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Huaier Granules
Release time:
2024-07-16
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【Name of drug】
【Name of drug】
Generic name: Sophora ear granules
【Composition】
【Composition】
Sophora Ear Paste, supplemented with maltodextrin.
【Traits】
【Traits】
This product is light yellow-brown to brown particles; fishy, slightly bitter.
【Functions and Indications】
【Functions and Indications】
Supporting the positive and consolidating the root, activating blood and eliminating artwork. It is suitable for weak positive qi, stagnation of blood stasis, primary liver cancer is not suitable for surgery and chemotherapy adjuvant therapy, improve the role of pain in the liver area, abdominal distension, fatigue and other symptoms. On the basis of standard anti-cancer treatment with chemicals, it can be used for lung cancer, gastrointestinal cancer and breast cancer caused by fatigue, less breath and lazy speech, pain or distension in the epigastric region, less warmth in the stomach and abdomen, dry or loose stools, or shortness of breath, coughing, excessive phlegm, 晄white color, chest pain, blood in the sputum, discomfort in the chest and hypochondrium, etc., to improve the quality of life of the patients.
【Specifications】
【Specifications】
10g per bag.
【Usage and dosage】
【Usage and dosage】
Take orally, 10g (1 bag) once, 3 times a day. One month is one course of treatment for adjuvant therapy of liver cancer, or as directed by doctor. Adjuvant treatment for lung cancer, gastrointestinal cancer and breast cancer: six weeks as one course of treatment.
【Adverse Reactions】
【Adverse Reactions】
Monitoring and literature data show that the following adverse reactions can be seen: nausea, vomiting, diarrhea, abdominal pain, rash, itching and so on.
【Contraindications】
【Contraindications】
Not yet known.
【Caveat】
【Caveat】
对本品及所含成份过敏者禁用。
对本品及所含成份过敏者禁用。
【Caveat】
【Caveat】
It should be taken after meals.
【Clinical trial】
【Clinical trial】
This product was approved by the Ministry of Health in 1992 for a clinical trial of 405 cases of primary liver cancer.
It was approved by the State Food and Drug Administration (Approval No. 2004B05259) from April 2005 to August 2006 for a randomized double-blind, placebo-controlled, multi-center trial, in which 199 cases were in the test group, 16 cases were shed and 1 case was excluded; 202 cases were in the control group, 13 cases were shed and 1 case was excluded. There were 65 cases in the lung cancer treatment group and 64 cases in the control group; 65 cases in the breast cancer treatment group and 71 cases in the control group; and 69 cases in the gastrointestinal cancer treatment group and 67 cases in the control group (45 cases in the gastric cancer treatment group and 30 cases in the control group, and 24 cases in the bowel cancer treatment group and 37 cases in the control group).
Diagnostic criteria:
Comply with the diagnosis of primary non-small cell lung cancer, breast cancer and gastrointestinal cancer belonging to Zhengqi weakness, blood stasis and obstruction syndrome [Chinese Norms for the Diagnosis and Treatment of Common Malignant Tumors, Reference Standards for the Definition of Deficiency in Traditional Chinese Medicine (1986), and Diagnostic Standards for Blood Stasis Syndrome (1986)]. 18-75 years of age; Kahn's score of ≥ 60 points, expected to survive for more than 3 months, and acceptable to receive chemotherapeutic treatments.
Observation items:
(1) Lung cancer: mental fatigue, less qi and laziness, shortness of breath, cough, excessive sputum, 晄white color, chest pain, nagara and less xin, blood in sputum, and distension and fullness of the chest; gastrointestinal cancer: mental fatigue, less qi and laziness, pain in the epigastrium and abdomen, distension and fullness of the epigastrium and abdomen, nagara and less xin, dryness of the stools, and loose stools; breast cancer: mental fatigue, less qi and laziness, discomfort in the chest and abdomen, nagara and less xin, and dryness of the stools, and loose stools. (2) Quality of life (Karnofsky).
Dosing regimen:
Sophora ear granules (as original granules containing sucrose, size 20g/bag), orally, 20g once, 3 times a day. Sophora ear granules placebo, size: 20g/bag; orally, 20g once, 3 times a day. Course of treatment: 42 days. All of them also underwent 2 cycles of standard chemotherapeutic anticancer treatment, the lung cancer regimen was NP (PDD+NVB), TP (TAXOL+PDD), the gastrointestinal cancer regimen was FLP (CF+5FU+PDD), 5FU+CF+Platinum oxalate, and the breast cancer regimen was CAF (CTX+ADM+5FU), TP (TAXOL+PDD).
