Journal of Traditional Chinese Medicine ›› 2023, Vol. 43 ›› Issue (6): 1234-1242.DOI: 10.19852/j.cnki.jtcm.20230630.004
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Traditional Chinese Medicine syndrome analysis on oxaliplatin-induced peripheral neuropathy and clinical efficacy of Bushen Yiqi formula (补肾益气方): a prospective randomized controlled study
PAN Longci1, QI Chunhui2, SHEN Xubo3, HUANG Yixian1, YANG Xinrong2(
), SUN Xianjun4()
- 1 Department of Tradition Chinese Medicine, Qingpu Branch of Zhongshan Hospital, Fudan University, Shanghai 201700, China
2 Department of Oncology, Shanghai Qingpu District Hospital of Traditional Chinese Medicine (the Clinical Base of The Institutes of Integrative Medicine, Fudan University), Shanghai 201799, China
3 Department of Oncology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200437, China
4 Department of Integrative Medicine, Huashan Hospital, Fudan University, Shanghai 200040, China
-
Received:2022-09-12Accepted:2022-12-23Online:2023-10-25Published:2023-06-30 -
Contact:Prof. SUN Xianjun, Department of Integrative Medicine, Huashan Hospital, Fudan University, Shanghai 200040, China.brightsun@163.com; YANG Xinrong, Shanghai Qingpu District Hospital of Traditional Chinese Medicine, Shanghai 201799, China. yxr123111@163.com. Telephone: +86-21-52888331 -
Supported by:Innovative Research Team of High-Level Local University in Shanghai; the Discipline Construction and Talent Training Project in Qingpu District of Shanghai: the Fourth Round of Key Discipline Construction in Qingpu District(WZ2019-04);Fourth Round of Discipline Leader Training Plan in Qingpu District(WD2019-17/39 and WT-2019-02);Project of Qingpu District Science and Technology Committee: Study on the Mechanism of Icariin Regulating GR in the Treatment of OIPN(QKY2020-34)
Cite this article
PAN Longci, QI Chunhui, SHEN Xubo, HUANG Yixian, YANG Xinrong, SUN Xianjun. Traditional Chinese Medicine syndrome analysis on oxaliplatin-induced peripheral neuropathy and clinical efficacy of Bushen Yiqi formula (补肾益气方): a prospective randomized controlled study[J]. Journal of Traditional Chinese Medicine, 2023, 43(6): 1234-1242.
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Table 1 Investigation of TCM syndrome elements and TCM syndromes in 89 patients with OIPN
| Syndrome element | Attribution of syndrome | Total number of cases (n) | Occurrence frequency (n) | Occurrence frequency (%) |
|---|---|---|---|---|
| Numbness or pain in the hands and feet | ABCDE | 89 | 89 | 100 |
| Paresthesia in the hands and feet | ABCDE | 89 | 89 | 100 |
| Fever in hands and feet | A | 89 | 4 | 4.49 |
| Cold in hands and feet | B | 89 | 17 | 19.1 |
| Numbness or pain in hands and feet, increased pain with cold, and decreased pain with heat | BC | 89 | 81 | 91.01 |
| Body lukewarm | C | 89 | 23 | 25.84 |
| Hand and foot pain and numbness, aggravated at night | E | 89 | 10 | 11.23 |
| Fever | A | 89 | 3 | 3.37 |
| Thirsty | A | 89 | 9 | 10.11 |
| Sweat | A | 89 | 6 | 6.74 |
| Yellow urine | A | 89 | 8 | 8.99 |
| Dry stool | A | 89 | 6 | 6.74 |
| Reluctance to drink | B | 89 | 16 | 17.98 |
| Aversion to wind and cold | B | 89 | 6 | 6.74 |
| Numbness and pain worsened on rainy days | B | 89 | 0 | 0 |
