Study on the diagnostic criteria of syndrome of dampness obstruction in idiopathic membranous nephropathy based on expert consensus

doi:10.19852/j.cnki.jtcm.2025.01.016

Journal of Traditional Chinese Medicine ›› 2025, Vol. 45 ›› Issue (1): 167-175.DOI: 10.19852/j.cnki.jtcm.2025.01.016

Study on the diagnostic criteria of syndrome of dampness obstruction in idiopathic membranous nephropathy based on expert consensus

WANG Dan¹, HUANG Xiaoyan², LI Ping²^,⁴, HONG Xiaofan², ZHANG Yumin², WANG Rongrong²^,³, BAO Kun²^,³^,⁴^,⁵(), LIANG Xing²^,³()

1 Nephrology Department, Qianxinan Autonomous Prefecture Hospital of Traditional Chinese Medicine, Xingyi 562400, China
2 Nephrology Department, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510120, China
3 State Key Laboratory of Dampness Syndrome of Chinese Medicine, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510120, China
4 Guangdong Provincial Key Laboratory of Chinese Medicine for Prevention and Treatment of Refractory Chronic Disease, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510120, China
5 Guangdong-Hong Kong-Macau Joint Lab on Chinese Medicine and Immune Disease Research, Guangzhou 510120, China

Received:2023-12-11 Accepted:2024-05-15 Online:2025-02-15 Published:2025-01-10
Contact: LIANG Xing, Nephrology Department, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510120, China. avislxx@21cn.com; BAO Kun, Nephrology Department, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510120, China. baokun@aliyun.com Telephone: +86-13560343752; +86-13711224369
Supported by:
the Special Project of State Key Laboratory of Dampness Syndrome of Chinese Medicine: Study on Criteria for Diagnosis of Dampness Syndrome of Idiopathic Membranous Nephropathy, Cohort Study on Pathogenesis and Material Basis of Dampness Syndrome of Idiopathic Membranous Nephropathy, Randomized Controlled Clinical Study of Sanqi Qushi Granule in Treatment of Membranous Nephropathy(SZ2021ZZ02);the Special Project of State Key Laboratory of Dampness Syndrome of Chinese Medicine: Study on Criteria for Diagnosis of Dampness Syndrome of Idiopathic Membranous Nephropathy, Cohort Study on Pathogenesis and Material Basis of Dampness Syndrome of Idiopathic Membranous Nephropathy, Randomized Controlled Clinical Study of Sanqi Qushi Granule in Treatment of Membranous Nephropathy(SZ2021ZZ09);the Special Project of State Key Laboratory of Dampness Syndrome of Chinese Medicine: Study on Criteria for Diagnosis of Dampness Syndrome of Idiopathic Membranous Nephropathy, Cohort Study on Pathogenesis and Material Basis of Dampness Syndrome of Idiopathic Membranous Nephropathy, Randomized Controlled Clinical Study of Sanqi Qushi Granule in Treatment of Membranous Nephropathy(SZ2021ZZ36);the 2020 Guangdong Provincial Science and Technology Innovation Strategy Special Fund: Guangdong-Hong Kong-Macau Joint Lab(2020B1212030006);the Natural Science Foundation of Guangdong Province: Study on the Mechanism of Sanqi Qushi Prescription Delaying Podocellular Senescence in Membranous Nephropathy based on Cyclic Guanosine Monophosphate-Adenosine Monophosphate Synthase-Stimulator of Interferon Genes-Nuclear Factor Kappa-B Signaling Pathway(2022A1515011628);the Guangzhou Science and Technology Plan Project: to Explore the Mechanism of Treating Membranous Nephropathy from the Perspective of Regulating Amino Acid Metabolism Disorder(2023A03J0746);Special Funding for Scientific and Technological Research on Traditional Chinese Medicine, Guangdong Provincial Hospital of Chinese Medicine: a Multimodular Machine Learning Prediction Model based on Pathological Image-transcriptomics and Traditional Chinese Medicine Syndromes was Used to Investigate the Prognostic Correlation of Long non-coding RNA Molecules in Nephropathy and the Intervention Mechanism of Sanqi Qushi Formula, to Investigate the Pathogenesis and Microbiological Mechanism of Dampness Syndrome of Membranous Nephropathy based on the Microecological Changes of Tongue Coating(YN2023MB02);Special Funding for Scientific and Technological Research on Traditional Chinese Medicine, Guangdong Provincial Hospital of Chinese Medicine: a Multimodular Machine Learning Prediction Model based on Pathological Image-transcriptomics and Traditional Chinese Medicine Syndromes was Used to Investigate the Prognostic Correlation of Long non-coding RNA Molecules in Nephropathy and the Intervention Mechanism of Sanqi Qushi Formula, to Investigate the Pathogenesis and Microbiological Mechanism of Dampness Syndrome of Membranous Nephropathy based on the Microecological Changes of Tongue Coating(YN2023MB10)