Evaluation Criteria:
Symptomatic efficacy (Nimodipine method): significant effect: post-treatment point reduction of more than 2/3 compared to pre-treatment. Effective: post-treatment points decreased by more than 1/3 but less than 2/3 compared to pre-treatment. ineffective: post-treatment points decreased by less than 1/3 or even increased compared to pre-treatment. Quality of life (Karnofsky): Improvement: increase of more than 10 points after treatment compared to before treatment. Stabilized: no change (less than 10 points) from pre-treatment. Decrease: decrease of more than 10 points after treatment compared to before treatment.
Test results:
(1) Symptom efficacy (FAS): among 200 cases in the experimental group, 99 cases (49.50%) showed obvious effect, 74 cases (37.00%) were effective, 27 cases (13.50%) were ineffective, with an effective rate of 86.50%; among 203 cases in the control group, 33 cases (16.26%) showed obvious effect, 52 cases (25.62%) were effective, 118 cases (58.13%) were ineffective, with an effective rate of 41.87%. Lung cancer: among 72 cases in the test group, 25 cases (34.72%) showed obvious effect, 30 cases (41.67%) were effective, 17 cases (23.61%) were ineffective, with an effective rate of 76.39%; among 71 cases in the control group, 10 cases (14.08%) showed obvious effect, 17 cases (23.94%) were effective, 44 cases (61.97%) were ineffective, with an effective rate of 38.03%. Gastrointestinal cancer: among 71 cases in the test group, 29 cases (40.85%) showed obvious effect, 32 cases (45.07%) were effective, 10 cases (14.08%) were ineffective, with an effective rate of 85.92%; among 72 cases in the control group, 12 cases (16.67%) showed obvious effect, 17 cases (23.61%) were effective, 43 cases (59.72%) were ineffective, with an effective rate of 40.28%. Breast cancer: of the 72 cases in the test group, 25 cases (34.72%) showed obvious effect, 29 cases (40.28%) were effective, 18 cases (25.00%) were ineffective, with an effective rate of 75.00%; of the 72 cases in the control group, 5 cases (6.94%) showed obvious effect, 19 cases (26.39%) were effective, 48 cases (66.67%) were ineffective, with an effective rate of 33.33%.
(2) Quality of life (FAS) Among 200 cases in the experimental group, 107 cases (53.50%) were improved, 82 cases (41.00%) were stabilized, and 11 cases (5.50%) were declined, with an improvement rate of 53.50%; among 203 cases in the control group, 38 cases (18.72%) were improved, 143 cases (70.44%) were stabilized, and 22 cases (10.84%) were declined, with an improvement rate of 18.72%. Lung cancer: among 65 cases in the test group, 36 cases (55.38%) were improved, 24 cases (36.92%) were stabilized, and 5 cases (7.69%) were decreased, with an improvement rate of 55.38%; among 66 cases in the control group, 15 cases (22.73%) were improved, 41 cases (62.12%) were stabilized, and 10 cases (15.15%) were decreased, with an improvement rate of 22.73%. Gastrointestinal cancer: among 69 cases in the test group, 39 cases (56.52%) were improved, 27 cases (39.13%) were stabilized, and 3 cases (4.35%) were decreased, with an improvement rate of 56.52%; among 67 cases in the control group, 11 cases (16.42%) were improved, 50 cases (74.63%) were stabilized, and 6 cases (8.96%) were decreased, with an improvement rate of 16.42%. Breast cancer: among 66 cases in the test group, 32 cases (48.48%) were improved, 31 cases (46.97%) were stabilized and 3 cases (4.55%) were decreased, with an improvement rate of 48.48%; among 70 cases in the control group, 12 cases (17.14%) were improved, 52 cases (74.29%) were stabilized and 6 cases (8.57%) were decreased, with an improvement rate of 17.14%.
When combined with anticancer chemotherapy, the incidence of adverse events was 12.50 (27/216)% in the experimental group, which could be seen in manifestations such as nausea, vomiting, abdominal distension, fever, diarrhea, chest tightness, palpitation, constipation, drug-induced liver damage, and infection of the right lower lung, and 13.89 (30/216)% in the control group, which could be seen in manifestations such as nausea, vomiting, abdominal distention, fever, malaise, common cold, chest tightness, palpitation, and platelet lowering and other manifestations. Nausea and vomiting occurred in 3 cases in the test group during drug administration, which was considered by the investigator to be related to the test drug.