| Limb weakness | BD | 89 | 34 | 38.2 |
| Complexion white | C | 89 | 14 | 15.73 |
| Mental exhaustion | C | 89 | 28 | 31.46 |
| Soreness and weakness of waist and knees | CD | 89 | 39 | 43.82 |
| Dizzy | D | 89 | 7 | 7.87 |
| Dysphoria in the chest, palms, and soles | D | 89 | 3 | 3.37 |
| Hectic fever | D | 89 | 4 | 4.49 |
| Subcutaneous hard knots of hands and feet | E | 89 | 0 | 0 |
| Local skin color dull on hands and feet | E | 89 | 9 | 10.11 |
| Squamous and dry skin | E | 89 | 8 | 8.99 |
| Red tongue | AD | 89 | 28 | 31.46 |
| Pale red tongue | BC | 89 | 52 | 58.42 |
| Dark purple tongue | E | 89 | 9 | 10.11 |
| Yellow and greasy moss | A | 89 | 13 | 14.61 |
| White moss | BC | 89 | 60 | 67.42 |
| Less moss | D | 89 | 16 | 17.98 |
| Tongue with petechiae | E | 89 | 5 | 5.62 |
| Pulse slip or string slip | A | 89 | 8 | 8.99 |
| Tight pulse | B | 89 | 12 | 13.48 |
| Thin and weak pulse | C | 89 | 48 | 53.93 |
| Pulse sink fine string | D | 89 | 18 | 20.22 |
| Pulse sink thin and astringent | E | 89 | 11 | 12.35 |
Table 1 Investigation of TCM syndrome elements and TCM syndromes in 89 patients with OIPN
| Syndrome element | Attribution of syndrome | Total number of cases (n) | Occurrence frequency (n) | Occurrence frequency (%) |
|---|---|---|---|---|
| Numbness or pain in the hands and feet | ABCDE | 89 | 89 | 100 |
| Paresthesia in the hands and feet | ABCDE | 89 | 89 | 100 |
| Fever in hands and feet | A | 89 | 4 | 4.49 |
| Cold in hands and feet | B | 89 | 17 | 19.1 |
| Numbness or pain in hands and feet, increased pain with cold, and decreased pain with heat | BC | 89 | 81 | 91.01 |
| Body lukewarm | C | 89 | 23 | 25.84 |
| Hand and foot pain and numbness, aggravated at night | E | 89 | 10 | 11.23 |
| Fever | A | 89 | 3 | 3.37 |
| Thirsty | A | 89 | 9 | 10.11 |
| Sweat | A | 89 | 6 | 6.74 |
| Yellow urine | A | 89 | 8 | 8.99 |
| Dry stool | A | 89 | 6 | 6.74 |
| Reluctance to drink | B | 89 | 16 | 17.98 |
| Aversion to wind and cold | B | 89 | 6 | 6.74 |
| Numbness and pain worsened on rainy days | B | 89 | 0 | 0 |
| Limb weakness | BD | 89 | 34 | 38.2 |
| Complexion white | C | 89 | 14 | 15.73 |
| Mental exhaustion | C | 89 | 28 | 31.46 |
| Soreness and weakness of waist and knees | CD | 89 | 39 | 43.82 |
| Dizzy | D | 89 | 7 | 7.87 |
| Dysphoria in the chest, palms, and soles | D | 89 | 3 | 3.37 |
| Hectic fever | D | 89 | 4 | 4.49 |
| Subcutaneous hard knots of hands and feet | E | 89 | 0 | 0 |
| Local skin color dull on hands and feet | E | 89 | 9 | 10.11 |
| Squamous and dry skin | E | 89 | 8 | 8.99 |
| Red tongue | AD | 89 | 28 | 31.46 |
| Pale red tongue | BC | 89 | 52 | 58.42 |
| Dark purple tongue | E | 89 | 9 | 10.11 |
| Yellow and greasy moss | A | 89 | 13 | 14.61 |
| White moss | BC | 89 | 60 | 67.42 |
| Less moss | D | 89 | 16 | 17.98 |
| Tongue with petechiae | E | 89 | 5 | 5.62 |
| Pulse slip or string slip | A | 89 | 8 | 8.99 |
| Tight pulse | B | 89 | 12 | 13.48 |
| Thin and weak pulse | C | 89 | 48 | 53.93 |
| Pulse sink fine string | D | 89 | 18 | 20.22 |
| Pulse sink thin and astringent | E | 89 | 11 | 12.35 |
Figure 1 Flow diagram of this trial BSYQF: Bushen Yiqi formula.
Figure 1 Flow diagram of this trial BSYQF: Bushen Yiqi formula.