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Abstract

Abstract:

OBJECTIVE: To reach consensus on the diagnostic criteria of syndrome of dampness obstruction in idiopathic membranous nephropathy (IMN) patients by literature research and expert investigation (interviews and a Delphi method).

METHODS: Our study was consistent with T/CACM 1336-2020. We searched the monographs and references published in the past 40 years (1983-2022), and established the diagnostic criteria pool of water-dampness syndrome and dampness-turbidity syndrome in Traditional Chinese Medicine (TCM) based on literature by using frequency statistics and correlation analysis. Expert investigation (interview method and two rounds of Delphi method) was used to form the diagnostic criteria of water-dampness syndrome and dampness-turbidity syndrome of idiopathic membranous nephropathy. Clinical diagnostic test research was carried out, and compared with “Diagnostic Criteria for dampness syndrome” (T/CACM 1454-2023) to evaluate the authenticity, reliability and clinical application value of the standard.

RESULTS: A total of 122 relevant guides, standards, monographs and documents were included through searching books and Chinese databases. Four experts were interviewed and two rounds of delphi method (75 experts nationwide) were carried out. The experts' opinions are relatively concentrated and the differences are small. Based on the weight of each index, the diagnostic criteria indexes of water-dampness syndrome and dampness-turbidity syndrome were selected. After discussion by the core group members, the diagnostic model of "necessary symptoms and optional symptoms" was established, and the final diagnostic criteria of water-dampness syndrome and dampness-turbidity syndrome were established. One hundred and ninety-one inpatients and outpatients of Guangdong Provincial Hospital of Chinese Medicine from January 2021 to February 2023 were included in Diagnostic test study. There was no statistical difference in gender, age and course of disease (P > 0.05). The sensitivity and specificity of the trial standard were 90.34% and 73.33% respectively, while the sensitivity and specificity of T/CACM 1454-2023 were 99.43% and 6.67%, respectively.

CONCLUSIONS: The consensus-based diagnostic criteria for IMN can be widely incorporated in TCM. A further clinical study will be conducted to analyze the diagnosis value and cut-off score of our IMN criteria.

Key words: glomerulonephritis, membranous, diagnostic tests, routine, syndrome of dampness obstruction, combination of disease and syndrome, syndrome diagnostic criteria

WANG Dan, HUANG Xiaoyan, LI Ping, HONG Xiaofan, ZHANG Yumin, WANG Rongrong, BAO Kun, LIANG Xing. Study on the diagnostic criteria of syndrome of dampness obstruction in idiopathic membranous nephropathy based on expert consensus[J]. Journal of Traditional Chinese Medicine, 2025, 45(1): 167-175.

Figures/Tables 10

Figure 1 Flow diagram of the literature research IMN: idiopathic membranous nephropathy.

