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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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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