Traditional Chinese medicine composition for treating hand-foot syndrome (HFS) after targeted drug treatment and method for making the same

Abstract

A traditional Chinese medicine composition for treating hand-foot syndrome after targeted drug treatment is mainly prepared from the following components by weight: 20-50 parts of Radix Sophorae Flavescentis, 20-50 parts of Herba Taraxaci, 20-50 parts of Flos Chrysanthemi Indici, and 20-50 parts of Herba Cum Radice Violae Yedoensitis, 20-50 parts of Rhizoma Smilacis Glabrae, 30-60 parts of Radix Astragali Seu Hedysari, 10-35 parts of Kochia scoparia (L.) Schrad, 10-45 parts of Carthamus tinctorius L., 15-45 parts of Cortex Radicis Dictamni Dasycarpi, 5-15 parts of Herba Ephedrae, 5-25 parts of Angelica sinensis, 5-25 parts of Rhizoma Ligustici Chuangxiong, 10-30 parts of Radix Rehmanniae, 5-15 parts of Ramulus cinnamomi, 10-30 parts of Cynanchum otophyllum Schneid, 5-15 parts of Semen Sinapis Albae, 5-20 parts of Arisaema heterophyllum Blume, 5-20 parts of Typhonium blumei Nicolson & Sivadasan, and 10-40 parts of Radix Glycyrrhizae.

Claims

1. A traditional Chinese medicine composition for treating hand-foot syndrome after targeted drug treatment, wherein the traditional Chinese medicine composition comprises consists of a decoction of the following components by weight: 20-50 parts of Radix Sophorae Flavescentis, 20-50 parts of Herba Taraxaci, 20-50 parts of Flos Chrysanthemi Indici, 20-50 parts of Herba Cum Radice Violae Yedoensitis, 20-50 parts of Rhizoma Smilacis Glabrae, 30-60 parts of Radix Astragali Seu Hedysari, 10-35 parts of Kochia scoparia (L.) Schrad, 10-45 parts of Carthamus tinctorius L., 15-45 parts of Cortex Radicis Dictamni Dasycarpi, 5-15 parts of Herba Ephedrae, 5-25 parts of Angelica sinensis, 5-25 parts of Rhizoma Ligustici Chuangxiong, 10-30 parts of Radix Rehmanniae, 5-15 parts of Ramulus cinnamomi, 10-30 parts of Cynanchum otophyllum Schneid, 5-15 parts of Semen Sinapis Albae, 5-20 parts of Arisaema heterophyllim Blume, 5-20 parts of Typhonium blumei Nicolson & Sivadasan, and 10-40 parts of Radix Glycyrrhizae.

2. The traditional Chinese medicine composition according to claim 1, wherein a mass ratio between the Radix Sophorae Flavescentis and the Rhizoma Smilacis Glabrae is 1:1.

3. The traditional Chinese medicine composition according to claim 1, wherein a mass ratio among the Flos Chrysanthemi Indici, Herba Taraxaci and Herba Cum Radice Violae Yedoensitis is 1:1:1.

4. The traditional Chinese medicine composition according to claim 1, wherein a mass ratio between the Angelica sinensis and the Rhizoma Ligustici Chuangxiong is 1:1.

5. The traditional Chinese medicine composition according to claim 1, wherein a mass ratio among the Arisaema heterophyllum Blume, the Typhonium blumei Nicolson & Sivadasan and the Radix Glycyrrhizae is 1:1:2.

6. A method for preparing the traditional Chinese medicine composition according to claim 1, comprising, (1) weighing medicinal materials according to a formula; (2) crushing the Arisaema heterophyllum Blume and the Typhonium blumei Nicolson & Sivadasan into a powdery mixture A; stirring, mixing, and then crushing remaining medicinal materials according to the formula into a powdery mixture B; (3) after adding water to the powdery mixture A for a period of decoction, adding the powdery mixture B for a period of continuous decoction, and conducting cooling and filtration to obtain a cooling liquid and medicinal residues; (4) adding water to the medicinal residues for a secondary decoction, and conducting cooling and filtration to obtain a filtrate; and (5) combining the cooling liquid in step (3) and the obtained filtrate in step (4), and performing sterilization and encapsulation to obtain the traditional Chinese medicine composition.

7. The method according to claim 6, wherein, in step (3), after added with water, the powder mixture A is heated to boiling for decoction for 40-50 min.

