Objective: To evaluate the long-term efficacy and safety of niraparib in Japanese women with heavily pretreated ovarian cancer. Methods: This was the follow-up analysis of a phase 2, multicenter, open-label, single-arm study in Japanese women with homologous recombination-deficient, platinum-sensitive, relapsed, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who had completed 3–4 lines of chemotherapy and were poly(ADP-ribose) polymerase inhibitor naïve. Participants received niraparib (starting dose, 300 mg) once daily in continuous 28-day cycles until objective disease progression, unacceptable toxicity, or consent withdrawal. The primary endpoint was confirmed objective response rate (ORR), as assessed using Response Evaluation Criteria in Solid Tumors version 1.1. Safety evaluations included treatment-emergent adverse events (TEAEs). Results: 20 patients were enrolled in the study and included in both efficacy and safety analyses. Median total study duration was 759.5 days. Median dose intensity was 201.3 mg/ day. Confirmed ORR was 60.0% (90% confidence interval [CI]=39.4–78.3); 2 patients had complete response and 10 patients had partial response. Median duration of response was 9.9 months (95% CI=3.9–26.9) and the disease control rate was 90.0% (95% CI=68.3–98.8).The most common TEAEs were anemia (n=15), nausea (n=12), and decreased platelet count (n=11). TEAEs leading to study drug dose reduction, interruption, or discontinuation were reported in 16 (80.0%), 15 (75.0%), and 2 patients (10.0%), respectively. Conclusion The long-term efficacy and safety profile of niraparib was consistent with previous findings in the equivalent population in non-Japanese patients. No new safety signals were identified.

Objective: To evaluate the long-term efficacy and safety of niraparib in Japanese women with heavily pretreated ovarian cancer. Methods: This was the follow-up analysis of a phase 2, multicenter, open-label, single-arm study in Japanese women with homologous recombination-deficient, platinum-sensitive, relapsed, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who had completed 3–4 lines of chemotherapy and were poly(ADP-ribose) polymerase inhibitor naïve. Participants received niraparib (starting dose, 300 mg) once daily in continuous 28-day cycles until objective disease progression, unacceptable toxicity, or consent withdrawal. The primary endpoint was confirmed objective response rate (ORR), as assessed using Response Evaluation Criteria in Solid Tumors version 1.1. Safety evaluations included treatment-emergent adverse events (TEAEs). Results: 20 patients were enrolled in the study and included in both efficacy and safety analyses. Median total study duration was 759.5 days. Median dose intensity was 201.3 mg/ day. Confirmed ORR was 60.0% (90% confidence interval [CI]=39.4–78.3); 2 patients had complete response and 10 patients had partial response. Median duration of response was 9.9 months (95% CI=3.9–26.9) and the disease control rate was 90.0% (95% CI=68.3–98.8).The most common TEAEs were anemia (n=15), nausea (n=12), and decreased platelet count (n=11). TEAEs leading to study drug dose reduction, interruption, or discontinuation were reported in 16 (80.0%), 15 (75.0%), and 2 patients (10.0%), respectively. Conclusion The long-term efficacy and safety profile of niraparib was consistent with previous findings in the equivalent population in non-Japanese patients. No new safety signals were identified.