Table 2 Comparison of baseline data between the two groups of patients ( x -± s)
| Group | Sex (n) | Age (years) | Single dose of oxaliplatin (mg) | Cumulative dose of oxaliplatin (mg) | |
|---|---|---|---|---|---|
| Male | Female | ||||
| Control | 23 | 8 | 64±9 | 190±45 | 801±113 |
| Treatment | 21 | 10 | 63±8 | 197±46 | 817±116 |
Table 2 Comparison of baseline data between the two groups of patients ( x -± s)
| Group | Sex (n) | Age (years) | Single dose of oxaliplatin (mg) | Cumulative dose of oxaliplatin (mg) | |
|---|---|---|---|---|---|
| Male | Female | ||||
| Control | 23 | 8 | 64±9 | 190±45 | 801±113 |
| Treatment | 21 | 10 | 63±8 | 197±46 | 817±116 |
Table 3 Changes in the Levi sensory neurotoxicity score before and after treatment in 62 patients in 2 groups (n)
| Group | Time | Total cases | Level 0 | Level 1 | Level 2 | Level 3 | Level 4 | Markedly effective cases | Effective cases |
|---|---|---|---|---|---|---|---|---|---|
| Treatment | Pretreatment | 31 | 0 | 9 | 9 | 10 | 3 | 11 | 24a |
| Post-treatment | 31 | 8 | 13 | 4 | 5 | 1 | |||
| Control | Pretreatment | 31 | 0 | 11 | 10 | 10 | 0 | 7 | 14 |
| Post-treatment | 31 | 0 | 9 | 9 | 10 | 3 |
Table 3 Changes in the Levi sensory neurotoxicity score before and after treatment in 62 patients in 2 groups (n)
| Group | Time | Total cases | Level 0 | Level 1 | Level 2 | Level 3 | Level 4 | Markedly effective cases | Effective cases |
|---|---|---|---|---|---|---|---|---|---|
| Treatment | Pretreatment | 31 | 0 | 9 | 9 | 10 | 3 | 11 | 24a |
| Post-treatment | 31 | 8 | 13 | 4 | 5 | 1 | |||
| Control | Pretreatment | 31 | 0 | 11 | 10 | 10 | 0 | 7 | 14 |
| Post-treatment | 31 | 0 | 9 | 9 | 10 | 3 |
Table 4 Changes in Levi sensory neurotoxicity scores before and after treatment in 18 patients with cold-dampness obstruction symptoms (n)
| Group | Time | Total cases | Level 0 | Level 1 | Level 2 | Level 3 | Level 4 | Markedly effective cases | Effective cases |
|---|---|---|---|---|---|---|---|---|---|
| Treatment | Pretreatment | 9 | 2 | 3 | 3 | 1 | 3 | 6 | |
| Post-treatment | 9 | 2 | 4 | 1 | 2 | 0 | |||
| Control | Pretreatment | 9 | 3 | 3 | 3 | 0 | 2 | 5 | |
| Post-treatment | 9 | 2 | 3 | 2 | 2 | 0 |
Table 4 Changes in Levi sensory neurotoxicity scores before and after treatment in 18 patients with cold-dampness obstruction symptoms (n)
| Group | Time | Total cases | Level 0 | Level 1 | Level 2 | Level 3 | Level 4 | Markedly effective cases | Effective cases |
|---|---|---|---|---|---|---|---|---|---|
| Treatment | Pretreatment | 9 | 2 | 3 | 3 | 1 | 3 | 6 | |
| Post-treatment | 9 | 2 | 4 | 1 | 2 | 0 | |||
| Control | Pretreatment | 9 | 3 | 3 | 3 | 0 | 2 | 5 | |