8. The method according to claim 6, wherein in step (3), the powdery mixture B is added for decoction for 30-40 min.

9. The method according to claim 6, wherein in step (4), the secondary decoction is a continuous decoction for 30-40 min after a heating to boiling.

10. The method according to claim 6, wherein a mass ratio between the Radix Sophorae Flavescentis and the Rhizoma Smilacis Glabrae is 1:1.

11. The method according to claim 6, wherein a mass ratio among the Flos Chrysanthemi Indici, Herba Taraxaci and Herba Cum Radice Violae Yedoensitis is 1:1:1.

12. The method according to claim 6, wherein a mass ratio between the Angelica sinensis and the Rhizoma Ligustici Chuangxiong is 1:1.

13. The method according to claim 6, wherein a mass ratio among the Arisaema heterophyllum Blume, the Typhonium blumei Nicolson & Sivadasan and the Radix Glycyrrhizae is 1:1:2.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) FIG. 1 shows a process flow diagram of the present disclosure for preparing a traditional Chinese medicine composition for treating HFS after targeted drug treatment.

DETAILED DESCRIPTION OF THE EMBODIMENTS

(2) In order to facilitate the understanding of the present disclosure, the embodiments will be described more comprehensively and in detail below with reference to the drawings and examples, but the claimed scope herein is not limited to the following specific embodiments.

(3) In the detailed description of the embodiment herein, the traditional Chinese medicine composition for treating HFS after targeted drug treatment is mainly prepared from the following components by weight: 20-50 parts of Radix Sophorae Flavescentis, 20-50 parts of Herba Taraxaci, 20-50 parts of Flos Chrysanthemi Indici, 20-50 parts of Herba Cum Radice Violae Yedoensitis, 20-50 parts of Rhizoma Smilacis Glabrae, 30-60 parts of Radix Astragali Seu Hedysari, 10-35 parts of Kochia scoparia (L.) Schrad, 10-45 parts of Carthamus tinctorius L., 15-45 parts of Cortex Radicis Dictamni Dasycarpi, 5-15 parts of Herba Ephedrae, 5-25 parts of Angelica sinensis, 5-25 parts of Rhizoma Ligustici Chuangxiong, 10-30 parts of Radix Rehmanniae, 5-15 parts of Ramulus cinnamomi 10-30 parts of Cynanchum otophyllum Schneid, 5-15 parts of Semen Sinapis Albae, 5-20 parts of Arisaema heterophyllum Blume, 5-20 parts of Typhonium blumei Nicolson & Sivadasan, and 10-40 parts of Radix Glycyrrhizae. A mass ratio between the Radix Sophorae Flavescentis and the Rhizoma Smilacis Glabrae is 1:1; a mass ratio among the Flos Chrysanthemi Indici, Herba Taraxaci and Herba Cum Radice Violae Yedoensitis is 1:1:1; a mass ratio between the Angelica sinensis and the Rhizoma Ligustici Chuangxiong is 1:1; a mass ratio among the Arisaema heterophyllum Blume, the Typhonium blumei Nicolson & Sivadasan and the Radix Glycyrrhizae is 1:1:2.

(4) In the detailed description of the embodiment herein, a method for preparing the traditional Chinese medicine composition for the treatment of HFS after targeted drug treatment, the process flow chart of which is shown in FIG. 1, and includes the following steps: (1) weighing medicinal materials according to a formula; (2) crushing the Arisaema heterophyllum Blume and the Typhonium blumei Nicolson & Sivadasan into a powdery mixture A; stirring, mixing and then crushing remaining medicinal materials into a powdery mixture B according to the formula; (3) adding water to the powdery mixture A, conducting heating to 100? C., followed by decoction for 40-50 min, then adding the powdery mixture B for decoction for 30-40 min, and conducting cooling and filtration to obtain a cooling liquid and medicinal residues; (4) adding water to the medicinal residues, conducting heating to 100? C. for continuous decoction for 30-40 min, and conducting cooling and filtration to obtain a filtrate; and (5) combining the cooling liquid in step (3) and the obtained filtrate in step (4), and conducting sterilization and encapsulation to obtain a traditional Chinese medicine composition for treating HFS after targeted drug treatment.

(5) In order to prove the effect of the traditional Chinese medicine composition of the present disclosure, a randomized double-blind trial research design is adopted, and a clinical study on the treatment of HFS is carried out in the Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine. There are 42 cases in the test group and 42 cases in the control group. 200 mL of the traditional Chinese medicine composition liquid in Example 1 of the present disclosure is used to soak and wash the affected part, twice a day in the test group; 200 mL of common extract of artemisia argyi liquid is used to soak and wash the affected part, twice a day in the control group; the observation time for both of the two groups is 2 weeks.

