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。
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.
ObjectiveTo systematically review the efficacy of Chinese medicine for endometrial hypoplasia. MethodsDatabases such as PubMed, EMbase, MEDLINE (Ovid), The Cochrane Library (Issue 8, 2014), CNKI, VIP and WanFang Data were searched for randomized controlled trials (RCTs) and quasi-RCTs concerning the efficacy of Chinese medicine for endometrial hypoplasia up to August 2014. According to the inclusion and exclusion criteria, two reviewers screened literature, extracted data, and assessed methodological quality of included studies. Then meta-analysis was performed using RevMan 5.3 software. ResultsA total of 5 RCTs and 6 quasi-RCTs involving 914 patients were included. The results of meta-analysis showed that Chinese medicine group was superior to control group in endometrial thickness (MD=0.86, 95%CI 0.35 to 1.37, P=0.000 01), clinical pregnancy rates (RR=2.62, 95%CI 2.02 to 3.38, P<0.000 01), endometrial morphous (RR=1.23, 95%CI 1.06 to 1.42, P=0.005), PI of uterine artery blood flow (MD=-0.54, 95%CI -0.80 to -0.28, P<0.000 1), RI of uterine artery blood flow (MD=-0.12, 95%CI -0.17 to -0.08, P<0.000 1), and estradiol level (MD=96.03, 95%CI 44.32 to 144.74, P=0.003); However, the two groups were alike in progesterone level without significant difference (MD=2.00, 95%CI -0.64 to 4.65, P=0.14). ConclusionCurrent evidence indicated that, Chinese medicine is beneficial for endometrial hypoplasia. Due to limited quantity and quality of the included studies, the above conclusion still needs to be verified by conducting more high quality studies.
目的:观察中药水疗配合功能训练对痉挛型脑瘫患儿临床痉挛指数的影响。方法:采用随机对照方法,在功能训练的基础上,进行中药水疗与传统水疗治疗痉挛型脑瘫患儿,并以临床痉挛指数评价其疗效。结果:两个疗程的治疗后,对照组和治疗组均能降低痉挛型脑瘫患儿的临床痉挛指数,与治疗前相比均有统计学意义(Plt;0.05),其中治疗组的差值为1.79±1.06较对照组1.23±0.84大,具有统计学意义(Plt;0.05)。结论:在综合功能训练的基础上进行水疗治疗痉挛型脑瘫患儿,具有较好的临床疗效,且中药水疗治疗痉挛型脑瘫优于传统水疗。
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.
Research on the Chinese medicine standardized calendar is not only required for the development of evidence-based pharmacy, but it is also needed in order to adapt to, and promote, clinical rational use of Chinese medicine. The experience of the clinical calendar is summarized in this article. This may provide some significant clues and basis for the design and conduct of research when constructing a Chinese medicine standardized calendar.
ObjectivesTo systematically review the efficacy of Chinese herbal medicine (CHM) combined with chemotherapy for ovarian cancer.MethodsCNKI, VIP, WanFang Data and PubMed databases were searched to collect randomized controlled trials on the CHM combined with chemotherapy for ovarian cancer from inception to March 31st, 2018. Two reviewers independently screened literature, extracted data and evaluated the risk bias of included studies. Meta-analysis was then performed using RevMan 5.3 software.ResultsThirteen studies were included. Meta-analysis showed that, CHM combined with chemotherapy group was superior to the chemotherapy alone group in effective rate of TCM syndrome (RR=1.72, 95%CI 1.46 to 2.03, P<0.00.000 1), effective rate of tumor change (RR=1.40, 95%CI 1.21 to 1.63,P<0.000 01), physical condition score (MD=9.19, 95%CI 5.89 to 12.48,P<0.000 01), tumor markers (MD=–18.00, 95%CI –20.62 to –1.538,P<0.000 01), leukocyte reduction (RR=0.67, 95%CI 0.58 to 0.77,P<0.000 01), granulocy tedepletion (RR=0.67, 95%CI 0.55 to 0.81,P<0.000 1), thrombocytopenia (RR=0.55, 95%CI 0.45 to 0.69,P<0.000 01), and digestive tract reaction (RR=0.66, 95%CI 0.50 to 0.87,P=0.004).ConclusionsThe current evidence shows that CHM combined with chemotherapy is superior to chemotherapy alone in the treatment of ovarian cancer. Due to limited quality and quantity of included studies, the above conclusions are required to be verified by more high-quality studies.