Table 1 Characteristics of water-dampness syndrome in idiopathic membranous nephropathy

Order number	Symptom	Support degree (%)	Confidence degree (%)	Order number	Symptom	Support degree (%)	Confidence degree (%)
1	Edema	13.45	100.00	19	Distention and fullness in the stomach	1.03	7.69
2	Greasy fur	11.72	87.18	20	Sticky and greasy in mouth	1.03	7.69
3	White fur	10.34	76.92	21	Asthma	0.69	5.13
4	Deep pulse	8.28	61.54	22	Palpitation	0.69	5.13
5	Anorexia	6.21	46.15	23	Greasy fur	0.69	5.13
6	Heavy body	5.86	43.59	24	Bubbly urine	0.69	5.13
7	Oppression in chest	5.86	43.59	25	Pink tongue	0.69	5.13
8	Moderate pulse	4.83	35.90	26	Slippery pulse	0.69	5.13
9	Thready pulse	4.83	35.90	27	Tastelessness	0.34	2.56
10	Abdominal fullness	4.48	33.33	28	Emaciation	0.34	2.56
11	Nausea and vomiting	4.14	30.77	29	Expectoration	0.34	2.56
12	Hypourocrinia	4.14	30.77	30	Pale complexion	0.34	2.56
13	Spiritlessness and weakness	2.07	15.38	31	Shortness of breath	0.34	2.56
14	Slow onset and long course of disease	2.07	15.38	32	Soreness of loins	0.34	2.56
15	Plump tongue	1.72	12.82	33	Teeth-printed tongue	0.34	2.56
16	Soft pulse	1.72	12.82	34	Fear of cold	0.34	2.56
17	Dysuria	1.38	10.26	35	Stringy pulse	0.34	2.56
18	Loose stool	1.03	7.69

Table 2 Characteristics of dampness-turbidity syndrome in idiopathic membranous nephropathy

Order number	Symptom	Support degree (%)	Confidence degree (%)	Order number	Symptom	Support degree (%)	Confidence degree (%)
1	Anorexia	7.59	100.00	18	Distention and fullness in the stomach	1.38	18.18
2	Heavy body	6.90	90.91	19	Red tongue	1.38	18.18
3	Nausea and vomiting	6.90	90.91	20	Rapid pulse	1.38	18.18
4	Greasy fur	6.90	90.91	21	Yellow fur	1.38	18.18
5	Spiritlessness and weakness	5.52	72.73	22	Turbid urine	1.03	13.64
6	Sticky and greasy in mouth	4.48	59.09	23	Moderate pulse	0.69	9.09
7	Abdominal fullness	4.48	59.09	24	Stringy pulse	0.69	9.09
8	High blood urea nitrogen and creatinine	2.76	36.36	25	Loose stool	0.69	9.09
9	Edema	2.76	36.36	26	Thready pulse	0.69	9.09
10	Soft pulse	2.41	31.82	27	Deep-colored urine	0.69	9.09
11	Slippery pulse	2.41	31.82	28	Halitosis	0.34	4.55
12	White fur	2.07	27.27	29	Loose stool and constipation	0.34	4.55
13	Deep pulse	2.07	27.27	30	Thirst without desire to drink	0.34	4.55
14	Dry mouth	1.72	22.73	31	Teeth-printed tongue	0.34	4.55
15	Difficulty and pain in micturition	1.38	18.18	32	Non-smooth bowel movements	0.34	4.55
16	Inflamed and sore throat	1.38	18.18	33	Hypourocrinia	0.34	4.55
17	Pink tongue	1.38	18.18

Table 3 Concentration degree and coordination degree of expert opinions in questionnaire round one