(6) The main contents of the experiment are as follows:

(7) 1. Materials and Methods

(8) 1.1 Clinical Design

(9) A random, double-blind, and controlled design is adopted and completed in the Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine. The cases are mainly from inpatient and outpatient tumor patients in the hospital, and 60 cases of effective patient data are selected. The traditional Chinese medicine composition according to the present disclosure is used for the treatment of HFS in the early stage with a cure rate of 83%. And the cure rate of the control group is 46%, as reported by previous literature.

(10) 1.2 Case Selection

(11) 1.2.1 Diagnostic Criteria

(12) 1.2.1.1 Western Medicine Diagnostic Criteria

(13) The diagnostic criteria of tumors can be found in Chinese standard for diagnosis and treatment of common malignant tumor by the Department of Medical Administration, Ministry of Health of the People's Republic of China, and the staging criteria are based on NCCN Clinical practice guidelines (Chinese version), 2012, 1st edition: HFS grading criteria can be found in the grading criteria for acute and subacute toxicity of anticancer drug formulated by National Cancer Institute (NCI).

(14) Grading criteria for HFS according to NCI: grade I: minor skin changes or dermatitis (e.g., erythema, desquamation) with paresthesias (e.g., numbness, tingling, burning), without affecting daily activities; grade II: skin changes as above accompanied by pain that mildly affect daily activities, with intact skin surface; grade III: ulcerative dermatitis or skin changes, accompanied by severe pain that seriously affect daily life, with obvious tissue destruction (such as peeling, blisters, bleeding, edema).

(15) 1.2.1.2 Diagnostic Criteria of Traditional Chinese Medicine

(16) Qi deficiency syndrome: dim skin of the affected part, short breath, low voice, mental fatigue, and hypodynamia; lack of strength to breath or talk; spontaneous sweating; pale and swollen tongue or tongue with teeth prints; empty pulse with little strength (weak, soft and float), with or without light-headedness. And movement may aggravate all symptoms above.

(17) Blood deficiency syndrome: pale skin of the affected area, less obvious changes in dermatitis, pale or sallow complexion, pale eyelids, lips, tongue, and nails, and head dizziness, with or without blurred vision, dry eyes, palpitations, dreaminess, forgetfulness, mental fatigue, numbness in hands and feet, or hypomenorrhea, pale color of menstrual blood, delayed or disappeared menstruation, thin and weak pulse.

(18) Damp-heat syndrome: sweaty affected area, frequent feeling of dampness, fullness in the flanks, emotional discomfortness, dry mouth and bitter taste, abdominal distension, loose stools, unpleasantness, difficulty in micturition, red and short urine with pain, yellow and greasy fur, stringy and slippery pulse.

(19) Phlegm-dampness syndrome: swollen affected part that is depressed when pressed; cough with excessive phlegm, chest tightness and epigastric fullness, anorexia; dull complexion, feeling of heaviness in the head and body, with or without edema of lower extremities; sticky stool, slippery pulse (stringy, float), greasy and slippery fur of tongue.

(20) Toxin and stasis syndrome: dull even purple-black skin of the affected area, with symptoms such as pain, lump, bleeding, and blood stasis-colored pulse. The pain of toxin and stasis syndrome is characterized by tingling, refusal to press and immobility of the sore; dull complexion, violaceous lips and nails, or purple spots on the subcutaneous, or scaly dry skin, or prominent abdominal veins, or filamentous red strands on the skin, or purple spots on the tongue, sublingual varicose veins, with thin or uneven pulse, or knotted and intermittent pulse, pulselessness and so on.

(21) 1.3 Test Drugs and Drug Assignment

(22) 1.3.1 Test Drugs

(23) Test group: 200 mL of the traditional Chinese medicine composition liquid of Example 1 of the present disclosure is used to soak and wash the affected part, twice a day.

(24) Control group: 200 mL of common extract of Artemisia argyi liquid is used to soak and wash the affected part, twice a day in the control group.

(25) Both groups are intervened for 14 days.

(26) 1.3.2 Drug Assignment

(27) The patients will be randomly divided into the test group and the control group according to the ratio of 1:1, and the observing doctors will assign the drugs according to the drug's number without selecting the medicine and disturbing the number, and the drug's number remains constant during test.

