Clinical Observation on the Treatment of Male Neoplastic Anemia with Yixuesheng Capsule Combined wit
CHENG Zhi 1, WU Jia-li 1, and CHEN Jun-fa 2
ABSTRACT Objective: TO explore the efficacy and mechanism of Yixuesheng capsule (YXS) combined with recombination human erythropoietin (RHE) in treating male neoplastic anemia (NA). Methods: Sixty-five patients were randomized into two groups, the 33 patients in the treated group treated with a combined therapy of YXS and RHE, and the 32 in the control group treated with RHE alone, all for 12 weeks. Related clinical indexes, including hemoglobin (Hgb), red blood cell (RBC), hematocrit (HMC), testosterone (T), estradiol (E2) and prolactin (PRL), were measured before and after treatment. Results: After treatment, Hgb in the treated group and the control group was 108± 5 g/L and 104± 8 g/L respectively, showing marked improvement as compared with that before treatment (P<0.01), and the improvement in the former was more significant than that in the latter (P<0.05). Further, the level of T was also increased in the treated group after treatment (P<0.05), and showed a significant difference from that of the control group (P<0.05). Conclusions: YXS capsule combined with RHE shows a better therapeutic effect in treating NA than that of RHE alone, and the effect might be through stimulation by YXS of erythropoiesis which could promote the secretion of testosterone.
KEY WORDS Yixuesheng capsule, recombination human erythropoietin, combined therapy, testosterone, neoplastic anemia
Anemia is a commonly encountered complication of tumors, occurring in about half of all tumor patients, and in the late stage when tumor patients receive chemo- or radiotherapy, the occurrence rate may reach 90%(1). This kind of anemia is called neoplastic anemia (NA). Current researches on the pathogenesis of NA indicate that there may be present a relative deficiency of endogenous erythropoietin (EPO)
production or a lagging response of bone marrow to EPO in patients(2). Another study illustrated that lowering of testosterone (T) always accompanies anemia in NA patients(3). The authors have found that the combined therapy of Yixuesheng capsule (YXS) and recombination human erythropoietin (RHE) shows a favorable effect in treating male NA, which is reported as follows.
METHODS
Subjects Selection
All the 65 NA patients selected were male inpatients hospitalized in the authors' hospital from October 2004 to June 2007, 14 of them with lung cancer, 18 with stomach cancer, 12 with liver cancer, 4 with esophageal cancer, 14 with colonic cancer and
3 with malignant lymphoma. All patients with liver or renal failure, or bone marrow metastasis, or having received blood transfusion in the last 2 weeks, as well as patients with anemia caused by other chronic systemic diseases, were excluded.
General Materials and Grouping
The patients were randomized by way of lottery into two groups. The 33 patients in the treated group were 28-70 years old, 56.4 ± 9.94 years on average; with illness course of 2-15 months, mean 9.30± 4.44 months. The 32 patients in the control group were 25-72 years old, 55.4± 14.5 years on average; with illness course of 3-18 months, mean 8.50± 3.66 months. The above factors in the two groups were not different significantly, so they were comparable.
Treatment
The control group was given RHE injection (product of Shenyang Sanshang Pharmaceutical Co., Ltd., certification number Guoyao Zhunzi $20010001, each ampoule containing 10 thousand international
Department of Hematology, Hangzhou Municipal Third People's Hospital, Hangzhou (310009), China; 2. Department of Hematology, Zhejiang Provincial Traditional Chinese Medicine Hospital, Hangzhou (310009), China
Correspondence to: Dr. CHENG Zhi, Tel: 86-571-87823134,
Fax: 86-571-87814481, E-mail: cenghis@ 163.com
DOl: 10.1007/sl 1655-009-0063-3
units) 150 u/kg per day by subcutaneous injection, 3 times every week. RHE was given to the treated group in the same dosage, while YXS was also administered 3 times per day, 4 capsules each time. YXS is the product of Zhuhai Pharmaceutical Co.,
Ltd., Aodong City, Jilin Province, consisting of ass-hide gelatin, antler glue, human placenta, prepared rehmannia root, Chinese angelica root, milkvetch root, asiabell root, etc., weighing 0.25 g/capsule. The treatment lasted for 12 weeks in both groups, with no other drugs for promoting erythropoiesis used in the therapeutic course.