Objective: To evaluate the long-term efficacy and safety of niraparib in Japanese women with heavily pretreated ovarian cancer. Methods: This was the follow-up analysis of a phase 2, multicenter, open-label, single-arm study in Japanese women with homologous recombination-deficient, platinum-sensitive, relapsed, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who had completed 3–4 lines of chemotherapy and were poly(ADP-ribose) polymerase inhibitor naïve. Participants received niraparib (starting dose, 300 mg) once daily in continuous 28-day cycles until objective disease progression, unacceptable toxicity, or consent withdrawal. The primary endpoint was confirmed objective response rate (ORR), as assessed using Response Evaluation Criteria in Solid Tumors version 1.1. Safety evaluations included treatment-emergent adverse events (TEAEs). Results: 20 patients were enrolled in the study and included in both efficacy and safety analyses. Median total study duration was 759.5 days. Median dose intensity was 201.3 mg/ day. Confirmed ORR was 60.0% (90% confidence interval [CI]=39.4–78.3); 2 patients had complete response and 10 patients had partial response. Median duration of response was 9.9 months (95% CI=3.9–26.9) and the disease control rate was 90.0% (95% CI=68.3–98.8).The most common TEAEs were anemia (n=15), nausea (n=12), and decreased platelet count (n=11). TEAEs leading to study drug dose reduction, interruption, or discontinuation were reported in 16 (80.0%), 15 (75.0%), and 2 patients (10.0%), respectively. Conclusion The long-term efficacy and safety profile of niraparib was consistent with previous findings in the equivalent population in non-Japanese patients. No new safety signals were identified.

Pulsatile tinnitus results from turbulence that occurs in the vascular lumen of the neck, skull base, and temporal bone region. Here we report two cases in which hachimijiogan was effective for pulsatile tinnitus which was thought to be caused by carotid artery stenosis. Case 1 was a 77-year-old man. He had been aware of left pulsatile tinnitus for more than 10 years, and visited our department. Ultrasonography revealed a 56% stenosis in the left carotid artery, which was considered to be the cause of tinnitus. We administered him hachimijiogan because he had a pattern of kidney yang deficiency. After 12 weeks of administration, his symptom disappeared. Case 2 was an 86-year-old man. He had been aware of pulsatile tinnitus for a year, and visited our department. He was pointed out about 70% stenosis in the left carotid artery at another hospital, and we thought this was the cause of tinnitus. We administered him hachimijiogan because he had a pattern of kidney yang deficiency. After 16 weeks of administration, his symptom improved to about one quarter. It is considered that there are cases where pulsatile tinnitus due to carotid artery stenosis associated with arteriosclerosis can be treated as kidney deficiency, as well as age-related inner ear tinnitus.

Laryngeal venous malformation has a risk of airway obstruction due to its enlargement or bleeding. It requires treatment such as sclerotherapy, laser treatment or surgery. However, adult-type laryngeal venous malformation occurs frequently in the upper part of the glottis, and causes almost no symptoms except when it occurs in the vocal cords. So some patients do not wish to undergo surgery. This time, we describe a case of an asymptomatic laryngeal venous malformation patient who did not wish to receive laser treatment, and was significantly improved by Kampo medicine. The patient was a 69-year-old man. He consulted us because of an accidental laryngeal mass on upper gastrointestinal endoscopy during a medical examination, but he had no particular pharyngeal symptoms. A venous malformation was found in the upper part of the right glottis, and we recommended him laser treatment. But he did not wish it because he had no symptoms. We considered the condition of static blood (oketsu), and administered keishibukuryogan for 7 weeks, but there was no change. Since he had constipation, we administered daiokanzoto together with keishibukuryogan, and his bowel movement improved. Thirteen weeks after the beginning of the combined use, the venous malformation also remarkably reduced.

In auditory processing disorder (APD), hearing difficulties occur in noisy or otherwise difficult environments, despite no hearing loss. Most APD patients have developmental disabilities, weak cognitive function, or psychological problems. Here, we report a case of a child who was thought to have developed APD due to mental stress and had a good course using shokenchuto. The case was a 12-year-old girl. She began to be bullied 2 years ago, and from that time she began to find it was difficult to hear the words in a noisy environment. She visited our department and was diagnosed with APD without any abnormalities in various hearing tests. We administered her shokenchuto. After 12 weeks, she felt almost no inconvenience in hearing. She also regained her usual energy and became to be able to shrug off bullying without worrying too much. Afterwards, her symptoms subsided. After 20 weeks, the medication was discontinued.