Item	n	Arithmetic mean	Grade sum	Full score rate (%)	Variation coefficient
1.edema	72	3.7222	268	72.22	0.121178335
2.anorexia	72	3.3472	241	34.72	0.14323315
3.spiritlessness and weakness	72	3.3056	238	30.56	0.140328533
4.dry mouth	72	3.0972	223	18.06	0.210990572
5.bitter taste in mouth	72	3.0972	223	18.06	0.210990572
6.sticky and greasy in mouth	72	3.3333	240	33.33	0.142414424
7.abdominal fullness	72	3.2639	235	26.39	0.135981495
8.distention and fullness in the stomach	72	3.2778	236	27.78	0.137607542
9.heavy body	72	3.4583	249	45.83	0.145088627
10.nausea and vomiting	72	3.2778	236	27.78	0.137607542
11.oppression in chest	72	3.1806	229	18.06	0.121785198
12.skin lesion	72	3.125	225	20.83	0.2144096
13.dysuria	72	3.4306	247	43.06	0.145347753
14.hypourocrinia	72	3.3889	244	38.89	0.144861164
15.loose stool	72	3.1667	228	16.67	0.118511384
16.pink tongue	72	3.125	225	25.00	0.251552
17.white and greasy fur	72	3.5417	255	54.17	0.141672078
18.deep pulse	72	3.3056	238	30.56	0.140328533
19.thready pulse	72	3.0833	222	20.83	0.247958356
20.soft pulse	72	3.1806	229	22.22	0.177592278

Table 4 Concentration degree and coordination degree of expert opinions in questionnaire round two

Syndrome	Item	n	Arithmetic mean	Grade sum	Full score rate (%)	Variation coefficient
Water-dampness syndrome	1.edema	22	4.7273	104	72.73	0.096427136
	2.anorexia	22	3.7273	82	18.18	0.236828267
	3.heavy body	22	4.1364	91	31.82	0.171685524
	4.white and greasy fur	22	4.4545	98	50.00	0.133752385
	5.deep pulse	22	3.7273	82	13.64	0.205859469
Dampness-turbidity syndrome	1.anorexia	22	4.1818	92	40.91	0.203931321
	2.heavy body	22	4.3182	95	40.91	0.149675791
	3.nausea and vomiting	22	4.1818	92	50.00	0.240678655
	4.greasy fur	22	4.5455	100	59.09	0.131074689
	5.spiritlessness and weakness	22	3.5909	79	13.64	0.252894817
	6.sticky and greasy in mouth	22	4.1818	92	36.36	0.175202066
	7.abdominal fullness	22	3.7273	82	13.64	0.250886701

Table 5 Weight coefficient of diagnostic items in water-dampness syndrome

Item	n	Grade sum	Initial weight	Integrative weight
1. edema	22	104	0.086164043	9
2. white and greasy fur	22	98	0.081193041	8
3. heavy body	22	91	0.075393538	8
4. anorexia	22	82	0.067937034	7
5. deep pulse	22	82	0.067937034	7
6. plump tongue	22	52	0.043082022	4
7. teeth-printed tongue	22	50	0.041425021	4
8. dysuria	22	46	0.038111019	4
9. loose stool	22	40	0.033140017	3
10. distention and fullness in the stomach	22	37	0.030654515	3
11. spiritlessness and weakness	22	37	0.030654515	3
12. abdominal fullness	22	35	0.028997514	3
13. slippery pulse	22	35	0.028997514	3
14. soft pulse	22	35	0.028997514	3
15. greasy fur	22	35	0.028997514	3
16. sticky and greasy in mouth	22	34	0.028169014	3
17. hypourocrinia	22	28	0.023198012	2
18. nausea and vomiting	22	28	0.023198012	2
19. bubbly urine	22	28	0.023198012	2
20. slow onset and long course of disease	22	28	0.023198012	2
21. oppression in chest	22	26	0.021541011	2
22. soreness of loins	22	26	0.021541011	2
23. shortness of breath	22	25	0.02071251	2
24. turbid urine	22	25	0.02071251	2
25. dirty face	22	25	0.02071251	2
26. asthma	22	25	0.02071251	2
27. pink tongue	22	25	0.02071251	2
28. thready pulse	22	25	0.02071251	2

