巢式病例对照研究在中医药治疗糖尿病肾病疗效评价中的应用探讨

doi:10.3736/jcim20120907

Abstract

Objective: A nested case-control study was carried out to assess the effectiveness of Chinese medicines in the treatment of diabetic nephropathy, so as to explore the feasibility of using nested case-control study on effect assessment of Chinese medicine

Methods: Nested case-control study was applied and the participants were enrolled from the subjects recruited in a cohort study. The cases and the controls were matched by 1 to 4 in age, gender, nationality and the stage of diabetic nephropathy when recruited in the cohort study. The EpiData 3.1 software was used for inputting data and SAS system was used for data analysis. Conditional logistic regress was applied to analyze the relationship between treatment and the progression of diabetic nephropathy. The study power was estimated and the sample sizes for case-control study and cohort study were recalculated based on the data from the cohort study

Results: Eight cases and 32 controls were recruited in this study. The education level, ratio of drug withdrawal, change of therapy, syndrome differentiation and treatment were not significantly different in case and control groups. The progression of diabetic nephropathy was not significantly related with the treatment and the odds ratio (OR) value was 0.725 with a 95% confidence interval from 0.174 to 3.030. The statistical power of the study was 5%. To achieve the statistical power of 80%, 1 350 (270∶1 080) participants were needed for 1∶4 matched case-control study, 880 (440∶440) for 1∶1 paired case-control study, and 1 020 (510∶510) for 1∶1 control study

Conclusion: The treatment method is not significantly related with the progress of diabetic nephropathy. The nested case-control study is applicable in the therapeutic effect evaluation of Chinese medicine. Basic studies such as cross-sectional studies should be carried out to supply fundamental information for other types of studies including case-control study, cohort study and randomized clinical trials. Large sample size studies were needed to appraise the effect of Chinese medicine.

Key words: case-control studies, diabetic nephropathies, logistic models, traditional Chinese medicine, treatment outcome

Zhao-lan Liu, Qing Li , Yu-jie Mu , Ying Gao, Jian-ping Liu. Using nested case-control study to appraise the effectiveness of Chinese medicines in the treatment of diabetic nephropathy. Journal of Chinese Integrative Medicine, 2012, 10(9): 991-996.

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URL: http://www.jcimjournal.com/EN/10.3736/jcim20120907

