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Objective: To evaluate the efficacy and safety of PEG-rhG-CSF therapy in the primary and secondary prevention of chemo-therapy-induced neutropenia . Methods: This single-center, one-arm, and open-label clinical study involved 217 patients with non-my-eloid malignant tumors. These patients included 18 gynecologic oncology (3 endometrial and 15 ovarian cancer), 50 breast cancer, 30 bone tumor, and 119 lymphoma patients who underwent a total of 774 cycles of chemotherapy, comprising 146 primary and 71 sec-ondary prevention patients. The patients ≥45 kg and those <45 kg received a single subcutaneous injection of 6 mg and 3 mg PEG-rhG-CSF, respectively, 24-48 h after the chemotherapy was completed. All patients received only one dose of PEG-rhG-CSF admin-istration per chemotherapy cycle. Results: The overall incidence of febrile neutropenia (FN) was found to be 5.7%, with rates of 4.9% and 7.2% in the primary and secondary prevention groups, respectively. Univariate and multivariate Logistic regression analyses re-vealed that the longer PEG-rhG-CSF was sustained in the treatment cycle, the lower the incidence of FN was. The incidence of FN was significantly lower in the second cycle of the treatment than in the first in both the primary and secondary prevention groups (cycle 1 vs. cycle 2: 11.6% vs. 4.4%, respectively, P=0.039, in the primary group; 16.9% vs. 5.6%, respectively, P=0.034, in the secondary group). The overall incidence of gradeⅣneutropenia was 10.3% (80/774), with rates of 6.7% (34/510) and 17.4% (46/264) in the primary and secondary prevention groups, respectively (P<0.001). The incidence of gradeⅣneutropenia was significantly lower in the second cy-cle of the treatment than in the first (cycle 1 vs. cycle 2: 17.1% vs. 5.3%, respectively, P=0.004, in the primary group; 46.5% vs. 11.3%, respectively, P<0.001, in the secondary group). The treatment-induced toxicity mainly involved bone pain, with 3.7% (8/217) and 1.8% (4/217) incidence rates for grade 1-2 and 3-4 bone pain, respectively. Conclusions: PEG-rhG-CSF administration can effectively reduce the incidence of FN (5.7%) when prophylactically applied to patients with non-myeloid malignant tumors. Primary prevention can sig- nificantly reduce the risk of grade IV neutropenia in all chemotherapy cycles relative to the secondary prevention.
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Objective:To detect the proportion of lymphocyte subsets in peripheral blood of the ad-vanced breast cancer patients before and after chemotherapy with docetaxel and thiotepa,as well as the association between the proportion of peripheral blood lymphocyte subsets with the response rate and prog-nosis.Methods:The proportions of lymphocyte subsets (CD3 +T cell,CD3 +/CD4 +T cell,CD3 +/CD8 +T cell,CD3 -/CD16 +56 +NK cell,CD3 +/CD16 +56 +T cell,CD19 +B cell,CD4 +/CD25 +T cell,CD8 +/CD28 -T cell,CD8 +/CD28 +T cell)in the peripheral blood of 86 patients were analyzed with flowcytometry before and after chemotherapy.The result was analyzed in combination with clinico-pathological data.Results:The proportion of regulatory T cells (Treg)after chemotherapy in the disease control patients decreased significantly compared with that of the progressive patients (P=0.034).The difference of the proportions of Treg before and after chemotherapy affected significantly the overall survi-val (OS).The OS of the patients with decreased proportion of Treg was significantly longer than that of the patients with increased proportion of Treg,which was 23.5 and 9.4 months respectively (P<0.05). Conclusion:The patients with decreased proportion of Treg after chemotherapy had higher response rate and better survival benefit.