Table 6 Weight coefficient of diagnostic items in dampness-turbidity syndrome

Item	n	Grade sum	Initial weight	Integrative weight
1. greasy fur	22	100	0.081900082	8
2. heavy body	22	95	0.077805078	8
3. nausea and vomiting	22	92	0.075348075	8
4. anorexia	22	92	0.075348075	8
5. sticky and greasy in mouth	22	92	0.075348075	8
6. abdominal fullness	22	82	0.067158067	7
7. spiritlessness and weakness	22	79	0.064701065	6
8. edema	22	56	0.045864046	5
9. non-smooth bowel movements	22	48	0.039312039	4
10. distention and fullness in the stomach	22	44	0.036036036	4
11. hypourocrinia	22	38	0.031122031	3
12. turbid urine	22	37	0.03030303	3
13. teeth-printed tongue	22	33	0.027027027	3
14. thirst without desire to drink	22	33	0.027027027	3
15. halitosis	22	32	0.026208026	3
16. deep-colored urine	22	30	0.024570025	2
17. slippery pulse	22	30	0.024570025	2
18. loose stool	22	29	0.023751024	2
19. soft pulse	22	28	0.022932023	2
20. red tongue	22	26	0.021294021	2
21. yellow fur	22	26	0.021294021	2
22. dry mouth	22	25	0.02047502	2
23. dirty face	22	25	0.02047502	2
24. white fur	22	25	0.02047502	2
25. deep pulse	22	24	0.01965602	2

Table 7 The basic clinical data of 191 patients

Item		Syndrome of dampness obstruction (n = 176)	Non-syndrome of dampness obstruction (n = 15)	$χ 2$ /Z value	P value
Gender	Male	107	8	0.321	0.571
	Female	69	7
Age (year)		59.5 (47, 68)	60 (45, 70)	－0.075	0.940
Disease course (month)		27 (18, 53)	28 (13, 41)	－0.610	0.548

Table 7 The basic clinical data of 191 patients

Item		Syndrome of dampness obstruction (n = 176)	Non-syndrome of dampness obstruction (n = 15)	$χ 2$ /Z value	P value
Gender	Male	107	8	0.321	0.571
	Female	69	7
Age (year)		59.5 (47, 68)	60 (45, 70)	－0.075	0.940
Disease course (month)		27 (18, 53)	28 (13, 41)	－0.610	0.548

Table 8 Evaluation results of the trial standard and T/CACM 1454-2023

Standard name		Reference standard (n)		Sensitivity (%)	Specificity (%)	Positive predictive value (%)	Negative predictive value (%)	Accuracy (%)	Missed diagnosis rate (%)	Misdiagnosis rate (%)
Standard name		Positive	Negative	Sensitivity (%)	Specificity (%)	Positive predictive value (%)	Negative predictive value (%)	Accuracy (%)	Missed diagnosis rate (%)	Misdiagnosis rate (%)
The trial standard	Positive	159	4	90.34	73.33	97.55	39.29	89.01	9.66	26.67
The trial standard	Negative	17	11	90.34	73.33	97.55	39.29	89.01	9.66	26.67
T/CACM 1454-2023	Positive	175	14	99.43	6.67	92.59	50.00	92.15	0.57	93.33
T/CACM 1454-2023	Negative	1	1	99.43	6.67	92.59	50.00	92.15	0.57	93.33

Table 9 Evaluation results of water-dampness syndrome and dampness-turbidity syndrome

The trial standard		Reference standard (n)		Sensitivity (%)	Specificity (%)	Positive predictive value (%)	Negative predictive value (%)	Accuracy (%)	Missed diagnosis rate (%)	Misdiagnosis rate (%)
The trial standard		Positive	Negative	Sensitivity (%)	Specificity (%)	Positive predictive value (%)	Negative predictive value (%)	Accuracy (%)	Missed diagnosis rate (%)	Misdiagnosis rate (%)
Water-dampness syndrome	Positive	72	2	97.30	98.29	97.30	98.29	97.91	2.70	1.71
Water-dampness syndrome	Negative	2	115	97.30	98.29	97.30	98.29	97.91	2.70	1.71
Dampness-turbidity syndrome	Positive	87	2	85.29	97.75	97.75	85.29	91.10	14.71	2.25
Dampness-turbidity syndrome	Negative	15	87	85.29	97.75	97.75	85.29	91.10	14.71	2.25

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