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CONSENSUS
Year : 2015  |  Volume : 2  |  Issue : 2  |  Page : 43-45

Diagnosis, Pattern-Based Classification, and Efficacy Evaluation in Chronic Kidney Disease (Pilot Protocol)


Date of Web Publication24-Apr-2015

Correspondence Address:
, Society of Nephrology of China Association of Chinese Medicine
,

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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2225-1243.155773

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How to cite this article:
Society of Nephrology of China Association of Chinese Medicine. Diagnosis, Pattern-Based Classification, and Efficacy Evaluation in Chronic Kidney Disease (Pilot Protocol). J Integr Nephrol Androl 2015;2:43-5

How to cite this URL:
Society of Nephrology of China Association of Chinese Medicine. Diagnosis, Pattern-Based Classification, and Efficacy Evaluation in Chronic Kidney Disease (Pilot Protocol). J Integr Nephrol Androl [serial online] 2015 [cited 2019 Jul 22];2:43-5. Available from: http://www.journal-ina.com/text.asp?2015/2/2/43/155773

Group leader (and written by): Prof. Liqun He, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Group members: Lvqi Han, The Institute of Traditional Chinese Medicine, Shanxi Province, China; Zhaodi Shao, Xiaoqin Wang, Hubei Provincial Hospital of Traditional Chinese Medicine, China; Wei Sun, Jiangsu Provincial Hospital of Traditional Chinese Medicine, China; Peiqing Zhang, The Institute of Traditional Chinese Medicine, Heilongjiang Province; Nizhi Yang, Xusheng Liu, Guangdong Provincial Hospital of Traditional Chinese Medicine, China.



  Diagnosis Top


Diagnosis and staging of chronic kidney disease

Chronic kidney disease (CKD) is diagnosed and staged according to Guideline 1: Definition and Stages of Chronic Kidney Disease, Kidney Disease Outcome Quality Initiative (K/DOQI) Clinical Practice Guidelines for Chronic Kidney Disease released in 2002.

Chronic kidney disease is defined as any of the following:

  • Kidney injury ≥3 months with or without decreased glomerular filtration rate (GFR). The kidney injury here is defined as structural or functional abnormalities of the kidney. It may present as one of the following: Pathologic abnormalities, markers of kidney impairment, including abnormalities in blood or urine test or imaging studies.
  • GFR <60 mL/min/1.73 m 2 ≥ 3 months, with or without kidney injury.


Staging of CKD: Stages 2-5 (Stage 1 is often regarded as primary renal abnormalities) are adopted as the criteria for classification of CKD, which are typically defined as mild, moderate, severe, and end-stage renal failure, respectively [Table 1].


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Previous classic diagnostic criteria

Compensated renal insufficiency (Stage 1)


C Cr 50-80 mL/min, S Cr 133-177 μmol/L, clinically asymptomatic.

Decompensated renal insufficiency (Stage 2)

C Cr 50-22 mL/min, S Cr 186-442 μmol/L. It may present with polyuria and nocturia, with the presence of mild anemia, but usually without marked symptoms.

Kidney failure (Stage 3)

C Cr 20-10 mL/min, S Cr 451-707 μmol/L. It may present with evident anemia and is often accompanied by nocturia, isosthenuria, water-electrolyte imbalance, mild to moderate metabolic acidosis, water and sodium retention, hypocalcemia and hyperphosphatemia. Hyperkalemia is generally absent. In addition, it may also present with gastrointestinal, cardiovascular or neurological disorders.

Uremia (Stage 4)

C Cr <10 mL/min, S Cr >707 μmol/L. Severe systemic disorders are likely to develop, with evident gastrointestinal, cardiovascular, and neurological disorders in particular. Severe water-electrolyte imbalance and metabolic acidosis are also present.


  Differential Diagnosis Top


The following conditions should be excluded in the differential diagnosis of CKD:

  1. Acute exacerbation of CKD;
  2. Nephritic syndrome;
  3. Gastrointestinal disorders and tumors;
  4. Hematologic diseases,
  5. Peripheral neuritis,
  6. Hypertensive encephalopathy, etc.



  Pattern Identification and Classification Top


Inherent patterns

Liver and kidney Qi-deficiency


Primary symptoms encompass soreness and weakness of the waist and knees, lassitude, lack of strength, refractory edema, indigestion, and abdominal distention. Secondary symptoms may include fear of cold and preference for warmth, nocturia, or loose stools. Patients with this pattern usually have a light purple tongue with a rough, thin, sunken, and slow pulse.

Liver and kidney Yin-deficiency

Its primary symptoms encompass weakness of the waist, knees and legs, dizziness and tinnitus, a vexing sensation in the chest, palms and soles, shortage of Qi and lack of strength. Secondary symptoms may include a dry mouth and throat, dry and bound stools, yellow urine with decreased output, and a dark purple facial complexion. Patients with this pattern usually have a dusky tongue with or without stasis macules (spots), and a sunken-thin and weak pulse.

