|
Male (%)
|
Female (%)
|
|
|
|
|
|
Gender[A1] [2]
|
8 (18.18%)
|
36 (81.82%)
|
|
|
|
|
|
|
Age distribution
|
|
|
|
|
|
Age
|
Ages 40 to 77
|
|
|
|
|
|
|
200mg (%)
|
300mg (%)
|
400mg (%)
|
Unknown (%)
|
|
|
|
Dosage of AP
|
8 (18.18%)
|
1 (2.27%)
|
16 (36.36%)
|
19 (43.18%)
|
|
|
|
|
None (%)
|
Diabetes
(%)
|
Hypertension (%)
|
Thyroid dysfunction
(%)
|
Osteoarthrosis
(%)
|
Neuropathy (%)
|
Others (%)
|
Comorbidities (some patients exhibited multiple comorbidities)
|
18 (40.91%)
|
11 (25%)
|
10 (22.73%)
|
4 (9.09%)
|
3 (6.82%)
|
1 (2.27%)
|
6 (13.64%)
|
|
Yes (%)
|
No (%)
|
|
|
|
|
|
Smoking
|
7 (15.91%)
|
37 (84.09%)
|
|
|
|
|
|
|
Yes (%)
|
No (%)
|
|
|
|
|
|
Alcohol consumption
|
7 (15.91%)
|
37 (84.09%)
|
|
|
|
|
|
|
Peripherally inserted central catheter (PICC)
(%)
|
Implantable venous access port (IVAP) (%)
|
Peripheral intravenous injection (PII) (%)
|
|
|
|
|
Administration of drugs during chemotherapy
|
19 (43.18%)
|
20 (45.45%)
|
5 (11.36%)
|
|
|
|
|
|
Yes (%)
|
No (%)
|
|
|
|
|
|
History of radiotherapy
|
23 (52.27%)
|
21 (47.73%)
|
|
|
|
|
|
|
Ongoing (%)
|
Finished within one month
(%)
|
Finished within 1-3 months
(%)
|
(%)
Finished within 4-6 months (%)
|
Finished within more than six months
(%)
|
|
|
Chemotherapy status
|
6 (13.64%)
|
5 (11.36%)
|
13 (29.55%)
|
7 (15.91)
|
13 (29.55%)
|
|
|
|
No (%)
|
Yes (%)
|
|
|
|
|
|
Use of other drugs before treatment
|
31 (70.45%)
|
13 (29.55%)
The proportion of vitamin-based drugs was 2.046%
|
|
|
|
|
|
3.1 Patient Characteristics
3.2 Questionnaire Summary
3.2.1 Results of EORTC QLQ-CIPN20 Scoring
Grade
|
Status
|
None
|
Seldom
|
Often
|
Very frequent
|
1
|
Acmesthesia in the fingers or hands
|
25.71%
|
51.43%
|
17.14%
|
5.71%
|
2
|
Acmesthesia in the toes or feet
|
25.71%
|
45.71%
|
20%
|
8.57%
|
3
|
Numbness in the fingers or hands
|
5.71%
|
25.71%
|
48.57%
|
20%
|
4
|
Numbness in the toes or feet
|
14.29%
|
22.86%
|
40%
|
22.86%
|
5
|
Burning sensation in the fingers or hands
|
28.57%
|
45.71%
|
20%
|
5.71%
|
6
|
Burning sensation in the toes or feet
|
34.29%
|
51.43%
|
11.43%
|
2.86%
|
7
|
Hand spasms
|
80%
|
11.43%
|
8.57%
|
0%
|
8
|
Foot spasms
|
68.57%
|
22.86%
|
8.57%
|
0
|
9
|
Difficulty in standing or walking owing to impaired foot perception
|
54.29%
|
25.71%
|
11.43%
|
8.57%
|
10
|
Difficulty in distinguishing between cold and hot water
|
85.71%
|
11.43%
|
0%
|
2.86%
|
11
|
Difficulty in holding a pencil, resulting in writing difficulties
|
74.29%
|
14.29%
|
8.57%
|
2.86%
|
12
|
Difficulty in manipulating small objects with fingers (e.g. fastening small buttons)
|
60%
|
22.86%
|
14.29%
|
2.86%
|
13
|
Difficulty in opening jars or bottles owing to hand weakness
|
57.14%
|
17.14%
|
22.86%
|
2.86%
|
14
|
Difficulty in lowering the foot
|
62.86%
|
22.86%
|
11.43%
|
2.86%
|
15
|
Difficulty in getting up from a chair or climbing stairs owing to foot weakness
|
51.43%
|
25.71%
|
14.29%
|
8.57%
|
16
|
Dizziness when standing up while sitting or lying down
|
65.71%
|
31.43%
|
2.86%
|
0%
|
17
|
Blurred vision
|
51.43%
|
28.57%
|
17.14%
|
2.86%
|
18
|
Auditory disorders
|
91.43%
|
2.86%
|
5.71%
|
0%
|
19
|
Falling owing to impaired foot perception
|
80%
|
20%
|
0%
|
0%
|
20
|
Difficulty in pressing the pedal when driving
|
82.86%
|
2.86%
|
0%
|
0%
|
3.2.2 Scoring based on the EORTC QLQ-CIPN20 Scale
Score
|
< 20
|
20-30
|
30-40
|
40-50
|
> 50
|
n
|
0
|
20
|
9
|
6
|
0
|
(%)
|
0%
|
57.14%
|
25.71%
|
17.14%
|
0%
|
3.3 Summary of the NCI-CTCAE questionnaire
Grade
|
Status
|
(%)
|
I
|
Asymptomatic; absence of deep tendon reflexes or abnormal sensations
|
5.71
|
II
|
Moderate symptoms; restricted tool use in terms of ADL
|
54.29
|
III
|
Severe symptoms; restricted self-care in terms of ADL
|
40
|
IV
|
Life-threatening consequences and the need for urgent intervention
|
0
|
V
|
Death
|
0
|
3.4 Questionnaire 3: Scoring of PN symptoms
For the assessment of immediate efficacy, patients were monitored individually for numbness or pain scores before and after SXAB treatment; a decrease in scores indicated that the treatment was efficacious, else it was inefficacious. Grading of numbness or pain in the fingers was as follows: 10 points for ‘the highest numbness or pain.’ The results showed that the immediate efficacy rate of SXAB therapy alone was 70.45%, while the sustained efficacy rate of SXAB-OCHM therapy was 72.7%, wherein 32 patients showed treatment efficacy, while 12 reported treatment inefficacy.