(28) 1.3.3 Drug Check

(29) At each follow-up visit, the number of drugs received, taken and returned by the patient in detail are recorded timely on the case report form by the observing doctor to determine the compliance of the subjects taking the drug, and to decide whether the patient continues to participate in the test. A patient is considered to be in good compliance if he undertakes regularly medication according to the protocol and reaches 80% of the required dose at each evaluation.

(30) 1.3.4 Provisions for Concomitant Medication

(31) {circle around (1)} During the test period, no other drugs for the treatment of HFS should be used.

(32) {circle around (2)} When combined with other drugs and therapeutic methods that must be taken or adopted for other diseases, the original treatment are still maintained after enrollment but must be recorded in detail in the combined medication table.

(33) 1.4 Adverse Reactions and Safety Evaluation Grade 1: no adverse reactions and no abnormality in safety indicators appear; grade 2: tolerable minor adverse reactions are present, no additional treatment is required, and there is no abnormality in safety indicators; grade 3: the subjects have moderate adverse reactions that require appropriate treatment, and the safety indicators is mildly or moderately abnormal; grade 4: the subjects have severe adverse reactions that are life-threatening or disabled, and need urgent treatment. The safety indicators are seriously abnormal, such that the treatment study should be interrupted immediately.

(34) 1.5 Statistical Processing

(35) SPSS26 software are used for statistical analysis. Measurement data were described as mean?standard deviation. T test is performed on data with normal distribution and homogeneity of variance, analysis of variance (ANOVA) is performed on those without homogeneity of variance, and rank sum test is performed on those without normal distribution and on ranked data. Two-sided test is performed on all the analyzed results. P>0.05 indicates that the difference between the compared two is not statistically significant, and P<0.05 indicates the difference is statistically significant.

(36) 2. Efficacy Evaluation after Two Weeks of Treatment

(37) As seen from the improvement of HFS symptom in Table 1, the HFS symptoms of patients taking the traditional Chinese medicine composition of the present disclosure are significantly improved.

(38) TABLE-US-00001 TABLE 1 Improvement of HFS Symptom Number Standard P P Index Group of case Mean deviation Max Min Statistic value Statistic value Insensitivity Experimental 30 2.900 1.777 5 0 87 0.003 4.678 <0.05 group Control group 30 0.867 1.500 4 ?3 26 0.207 <0.05 Numbness Experimental 30 7.033 1.426 10 5 211 0.043 4.826 <0.05 group Control group 30 3.567 1.627 8 1 107 0.077 <0.05 Tingling Experimental 30 6.533 1.979 9 1 196 0.006 4.816 <0.05 group Control group 30 2.800 2.301 7 ?2 84 0.514 <0.05 Burning Experimental 30 5.600 2.169 10 2 168 0.105 4.677 <0.05 group Control group 30 3.233 1.944 7 ?1 97 0.541 <0.05 Swelling Experimental 30 3.500 2.432 10 1 105 0.001 4.859 <0.05 group Control group 30 1.467 2.045 8 ?2 44 0.001 <0.05 Pruritus Experimental 30 7.433 1.764 10 4 223 0.031 4.841 <0.05 group Control group 30 3.900 1.660 7 0 117 0.252 <0.05 Pain Experimental 30 3.800 1.661 7 1 114 0.068 4.687 <0.05 group Control group 30 1.733 1.843 5 ?2 52 0.162 <0.05 Erythema Experimental 30 2.933 1.289 5 1 88 0.004 4.766 <0.05 group Control group 30 1.033 1.378 4 ?2 31 0.265 <0.05 HFS Experimental 30 4.967 2.559 10 0 1192 0.002 13.336 <0.05 total group score Control group 30 2.325 2.126 8 ?3 558 0.001 <0.05

(39) The cases in the following examples are all from patients with HFS after targeted drug treatment of malignant tumors from January 2010 to November 2021. For the diagnostic criteria of tumors, see Chinese standard for diagnosis and treatment of common malignant tumor. The HFS grading criteria for HFS are as follows (see the grading criteria for acute and subacute toxicity of anticancer drug formulated by NCI): grade I: minor skin changes or dermatitis (eg, erythema, desquamation) with paresthesias (eg, numbness, tingling, burning), without affecting daily activities; grade II: skin changes accompanied by pain as above that mildly affect daily activities, with intact skin surface; grade III: ulcerative dermatitis or skin changes, accompanied by severe pain that seriously affect daily life, with obvious tissue destruction (such as peeling, blisters, bleeding, edema).

