[an error occurred while processing this directive]

Journal of Chinese Integrative Medicine ›› 2011, Vol. 9 ›› Issue (11): 1199-1205.doi: 10.3736/jcim20111107

• Study Protocol • Previous Articles     Next Articles

Study protocol for a self-controlled case study to evaluate the safety and standardization for external application of Chinese medicine Jiuyi Powder

Mei-na Ye1, Hong-feng Chen()1, Yi-qin Cheng1, Yan-sheng Zhang2, Ping Li3, Gang Gui4, Li-ying Chen1, Hao Chen1, Hong-yu Dai2   

  1. 1. Department of Breast Surgery, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China
    2. Department of Traditional Chinese Surgery, Dongfang Hospital, Beijing University of Chinese Medicine, Beijing 100078, China
    3. Department of Traditional Chinese Surgery, Shanghai Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200071, China
    4. Department of Traditional Chinese Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200011, China
  • Received:2011-08-14 Accepted:2011-09-12 Online:2011-11-20 Published:2011-11-15

RichHTML

1

PDF (PC)

83

Like

Background: As the main medicinal powder for drawing out pus and removing necrotic tissue in external therapies of traditional Chinese surgery, Sheng Powder has made great contributions to the treatment of inflammatory wounds and has the unique bactericidal and decay-discharging function that can not be replaced by antibiotics. However, Sheng Powder has toxicity because it contains mercury. So far, there is no clinical research on the standards of dose and usage of Sheng Powder and there is a lack of objective and quantitative criteria for operating standards and monitoring of toxicity and side effects. Therefore, the authors choose Jiuyi Powder, one of the most commonly used Sheng Powder, to evaluate the safety of its external use, and form a standardization program for clinical implementation.
Methods and design: This study is a nonrandomized, nonblinded, self-controlled case study. There will be two key stages in the study. In stage one, 10 patients with plasma cell mastitis will be enrolled. The patients will receive continuous external application of Jiuyi Powder with a fixed dose (160 mg/d). Blood mercury and urine mercury levels will be dynamically tested at different time intervals, and the observation of pharmacokinetic parameters will be conducted after Jiuyi Powder has been absorbed by the surface of the wound. In stage two, 30 patients with each of the four conditions including postoperative wounds of head or facial surgeries, plasma cell mastitis, anal fistula and chronic absorption ulcer of the shank will be enrolled, respectively. According to the dose of 1.5 mg/cm 2, Jiuyi Powder will be externally applied to the wound surface for 14 d. On the basis of the first-phase study, the test time will be chosen and the toxicity outcome will be detected to evaluate the safety of external application of Jiuyi Powder and to establish recommendations for standardized clinical use.
Discussion: The purpose of this study is to evaluate the safety of the external application of Jiuyi Powder through a two-stage study. The pharmacokinetic parameters of external application of Jiuyi Powder at the clinical dose range, the changes in blood and urinary mercury levels and related safety indexes will be observed on different wounds located in different positions externally. The evaluation of whether Jiuyi Powder could be a routine medication for drawing out pus and removing necrotic tissue in inflammatory and refractory wounds will be stated.
Trial registration number: ChiCTR-TNC-11001366.

Key words: Jiu-yi powder, safety, standardization, external therapy

Figure 1

Flow chart of this trial"