| Post-treatment | 9 | 2 | 3 | 2 | 2 | 0 |
Table 5 Changes in the Levi sensory neurotoxicity score before and after treatment in 44 patients with kidney-Qi deficiency and cold symptom (n)
| Group | Time | Total cases | Level 0 | Level 1 | Level 2 | Level 3 | Level 4 | Markedly effective case | Effective case |
|---|---|---|---|---|---|---|---|---|---|
| Treatment | Pretreatment | 22 | 7 | 6 | 7 | 2 | 8 | 18a | |
| Post-treatment | 22 | 6 | 9 | 3 | 3 | 1 | |||
| Control | Pretreatment | 22 | 8 | 7 | 7 | 0 | 5 | 9 | |
| Post-treatment | 22 | 4 | 9 | 4 | 5 | 0 |
Table 5 Changes in the Levi sensory neurotoxicity score before and after treatment in 44 patients with kidney-Qi deficiency and cold symptom (n)
| Group | Time | Total cases | Level 0 | Level 1 | Level 2 | Level 3 | Level 4 | Markedly effective case | Effective case |
|---|---|---|---|---|---|---|---|---|---|
| Treatment | Pretreatment | 22 | 7 | 6 | 7 | 2 | 8 | 18a | |
| Post-treatment | 22 | 6 | 9 | 3 | 3 | 1 | |||
| Control | Pretreatment | 22 | 8 | 7 | 7 | 0 | 5 | 9 | |
| Post-treatment | 22 | 4 | 9 | 4 | 5 | 0 |
Table 6 Neuroelectrophysiological changes before and after treatment in 62 patients
| NCV | Measuring limbs | Control group | Treatment group | |||
|---|---|---|---|---|---|---|
| Pretreatment (n = 31) | Post-treatment (n = 31) | Pretreatment (n = 31) | Post-treatment (n = 31) | |||
| Ulnar nerve (M, m/s) | Left | 49.1±3.6 | 50.3±3.1 | 48.7±3.2 | 54.5±3.5b | |
| Right | 47.6±4.2 | 48.3±3.3 | 46.2±3.9 | 53.6±4.6b | ||
| Radial nerve (M, m/s) | Left | 48.2±5.1 | 48.9±4.7 | 47.2±8.3 | 49.5±7.7 | |
| Right | 47.9±3.2 | 48.5±8.5 | 46.8±4.9 | 48.1±3.9 | ||
| Median nerve (M, m/s) | Left | 56.8±4.5 | 55.9±8.9 | 55.7±9.2 | 54.9±8.5 | |
| Eight | 56.1±5.1 | 57.0±7.4 | 55.6±3.5 | 55.1±5.6 | ||
| Peroneal nerve (M, m/s) | Left | 47.6±4.2 | 48.1±4.3 | 47.1±7.2 | 47.9±7.6 | |
| Right | 46.9±3.7 | 47.5±6.7 | 46.3±5.1 | 46.8±4.1 | ||
| Ulnar nerve (S, m/s) | Left | 48.7±8.3 | 52.7±6.2a | 48.1±5.9 | 55.5±3.5b | |
| Right | 47.6±3.9 | 51.3±3.3a | 46.8±5.6 | 54.6±4.6b | ||
| Radial nerve (S, m/s) | Left | 58.5±7.1 | 58.9±7.8 | 57.1±8.5 | 58.7±8.4 | |
| Right | 57.1±6.2 | 58.5±7.2 | 56.4±7.5 | 57.1±6.9 | ||
| Median nerve (S, m/s) | Left | 57.1±4.9 | 57.9±4.1 | 56.7±5.1 | 57.9±4.6 | |
| Right | 56.7±5.2 | 57.0±4.2 | 55.9±4.5 | 56.3±4.6 | ||
| Peroneal nerve (S, m/s) | Left | 41.7±6.3 | 42.5±5.1 | 40.1±7.8 | 45.8±7.5b | |
| Right | 42.3±6.7 | 43.8±8.8 | 41.6±5.1 | 46.9±7.1b | ||
Table 6 Neuroelectrophysiological changes before and after treatment in 62 patients
| NCV | Measuring limbs | Control group | Treatment group | |||
|---|---|---|---|---|---|---|