Example 1

(40) A traditional Chinese medicine composition for treating HFS after targeted drug treatment was mainly prepared from the following components by weight: 30 parts of Radix Sophorae Flavescentis, 50 parts of Herba Taraxaci, 50 parts of Flos Chrysanthemi Indici, and 50 parts of Herba Cum Radice Violae Yedoensitis, 30 parts of Rhizoma Smilacis Glabrae, 30 parts of Radix Astragali Seu Hedysari, 15 parts of Kochia scoparia (L.) Schrad, 20 parts of Carthamus tinctorius L., 20 parts of Cortex Radicis Dictamni Dasycarpi, 5 parts of Herba Ephedrae, 10 parts of Angelica sinensis, 10 parts of Rhizoma Ligustici Chuangxiong, 15 parts of Radix Rehmanniae, 5 parts of Ramulus cinnamomi, 10 parts of Cynanchum otophyllum Schneid, 5 parts of Semen Sinapis Albae, 5 parts of Arisaema heterophyllum Blume, 5 parts of Typhonium blumei Nicolson & Sivadasan, and 10 parts of Radix Glycyrrhizae.

(41) The method for preparing the traditional Chinese medicine composition for the treatment of HFS after targeted drug treatment of the present example was carried out as follows: (1) the medicinal materials was weighted according to the formula; (2) the Arisaema heterophyllum Blume and the Typhonium blumei Nicolson & Sivadasan were crushed into a powdery mixture A; the other medicinal materials according to the formula were stirred, mixed, then crushed into a powdery mixture B; (3) the powdery mixture A was added with distilled water 10 times of its volume, heated to 100? C., and decocted continuously for 40 min, then the powdery mixture B was added, and a resulting mixture was decocted continuously for 40 min, cooled and filtered to obtain a cooling liquid and medicinal residues; (4) the medicinal residues were added with distilled water 8 times of its volume, heated to 100? C., decocted continuously for 40 min, cooled and then filtered to obtain a filtrate; and (5) the cooling liquid in step (3) and the filtrate in step (4) were combined, and a resulting mixed filtrate was centrifuged at 4000 g for 10 minutes at room temperature, a supernatant was collected, and the supernatant was concentrated to 1 g/ml, a resulting medicine solution was yellowish-brown, and had strong smell of traditional Chinese medicine, after sterilization and encapsulation, a traditional Chinese medicine composition for treating HFS after targeted drug treatment was obtained. The obtained traditional Chinese medicine had a liquid pharmaceutical dosage form.

(42) 80 cases were selected, including 44 males and 36 females. The youngest patient was 35 years old and the oldest was 82 years old, with an average age of 53 years. The cases were randomly divided into 8 groups according to age and condition, with 10 cases in each group. Efficacy was judged based on HFS grading, in which skin changes or dermatitis, paresthesias, and tissue destruction took the first place.

(43) The traditional Chinese medicine composition of this example was used for treatment, and the dosage was as follows: for patients of 35-55 years old, 200 ml was used for each fumigation and wash of the affected part once a day; for patients of 56-82 years old, 200 ml was used for each fumigation and wash of the affected part twice a day. After one week of fumigation and washing, the HFS grade of 72% of the patients was decreased by one level (level 3 was decreased to level 2, and level 2 was decreased to level 1). After two weeks of fumigation and washing, 85% of patients with skin changes or dermatitis returned to normal basically, and sensory abnormalities disappeared basically. No obvious adverse reactions appeared in patients during the treatment, and no adverse reactions of the test medicine were observed.

Example 2

(44) A traditional Chinese medicine composition for treating HFS after targeted drug treatment was mainly prepared from the following components by weight: 50 parts of Radix Sophorae Flavescentis, 25 parts of Herba Taraxaci, 25 parts of Flos Chrysanthemi Indici, and 25 parts of Herba Cum Radice Violae Yedoensitis, 50 parts of Rhizoma Smilacis Glabrae, 35 parts of Radix Astragali Seu Hedysari, 35 parts of Kochia scoparia (L.) Schrad, 20 parts of Carthamus tinctorius L., 45 parts of Cortex Radicis Dictamni Dasycarpi, 5 parts of Herba Ephedrae, 15 parts of Angelica sinensis, 15 parts of Rhizoma Ligustici Chuangxiong, 10 parts of Radix Rehmanniae, 5 parts of Ramulus cinnamomi, 15 parts of Cynanchum otophyllum Schneid, 5 parts of Semen Sinapis Albae, 10 parts of Arisaema heterophyllum Blume, 10 parts of Typhonium blumei Nicolson & Sivadasan, and 10 parts of Radix Glycyrrhizae.