This product was approved by the Ministry of Health in 1992 for a clinical trial of 405 cases of primary liver cancer.
It was approved by the State Food and Drug Administration (Approval No. 2004B05259) from April 2005 to August 2006 for a randomized double-blind, placebo-controlled, multi-center trial, in which 199 cases were in the test group, 16 cases were shed and 1 case was excluded; 202 cases were in the control group, 13 cases were shed and 1 case was excluded. There were 65 cases in the lung cancer treatment group and 64 cases in the control group; 65 cases in the breast cancer treatment group and 71 cases in the control group; and 69 cases in the gastrointestinal cancer treatment group and 67 cases in the control group (45 cases in the gastric cancer treatment group and 30 cases in the control group, and 24 cases in the bowel cancer treatment group and 37 cases in the control group).
Diagnostic criteria:
Comply with the diagnosis of primary non-small cell lung cancer, breast cancer and gastrointestinal cancer belonging to Zhengqi weakness, blood stasis and obstruction syndrome [Chinese Norms for the Diagnosis and Treatment of Common Malignant Tumors, Reference Standards for the Definition of Deficiency in Traditional Chinese Medicine (1986), and Diagnostic Standards for Blood Stasis Syndrome (1986)]. 18-75 years of age; Kahn's score of ≥ 60 points, expected to survive for more than 3 months, and acceptable to receive chemotherapeutic treatments.
Observation items:
(1) Lung cancer: mental fatigue, less qi and laziness, shortness of breath, cough, excessive sputum, 晄white color, chest pain, nagara and less xin, blood in sputum, and distension and fullness of the chest; gastrointestinal cancer: mental fatigue, less qi and laziness, pain in the epigastrium and abdomen, distension and fullness of the epigastrium and abdomen, nagara and less xin, dryness of the stools, and loose stools; breast cancer: mental fatigue, less qi and laziness, discomfort in the chest and abdomen, nagara and less xin, and dryness of the stools, and loose stools. (2) Quality of life (Karnofsky).
Dosing regimen:
Sophora ear granules (as original granules containing sucrose, size 20g/bag), orally, 20g once, 3 times a day. Sophora ear granules placebo, size: 20g/bag; orally, 20g once, 3 times a day. Course of treatment: 42 days. All of them also underwent 2 cycles of standard chemotherapeutic anticancer treatment, the lung cancer regimen was NP (PDD+NVB), TP (TAXOL+PDD), the gastrointestinal cancer regimen was FLP (CF+5FU+PDD), 5FU+CF+Platinum oxalate, and the breast cancer regimen was CAF (CTX+ADM+5FU), TP (TAXOL+PDD).
Evaluation Criteria:
Symptomatic efficacy (Nimodipine method): significant effect: post-treatment point reduction of more than 2/3 compared to pre-treatment. Effective: post-treatment points decreased by more than 1/3 but less than 2/3 compared to pre-treatment. ineffective: post-treatment points decreased by less than 1/3 or even increased compared to pre-treatment. Quality of life (Karnofsky): Improvement: increase of more than 10 points after treatment compared to before treatment. Stabilized: no change (less than 10 points) from pre-treatment. Decrease: decrease of more than 10 points after treatment compared to before treatment.
Test results:
(1) Symptom efficacy (FAS): among 200 cases in the experimental group, 99 cases (49.50%) showed obvious effect, 74 cases (37.00%) were effective, 27 cases (13.50%) were ineffective, with an effective rate of 86.50%; among 203 cases in the control group, 33 cases (16.26%) showed obvious effect, 52 cases (25.62%) were effective, 118 cases (58.13%) were ineffective, with an effective rate of 41.87%. Lung cancer: among 72 cases in the test group, 25 cases (34.72%) showed obvious effect, 30 cases (41.67%) were effective, 17 cases (23.61%) were ineffective, with an effective rate of 76.39%; among 71 cases in the control group, 10 cases (14.08%) showed obvious effect, 17 cases (23.94%) were effective, 44 cases (61.97%) were ineffective, with an effective rate of 38.03%. Gastrointestinal cancer: among 71 cases in the test group, 29 cases (40.85%) showed obvious effect, 32 cases (45.07%) were effective, 10 cases (14.08%) were ineffective, with an effective rate of 85.92%; among 72 cases in the control group, 12 cases (16.67%) showed obvious effect, 17 cases (23.61%) were effective, 43 cases (59.72%) were ineffective, with an effective rate of 40.28%. Breast cancer: of the 72 cases in the test group, 25 cases (34.72%) showed obvious effect, 29 cases (40.28%) were effective, 18 cases (25.00%) were ineffective, with an effective rate of 75.00%; of the 72 cases in the control group, 5 cases (6.94%) showed obvious effect, 19 cases (26.39%) were effective, 48 cases (66.67%) were ineffective, with an effective rate of 33.33%.
