Efficacy and safety of oral pyrotinib in HER2 positive metastatic breast cancer: real-world practice / 北京大学学报(医学版)

OBJECTIVE@#Pyrotinib, a novel irreversible pan-ErbB receptor tyrosine kinase inhibitor, showed promising antitumor activity and acceptable tolerability in phase II and phase III randomized clinical trials. We assessed the activity and safety of oral pyrotinib for human epidermal growth factor receptor 2 (HER2) positive metastatic breast cancer patients in the real world.@*METHODS@#We retrospectively analyzed 72 HER2 positive metastatic breast cancer (MBC) patients who received oral pyrotinib based regimens at Beijing Cancer Hospital and other four hospitals (Peking University First Hospital, China-Japan Friendship Hospital, General Hospital of PLA, Peking University Third Hospital) from August 2018 to September 2019. Progression free survival (PFS), objective response rate (ORR), adverse events (AE) of pyrotinib were investigated.@*RESULTS@#Seventy-two patients with HER2 positive MBC were enrolled. The median age of the patients was 55 years (range: 32-79 years). Sixty-nine (95.8%) patients had received anti-HER2 treatment in the metastatic and/or (neo) adjuvant settings; 61 (84.7%) patients had received anti-HER2 treatments in the metastatic setting in terms of trastuzumab 56 (77.8%) patients, lapatinib 36 (50.0%) patients, and T-DM1 4 (5.6%) patients. Among these 72 patients who received oral pyrotinib based regimens, 62 (86.1%) patients received pyrotinib (±trastuzumab) in combination with chemotherapy, 6 (8.3%) patients received pyrotinib (± trastuzumab) in combination with endocrine therapy and 4 (5.6%) patients received pyrotinib (±trastuzumab). Sixty-five (90.3%) patients received 400 mg pyrotinib once daily as initial dose, and 7 (9.7%) patients received 320 mg. OBJECTIVE response and safety to pyrotinib based therapy were evaluable in all the 72 patients. One (1.4%) patient achieved complete response (CR), 18 (25.0%) patients achieved partial response (PR), 41 (56.9%) patients had stable disease (SD), and 12 (16.7%) patients had progressive disease (PD). The ORR (CR+PR) was 26.4% and the median PFS was 7.6 months (95%CI: 5.5-9.7 months). Among the 36 patients with prior lapatinib therapy, the median PFS was 7.9 months (95%CI: 4.1-11.7 months). Among the 15 patients with brain metastasis, the median PFS was 6.0 months (95%CI: 2.2-9.8 months). The main toxicities related to pyrotinib were diarrhea in 57 (79.2%) cases, and 48 (66.7%) cases with grade 1-2 as well as 9 (12.5%) cases with grade 3.@*CONCLUSION@#Pyrotinib based therapy is an effective treatment for patients with HER2 positive MBC, including patients with lapatinib treatment failure and brain metastasis, and the toxicities can be tolerated.

Bushen Daozhuo Granules for type Ⅲ prostatitis: A multicenter randomized controlled clinical trial / 中华男科学杂志

Objective@#To study the safety and efficacy of Bushen Daozhuo Granules (BDG) in the treatment of type Ⅲ prostatitis.@*METHODS@#This multicenter randomized controlled clinical trial included 478 patients with type Ⅲ prostatitis, 290 in the trial group and 188 as controls, the former treated with BDG at 200 ml bid and the latter with tamsulosin hydrochloride sustainedrelease capsules at 0.2 mg qd, both for 4 weeks. Before treatment, after 4 weeks of medication, and at 4 weeks after drug withdrawal, we obtained the NIH Chronic Prostatitis Symptom Index (NIHCPSI) scores and compared the safety and effectiveness rate between the two groups of patients.@*RESULTS@#Compared with the baseline, the NIHCPSI score was markedly decreased in the control group after 4 weeks of medication (21.42 ± 4.02 vs 15.67 ± 3.65, P 0.05), while the NIHCPSI score in the trial group was remarkably lower than the baseline both after 4 weeks of medication and at 4 weeks after drug withdrawal (10.92 ± 2.06 and 12.91 ± 2.64 vs 21.58 ± 3.67, P < 0.05). The trial group exhibited both a higher rate of total effectiveness and safety than the control (P < 0.05).@*CONCLUSIONS@#BDG is safe and effective for the treatment of type Ⅲ prostatitis.