(45) The method for preparing the traditional Chinese medicine composition for the treatment of HFS after targeted drug treatment of the present example was carried out as follows: (1) the medicinal materials was weighted according to the formula; (2) the Arisaema heterophyllum Blume and the Typhonium blumei Nicolson & Sivadasan were crushed into a powdery mixture A; the other medicinal materials according to the formula were stirred, mixed, then crushed into a powdery mixture B; (3) the powdery mixture A was added with distilled water 10 times of its volume, heated to 100? C., and decocted continuously for 45 min, then the powdery mixture B was added, decocted continuously for 40 min, cooled and filtered to obtain a cooling liquid and medicinal residues; (4) the medicinal residues were added with distilled water 8 times of its volume, heated to 100? C., decocted continuously for 35 min, cooled and then filtered to obtain a filtrate; and (5) the cooling liquid in step (3) and the filtrate in step (4) were combined, and a resulting mixed filtrate was centrifuged at 4000 g for 10 minutes at room temperature, a supernatant was collected for vacuum concentration at 60? C., a resulting extract was freeze-dried to powder, and stored at ?20? C. A traditional Chinese medicine composition for treating HFS after targeted drug treatment was obtained. The obtained traditional Chinese medicine had a pharmaceutical dosage form of Semi-solid powdered mixture. The powder was dissolved in water of equal volume, then heated to 45? C., mixed evenly for use. A resulting medicine solution was yellowish-brown, and had strong smell of traditional Chinese medicine.

(46) 70 cases were selected, including 38 males and 32 females. The youngest patient was 32 years old and the oldest was 65 years old, with an average age of 45 years. The cases were randomly divided into 7 groups according to age and condition, with 10 cases in each group. Efficacy was judged based on HFS grading, in which skin changes or dermatitis, paresthesias, and tissue destruction took the first place.

(47) The traditional Chinese medicine composition of this example was used for treatment, and the dosage was as follows: for patients of 32-48 years old, 200 ml was used once a day to fumigate and wash the affected part each time; for patients of 49-65 years old, 200 ml was used for each fumigation and wash of the affected part twice a day. After one week of fumigation and washing, the HFS grade of 75% of the patients was decreased by one level (level 3 was decreased to level 2, and level 2 was decreased to level 1). After two weeks of fumigation and washing, 82% of patients with skin changes or dermatitis returned to normal basically, and sensory abnormalities disappeared basically. No obvious adverse reactions appeared in patients during the treatment, and no adverse reactions of the test medicine were observed.

Example 3

(48) A traditional Chinese medicine composition for treating HFS after targeted drug treatment was mainly prepared from the following components by weight: 25 parts of Radix Sophorae Flavescentis, 35 parts of Herba Taraxaci, 35 parts of Flos Chrysanthemi Indici, and 35 parts of Herba Cum Radice Violae Yedoensitis, 25 parts of Rhizoma Smilacis Glabrae, 40 parts of Radix Astragali Seu Hedysari, 15 parts of Kochia scoparia (L.) Schrad, 35 parts of Carthamus tinctorius L., 20 parts of Cortex Radicis Dictamni Dasycarpi, 15 parts of Herba Ephedrae, 25 parts of Angelica sinensis, 25 parts of Rhizoma Ligustici Chuangxiong, 15 parts of Radix Rehmanniae, 15 parts of Ramulus cinnamomi, 20 parts of Cynanchum otophyllum Schneid, 10 parts of Semen Sinapis Albae, 10 parts of Arisaema heterophyllum Blume, 10 parts of Typhonium blumei Nicolson & Sivadasan, and 20 parts of Radix Glycyrrhizae.

(49) The method for preparing the traditional Chinese medicine composition for the treatment of HFS after targeted drug treatment of the present example was carried out as follows: (1) the medicinal materials was weighted according to the formula; (2) the Arisaema heterophyllum Blume and the Typhonium blumei Nicolson & Sivadasan were crushed into a powdery mixture A; the other medicinal materials according to the formula were stirred, mixed, then crushed into a powdery mixture B; (3) the powdery mixture A was added with distilled water 10 times of its volume, heated to 100? C., and decocted continuously for 50 min, then the powdery mixture B was added and decocted continuously for 35 min, cooled and filtered to obtain a cooling liquid and medicinal residues; (4) the medicinal residues were added with distilled water 8 times of its volume, heated to 100? C., decocted continuously for 30 min, cooled and then filtered to obtain a filtrate; and (5) the cooling liquid in step (3) and the filtrate in step (4) were combined, and a resulting mixed filtrate was centrifuged at 4000 g for 10 minutes at room temperature, a supernatant was collected, and the supernatant was concentrated to 1 g/ml, a resulting medicine solution was yellowish-brown, and had strong smell of traditional Chinese medicine, after sterilization and encapsulation, a traditional Chinese medicine composition for treating HFS after targeted drug treatment was obtained. The obtained traditional Chinese medicine had a liquid pharmaceutical dosage form.