Spleen and kidney Yang-deficiency

Its primary symptoms encompass fear of cold and cold limbs, a cold stomach and preference for hot drinks, regurgitation of water, cold pain in the loin and knees, loose stools or fifth-watch diarrhea. Secondary symptoms may include a pallid or dull complexion, hair loss or loosened teeth, sexual dysfunction, nocturia or clear urine. Patients with this pattern usually have a teeth-marked tongue with a sunken, thin or sunken, weak pulse.

For each of the above patterns, diagnosis is made if two of the above primary symptoms, or one primary symptom plus two secondary symptoms are present.

Qi and Yin-deficiency

The diagnosis of Qi and Yin-deficiency is achieved either with one primary symptom each of spleen and kidney Qi-deficiency, and liver and kidney Yin-deficiency, or with one primary symptom of one pattern plus two secondary symptoms of the other pattern. Yin-deficiency may accompany blood-deficiency, which can present with a yellowish and dull complexion, a thin tongue, and a thin, weak pulse.

Yin and Yang-deficiency

Diagnosis of Yin and Yang-deficiency is achieved if enduring disease is seen and any three of the following symptoms are present: Lassitude of spirit and lack of strength, loss of appetite, low urine output, soreness of the waist and knees, a lusterless complexion, dizziness and dizzy vision.

Accompanying patterns

Pattern of turbid-dampness


Symptoms may include nausea, vomiting, a dry and bitter taste in mouth, indigestion, abdominal distention, dry stools, and low urine output. Yellow, greasy, thick or dry tongue coating is often seen. The pulse of this pattern tends to be stringy and slippery.

Heat-dampness pattern

Symptoms may include frequent, unsmooth and painful urination with a dark-yellow appearance, and distention and fullness in the lower abdomen. Yellow and greasy tongue coating is often seen. The pulse of this pattern tends to be soggy and rapid.

Pattern of heat-toxicity

Symptoms of this pattern may include a dry and sore throat, thirsty with vexing heat, scanty and dark urine, and dry stools. The tongue is red with a yellow coating. The pulse tends to be rapid.

Pattern of blood stasis

Symptoms of this pattern may include purple and dark lips and nail beds, dry scaly skin, pain of fixed location or tingling pain in the lower back. The tongue is dark purple or has stasis macules or stasis spots. The pulse may be rough or thin-rough.

Pattern of wind disorder

Symptoms may include finger tics, spasm, loss of consciousness and delirium. Patients with this pattern tend to have a wriggling tongue with a floating pulse.


  Assessment of Treatment Efficacy Top


Criteria for classification of symptoms

Based on the Stanghellini criteria, CKD is classified on a 0-3 scale according to the severity of symptoms. 0 point is defined as no symptoms, 1 point as occasional occurrence with no limitation in ordinary physical activities, 2 points as mild limitation in activity due to marked symptoms, and 3 points as severe and frequent symptoms with marked limitation in activity.

Treatment efficacy based on Traditional Chinese Medicine Patterns

Treatment efficacy (%) = (difference of total scores before and after treatment)/total score before treatment × 100%.

Clinically controlled is defined as post-treatment efficacy ≥ 90%; clinically effective as post-treatment efficacy ≥ 70% and < 90%; no response is defined as post-treatment efficacy <30%.

Criteria for clinical lab results

The criteria adopted are in accordance with The Guiding Principles of Clinical Study on New Drug of Traditional Chinese Medicine.
"Markedly effective" is defined as the following:

  • Decrease in symptom scores ≥60%.
  • Increase in C Cr or GFR ≥30%.
  • Decrease in S Cr ≥30%.

"Effective" is defined as the following:

  • Decrease in symptom scores ≥30%.
  • Increase in C Cr or GFR ≥15%.
  • Decrease in S Cr ≥15%.

"Stable" is defined as the following:

  • Improved clinical symptoms with a decrease in score <30%.
  • C Cr or GFR unchanged or with an increase <15%.
  • S Cr unchanged or with a decrease <15%;

"No response" is defined as the following:

  • No improvement or even exacerbated symptoms.
  • Decrease in C Cr or GFR.
  • Increase in S Cr­.


It should be noted that item 1 combined with either of the second or third item necessitates the assessment criteria for each level.

Assessment of long-term efficacy (over 6 months)

Treatment efficacy based on Traditional Chinese Medicine pattern (same as above)


Criteria for clinical lab results


Based on the reciprocal of S Cr by month; the development tendency of renal function impairment can be observed with analyses of regression coefficient of 1/S Cr and time (statistical slope b), and regression line (regression slope b).

  1. Statistical slope b: A negative value indicates an uncontrolled development of disease, and deterioration of overall renal function; a positive value indicates an improved condition.
  2. Regression slope b: A negative value indicates a decline of regression line, and deterioration of renal function; a positive value indicates an improvement.
  3. The natural course of renal function impairment is a continuously declining procedure. Thus a stable renal function (b = 0) can be classified as "effective."




 
 
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