[1] Tang HJ, Que HF, Chen HF, Liu S, Cheng YQ, Huang Z, Xiang HY, Zheng Y . Effects of incision-threaddrawing and drawing out pus and dispelling putridity method in treating patients with plasma cell mastitis: a report of 148 cases. Zhong Yi Za Zhi. 2000; 41(2): 99-100. Chinese.
doi: 10.1007/s11769-000-0028-3
唐汉钧, 阙华发, 陈红风, 刘胜, 程亦勤, 黄铮, 向寰宇, 郑勇 . 切开拖线祛腐生肌法治疗浆细胞性乳腺炎 148 例.中医杂志. 2000; 41(2):99-100.
doi: 10.1007/s11769-000-0028-3
[2] Tang HJ, Chen HF, Cheng YQ, Liu XD, Que HF, Xiang HY, Zheng Y, Xing J, Shen L, Chen LY, Shan W . Chinese medical treatment of refractory wounds with Pseudomonas aeruginosa infection : an analysis of 72 cases. Shanghai Zhong Yi Yao Za Zhi. 2004; 387 (4) : 26-28. Chinese with abstract in English.
doi: 10.3969/j.issn.1007-1334.2004.04.012
唐汉钧, 陈红风, 程亦勤, 刘晓鸫, 阙华发, 向寰宇, 郑勇, 邢捷, 沈亮, 陈莉颖, 单玮 . 合并绿脓杆菌感染的难愈性创面的中医药治疗——附72例临床资料分析.上海中医药杂志. 2004; 38(4):26-28.
doi: 10.3969/j.issn.1007-1334.2004.04.012
[3] Zhang ZH, Ma J, Peng J . Clinical research about bacteriostasis function of Hongsheng Dan on diabetic food wound. Liaoning Zhong Yi Yao Za Zhi. 2008; 35 (7) : 1051-1052. Chinese with abstract in English.
张朝晖, 马静, 彭娟 . 红升丹在糖尿病足伤口抑菌作用的临床研究.辽宁中医杂志. 2008; 35(7):1051-1052.
[4] Jiang AQ, He XY . Effect of Jiuyi Powder in treating chronic skin ulcers: a report of 52 cases. Zhong Yi Wai Zhi Za Zhi. 2008; 17(4): 37. Chinese.
蒋爱琼, 何小燕 . 九一丹治疗慢性皮肤溃疡52例.中医外治杂志. 2008; 17(4):37.
[5] State Bureau of Technical Supervision. Clinical terminology of traditional Chinese medical diagnosis and treatment—diseases. Beijing: Standards Press of China. 1997: 19,27,58. Chinese.
国家技术监督局. 中华人民共和国国家标准中医临床诊疗术语疾病部分.北京: 中国标准出版社.1997: 19, 27, 58.
[6] Shanghai Municipal Health Bureau. Criteria for diagnosis and treatment of traditional Chinese medicine syndromes in Shanghai. 2nd ed. Shanghai: Shanghai University of Traditional Chinese Medicine Press. 2003: 156-157, 180-181, 331-332. Chinese.
上海市卫生局. 上海市中医病证诊疗常规.第2版.上海: 上海中医药大学出版社.2003: 156-157, 180- 181, 331-332.
[7] Shanghai Municipal Health Bureau. Criteria for diagnosis and treatment of surgery. Shanghai: Shanghai Scientific and Technical Publishers. 1999 : 14, 44, 450-451. Chinese.
上海市卫生局.外科诊疗常规.上海:上海科学技术出版社. 1999: 14, 44, 450-451.
[8] Zhou BJ, Zhou LG . Determination of bactericidal effects of Chinese patent medicine Hongsheng Powder and Baijiang Powder on Staphylococcus aureus and Escherichia coli. Chengdu Zhong Yi Xue Yuan Xue Bao. 1982; ( 3): 60-61. Chinese.
周邦靖, 周六贵 . 红升丹､白降丹对金黄色葡萄球菌和大肠杆菌杀菌效力的测定.成都中医学院学报. 1982; ( 3):60-61.
[9] Zhu XD, Zhang Y, Chen RD . Study of regulatory control of microenvironment of wound on the growth of tissue-repair cell. Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi. 1996; 10(3): 139-141. Chinese with abstract in English.
朱旭东, 张艳, 陈荣德 . 伤口微环境对修复细胞生长调控规律的研究.中国修复重建外科杂志. 1996; 10(3):139-141.