(2) Quality of life (FAS) Among 200 cases in the experimental group, 107 cases (53.50%) were improved, 82 cases (41.00%) were stabilized, and 11 cases (5.50%) were declined, with an improvement rate of 53.50%; among 203 cases in the control group, 38 cases (18.72%) were improved, 143 cases (70.44%) were stabilized, and 22 cases (10.84%) were declined, with an improvement rate of 18.72%. Lung cancer: among 65 cases in the test group, 36 cases (55.38%) were improved, 24 cases (36.92%) were stabilized, and 5 cases (7.69%) were decreased, with an improvement rate of 55.38%; among 66 cases in the control group, 15 cases (22.73%) were improved, 41 cases (62.12%) were stabilized, and 10 cases (15.15%) were decreased, with an improvement rate of 22.73%. Gastrointestinal cancer: among 69 cases in the test group, 39 cases (56.52%) were improved, 27 cases (39.13%) were stabilized, and 3 cases (4.35%) were decreased, with an improvement rate of 56.52%; among 67 cases in the control group, 11 cases (16.42%) were improved, 50 cases (74.63%) were stabilized, and 6 cases (8.96%) were decreased, with an improvement rate of 16.42%. Breast cancer: among 66 cases in the test group, 32 cases (48.48%) were improved, 31 cases (46.97%) were stabilized and 3 cases (4.55%) were decreased, with an improvement rate of 48.48%; among 70 cases in the control group, 12 cases (17.14%) were improved, 52 cases (74.29%) were stabilized and 6 cases (8.57%) were decreased, with an improvement rate of 17.14%.
When combined with anticancer chemotherapy, the incidence of adverse events was 12.50 (27/216)% in the experimental group, which could be seen in manifestations such as nausea, vomiting, abdominal distension, fever, diarrhea, chest tightness, palpitation, constipation, drug-induced liver damage, and infection of the right lower lung, and 13.89 (30/216)% in the control group, which could be seen in manifestations such as nausea, vomiting, abdominal distention, fever, malaise, common cold, chest tightness, palpitation, and platelet lowering and other manifestations. Nausea and vomiting occurred in 3 cases in the test group during drug administration, which was considered by the investigator to be related to the test drug.
【Pharmacology and Toxicology】
【Pharmacology and toxicology】
It has certain tumor suppressing effect on mouse sarcoma S180 and hepatocellular carcinoma Heps, and can promote the delayed hypersensitivity reaction of Dutch hepatocellular carcinoma Heps mice, and improve their serum hemolysin level, carbon granule contouring function, and T lymphocyte esterase staining rate.
【Storage】
【Storage】
【Storage】
Sealed, moisture-proof.
Packing
【Packaging】
Composite aluminum plastic film bag. Each box contains 6 bags.
Effective period] [Effective period] [Effective period] [Effective period] [Effective period] [Effective period
Effective period
24 months
Execution standard
【Execution standard】
State Drug Administration drug registration standard YBZ00352022
Approval number
【Approval number】
State Drug License Z20000109
Enterprise Information
【Enterprise Information】
Listed licensee and manufacturer: Qidong Gaitanli Pharmaceutical Co.
Address of the listed licensee and manufacturer: No. 1166, Nanyuan West Road, Huilong Town, Qidong City, Jiangsu Province, P.R. China
Postal Code: 226200
Telephone number: 0513-83321533
Fax: 0513-83321533
Packing
【Packaging】
Composite aluminum plastic film bag. Each box contains 6 bags.
Effective period] [Effective period] [Effective period] [Effective period] [Effective period] [Effective period
Effective period
24 months
Execution standard
【Execution standard】
State Drug Administration drug registration standard YBZ00352022
Approval number
【Approval number】
State Drug License Z20000109
Enterprise Information
【Enterprise Information】
Listed licensee and manufacturer: Qidong Gaitanli Pharmaceutical Co.
Address of the listed licensee and manufacturer: No. 1166, Nanyuan West Road, Huilong Town, Qidong City, Jiangsu Province, P.R. China
Postal Code: 226200
Telephone number: 0513-83321533
Fax: 0513-83321533