Prostatic inflammation-induced chronic pelvic pain: Roles of substance P and c-fos in the spinal cord / 中华男科学杂志

<p><b>OBJECTIVE</b>To explore the possible pain mechanism of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS).</p><p><b>METHODS</b>The models of CP/CPPS were established in male Wistar rats by the autoimmune method. The paw withdrawal threshold (PWT) was detected using Von Frey filament. The expressions of the substance P and c-fos in the prostate and spinal L5-S2 segments were determined by immunohistochemistry followed by analysis of their correlation with CP/CPPS.</p><p><b>RESULTS</b>Compared with the control rats, the CP/CPPS models showed significantly decreased PWT (P < 0.05), remarkable prostatic inflammation, enlarged scope of lesions, and obvious interstitial lymphocytic infiltration (P < 0.05). Both the expressions of substance P and c-fos were markedly elevated in the prostate and spinal dorsal horn (L5-S2) of the rat models (P < 0.05), but the expression of substance P in the prostate exhibited no correlation with that in the spinal cord (r = 0.099, P = 0.338), nor did that of c-fos (r = 0.027, P = 0.454).</p><p><b>CONCLUSION</b>The upregulated expressions of substance P and c-fos in the spinal cord L5-S2 sections may be associated with the pain mechanism of CP/CPPS.</p>

Roles of substance P and transient receptor potential vanilloid 1 in neuralgia in rats with chronic nonbacterial prostatitis / 中华男科学杂志

<p><b>OBJECTIVE</b>To study the possible mechanisms of chronic nonbacterial prostatitis (CNP) pain.</p><p><b>METHODS</b>CNP models were established in male Wistar rats by the autoimmune method. Then the paw withdrawal threshold (PWT) was detected using the Von Frey filament, prostate pathological examination was conducted, the expressions of substance P (SP) and transient receptor potential vanilloid 1 (TRPV1) in the prostate tissue and L5-S2 spinal segments were determined by immunohistochemistry and their correlations were analyzed.</p><p><b>RESULTS</b>Compared with the control group, the CNP model rats showed markedly decreased PWT (P < 0.05) and obvious inflammation in the prostate tissue, with significant differences in the scope of lesion and interstitial lymphocyte infiltration (P < 0.05). The expressions of SP and TRPV1 in the prostate and spinal cord dorsal horn L5-S2 were remarkably upregulated in the models as compared with the control rats (P < 0.05). However, the expression of SP in the prostate was not correlated with that in the spinal cord (r = 0.099, P = 0.338), nor was that of TRPV1 (r = 0.000, P = 0.5).</p><p><b>CONCLUSION</b>SP and TRPV1 were involved in the formation and persistence of pain in CNP rats through their upregulated expressions in the L5-S2 spinal segments.</p>

Changes of mechanical pain threshold in rats with experimental autoimmune prostatitis / 中华男科学杂志

<p><b>OBJECTIVE</b>To observe the changes of the mechanical pain threshold in the rat model of autoimmune prostatitis, explore the mechanism of autoimmune prostatitis pain and offer some animal experimental evidence for the drug therapy of the condition.</p><p><b>METHODS</b>Twenty male Wistar rats weighing 180 - 220 g were divided into a model and a control group. The autoimmune prostatitis model was established by subcutaneous injection of an extract of male rat prostate glands (RPG) at 60 mg/ml in Freund's complete adjuvant (FCA) and pertussis-diphtheria-tetanus vaccine at 0 and 30 days, respectively. Mechanical tactile hyperalgesia was measured once a week using Von Frey Filaments from the beginning of the study. At 8 weeks after modeling, the rats were sacrificed and the prostate tissues harvested for observation of histomorphological changes by HE staining.</p><p><b>RESULTS</b>HE staining revealed different degrees of benign prostatitis in the model rats. Compared with the controls, the mechanical pain threshold in the model rats was significantly decreased with the increased time of modeling, from (65.52 +/- 6.27) g at 0 week to (23.67 +/- 4.09) g at 8 weeks (P < 0.01). Statistically significant differences were found in the variation trend at different time points between the two groups (P < 0.01).</p><p><b>CONCLUSION</b>Autoimmune prostatitis models were successfully established in rats and hyperalgesia was induced after modeling.</p>

Erectile function of male rats in different age groups: an experimental study / 中华男科学杂志

<p><b>OBJECTIVE</b>To explore the relationship between aging and erectile function changes in rats in order to establish a rat model of aging-related erectile dysfunction (ED).</p><p><b>METHODS</b>Eighty male Wistar rats were equally divided into four age groups (3-, 6-, 12- and 18-month) and treated with intragastric administration of sildenafil citrate (Sn) for penile erection tests. Twenty 3-month-old female Wistar rats were randomized to four groups as oestrous rat models. We recorded the rate and frequency of penile erections of the male rats in different age groups.</p><p><b>RESULTS</b>The rates of penile erection were 85%, 75%, 40% and 30% and erectile frequencies were 2.27 +/- 0.80, 2.00 +/- 0.61, 1.40 +/- 0.51 and 1.29 +/- 0.49 in the 3-, 6-, 12- and 18-month rats, respectively, with statistically significant differences among different age groups (P < 0.01). And their erectile function exhibited a tendency to decrease with the increase of age. Besides, comparison of the 3-month with the 6-, 12- and 18-month groups showed significantly reduced erectile function in the 18-month rats (P < 0.05) but no remarkable difference between the 3-month and the 6- and 12-month groups (P > 0.05).</p><p><b>CONCLUSION</b>Aging is one of the main risk factors of rat erectile dysfunction, and 18-month-old male rats are qualified for the establishment of the rat model of aging-related erectile dysfunction.</p>