Laboratory Index Determination
Fasting venous blood samples (4 mL) of patients were collected in the morning on different days (time points) in the treatment course, i.e. before treatment (TO, baseline), and at the end of the 4th, 8th and 12th week of treatment (T1, T2 and T3). After being placed under room temperature for 2 h, the blood sample was centrifuged at 3 000 r/min for 10 min to separate the serum to determine the sex hormones, estradiol (E2), prolactin (PRL) and testosterone (T), by electrochemical luminescence immunoassay with Roche an Elecsys 2010 analysor.
Further, blood routine tests of red blood cell (RBC), hemoglobin (Hgb) and hematocrit (HMC) were performed at the same time points.
Efficacy Assessment
Efficacy was assessed at the end of every 4-week segment in the whole treatment period, according to the domestic universal criterion(4), that is, "Basically cured" means that Hgb levels are restored to or over 120 g/L after treatment; "Effective" means that HgB levels are increased by 15 g/L over the baseline; and "Ineffective" means no improvement.
Statistic Analysis
Analysis was done using SPSS 12.0 software; the measurement data were expressed as x(__) ± s, intergroup comparison was conducted by t-test and Chi-square test for two separate samples, and intra-group comparison was done by variance analysis.
RESULTS
Comparison of Levels of Hgb, RBC and HMC
Levels of Hgb, RBC and HMC started to ri se at the end of the first 4-week treatment (T1), and all levels were markedly improved in both groups, showing significant differences as compared with baseline values (P<0.01), but no statistical significance was seen between the groups. After being treated for 12 weeks, the improvement of the three indexes in the treated group did show statistical significance compared with the control group (P<0.05, Table 1).
Comparison of Blood Levels of Sex Hormones
The level of T in the control group showed no significant change after treatment, while that in the treated group increased after treatment and showed a significant difference at T3 compared with both the baseline and the control group values at the corresponding time points (P<0.05). As for the levels of E2 and PRL, they showed no significant changes after treatment, though they somewhat declined (Table 2).
Comparison of Therapeutic Efficacy between Groups
The total effective rate when the whole course of the 12-week treatment was finished was 84.4% (27/32) in the control group and 90.9% (30/33) in the
DISCUSSION
Neoplastic anemia is categorized as an anemia of chronic disease, and its pathogenesis is presumed to be the production deficiency of EPO, with its activity inhibited by inflammatory factors(5,6). Several studies showed that levels of some inflammation promoting factors, such as tumor necrosis factor a (TNF-a), interleukin-6 (IL-6) and interferons, all of which have an inhibitory action on EPO secretion, are obviously elevated in tumor patients, thus inducing EPO secretion deficiency.
EPO is a kind of protein hormone produced by the kidney, with a molecular weight of 30KD. It is the chief factor in regulating erythropoiesis in mammals(7), which could promote the development, differentiation and maturation of bone marrow erythrocytes, showing a specific effect on the myeloid red cell series. A decrease in EPO secretion and its suppressed activity is the chief cause of anemia that occurs in tumor patients. Some researches have illustrated that using EPO for the treatment of NA could markedly diminish the amount of blood transfusion required and improve symptoms in patients(8,9).
Testosterone, through its metabolism in the body, could promote the secretion of erythropoietin in the kidney, and directly stimulate the proliferation and differentiation of the progenitor of the red cell series. It has been indicated that the level of testosterone is lowered in patients with NA(2), and the study carried out by the authors has also shown the same result.
The YXS capsule consists of 22 precious Chinese drugs such as ass-hide gelatin, antler glue, human placenta, prepared rehmannia root, Chinese angelica root, milkvetch root, asiabell root, etc., which function to strengthen Pi to produce blood, and reinforce Shen to supplement the prime. This study showed that anemia in NA patients could be obviously improved by administering a combination of YXS with RHE for 12 weeks, and the blood level of T could be raised accordingly. The authors hold that the mechanism of the YXS capsule is possibly by way of promoting the secretion of T to stimulate erythropoiesis.
It was also found that the levels of E2 and PRL were lowered to some extent, suggesting that these changes might be related to the elevation of T and improvement of anemic symptoms after YXS treatment.
To sum up, the efficacy of YXS combined with RHE for NA treatment is better than that of RHE alone, and the acting mechanism of YXS is possibly through promoting the secretion of endogenous erythropoietin to stimulate erythropoiesis and thus enhance the effect of RHE.
Platform for TCM Education relies on Guilin Sino-western Medicine Joint Hospital and Guilin International Exchange Center for Traditional Chinese Medicine and bases on strong internet function of www.tcmdiscovery.com to set up a platform where people can learn and practice TCM so as to contribute to humankind health.