http://www.jcimjournal.com/EN/Y2012/V10/I9/991

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[1]	Kauppinen TP, Partanen TJ, Nurminen MM, Nickels JI, Hernberg SG, Hakulinen TR, Pukkala EI, Savonen ET . Respiratory cancers and chemical exposures in the wood industry: a nested case-control study[J]. Br J Ind Med, 1986,43(2):84-90
[2]	He SL, Xu XK, Shen TH, Wang MD . A nested case-control study on the effect of three cell latrine for preventing the infection of the intestinal parasite[J]. Huan Jing Yu Jian Kang Za Zhi, 1996,13(5):206-208, 212
	何升良, 徐祥宽, 申屠杭, 王明娣 . 三缸厕所预防肠寄生虫感染效果的“巢式”病例-对照研究[J]. 环境与健康杂志, 1996,13(5):206-208, 212
[3]	Xiao Y, Zhao YB, Xie YM . Application of nested case-control study on safe evaluation of post-marketing traditional Chinese medicine injection[J]. Zhongguo Zhong Yao Za Zhi, 2011,36(20):2796-2798
	肖颖, 赵玉斌, 谢雁鸣 . 巢式病例对照研究在中药注射剂上市后安全性研究中的应用[J]. 中国中药杂志, 2011,36(20):2796-2798
[4]	Zhao YB, Xiao Y, Xie YM, Li YY . Change of serum immunotoxicology indexes in patients with anaphylaxis induced by Qingkailing injection: prospective nested case-control study[J]. Zhong Cheng Yao, 2011,33(5):746-751
	赵玉斌, 肖颖, 谢雁鸣, 黎元元 . 清开灵注射液过敏反应患者血清免疫毒理学指标变化规律的巢式病例对照研究[J]. 中成药, 2011,33(5):746-751
[5]	Li LM. Epidemiology.6th ed[M]. Beijing: People’s Medical Publishing House, 2008,87
	李立明. 流行病学. 第6版[M]. 北京: 人民卫生出版社, 2008,87
[6]	Mogensen CE, Christensen CK, Vittinghus E . The stages in diabetic renal disease. With emphasis on the stage of incipient diabetic nephropathy[J]. Diabetes, 1983,32(Suppl 2):64-78 doi: 10.2337/diab.32.2.S64
[7]	Li Q, Zhang HM, Fei YT, Xing JM, Luo H, Liu JP . Treatment of diabetic nephropathy by integrative medicine: a multi-center prospective cohort study[J]. Zhongguo Zhong Xi Yi Jie He Za Zhi, 2012,32(3):317-321
	李青, 张惠敏, 费宇彤, 邢建民, 罗辉, 刘建平 . 中西医结合治疗糖尿病肾病多中心前瞻性队列研究[J]. 中国中西医结合杂志, 2012,32(3):317-321
[8]	Molitch ME , DeFronzo RA, Franz MJ, Keane WF, Mogensen CE, Parving HH, Steffes MW; American Diabetes Association.Nephropathy in diabetes[J]. Diabetes Care, 2004,27(Suppl 1):S79-S83 doi: 10.2337/diacare.27.2007.S79
[9]	Mogensen CE . Microalbuminuria, blood pressure and diabetic renal disease: origin and development of ideas[J]. Diabetologia, 1999,42(3):263-285 doi: 10.1007/s001250051151
[10]	Zhang LF, Zhao JX, Lü RH, Yang HT, Cao SL, Huang XM, Zhang SE, Ma JW, Xu LM, Zhu ZZ, Liu M, Zhou CH, Yang J, Qi LG, Li ZM, Feng XZ, Jiang M, Cheng YC, Guo BR . Study on effectiveness and safety of optimum program for prevention and treatment of renal insufficiency of diabetic nephropathy[J]. Zhong Yi Za Zhi, 2006,47(10):755-758
	张丽芬, 赵进喜, 吕仁和, 杨洪涛, 曹式丽, 黄学民, 张淑娥, 马建伟, 徐丽梅, 朱章志, 刘敏, 周春华, 杨君, 亓鲁光, 李朝敏, 冯兴中, 姜敏, 程益春, 郭宝荣 . 糖尿病肾病肾功能不全防治优化方案的有效性和安全性研究[J]. 中医杂志, 2006,47(10):755-758
[11]	Zhao JX, Mou X, Wang SD, Song ML, Huang XM, Yu XC, Xiao YH, Li J, Song B, Feng XZ, Xu LM, Yang J, Jiang S, Lü RH . Clinical observation on 31 cases of diabetic nephropathy with renal insufficiency at compensatory phase treated with Zhixiao Wenshenning granule[J]. Zhong Yi Za Zhi, 2005,46(9):677-679
	赵进喜, 牟新, 王世东, 宋美铃, 黄学民, 于秀辰, 肖永华, 李靖, 宋冰, 冯兴忠, 徐丽梅, 杨君, 姜森, 吕仁和 . 止消温肾宁颗粒剂治疗糖尿病肾病肾功能不全代偿期31例临床观察[J]. 中医杂志, 2005,46(9):677-679
[12]	Zhang Y, Ye XF, Shen W, Tu X, Luo M . The effect of combined treatment of Chinese medicine and Western medicine on diabetic nephropathy: a meta-analysis[J]. Yunnan Zhong Yi Xue Yuan Xue Bao, 2011,34(4):31-34
	张嬿, 叶学锋, 沈伟, 涂翔, 罗梅 . 中西医结合治疗糖尿病肾病疗效的系统评价[J]. 云南中医学院学报, 2011,34(4):31-34
[13]	Song ML, Yang M, Mou X, Zhang LF, Zhao JX . Evaluation of curative effects of Chinese medical therapies on renal function and symptoms of renal failure of diabetic nephropathy[J]. Beijing Zhong Yi Yao Da Xue Xue Bao, 2006,29(6):429-432
	宋美铃, 杨敏, 牟新, 张丽芬, 赵进喜 . 中医辨证治疗糖尿病肾病肾功能不全的肾功能指标疗效和证候疗效评价[J]. 北京中医药大学学报, 2006,29(6):429-432

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Item	n	Proportion (%)
Time of progression (months)
24	3	37.5
12	3	37.5
6	2	25.0
Recruitment stage of diabetic nephropathy
Ⅲ	5	62.5
Ⅳ	3	37.5

Item	Case group (n=8)	Control group (n=32)	χ²/Zvalue	Pvalue
Age ($\overline{x}$±s, years)	58.63±11.07	59.28±9.42	—	—
Duration (Median (P₂₅, P₇₅), months)	7 (1.00, 20.75)	1 (0, 11.00)	1.036	0.300
Gender
Male	5	20	—	—
Female	3	12
Education degree^*
Primary school (≤6 years)	1	3	—	0.719^a
Junior high school (6 to 9 years)	2	4
Senior high school or technical secondary school (9 to 12 years)	2	13
Senior high school above (>12 years)	2	10
Recruitment stage of diabetic nephropathy
Ⅲ	5	20	—	—
Ⅳ	3	12
Drug withdrawal during follow-up
Yes	0	5	—	0.563^a
No	8	27
Treatment based on syndrome differentiation
Yes	4	19	—	0.702^a
No	4	13
Therapy adjustment
Yes	3	6	—	0.348^a
No	5	26

Matching No	Case group		Control group		χ²	OR (95% CI)
Matching No	Integrative treatment	Western treatment	Integrative treatment	Western treatment	χ²	OR (95% CI)
1	1	0	2/4	2/4	0.194	0.725 (0.174, 3.030)
2	1	0	3/4	1/4
3	1	0	2/4	2/4
4	0	1	2/4	2/4
5	0	1	3/4	1/4
6	0	1	3/4	1/4
7	1	0	1/4	3/4
8	0	1	3/4	1/4
Total	4 (50.0%)	4 (50.0%)	19 (59.4%)	13 (40.6%)

Using nested case-control study to appraise the effectiveness of Chinese medicines in the treatment of diabetic nephropathy

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