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Objective To observe the efficacy of modified Tianma?Sanqi Decoction on hypertension patients with anxiety. Methods Totally 64 hypertension patients with anxiety patients were randomly divid?ed into control group (32 cases) and treatment group (32 cases).The control group with standard medica?tions for hypertension and treatment group with addition of Tianma?Sanqi Decoction, and both groups were continuously treated for 8 weeks. The changes of 24 hours ambulatory blood pressure and SAS scores were compared.Results ( 1) After treatment in the control group and treatment group of 24 h mean systolic blood pressure (24 hSBP) ((130.13±3.81)mmHg,(123.56±4.37)mmHg) (1 mmHg=0.133 kPa) were lower than before treatment((145.36±7.17) mmHg,(145.16±6.77) mmHg) and the difference was statisti?cally significant( P<0.01).(2) After treatment in the control group and treatment group 24 h systolic pres?sure standard deviation,diurnal systolic pressure standard deviation and nocturnal systolic pressure standard deviation((12.19±3.21) mmHg,(11.16±2.26) mmHg,(10.49±3.76) mmHg and (10.95±2.35) mmHg, (10.08±2.67) mmHg,(10.12±3.78)mmHg) were lower than before treatment ((14.53±3.65) mmHg, (13.81±4.04) mmHg,(12.47±4.23) mmHg and (16.73±7.90)mmHg,(16.06±4.14)mmHg,(13.65± 4.92)mmHg),and the difference was statistically significant( P<0.01 or P<0.05).After treatment in the treatment group, 24 h systolic pressure standard deviation, nocturnal systolic pressure standard deviation ((10.95±2.35) mmHg,(10.08±2.67) mmHg) were lower than control group((12.19±3.21) mmHg, (11.16±2.26) mmHg) and the difference was statistically significant.( P<0.01).(3) After treatment in the treatment group,SAS scores (36.68±3.88) points were lower than before treatment (58.66±3.13) points and the difference was statistically significant(P<0.01).After treatment the SAS score ((36.68±3.88) points) in the treatment group was lower than control group((51.86+2.62) points).Conclusion The hypertension patients with anxiety treated with Tianma?Sanqi Decoction and benazapril can improve blood pressure variability and the symp?toms of anxiety.
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Objective To investigate and evaluate the diagnostic value of transcranial doppler ultrasound (TCD) on brain death in patients with severe craniocerebral injury.Methods Forty-two cases of severe craniocerebral injury from Affiliated Hospital of Jining Medical University were divided into brain death group and survival group,according to the clinical prognosis.TCD was conducted to examine brain blood flow numerical and changed characteristics of the spectrum.Average blood flow velocity (Vm),pulse index (PI),diastolic blood flow in reverse (reverberating flow) and small systolic peaks in early systole (wave of spikes)were documented.TCD parameters were compared between the two groups with t test.Results In the brain death group,frequency of reverberating flow was 86.67％ and frequency of wave of spikes was 13.33％.In survival group,frequency of reverberating flow was 14.81％ and no wave of spikes was recorded.The difference in frequencies of reverberating flow and wave of spikes between the two groups was significant(x2 =28.25,P ＜0.01).The average speed of bilateral middle cerebral artery blood flow in brain death group((20.02±13.96) cm/s) was significantly reduced compared with survival group((56.81± 16.84) cm/s,t=2.30,P＜0.05).Pulse index (PI) values in brain death group (4.02±3.49)were significantly increased compared with survival group (1.24±1.03) (t=2.10,P＜0.05).Conclusion Reverberating flow or wave of spikes is an important marker for brain death in patients with severe craniocerebral injury.TCD may be applied to clinically confirm the diagnosis of brain death.
