Clinical Study On Allactin Injection In Reducing Side Reaction Of Cisplatin

Objective: Cisplatin is the preferable chemotherapy medicine to cure many kinds of cancers. Its curative effect is positive. But it has harm to propagating cells while killing the tumor cells and may cause serious side reaction if a great deal of cisplatin being used for a long time. As a result the patients'quality of life will descend obviously and the curative effect of chemotherapy will be reduced correspongdingly. So it is very important to look for the natural medicine that has little toxicity and side reaction to cure the tumor or to reduce the side reaction of chemotherapy medicine. Allactin is a compound with many kinds of biological active substance. In recent years, it is approved that the active substance in allactin has an effect on therapy of the tumor by many experiments on animals and ecto-study and it can add the sensitivity of cisplatin and reduce the DDP-induced mice nephrotoxicity. The research aims at the effects of allactin injection on the DDP-induced nephrotoxicity, gastrointestinal side reaction and patients'immunologic function, quality of life, providing a new way of medication to cure cancer in clinic.Methods:1 Case resource and grouping: 60 cases with ovarial cancer of our department were selected from 2004.10 to 2006.12. All the 60 cases were patients who would receive high dose DDP treatment and had received standard operation,diagnosed by histopathology and whose karnofsky'scores were greater than 60 scores and expectant survival time was long than six months. Those patients were excluded who suffered from organic disease of any other systems, or were hyperergic constitution, or received homo-nutrition via ecto-bowel, or took steroid hormone and immune medicine within three months. 60 cases were randomized into two groups: The test group (used DDP and allactin injection) 30 cases and the control group (used DDP alone) 30 cases. There was no significant difference among the two groups in ages, disease-process, and chemotherapy time.2 The methods of taking medicine: All 60 cases were treated with PC or PP chemotherapy scheme. The test group: Allactin injection was infused three days before DDP and the dose was 60mg/d, for ten continuous days. The control group: Just treated with chemotherapy. Other routine treatments were just the same in the two groups. In each treatment period three to four weeks treatment was applied and the curative effects were evaluated after each two treatment periods.3 Observation target: Gastrointestinal symptoms in chemotherapy process were observed. Weight, karnofsky'scores,β2-MG in blood and urine, NAG in urine, T lymphocyte subsets were measured respectively before and after using DDP. The side reactions of allactin injection were observed. 4 Statistical analysis: All the data were analyzed with SAS 6.12. Measurement data were presented as x±s, statistical analysis was performed by t test. Enumeration data were analyzed by x2 and Wilcoxon rank sum test. P<0.05 was considered statistically significant.Results:1 Effect of allactin injection on the DDP-induced gastrointestinal side reaction in chemotherapy process: (1) Effect of allactin injection on the patients'nausea symptom: From zero to four grade, there were one, six, nine, thirteen, one patients in the test group and zero, four, ten, fourteen, two patients in the control group respectively. The degree of the patients'nausea symptom was no significant difference between the two groups (P>0.05). (2) Effect of allactin injection on the patients'vomiting symptom: From zero to four grade, there were one, fifteen, ten, three, one patients in the test group and zero, five, eight, fifteen, two patients in the control group respectively. Compared with the control group, the degree of the patients'vomiting symptom of the test group was significantly relieved (P<0.05). (3) Effect of allactin injection on the patients'diarrhea symptom: From zero to four grade, there were twenty, five, three, two, zero patients in the test group and seventeen, six, four, three, zero patients in the control group respectively. Compared with the control group, though the degree of the patients'diarrhea symptom of the test group had a little tendency to relieve, there was no significant difference between the two groups (P>0.05).2 Effect of allactin injection on the DDP-induced nephrotoxicity: (1) Effect of allactin injection on ?2-MG in blood: The average value of ?2-MG in blood before and after chemotherapy was (1.37±0.23) mg/L, (1.48±0.25) mg/L in the test group and (1.33±0.14) mg/L, (1.83±0.33) mg/L in the control group. There was no significant difference between the two groups before chemotherapy (P>0.05) and no significant difference between the test group before and after chemotherapy (P>0.05). After chemotherapy, ?2-MG in blood of the control group was significantly increased (P<0.05), while there was significant difference between the two groups (P<0.05). (2) Effect of allactin injection on ?2-MG in urine: The average value of ?2-MG in urine before and after chemotherapy was (0.13±0.05) mg/L, (0.15±0.03) mg/L in the test group and(0.15±0.03)mg/L, (0.23±0.06) mg/L in the control group. There was no significant difference between the two groups before chemotherapy (P>0.05) and no significant difference between the test group before and after chemotherapy (P>0.05). After chemotherapy, ?2-MG in urine of the control group was significantly increased (P<0.05), while there was significant difference between the two groups (P<0.05). (3) Effect of allactin injection on NAG in urine: The average value of NAG in urine before and after chemotherapy was (394.8±21.2) U/L, (402.4±34.5) U/L in the test group and (403.5±33.2) U/L, (420.2±25.3) U/L in the control group. There was no significant difference between the two groups before chemotherapy (P>0.05) and no significant difference between the test group before and after chemotherapy (P>0.05). After chemotherapy, NAG in urine of the control group was significantly increased (P<0.05), while there was significant difference between the two groups (P<0.05). The data indecate that DDP can induce nephrotoxicity in patients, so ?2-MG in blood and in urine and NAG in urine were increased. Allactin injection can reduce this side reaction.3 Effect of allactin injection on the patients'quality of life: (1) Effect of allactin injection on the patients'weight: After chemotherapy there were nine, eighteen, three patients whose weight increased, stabilized, decreased in the test group and six, fifteen, nine patients in the control group respectively. Compared with the control group, the weight of patients of the test group had a little tendency to increase, there was no significant difference between the two groups (P>0.05). (2) Effect of allactin injection on the patients'physical condition: The average value of the patients'physical condition before and after chemotherapy was (75.86±5.62) scores, (77.13±4.21) scores in the test group and (76.38±5.16) scores, (70.52±3.34) scores in the control group respectively. There was no significant difference between the two groups before chemotherapy (P>0.05). After chemotherapy, compared with the control group, the physical condition of patients of the test group was significantly strengthened (P<0.05). 4 Effect of allactin injection on the patients'immunologic function of T lymphocyte: Before chemotherapy the average value of the T lymphocyte subsets of patients were CD₄⁺ (42.56±2.8) %, CD₈⁺ (31.62±2.9) %, CD₄⁺/ CD₈⁺ 1.42±0.7 in the test group and CD₄⁺ (41.87±3.2) %, CD₈⁺ (31.73±2.1) %, CD₄⁺/CD₈⁺ 1.30±0.8 in the control group. There was no significant difference between the two groups (P>0.05). After chemotherapy those was CD₄⁺ (42.24±3.1) %, CD₈⁺ (30.59±2.7) %, CD₄⁺/CD₈⁺ 1.38±0.8 in the test group and CD₄⁺ (41.35±2.4) %, CD₈⁺ (33.91±3.1) %, CD₄⁺/CD₈⁺ 0.92±0.6 in the control group. There was no significant difference between the test group before and after chemotherapy (P>0.05). After chemotherapy CD₈⁺ of the control group was significantly increased and CD₄⁺/CD₈⁺ ratio of the control group was significantly decreased (P<0.05), while these changes were significant between the two groups (P<0.05). The changes of CD₄⁺ of both the two groups were not significant after chemotherapy (P>0.05).5 The side reactions of allactin injection: Allactin injection had serious stimulation on veins. In the infusion process 43 of the 60 patients presented with different degree venous pain. Fomentation or slowing down the infusion could relieve the pain. No person suffered from phlebitis. Allactin injection gave off obvious beastly smell and could cause nausea. No other side reaction was found. Conclusions:1 Allactin injection can reduce the DDP-induced vomiting symptom in patients and the effective rate is 53.3%. Allactin injection has no effect on nausea and diarrhea symptom in patients. It is likely to relate with the nausea induced by the beastly smell of allactin injection.2 Allactin injection can reduce the DDP-induced nephrotoxicity in patients.3 Allactin injection can strengthen the patients'physical condition, improve the quality of life of patients. But allactin injection has no effect on the patients'weight.4 Allactin injection can decrease CD₈⁺ and increase CD₄⁺/CD8 ratio, so enhance the immunologic function of T lymphocyte in patients. But allactin injection has no effect on CD₄⁺.