[10] Zhang B, Meng ZQ . Effects of Hg and Ni on transformation of lymphocyte and synthesis of DNA. Guangdong Wei Liang Yuan Su Ke Xue. 1998; 5(4): 30-33. Chinese with abstract in English.
张波, 孟紫强 . 汞和镍对人血淋巴细胞转化及DNA合成的效应.广东微量元素科学. 1998; 5(4):30-33.
[11] Xie XB, Kuang DX, Tan XH, Zhu HB, Xia L, Li W . Monitoring blood mercury and urinary mercury concen- tration during treatment of condylomata acuminata by Hongsheng Powder. Shi Yong Yu Fang Yi Xue. 2008; 15(2) : 531. Chinese.
doi: 10.3969/j.issn.1006-3110.2008.02.104
谢小兵, 匡多秀, 谭新华, 朱惠斌, 夏历, 李武 . 红升丹治疗尖锐湿疣时病人血汞与尿汞浓度监测.实用预防医学. 2008; 15(2):531.
doi: 10.3969/j.issn.1006-3110.2008.02.104
[12] Pan LQ, Chen RM . The indicators observation of clinical safety of Sheng Powder agents: a report of 39 cases. Jiangsu Zhong Yi. 2000 ; 21(8) : 40. Chinese.
潘立群, 陈荣明 . 升丹制剂临床安全用药的指标观察——附39例临床资料.江苏中医. 2000; 21(8):40.
[13] Chen RM, Xu ZY . Renal toxicity of external use of Hongsheng Powder and its related agents. Nanjing Zhong Yi Yao Da Xue Xue Bao. 1995; 11(2): 73-75. Chinese.
陈荣明, 许芝银 . 小鼠皮肤创面外用红升丹及其制剂对肾脏的毒性和机理初探.南京中医药大学学报. 1995; 11(2):73-75.
[1] Xiao-hui Sun, Sheng Liu . External Chinese medical therapy for pain associated with hyperplastic disease of the breast: Study protocol of a randomized, double-blind, multicenter, controlled trial. Journal of Chinese Integrative Medicine, 2012, 10(4): 384-389.
[2] Peng Jin, Wu Xia-qiu, He Li-yun, Fang Yi-gong, Zi Ming-jie, Yan Shi-yan, Liu Bao-yan. Effects of summer acupoint application therapy in reducing exacerbation frequency of chronic lung diseases: protocol of a retrospective and prospective study. Journal of Chinese Integrative Medicine, 2012, 10(1): 39-47.
[3] Shi-jie Zhu , Li-qun Jia, Pei-wen Li. Clinical evaluation of the efficacy of external therapies of traditional Chinese medicine in treatment of cancer pain. Journal of Chinese Integrative Medicine, 2011, 9(1): 11-14.
[4] the Project Group for Demonstration Study of Syndrome Differentiation Protocol Effect Evaluation of Acute Ischemic Stroke, Yan Huang, Jian-wen Guo. Outcome and safety assessment of an herbal medicine treatment protocol for yin pattern of acute ischemic stroke. Journal of Chinese Integrative Medicine, 2010, 8(5): 417-426.
[5] Wen-yan Gao, Yi-fan Lin , Shan-quan Chen, Yu-ping Lu, Zhuo Yang, Yang Gong, Yang Liu, Li-xin Wang, Chang-hong Wang. Effects of Changjishu soft elastic capsule in treatment of diarrhea-predominant irritable bowel patients with liver-qi stagnation and spleen deficiency syndrome: A randomized double-blinded controlled trial. Journal of Chinese Integrative Medicine, 2009, 7(3): 212-217.
[6] Mei-ping Fan. Treatment of puerperal breast pain and distension with external application of cabbage. Journal of Chinese Integrative Medicine, 2005, 3(5): 362-362.
[7] Tong Zhang, Lian-ying Xu. Progress in research on pharmaceutics for intranasal medication. Journal of Chinese Integrative Medicine, 2004, 2(3): 223-225.
Viewed
Full text