Postoperative maxillary cyst is a late complication that occurs after maxillary sinus radical surgery. The only curative treatment is surgery, and endoscopic fenestration is currently performed in most cases. However, in some cases, it is difficult to form a permanent fenestration. Here, we report a case of postoperative maxillary cyst which was reduced by administration of kumibinroto and could avoid surgery. The case was a 58-year-old man. He received bilateral maxillary sinus radical surgery 40 years ago. He had swelling of his left cheek for half a year and took an antibacterial drug at a nearby doctor, but he was referred to our department because there was no improvement. We diagnosed him with a postoperative maxillary cyst based on CT findings, but it was considered difficult to form a permanent fenestration due to the small contact area between the nasal cavity and the cyst. He refused to puncture from the oral cavity, so we planned endoscopic surgery and administered kumibinroto to him. After 6 weeks, the swelling of the left cheek disappeared. After 12 weeks, CT showed shrinkage of the cyst, and surgery could be avoided. No further cyst shrinkage was observed, and we reduced the dose of kumibinroto after 20 weeks. He is now being followed up.

One of the symptoms of COVID-19 is olfactory dysfunction. Most of them resolve spontaneously at an early stage, but there are some cases that remain as sequelae, and there is no established drug treatment at present. This time, we report two cases of olfactory dysfunction after COVID-19 successfully treated with Kampo medicine centered on kososan. Case 1 was a 32-year-old woman. She was diagnosed with COVID-19 eight months ago, and olfactory dysfunction remained after that. She was yin pattern and slight deficiency pattern, and tenderness was found in the groin. We prescribed her tokishigyakukagoshuyushokyoto. After 8 weeks of administration, she felt warm and well, but her olfaction did not change. Depression due to olfactory dysfunction was also conspicuous, so we administered her kososan in combination. Since then, her olfaction has gradually improved. Case 2 was a 17-year-old man. He was diagnosed with COVID-19 four months ago, and olfactory dysfunction remained after that. He was yang pattern and medium or slight deficiency pattern, and with noticeable signs of qi stagnation. We administered him kososan, and his olfaction has gradually improved.

The cause of dizziness is often phlegm-rheum, and most of them are treated with drugs, which eliminate excessive fluids. However, in recent years, the causes of dizziness have become diversified and complicated, and in some cases it is difficult to treat with general-purpose agents. This time, we present a case of chronic refractory dizziness successfully treated with goshakusan. The patient was a 70-year-old woman. She had wobbled while walking for 2 years, and consulted nearby doctors. No particular abnormality was pointed out, and oral treatment was performed, but there was no improvement. In our department, ryokeijutsukanto, hangebyakujutsutenmato, goreisan, hochuekkito, kamishoyosan, chotosan, and shinbuto were prescribed by the doctor at the first visit. However, there was no improvement, and the author took over the charge. We diagnosed her with orthostatic dysregulation and prescribed tofisopam, but her dizziness did not improve. We conducted oriental medical examination, and diagnosed that phlegm-rheum associated with food accumulation was the main pathological condition, and that qi stagnation and blood stasis were combined. After 16 weeks of administration of goshakusan, her dizziness improved.

Sleep disorders may be involved in unexplained dizziness. This time, we report 2 cases of dizziness with sleep disorders improved with keishikaryukotsuboreito. Case 1 is a 67-year-old woman. She had had vertigo attacks for 4 years, was very anxious about the attacks, had trouble falling asleep, and was aware of dizziness even between the attacks. After 4 weeks of administration of keishikaryukotsuboreito, her anxiety disappeared and she was able to sleep soundly. After 10 weeks, the lightheadedness disappeared and the medication was terminated at 17 weeks. Case 2 is a 38-year-old woman. She was exhausted because she had a personnel change in her workplace 3 months ago and she was concerned about many things. From 2 months ago, she had trouble falling asleep at night. After 2 weeks of administration of keishikaryukotsuboreito, she was able to sleep soundly. The dizziness disappeared after 6 weeks, and the medication was terminated at 10 weeks.