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Background and purpose:Nab-paclitaxel (Abraxane) is an albumin-bound form of paclitaxel that utilizes the natural properties of albumin to improve paclitaxel delivery to the tumor. It has recently been approved for treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within short time after adjuvant chemotherapy. The purpose of this study was to evaluate the efifcacy and safety of albumin-bound paclitaxel in patients with aggressive and refractory metastatic breast cancer (MBC).Methods:A total of 58 patients with MBC were enrolled into this study from Jul. 2009 to Jan. 2014. All patients received albumin-bound paclitaxel-based chemotherapy. The adverse reactions were evaluated every cycle, and the short-term response was evaluated every two cycles. The patients were followed-up, and the survival was analyzed.Results:58 patients with refractory MBC were evaluable for response, 67.2% of patients received multiple line (≥3 lines) chemotherapy, 32.8% of patients with first and second line of chemotherapy were involved metastasis within one year after adjuvant chemotherapy, 84.5% of patients with visceral metastasis and 93.1% with prior taxane treatment. The objective response rate (ORR) was 13.8%, and disease control rate (DCR) was 60.3%, the median progression free survival (PFS) was 4.0 months, and the overall survival (OS) was 10.1 months. For 23 patients with triple negative breast cancer, ORR was 13.0% and DCR was 56.5%, the median PFS was 4.1 months, and OS was 6.6 months. The main toxicity was myelosuppression (grades 3 and 4 neutropenia, anemia and thombocytopenia were seen in 34.5%, 12.1% and 6.9% of patients, respectively), gastrointestinal reactions, sensory neuropathy, myodynia/arthragia, fatigue, alopecia and so on.Conclusion:The albumin-bound paclitaxel-based chemotherapy can be used in aggressive and refractory MBC. It also showed antitumor activity in taxanes-resistance patients and triple negative patients with good safety and tolerance.
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Objective:To investigate the expression status of Sonic Hedgehog signaling genes and molecules in human hepatocellular carcinomas(HCC),and to explore the relationship between these genes and clinical prognosis.Methods:HCC tissue and adjacent normal tissue from 29 HCC patients were assayed for the expression of hedgehog signaling genes by reverse transcription-polymerase chain reaction chain reaction(RT-PCR) techniques and for the expression of hedgehog signaling molecules by immunohistochemistry.The expressions of Shh,Ptch,Smoh,Gli-1 mRNA were assayed as well as Shh,Ptch proteins in 29 cases of HCC and in 29 liver tissues adjacent to the tumor.Results:Expression of Shh mRNA was detectable in about 51% of HCCs examined.Consistent with this,hedgehog target genes Ptch,Smoh and Gli-1 mRNA were expressed in over 68%,48% and 62% of the tumors,respectively,and the expressions of Shh and Ptch proteins in HCC tumor tissues correlated with those of Shh and Ptch mRNA in tumor tissues(P=0.041 and P=0.035).This suggested that the hedgehog pathway was frequently activated in HCCs.The simultaneous expression of Gli-1 in HCC and liver tissues adjacent to the tumor had significantly relationship with poor prognosis.Conclusion:Hedgehog signaling activation is an important event for development of human HCCs.It also suggests that markers for hedgehog signaling activation may be useful for the determination of prognosis.
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Objective To evaluate open surgery vs transurethral management for bladder outlet obstruction (BOO) caused by benign prostatic hyperplasia (BPH) of small volume. Methods From May 1993 to June 2002,50 patients were surgically treated.Of them 22 underwent open surgery and 28 underwent TURP plus transurethral incision of bladder neck(TUIBN).There was no statistically significant difference between the 2 groups in age,disease course,preoperative prostate weight and the excised prostate weight.All the surgical procedures were conducted by the same urologist.The efficacy of open surgery and TURP plus TUIBN was comparatively evaluated by IPSS,Qmax and post void residual urine volume(PVR) and hospitalization days. Results The IPSS of those undergoing open surgery decreased from 24.6?3.8 of preoperation to 15.2?3.4 of postoperation ,and the Qmax increased from (8.3?2.9)ml/s to (9.5?3.6)ml/s,and the PVR decreased from(220.0?30.0)ml to(90.0?20.0)ml,and the postoperative hospital stay was 14.2 days.The IPSS of the patients undergoing TURP plus TUIBN decreased from 24.9?4.2 to 5.8?2.7,and the Qmax increased from (8.0?3.1)ml/s to (23.2? 3.8)ml/s,and the PVR decreased from(230.0?28.0)ml to(15.0?4.0)ml,and the postoperative hospital stay was 8.5 days.The postoperative improvement was much greater in the patients undergoing TURP plus TUIBN than those undergoing open surgery as assessed by IPSS,Qmax and PVR (all P