Abstract

Cited
  Shared   
  Discussed   
[1] Jin-zhou Tian, Jing Shi, Xin-qing Zhang, Qi Bi, Xin Ma, Zhi-liang Wang, Xiao-bin Li, Shu-li Shen, Lin Li, Zhen-yun Wu, Li-yan Fang, Xiao-dong Zhao, Ying-chun Miao, Peng-wen Wang, Ying Ren, Jun-xiang Yin, Yong-yan Wang, Beijing United Study Group on MCI of the Capital Foundation of Medical Developments. An explanation on "guiding principles of clinical research on mild cognitive impairment (protocol)". Journal of Chinese Integrative Medicine, 2008, 6(1): 15-21
[2] Yi-ting He, Qing-lin Zha, Jian-ping Yu, Yong Tan, Cheng Lu, Ai-ping Lv. Principal factor analysis of symptoms of rheumatoid arthritis and their correlations with efficacy of traditional Chinese medicine and Western medicine. Journal of Chinese Integrative Medicine, 2008, 6(1): 32-36
[3] Jun Cai, Hua Wang, Sheng Zhou, Bin Wu, Hua-rong Song, Zheng-rong Xuan. Effect of Sijunzi Decoction and enteral nutrition on T-cell subsets and nutritional status in patients with gastric cancer after operation: A randomized controlled trial. Journal of Chinese Integrative Medicine, 2008, 6(1): 37-40
[4] Wei Zhang, Xiang-feng Lu, Xiao-mei Zhang, Jian-jun Wu, Liang-duo Jiang. A rat model of pulmonary fibrosis induced by infusing bleomycin quickly through tracheal intubation. Journal of Chinese Integrative Medicine, 2008, 6(1): 60-67
[5] A-gao Zhou, Yong Zhang, Gang Kui, De-Yun Kong, Hai-liang Ge, Qiu-hua Ren, Jia-rong Dong, Sheng Hong, Xu-ming Mao, Yin Wang, Hui-zheng Zhang, Shu-jun Wang. Influence of traditional Chinese compound recipes with different efficacy on body weight, tumor weight and immune function in H22 cancer-bearing mice. Journal of Chinese Integrative Medicine, 2008, 6(1): 77-82
[6] Guo-hong Yuan, Xiao-jing Pang, He-chao Ma. Synergic effects of Danggui Buxue Decoction in reducing toxicity of cytoxan in tumor-bearing mice. Journal of Chinese Integrative Medicine, 2008, 6(1): 83-88
[7] Li Zhou, Hong-xing Zhang, Ling-guang Liu, Wen-jun Wan. Effect of electro-acupuncture at Fenglong (GV 16) on nitric oxide and endothelin in rats with hyperlipidemia. Journal of Chinese Integrative Medicine, 2008, 6(1): 89-92
[8] Jin-zhou Tian, Jing Shi, Xin-qing Zhang, Qi Bi, Xin Ma, Zhi-liang Wang, Xiao-bin Li, Shu-li Shen, Lin Li, Zhen-yun Wu, Li-yan Fang, Xiao-dong Zhao, Ying-chun Miao, Peng-wen Wang, Ying Ren, Jun-xiang Yin, Yong-yan Wang, Beijing United Study Group on MCI of the Capital Foundation of Medical Developments. Guiding principles of clinical research on mild cognitive impairment (protocol). Journal of Chinese Integrative Medicine, 2008, 6(1): 9-14
[9] Xin-jun Wang, Ling-ling Wang . A mechanism of endogenous opioid peptides for rapid onset of acupuncture effect in treatment of depression. Journal of Chinese Integrative Medicine, 2010, 8(11): 1014-1017
[10] Bo Wang , Wei Yan , Li-hui Hou, Xiao-ke Wu. Disorder of Tiangui (kidney essence) and reproductive dysfunction in patients with polycystic ovary syndrome. Journal of Chinese Integrative Medicine, 2010, 8(11): 1018-1022
[an error occurred while processing this directive]