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.
【摘要】 目的 评价中药治疗贝尔（Bell’s）面瘫的有效性和安全性。 方法 以中药、中西医结合、Bell’s面瘫、特发性面瘫、面神经疾病和（或）麻痹、颅神经、颅神经疾病/麻痹为主题词，检索ECSCO数据库系列的ASP（Academic Source Premier）、 NSTL数据库系列的ACP美国医师协会电子期刊数据库及Medicines Complete英国医药出版社医药数据库、MEDLINE数据库、CNKI中国期刊全文数据库、VIP中文科技期刊全文数据库和万方数据库，并在因特网上检索相关学位论文和正在进行的研究。相关的学术会议论文和学位论文汇编也同时予以检索。鉴定相关文章附录的参考文献作为补充检索。 结果 所有以中药治疗Bell’s面瘫的随机对照试验均被纳入。 结论 对纳入的随机对照试验进行方法学质量的评估，数据提取和数据分析。【Abstract】 Objective To evaluate the efficacy and safety of Chinese herbs on Bell’s palsy. Methods With the searching terms including chinese herbs, integrated chinese and western medicine, Bell’s palsy, peripheral facial palsy,facial nerve disease/paralysis, cranial nerve,cranial nerve disease/paralysis were searched in the database of ASP, ACP, Medicines Complete, MEDLINE, CNKI,VIP and Wanfang. While to search the related academic dissertation and ongoing researches on internet. Relevant academic conference and dissertation proceedings have also been searched. Results All randomized trials about Chinese herbs for Bell’s palsy were included in this review. Conclusion Assessment of methodological quality, data extraction and syntheses were carried out.
Assessment on adverse drug reactions (ADR) that directly affects the quality of life and mortality and an important part of the post-marketed reassessment are developing gradually in China. Many problems have been identified in clinical validity and safety for the authorized Chinese herbs. An effective and standardized system is needed in the post-marketed drug reassessment. Evidence-based drug evaluation, which mainly includes clinical epidemiology, systematic review and health technology, will be used to assess the clinical validity, safety and cost of post-marketed drug and play an important role in the process of modernization and internationalization of Chinese herbs.
Objective To evaluate the efficacy and safety of Chinese herb compared with an analgesic drug in the treatment of cancer pain. Methods We electronically searched CBM (1990 to 2008), CNKI (1990 to 2008), VIP (1990 to 2008), The Cochrane Library (Issue 3, 2008), and MEDLINE (1990 to 2008). Relevant journals and conference proceedings were also handsearched. The quality of the included trials was assessed according to the criteria recommended by the Cochrane Handbook for systematic reviews of interventions and meta-analyses were performed for homogeneous studies using the Cochrane collaboration’s review manager 4.2.2 software. Results Five randomized controlled trails (RCTs), all published in Chinese, involving 590 participants, were included. The quality of all RCTs was graded C (low). Meta-analyses were not performed due to heterogeneity. Instead, descriptive analyses were conducted. The results showed that as for the total effective rate in pain-relieving, Zhentongsan (RR=1.11, 95%CI 1.00 to 1.24, P=0.05) and Xiaozhengzhitong paste (RR=1.35, 95%CI 1.02 to 1.78, P=0.04) were more effective than Indometacin, with significant differences. There were no significant differences between Duyiwei capsule and Indometacin, and so were between Huajianbadumo as well as Shebingzhitong paste and Tramado. In terms of early potency, there were significant differences between Zhentongsan (SMD= –?9.87, 95%CI –10.84 to –8.89, Plt;0.000 01) as well as Xiaozhengzhitong paste (SMD= –8.74, 95%CI –10.164 to –7.32, Plt;0.000?01) and Indometacin, and so were between Shebingzhitong paste and Tramadol (SMD= –2.24, 95%CI –3.00 to –1.49, Plt;0.000?01). There were no significant differences between Huajianbadumo and Tramodo. With regard to the durative effect on pain-relieving, there were significant differences between Xiaozhengzhitong paste and Indometacin (WMD=4.78, 95%CI 2.99 to 6.57, Plt;0.00001), but not between Shebingzhitong paste and Tramadol. Conclusion Because of low quality of the existing studies, the current evidence is insufficient to define the efficacy and safety of compound Chinese herb, and further large-scale and high-quality RCTs are needed.
ObjectiveTo explore the effect of " washing, blowing and plugging” triple therapy on wound treatment after procedure for prolapse and hemorrhoids (PPH) operation.MethodsTwo hundreds and four patients with moderate to severe hemorrhoids treated by PPH from June 2017 to September 2018 in the Fifth Hospital of Zhangjiakou City of Hebei province were selected as study subjects and divided into two groups according to the random number table, the control group received saline fumigation followed by sitz bath and conventional wound dressing change on the second day after operation, the observation group were treated with " washing, blowing and plugging” triple therapy and routine wound dressing change on the 2nd day after operation. The clinical efficacy, wound pain, wound exudation, skin margin edema, hemorrhage, granulation tissue filling time and complete wound healing time were compared between the two groups.ResultsThere was no significant difference in the effective rate between the observation group and the control group in degree Ⅱ hemorrhoids (P>0.05), while the effective rates of patients with degree Ⅲ and Ⅳ hemorrhoids were higher than those of the control group (P<0.05). The visual analogue scale (VAS), wound exudation, skin margin edema and hemorrhage scores of the two groups decreased gradually with time (P<0.05), meanwhile, the scores of VAS, wound exudation, skin margin edema and hemorrhage at each time point in the observation group were lower than those in the control group (P<0.05). The granulation tissue filling time and complete wound healing time in the observation group were shorter than those in the control group (P<0.05).ConclusionsAfter PPH operation, the " washing, blowing and plugging” triple therapy has definite clinical effect, can significantly improve wound pain, wound exudation, skin margin edema and hemorrhage, and effectively shorten the wound healing time.