traditional Chinese medicine. MethodsPubMed, EMbase, The Cochrane Library, CNKI, WanFang Data, CBM, VIP databases, official websites of governments and societies associated with TDM were electronically searched to collect studies on TDM for traditional Chinese medicine from inception to January, 2022. Two reviewers independently screened literature and extracted data. Then, a qualitative systematic review was conducted. ResultsA total of 13 studies were included, all of which came from China and were small sample size studies. The studied population consisted mainly of healthy volunteers (85%), followed by patients of coronary artery disease with blood stasis pattern (31%), patients of rheumatoid arthritis (8%), and patients of acquired immune deficiency syndrome (8%). There were two types of medicine, including proprietary Chinese medicine (69%) and Chinese herbal pieces (31%). The research topics were all theoretical research of TDM, mainly concentration detection methods (77%), followed by influence factors of blood drug concentration (15%), the selection of specimen (15%), the selection of monitoring object (8%) and the concentration reference range (8%). There was no clinical practice study on TDM of traditional Chinese medicine. ConclusionTDM of traditional Chinese medicine is still in the exploratory stage in China. Published studies are mainly on the theoretical research of TDM, and no relevant studies is on clinical practice of TDM of traditional Chinese medicine.
ObjectiveTo systematically review the efficacy of Chinese herbal enema in ileus patients. MethodsThe randomized controlled trials (RCTs) and quasi-RCTs about Chinese herbal enema and gastrointestinal intubation versus western medicines in the treatment of ileus disease was searched in PubMed, Web of Science, EMbase, The Cochrane Library (Issue 4, 2013), CBM, CNKI, VIP and WanFang Data from the date of their establishment to July 2013. Two reviewers independently screened literature according to the inclusion and exclusion criteria, extracted data, and assessed the methodological quality of included studies. Then meta-analysis was performed using RevMan 5.1. ResultsA total of 27 RCTs and 3 quasi-RCTs involving 3 074 patients were included. The results of meta-analysis showed that the Chinese herbal enema and gastrointestinal intubation group was superior to the control group in raising the total clinical effective rate (OR=4.69, 95%CI 3.70 to 5.94, P < 0.000 01), as well as shortening the hospitalization time (SMD=-1.19, 95%CI-1.42 to-0.96, P < 0.000 01), time of anus exhaust (SMD=-1.52, 95%CI-1.76 to-1.28, P < 0.000 01), defecation (SMD=-2.27, 95%CI-3.43 to-1.11, P=0.000 1), time of gastric tube indwelling (SMD=-1.56, 95%CI-1.86 to-1.27, P < 0.000 01), and symptoms complete resolution (SMD=-0.74, 95%CI-1.11 to-0.37, P < 0.000 1), all with significant differences. ConclusionChinese herbal enema and gastrointestinal intubation is more beneficial than western medicine alone for ileus. Due to limited quality of the included studies, the abovementioned conclusion still needs to be verified by conducting more high quality blinding RCTs.