(50) 90 cases were selected, including 48 males and 42 females. The youngest patient was 28 years old and the oldest was 69 years old, with an average age of 46 years. The cases were randomly divided into 9 groups according to age and condition, with 10 cases in each group. Efficacy was judged based on HFS grading, in which skin changes or dermatitis, paresthesias, and tissue destruction took the first place.

(51) The traditional Chinese medicine composition of this example was used for treatment, and the dosage was as follows: for patients of 38-48 years old, 200 ml was used once a day to fumigate and wash the affected part; for patients of 49-69 years old, 200 ml was used for each fumigation and wash of the affected part twice a day. After one week of fumigation and washing, the HFS grade of 81% of the patients was decreased by one level (level 3 was decreased to level 2, and level 2 was decreased to level 1). After two weeks of fumigation and washing, 90% of patients with skin changes or dermatitis returned to normal basically, and sensory abnormalities disappeared basically. No obvious adverse reactions appeared in patient during treatment, and no adverse reactions of the test medicine were observed.

Example 4

(52) A traditional Chinese medicine composition for treating HFS after targeted drug treatment was mainly prepared from the following components by weight: 30 parts of Radix Sophorae Flavescentis, 20 parts of Herba Taraxaci, 20 parts of Flos Chrysanthemi Indici, and 20 parts of Herba Cum Radice Violae Yedoensitis, 30 parts of Rhizoma Smilacis Glabrae, 60 parts of Radix Astragali Seu Hedysari, 10 parts of Kochia scoparia (L.) Schrad, 45 parts of Carthamus tinctorius L., 15 parts of Cortex Radicis Dictamni Dasycarpi, 5 parts of Herba Ephedrae, 25 parts of Angelica sinensis, 25 parts of Rhizoma Ligustici Chuangxiong, 30 parts of Radix Rehmanniae, 10 parts of Ramulus cinnamomi, 25 parts of Cynanchum otophyllum Schneid, 5 parts of Semen Sinapis Albae, 15 parts of Arisaema heterophyllum Blume, 15 parts of Typhonium blumei Nicolson & Sivadasan, and 30 parts of Radix Glycyrrhizae.

(53) The method for preparing the traditional Chinese medicine composition for the treatment of HFS after targeted drug treatment of the present example was carried out as follows: (1) the medicinal materials was weighted according to the formula; (2) the Arisaema heterophyllum Blume and the Typhonium blumei Nicolson & Sivadasan were crushed into a powdery mixture A; the other medicinal materials according to the formula were stirred, mixed, then crushed into a powdery mixture B; (3) the powdery mixture A was added with distilled water 10 times of its volume, heated to 100? C., and decocted continuously for 50 min, then the powdery mixture B was added and decocted continuously for 40 min, cooled and filtered to obtain a cooling liquid and medicinal residues; (4) the medicinal residues were added with distilled water 8 times of its volume, heated to 100? C., decocted continuously for 35 min, cooled and then filtered to obtain a filtrate; and (5) the cooling liquid in step (3) and the filtrate in step (4) were combined, and a resulting mixed filtrate was centrifuged at 4000 g for 10 minutes at room temperature, a supernatant was collected for vacuum concentration at 60? C., a resulting extract was freeze-dried to powder, and stored at ?20? C. A traditional Chinese medicine composition for treating HFS after targeted drug treatment was obtained. The obtained traditional Chinese medicine had a pharmaceutical dosage form of Semi-solid powdered mixture. The powder was dissolved in water of equal volume, then heated to 45? C., mixed evenly for use. A resulting medicine solution was yellowish-brown, and had strong smell of traditional Chinese medicine.

(54) 150 cases were selected, including 80 males and 70 females. The youngest patient was 24 years old and the oldest was 87 years old, with an average age of 54 years. The cases were randomly divided into 15 groups according to age and condition, with 10 cases in each group. Efficacy was judged based on HFS grading, in which skin changes or dermatitis, paresthesias, and tissue destruction took the first place.