| Pretreatment (n = 31) | Post-treatment (n = 31) | Pretreatment (n = 31) | Post-treatment (n = 31) | |||
| Ulnar nerve (M, m/s) | Left | 49.1±3.6 | 50.3±3.1 | 48.7±3.2 | 54.5±3.5b | |
| Right | 47.6±4.2 | 48.3±3.3 | 46.2±3.9 | 53.6±4.6b | ||
| Radial nerve (M, m/s) | Left | 48.2±5.1 | 48.9±4.7 | 47.2±8.3 | 49.5±7.7 | |
| Right | 47.9±3.2 | 48.5±8.5 | 46.8±4.9 | 48.1±3.9 | ||
| Median nerve (M, m/s) | Left | 56.8±4.5 | 55.9±8.9 | 55.7±9.2 | 54.9±8.5 | |
| Eight | 56.1±5.1 | 57.0±7.4 | 55.6±3.5 | 55.1±5.6 | ||
| Peroneal nerve (M, m/s) | Left | 47.6±4.2 | 48.1±4.3 | 47.1±7.2 | 47.9±7.6 | |
| Right | 46.9±3.7 | 47.5±6.7 | 46.3±5.1 | 46.8±4.1 | ||
| Ulnar nerve (S, m/s) | Left | 48.7±8.3 | 52.7±6.2a | 48.1±5.9 | 55.5±3.5b | |
| Right | 47.6±3.9 | 51.3±3.3a | 46.8±5.6 | 54.6±4.6b | ||
| Radial nerve (S, m/s) | Left | 58.5±7.1 | 58.9±7.8 | 57.1±8.5 | 58.7±8.4 | |
| Right | 57.1±6.2 | 58.5±7.2 | 56.4±7.5 | 57.1±6.9 | ||
| Median nerve (S, m/s) | Left | 57.1±4.9 | 57.9±4.1 | 56.7±5.1 | 57.9±4.6 | |
| Right | 56.7±5.2 | 57.0±4.2 | 55.9±4.5 | 56.3±4.6 | ||
| Peroneal nerve (S, m/s) | Left | 41.7±6.3 | 42.5±5.1 | 40.1±7.8 | 45.8±7.5b | |
| Right | 42.3±6.7 | 43.8±8.8 | 41.6±5.1 | 46.9±7.1b | ||
Table 7 Hematological indicators in 62 patients( x - ± s)
| Item | Control group | Treatment group | ||||
|---|---|---|---|---|---|---|
| Pretreatment (n = 31) | Post-treatment (n = 31) | Pretreatment (n = 31) | Post-treatment (n = 31) | |||
| Leukocyte (×109/L) | 5.8±2.0 | 5.6±2.1 | 5.7±2.7 | 6.1±2.9 | ||
| Hemoglobin (g/L) | 98.4±25.7 | 102.1±32.4 | 89.5±28.3 | 97.4±37.5 | ||
| Platelets (×109/L) | 198.6±72.3 | 209.1±75.6 | 205.2±79.1 | 219.1±76.4 | ||
| AST (U/L) | 29.5±14.2 | 28.2±17.6 | 31.2±17.1 | 30.8±18.7 | ||
| ALT (U/L) | 28.2±18.3 | 25.8±16.7 | 29.4±15.8 | 32.5±19.8 | ||
| Urea (mmol/L) | 4.6±1.1 | 4.6±1.8 | 5.0±1.0 | 4.8±1.6 | ||
| Creatinine (μmol/L) | 67.3±24.1 | 64.9±19.1 | 61.7±15.2 | 58.3±14.9 | ||
Table 7 Hematological indicators in 62 patients( x - ± s)
| Item | Control group | Treatment group | ||||
|---|---|---|---|---|---|---|
| Pretreatment (n = 31) | Post-treatment (n = 31) | Pretreatment (n = 31) | Post-treatment (n = 31) | |||
| Leukocyte (×109/L) | 5.8±2.0 | 5.6±2.1 | 5.7±2.7 | 6.1±2.9 | ||
| Hemoglobin (g/L) | 98.4±25.7 | 102.1±32.4 | 89.5±28.3 | 97.4±37.5 | ||
| Platelets (×109/L) | 198.6±72.3 | 209.1±75.6 | 205.2±79.1 | 219.1±76.4 | ||
| AST (U/L) | 29.5±14.2 | 28.2±17.6 | 31.2±17.1 | 30.8±18.7 | ||
| ALT (U/L) | 28.2±18.3 | 25.8±16.7 | 29.4±15.8 | 32.5±19.8 | ||
| Urea (mmol/L) | 4.6±1.1 | 4.6±1.8 | 5.0±1.0 | 4.8±1.6 | ||
| Creatinine (μmol/L) | 67.3±24.1 | 64.9±19.1 | 61.7±15.2 | 58.3±14.9 | ||
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