Before treatment
|
After treatment
|
Minimum score
|
Efficacious (1); inefficacious (0)
|
Sustain efficacy (1); sustained inefficacy (0)
|
P-value
|
Test method
|
2
|
2
|
1
|
0
|
1
|
0.00
|
Rank-sum test
|
1
|
0
|
0
|
0
|
1
|
|
|
9
|
7
|
7
|
1
|
0
|
|
|
10 (left); 8 (right)
|
8 (left); 6 (right)
|
8
|
1
|
0
|
|
|
4
|
3
|
3
|
1
|
1
|
|
|
10
|
7 (left); 6-7 (right)
|
6
|
1
|
0
|
|
|
3-4
|
1-2
|
2
|
1
|
1
|
|
|
8
|
5
|
5
|
1
|
1
|
|
|
6
|
0
|
0
|
1
|
1
|
|
|
4
|
4
|
2
|
0
|
1
|
|
|
10
|
10
|
10
|
0
|
0
|
|
|
10
|
8
|
8
|
1
|
0
|
|
|
7
|
4
|
4
|
1
|
1
|
|
|
8
|
5
|
5
|
1
|
1
|
|
|
5
|
2
|
2
|
1
|
1
|
|
|
10
|
7
|
7
|
1
|
1
|
|
|
9-10
|
5
|
5
|
1
|
1
|
|
|
7
|
4
|
3
|
1
|
0
|
|
|
7
|
4
|
4
|
1
|
0
|
|
|
10
|
10
|
5
|
0
|
1
|
|
|
6
|
6
|
5
|
0
|
1
|
|
|
3
|
0
|
0
|
1
|
1
|
|
|
1-2
|
1-2
|
1
|
0
|
1
|
|
|
3-4
|
1-2
|
1
|
1
|
1
|
|
|
8-9
|
5
|
5
|
1
|
0
|
|
|
7
|
6
|
4
|
1
|
1
|
|
|
8-9
|
6-7
|
6
|
1
|
0
|
|
|
7
|
7
|
4
|
0
|
1
|
|
|
1-2
|
1-2
|
0
|
0
|
1
|
|
|
7 (hands); 10 (feet)
|
2 (hands); 5 (feet)
|
5
|
1
|
1
|
|
|
8
|
8
|
8
|
0
|
0
|
|
|
6
|
3
|
3
|
1
|
1
|
|
|
10
|
8
|
8
|
1
|
1
|
|
|
5
|
0
|
0
|
1
|
1
|
|
|
10
|
5
|
5
|
1
|
1
|
|
|
10
|
5
|
5
|
1
|
1
|
|
|
10
|
7
|
7
|
1
|
1
|
|
|
10
|
10
|
5
|
0
|
1
|
|
|
5-6
|
3-4
|
3
|
1
|
1
|
|
|
10
|
5
|
5
|
1
|
0
|
|
|
3
|
2
|
2
|
1
|
0
|
|
|
4
|
4
|
1
|
0
|
1
|
|
|
10
|
7
|
7
|
1
|
1
|
|
|
2
|
2
|
0
|
0
|
1
|
|
|
3.5 Relationship between therapeutic efficacy and relevant factors
3.5.1 The number of cycles of AP chemotherapy was not correlated with the immediate efficacy of the treatment. Only two patients reported no immediate or sustained efficacy, one of whom underwent 16 cycles of AP chemotherapy; this was identified as the deficiency in TCM theory and was not administered MHGW decoction. Overall, the immediate or sustained efficacious rate of the treatment was 95.4%. P>0.05 indicated that the immediate efficacy was not significantly correlated with the number of chemotherapy cycles.