ABSTRACT Objective: TO explore the efficacy and mechanism of Yixuesheng capsule (YXS) combined with recombination human erythropoietin (RHE) in treating male neoplastic anemia (NA). Methods: Sixty-five patients were randomized into two groups, the 33 patients in the treated group treated with a combined therapy of YXS and RHE, and the 32 in the control group treated with RHE alone, all for 12 weeks. Related clinical indexes, including hemoglobin (Hgb), red blood cell (RBC), hematocrit (HMC), testosterone (T), estradiol (E2) and prolactin (PRL), were measured before and after treatment. Results: After treatment, Hgb in the treated group and the control group was 108± 5 g/L and 104± 8 g/L respectively, showing marked improvement as compared with that before treatment (P<0.01), and the improvement in the former was more significant than that in the latter (P<0.05). Further, the level of T was also increased in the treated group after treatment (P<0.05), and showed a significant difference from that of the control group (P<0.05). Conclusions: YXS capsule combined with RHE shows a better therapeutic effect in treating NA than that of RHE alone, and the effect might be through stimulation by YXS of erythropoiesis which could promote the secretion of testosterone.
KEY WORDS Yixuesheng capsule, recombination human erythropoietin, combined therapy, testosterone, neoplastic anemia
Anemia is a commonly encountered complication of tumors, occurring in about half of all tumor patients, and in the late stage when tumor patients receive chemo- or radiotherapy, the occurrence rate may reach 90%(1). This kind of anemia is called neoplastic anemia (NA). Current researches on the pathogenesis of NA indicate that there may be present a relative deficiency of endogenous erythropoietin (EPO)
production or a lagging response of bone marrow to EPO in patients(2). Another study illustrated that lowering of testosterone (T) always accompanies anemia in NA patients(3). The authors have found that the combined therapy of Yixuesheng capsule (YXS) and recombination human erythropoietin (RHE) shows a favorable effect in treating male NA, which is reported as follows.
METHODS
Subjects Selection
All the 65 NA patients selected were male inpatients hospitalized in the authors' hospital from October 2004 to June 2007, 14 of them with lung cancer, 18 with stomach cancer, 12 with liver cancer, 4 with esophageal cancer, 14 with colonic cancer and
3 with malignant lymphoma. All patients with liver or renal failure, or bone marrow metastasis, or having received blood transfusion in the last 2 weeks, as well as patients with anemia caused by other chronic systemic diseases, were excluded.
General Materials and Grouping
The patients were randomized by way of lottery into two groups. The 33 patients in the treated group were 28-70 years old, 56.4 ± 9.94 years on average; with illness course of 2-15 months, mean 9.30± 4.44 months. The 32 patients in the control group were 25-72 years old, 55.4± 14.5 years on average; with illness course of 3-18 months, mean 8.50± 3.66 months. The above factors in the two groups were not different significantly, so they were comparable.
Treatment
The control group was given RHE injection (product of Shenyang Sanshang Pharmaceutical Co., Ltd., certification number Guoyao Zhunzi $20010001, each ampoule containing 10 thousand international
Department of Hematology, Hangzhou Municipal Third People's Hospital, Hangzhou (310009), China; 2. Department of Hematology, Zhejiang Provincial Traditional Chinese Medicine Hospital, Hangzhou (310009), China
Correspondence to: Dr. CHENG Zhi, Tel: 86-571-87823134,
Fax: 86-571-87814481, E-mail: cenghis@ 163.com
DOl: 10.1007/sl 1655-009-0063-3
units) 150 u/kg per day by subcutaneous injection, 3 times every week. RHE was given to the treated group in the same dosage, while YXS was also administered 3 times per day, 4 capsules each time. YXS is the product of Zhuhai Pharmaceutical Co.,
Ltd., Aodong City, Jilin Province, consisting of ass-hide gelatin, antler glue, human placenta, prepared rehmannia root, Chinese angelica root, milkvetch root, asiabell root, etc., weighing 0.25 g/capsule. The treatment lasted for 12 weeks in both groups, with no other drugs for promoting erythropoiesis used in the therapeutic course.