Establishment of a nonbacterial prostatitis model in rats using the autoimmune method: a dose-effect study / 中华男科学杂志

<p><b>OBJECTIVE</b>To establish an animal model of chronic nonbacterial prostatitis (CNP) using different doses of purified prostate protein with Freund's complete adjuvant (FCA), and to investigate the relationship of the doses with the success of the model construction.</p><p><b>METHODS</b>Thirty male Wistar rats were divided into a control (A) and 4 experimental groups (B, C, D and E) of equal number. The latter 4 groups were given multi-loci intracutaneous injection of 1.0 ml of a 1:1 mixture of purified prostate protein at 20, 40, 60 and 80 mg/ml with Freund's complete adjuvant (FCA), and meanwhile intraperitoneally injected with 0.5 ml of pertussis-diphtheria-tetanus vaccine at 0 and 30 days. On the 45th day, the rats were sacrificed for observation of the pathomorphological changes in the prostate glands with the naked eyes and microscope.</p><p><b>RESULTS</b>Different degrees of chronic inflammation were observed with different degrees of lymphocyte infiltration and interstitial hyperplasia in the experimental rats. More obvious changes were found in Groups C and D than in A, and even more significant in Group E (P < 0.05).</p><p><b>CONCLUSION</b>The rat model of CNP can be successfully established by multi-loci intracutaneous injection of 1.0 ml of a 1: 1 mixture of purified prostate protein at 40 - 60 mg/ml with FCA, and simultaneously intraperitoneal injection of 0.5 ml of pertussis-diphtheria-tetanus vaccine twice within 30 days.</p>

Clinical study on the treatment of premature ejaculation by Uighur medicine gu-jing-mai-si-ha tablet / 中国结合医学杂志

<p><b>OBJECTIVE</b>To observe the effect of Uighur medicine gu-jing-mai-si-ha tablet (GJMSHT) for treatment of premature ejaculation (PE) and to explore part of its mechanism.</p><p><b>METHODS</b>The condition of patients was scored by related questionnaire, and the intravaginal ejaculation latency time (IELT) was observed before and after GJMSHT treatment, with the blood levels of nitric oxide (NO) and prostaglandin F2alpha (PGF2alpha) detected in PE patients as well. The results were compared with those in the control group.</p><p><b>RESULTS</b>After treatment, the scores of PE and IELT, as well as the levels of NO and PGF2alpha, all increased significantly compared to those before treatment in the treated group (P<0.01), while in the control group, all the parameters were insignificantly changed (P>0.05). Therefore, the difference of these parameters between the two groups after treatment all showed statistical significance (P<0.01).</p><p><b>CONCLUSION</b>GJMSHT could treat PE effectively, its mechanism is possibly by strengthening the coordination of the related smooth muscles through increasing the blood levels of NO and PGF2alpha, and the endurance of patients to the cavitary effect of prostatico-urethral pressure, thus postponing the arrival of urgent ejaculatory feeling.</p>

Clinical analysis of 2643 cases of trigeminal neuralgia treated by microvascular decompression / 中华外科杂志

<p><b>OBJECTIVE</b>To evaluate the clinical effects of microvascular decompression in treating trigeminal neuralgia.</p><p><b>METHODS</b>Surgical experience and operative findings of 2643 cases of trigeminal neuralgia treated by microvascular decompression were analyzed retrospectively.</p><p><b>RESULTS</b>Two thousand four hundred and eighty-seven of 2643 cases were cured, 76 cases were ineffectiveness, 48 cases were effectiveness and 31 were ineffective. One patient died. Two thousand one hundred and thirty-six cases were followed up in 3-240 months, 1918 cases were cured, 85 cases were obviously effective, 39 cases were effective and 30 were ineffective. Sixty-four cases were pain relapsed and 37 cases were cured by second operation among them.</p><p><b>CONCLUSION</b>The etiology of trigeminal neuralgia is that the unusual vascular oppress the root entry zone, and arachnoid membrane circling the nerve is thickened and sticked. To untie the arachnoid membrane and decompress the offending vascular is the effective methods in treating trigeminal neuralgia.</p>

Recombinant human erythropoietin in the treatment of cisplatin-based-chemotherapy-induced a-nemia / 中国癌症杂志

Purpose:To study the efficiency and the safety of recombinant human erythropoietin (rHuEPO) in the treatment of chemotherapy-induced anemia.Methods:41 tumor patients were randomized into two groups:EPO-treatment group and control group,in order to observe the changes of the haemoglobin level,transfusion requirement and quality of life for the two groups respectively.Results:①the increase of haemoglobin level and the quality of life in the EPO-treat- ment group compared with that in the control group was statistically significant.②the reduction of transfusion requirement in the EPO-treatment group compared with that in the control group was not statistically significant.③treatment of EPO has few side-effects and a good tolerance.Conclusions:rHuEPO in the treatment of chemotherapy-induced anemia is effec- tive and safe.Not only can it increase the haemoglobin level but also improve the quality of life for the patients,so it should be used widely.