|
1
|
2
|
3
|
4
|
5
|
6
|
7
|
8
|
Greater than eight
|
P-value
|
Test method
|
Inefficacious
|
0
|
0
|
1
|
4
|
1
|
2
|
0
|
1
|
2
|
0.799
|
Chi-square test
|
Efficacious
|
1
|
2
|
1
|
10
|
4
|
5
|
0
|
5
|
2
|
|
|
3.5.2 Relationship between the deficiency or excess and treatment efficacy: The evaluation of 38 patients showed that the immediate efficacy was not significantly correlated with deficiency or excess (p>0.05).
|
Deficiency(%)
|
Excess(%)
|
Total
|
P-value
|
Test method
|
Inefficacy
|
6(27.2)
|
4(25%)
|
10
|
0.875
|
Chi-square test
|
Efficacy
|
16(72.7)
|
12(75%)
|
28
|
|
|
Total
|
22
|
16
|
38
|
|
|
3.5.3 Sustained efficacy: The evaluation of 28 patients showed that the sustained efficacy was not significantly correlated with deficiency or excess (p>0.05).
|
Deficiency(%)
|
Excess(%)
|
Total
|
P-value
|
Test method
|
Inefficacy
|
6(27.2)
|
5(31.25%)
|
11
|
0.79
|
Chi-square test
|
Efficacy
|
16(72.7)
|
11(68.75%)
|
27
|
|
|
Total
|
22
|
16
|
38
|
|
|
3.5.4 Relationship between the use of MHGW decoction and treatment efficacy: The evaluation of 39 patients showed that immediate or sustained efficacy rate of patients who received SXAB-OCHM therapy with MHGW decoction was 100%, while 13.3% of the patients treated with SXAB-OCHM therapy alone (without MHGW decoction) reported inefficacious effects.
|
Immediate efficacy and sustained inefficacy
|
Immediate inefficacy and sustained efficacy
|
Immediate efficacy and sustained efficacy
|
Immediate inefficacy and sustained inefficacy
|
SXAB-OCHM therapy with MHGW decoction
|
8
|
3
|
13
|
0
|
SXAB-OCHM therapy without MHGW decoction
|
2
|
5
|
6
|
2
|
|
Immediate efficacy
|
Immediate inefficacy
|
P-value
|
Test method
|
SXAB-OCHM therapy with MHGW decoction
|
21
|
3
|
0.45
|
Chi-square test
|
SXAB-OCHM therapy without MHGW decoction
|
8
|
7
|
|
|
|
Sustained efficacy
|
Immediate inefficacy
|
P-value
|
Test method
|
SXAB-OCHM therapy with MHGW decoction
|
16
|
8
|
0.934
|
Chi-square test
|
SXAB-OCHM therapy without MHGW decoction
|
11
|
4
|
|
|
This study aimed to evaluate the efficacy of SXAB-OCHM therapy with MHGW decoction for the treatment of APPN symptoms. As AP is generally used for the treatment of breast cancer[A3] , breast cancer patients accounted for the highest proportion in this study (47.7%), followed by gynecological tumor cases (11.4%). The total proportion of women patients was 81.82%. PN injuries such as numbness, pain, burning sensation, and weakness in the extremities were present in 79.55% of the patients. 40.91% of the enrolled patients had no comorbidities; 25% suffered from diabetes, 22.73% from hypertension, 9.09% exhibited vitamin deficiencies, and 6.82% had an osteoarticular disease. The mode of administration of chemotherapeutic drugs as shown in the above table, suggested that central vein infusion (CII) could not prevent the occurrence of APPN symptoms. Among the enrolled patients, 13.64% did not finish their chemotherapy regimens; 29.55% had finished chemotherapy before more than six months, 15.92% for 4-6 months, and 40.91% before 1-3 months, which suggested that APPN symptoms may occur during chemotherapy and patients remained symptomatic even six months after chemotherapy, thereby causing significant physical and psychological harm to these individuals. 70.45% of the patients enrolled in this study were not prescribed other drugs and 20.46% of the patients took vitamins and mecobalamin; however, none of these were able to relieve the patients' symptoms. These results suggested that there was no specific drug prescribed for the treatment of APPN symptoms.
According to the EORTC QLQ-CIPN20 Scale, none of the enrolled patients scored less than 20; 57.14% scored 20-30; 25.71% scored 30-40; 17.14% scored 40-50, and none scored 50 or more. In the Peripheral Neuropathy Grading Scale (NCI-CTCAE) (version: 5.0), grade I accounted for 5.71%, grade II for 54.29%, grade III for 40%, and grade IV or more for 0%. According to the results of this study, immediate efficacy was not significantly correlated with the number of chemotherapy cycles; neither immediate efficacy nor sustained efficacy was correlated with deficiency or excess. The evaluation of 39 patients showed that the immediate or sustained efficacious rate of patients who received SXAB-OCHM therapy combined with MHGW decoction was 100%, whereas 13.3% of the patients treated with SXAB-OCHM therapy alone (without MHGW decoction) reported inefficacious results. However, the chi-square test suggested that SXAB-OCHM therapy with or without MHGW decoction was not significantly correlated with immediate or sustained efficacy.