(55) The traditional Chinese medicine composition of this example was used for treatment, and the dosage was as follows: for patients of 24-55 years old, 200 ml was used once a day to fumigate and wash the affected part; for patients of 56-87 years old, 200 ml was used for each fumigation and wash of the affected part twice a day. After one week of fumigation and washing, the HFS grade of 82% of the patients was decreased by one level (level 3 was decreased to level 2, and level 2 was decreased to level 1). After two weeks of fumigation and washing, 9% of patients with skin changes or dermatitis returned to normal basically, and sensory abnormalities disappeared basically. No obvious adverse reactions appeared in patient during treatment, and no adverse reactions of the test medicine were observed.

Example 5

(56) A traditional Chinese medicine composition for treating HFS after targeted drug treatment was mainly prepared from the following components by weight: 20 parts of Radix Sophorae Flavescentis, 25 parts of Herba Taraxaci, 25 parts of Flos Chrysanthemi Indici, and 25 parts of Herba Cum Radice Violae Yedoensitis, 20 parts of Rhizoma Smilacis Glabrae, 45 parts of Radix Astragali Seu Hedysari, 20 parts of Kochia scoparia (L.) Schrad, 35 parts of Carthamus tinctorius L., 25 parts of Cortex Radicis Dictamni Dasycarpi, 10 parts of Herba Ephedrae, 15 parts of Angelica sinensis, 15 parts of Rhizoma Ligustici Chuangxiong, 20 parts of Radix Rehmanniae, 10 parts of Ramulus cinnamomi, 30 parts of Cynanchum otophyllum Schneid, 15 parts of Semen Sinapis Albae, 20 parts of Arisaema heterophyllum Blume, 20 parts of Typhonium blumei Nicolson & Sivadasan, and 40 parts of Radix Glycyrrhizae.

(57) The method for preparing the traditional Chinese medicine composition for the treatment of HFS after targeted drug treatment of the present example was carried out as follows: (1) the medicinal materials was weighted according to a formula; (2) the Arisaema heterophyllum Blume and the Typhonium blumei Nicolson & Sivadasan were crushed into a powdery mixture A; the other medicinal materials according to the formula were stirred, mixed, then crushed into a powdery mixture B; (3) the powdery mixture A was added with distilled water 10 times of its volume, heated to 100? C., and decocted continuously for 40 min, then the powdery mixture B was added and decocted continuously for 40 min, cooled and filtered to obtain a cooling liquid and medicinal residues; (4) the medicinal residues were added with distilled water 8 times of its volume, heated to 100? C., decocted continuously for 35 min, cooled and then filtered to obtain a filtrate; and (5) the cooling liquid in step (3) and the filtrate in step (4) were combined, and a resulting mixed filtrate was centrifuged at 4000 g for 10 minutes at room temperature, a supernatant was collected, and the supernatant was concentrated to 1 g/ml, a resulting medicine solution was yellowish-brown, and had strong smell of traditional Chinese medicine, after sterilization and encapsulation, a traditional Chinese medicine composition for treating HFS after targeted drug treatment was obtained. The obtained traditional Chinese medicine had a liquid pharmaceutical dosage form.

(58) 80 cases were selected, including 46 males and 44 females. The youngest patient was 33 years old and the oldest was 66 years old, with an average age of 43 years. The cases were randomly divided into 8 groups according to age and condition, with 10 cases in each group. Efficacy was judged based on HFS grading, in which skin changes or dermatitis, paresthesias, and tissue destruction took the first place.

(59) The traditional Chinese medicine composition of this example was used for treatment, and the dosage was as follows: for patients of 33-47 years old, 200 ml was used once a day to fumigate and wash the affected part; for patients of 48-66 years old, 200 ml was used for each fumigation and wash of the affected part twice a day. After one week of fumigation and washing, the HFS grade of 76% of the patients was decreased by one level (level 3 was decreased to level 2, and level 2 was decreased to level 1). After two weeks of fumigation and washing, 88% of patients with skin changes or dermatitis returned to normal basically, and sensory abnormalities disappeared basically. No obvious adverse reactions appeared in patient during treatment, and no adverse reactions of the test medicine were observed.

(60) In summary, the traditional Chinese medicine composition of the present disclosure is used for the affected part of hand-foot skin after targeted drug treatment, has the effects of tonifying qi and nourishing blood, clearing heat and toxic materials, drying dampness and reducing phlegm. It has a good therapeutic effect on the HFS after targeted drug treatment, and is simple, convenient, cost effective and easy to implement.