Laboratory Index Determination
Fasting venous blood samples (4 mL) of patients were collected in the morning on different days (time points) in the treatment course, i.e. before treatment (TO, baseline), and at the end of the 4th, 8th and 12th week of treatment (T1, T2 and T3). After being placed under room temperature for 2 h, the blood sample was centrifuged at 3 000 r/min for 10 min to separate the serum to determine the sex hormones, estradiol (E2), prolactin (PRL) and testosterone (T), by electrochemical luminescence immunoassay with Roche an Elecsys 2010 analysor.
Further, blood routine tests of red blood cell (RBC), hemoglobin (Hgb) and hematocrit (HMC) were performed at the same time points.
Efficacy Assessment
Efficacy was assessed at the end of every 4-week segment in the whole treatment period, according to the domestic universal criterion(4), that is, "Basically cured" means that Hgb levels are restored to or over 120 g/L after treatment; "Effective" means that HgB levels are increased by 15 g/L over the baseline; and "Ineffective" means no improvement.
Statistic Analysis
Analysis was done using SPSS 12.0 software; the measurement data were expressed as x(__) ± s, intergroup comparison was conducted by t-test and Chi-square test for two separate samples, and intra-group comparison was done by variance analysis.
RESULTS
Comparison of Levels of Hgb, RBC and HMC
Levels of Hgb, RBC and HMC started to ri se at the end of the first 4-week treatment (T1), and all levels were markedly improved in both groups, showing significant differences as compared with baseline values (P<0.01), but no statistical significance was seen between the groups. After being treated for 12 weeks, the improvement of the three indexes in the treated group did show statistical significance compared with the control group (P<0.05, Table 1).
Comparison of Blood Levels of Sex Hormones
The level of T in the control group showed no significant change after treatment, while that in the treated group increased after treatment and showed a significant difference at T3 compared with both the baseline and the control group values at the corresponding time points (P<0.05). As for the levels of E2 and PRL, they showed no significant changes after treatment, though they somewhat declined (Table 2).
Comparison of Therapeutic Efficacy between Groups
The total effective rate when the whole course of the 12-week treatment was finished was 84.4% (27/32) in the control group and 90.9% (30/33) in the
DISCUSSION
Neoplastic anemia is categorized as an anemia of chronic disease, and its pathogenesis is presumed to be the production deficiency of EPO, with its activity inhibited by inflammatory factors(5,6). Several studies showed that levels of some inflammation promoting factors, such as tumor necrosis factor a (TNF-a), interleukin-6 (IL-6) and interferons, all of which have an inhibitory action on EPO secretion, are obviously elevated in tumor patients, thus inducing EPO secretion deficiency.
EPO is a kind of protein hormone produced by the kidney, with a molecular weight of 30KD. It is the chief factor in regulating erythropoiesis in mammals(7), which could promote the development, differentiation and maturation of bone marrow erythrocytes, showing a specific effect on the myeloid red cell series. A decrease in EPO secretion and its suppressed activity is the chief cause of anemia that occurs in tumor patients. Some researches have illustrated that using EPO for the treatment of NA could markedly diminish the amount of blood transfusion required and improve symptoms in patients(8,9).
Testosterone, through its metabolism in the body, could promote the secretion of erythropoietin in the kidney, and directly stimulate the proliferation and differentiation of the progenitor of the red cell series. It has been indicated that the level of testosterone is lowered in patients with NA(2), and the study carried out by the authors has also shown the same result.
The YXS capsule consists of 22 precious Chinese drugs such as ass-hide gelatin, antler glue, human placenta, prepared rehmannia root, Chinese angelica root, milkvetch root, asiabell root, etc., which function to strengthen Pi to produce blood, and reinforce Shen to supplement the prime. This study showed that anemia in NA patients could be obviously improved by administering a combination of YXS with RHE for 12 weeks, and the blood level of T could be raised accordingly. The authors hold that the mechanism of the YXS capsule is possibly by way of promoting the secretion of T to stimulate erythropoiesis.
It was also found that the levels of E2 and PRL were lowered to some extent, suggesting that these changes might be related to the elevation of T and improvement of anemic symptoms after YXS treatment.
To sum up, the efficacy of YXS combined with RHE for NA treatment is better than that of RHE alone, and the acting mechanism of YXS is possibly through promoting the secretion of endogenous erythropoietin to stimulate erythropoiesis and thus enhance the effect of RHE.
Platform for TCM Education relies on Guilin Sino-western Medicine Joint Hospital and Guilin International Exchange Center for Traditional Chinese Medicine and bases on strong internet function of www.tcmdiscovery.com to set up a platform where people can learn and practice TCM so as to contribute to humankind health.
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